Ventilation arrangement for patient interface

Abstract

To provide a medical device for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders that has one or more of the following advantages: improved comfort, cost-effectiveness, efficacy, ease of use, and manufacturability. [Solution] The patient interface includes a plenum chamber, a sealing structure that forms a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, and a ventilation structure configured to allow gas exhaled by the patient to flow out of the plenum chamber to the surrounding area. The plenum chamber includes a front section including an entrance configured to receive an airflow at therapeutic pressure for the patient to breathe. The ventilation structure is configured to ventilate the gas flow from the inside of the plenum chamber substantially laterally when in use, and the patient interface includes a deflector configured to redirect the laterally ventilated gas flow, and further includes a diffuser for diffusing the ventilated gas flow.

Description

Technical Field

[0001] 1.1 Field of the Technology The present technology relates to one or more of screening, diagnosis, monitoring, treatment, prevention, and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatuses, and their use.

Background Art

[0002] 1.2 Description of Related Technologies 1.2.1 Human Respiratory System and Its Disorders The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0003] The airway includes a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The primary function of the lungs is gas exchange, which enables the transfer of oxygen from the inhaled air into the venous blood and the transfer of carbon dioxide in the opposite direction. The trachea divides into the right and left main bronchi, which further divide and ultimately become the terminal bronchioles. The bronchioles constitute the conducting airways and are not involved in gas exchange. The airway further divides and connects to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory region. See "Respiratory Physiology" by John B. West, 9th Edition, published by Lippincott Williams & Wilkins (2012).

[0004] There are various respiratory disorders. Certain disorders may be characterized by specific events (e.g., apnea, hypopnea, and hyperpnea).

[0005] 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.

[0006] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events including obstruction or closure of the upper airway during sleep. This results from a combination of an abnormally small upper airway and a normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharynx during sleep. This condition forces affected patients to pause breathing for typically 30–120 seconds, and in some cases 200–300 times per night. It often causes excessive daytime sleepiness and can lead to cardiovascular disease and brain injury. This syndrome is a common disorder, particularly prevalent in overweight middle-aged men, although those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0007] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, which includes periods of rhythmic alternation of ventilation increases and decreases, known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. CSR can be harmful because of the repeated hypoxia. In some patients, CSR is associated with repeated awakenings from sleep, which cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0008] Respiratory failure is a general term for respiratory disorders in which the lungs are unable to adequately inhale oxygen or exhale CO2 to meet the patient's needs. Respiratory failure may encompass some or all of the following disorders:

[0009] Patients with respiratory failure (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0010] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of other clearly identifiable causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0011] Chronic obstructive pulmonary disease (COPD) encompasses a group of lower respiratory tract diseases that share certain characteristics. These include increased resistance to air movement, prolonged expiratory phase of respiration, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0012] Neuromuscular diseases (NMDs) are a broad term encompassing numerous disorders and illnesses that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage that leads to inability to walk, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over years but with only a mild reduction in life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include increased general weakness, difficulty swallowing, shortness of breath during exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0013] Chest wall disorders are a group of thoracic deformities that cause a failure of the connection between the respiratory muscles and the rib cage. The disorders are usually characterized by restrictive disorders and share the potential for prolonged hypercapnic respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0014] Various therapies have been used to treat or improve such diseases. Furthermore, even otherwise healthy individuals can utilize such therapies to prevent the onset of respiratory problems. However, these therapies have numerous shortcomings.

[0015] 1.2.2 Therapy A variety of respiratory therapies (e.g., continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT)) have been used to treat one or more of the aforementioned respiratory disorders.

[0016] 1.2.2.1 Respiratory pressure therapy Respiratory pressure therapy (as opposed to negative pressure therapy, such as tank ventilators or positive / negative pressure external ventilators (cuirass)) involves applying a controlled target pressure, nominally positive relative to the atmosphere, to the airway inlet throughout the patient's entire respiratory cycle.

[0017] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as an air pressure splint, preventing upper airway obstruction by pushing the soft palate and tongue forward and backward against the posterior oropharyngeal wall. Treatment of OSA with CPAP therapy can be voluntary, and patients may choose not to follow the therapy if they notice one or more of the following about the devices used to deliver such therapy: discomfort, difficulty of use, high cost, and poor aesthetics.

[0018] Non-invasive ventilation (NIV) assists a patient's breathing by providing ventilatory support through the upper airway to perform some or all of the work of breathing and / or maintain adequate oxygen levels throughout the body. Ventilation support is provided through a non-invasive patient interface. NIV has been used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, NMD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0019] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] 1.2.2.2 Flow Therapy Not all respiratory therapies aim to deliver prescribed therapeutic pressures. Some respiratory therapies aim to deliver prescribed ventilatory volume by delivering an inspiratory flow profile, possibly superimposed on a positive baseline pressure, over a target duration. In other cases, the patient's airway interface is "open" (unsealed), and respiratory therapy may supplement only the patient's own spontaneous breathing with a flow of regulated or concentrated gas. In one example, high-flow therapy (HFT) involves delivering a continuous, heated, humidified airflow at the airway inlet through an unsealed or open patient interface at a "therapeutic flow rate" that can be maintained nearly constant throughout the entire respiratory cycle. The therapeutic flow rate is nominally set to exceed the patient's peak inspiratory flow rate. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory disorders. One mechanism of action is that a high flow of air at the airway inlet improves ventilation efficiency by flushing or pushing out exhaled CO2 from the patient's anatomical dead space. Therefore, HFT is sometimes called dead space therapy (DST). Other benefits may include increased warmth and humidification (perhaps due to the benefits of secretion management) and the possibility of a gradual increase in airway pressure. As an alternative to a constant flow rate, the therapeutic flow rate can follow a fluctuating profile throughout the respiratory cycle.

[0021] Other forms of flow therapy include long-term oxygen therapy (LTOT) or supplemental oxygen therapy. A physician may prescribe a continuous flow of oxygen-enriched air at a specific oxygen concentration (oxygen fraction of ambient air, from 21% to 100%) delivered to the patient's airways at a specific flow rate (e.g., 1 liter / minute (LPM), 2 LPM, 3 LPM, etc.).

[0022] 1.2.3 Respiratory Therapy System These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used for screening, diagnosis, or monitoring without treating the disease.

[0023] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0024] 1.2.3.1 Patient Interface A patient interface can be used to provide a wearer with an interface to a breathing apparatus, for example, by providing an air flow to the entrance of the airway. 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 promote gas delivery at a pressure sufficiently different from the ambient pressure, for example, a positive pressure of about 10 cmH2O relative to the ambient pressure, by forming a seal with a part of the patient's face, and can effectively perform the treatment.

[0025] Certain other mask systems may be functionally inappropriate in this field. For example, in the case of a purely decorative mask, it may not be able to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water intrusion from a higher external pressure but not maintain the internal air at a pressure higher than the ambient.

[0026] For example, certain masks may be clinically unfavorable in this technology if they block the air flow through the nose and only allow the air flow through the mouth.

[0027] In certain masks, if the patient has to insert a part of the mask structure into the mouth and create and maintain a seal through the lips, it may be uncomfortable or impractical in this technology.

[0028] Certain masks may be impractical for use during sleep (e.g., when sleeping in bed on one's side with the head on a pillow).

[0029] Some masks may cause claustrophobia, anxiety, and / or may be perceived as overly conspicuous by patients.

[0030] The design of patient interfaces has presented many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from individual to individual. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. The jaw or mandible may move relative to other bones of the skull. The entire head can move throughout the course of a respiratory treatment.

[0031] As a result of these challenges, some masks are subject to one or more of the following disadvantages: excessive pressure, particularly for long wear times or when the patient is unfamiliar with the system; unaesthetic; costly; poor fit; difficult to use; and uncomfortable. Use of an incorrectly sized mask can lead to decreased compliance, decreased comfort, and decreased patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthetic mask may be tolerable for their original use, but may be uncomfortable or undesirable for extended wear (e.g., for several hours). Such discomfort can lead to decreased patient compliance with treatment. This is particularly true when the mask must be worn during sleep.

[0032] CPAP therapy is very effective in treating certain respiratory diseases if the patient adheres to the treatment. If the mask is uncomfortable or difficult to use, the patient may not accept the treatment.

[0033] Patients are often advised to clean their masks regularly, so if cleaning the mask is difficult (for example, if it is difficult to assemble or disassemble), patients may be unable to clean their masks, which can affect patient compliance.

[0034] Masks designed for other purposes (e.g., for pilots) may be unsuitable for treating sleep-disordered breathing, while masks designed for treating sleep-disordered breathing may be suitable for other purposes.

[0035] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0036] 1.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the seal-forming structure comes into direct contact with the patient's face, its shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0037] Patient interfaces can be partially characterized according to the design intent when the seal-forming structure is designed to engage with the face during use. In one embodiment of the patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one embodiment of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to rest, for example, on the upper lip region and the nasal bridge region of the face. In one embodiment of the patient interface, the seal-forming structure may 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 embodiment of the patient interface, the seal-forming structure may include a single element that surrounds both the nostril region and the mouth region during use. These different types of patient interfaces may be known by a variety of names by their manufacturers, such as nasal masks, full-face masks, nasal pillows, nasal puffs, and mouth-nasal masks.

[0038] A seal-forming structure that may be effective in one area of ​​a patient's face may be unsuitable in another area, for example, due to differences in the shape, structure, variability, and sensitivity of the patient's face. For instance, a seal on swimming goggles that rests on a patient's forehead may be unsuitable for use over the patient's nose.

[0039] A specific seal-forming structure can be designed for mass production so that a single design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form a seal, one or both the patient's face shape and the mass-produced patient interface seal-forming structure must be adapted to the extent that there is a mismatch between them.

[0040] Certain types of seal-forming structures extend around and surround the patient interface, and are intended to seal the patient's face when force is applied to the patient interface while the seal-forming structure is engaged with the patient's face. This seal-forming structure may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of seal-forming structure, if the fit is improper, a gap may form between the seal-forming structure and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0041] Another type of seal-forming structure uses a thin flap seal positioned around the periphery of the mask to provide a self-airtight seal to the patient's face when positive pressure is applied inside the mask. Similar to the previously described type of seal-forming structure, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the seal-forming structure does not conform to the shape of the patient, wrinkles or buckling may occur in the seal-forming structure during use, which can cause leakage.

[0042] Other types of seal-forming structures may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find these uncomfortable.

[0043] Another form of seal-forming structure may use an adhesive portion to obtain a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive portion from their face.

[0044] A series of patient interface seal formation technologies are disclosed in patent applications WO 1998 / 004,310, WO 2006 / 074,513, and WO 2010 / 135,785, which have been assigned to ResMed Limited.

[0045] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), which was transferred to Puritan-Bennett Corporation.

[0046] 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 nose pillow masks: International Patent Application WO2004 / 073, 778 (in particular, describing the features of ResMed Limited's SWIFT® nose pillow); U.S. Patent Application 2009 / 0044808 (in particular, describing the features of ResMed Limited's SWIFT® LT nose pillow); International Patent Applications WO2005 / 063, 328 and WO2006 / 130, 903 (in particular, describing the features of ResMed Limited's MIRAGE LIBERTY® full-face mask); International Patent Application WO2009 / 052, 560 (in particular, describing the features of ResMed Limited's SWIFT® FX nose pillow).

[0047] 1.2.3.1.2 Positioning and Stabilization The seal-forming structures of patient interfaces used in positive pressure therapy are subjected to the corresponding force of air pressure, which can impair the seal. Therefore, various techniques have been used to position the seal-forming structures and maintain a proper seal relationship with the appropriate part of the face.

[0048] When comparing different positioning and stabilization technologies, several factors should be considered. These include the effectiveness of this technology in maintaining the seal-forming structure in the desired position and engaging with the face seal during patient interface use, the comfort of the interface to the patient, whether the patient feels invaded and / or claustrophobic when the patient interface is worn, and the aesthetic appeal.

[0049] In one technology, adhesive joints are used. See, for example, U.S. Patent Application Publication No. 2010 / 0000534. However, the use of adhesive joints can sometimes cause discomfort.

[0050] In other technologies, one or more straps and / or stabilization harnesses are used. Many such harnesses suffer from one or more of the following: poor fit, bulkiness, discomfort, and cumbersome handling.

[0051] 1.2.3.1.3 Pressurized Air Conduit In one type of treatment system, a pressurized airflow is supplied to the patient interface via a conduit in an air circuit that is fluidly connected to the patient interface at a position in front of the patient's face when the patient interface is positioned on the patient's face during use. The conduit may extend from the patient interface forward from the patient's face.

[0052] 1.2.3.1.4 Pressurized air conduits for positioning and stabilizing the seal molding structure Another type of treatment system includes a patient interface, and a tube that delivers pressurized air to the patient's airway is also used as part of the headgear to position and stabilize the sealing portion of this patient interface in the appropriate part of the patient's face. This type of patient interface is sometimes referred to as having a “conduit headgear” or “headgear tube.” This patient interface allows a conduit in an air circuit that provides pressurized airflow from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a position other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication 2007 / 0246043, which is incorporated herein by reference, and in which the conduit is connected to a tube inside the patient interface via a port positioned above the patient's head when in use.

[0053] A patient interface incorporating a headgear tube should be comfortable for the patient to wear for extended periods during sleep, form an airtight and stable seal with the patient's face, and simultaneously adapt to various head shapes and sizes.

[0054] 1.2.3.2 Respiratory Pressure Therapy (RPT) Devices Respiratory pressure therapy (RPT) devices can be used individually or as part of a system to deliver one or more of the aforementioned therapies, for example, by operating the device to generate an airflow for delivery to an interface with the airway. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Therefore, RPT devices can also function as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0055] Device designers may be presented with countless options. Design criteria often conflict, meaning that certain design choices may deviate significantly from convention, or even be unavoidable. Furthermore, the comfort and effectiveness of a particular design may be highly sensitive to even minor changes in one or more parameters.

[0056] 1.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and positioned to allow airflow to move between two components of a respiratory therapy system (e.g., an RPT device and a patient interface) during use. In some cases, an air circuit may have separate branches for inhalation and exhalation. In other cases, a single-branch air circuit is used for both inhalation and exhalation.

[0057] 1.2.3.4 Humidifier Delivering airflow without humidification can lead to airway dryness. Using a humidifier with the RPT device and patient interface generates humidifying gas, minimizing nasal mucosal dryness and improving patient airway comfort. Furthermore, in cooler climates, warmer air is generally more comfortable than cold air for the facial area inside and around the patient interface.

[0058] 1.2.3.5 Ventilation Technology Some forms of therapeutic systems may include a vent for expelling exhaled carbon dioxide. This vent may allow gas to 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).

[0059] These vents may include orifices, through which gas can flow when the mask is in use. Many of these vents are noisy. In other cases, they may become blocked during use, resulting in insufficient airflow. In some cases, the sleep of a patient's bedmate may be disturbed, for example, due to noise or concentrated airflow.

[0060] ResMed Limited has developed several improved mask ventilation technologies. See International Patent Application Publication No. 1998 / 034,665, International Patent Application Publication No. 2000 / 078,381, U.S. Patent No. 6,581,594, U.S. Patent Application Publication No. 2009 / 0050156, and U.S. Patent Application Publication No. 2009 / 0044808.

[0061] Table of noise levels for conventional masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m) [Table 1]

[0062] (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744.)

[0063] The sound pressure values ​​of various objects are listed below. [Table 2] [Overview of the Initiative] [Problems that the invention aims to solve]

[0064] Shear effects or contact between airflows in different directions within the patient interface can cause turbulence, which can generate noise. This effect may be influenced by the patient's respiratory cycle, resulting in periodic noise. Within the patient interface, air received from the delivery tube may move in a different direction than the air exhaled by the patient, and may even move in the opposite direction. During exhalation, the exhaled airflow may shear or contact the airflow entering the patient interface from the tube. This can create turbulence and generate noise. During inhalation or respiratory arrest (i.e., the period between inhalation and exhalation), the airflow entering the patient interface from the tube may shear or contact the airflow within the patient interface. This can create turbulence and generate noise. The periodic nature of the noise may be particularly undesirable.

[0065] Furthermore, when air is expelled laterally from the patient interface, noise may occur when a patient is using the patient interface while lying on their side. While the patient is sleeping, the airflow may come into contact with objects such as pillows or other parts of the patient's body such as their hands, which can generate noise. This can increase discomfort and therefore prevent the patient from receiving treatment. In some embodiments, if a patient using the patient interface is lying on their back, the air expelled laterally from the patient interface may flow towards the patient's sleeping partner, disrupting their sleep. This can confuse or cause discomfort to the patient's sleeping partner and may increase the patient's disobedience.

[0066] Diffusing the airflow expelled from the patient interface contributes to noise reduction. Additionally, diffusing the airflow directed towards the sleeping partner during use can reduce discomfort for the patient. However, diffusers require additional components / parts for the mask, potentially increasing manufacturing costs and complexity. [Means for solving the problem]

[0067] This technology relates to providing medical devices used for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, and possesses one or more of the following advantages: improved comfort, cost-effectiveness, efficacy, ease of use, and manufacturability.

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

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

[0070] One aspect of a particular form of this technology is to provide a method and / or device for improving a patient's compliance with respiratory therapy.

[0071] One aspect of this technology relates to a ventilation structure for a patient interface. Another aspect relates to a patient interface including a ventilation structure. Yet another aspect includes a positioning and stabilizing structure for holding the patient interface in a therapeutically effective position on the patient's head.

[0072] Another aspect of the technology includes a patient interface, which may include a plenum chamber pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure. The plenum chamber may include an inlet configured to receive an airflow at therapeutic pressure for the patient to breathe. The patient interface includes a seal-forming structure configured to form a seal with the area of ​​the patient's face surrounding the inlet of the patient's airway. The seal-forming structure may be configured to maintain therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. The patient interface may also include a ventilation structure configured to allow gases exhaled by the patient to flow from inside the plenum chamber outwards. The ventilation structure may be configured to maintain therapeutic pressure within the plenum chamber during use.

[0073] In various cases, ● The plenum chamber may include an anterior portion. ● The front section may include an entrance. ● The plenum chamber may include an internal portion. ● The medial portion may be positioned so that the patient's median sagittal plane passes through the medial portion during use. ● The entrance may be located on the inside. ● The patient interface may include a delivery tube connected to the plenum chamber and configured to communicate with the inlet and fluid.

[0074] In various cases, ● The ventilation structure may be configured to ventilate the gas flow from within the plenum chamber in a substantially lateral direction during use. ● The ventilation structure may include multiple ventilation holes. ● The ventilation structure may be located on a portion of the patient interface on the side of the entrance when in use. ● The ventilation structure may be located on top of the plenum chamber. ● The ventilation structure may include a ventilation module. ● The patient interface may include ventilation module openings. ● The ventilation module may be configured to connect to a portion of the patient interface, including the ventilation module opening. ●This ventilation structure may be a first ventilation structure configured to ventilate a first gas flow from within the plenum chamber during use, and the patient interface may include a second ventilation structure configured to ventilate a second gas flow from within the plenum chamber. ● The first ventilation structure may be configured to ventilate the first gas flow from inside the plenum chamber in a first substantially lateral direction during use. ● The second ventilation structure may be configured to ventilate the second gas flow from inside the plenum chamber in a second substantially lateral direction during use. ●The first approximately horizontal direction may basically be the opposite of the second approximately horizontal direction. ● The first ventilation structure may be located on one side of the patient interface, lateral to the inlet. ● The second ventilation structure may be located on the other side of the patient interface, lateral to the inlet.

[0075] In various cases, ● The patient interface may include a deflector configured to redirect at least a portion of the ventilated gas flow when in use. ● The patient interface may include a deflector configured to redirect a substantial amount of ventilated gas flow during use. ● The patient interface may include a deflector configured to redirect at least a portion of the laterally ventilated gas flow in a direction having a forward component relative to the patient when in use. ● The patient interface may include a deflector configured to redirect a substantial amount of laterally ventilated gas flow in a direction having a forward component relative to the patient during use. ● The patient interface may include a deflector configured to substantially redirect a substantial amount of laterally ventilated gas flow forward during use. ● The deflector may include an arrangement structure of one or more deflector walls. ● The deflector may be configured to direct the ventilated gas flow in the direction toward the inner part. ● The deflector may be configured to redirect a considerable amount of gas flow that is ventilated laterally towards the front of the plenum chamber during use. ● The deflector may be configured to redirect a considerable amount of gas flow that is ventilated laterally towards a portion of the delivery tube during use. ● The deflector may be used as part of the ventilation structure. ● The deflector may include a first deflector configured to redirect a first ventilation gas flow when in use, and the patient interface may include a second deflector configured to redirect a second ventilation gas flow. ● The patient interface may include a first deflector configured to redirect at least a substantial amount of a first gas flow in a first direction when in use, and the patient interface may include a second deflector configured to redirect a substantial amount of a second gas flow in a second direction when in use. ● The positioning and stabilization structure may include a first deflector configured to redirect at least a substantial amount of the first gas flow in a first direction during use, and the positioning and stabilization structure may also include a second deflector configured to redirect a substantial amount of the second gas flow in a second direction during use. ●The first ventilation gas flow may be the first lateral ventilation gas flow. ●The second ventilation gas flow may be a second lateral ventilation gas flow. ● The first deflector may be configured to redirect a considerable amount of the first lateral ventilation gas flow forward when in use. ● The second deflector may be configured to redirect a considerable amount of the second lateral ventilation gas flow forward when in use.

[0076] In various cases, ● The patient interface may include a spacer that provides a gap between the surface of the ventilation structure and the surface of the deflector. ● The spacer may include at least one rib, preferably more than one rib. ● The ribs may provide multiple channels for redirecting the gas flow from the ventilation structure. ● The spacer may include part of the ventilation structure. ● The spacer may include part of the deflector. ● The spacer may include at least one deflector wall.

[0077] In various cases, ● The patient interface may include a pair of connectors to facilitate the attachment of the plenum chamber to a positioning and stabilizing structure. ● At least one of the connectors may be included as part of the ventilation structure. ● At least one of the connectors may be included as part of the deflector.

[0078] In various cases, ● The patient interface may include positioning and stabilizing structures for holding the seal-forming structure in a position effective for treatment on the patient's head. ● The positioning and stabilization structure may include at least one headgear strap, preferably multiple headgear straps. ● At least one headgear strap may be detachably attached to the connector by a button fastening. ●At least one headgear strap may include a buttonhole. ● At least one headgear strap includes a sleeve-like configuration that receives the insertion of a portion of a connector into at least one headgear strap via a buttonhole.

[0079] In various cases, ● The positioning and stabilization structure may include a diffuser. ● The diffuser may be positioned to diffuse the gas flow from the ventilation structure. ● The positioning and stabilization structure may include components. ●This component may include a diffuser. ●This component may include a side facing the ventilation section. ● The side facing the ventilation section may be located within the path of the ventilation gas flow from the ventilation structure during use. ● The diffuser may be positioned on the ventilation-facing side of the component. ● Components may include frames. ● The frame may be configured to facilitate indirect attachment of the plenum chamber to at least one headgear strap. ●The component may include at least one tube. ● At least one tube may be configured to deliver airflow into the plenum chamber via an inlet from an air circuit fluidically connected to at least one tube during use. ●At least one tube may be a headgear tube. ●This component may include a rigidizer arm. ● The rigidizer arm may be configured to stiffen at least one headgear strap for positioning and stabilization. ● The diffuser may be detachably attached to the component. ● The diffuser may be detachably mounted to the frame. ● The diffuser may be detachably attached to at least one tube. ● The diffuser may be detachably mounted on the rigidizer arm.

[0080] In various cases, ● The positioning and stabilization structure may include a frame. ● The frame may be configured to facilitate indirect attachment of the plenum chamber to at least one headgear strap. ● The frame may be attached to the plenum chamber, and at least one headgear strap may be attached to the frame. ● The delivery tube may be attached to at least one of the frame and the plenum chamber. ● The delivery tube may be attached to the frame. ●The frame may include an opening. ● The delivery tube may be configured to communicate with the inlet and fluid through an opening in the frame when in use. ● The frame may include a diffuser positioned to diffuse the gas flow from the ventilation structure. ● The frame covering may cover at least a portion of the ventilation structure in use. ● The diffuser may be positioned on the covering portion of the frame. ● The diffuser may be detachably mounted to the frame. ● The frame may include at least one, preferably a pair of, connectors to facilitate attachment of the frame to at least one headgear strap. ●At least one headgear strap may be detachably attached to the frame's connector(s). ● The frame may include a deflector. ● Part of the frame may be positioned to redirect the gas flow from the ventilation structure when in use.

[0081] In various cases, ● The positioning and stabilization structure may include at least one tube. ● At least one tube may be configured to deliver airflow into the plenum chamber via an inlet from an air circuit fluidically connected to at least one tube during use. ●At least one tube may be a headgear tube. ●At least one tube may include a diffuser positioned to diffuse the gas flow from the ventilation structure. ● The covering of at least one tube may cover at least a portion of the ventilation structure when in use. ● The diffuser may be located on the covering of at least one tube. ● The diffuser may be detachably attached to at least one tube.

[0082] In various cases, ● The ventilation structure is located on the positioning and stabilizing structure. ● The positioning and stabilization structure may include a conduit section. ● The plenum chamber may include an opening, and the conduit may be configured to communicate fluidly with the inside of the plenum chamber through the opening during use. ● The patient interface may include a connector configured to facilitate the attachment of the conduit to the opening. ● The ventilation structure may be located above the conduit. ● The conduit section may be a first conduit section including a ventilation structure as a first ventilation structure and an opening as a first opening, and the first conduit section is configured to communicate fluidly with the inside of the plenum chamber through the first opening when in use, and the positioning and stabilizing structure may include a second conduit section including a second ventilation structure, the plenum chamber includes a second opening, and the second conduit section is configured to communicate fluidly with the inside of the plenum chamber through the second opening when in use. ● The connector may be a first connector configured to facilitate the attachment of a first conduit to a first opening, and the patient interface may include a second connector configured to facilitate the attachment of a second conduit to a second opening. ● The conduit section may be configured to have relatively high rigidity. ● The conduit section may be constructed to be relatively flexible. ● The conduit section may include support structures to limit and / or prevent blockage of the conduit section. ● The support structure may be provided by one or more of the following: a reinforcing structure, a thickened region, and a reinforcing region. ● The positioning and stabilization structure may include a lower end connected to the plenum chamber during use, and the conduit portion includes the lower end. ● The ventilation structure may be located near the lower end of the positioning and stabilization structure during use. ● The plenum chamber may include a lateral projection connector whose opening is located on the lateral projection connector. ●The lateral projection connection portion may be a first lateral projection connection portion including a first opening, and the plenum chamber includes a second lateral projection connection portion, the second opening being located on the second lateral projection connection portion. ●At least one headgear strap may be connected to the conduit. ●At least a portion of at least one headgear strap covers at least a portion of the conduit and at least a portion of the ventilation structure. ● The ventilation structure may be located to the side of the plenum chamber during use. ● The ventilation structure may be located near the lower end of the positioning and stabilization structure during use. ● The conduit section may include a deflector.

[0083] In various cases, ● The patient interface may include a diffuser positioned to diffuse the gas flow from the ventilation structure. ● The diffuser may be configured to diffuse the gas flow ventilated from inside the patient interface into the surroundings via the ventilation structure. ●At least one headgear strap may include a diffuser. ●At least one headgear strap may include a covering portion which may be configured to cover at least a portion of the ventilation structure when in use. ● The diffuser may be positioned on the covering of at least one headgear strap. ● The diffuser may be detachably attached to at least one headgear strap. ● The diffuser may be made of a woven material. ● The diffuser may be formed by raising the nap on a portion of the surface of the woven material. ● The diffuser may be formed separately and attached to at least one headgear strap. ● The diffuser may be formed from headgear strap material. ● The diffuser may be formed by raising the nap on a portion of the surface of the headgear strap material. ● The diffuser may form at least a portion of the deflector.

[0084] In various cases, ● The patient interface may be in the form of a nasal mask. ● The seal-forming structure may be configured to form a seal with the underside of the nose around the nostrils when in use. ● The seal-forming structure may be configured to form a seal around the patient's nostrils rather than the patient's mouth when in use.

[0085] In various cases, ● The seal-forming structure may be configured to form a seal around the patient's nose and mouth when in use.

[0086] One embodiment of this technology relates to a patient interface. The patient interface may include a plenum chamber pressurized to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure. The plenum chamber may include a front section including an inlet configured to receive an airflow at therapeutic pressure for the patient to breathe. The patient interface includes a seal-forming structure configured to form a seal with the area of ​​the patient's face surrounding the inlet of the patient's airway. The seal-forming structure may be configured to maintain therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. The patient interface may also include a ventilation structure configured to allow gas exhaled by the patient to flow from the inside of the plenum chamber outwards. The ventilation structure may be configured to maintain therapeutic pressure within the plenum chamber during use. The ventilation structure may be configured to ventilate the gas flow from the inside of the plenum chamber substantially laterally during use. The patient interface may also include a deflector configured to redirect a substantial amount of laterally ventilated gas flow toward a direction having an anterior component to the patient during use.

[0087] In the example, the patient interface may include one or more of the previously described embodiments and / or examples of the present invention.

[0088] Another embodiment of this technology relates to a patient interface. The patient interface may include a plenum chamber pressurized to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure. The plenum chamber may include an inlet configured to receive an airflow at the therapeutic pressure for the patient to breathe. The patient interface includes a seal-forming structure configured to form a seal with the area of ​​the patient's face surrounding the inlet of the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. The patient interface may also include a ventilation structure configured to allow gases exhaled by the patient to flow from the inside of the plenum chamber outwards. The ventilation structure may be configured to maintain the therapeutic pressure within the plenum chamber during use. The patient interface includes a positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure may include at least one headgear strap, at least one of which includes a diffuser. The diffuser may be positioned to diffuse the gas flow from the ventilation structure.

[0089] In the example, the patient interface may include one or more of the previously described embodiments and / or examples of the present invention.

[0090] Another embodiment of this technology relates to a patient interface. The patient interface may include a plenum chamber pressurized to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure. The plenum chamber may include an inlet configured to receive an airflow at the therapeutic pressure for the patient to breathe. The patient interface includes a seal-forming structure configured to form a seal with the area of ​​the patient's face surrounding the inlet of the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. The patient interface may also include a ventilation structure configured to allow the gas exhaled by the patient to be ventilated from inside the plenum chamber to the surroundings. The ventilation structure may be configured to maintain the therapeutic pressure within the plenum chamber during use. The patient interface includes a positioning and stabilization structure for holding the seal-forming structure in a therapeutically effective position above the patient's head. The positioning and stabilization structure may include a component. This component may include a ventilation-facing surface. The ventilation-facing surface may be located in the path of the ventilation gas flow from the ventilation structure during use. The patient interface may further include a diffuser. The diffuser may be located on the ventilation-facing surface of the component. The diffuser may be positioned to diffuse the ventilation gas flow from the ventilation structure.

[0091] In one example, the patient interface may include one or more of the previously described embodiments and / or examples of the present invention.

[0092] One embodiment of this technology includes a positioning and stabilization structure for holding a seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure may include a diffuser. The diffuser may be configured to diffuse a gas flow ventilated from inside the patient interface to the surrounding area via a ventilation structure configured on the patient interface.

[0093] In one example, the positioning and stabilization structure may include one or more of the previously described embodiments and / or examples of the present invention.

[0094] One embodiment of this technology includes a positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure may include a component, which may include a ventilation-facing surface. The ventilation-facing surface may, during use, be located within the path of the ventilation gas flow from the ventilation structure of the patient interface. The positioning and stabilizing structure may further include a diffuser. The diffuser may be located on the ventilation-facing surface of the component. The diffuser may be configured to diffuse the ventilation gas flow of the gas from the ventilation structure.

[0095] In one example, the positioning and stabilization structure may include one or more of the previously described embodiments and / or examples of the present invention.

[0096] Another embodiment of this technology relates to a patient interface. The patient interface may include a plenum chamber pressurized to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure. The plenum chamber may include an inlet configured to receive an airflow at the therapeutic pressure for the patient to breathe. The patient interface may further include a seal-forming structure configured to form a seal with the area of ​​the patient's face surrounding the inlet of the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle during use. The patient interface may further include a positioning and stabilizing structure to maintain the seal-forming structure in a therapeutically effective position above the patient's head. The positioning and stabilizing structure may include a conduit, and the plenum chamber may include an opening. The conduit may be configured to fluidly communicate with the interior of the plenum chamber through the opening during use. The conduit may include a ventilation structure configured to allow gases exhaled by the patient to flow from the interior of the plenum chamber outwards. The ventilation structure may be configured to maintain the therapeutic pressure within the patient interface during use.

[0097] In the example, the patient interface may include one or more of the previously described embodiments and / or examples of the present invention.

[0098] Another embodiment of this technology relates to a positioning and stabilization structure for holding a patient interface in a therapeutically effective position on the patient's head. The positioning and stabilization structure may include a conduit configured to fluidize the inside of the patient interface during use. The conduit may include a ventilation structure configured to allow gases exhaled by the patient to flow from the inside of the patient interface outwards. The ventilation structure may be configured to maintain therapeutic pressure inside the patient interface during use.

[0099] In one example, the positioning and stabilization structure may include one or more of the previously described embodiments and / or examples of the present invention.

[0100] Another embodiment of this technology relates to a patient interface. The patient interface may include a plenum chamber pressurized to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure. The plenum chamber may include an inlet configured to receive an airflow at the therapeutic pressure for the patient to breathe. The patient interface may further include a seal-forming structure configured to form a seal with the area of ​​the patient's face surrounding the inlet of the patient's airway. The seal-forming structure may be configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use. The patient interface may further include a positioning and stabilizing structure that provides force to hold the seal-forming structure in a therapeutically effective position above the patient's head. The patient interface may also include a ventilation structure configured to allow gases exhaled by the patient to flow from the inside of the plenum chamber outwards. The ventilation structure may be configured to maintain the therapeutic pressure within the plenum chamber during use. The patient interface may also include a deflector configured to redirect the large volume of ventilated gas flow during use. The positioning and stabilizing structure may include the deflector.

[0101] In one example, the patient interface may include one or more of the previously described embodiments and / or the patient interface described in one example of the present invention.

[0102] Another aspect of the present technology relates to a method for manufacturing a diffuser that includes a portion of a headgear strap of a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on the patient's head. The method may include the following steps, which are performed in any order. (a) A diffusion layer is formed on the surface of the headgear belt material, and this diffusion layer is configured to diffuse the gas flow that is ventilated through the ventilation structure located at the patient interface during use. and (b) Form a headgear strap with the headgear strap material.

[0103] In various cases, ●Step (a) may include raising the nap on a portion of the surface of the headgear strap material. ●Step (a) may include trimming the napped portion of the surface of the headgear strap material. Step (a) may include forming a diffusion layer with a woven material and attaching the diffusion layer to the surface of the headgear strap material using an adhesive or other known bonding method. ● The diffusion layer may be formed by cutting the woven material.

[0104] In various cases, ●Step (b) may include cutting the headgear strap material into headgear straps. ● The headgear strap material may include woven material.

[0105] Another aspect of the present technology relates to a method for manufacturing a diffuser that includes a portion of at least one headgear tube of a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on the patient's head. The method may include the following steps, performed in any order: (a) A diffusion layer is formed on the surface of at least one headgear tube, and the diffusion layer is configured to diffuse the ventilated gas flow through the ventilation structure positioned at the patient interface during use. and (b) Form the headgear tube.

[0106] In various cases, ●Step (a) may include raising the nap on a portion of the surface of the headgear tube, which is formed of a layer of woven material, in which the headgear conduit is located. ●Step (a) may include trimming the napped portion of the surface of the woven material. Step (a) may include forming a diffusion layer with a woven material and attaching the diffusion layer to the surface of the headgear conduit using an adhesive or other known bonding method. ● The diffusion layer may be formed by cutting the woven material and then raising the nap of the woven material, in either order.

[0107] In various cases, ●Step (b) may include forming the headgear tube 3350 from one or more materials (e.g., silicone resin). ●The woven material may include fleece material.

[0108] Another aspect of the present technology relates to a method for manufacturing a diffuser that includes a portion of a frame of a positioning and stabilizing structure for holding a patient interface in a therapeutically effective position on the patient's head. The method may include the following steps, performed in any order: (a) A diffusion layer is formed on the surface of the frame, and the diffusion layer is configured to diffuse the ventilated gas flow through the ventilation structure located at the patient interface during use. and (b) Form the frame.

[0109] In various cases, ●Step (a) includes raising a portion of the surface of the frame, and the frame may be formed of layers of woven material. ●Step (a) may include trimming the napped portion of the surface of the woven material. Step (a) may include forming a diffusion layer with a woven material and attaching the diffusion layer to the surface of the frame using an adhesive or other known bonding method. ● The diffusion layer may be formed by cutting the woven material and then raising the nap of the woven material, in either order.

[0110] In various cases, ●Step (b) may include forming a frame with one or more materials (e.g., polymers). Suitable polymers may include thermoplastics or elastomers such as silicones. ●The woven material may include fleece material.

[0111] Another aspect of one form of this technology is a patient interface molded or constructed to have a circumferential shape complementary to the circumferential shape of the intended wearer.

[0112] One particular aspect of this technology is a medical device that is easy to use for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person who has limited experience using this type of medical device.

[0113] One embodiment of this technology is a patient interface that can be cleaned at the patient's home with, for example, soapy water, without the need for special cleaning equipment.

[0114] Of course, some of the above embodiments may form subordinate embodiments of the present technology. Furthermore, various subordinate embodiments and / or embodiments can be combined in various ways to constitute further embodiments or subordinate embodiments of the present technology.

[0115] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing]

[0116] This technology is illustrated non-limitingly as an example in the diagrams of the attached drawings, and similar reference numbers in the drawings refer to similar elements, including the following:

[0117] [Figure 1A]3.1 The respiratory therapy system, including a patient 1000 wearing a patient interface 3000, is shown. This system takes the form of a nasal pillow and receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 through an air circuit 4170. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position. [Figure 1B] The system includes a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. [Figure 1C] The system includes a patient 1000 wearing a patient interface 3000 in the form of a full-face mask that receives positive-pressure air supplied from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral sleeping position. 3.2 Anatomy of the Respiratory System and Face [Figure 2A] This diagram outlines the human respiratory system, including the nasal and oral cavities, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] This is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] This is a frontal view of the face, including several features of surface anatomical structures, such as the upper lip, upper lip robe, lower lip robe, lower lip, width of the mouth, medial canthus, nasal wings, nasolabial folds, and cheirion. Superior, inferior, radially medial, and radially lateral directions are also indicated. [Figure 2D] This is a lateral view of the head, including several features of surface anatomical structures, such as the glabella, therion, nasal tip, subnasal point, upper lip, lower lip, supramenton, nasal ridge, ala apex, superior and inferior base of the ear. The superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] This is a further lateral view of the head. The approximate positions of the Frankfort horizontal and nasolabial angles are indicated. The coronal plane is also shown. [Figure 2F] This is a pedicle view of the nose, including several features such as the nasolabial folds, lower lip, upper lip red, nostrils, subnasal point, columella, nasal tip, main axis of the nostrils, and median sagittal plane. [Figure 2G] This is a lateral view of the surface features of the nose. [Figure 2H] This shows the subcutaneous structure of the nose, including the lateral nasal cartilages, nasal septal cartilages, greater alar cartilages, lesser alar cartilages, nasal sesamoid cartilages, nasal bone, epidermis, adipose tissue, the frontal process of the maxilla, and fibrous adipose tissue. [Figure 2I] This shows a mid-nasal incision located approximately a few millimeters from the midline sagittal plane, particularly the medial crura of the nasal septum cartilage and the greater alar cartilage. [Figure 2J] This is a frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K] This is a lateral view of the skull showing the external shape of the head surface and several muscles. The following bones are illustrated: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is illustrated. The following muscles are illustrated: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle. [Figure 2L] This shows the anterolateral aspect of the nose. 3.3 Patient Interface [Figure 3A] This shows a patient interface in the form of a nasal mask, which is one embodiment of this technology. [Figure 3B] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the magnitude of curvature shown in Figure 3C. [Figure 3C] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D]This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] This is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G] The mask cushion, including two pillows, is shown. The outer surface of the cushion is shown. The edges of the surface are shown. The dome and saddle regions are illustrated. [Figure 3H] The mask cushion is shown. The outer surface of the cushion is shown. The edge of the surface is shown. The path on the surface between point A and point B is illustrated. The straight-line distance between A and B is illustrated. Two saddle regions and a dome region are illustrated. [Figure 3I] The surface of the structure is shown, and one-dimensional holes are present within this surface. The planar curves in the illustration form the boundaries of the one-dimensional holes. [Figure 3J] This is a cross-sectional view through the structure in Figure 3I. The illustrated surface defines the two-dimensional hole in the structure in Figure 3I. [Figure 3K] Figure 3I is a perspective view of the structure including two-dimensional and one-dimensional holes. The surfaces that define the two-dimensional holes in the structure are also shown. [Figure 3L] This shows a mask with an inflatable bladder that acts as a cushion. [Figure 3M] Figure 3L is a cross-sectional view of the mask, showing the inner surface of the bladder. The inner surface defines the two-dimensional holes within the mask. [Figure 3N] Figure 3L shows a further cross-section through the mask. The inner surface is also illustrated. [Figure 3O] This demonstrates the left-hand rule. [Figure 3P] I will demonstrate the right-hand rule. [Figure 3Q] Shows the left ear, including the left ear spiral. [Figure 3R] Shows the right ear, including the right ear spiral. [Figure 3S] The right hand shows a spiral. [Figure 3T] This is a diagram of a mask that includes a sign of the twist of the spatial curve defined by the edges of the sealing film in different regions of the mask. [Figure 3U] This is a diagram of the plenum chamber 3200, showing the sagittal plane and the central contact surface. [Figure 3V] Figure 3U is a rear view of the plenum chamber. The directions in the figure are perpendicular to the central contact surface. In Figure 3V, the sagittal plane divides the plenum chamber into left-hand and right-hand sides. [Figure 3W] Figure 3V is a cross-sectional view through the plenum chamber, taken in the sagittal plane shown in Figure 3V. The "central contact" surface is illustrated. The central contact surface is perpendicular to the sagittal plane. The orientation of the central contact surface corresponds to the orientation of chord 3210. Chord 3210 rests on the sagittal plane and contacts only the cushion of the plenum chamber at two points on the sagittal plane (i.e., upper point 3220 and lower point 3230). Depending on the geometry of the cushion in this region, the central contact surface may contact both the upper and lower points. [Figure 3X] Figure 3U shows the plenum chamber 3200 in the position for use on the face. The sagittal plane of the plenum chamber 3200 generally coincides with the midline sagittal plane of the face when the plenum chamber is in the position for use. The central contact surface generally corresponds to the "face plane" when the plenum chamber is in the position for use. In Figure 3X, the plenum chamber 3200 is part of a nasal mask, with the upper point 3220 located approximately on the serion and the lower point 3230 located on the upper lip. [Figure 3Y] This shows a patient interface in the form of a nasal mask, one embodiment of this technology. 3.4 RPT device [Figure 4A] This shows an RPT device based on one form of this technology. [Figure 4B]This is a schematic diagram of the pneumatic path of an RPT device according to one embodiment of this technology. Upstream and downstream directions are indicated with reference to the blower and patient interface. Regardless of the actual flow direction at any particular moment, the blower is defined as being upstream of the patient interface, and the patient interface is defined as being downstream of the blower. Items in the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface. 3.5 Humidifier [Figure 5A] An isometric view of a humidifier based on one embodiment of this technology is shown. [Figure 5B] This shows an isometric view of a humidifier according to one embodiment of this technology, illustrating the humidifier reservoir 5110 being removed from the humidifier reservoir dock 5130. 3.6 Other Forms of Patient Interfaces [Figure 6] This shows a cross-sectional view of the first part of a patient interface using conventional technology. [Figure 6A] A perspective view of a patient interface used in one form of this technology is shown. [Figure 6B] Figure 6A shows an enlarged perspective view of the patient interface. [Figure 6C] Figure 6A shows a cross-sectional view of the first part of the patient interface. [Figure 6C-1] A plan view of an exemplary headgear strap including buttonholes according to one embodiment of this technology is shown. [Figure 6D] Figure 6A shows a cross-sectional view of the second part of the patient interface. [Figure 7A] This is a perspective view of a patient interface according to another embodiment of the present technology, showing a patient interface without positioning and stabilization structures connected. [Figure 7B] Figure 7A is a perspective view of the patient interface, showing some of the positioning and stabilization structures connected to it. [Figure 8A] A perspective view of a patient interface in another form of this technology is shown. [Figure 8B] Figure 8A shows a cross-sectional view of the first part of the patient interface. [Figure 8C] Figure 8A shows a perspective view without the positioning and stabilization structures connected to the patient interface. [Figure 9A] A perspective view of a patient interface in another form of this technology is shown. [Figure 9B] Figure 9A shows a cross-sectional view of the first part of the patient interface. [Figure 9C] Figure 9A shows a perspective view of the patient interface without the positioning and stabilization structures connected. [Figure 9D] Figure 9A shows a perspective view of part of the positioning and stabilization structure for use with the patient interface. [Figure 10A] A perspective view of a patient interface in another form of this technology is shown. [Figure 10B] Figure 10A shows a cross-sectional view of the first part of the patient interface. [Figure 10C] Figure 10A shows an enlarged cross-sectional view of the first part of the patient interface. [Figure 11A] A perspective view of a patient interface in use, representing another form of this technology, is shown. [Figure 11B] Figure 11A shows a perspective view of the patient interface. [Figure 11C] Figure 11A shows a cross-sectional view of the first part of the patient interface. [Figure 12A] A perspective view of a patient interface in use, representing another form of this technology, is shown. [Figure 12B] Figure 12A shows a perspective view of the patient interface. [Figure 12C] Figure 12A shows a cross-sectional view of the first part of the patient interface. [Figure 12D] Figure 12A shows a perspective view of the patient interface with the air circuit not connected. [Figure 12E] Figure 12A shows a magnified perspective view of a portion of the patient interface, excluding the headgear strap material attached to the ventilation module. [Figure 13A]A perspective view of a patient interface in use, representing another form of this technology, is shown. [Figure 13B] Figure 13A shows a perspective view of the patient interface. [Figure 13C] Figure 13A shows a cross-sectional view of the first part of the patient interface. [Figure 14A] This is a perspective view of a patient interface in use, representing another form of this technology. [Figure 14B] Figure 14A shows an enlarged perspective view of the patient interface. [Figure 15A] A perspective view of a patient interface in use, representing another form of this technology, is shown. [Figure 15B] Figure 15A shows a perspective view of the patient interface. [Figure 15C] Figure 15A shows a side view of the patient interface. [Figure 15D] Figure 15A shows a cross-sectional view of the first part of the patient interface. [Figure 16A] This shows a diffuser included as part of a positioning and stabilization structure provided to a patient interface, according to one embodiment of this technology. [Figure 16B] This is a side view of a portion of a headgear strap, including a diffuser, based on one embodiment of this technology. [Figure 16C] A plan view of a portion of a headgear strap, including a diffuser, in another form of this technology is shown. [Figure 16D] Figure 16C is a side perspective view of the headgear strap. [Figure 17] A perspective view of a patient interface in use, representing another form of this technology, is shown. [Figure 18] Figure 17 shows an enlarged cross-sectional perspective view of the patient interface. [Figure 19] Figure 17 shows an enlarged cross-sectional view of the first part of the patient interface. [Figure 20] Figure 17 is a perspective view of the patient interface, showing the patient interface before the positioning and stabilization structures are connected. [Figure 21] Figure 17 shows an enlarged perspective view of the positioning and stabilization structure of the patient interface. [Figure 22] A perspective view of a patient interface in another form of this technology is shown. [Figure 23] This figure shows an enlarged cross-sectional view of the first part of the patient interface shown in Figure 22. [Figure 24] Figure 22 is an enlarged perspective view of the positioning and stabilization structure of the patient interface. [Modes for carrying out the invention]

[0118] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and that these examples are subject to change. It should also be understood that the terminology used in this disclosure is intended solely to illustrate the specific examples discussed herein and is not limiting.

[0119] The following description is provided in relation to a variety of examples that may share one or more common properties and / or features. It should be understood that one or more features of any example may be combined with one or more features of another example or any other example. In addition, any single feature or combination of features in any of these examples may lead to further examples.

[0120] 4.1 Treatment In one embodiment, the technology includes a method for treating respiratory distress, which involves applying positive pressure to the airway entrance of patient 1000.

[0121] In a specific example of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0122] In certain applications of this technology, mouth breathing is restricted, limited, or prevented.

[0123] 4.2 Respiratory Therapy Systems In one embodiment, the technology includes a respiratory therapy system for the treatment of respiratory disorders. The respiratory therapy system may comprise an air circuit 4170 and an RPT device 4000 for supplying airflow to a patient 1000 via a patient interface 3000.

[0124] 4.3 Patient Interface Referring to Figure 3A, a non-invasive patient interface 3000 according to one aspect of the present technology includes, as a functional mode, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation section 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support section 3700. In some embodiments, the functional mode may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the seal-forming structure 3100 is positioned to surround the entrance to the patient's airway so as to maintain positive pressure at the entrance to the patient's airway 1000. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0125] Referring to Figures 6A-624, a patient interface 3000 according to one aspect of the present technology includes a seal-forming structure 3100, a plenum chamber 3200, a connection port 3600 for connection to an air circuit 4170, and a ventilation structure 3400 or a pair of ventilation structures 3400 configured to ventilate the gas flow from inside the plenum chamber 3200. In the illustrated embodiment, the ventilation structure 3400 or the pair of ventilation structures 3400 is configured to ventilate the gas flow substantially laterally when in use.

[0126] References to directions (e.g., "lateral direction") should be understood to refer to the anatomical orientation relative to the body when the patient interface 3000 is fitted by the patient in its normal use position, unless otherwise specified in the context. Such references to "substantially" directions, such as "substantially lateral," can be understood to mean extending in a direction that is at least partially relevant. For example, a direction may be "lateral" if it generally extends perpendicular to the median sagittal plane of the patient's face (shown in Figure 2C) and / or relative to the median sagittal plane of the plenum chamber (shown in Figures 3U-3W). Components extending laterally may also extend in other directions.

[0127] Therefore, the embodiment of this technology relates to a patient interface 3000 configured to achieve “lateral ventilation,” which ventilates air substantially laterally (i.e., laterally) from a portion of the patient interface (e.g., a plenum chamber 3200 or conduit) from a patient in use. As described, another component may deflect the airflow from that direction before the airflow dissipates into the surroundings.

[0128] In some forms, the patient interface 3000 includes an air circuit 4170 such as a delivery tube 4172. In the examples shown in Figures 6A–16A and Figures 17–24, the patient interface 3000 is configured to connect to a delivery tube 4172 (not shown in some figures). As shown in these examples, the delivery tube 4172 is connected to the plenum chamber 3200 via a connection port 3600. The connection port 3600 may be provided on the plenum chamber and the delivery tube 4172 which is directly connected to the plenum chamber 3200. Alternatively, the connection port 3600 may be provided on other components, and the delivery tube 4172 may be indirectly connected to the plenum chamber 3200 via one or more other components. In the example shown in Figure 22, the patient interface 3000 is configured to connect to a delivery tube (not shown). In this example, the delivery tube may be connected to the plenum chamber 3200 via at least one headgear tube 3350 which includes a connection port 3600.

[0129] In some embodiments of this technology, for example, as shown in Figures 6A-624, the patient interface 3000 includes a deflector 3500, preferably a pair of deflectors 3500, which are configured to redirect or rotate at least a portion of the ventilated gas flow before the airflow merges with the surrounding air body and dissipates. Unless otherwise specifically required in the context, references to “redirection,” “rotation,” etc., should be understood as a change in direction between the direction of the ventilated gas flow and the direction of the gas flow after it has been redirected or rotated by the deflector 3500, i.e., the direction of the gas flow after it has been redirected or rotated by the deflector 3500.

[0130] In the embodiments of this technology shown in Figures 6A to 24, the patient interface 3000 includes a positioning and stabilizing structure 3300 that provides force to hold the seal-forming structure 3100 in a therapeutically effective position on the patient's face. In certain embodiments, the positioning and stabilizing structure 3300 includes at least one headgear strap 3310, preferably multiple headgear straps 3310 or a headgear strap assembly, as shown, for example, in Figures 6A, 11A, 12A, 13A, 14A, 15A and 17. The positioning and stabilizing structure 3300 may also include a frame 3360, as shown, for example, in Figures 22 to 24. In other embodiments, the positioning and stabilizing structure 3300 may include, for example, one or more headgear tubes 3350 that deliver pressurized air received from a conduit. The delivery tube 4172 reaches the patient's airway, for example, through a plenum chamber 3200 and the seal-forming structure 3100.

[0131] In some embodiments of the present technology shown in Figures 6A to 15D, the patient interface 3000 includes a pair of connectors 3800 to facilitate attachment of the patient interface 3000 to the positioning and stabilization structure 3300.

[0132] In embodiments of this technology, for example, as shown in Figures 6A-9D, 11A-15D, and 17-24, the patient interface 3000 may include a diffuser 3900 for diffusing airflow. This may help reduce or prevent noise. In some embodiments of this technology, the plenum chamber 3200 and the seal-forming structure 3100 are provided by a single physical component. In the example shown in Figures 6A-23, the patient interface 3000 includes a cushion module 3150. In this example, the cushion module 3150 provides the plenum chamber 3200 and the seal-forming structure 3100 of the patient interface 3000. The seal-forming structure 3100 and the other walls of the cushion module 3150 form the plenum chamber 3200 in this example. In other embodiments of this technology, the plenum chamber 3200 and the seal-forming structure 3100 are provided by multiple physical components, for example, one component for the plenum chamber 3200 and another component for the seal-forming structure 3100.

[0133] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, it may not be suitable for respiratory pressure therapy.

[0134] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 6 cmH2O relative to the surroundings.

[0135] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 10 cmH2O relative to the surroundings.

[0136] A patient interface 3000 according to one embodiment of this technology is constructed and positioned to provide an air supply with a positive pressure of at least 20 cmH2O relative to the surroundings.

[0137] 4.3.1 Plenum Chamber In some examples of this technology, the patient interface 3000 includes a plenum chamber 3200 that can be pressurized to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure. The plenum chamber 3200 can receive an airflow at the therapeutic pressure for the patient to breathe.

[0138] In some forms of this technology, the plenum chamber 3200 is provided at least partially by the action module 3150 of the patient interface 3000.

[0139] According to some examples (for example, the examples shown in Figures 6A to 24), the cushion module 3150 may include a frame portion 3210 and a seal-forming structure 3100.

[0140] The plenum chamber 3200 can be formed at least partially by both the frame portion 3210 and the seal-forming structure 3100. The frame portion 3210 can support the seal-forming structure 3100 against the patient's face during use. The frame portion 3210 and the seal-forming structure 3100 can form the plenum chamber 3200 by partially closing a spatial volume having air at a pressure higher than atmospheric pressure during use.

[0141] In particular, the frame portion 3210 can at least partially form a plenum chamber 3200 that can be pressurized to a therapeutic pressure at least 6 cmH2O higher than the ambient air pressure.

[0142] In some embodiments of this technology, for example, as shown in Figures 10A to 10C and Figure 10C, the frame portion 3210 may include one or more lateral projection connection portions 3212 configured to connect to a positioning and stabilizing structure 3300. The lateral projection connection portions 3212 may also partially form a plenum chamber 3200 together with other parts of the cushion module 3150, that is, the lateral projection connection portions 3212 may be configured to include their respective volumes, and the volume within the lateral projection connection portions 3212 is part of the volume within the plenum chamber 3200.

[0143] The seal-forming structure 3100 may be positioned on the frame portion 3210 and may at least partially form the plenum chamber 3200. The seal-forming structure 3100 may be permanently or removablely connected to the frame portion 3210. The seal-forming structure 3100 is supported by the frame portion 3210.

[0144] In a particular configuration, the plenum chamber 3200 has a perimeter shape that is complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the periphery of the plenum chamber 3200 is positioned in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the plenum chamber 3200.

[0145] In some embodiments, the plenum chamber 3200 and the seal-forming structure 3100 are formed from a single, homogeneous sheet of material. In some embodiments, the plenum chamber 3200 may be formed from a homogeneous sheet with connectors formed from other materials. In other embodiments, the plenum chamber 3200 is composed of multiple materials, for example, one material used to form the frame portion 3210 and another material used to form the seal-forming structure 3100, and the plenum chamber 3200 includes at least a portion of the frame portion 3210 and the seal-forming structure 3100.

[0146] In certain forms of this technology, the plenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the plenum chamber. In such forms, the pressure is often reduced and / or the wearer's comfort is increased, which can improve treatment compliance.

[0147] In certain embodiments of this technology, the plenum chamber 3200 is constructed from a transparent material (e.g., transparent polycarbonate). For example, in the examples shown in Figures 6A to 24, the majority of the cushion module 3150 is formed from silicone resin. Specifically, in these embodiments, both the frame portion 3210 and the seal-forming structure 3100 are formed from silicone resin. The use of transparent materials can reduce the intrusiveness of the patient interface and may help improve compliance with treatment. The use of transparent materials may also help clinicians confirm the placement and function of the patient interface.

[0148] In a specific form of this technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the intrusiveness of the patient interface, thereby helping to improve compliance with treatment.

[0149] In exemplary embodiments of the technology shown in Figures 6A to 23, the frame portion 3210 may be flexible and may be formed of a material having a relatively low modulus of elasticity, for example. This allows for deflection and bending of the frame portion 3210. The seal forming structure 3100 may be flexible, for example, formed of the same material or another material having a relatively low modulus of elasticity. In some examples, the frame portion 3210 and the seal forming structure 3100 may be formed integrally and made of a deformable material. The frame portion 3210 may be formed of an elastic material such as silicone resin. The seal forming structure 3100 may be formed of an elastic material. The frame portion 3210 and the seal forming structure 3100 may be integral. In these embodiments, the frame portion 3210 and the seal forming structure 3100 are molded together as a single part formed of an elastic material (e.g., silicone resin). The seal-forming structure 3100 and the frame portion 3210 (or at least a large portion of the frame portion 3210) may be formed together (e.g., constructed, molded, etc.) from a single, homogeneous sheet of a deformable material (e.g., an elastic material such as silicone resin). The frame portion 3210 and the seal-forming structure 3100 may be an integral structure.

[0150] In another example of this technology, the seal-forming structure 3100 may be removably connected to the frame portion 3210. The seal-forming structure 3100 may be connected to the frame portion 3210 by soft-to-soft, soft-to-hard, or hard-to-hard connections.

[0151] In the embodiments of this technology shown in Figures 6A to 23, the plenum chamber 3200 includes an inlet 3220 configured to receive an airflow at therapeutic pressure for the patient to breathe. In the examples shown in Figures 6A to 15D, the plenum chamber 2300 includes an inlet 3220 and a pair of openings 3240 configured to communicate fluidly with the interior of the plenum chamber 3200. In the examples shown in Figures 6A to 15D, the inlet 3220 and the openings 3240 may be located on a frame portion 3210. In the examples shown in Figures 17 to 24, the plenum chamber 2300 includes an inlet 3220 and does not include any additional openings 3240 other than the opening 3240 necessary for delivering gas to the patient's airway.

[0152] In some embodiments, the entrance 3220 may be circular. For example, in the examples of Figures 6A to 9D, the entrance 3220 is substantially circular. In some embodiments, the entrance 3220 may not be circular. For example, the entrance 3220 may be roughly elliptical or oval, as shown in Figures 10A to 13C and Figures 15 to 15D. As shown in Figure 20, in some embodiments, the entrance 3220 may have the shape of a triangle with curved angles when viewed from a certain angle. The shape of the entrance 3220 is not entirely planar, and the contour of the entrance 3220 may form a three-dimensional spatial curve, such as the shape in Figure 20. In these examples, the entrance 3220 may have a width (i.e., the distance between the first and second side edges of the entrance 3220) that is greater than the height (i.e., the distance between the upper and lower edges of the entrance 3220).

[0153] As shown in the examples in Figures 6A to 24, the plenum chamber 3200 includes a front section 3211. The frame section 3210 may also include a front section 3211. The inlet 3220 may be located within the front section 3211.

[0154] In some configurations, the inlet 3220 or a portion thereof may be located on the side 3213 of the plenum chamber 3200. For example, as shown in Figures 10A to 13C, 15A to 15D, and 20, at least a portion of the inlet 3220 is located on the side 3213 of the plenum chamber 3200.

[0155] The frame portion 3210 may include a pair of lateral projection connectors 3212, as shown in Figures 10A-10C, 13A-13C, and 15A-15D. Each lateral projection connector 3212 includes an opening 3240 configured to communicate fluidly with the interior of the plenum chamber 3200.

[0156] In some examples, a rigidizer may be provided to make the frame portion 3210 more rigid (while still being flexible). In some examples, the frame portion 3210 and the seal-forming structure 3100 are formed of a material having a relatively low modulus of elasticity (e.g., silicone resin, TPE, etc.), and the frame portion 3210 includes a rigidizer. In particular, the patient interface 3000 or the cushion module 3150 may include a rigidizer. The rigidizer may be provided for the frame portion 3210. The rigidizer may be configured to stiffen the frame portion 3210. The rigidizer may be configured to resist deformation of the frame portion 3210. The rigidizer may be configured to provide support to the frame portion 3210. The rigidizer may be more rigid than the frame portion 3210. For example, the rigidizer may be formed of a material with a higher modulus of elasticity than the material forming the frame portion 3210.

[0157] In the examples shown in Figures 22-24, frame 3360 may function as a rigidizer. Other embodiments of frame 3360 are described elsewhere in this specification.

[0158] However, in other examples, the frame portion 3210 may be relatively rigid. For example, a relatively rigid frame portion 3210 may be formed from a material with a relatively high modulus of elasticity.

[0159] In the example shown in Figure 17, the plenum chamber 3200 includes an inlet 3220, and at least one headgear tube 3350 is configured to be in fluid communication with the inlet 3220 during use. For example, as best shown in Figure 21, at least one headgear tube 3350 includes an opening 3356 that is positioned and shaped such that the headgear tube 3350 is in fluid communication with the inlet 3220 during use.

[0160] Referring to the examples in Figures 17 and 18, the inlet 3220 may be configured to provide an introduction to the plenum chamber 3200 when at least one headgear tube 3350 is connected to the plenum chamber 3200. The size, position, and shape of the inlet 3220 may be selected to provide a lead-in. For example, the portion of the inlet 3220 located on the side 3213 of the plenum chamber 3200 may have a size and shape to fit the shape of at least one headgear tube 3350. This facilitates the assembly of the patient interface 3000 even when at least one headgear tube 3350 is positioned and mounted in the plenum chamber 3200.

[0161] Furthermore, an inlet 3220 located on one or more sides 3213 of the plenum chamber 3200 may provide a side passage into the interior of the plenum chamber 3200. In other words, the inlet 3220 allows the airflow delivered from the air circuit 4170 by at least one headgear tube 3350 to flow substantially laterally into the interior of the plenum chamber 3200 through the inlet 3220.

[0162] 4.3.2 Seal Molding Structure In some examples of this technology, the patient interface 3000 includes a seal-forming structure 3100 configured to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure 3100 may be configured to maintain therapeutic pressure within the plenum chamber 3200 throughout the patient's entire respiratory cycle during use.

[0163] In some forms, the seal-forming structure 3100 is configured to form a seal with or around the patient's nose when in use. Therefore, in some forms, the patient interface 3000 may be just a nasal mask and should be understood to be also called a nasal mask.

[0164] In other embodiments not shown, the seal-forming structure 3100 may be configured to form a seal when used in conjunction with other parts of the patient's face, such as a portion having or surrounding the patient's nose and a portion having or surrounding the patient's mouth. Thus, in some embodiments, the patient interface 3000 may be a nasal mask, also known as a full-face or nasal mask, and it should be understood that embodiments of this technology are not limited to nasal masks or nasal masks only.

[0165] In one embodiment of this technology, the seal-forming structure 3100 may provide a target seal-forming region and further provide a buffering function. The target seal-forming region is the region in the seal-forming structure 3100 where sealing can occur. The region where sealing actually occurs (i.e., the actual sealed surface) may change from day to day and from patient to patient in a given treatment session due to various factors such as the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0166] In one embodiment, the target seal-forming region is located on the outer surface of the seal-forming structure 3100.

[0167] In a particular form of this technology, the seal-forming structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0168] The seal-forming structure 3100 according to this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0169] In certain forms of the present technology, a system is provided that includes a plurality of seal-forming structures 3100 configured to correspond to different size and / or shape ranges, respectively. For example, the system may include one form of the 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.

[0170] 4.3.2.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can easily respond to the system positive pressure in the plenum chamber 3200 acting on its underside to form a tight sealing engagement with the face. The pressure-assisted mechanism can act together with the elastic tension in the positioning and stabilizing structure.

[0171] 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., about 0.25 mm to about 0.45 mm). This member extends around the periphery of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the peripheral edge of the plenum chamber 3200 and extends at least partially around the peripheral length. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange so that it does not buckle during use.

[0172] In one form, the seal-forming structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged to be in a compressed state, for example, due to the elastic tension in the positioning and stabilizing structure.

[0173] 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.

[0174] In one form, the seal-forming structure includes a region having an adhesive surface or an adhesive bonding surface.

[0175] In certain forms of the present technology, the seal-forming structure can include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension portion, and a portion having an adhesive surface or an adhesive bonding surface.

[0176] 4.3.2.2 Region of the nasal bridge or nasal sill In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used over the nasal bridge or nasal sill region of the patient's face.

[0177] In one form, the seal-forming structure includes a saddle region arranged to form a seal when used over the nasal bridge or nasal sill region of the patient's face.

[0178] 4.3.2.3 Upper lip region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used over the upper lip region (i.e., above the lip) of the patient's face.

[0179] In one form, the seal-forming structure includes a saddle region arranged to form a seal l when used over the upper lip region of the patient's face.

[0180] 4.3.2.4 Jaw region In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal when used over the jaw region of the patient's face.

[0181] 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.

[0182] 4.3.2.5 Forehead region In one embodiment, the seal-forming structure forms a seal when used on the forehead area of ​​the patient's face. In this embodiment, the plenum chamber may cover the eye when in use.

[0183] 4.3.2.6 Nasal pillow In one embodiment, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows, each of which is constructed and positioned to form a seal with each nostril of the patient's nose.

[0184] A nasal pillow according to one aspect of this technology includes a frustocone, at least a portion of which forms a seal on the underside of the patient's nose; a handle; and a flexible region connecting the lower part of the frustocone to the handle. Furthermore, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the handle. The flexible regions work together to facilitate a universal joint structure that adapts to relative movement (both displacement and angle) between the frustocone and the structure to which the nasal pillow is connected. For example, the frustocone can be displaced axially toward the structure to which the handle is connected.

[0185] 4.3.2.7 Nasal Mask In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airway but not around the patient's mouth. The seal-forming structure 3100 may be configured to seal over the patient's lip. The patient interface 3000 may not cover the patient's mouth. The patient interface 3000 may deliver air or breathable gas to the patient's two nostrils rather than to the oral cavity. This type of patient interface may be identified as a nasal mask only.

[0186] The nasal mask-only form of this technology is the form conventionally considered a "nasal mask" and has a seal-forming structure 3100 configured to seal around the nose and above the nasal bridge of the patient's face. The nasal mask may also be triangular in shape. In one embodiment, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal with the upper lip region (e.g., the upper lip), at least a portion of the nasal ridge above the patient's nasal bridge or anterior nostrils, and the patient's face on each side of the patient's nose (e.g., the nasolabial folds near the patient). The patient interface 3000 shown in Figure 1B has this type of seal-forming structure 3100. The patient interface 3000 may deliver air or breathable gas to the two nostrils of the patient 1000 via a single orifice.

[0187] Another form of nasal mask may seal around the area below the patient's nose without engaging with the user's nasal bridge. For example, this type of patient interface 3000 may be identified as a “nasal cradle” mask, and the seal-forming structure 3100 may be identified as a “nasal cradle cushion.” In one embodiment, as shown, for example, in Figure 3Y, the seal-forming structure 3100 is configured to form a seal with the underside of the nose around the nostrils when in use. The seal-forming structure 3100 may be configured to seal around the patient's nostrils with respect to the underside and / or anterior surface of the anterior nasal region of the patient's nose and the lower periphery of the patient's nose, including the wings of the patient's nostrils. The seal-forming structure 3100 may also seal the patient's upper lip. The shape of the seal-forming structure 3100 may be configured to conform to the underside of the patient's nose or to be tightly fitted to the underside of the patient's nose, and may be configured not to contact the nasal bridge region of the patient's nose or any part above the anterior nasal region of the patient's nose. In one embodiment of the nasal cradle cushion, the seal-forming structure 3100 includes a bridge portion that divides an opening into two holes, each opening supplying air or breathable gas to a corresponding one of the patient's nostrils during use. The bridge portion may be configured to contact or seal with the patient's trabeculae during use. Alternatively, the seal-forming structure 3100 may include a single opening that supplies airflow or air or breathable gas to two of the patient's nostrils.

[0188] In some forms, as described above, only the nasal mask may include a nasal pillow.

[0189] Referring to the examples shown in Figures 6A to 15D, the seal-forming structure 3100 is configured to form a seal with the underside of the patient's nose around the patient's nostrils when in use. In the examples shown in Figures 6A to 15D, the patient interface 3000 is in the form of a nasal mask or nasal face mask.

[0190] In the illustrated embodiments shown in Figures 6A to 15D, the seal-forming structure 3100 includes at least one hole 3110 or a pair of holes 3110, which are configured to deliver airflow to the patient's nostrils at therapeutic pressure. Each hole 3110 is aligned to a corresponding site on the patient during use. In some examples, the seal-forming structure 3100 may include a single hole 3110 configured to allow airflow to be delivered to two nostrils of the patient. In one example, the cushion module 3150 includes at least one hole 3110. In some examples, at least one hole 3110 is formed in the central part of the seal-forming structure 3100.

[0191] 4.3.2.8 Mouth and Nose Mask In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 configured to seal around the entrance to the patient's nasal airway and around the patient's oral cavity. The seal-forming structure 3100 may be configured to seal to the patient's face near the jaw region. The patient interface 3000 may deliver air or breathable gas to the patient's nostrils and oral cavity. This type of patient interface may be identified as a nasal and oral mask.

[0192] One form of the mouth-nose mask according to this technology has been conventionally considered a “full-face mask” having a seal-forming structure 3100 configured to seal around the patient’s nose, below the mouth, and above the nasal bridge. Typically, a full-face mask may also be triangular. In one embodiment, the patient interface 3000 includes a seal-forming structure 3100 that, when in use, forms a seal with the patient’s jaw region (which may include the patient’s lower lip and / or the region directly below the lower lip), at least a portion of the nasal bridge or the nasal ridge above the anterior nostrils of the patient, and the cheek region of the patient’s face. The patient interface 3000 shown in Figure 1C is of this type. The patient interface 3000 may deliver air or breathable gas to the patient 1000’s nostrils and oral cavity through a single orifice. This type of seal-forming structure 3100 may be called a “full-face cushion.”

[0193] In another embodiment, the patient interface 3000 includes a seal-forming structure 3100 that forms a seal in use on the patient's face (e.g., near the nasolabial folds) over the patient's jaw region (which may include the patient's lower lip and / or the area directly below the lower lip), the underside and / or anterior surface of the anterior part of the patient's nose, the nostrils of the patient's nose, and each side of the patient's nose. The seal-forming structure 3100 may also form a seal over the patient's upper lip. The patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver a gas flow or breathable gas to the patient's nostrils and oral cavity, or it may have an oral opening configured to deliver air or breathable gas to the oral cavity and nostrils configured to deliver air or breathable gas to the nostrils, or it may have an oral opening for delivering air to the patient's oral cavity and two nostrils for delivering air to the corresponding nostrils. The patient interface 3000 may have a nasal portion and an oral portion sealed to the patient's face in a position similar to that of a nasal cradle mask.

[0194] In another form of the nasal and oral mask, the patient interface 3000 may include a sealing structure 3100 having a nasal portion that includes nasal pillows and an oral portion configured to form a seal around the patient's face around the patient's mouth.

[0195] In some forms, the sealing structure 3100 may have a different nasal portion separated from the oral portion. In other forms, the sealing structure 3100 may form a continuous seal around the patient's nose and mouth.

[0196] It should be understood that the above examples of the different forms of the patient interface 3000 do not constitute a detailed list of possible configurations. In some forms, the patient interface 3000 may include a combination of different features of the above examples of nasal-only and nasal-oral masks only.

[0197] Referring to the examples shown in FIGS. 17-24, the sealing structure 3100 is configured to form a seal around the patient's nostrils and oral cavity during use. In these examples, the patient interface 3000 is in the form of a nasal-oral mask or a full-face mask.

[0198] In some forms, the sealing structure 3100 includes at least one hole 3110 or at least one pair of holes (at least one hole is for the nostrils and the other hole is for the oral cavity) and is configured to allow gas flow under treatment pressure to be sent to the patient's nostrils and oral cavity. In one example, the cushion module 3150 includes at least one hole 3110. In some examples, at least one hole 3110 is formed in the central portion of the sealing structure 3100. In the examples shown in FIGS. 17-24, the sealing structure 3100 includes a single hole 3110 configured to allow air flow to be delivered to the patient's nostrils and oral cavity.

[0199] 4.3.3 Connection Port The connection port 3600 allows the patient interface 3000 to be connected to the air circuit 4170. As shown in Figures 6A-624, the patient interface 3000 includes the connection port 3600 for connecting to the air circuit 4170. In the illustrated example, the air circuit 4170 is in the form of a delivery tube 4172.

[0200] 4.3.3.1 Connecting to the Plenum Chamber The delivery tube 4172 may be connected to the plenum chamber 3200 via a connection port 3600 so that the delivery tube 4172 is in fluid communication with the inlet 3220 in use. In some embodiments of the art, for example, as shown in Figures 7A-7B, 9A-11C, and 13A-15D, the connection port 3600 is attached to or forms part of the inlet 3220.

[0201] In some configurations, the connection port 3600 may be located on the front region of the plenum chamber 3200 during use. As shown in the examples in Figures 6A–15D and Figures 22–24, the connection port 3600 is located on the inner region of the plenum chamber 3200 during use. The inner region of the plenum chamber 3200 is centrally located during use, i.e., the patient's median sagittal plane passes through the inner portion during use. In the examples in Figures 22–24, a frame 3360 provides the connection port 3600. The frame 3360 may include an opening 3362. An air circuit (not shown in Figures 22–24) is connected to the inlet 3220 via the opening 3362 of the frame 3360 and is configured to be in fluid communication with the inlet 3220 during use. That is, in some embodiments, the delivery tube 4172 may be physically connected to the frame 3360 via the inlet port 3220 to deliver breathable gas into the plenum chamber 3200, and in other embodiments, the delivery tube 4172 may be physically connected to the inlet port 3220 of the plenum chamber 3200 through an opening 3362 in the frame 3360.

[0202] In the examples shown in Figures 6A to 15D and Figures 22 to 24, the air circuit 4170 is connected to the front section 3211. As shown, the connection port 3600 may be located in the inner region of the front section 3211. During use, the inner region may be centrally located, i.e., the patient's median sagittal plane may pass through the inner portion during use. As shown in Figures 6A to 15D, the air circuit 4170 is connected to the frame section 3210 via the connection port 3600. In the examples shown in Figures 22 to 24, the air circuit (not shown) may be connected to the frame 3360. In other embodiments not shown, the air circuit may be connected to the frame 3360 and / or the plenum chamber 3200, e.g., the frame section 3210.

[0203] 4.3.3.2 Connection to the headgear tube In some embodiments of this technology, the air circuit 4170 is connected to at least one headgear tube 3350. This will be described in more detail below. For example, as shown in Figure 17, the connection port 3600 is located on at least one headgear tube 3350 so as to connect to a portion of the headgear tube 3350 configured to be positioned on top of the patient's head when in use. In this example, the connection port 3600 receives a breathable gas flow from the delivery tube 4172 and sends this gas flow to the headgear tube 3350.

[0204] 4.3.4 Positioning and Stabilization Structures One embodiment of this technology includes a positioning and stabilizing structure for holding a seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure 3300 may also be called a "headgear" because it engages with the patient's head to hold the patient interface 3000 in a sealed position.

[0205] The seal-forming structure 3100 of the patient interface 3000 of this technology may be held in the sealing position during use by the positioning and stabilizing structure 3300.

[0206] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure effect of the plenum chamber 3200 separating from the face.

[0207] In one embodiment, the positioning and stabilizing structure 3300 provides sufficient holding force to overcome the gravitational force acting on the patient interface 3000.

[0208] In one embodiment, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive effects on the patient interface 3000 (e.g., due to tube dragging or accidental interference with the patient interface).

[0209] In one embodiment of this technology, a positioning and stabilization structure 3300 is provided, configured to be worn by a patient during sleep. 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.

[0210] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a supine position with the posterior region of the patient's head resting on a pillow.

[0211] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided that is configured not to be excessively large or bulky in a way that would interfere with a patient sleeping in a lateral position with the side of their head resting on a pillow.

[0212] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a release section positioned between the front portion and the rear portion of the positioning and stabilizing structure 3300. This release section is not compressible and may be, for example, a flexible or pliable strap. The release section is constructed and positioned so as to prevent a situation in which, when a patient lies down with their head on a pillow, the presence of the release section transmits force to the rear along the positioning and stabilizing structure 3300, thereby disrupting the seal.

[0213] In one embodiment of this technology, the positioning and stabilizing 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 embodiment, the foam is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the fabric outer layer includes a loop material that engages with a hook material portion.

[0214] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., extendable with elasticity) strap. For example, the strap may be configured to be taut when in use to direct the force that causes the seal-forming structure to adhere to a portion of the patient's face. In one example, the strap may be configured as a tie.

[0215] In one embodiment of this technology, the positioning and stabilizing structure includes a first tie, which is constructed and positioned such that, during use, at least a portion of its lower edge passes over the patient's head to the upper base of the ear and covers a portion of the parietal bone without covering the occipital bone.

[0216] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a second tie. The second tie is constructed and positioned such that, when in use, at least a portion of its upper edge passes below the inferior foot of the patient's head and covers the occipital bone of the patient's head or rests on the underside of the occipital bone of the patient's head.

[0217] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilizing structure includes a third tie constructed and positioned to interconnect the first tie and the second tie in such a way that the tendency of the first tie and the second tie to move away from each other is reduced.

[0218] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient is lying down while sleeping.

[0219] In a particular embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap configured to be breathable, allowing water vapor to pass through its interior.

[0220] In a particular embodiment of this technology, a system is provided comprising a plurality of positioning and stabilizing structures 3300, each positioning and stabilizing structure 3300 configured to provide holding forces corresponding to a range of different sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large-sized heads but not for small-sized heads, and another form of positioning and stabilizing structure 3300 that is suitable for small heads but not for large heads.

[0221] 4.3.4.1 Frame As shown in Figures 22-24, in some embodiments, the positioning and stabilization structure 3300 includes a frame 3360. The frame 3360 is configured to facilitate indirect attachment of the plenum chamber 3200 to at least one headgear strap (not shown) of the positioning and stabilization structure 3300.

[0222] The frame 3360 may be constructed and positioned to extend through at least a portion of the plenum chamber 3200 when in use. The frame 3360 may extend laterally across the front portion 3211, and in some embodiments, it may extend across the side portion 3213 of the plenum chamber 3200. As shown in Figure 22, in some embodiments, the frame 3360 may extend through the entire width of the plenum chamber 3200 (i.e., the distance between the lateral edges or ends of the frame portion 3210). As shown, the ends of the frame 3360 may extend beyond the side edges or ends of the plenum chamber 3200. In other embodiments, the frame 3360 may be shorter so as to have a length shorter than the width of the plenum chamber 3200.

[0223] As shown in Figures 22 and 24, in some embodiments, the frame 3360 may be substantially elongated. That is, the distance between the upper and lower edges of the frame 3360 is smaller than the width of the frame 3360 (i.e., the distance between the side ends of the frame 3360), for example, substantially small.

[0224] As shown in Figures 22 and 24, in some embodiments, the opening 3362 may be located on the inner region of the frame 3360. The inner region of the frame 3360 is centrally located during use, i.e., the patient's median sagittal plane passes through the inner portion of the frame 3360 during use.

[0225] The frame 3360 may generally be arched when viewed from above or below (not shown), with the concave surface of the frame 3360 facing the patient's face during use. The surface of the plenum chamber 3200, to which the frame, such as the frame portion 3210, is attached or engaged during use, may also be substantially arc-shaped when viewed from the same direction. Therefore, as shown in Figure 22, the shape of the frame 3360 and the shape of the frame portion 3210 may have complementary contours that allow the two components to fit together. In some embodiments, the frame 3360 may have a pre-formed or pre-defined arched shape, and in other embodiments, the frame 3360 may bend into an arched or greater shape when tension from the headgear strap is applied to the ends of the frame 3360.

[0226] The frame 3360 may include at least one, preferably a pair of, connectors 3364 to facilitate attachment of the frame 3360 to at least one headgear strap (not shown in Figures 22 and 23). At least one headgear strap may be detachably attached to the connector 3800. In the illustrated embodiment of the technique, each of the connectors 3364 includes a slot 3364a. The slot 3364a is configured to receive a portion of the headgear strap for connecting the headgear strap to the frame 3360.

[0227] In the illustrated configuration, the connector 3364 is located at the side end of the frame 3360. The connector 3364 may be formed as part of the frame 3360, for example, integrally with the frame, as shown in Figures 22 and 24. In other configurations not shown, the connector 3364 may be formed separately and may be removable or permanently connected to the frame 3360.

[0228] In the examples of Figures 22 and 24, the frame 3360 includes a main body 3368 and a pair of arms 3366 extending laterally outward from the main body 3368. One of a pair of connectors 3364 may be provided at the end of each arm 3366. The main body 3368, arms 3366, and connectors 3364 may be formed together, for example, to provide an integrally formed frame 3360.

[0229] In some configurations, the patient interface 3000 is in the form of a full-face mask, as described above, and is configured to provide two headgear connections rather than four. As shown in the figure, the frame 3350 is configured to provide two headgear connections. That is, the frame includes two connectors 3364, one on each side. Fewer headgear connection points make it easier to put on the patient interface 3000, reduce feelings of claustrophobia when wearing the patient interface, and reduce the amount of facial marks caused by the effect of the headgear straps in contact with the patient's skin and hair.

[0230] In other embodiments not shown, the connector 3364 may include any other suitable connector or connection mechanism, such as a clip or button fastener. In other embodiments, it should be understood that at least one headgear strap may be permanently attached to the frame 3360 or formed together with the frame 3360.

[0231] As shown in Figure 22, the frame 3360 may be configured to be maintained in an appropriate position relative to the plenum chamber 3200.

[0232] In some examples, the frame 3360 may be attached to the plenum chamber 3200, for example, the patient (rear) side of the frame 3360 may be attached to the front frame portion 3210 of the plenum chamber. In the illustrated example, the frame 3360 is detachably attached to the frame portion 3210. This facilitates replacement, cleaning, and / or storage of the frame 3360. The frame 3360 may include a connector (not shown in Figures 22-24) that detachably connects the frame 3360 to the plenum chamber 3200 and facilitates holding the frame 3360 in the appropriate position. For example, the connector may include a lip extending around at least a portion of the opening 3362, which may be connected to the plenum chamber 3200 by an interference fit or friction fit. For example, the lip may be interlocked with the periphery of the entrance 3220 within the plenum chamber 3200. However, in other forms, the connector may include any other suitable connector or mounting mechanism that facilitates a removable attachment between two components, including interlocks, clips, hook-and-loop connectors, high-friction surfaces, etc.

[0233] In some configurations, the frame 3360 does not have to be directly connected to the plenum chamber 3200. For example, the frame 3360 may be held in the appropriate position on the plenum chamber 3200 by a force applied to the frame 3360 in the rearward direction. That is, the frame 3360 can be held in the appropriate position by the tension of the headgear strap. The outer (i.e., front) surface of the plenum chamber 3200 may include a recess 3230, as shown in Figure 20 and described below. The recess may be elongated and extend laterally across the plenum chamber 3200. The recess may be configured so that the frame 3360 can be nested within the recess to help hold the plenum chamber 3200 in place during use.

[0234] In some embodiments, the frame 3360 may at least partially form a plenum chamber 3200 having a frame portion 3210 and a seal-forming structure 3100. For example, the length around the frame opening 3362 may be greater than the length around the inlet 3220. Thus, a portion of the frame 3360 may form a portion of the plenum chamber 3200. However, the frame portion 3210 and the seal-forming structure 3100 may form the main portion of the plenum chamber 3200.

[0235] The frame may be formed from a polymer or a combination of materials. Suitable polymers may include thermoplastics or elastomers such as silicone.

[0236] 4.3.4.2 Conduit-type headgear 4.3.4.2.1 Conduit-type headgear tube In some embodiments of this technology, the positioning and stabilizing structure 3300 includes one or more tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through a plenum chamber 3200 and a seal-forming structure 3100. Thus, in use, at least one headgear tube 3350 is configured to deliver airflow from the air circuit 4170, which is fluidically connected to at least one headgear tube 3350, into the interior of the plenum chamber 3200 via an inlet 3220.

[0237] In the embodiment of the technology shown in Figures 3Y and 17, the positioning and stabilization structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the seal-forming structure 3100. The tubes 3350 are an integral part of the positioning and stabilization structure 3300 of the patient interface 3000, positioning and stabilizing the seal-forming structure 3100 of the patient interface in the appropriate part of the patient's face (e.g., nose and / or mouth). This allows the conduits of the air circuit 4170, which provide pressurized airflow, to connect to the connection port 3600 of the patient interface at a location other than in front of the patient's face.

[0238] In the embodiment of the technology shown in Figures 3Y and 17, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 positioned on a different side of the patient's head during use, extending through the respective cheek regions and over each ear (above the earlobes on the patient's head) to the elbow 3610 at the top of the patient's head 1000. This embodiment of the technology may be advantageous because, when the patient turns their head to the side during sleep, and one of the tubes is compressed, blocking or partially blocking the gas flow along the tube, the other tube remains open, supplying pressurized gas to the patient. In other examples of the technology, the patient interface 3000 may include a different number of tubes, e.g., one tube or three or more tubes. In an example where the patient interface has a single tube 3350, the single tube 3350 is positioned on one side of the patient's head (e.g., across the cheek area) during use, and the strap forms part of the positioning and stabilizing structure 3300, which is positioned on the other side of the patient's head (e.g., across another area) during use to help secure the patient interface 3000 to the patient's head.

[0239] In the embodiments of the present technology shown in Figures 3Y and 17, the two tubes 3350 are fluidly connected to each other at their upper ends and to a connecting port 3600. In some embodiments, the two tubes are integrally formed, while in other embodiments, these tubes are separate components that are connected together in use and can be disconnected, for example, for cleaning or storage. When separate tubes are used, they may be indirectly connected together, for example, each tube may be connected to a T-shaped conduit having two conduit arms to which the tube 3350 can be fluidly connected and a third conduit arm or opening that functions as a connecting port 3600 and can be connected to an air circuit 4170 in use.

[0240] The tube 3350 can be formed from a flexible material such as silicone resin or an elastomer such as TPE, and / or one or more woven and / or foamed materials. The tube 3350 may have a pre-formed shape and can be bent or moved into other shapes when force is applied, but can return to its original pre-formed shape when no force is applied. The tube 3350 may have a shape that approximates the contour of the patient's head between the top of the head and the nasal or oral cavity area, and may generally be arched or curved.

[0241] In some examples, one or more tubes 3350 are not compressed to prevent blockage when compressed during use, for example, when compressed between a patient's head and a pillow, especially when there is only one tube 3350. The tubes 3350 may be formed to have sufficient structural rigidity against crushing and may be configured as in U.S. Patent No. 6,044,844, the content of which is incorporated herein by reference.

[0242] Each tube 3350 may be configured to receive airflow from a connection port 3600 at the top of the patient's head and deliver the airflow to a sealing structure 3100 at the entrance to the patient's airway. In the example shown in Figures 3Y and 17, each tube 3350 is used positioned along a path extending from the plenum chamber 3200 through the patient's cheek region and over the patient's ear to the elbow 3610. For example, the portion of each tube 3350 near the plenum chamber 3200 may cover the maxillary region of the patient's head during use. Other portions of each tube 3350 may cover the head region of the patient above the base of the ear at the top of the patient's head. Each of one or more tubes 3350 may also be positioned over the patient's sphenoid bone and / or temporal bone, as well as one or both of the patient's frontal and parietal bones. The connection port 3600 and elbow 3610 may be positioned over the patient's parietal bone, frontal bone, or the junction between them during use.

[0243] In certain embodiments of this technology, the patient interface 3000 is configured such that the connection ports 3600 are positioned at a series of locations across the top of the patient's head, thereby allowing the patient interface 3000 to be positioned to suit the comfort or fit of an individual patient. In some examples, the headgear tube 3350 is configured to allow the upper part of the patient interface 3000 (e.g., the connection ports 3600) to move relative to the lower part of the patient interface 3000 (e.g., the plenum chamber 3200). That is, the connection ports 3600 may be at least partially separated from the plenum chamber 3200. In this way, the seal-forming structure 3100 can form an effective seal with the patient's face regardless of the position (at least within a predetermined position range) of the connection ports 3600 on the patient's head.

[0244] As described above, in some examples of this technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cradle cushion, typically located below the nose and sealed around the area below the nose. The positioning and stabilizing structure 3300 may be constructed and positioned to pull the seal-forming structure 3100 into the patient's face below the nose using a seal force vector having a posterior and upward direction (e.g., posterior-upward direction). The posterior-upward seal force vector facilitates the seal-forming structure 3100 to form a good seal between the area below the patient's nose and the front-facing surface of the patient's face on either the side of the patient's nose and upper lip.

[0245] 4.3.4.2.2 Stretchable and non-stretchable tube sections In some examples of this technology, the length of one or two tubes 3350 is not extendable. However, in some embodiments, the tube 3350 may include one or more extendable tube portions formed, for example, by an extendable bellows structure. In some embodiments, the patient interface 3000 may include a positioning and stabilizing structure 3300 which includes at least one gas delivery tube having a tube wall having an extendable bellows structure. The patient interface 3000 shown in Figure 3Y includes a tube 3350 whose upper part has an extendable tube portion, and each tube portion is in the form of an extendable bellows structure 3362.

[0246] The cross-sectional shape of the non-stretchable segment 3363 of tube 3350 can be circular, elliptical, D-shaped, or a rounded rectangle, for example, as described in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flat surface on the side of the tube that is in contact with the patient's face or other part of the head may be proportionally more comfortable to wear, as a tube with a circular cross-section.

[0247] In some examples of this technology, a non-extendable tube segment 3363 is connected to the plenum chamber 3200 at a low angle. The headgear tube 3350 may extend downward along both sides of the patient's head and then curve forward and in the middle to connect to the plenum chamber 3200 in front of the patient's face. The tube 3350 may extend to the same (or, in some examples, lower) vertical position as the connection to the plenum chamber 3200 before connecting to the plenum chamber 3200. That is, the tube 3350 may project at least partially upward before connecting to the plenum chamber 3200. A portion of the tube 3350 may be located below the cushion module 3150 and / or the seal-forming structure 3100. The tube 3350 may contact the patient's face below the patient's cheekbones, which is more comfortable than contacting above the patient's cheekbones and can avoid excessive blurring of the patient's peripheral vision.

[0248] 4.3.4.2.3 Conduit-type headgear connection port In certain embodiments of this technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or rear of the patient's head. For example, in the embodiments of this technology shown in Figures 3Y and 17, the connection port 3600 is located at the top of the patient's head. In this example, the patient interface 3000 includes an elbow 3610 to which the connection port 3600 is provided. The elbow 3610 may be configured to fluidly connect to a conduit of the air circuit 4170. The elbow 3610 is rotatable relative to the positioning and stabilizing structure 3300 to isolate the movement of the conduit connected to the connection port 3600 from the positioning and stabilizing structure 3300. In some embodiments, the elbow 3610 may be configured to rotate by rotating around a substantially vertical axis, and in some specific embodiments, it may be configured to rotate by rotating around two or more axes. In some embodiments, the elbow may include a tube 3350 or be connected to the tube 3350 via a ball-socket fitting. The connection port 3600 may be located in the sagittal plane of the patient's head in use.

[0249] A patient interface in which the connection port is not positioned in front of the patient's face may be advantageous because some patients may find the connection of the conduit to the patient interface in front of their face to be visually distracting and intrusive. For example, a conduit connecting to the patient interface in front of the face may be prone to entanglement with bedding or bed linens (especially if the conduit extends downward from the patient interface during use). Embodiments of this technology include a patient interface having a connection port positioned above the patient's head during use, allowing the patient to sleep more easily or comfortably in one or more positions, such as lateral, supine (e.g., supine, substantially upward), or prone (e.g., prone, substantially downward). Furthermore, if the conduit is connected in front of the patient interface, the conduit may exert undesirable forces on the patient interface during movement of the patient's head or the conduit, thereby exacerbating a problem known as tube drag, which can cause the conduit to detach from the face. Tube resistance may not be a problem if the force is applied at a position above the patient's head rather than in front of the patient's face, which is closer to the seal formation structure (tube resistance is more likely to break the seal).

[0250] 4.3.4.2.4 Headgear Tube Fluid Connection In the example of Figure 3Y, two tubes 3350 are fluidly connected to a plenum chamber 3200 at their lower ends. In certain embodiments of the art, the connection between the tubes 3350 and the plenum chamber 3200 is achieved by connecting two rigidizer connectors. The tubes 3350 and the plenum chamber 3200 may be configured to allow a patient to easily and reliably connect the two components. The tubes 3350 and the plenum chamber 3200 may be configured to provide tactile and / or auditory feedback in the form of a “reassurance click” or similar sound so that the patient can easily know that each tube 3350 is properly connected to the plenum chamber 3200. In one embodiment, the tubes 3350 are formed of silicone, and the lower end of each silicone tube 3350 is overmolded into a rigid connector, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector may include a male mating feature configured to connect to a female mating feature on a cradle cushion module 3150. Alternatively, the rigid connector may include a female mating feature configured to connect to a male mating feature on the cradle cushion module 3150. In another example, the tube 3350 may include a male or female connector formed from a flexible material such as silicone resin or TPE, the same material that forms the tube 3350.

[0251] In other examples, compression seals are used to connect each tube 3350 to the plenum chamber 3200. For example, an elastically flexible (e.g., silicone) tube 3350 without a rigid connector needs to be slightly extruded to reduce its diameter so that it can fit into a port in the plenum chamber 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward, allowing it to airtightly seal to the port. Alternatively, in a hard-to-hard type engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or the plenum chamber 3200 may include a pressure-actuated seal, such as a circumferential sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange is pressed against the junction between the tube and the inner circumferential surface of the port in the plenum chamber 3200, reinforcing the seal between them.

[0252] The tube 3350 may be configured to be held in a suitable position relative to the plenum chamber 3200.

[0253] Referring to Figure 17, in some embodiments, at least one headgear tube 3350 is attached to the plenum chamber 3200, and for example, the patient-facing (posterior) side of the headgear tube 3350 may be attached to the frame portion 3210. In the example shown, at least one headgear tube 3350 is detachably connected to the frame portion 3210. This facilitates the replacement, cleaning, and / or storage of the headgear conduit 3350.

[0254] In the example shown in Figure 21, at least one headgear tube 3350 includes a connector 3358 that facilitates the removable mounting of at least one headgear tube 3350 to the plenum chamber 3200. As shown, the connector 3358 includes a lip extending around at least a portion of the opening 3356, which may be connected to the plenum chamber 3200 by an interlocking or friction fit. For example, the lip may be interlocked around the inlet 3220 in the plenum chamber 3200. However, in other embodiments, the connector 3358 may include any other suitable connector or connecting mechanism to facilitate removable mounting between two components, including interlocks, clips, shackle connectors, high-friction surfaces, etc.

[0255] In some configurations, at least one headgear tube 3350 does not have to be directly connected to the plenum chamber 3200. For example, at least one headgear tube 3350 may be held in place on the plenum chamber 3200 by a force applied to the at least one headgear tube 3350 in a rearward direction. That is, the tension of the headgear strap can hold the frame 3360 in place. The outer (i.e., front) surface of the plenum chamber 3200 may include a recess 3230, as shown in Figure 20 and described below. The recess may be elongated and extend laterally across the plenum chamber 3200. The recess may be configured to allow the lower part of the tube 3350 to be nested into the groove in order to help hold the plenum chamber 3200 in place during use.

[0256] In the embodiments of this technology shown in Figures 17 to 21, the positioning and stabilizing structure 3300 includes two tubes 3350. As shown in Figures 17 and 18, in some embodiments, the two tubes 3350 are fluidly connected to each other at their lower ends and connected to an inlet 3220. The two tubes 3350 may be integrally formed as shown in Figure 18, or they may be formed separately but connected and disconnected during use, as shown in Figures 17 and 21. This facilitates cleaning, replacement, or storage of the tubes 3350.

[0257] For example, as shown in Figures 17 and 21, the positioning and stabilizing structure 3300 may include a tubular section 3354. The tubular section 3354 may be located in front of the plenum chamber 3200 during use.

[0258] The tubular section 3354 may be constructed and positioned to extend through at least a portion of the plenum chamber 3200 when in use. The tubular section 3354 may extend through the front portion 3211 and the side portion 3213 of the plenum chamber 3200. As shown in Figures 17 and 18, in some embodiments, the tubular section 3354 may extend through the entire width of the plenum chamber 3200 (i.e., the distance between the lateral edges or ends of the plenum chamber 3200).

[0259] In some configurations, the tubing portion 3354 is configured to connect the lower ends of two pipes 3350 to each other. As shown in Figure 21, the tubing portion 3354 may include a connector 3358.

[0260] In the embodiments shown in Figures 17 and 21, the tube portion 3354 is formed separately, and two tubes 3350 are attached to the tube portion 3354. However, in some embodiments, as shown in Figure 18, for example, the tube portion 3354 may be formed integrally with the two tubes 3350 to form a single tube structure.

[0261] The tube portion 3354 may be made of a different material(s) from the two tubes 3350. For example, the tube portion 3354 may be harder than the two tubes 3350. The tube portion 3354 may also be made of the same material as the tubes 3350.

[0262] In some configurations, the tube portion 3354 may be considered to function as a rigidizer for the plenum chamber 3200, as described above.

[0263] 4.3.4.2.5 Conduit-type headgear, headgear strap In a particular embodiment of this technology, the positioning and stabilization structure 3300 includes at least one headgear strap acting in addition to the tube 3350 to position and stabilize the seal-forming structure 3100 at the entrance to the patient's airway. As shown in Figures 3Y and 17, the patient interface 3000 includes a headgear strap 3310 that forms part of the positioning and stabilization structure 3300. The headgear strap 3310 is also known, for example, as a back strap or rear head strap. The strap 3310 may be connected between two tubes 3350 positioned on either side of the patient's head and, when worn, lies over or under the occipital bone of the patient's head, for example during use, passing around the back of the patient's head. The strap 3310 may be connected to each tube over the patient's ears. Referring to Figures 3Y and 17, the positioning and stabilization structure 3300 includes a pair of tabs 3352 provided on the front side of the tube 3350. During use, the strap 3310 can be connected between the tabs 3352. Tab 3352 facilitates the connection of strap 3310 to tube 3350. For example, tab 3352 may include a hole through which strap 3310 can pass. Strap 3310 has sufficient flexibility to bypass the back of the patient's head and rest comfortably against the patient's head, even when tension is applied during use.

[0264] In other examples of the technology, one or more additional straps may be provided. For example, a patient interface 3000 according to an example of the technology that adopts the form of a full face mask may have two connections to a plenum chamber and / or cushion module on both sides of the patient's face, forming a "four-point connection" (opposite to the two-point connection in Figure 17). In these embodiments, the positioning and stabilizing structure may include a second strap connected between the plenum chamber and / or cushion module and a portion of the positioning and stabilizing structure, and positioned on the upper and / or rear of the patient's head when in use. For example, the second strap may be located below the conduit-type headgear tube 3350 when worn, and may be configured to follow the posterior surface of the patient's head and / or neck, close to the patient's neck.

[0265] 4.3.4.3 Headgear Rigidizer As shown in Figures 6A-9D and 11A-15D, the positioning and stabilizing structure 3300 includes a headgear rigidizer such as a rigidizer arm 3330 and / or a ventilation module 3420 in several embodiments. For example, in Figures 6A-9D and 11A-12E, the positioning and stabilizing structure 3300 includes a rigidizer arm 3330. In the example of Figures 11A-12E, the ventilation module 3420 functions as a headgear rigidizer. In another example, in Figures 13A-15D, the positioning and stabilizing structure 3300 includes a ventilation module 3420 that functions as a headgear rigidizer. In these embodiments, the ventilation module 3420 is considered to function as a rigidizer arm 3330.

[0266] 4.3.4.4 Connectors In some configurations, the patient interface 3000 includes a pair of connectors 3800 to facilitate the attachment of the plenum chamber 3200 to the positioning and stabilization structure 3300.

[0267] According to various aspects of this technology, the connector 3800 may be included as part of the ventilation structure 3400, as shown in Figures 6A to 12E. For example, part of the ventilation module 3420 may be configured to provide the connector 3800. These aspects of this technology will become clearer from the following description.

[0268] In certain configurations, the patient interface 3000 may include other types of connectors, for example, as shown in Figures 10A-10C and 13A-15D. The plenum chamber 2300 includes a pair of connectors 3214 configured to connect the plenum chamber 2300 to the conduit section 3320. The connectors 3214 may be provided on either side of the frame section 3210. As shown, each connector 3214 is provided on its respective lateral projection connection section 3212. In the illustrated example, the connector 3214 is provided on the opening 3240 of the lateral projection connection section 3212.

[0269] The patient interface 3000 may have a connector 3214 that also functions as a connector 3800. For example, the connector that connects the plenum chamber 2300 to the conduit section 3320 can also be used to connect the patient interface 3000 to the positioning and stabilization structure 3300, since the conduit section 3320 forms part of the positioning and stabilization structure 3300. For example, this is the case in the configurations shown in Figures 13C and 15D, where the conduit section 3320 is formed as part of the positioning and stabilization structure 3300, which is connected to the patient interface 3000 using the connector 3214. Alternatively, the patient interface may have a connector 3214 for connecting the plenum chamber 2300 to the conduit section 3320, and the conduit section 3320 is separate from the connector 3800 that connects the patient interface 3000 to the positioning and stabilization structure 3300. In other configurations, the connector 3214 may connect a ventilation structure 3400 (e.g., a ventilation module 3240) to the plenum chamber 3200, and the positioning and stabilization structure 3300 is connected to the patient interface 3000 via a separate connector 3800. In the example shown in Figures 10A-10C, the connector 3214 is configured to connect to a ventilation module 3420, which includes a separate connector 3800 that connects to the headgear strap 3310 when in use, as described later.

[0270] 4.3.4.5 Attaching the headgear strap to the connector Referring to Figures 6A and 6D, the headgear strap 3310 may be detachably attached to the connector 3800. For example, in the examples of Figures 10A to 10C, the headgear strap 3310 (not shown) can be detachably attached to the connector 3800, which includes a slot 3820. In the examples of Figures 6A to 6D, the headgear strap 3310 can be detachably attached to the connector by a button fastener.

[0271] Referring to Figure 6C-1, the headgear strap 3310 may include a buttonhole 3312. In this embodiment, the headgear strap 3310 includes a tubular or sleeve-like configuration that receives a portion of a connector 3800 inserted into at least one headgear strap 3310 via the buttonhole 3312. This allows a portion of the headgear strap 3310 to enclose the connector 3800 when connected. Referring to the embodiment shown in Figure 6B, the rigidizer arm 3330 or a portion thereof may function as a connector 3800 that is connected to the headgear strap 3310 and, for example, packaged by the headgear strap 3310. In these embodiments, the headgear strap 3310 may be detachably attached to the rigidizer arm 3330.

[0272] As shown in Figure 6C-1, the buttonhole 3312 is located on the inner surface of the headgear strap 3310 and may be adapted to receive a connector 3800 such as a rigidizer arm 3330, and as described above, it can be inserted into or removed from the inside of the headgear strap 3310, and the headgear strap 3310 may have a tubular or sleeve-like configuration. The buttonhole 3312 may be oriented and / or shaped so that the rigidizer arm 3330 can be inserted into and / or removed through the buttonhole 3312 in order to assemble the positioning and stabilizing structure 3300, and also so as to prevent the rigidizer arm 3330 from being unintentionally removed or separated from the strap 3310 during use. As shown in Figure 6C-1, the buttonhole 3312 may have a slit-like structure oriented longitudinally or transversely with respect to the length of the headgear strap 3310. In other words, the elongated extension of the buttonhole 3312 may extend substantially coaxially with the longitudinal axis of the headgear strap 3310 and the rigid arm 3330. This allows the rigidizer arm 3330 to be easily inserted into the tubular or sleeve-shaped headgear strap 3310 or a portion of the headgear strap 3310, particularly due to the elasticity of the headgear strap 3310, and prevents accidental removal. The end of the headgear strap 3310 between its tip and the buttonhole 3312 can be wrapped around the edge of the rigidizer arm 3330 to form an anchor point. This edge or anchor of the rigidizer arm 3330 may be used as a capture member. This end of the headgear strap 3310 may also be called the pocket end 3311. This prevents the headgear strap 3310 from slipping off the inserted rigidizer arm 3330 when the headgear strap 3310 is stretched and adjusted during attachment and detachment of the patient interface 3000.

[0273] 4.3.5 Ventilation Structure In some examples of this technology, the patient interface 3000 includes a ventilation structure 3400 configured to allow gases exhaled by the patient to flow from inside the plenum chamber 3200 outwards. The ventilation structure 3400 may be configured to have a ventilation flow rate large enough to reduce the rebreathing of the patient's exhaled CO2 while maintaining therapeutic pressure within the plenum chamber 3200 during use.

[0274] As described above, in the embodiments of this technology shown in Figures 6A to 23, the ventilation structure 3400 may be configured to ventilate the gas flow from inside the plenum chamber 3200 in a substantially lateral direction during use.

[0275] As shown in Figures 6A and 623, each ventilation structure 3400 is located on the side of the patient interface 3000 or on the side of the inlet 3220 above the side, for example, on the side 3213 of the plenum chamber 3200.

[0276] In some forms, as shown in Figures 10A–11C, 13A–13C, and 15A–15C, the patient interface 3000 may include a separate ventilation structure 3400A configured to ventilate another gas flow from inside the plenum chamber 3200. The ventilation structure 3400A may be configured to ventilate the gas flow substantially forward when in use. The ventilation structure 3400A may be located near an inlet 3220 located in the inner region of the plenum chamber 3200. The ventilation structure 3400A may be included as part of a connection port 3600 connected to the inlet 3220.

[0277] In a preferred embodiment, the ventilation structure 3400 includes a plurality of ventilation holes 3410. In embodiments shown in Figures 6A to 9D, 11A to 15D, and 17 to 23, the ventilation structure 3400 may also include a ventilation wall 3412 containing the ventilation holes 3410. In some embodiments, as shown in Figures 6A, 8B, 9B, and 11C, the diameter of the inlet opening of each ventilation hole 3410 may be larger than the diameter of the outlet opening of each ventilation hole 3410. Thus, the opposing inner walls of each ventilation hole 3410 may converge toward each other.

[0278] In the embodiments shown in Figures 10B to 10C, the ventilation holes 3410 are provided in the form of channels defined by the arrangement of flow paths, such as the ventilation wall 3414. In other words, in this example, the ventilation structure 3400 does not have to include a plurality of individual ventilation holes 3410 formed in the ventilation wall 3412.

[0279] 4.3.5.1 Location of Ventilation Structures As shown in Figures 6A to 23, the ventilation structure 3400 is positioned laterally in the inner region of the patient interface 3000, for example, in the inner region of the plenum chamber 3200. The ventilation structure 3400 may be substantially oriented laterally during use, that is, it may be positioned on a surface that has at least a partial lateral angle.

[0280] In conventional patient interfaces or masks, ventilation holes or structures are typically located in the anterior region of the mask, particularly the inner region, and the inlet, connected to the delivery tube, is located near the ventilation holes in the same region of the mask. In other words, the ventilation holes and inlet are usually located in the anterior and / or central region of the mask. As shown in the conventional mask 3000 in Figure 6, during exhalation, air entering the mask 3000 from the air circuit 3700 through the inlet 3220 collides with the air exhaled from the patient and moves away from the mask 3000 through the outlet 3400 at a significant angle (approximately 180° in the case of Figure 6). In some configurations, as indicated by the arrows in Figure 6, this can result in a lot of shear and contact between the airflow entering through the inlet 3220 and the air exhaled through the patient's nostrils. During inspiration or apnea, air entering the plenum chamber 3200 through the inlet port 3220 and / or the airflow during the patient's inspiration collides with the air in the plenum chamber 3200. The air in the plenum chamber 3200 may include air exhaled by the patient flowing at a significant angle to the direction of airflow into the plenum chamber 3200, for example, a relative angle of about 180°. These two airflows collide, creating shear between the airflow entering from the inlet 3220 and the air in the mask 3000 (which may include patient exhalation). Such shear and contact increase the turbulence and cyclic noise generated by the patient interface 3000 during use. The amount of shear and contact, and the resulting amount of turbulence and noise, may be greater during inspiration than during expiration. This is because the volume and / or velocity of the airflow entering the mask 3000 through the inlet port 3220 during inspiration, for example, the volume and / or velocity of the airflow supplied by the delivery tube 4172, may be greater than the volume and / or velocity of the airflow during expiration. This relatively large inflow of air helps maintain positive pressure inside the mask 3000 during inhalation, while maintaining pressure inside the mask 3000 during exhalation requires less air to flow in through the inlet port 3220, for example, from the delivery tube 4172.

[0281] Compared to the prior art, the arrangement of the ventilation structure 3400 in this technology reduces static acoustic power and cycle noise by reducing the angle at which the direction of gas flow changes direction between entering the plenum chamber 3200 via the inlet 3220 and exiting the plenum chamber 3200 via the ventilation structure 3400, compared to the prior art mask shown in Figure 6. For example, the ventilation arrangement of the prior art mask shown in Figure 6 moves air at an angle of approximately 180° (i.e., air enters the plenum chamber 3200 almost rearward and is discharged almost forward through the ventilation structure 3400). In contrast, in the embodiment of this technology, the ventilation arrangement, for example, the position and / or orientation of the ventilation structure 3400 on the patient interface 3000, is configured to reduce the angle at which the direction of gas flow changes direction from inlet to outlet. For example, the position and / or orientation of the ventilation structure 3400 may reduce the angle of the direction of the gas flow entering the plenum chamber 3200 through the inlet 3220, causing a deflection or shift of approximately 60°. This can reduce shear and turbulence between the air entering the plenum chamber 3200 and the exhaled air, thereby reducing noise. The ventilation arrangement of this technology can also separate the airflow during inspiration, as will be described in more detail below.

[0282] In this embodiment of the technology, the air circuit 4170 is connected to the plenum chamber 3200, and as shown in the examples in Figures 6A-15D, the ventilation structure 3400 is located laterally away from the inlet 3220 rather than in the vicinity of either side of the inlet 3220. In the example of Figure 22, the ventilation structure 3400 is located near the side edge of the inlet 3220, but as described herein, the connection port 3600 provided in the frame 3360 effectively reduces the size of the inlet 3220. Therefore, in this example, the ventilation structure 3400 is also located laterally away from the connection port 3600. By positioning the ventilation structure 3400 away from the inlet 3220 and / or connection port 3600 on the side of the patient interface 3000, the angle at which the direction of gas flow into the plenum chamber 3200 is directed away from the plenum chamber 3200 is reduced, thereby reducing air shear, turbulence, and noise. Referring to Figures 9B, 10B, 11C, 12C, 13C, and 15D, the position and / or orientation of each ventilation structure 3400 can reduce the angle at which the airflow direction is oriented before leaving the ventilation structure 3400 compared to the prior art design. This can reduce shear, turbulence, and noise compared to the prior art. Sharper turns or changes of direction of airflow, or larger changes of direction or angles of change of direction, as shown in the prior art mask in Figure 6, can cause more exhaust noise. By positioning the ventilation structure 3400 laterally away from the inlet 3220 and / or connection port 3600, turbulence resulting from the mixing of gas flow from the air circuit into the plenum chamber 3200 during exhalation and gas flow from the patient's nostrils into the plenum chamber 3200 can be reduced. Turbulence generated in the vicinity of the ventilation structure 3400 can negatively impact patient interface acoustics because it generates noise in the ventilation structure 3400, limiting the isolation or absorption of noise before it reaches the patient or their sleeping partner. As shown in Figure 6, in conventional patient interfaces where the ventilation structure is located close to the inlet, it was observed that the air circuit and the gas flow entering the plenum chamber from the patient's nostrils collide, causing turbulence near the ventilation structure.As indicated by the arrows in Figures 9B, 10B, 11C, 12C, 13C, and 15D, various forms of exhaust systems of this technology can divide the air circuit 4170 and the gas flow entering the plenum chamber 3200 from the patient's nostrils into two spaced-apart ventilation structures 3400 that form separate arcs toward their respective ventilation structures 3400. This may contribute to gas diffusion. It should be understood that the examples in Figures 17, 18, and 22 have similar exhaust systems.

[0283] The ventilation structure 3400 may be located on the plenum chamber 3200, for example, on the frame portion 3210. As shown in Figures 6A to 9D, 11A to 12E, and Figures 18, 20, and 22, the ventilation structure 3400 may be located on the portion of the plenum chamber 3200 that is close to the side end of the plenum chamber 3200.

[0284] In the embodiments of the technology shown in Figures 10A-10C and 13A-15D, the ventilation structure 3400 may be provided as part of the patient interface 3000 located laterally to the plenum chamber 3200 during use. As shown in the figures, the ventilation structure 3400 may be positioned laterally to the cushion module 3150 during use. The ventilation structure 3400 may be separated from the lateral end of the plenum chamber 3200, for example, from the lateral end of the cushion module 3150. In these embodiments, part of the positioning and stabilization structure 3300 may include the ventilation structure 3400, as will be further described below.

[0285] 4.3.5.2 Ventilation Module In some configurations, as shown in Figures 9A–13C and 15A–15D, each ventilation structure 3400 includes a ventilation module 3420. The ventilation module 3420 is a component that may be formed separately and is connected to the patient interface 3000 during manufacturing or use. For example, during manufacturing, the ventilation module 3420 may be connected to a part of the patient interface 3000, such as a plenum chamber 2300. The ventilation module 3420 may be permanently or detachably connected to the patient interface 300. In examples where the ventilation module 3420 can be detached from the patient interface 3000, this facilitates cleaning or replacement of the ventilation module 3420.

[0286] As shown in Figures 9A to 13C and 15A to 15D, the ventilation module 3420 may include a ventilation wall 3412 containing one or more ventilation holes 3410 that ventilate laterally from the patient interface 3000. In some examples, one or more other walls may form a conduit section 3320.

[0287] The ventilation module 3420 may be configured to connect to an opening 3240 or a portion of a plenum chamber 3200 that includes a ventilation module opening. In some embodiments, as shown in Figures 10B, 10C, 13C, and 15D, the lateral projection connection 3212 includes an opening 3240. In some embodiments, as shown in Figures 6C, 6D, 8B, 9B, 11C, and 12C, the opening 3240 is provided in a frame portion 3210, for example, in a front portion 3211. The opening 3240 may be provided in a lateral region of the front portion 3211, which is oriented laterally with respect to the inlet 3220. The lateral region may be substantially lateral or may have a lateral angle.

[0288] In some examples shown in Figures 6A to 15D, the plenum chamber 3200 includes a rigidizer. The rigidizer may also be in the form of a ventilation module 3420 and / or a connection port 3600. The rigidizer may be used to increase the rigidity of the plenum chamber 3200. For example, the frame portion 3210 is rigidified by the ventilation module 3420 and / or the connection port 3600. The rigidizer is configured as a relatively rigid component, for example, by being formed from a material having a relatively high modulus of elasticity and / or by forming a relatively rigid shape.

[0289] 4.3.5.3 Positioning and stabilization structures including ventilation structures In some embodiments of this technology, for example, as shown in Figures 13A to 15D, the positioning and stabilizing structure 3300 includes a ventilation structure 3400. In the illustrated examples of Figures 13 to 15, the positioning and stabilizing structure may include a conduit section 3320, and the conduit section 3320 may include a ventilation structure 3400.

[0290] As shown in Figures 13C and 15D, the plenum chamber 3100 may include a lateral opening 3240, and the conduit section 3320 is configured to communicate fluidly with the interior of the plenum chamber 3100 through the lateral opening 3240 during use. Each conduit section 3320 may be connected to each connector 3214 provided in each opening 3240.

[0291] In the examples of Figures 13C and 15D, the headgear strap 3310 may be included as part of the conduit section 3320. For example, the headgear strap 3310 may be permanently attached to the conduit section 3320. As shown in Figures 13B, 13C, 15C, and 15D, at least a portion of the headgear strap material may cover at least a portion of the conduit section 3320 and further cover at least a portion of the ventilation structure 3400. The portion of the ventilation structure 3400 that covers the headgear strap material can serve to diffuse the ventilation airflow, i.e., it can form a diffuser 3900. In these embodiments, the conduit section 3320 is considered to be part of the positioning and stabilization structure 3300. As shown in Figures 13A to 15D, the conduit section 3320 is included as part of the ventilation module 3420.

[0292] As shown in Figures 13A, 14A, and 15A, the lower end of the positioning and stabilizing structure 3300 is connected to the plenum chamber 3200 during use, and the upper end of the positioning and stabilizing structure 3300 is located in the upper and / or posterior region of the patient's head during use. The conduit section 3320 may include the lower end portion of the positioning and stabilizing structure 3300. This allows the ventilation structure 3400 to be located closer to the lower end during use.

[0293] In the examples of Figures 13A to 13C, the patient interface 3000 includes the deflector 3500 described above. In the examples of Figures 15A to 15D, the patient interface 3000 may not have the deflector 2500 described above. However, in some embodiments, as shown in Figures 15C and 15D, the ventilation structure 3400, such as the ventilation module 3420, may include a rear wall 3514 configured to redirect some ventilation.

[0294] In some embodiments, for example, as shown in Figures 13A and 15D, the conduit 3320 may be configured to be relatively rigid, such as by being formed from a material with a relatively high modulus of elasticity or by being formed in a shape that promotes rigidity. In some embodiments, the conduit 3320 may be formed from a relatively flexible material, and the conduit 3320 may include a support structure (not shown) to increase rigidity and limit and / or prevent blockage of the conduit 3320, thereby preventing or limiting the release of air into the surrounding area. This can help limit and / or prevent blockage of forces applied while a patient is lying on their side, for example. The support structure may be provided by one or more of the following: a reinforcing structure, a thickened region, and a reinforced region.

[0295] 4.3.5.4 Plenum Chamber with Ventilation Structure In some embodiments of this technology, the plenum chamber 3200 includes a ventilation structure 3400, as shown in Figures 17-23, for example. For example, the ventilation structure 3400 may be located on the side of the inner region of the plenum chamber 3200, i.e., in the lateral region of the plenum chamber 3200.

[0296] As shown in Figure 20, ventilation holes 3410 may be formed in the side portion 3213 of the frame portion 3210 of the plenum chamber 3200. In this embodiment, the plenum chamber 3200 provides a ventilation wall 3412.

[0297] 4.3.6 Deflector In some embodiments of this technology, for example as shown in Figures 6A to 6C, the patient interface 3000 includes a deflector 3500 configured to redirect or rotate at least a portion of the ventilated gas flow. In a particular embodiment, the patient interface 3000 includes, for example, a pair of deflectors 3500 arranged symmetrically on both sides of the patient interface 3000.

[0298] 4.3.6.1 The ventilated gas flow is redirected forward. In some embodiments of this technology, as shown in Figures 6A to 6C, for example, each deflector 3500 is configured to alter a portion of the gas flow ventilated laterally in any direction having the front of the patient. That is, the airflow deflected by the deflector 3500 has a velocity, which is a vector having magnitude (velocity) and direction. In some embodiments, the forward direction is generally understood as the velocity vector of the deflected airflow having a positive component relative to the front of the patient. The velocity vector of the deflected gas flow may also have a positive component in directions perpendicular to the forward direction, such as upward, downward, or laterally. For example, the velocity vector may be in the upward forward direction, downward forward direction, upward forward lateral direction, or downward forward lateral direction.

[0299] For the purposes to be explained later, when referring to the direction of the ventilation gas flow redirected by the deflector 3500, for convenience we will refer to any direction having a forward component relative to the patient (i.e., as described above) as "one forward direction" (this is intended to distinguish it from "the aforementioned forward direction").

[0300] In some forms, the direction of the velocity vector of a redirected airflow may be substantially forward. Substantially forward can be understood as meaning that the maximum component of the velocity vector in a reference frame of mutually perpendicular axes of the object is forward in that direction. In other words, a redirected gas flow may be moving further forward than in any other direction.

[0301] In some configurations, each deflector 3500 is configured to redirect most of the laterally ventilated gas flow forward during use. In some configurations, each deflector 3500 is configured to redirect all of the laterally ventilated gas flow forward during use. The forward direction is shown in Figure 2D. In other words, the deflector 3500 is configured to redirect a portion, preferably at least most, of the laterally ventilated air toward the front during use away from the patient's face.

[0302] The deflector 3500 may be configured to redirect laterally ventilated air toward the anterior portion of the patient's face located in the median sagittal plane during use. In some embodiments, the deflector 3500 may be configured to redirect most of the laterally ventilated gas flow toward a portion of the air delivery tube 4172 during use. These embodiments of the Art will be described in more detail below.

[0303] In the illustrated examples in Figures 6A to 13C, each deflector 3500 includes an arrangement structure of one or more deflector walls 3512, 3514, 3516, and 3518.

[0304] Referring to the examples shown in Figures 6A to 13C, at least a portion of one of the deflector walls 3512, 3514, 3516, and 3518 is configured to be located in the path of the airflow ventilated laterally from at least a portion of the ventilation structure 3400 when in use. This can be called a deflector 3500 that "covers" the ventilation structure. It should be understood that the deflector 3500 may be separated from the ventilation structure 3400 while being located in the flow path of the air ventilated from the ventilation structure 3400. At least one wall may be a side wall 3512 configured to restrict / prevent the ventilated air from flowing laterally away from the patient's face, i.e., in the same direction as the air expulsion.

[0305] As shown in Figures 6C, 6D, 8B, 9B, 11C, 12C, and 13C, the side wall 3512 has a ventilation-facing surface 3512a spaced apart from the opposing surface 3412a of the ventilation wall 3412 in use. This provides a gap 3520 between the side wall 3512 and the ventilation wall 3412, allowing air to be ventilated through this gap.

[0306] In some embodiments, as shown in Figures 6A to 9D and Figures 13A to 13C, a portion of the side wall 3512 covering a portion of the ventilation structure 3400 may extend in a direction substantially perpendicular to the direction in which air is ventilated from the ventilation structure 3400. In some embodiments, as shown in Figures 6A to 9D and Figures 13A to 13C, a portion of the side wall 3512 covering a portion of the ventilation structure 3400 may extend in a direction substantially parallel to the direction in which the surface of the ventilation wall 3412 extends.

[0307] In some embodiments, the deflector 3500 includes several other deflector walls, such as a rear wall 3514, an upper wall 3516, and a lower wall 3518. The rear wall 3514 may be configured to restrict / prevent airflow in the rearward direction, i.e., airflow in the rearward direction. The rearward direction is directed, for example, towards the patient's face, eyes, and / or ears. The upper wall 3516 may be configured to restrict / prevent airflow in the upward direction, for example, upward along the patient's face. The lower wall 3518 may be configured to restrict / prevent airflow in the downward direction, for example, downward along the patient's face. For example, in some embodiments, the gas flow is meant to flow uniformly out of the gap 3520 between the deflector walls 3512, 3514, 3516, 3518 and the ventilation wall 3412. The distribution of redirected air can be made equal as the air leaves the gap 3520. The gap 3520 may be configured to surround a portion of the ventilation structure 3400. The gap 3520 may be configured to enclose most of the ventilation structure 3400. The gap 3520 may be configured to allow airflow such that the angle A between the direction of the highest gas flow and the direction of the lowest gas flow is between about 0° and about 280°. Figure 9A shows angle A in one embodiment of the art. The gap 3520 may be configured to allow forward gas flow such that the angle A between the direction of the highest and lowest gas flow is about 0° to about 280°, preferably about 0° to about 180°, and in some examples about 0° to about 120°, about 0° to about 100°, about 20° to about 180°, about 30° to about 120°, about 10° to about 90°, or about 45° to about 90°.

[0308] In some forms, the gap 3520 may be configured such that angle α limits / blocks the concentration of airflow and promotes the diffusion of airflow. In some forms, the gap 3520 may be configured such that angle A improves patient comfort during use by limiting / preventing airflow to the patient's face, eyes, and / or ears. The temperature of the airflow may be lower than the ambient temperature, such as cold air, and if the airflow comes into contact with the patient's face, eyes, ears, or other temperature-sensitive areas, it may cause discomfort to the patient. Thus, the gap 3520 may be configured to give an angle α between the direction of the uppermost and lowermost airflows that is large enough to limit and prevent the concentration of gas flow and promote some diffusion, but small enough to limit and prevent patient discomfort from gas flow contact with the patient.

[0309] Other deflector walls 3514, 3516, and 3518 may extend from the lateral surface 3412a. For example, as shown in Figures 6A to 13C, the other deflector walls 3514, 3516, and 3518 may extend in a direction substantially perpendicular to the direction in which the lateral surface 3412a extends. A gap 3520 is provided between the other deflector walls 3514, 3516, and 3518, the side wall 3512, and the ventilation wall 3412.

[0310] In some examples, as shown in Figures 6A to 6C, the deflector 3500 may include a spacer 3530 that positions the side wall 3512 above the ventilation wall 3412 in use. In some examples, the spacer 3530 may extend from either the lateral surface 3412a or the ventilation-facing surface 3512a. The spacer 3530 may extend in a direction substantially perpendicular to the direction in which the lateral surface 3412a extends.

[0311] One or more other deflector walls 3514, 3516, 3518 may provide spacers 3530.

[0312] In some embodiments, for example in the embodiments shown in Figures 6A to 13C, the deflector 3500 or at least a portion thereof, for example, one or more of the deflector walls 3512, 3514, 3516, and 3518, may be included as part of the ventilation structure 3400. In some embodiments shown in the examples in Figures 6A to 13C, the deflector 3500 or at least a portion thereof may be included as part of the connector 3800, for example, one or more of the deflector walls 3512, 3514, 3516, and 3518 may be included as part of the connector 3800. In some embodiments, the connector 3800 is included as part of the ventilation structure 3400. For example, referring to embodiments in Figures 6A to 12E, a portion of each ventilation module 3420 is configured to provide the connector 3800.

[0313] 4.3.6.2 Air-impermeable deflectors In certain forms of technology, such as those shown in Figures 6A-6C, the deflector 3500 is air-impermeable. As shown in Figures 9A, 9B, 10B, and 10C, the side wall 3512 deflects the discharged air from the deflector 3500 through the gap 3520 in the direction indicated by the arrows included for illustrative purposes.

[0314] As shown in the examples in Figures 10B and 10C, the deflector walls 3512, 3514, 3516, and 3518 are arranged to form a rotating section 3414 that rotates or redirects the air ventilated laterally from inside the plenum chamber 3200 through the ventilation holes 3410. In the illustrated embodiments of Figures 10A to 10C, the ventilation module 3420 is configured such that the deflector walls 3512, 3514, 3516, and 3518 are spaced apart from the ventilation wall 3412. The deflector 3500 in this example can rotate the air by approximately 180°. Referring to Figures 10A to 10C, the ventilation module 3420 includes a connector 3800. For example, the connector 3800 may be located at the side end of the ventilation module 3420. In the illustrated examples in Figures 10A to 10C, the connector 3800 is a slot 3810 configured to receive a portion of the headgear strap 3310 for connecting the headgear strap 3310 to the patient interface 3000.

[0315] In the illustrated configurations of Figures 6A to 6D, the deflector 3500 does not include other deflector walls 3514, 3516, and 3518. It comprises a side wall 3512 and a spacer 3530. In this configuration, the ventilated air may be directed not only forward but also backward, upward, and / or downward. In this configuration, the lower surface of the spacer 3530 may function as the upper wall of a ventilation hole 3410 located below the spacer 3530, and the upper surface of the spacer may function as the lower wall of a ventilation hole located above the spacer 3530.

[0316] In some embodiments, as shown in Figures 7A–9D, the deflector 3500 may include one or more other walls 3514, 3516, 3518. For example, the deflector 3500 includes a rear wall 3514. The rear wall 3514 may have a substantially arc-shaped or curved shape when the patient interface 3000 is viewed substantially laterally (i.e., from the side). As shown in Figures 8A–8C, the rear wall 3514 may extend to form at least a portion of the lower wall 3518 and the upper wall 3516. In Figures 7A–8C, the upper wall 3516 and the lower wall 3518 may extend through portions of the upper and lower regions, respectively, of the ventilation structure 3400. This allows some of the air to be redirected up and down through the gap 3520 between the side wall 3512 and the ventilation wall 3412. However, referring to Figures 9A to 9D, the upper wall 3516 and the lower wall 3518 may extend through the majority of the upper and lower regions, respectively, of the ventilation wall 3412. This can limit and prevent the amount of air redirected vertically. This can help concentrate airflow that is substantially redirected forward.

[0317] In the examples shown in Figures 6A to 9D, the connector 3800 is included as part of the deflector 3500, i.e., the deflector 3500 is configured to function as the connector 3800 connecting the positioning and stabilization structure 3300 to the patient interface 3000.

[0318] In the embodiments shown in Figures 6A to 9D, the positioning and stabilization structure 3300 includes a headgear rigidizer. The rigidizer may include rigidizer arms 3330 on each side of the patient interface, for example, to connect to the corresponding headgear strap. The deflector 3500 may be included as part of the rigid arm 3330, so that a portion of the rigid arm 3330 functions as the deflector 3500 and connector 3800. In these embodiments, the side wall 3512 is included as part of the rigidizer arm 3332.

[0319] In Figures 8A to 9D, the rigidizer arm 3330 is detachably connected to the connector 3800, for example, by a snap fit. The rigidizer arm 3332 includes an opening 3332 that engages with a projection 3810 of the connector 3800 to connect the rigidizer arm 3332 to the patient interface 3000. This allows a portion of the deflector 3500, such as a side wall 3512, to be detachably connected to the connector 3800.

[0320] In the embodiments shown in Figures 6A to 9D, the headgear strap 3310 may be attached to the rigidizer arm 3330. In the examples shown in Figures 6A to 8C, the headgear strap 3310 is attached to the deflector 3500. Part of the headgear strap 3310 may cover the ventilation-facing surface 3512a. As shown, the headgear strap 3310 may be positioned to diffuse the ventilated air during use. Although not shown in Figure 9, in this embodiment, the headgear strap 3310 is attached to the rigidizer arm 3330 but does not cover the ventilation-facing surface 3512a. As shown, a diffuser 3900 may be attached to the ventilation-facing surface 3512a so as to be positioned to diffuse the ventilated air during use. These embodiments of the present technology will be described in more detail below.

[0321] In Figures 6A to 6D, the headgear strap 3310 may be detachably attached to the deflector 3500, for example, using the buttonhole attachment mechanism described above. It should also be understood that the headgear strap 3310 may be detachably attached to the deflector 3500 in other forms using mechanical fasteners or snaps or other suitable attachment mechanisms.

[0322] Referring to the configurations in Figures 8A-9D, the headgear strap 3310 may be permanently attached to the deflector 3500. For example, welding, lamination, overmolding, or adhesive can be used to achieve permanent attachment.

[0323] In some embodiments, one or more of the deflector walls 3512, 3514, 3516, 3518 and / or spacers 3530 may be integrally formed as part of a ventilation module 3420. The ventilation module 3420 may be connected to a portion of the plenum chamber 3200 that forms around the opening 3240. In one embodiment shown in Figures 6A to 6D, the side wall 3512, ventilation wall 3412 and spacer 3530 are integrally formed as a ventilation module 3420. In another embodiment shown in Figures 8A to 9D, the ventilation wall 3412 and rear wall 3414, upper wall 3416 and lower wall 3418 are integrally formed as a ventilation module 3420.

[0324] In some embodiments, the patient interface 3000 may include one or more ribs 3430 provided in or near the ventilation structure 3400 and / or the deflector 3500. For example, Figures 9A–9C show a patient interface 3000 in which one or more ribs 3430 are provided in the ventilation wall 3412. The ribs 3430 may extend outward from the surface of the ventilation wall 3412, or they may have a length that extends along the surface of the ventilation wall 3412 from a rear region to a front region. The ribs 3430 may provide a plurality of flow channels 3432, such as channels, that can help diffuse the airflow from the deflector 3500.

[0325] 4.3.6.3 Deflector with air permeable portion In some embodiments, as shown in Figures 11A to 13C, a portion of the deflector 3500 may include an air-permeable portion 3512b. For example, the side wall 3512 may include an air-permeable portion 3512b. In some embodiments, an air-permeable portion 3512b may be provided in addition to the air-impermeable portion 3512c of the deflector 3500.

[0326] As shown in the examples in Figures 11A to 13C, the deflector 3500 may be configured to operate similarly to the other forms of deflector 3500 described above. In contrast, for example, the side wall 3512 is provided with an air permeable portion 3512b that allows some air to pass through. By allowing some of the airflow to pass through the air permeable portion 3512b, the air permeable portion 3512b may play a role in diffusing the ventilated airflow. The air permeable portion 3512b may redirect some of the airflow so that it moves away from the deflector 3500 through the gap 3520. In the examples shown in Figures 11A to 13C, air moves away from the deflector 3500 through the gap 3520, and a certain amount of air may move away through the air permeable portion 3512b. More air can exit through the gap 3520 than the air that exits through the air permeable portion 3512b. For example, the air-permeable portion 3512b is formed of a breathable material such as a woven material, including the headgear strap material that also serves as the diffuser 3900, as shown in Figures 11A to 13C. Various embodiments of the diffuser 3900 will be described in more detail below.

[0327] In the configurations shown in Figures 11A to 13C, the rib 3430 may separate the headgear strap material from the lateral surface 3412a by a predetermined distance (e.g., the height of the rib). The rib 3430 can help prevent / suppress the breathable material from sagging towards the ventilation structure 3400 during use. This can help / suppress / suppress blockage of the ventilation structure 3400 when the headgear strap material is immersed in water and / or blocked. The spacer 3530 may provide one or more ribs 3430, as shown in Figures 11A to 12E.

[0328] In the examples shown in Figures 11A to 12E, most of the side wall 3512 may be permeable. The side wall 3512 may include an air-impermeable portion 3512c. The air-impermeable portion 3512c may consist of one or more openings 3512d. Headgear strap material forming an air-permeable portion 3512b may be attached to the air-impermeable portion 3512c such that the openings 3512d are covered by the headgear strap material. In the illustrated example, the headgear strap material may be attached to the side surface of the air-impermeable portion 3512c.

[0329] As shown in Figures 11A to 12E, in some embodiments, the deflector 3500 may include part of the positioning and stabilization structure 3300. For example, the deflector 3500 may include part of the headgear strap 3310. The headgear strap 3310 may be permanently attached to the non-breathable section 3512c, for example, by welding, sewing, or adhesive.

[0330] In the configurations shown in Figures 11A to 12E, the headgear strap may also be provided on the rigidizer arm 3330. Referring to the example in Figures 12A to 12E, the rigidizer arm 3330 may be substantially longer than the rigidizer arm 3330 shown in Figures 11A to 11C.

[0331] In the example shown in Figure 13, the entire side wall 3512 may be breathable.

[0332] 4.3.6.4 Further forms of deflectors In some embodiments of this technology, for example, as shown in Figures 17-24, the positioning and stabilizing structure 3300 includes a deflector 3500. That is, a portion of the positioning and stabilizing structure 3300 is used to deflect the airflow out of the ventilation structure 3400.

[0333] In these embodiments, the ventilation structure 3400 is at least partially concealed by the deflector 3500, preferably, the majority of the ventilation structure 3400 is concealed (from the angle of an observer positioned in front of the patient interface during use). In the embodiments shown in Figures 17, 18, 19, 22, and 23, the ventilation holes 3410 are completely shielded by the deflector 3410. Thus, in some embodiments, the patient interface 3000 may include a substantially concealed or concealed ventilation structure 3400. This may improve the aesthetic appeal of the patient interface 3000 and potentially improve patient compliance with treatment.

[0334] The deflector 3500 in these examples has one or more components, including a side wall 3512, a ventilation-facing surface 3512a, and one or more deflector walls, the same as the deflector 3500 described above. The ventilation structure 3400 in these examples also has one or more components, including a ventilation wall 3412 and a lateral surface 3412a, the same as the ventilation structure 3400 described above. Similar to the example above, the ventilation-facing surface 3512a of the deflector 3500 in these examples is separated from the ventilation wall 3412 when in use, forming a gap 3520 between them for the gas flow to pass through.

[0335] In the examples shown in Figures 19 and 23, as in the examples described above, the ventilation-facing surface 3512a may extend in a direction substantially perpendicular to the direction of air discharge from the ventilation structure 3400. As shown in Figures 19 and 23, the ventilation wall 3412 / lateral surface 3412a of the plenum chamber 3200 is substantially concave in some embodiments when viewed from a side cross section. As shown in Figures 19 and 23, in some embodiments, the side wall 3512 / ventilation-facing surface 3350a of the deflector 3500 is substantially convex when viewed from a side cross section. This allows the shape of the lateral surface 3412a and the shape of the ventilation-facing surface 3512a to be complementary. In other embodiments (not shown in these figures), the lateral surface 3412a and / or the ventilation-facing surface 3512a may have any other suitable shape, such as being substantially planar.

[0336] Therefore, in some forms, the outer surface portion of the plenum chamber 3200 that faces away from the patient during use may include a recess 3230. This portion may be recessed or indented relative to the surrounding or adjacent portion of the plenum chamber 3200. This helps to make the patient interface 3000 less cumbersome and bulky, improving patient comfort and compliance. As shown in Figures 17, 18, and 22, at least a portion of the patient interface assembly, such as the frame 3360 or headgear tube(s) 3350, may be positioned within the recess 3230 during use. A concave ventilation wall 3412 may provide at least a portion of the recess 3230, as shown in Figures 19–21. The recess may also facilitate holding the frame 3360 or headgear tube(s) 3350 in the correct position during use.

[0337] Similar to the examples above, in the examples shown in Figures 18 and 20, the patient interface 3000 may include a spacer 3530 that positions the ventilation-facing surface 3512a of the deflector 3500 at a distance from the lateral surface 3412a of the plenum chamber 3200 in use. In one example, the spacer 3530 may extend from at least one of the lateral surface 3412a and the ventilation-facing surface 3512a. That is, the spacer 3530 may be formed of multiple structures. The spacer 3530 may extend in a direction substantially perpendicular to the direction in which the lateral surface 3412a extends.

[0338] The spacer 3530 may include at least one rib 3430, as shown in the examples in Figures 18 and 20. Figures 18 and 20 show one or more ribs 3430, for example, multiple ribs 3430, projecting outward from the ventilation wall 3412. In another embodiment, the spacer may include at least one rib 3430 projecting outward from the ventilation facing surface 3512a. In embodiments with multiple ribs 3430, the ribs may be arranged parallel to each other. In the embodiments of the technology shown in Figures 18 and 20, the ribs may be arranged to extend substantially vertically when the patient is fitted with the patient interface 3000. In other embodiments, the ribs may be arranged in different directions. The spacer 3530 may include any other suitable components of other embodiments not shown, for example, the spacer 3530 may include one or more protrusions.

[0339] The ribs 3430 can form multiple channels between them, allowing the gas flow from the ventilation structure 3400 to pass through the gap 3520. This allows the gas flow away from the gap 3520 to diffuse.

[0340] The spacer 3530, for example, the rib(s) 3430, may include part of the ventilation structure 3400. The rib(s) 3430 may be formed, for example, as part of the plenum chamber 3200. In other embodiments, the spacer 3530, for example, the rib(s) 3430, may include part of the deflector 3500. For example, the spacer(s) 3540 may include at least one of the deflector walls.

[0341] 4.3.6.4.1 Headgear tube with deflector In some embodiments, as shown in the examples in Figures 17 to 21, the positioning and stabilization structure 3100 of the patient interface 3000 includes at least one headgear tube 3350 for delivering airflow from the connection port 3600 to the plenum chamber 3200, and at least one headgear tube 3350 includes a deflector 3500. That is, as shown in these figures, a portion of each headgear tube 3350 may function as a deflector 3500. This portion of each headgear tube 3350 is positioned to redirect the gas flow from the ventilation structure 3400. In this example, this portion of each headgear tube 3350 is provided by the ventilation-facing surface 3350a of the corresponding headgear tube, which forms the ventilation-facing surface 3512a as described above. This portion of each headgear tube 3350 may also be provided by a tube portion 3354. In another configuration, the deflection portion of each headgear tube 3350 may be the lower end of the headgear tube 3350 or a portion close to the lower end. When in use, the deflection portion of each headgear tube 3350 may be positioned to cover the patient's cheek area.

[0342] In these examples, at least one headgear tube 3350 conceals the ventilation structure 3400 (concealing it from the angle of an observer positioned in front of the patient interface during use).

[0343] In the illustrated example, the portion of the deflector 3350 that functions as at least one headgear tube 3350 is essentially air-impermeable. However, as will be further described below, at least one headgear tube 3350 may include a diffuser 3900. However, the diffuser 3900, which is considered to be part of the headgear tube(s) 3350 in these embodiments, may be air-permeable.

[0344] 4.3.6.4.2 Frame with deflector In some embodiments, as shown in the examples in Figures 22-24, the positioning and stabilization structure 3100 of the patient interface 3000 includes a frame 3360 that facilitates engagement with the plenum chamber 3200. In these embodiments, the frame 3360 includes a deflector 3500. That is, as shown in Figure 22, a portion of the frame 3360 functions as a deflector 3500. A portion of the frame 3360 is positioned to redirect the gas flow exiting the ventilation structure 3400. In this example, the deflection portion of the frame 3360 is provided by a ventilation-facing surface 3360a that forms the ventilation-facing surface 3512a described above. The surface of the frame 3360 facing the patient in use is provided with the ventilation-facing surface 3360a.

[0345] In these examples, frame 3360 conceals the ventilation structure 3400 (from the perspective of an observer positioned in front of the patient interface 3000).

[0346] In the illustrated example, the frame 3360 is essentially air-impermeable. However, the frame 3360 may include a diffuser 3900, as will be further described below. However, the diffuser 3900, which is considered part of the frame 3360 in these embodiments, may be air-permeable.

[0347] It should be understood that in other embodiments not shown, a portion of the frame 3360 may include an air-permeable portion similar to the air-permeable portion 3512b described above. Therefore, the frame 3360 may include these other embodiments of air-permeable and air-impermeable portions.

[0348] 4.3.6.5 Redirection of ventilated gas flow upward and / or downward In some forms, as shown in the examples in Figures 17–23, the deflector 3500 is configured, when in use, to redirect at least a portion of the ventilation gas flow (e.g., the majority of the gas flow ventilated laterally) in at least one of the upward and downward directions (e.g., substantially upward and substantially downward). The references to “upward” and “downward” are intended to mean any direction having components that are upward or inward relative to the patient, respectively, as is the similar term “forward” used above. Components extending in the height direction may also extend in one or more other directions, and similarly, components extending in the downward direction may also extend in one or more other directions. For example, a gas flow redirected substantially upward may be redirected laterally and / or forward, but not downward, and similarly, a gas flow redirected substantially downward may also be redirected laterally and / or forward, but not upward. These examples will be further discussed below. Similarly, the references to "substantially high" or "substantially low" are understood to mean the directions in which the maximum component of the velocity vector of an object in a frame of mutually orthogonal axes is, respectively, in the high or low direction.

[0349] The shape and / or orientation of the ventilation-facing surface 3512a, and the shape and / or arrangement of the outer surface of the plenum chamber 3200, can indicate the direction(s) in which the gas flow exits the gap 3520. In some embodiments, the spacers 3430 and / or ribs 3530 can also indicate the direction(s) in which the gas flow exits the gap 3520. For example, as shown in Figures 19 and 23, the convex ventilation-facing surface 3350a of at least one headgear tube 3350, or the convex ventilation-facing surface 3360a of the frame 3360, and the concave ventilation wall 3412 and / or transverse surface 3412a can guide the gas flow substantially downwards or upwards from the gap 3520, or both.

[0350] As shown in Figures 19 and 23, when the gas flow is substantially redirected in the higher and / or lower directions, the gas flow may also be partially redirected forward. As shown in Figure 22, the gas flow may be redirected in a portion of the lateral direction. Thus, the gas flow may be redirected in the upper-front lateral and / or lower-front lateral directions. This may help to move the ventilated gas flow away from the patient's face. This can improve patient comfort and treatment compliance. This allows the opening in the gap 3520 (the opening through which the redirected gas flow is ventilated) to be oriented in the upper-front and / or lower-front directions.

[0351] The flow channels(s) generated by the gap 3520 may extend substantially in the upward and / or downward directions. However, as illustrated, in some embodiments, the flow channels(s) may extend partially forward. Also, as shown in the figure, in some embodiments, a portion of the flow channels(s) may extend laterally. Thus, the flow channels(s) may extend in the upward-anterior-lateral and / or downward-anterior-lateral directions. When in use, the flow channels(s) may be inclined, for example, anterior-upward and / or anterior-downward with respect to the coronal plane of the patient shown in Figure 2E, and laterally-upward and / or laterally-downward with respect to the sagittal plane of the patient shown in Figure 2C.

[0352] The ribs 3430 may extend substantially upward, as shown in Figures 18-20. In some embodiments, the ribs 3430 extend above or to a region higher than the ventilation holes 3410 of the plenum chamber 3200. The ribs 3430 extend substantially downward, as shown. In some embodiments, the ribs 3430 extend below or to a region lower than the ventilation holes 3410 of the plenum chamber 3200. The direction in which the ribs 3430 extend helps to limit or avoid obstruction of the ventilation gas flow by the gap 3520 and helps to guide the ventilation flow in the desired direction.

[0353] The ribs 3430 may extend between the ventilation holes 3410, as shown in Figures 18 to 20. For example, the rib 3530 may extend between a pair of ventilation holes 3410, as shown. In the illustrated example, the ventilation structure 3400 may include multiple pairs of ventilation holes, such as three pairs separated by the ribs 3530. However, it should be understood that any number of ventilation holes 3400 can be provided that are adapted to provide sufficient gas cleaning while maintaining the therapeutic pressure within the plenum chamber 3200 during use. Furthermore, any number of ribs 3539 may be provided to extend in one or more other directions.

[0354] 4.3.7 Diffuser In some examples of this technology, the patient interface 3000 includes a diffuser 3900 for diffusing the gas flow. The diffuser 3900 may be positioned to diffuse the gas flow from the ventilation structure 3400.

[0355] In some configurations, the deflector 3500 may function at least partially as a diffuser 3900. That is, the deflector 3500 can perform a deflection / direction change role, and in the process can diffuse the ventilated gas flow. Alternatively or additionally, the ventilation structure 3400 may function as a ventilator and diffuser of the gas flow.

[0356] In other embodiments, for example as shown in Figures 6A-9D, 11A-16A, and 17-24, the diffuser 3900 is configured to allow gas to flow through it and to diffuse the gas flow as it does so. For example, the diffuser 3900 may include an air-permeable layer such as a woven material. In the shown embodiments, the diffuser 3900 is positioned in the gas flow path from the ventilation structure 3400 so as to cover, for example, at least a portion of the ventilation structure 3400 in use, preferably the entire ventilation structure 3400. The diffuser 3900 may be positioned directly in front of the ventilation structure 3400, or it may be separated from the ventilation structure 3400 and positioned in the flow path of the ventilation gas when in use. Spacers 3530, for example ribs 3430, may offset the diffuser 3900 from the ventilation wall 3412.

[0357] The diffuser 3400 may be at least partially hidden by the deflector 3500 from the viewpoint of an observer positioned, for example, in front of the patient interface 3000. As shown in Figures 17 and 22, the diffuser 3900 may be substantially hidden as shown in the figures. In some embodiments, as shown in Figures 18, 19 and 23, the ventilation holes 3410 are completely hidden by the deflector 3410. Thus, in some embodiments, the patient interface 3000 may include a substantially hidden or hidden diffuser 3900. This may improve the aesthetic appeal of the patient interface 3000 and potentially improve patient compliance with treatment.

[0358] In some configurations, the spacer 3530, for example, the rib 3430, is configured to ensure that the diffuser is positioned at a selected distance from the ventilation wall 3412 and remains in that position during use. This distance may be determined by the size of the rib, particularly the height of the rib. The distance between the diffuser 3900 and the ventilation wall 3412 can limit or prevent noise during use.

[0359] In some forms, the diffuser 3900 is formed from a woven material such as fleece. The woven material may also be a headgear strap material. In one example, the diffuser 3900 is formed by raising a portion of the surface of the woven material.

[0360] In some embodiments, for example, in the embodiments shown in Figures 6A-9D, 11A-16A, and 17-24, the positioning and stabilizing structure 3300 includes a diffuser 3900.

[0361] In some embodiments, for example, in the embodiments shown in Figures 6A to 8C and Figures 11A to 15D, the headgear strap 3310 includes a diffuser 3900.

[0362] In some embodiments, for example, in the embodiments shown in Figures 8A-9D and Figures 17-24, the positioning and stabilizing structure 3300 includes a component. As shown, the component may have a ventilation-facing surface 3512a that, when in use, is located within the path of the ventilation gas flow from the ventilation structure 3400 in use. The diffuser may be located on the ventilation-facing surface 3512a of the component. In some embodiments, the component described may be a frame 3360, and in other embodiments, it may be a headgear tube 3350.

[0363] In some configurations, the diffuser 3900 may be removed from the rest of the positioning and stabilization structure 3300. This facilitates cleaning, replacement, and / or storage of the components.

[0364] In some configurations, the diffuser 3900 may be formed into or permanently connected to a positioning and stabilization structure 3300 that is removable from the rest of the patient interface 3000. This reduces the number of patient interface assemblies and facilitates cleaning, replacement, and / or storage of the assemblies.

[0365] 4.3.7.1 Headgear Straps with Diffuser In the examples shown in Figures 6A to 8C and 11A to 15D, the headgear strap 3310 may include a diffuser 3900. That is, a portion of the headgear strap 3310 is used to diffuse the ventilated gas flow.

[0366] Using a headgear strap 3310 to provide the diffuser 3900 can contribute to reducing manufacturing costs compared to patient interfaces where the diffuser and headgear strap are separate components. It can also reduce the number of parts that need to be manufactured, replaced, and / or cleaned compared to such interfaces. The diffuser 3900 is detachable via the headgear strap 3310.

[0367] In exemplary embodiments, the headgear strap 3310 includes a portion configured to cover at least a portion of the ventilation structure 3400 in use. This covering portion includes a diffuser 3900. Thus, the headgear strap 3310 is connected to the patient interface 3000 so as to cover at least a portion of the ventilation structure 3400, preferably the entire ventilation structure 3400. In some examples, the headgear strap 3310 may be connected to the patient interface 3000 using a buttonhole attachment or the snap-fit ​​connection described above.

[0368] In these embodiments, the diffuser 3900 is formed from headgear strap material. In Figure 16B, the diffuser 3900 is formed by raising a portion of the surface of the headgear strap material to form a napped portion 3310a. The headgear strap material may include woven material.

[0369] In other embodiments, for example, as shown in Figures 16C and 16D, the diffuser 3900 may be formed separately and attached to the headgear strap 3310. The diffuser 3900 may be formed of, for example, a woven material. In some embodiments, the diffuser 3900 may be detachably connected to a portion of the headgear strap 3310.

[0370] 4.3.7.2 Rigidizer arm with diffuser In some forms, for example, as shown in Figures 8A to 9D, the components of the positioning and stabilization structure 3300 described above include a rigidizer arm 3330.

[0371] For example, in some embodiments, the rigidizer arm 3330 may include a diffuser 3900. As shown in Figure 9D, in some embodiments, the diffuser 3900 may be formed separately from, for example, a textile material and attached to the ventilation-facing surface 3512a of the rigidizer arm 3330, so that the diffuser 3900 covers at least a portion of the ventilation structure 3400 to diffuse the gas flow from the ventilation structure 3400. In this example, the headgear strap 3310 is attached to the rest of the rigidizer arm 3330. In other words, the headgear strap 3310 does not form such a particular form of the diffuser 3900. The diffuser 3900 may be permanently or detachably connected to the ventilation-facing surface 3512a. This allows the diffuser 3900 to be replaced, removed, cleaned, and reconnected. As already described, in some embodiments, the deflector 3500 may be detached from the patient interface 3000. Therefore, the diffuser 3900 may be removed along with the diffuser 3500.

[0372] In the embodiments shown in Figures 8A to 9D, the rigidizer arm 3330 (and the attached headgear strap 3310) can be detached from the connector 3800, thereby improving access to the diffuser 3900 for removal and / or cleaning.

[0373] 4.3.7.3 Headgear tube with diffuser In some forms, for example as shown in Figures 17-21, the components of the positioning and stabilizing structure 3300 include at least one headgear tube 3350.

[0374] In the examples shown in Figures 17-21, at least one headgear tube 3350 includes a diffuser 3900. That is, a portion of at least one headgear tube 3350 is used to diffuse the ventilated airflow.

[0375] In these exemplary embodiments, the headgear tube(s) 3350 includes one or more portions configured to be located within the path of the ventilation gas flow from the ventilation structure 3400 in use. For example, the diffuser 3900 may be located on the covering portion of the headgear tube 3350. As shown in the examples in Figures 17 and 18, the tubular portion 3354 of the headgear tube 3350 provides the covering portion.

[0376] At least one headgear tube 3350 may include a ventilation-facing surface 3350a. For example, as shown in Figures 18 and 19, the ventilation-facing surface 3350a may be positioned to cover at least a portion of the ventilation structure 3400 in use. As shown in the examples in Figures 19 and 21, the diffuser 3900 may be located on the ventilation-facing surface 3350a of at least one headgear tube 3350. The ventilation-facing surface 3350a may be included as part of the covering.

[0377] The ventilation-facing surface 3350a may be the patient-facing surface during use. At least one headgear tube 3350 may have a non-patient-facing surface during use.

[0378] In these examples, one or more portions of at least one headgear tube 3350 cover the diffuser 3900, for example, the covering portion conceals the diffuser 3900 (as well as from the viewpoint of an observer positioned in front of the patient). This allows the ventilation-facing side 3350a to conceal the diffuser 3900. Furthermore, the non-patient-facing side may also conceal the diffuser 3900.

[0379] The diffuser 3900 may be formed separately and connected to the covering(s). In the example in Figure 19, the diffuser 3900 is attached to the ventilation-facing surface 3350a of the headgear tube(s) 3350.

[0380] In some configurations, the diffuser 3900 may be detachably connected to the covering portion(s). This allows the diffuser 3900 to be removed from the rest of the headgear tube 3350. This facilitates cleaning, replacement, and / or storage of the component.

[0381] In some forms, the diffuser 3900 may be permanently attached to the headgear tube 3350 by overmolding, adhesive, lamination, thermoforming, welding, or one or more other known mounting methods. As described above, the headgear tube 3350 may be removed from the rest of the patient interface 3000. Thus, the diffuser 3900 may be removed from the rest of the patient interface 3000 by the headgear tube 3350. This can reduce the number of patient interface assemblies and facilitate cleaning, replacement, and / or storage of the assemblies.

[0382] In other embodiments, the headgear tube 3350 may be formed, for example, with a layer of woven material on at least the patient contact surface of the headgear tube 3350. An example of this embodiment is the headgear tube 3350 having a removable or permanently attached fiber sleeve, or the headgear tube 3350 having an integrally formed layer of woven material. The woven layer of woven material may be napped as described above. The napped layer of woven material can form a diffuser 3900. In such embodiments, the layer of woven material can serve a dual purpose: to provide comfort where the headgear tube 3350 contacts the patient's skin, and to diffuse the ventilated gas flow.

[0383] 4.3.7.4 Frame with diffuser In some forms, for example, as shown in Figures 22 to 24, the components of the positioning and stabilizing structure 3300 include a frame 3360.

[0384] In the examples shown in Figures 22-24, the frame 3360 includes a diffuser 3900. That is, a portion of the frame 3360 is used to diffuse the ventilated gas flow.

[0385] In exemplary embodiments, the frame 3360 includes one or more components configured to be located within the path of the ventilation gas flow from the ventilation structure 3400 in use. For example, the diffuser 3900 may be located on the covering portion of the frame 3360. In the examples shown in Figures 22 and 24, at least one of the body portion 3368 and the arm 3366 of the frame 3360 provides the covering portion.

[0386] The frame 3360 may include a ventilation-facing surface 3360a. For example, as shown in Figures 22 and 23, the ventilation-facing surface 3360a may be positioned to cover at least a portion of the ventilation structure 3400 in use. As shown in the example in Figures 23 and 24, the diffuser 3900 may be located on the ventilation-facing surface 3360a of the frame 3360. The ventilation-facing surface 3360a may be included as part of the covering.

[0387] The ventilation-facing surface 3350a may be the patient-facing surface during use. The frame 3360 may have a non-patient-facing surface during use.

[0388] In these examples, one or more parts of the frame 3360 cover the diffuser 3900, for example, the covering part covers and conceals the diffuser 3900. This means that the ventilation-facing side 3360a may conceal the diffuser 3900. Furthermore, the non-patient-facing side may also conceal the diffuser 3900.

[0389] The diffuser 3900 may be formed separately and connected to various parts of the frame 3360. As shown in Figure 23, the diffuser may be attached to the ventilation-facing surface 3360a of the frame 3360.

[0390] In some configurations, the diffuser 3900 may be detachably attached to one or more parts of the frame 3360. Thus, the diffuser 3900 may be detached from the rest of the frame 3360. This facilitates cleaning, replacement, and storage of the component.

[0391] In some configurations, the diffuser 3900 may be permanently attached to the frame 3360 by overmolding, adhesive, lamination, thermoforming, welding, or one or more other known mounting methods. Thus, the diffuser 3900 may be detached from the rest of the patient interface 3000 by the frame 3360. This reduces the number of components in the patient interface and facilitates cleaning, replacement, and storage.

[0392] 4.3.8 Debonding structure(s) (multiple structures possible) In one embodiment, the patient interface 3000 includes at least one decoupling structure (e.g., a swivel or bulbolar fovea).

[0393] 4.3.9 Forehead support In one embodiment, the patient interface 3000 includes a forehead support portion 3700.

[0394] 4.3.10 Choking prevention valve In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve.

[0395] 4.3.11 Port In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows direct measurement of the gas properties (e.g., pressure) within the plenum chamber 3200.

[0396] 4.4 Manufacturing Method of Headgear Strap Diffuser Embodiments of this technology provide a method for manufacturing a diffuser 3900 as part of a headgear strap 3310 of a positioning and stabilization structure 3300 for holding a patient interface 3000 in a therapeutically effective position on the patient's head. In these embodiments, the diffuser 3900 may be incorporated into the headgear strap 3310.

[0397] In certain forms, this method may include the following steps, which are performed in any order. (a) A diffusion layer 3900 is formed on the surface of the headgear strap material, and this diffusion layer 3900 is configured to diffuse the gas flow ventilated through the ventilation structure 3400 located on the patient interface 3000 when in use. and (b) Form the headgear strap 3310 with the headgear strap material.

[0398] 4.4.1 Method for forming a diffusion layer 4.4.1.1 Brushed Headgear Strap Material In a particular embodiment, step (a) may include flocking a portion of the surface of the headgear strap material. This may form a flocked portion 3310a on the headgear strap 3310. Step (a) may be performed by a flocking device including a roller configured to flock the headgear tape material when the headgear tape material comes into contact with the roller. Step (a) may also include trimming the flocked portion 3310a on the surface of the headgear strap material. This trimming step may be performed by the flocking device or a trimming device.

[0399] In one embodiment, the diffuser 3900 may be integrated with the headgear strap using a localized napping treatment on the headgear strap material forming the headgear strap 3310. The localized napping treatment generates a napping portion 3310a. The napping helps to raise a soft, velvety surface composed of a variety of napping fibers. The napping portion 3310a may contain napping fibers. Subsequently, a certain height can be obtained by shearing / shaving the napping fibers. This results in a relative uniformity in the height of the napping fibers in the napping portion 3310a.

[0400] In some embodiments, a roll of fabric, such as headgear strap material, may be napped by a napping device, and then the fabric may be cut to form a headgear strap 3310 or a portion thereof. In other embodiments, a headgear tape 3310 or a portion thereof may be cut and then napped using a roller of a narrower width napping device.

[0401] 4.4.1.2 Use of Adhesives In certain embodiments, step (a) includes forming a diffusion layer 3900 with a woven material and attaching it to the surface of the headgear strap 3310 using an adhesive.

[0402] In one embodiment, the diffuser 3900 may be integrated with the headgear strap 3310 by using an adhesive, by potting, or by applying an adhesive film.

[0403] The diffusion layer 3900 may be formed by cutting a single piece of woven material into a desired shape. It may then be attached to the headgear strap 3310.

[0404] It should be understood that in other embodiments of this technology, the diffusion layer 3900 may be attached to the surface of the headgear strap 3310 using fasteners or other connecting means. In some embodiments, the diffusion layer 3900 may be detachably attached to the surface of the headgear strap 3310 using other fasteners or connecting means.

[0405] 4.4.2 Formation of Headgear Straps In certain embodiments, step (b) includes cutting the headgear strap material into headgear straps. Step (b) may be performed by a cutting device. The headgear strap material may include a woven material.

[0406] 4.5 Method for Manufacturing a Headgear Conduit Diffuser Embodiments of this technology provide a method for manufacturing a diffuser 3900 as part of at least one headgear conduit 3350 of a positioning and stabilizing structure 3300 to hold a patient interface 3000 in a therapeutically effective position on the patient's head. In these embodiments, the diffuser 3900 may be incorporated within the headgear conduit 3350.

[0407] In certain forms, this method may include the following steps, which are performed in any order. A diffusion layer 3900 is formed on the surface of the headgear conduit 3350, and the diffusion layer 3900 is configured to diffuse the gas flow ventilated through the ventilation structure 3400 located on the patient interface 3000 during use. Forms the headgear conduit 3350.

[0408] 4.5.1 Method for forming a diffusion layer Step (a) includes raising a portion of the surface of the headgear tube 3350, which is formed of a layer of woven material.

[0409] Step (a) may include trimming the napped surface of the woven material.

[0410] Step (a) may include forming a diffusion layer 3900 with a woven material and attaching the diffusion layer 3900 to the surface of the headgear conduit 3350 using an adhesive or other known attachment method.

[0411] The diffusion layer 3900 may be formed by cutting the woven material and the napped woven material in either order.

[0412] The woven material may include fleece material.

[0413] 4.5.2 Formation of the headgear tube Step (b) may include forming conduits from one or more materials (e.g., silicone resin). For example, a silicone resin headgear tube 3350 may be formed individually, and the diffuser 3900 may be attached to this silicone resin headgear tube 3350. In other embodiments, the headgear tube 3350 may be formed to include a layer of woven material formed as a diffusion layer 39000.

[0414] 4.6 Method for Manufacturing a Flame Diffuser Embodiments of this technology provide a method for manufacturing a diffuser 3900 as part of a frame 3360 of a positioning and stabilizing structure 3300 for holding a patient interface 3000 in a therapeutically effective position on the patient's head. In these embodiments, the diffuser 3900 may be incorporated into the frame 3360.

[0415] In certain forms, this method may include the following steps, which are performed in any order. (a) A diffusion layer 3900 is formed on the surface of the frame 3360, and the diffusion layer 3900 is configured to diffuse the gas flow ventilated through the ventilation structure 3400 located on the patient interface 300 when in use. and (b) Form frame 3360.

[0416] 4.6.1 Method for forming a diffusion layer Step (a) includes raising a portion of the surface of the frame 3360, which is formed of layers of woven material.

[0417] Step (a) may include trimming the napped surface of the woven material.

[0418] Step (a) may include forming a diffusion layer 3900 with a woven material and attaching the diffusion layer 3900 to the surface of the frame 3360 using an adhesive or other known attachment method.

[0419] The diffusion layer 3900 may be formed by cutting the woven material.

[0420] The diffusion layer 3900 may be formed by cutting the woven material and the napped woven material in either order.

[0421] The woven material may include fleece material.

[0422] 4.6.2 Formation of the headgear tube Step (b) may include forming a frame from one or more materials. For example, the frame 3360 may be formed separately, and the diffuser 3900 may be attached to the frame 3650. In another embodiment, the frame 3360 may be formed to include a layer of woven material formed as the diffusion layer 3900.

[0423] 4.7 RPT devices An RPT device 4000 according to one aspect of this technology includes mechanical components, pneumatic components, and / or electronic components and is configured to perform one or more algorithms 4300 (e.g., any of the methods described herein, either entirely or in part). The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, such as to treat one or more respiratory conditions as described elsewhere herein.

[0424] 4.7.1 RPT Device Algorithm As described above, in some forms of this technology, the central controller 4230 may be configured to implement one or more algorithms 4300, which are represented as computer programs stored in a non-temporary computer-readable storage medium such as memory 4260. The algorithms 4300 are basically grouped into groups called modules.

[0425] In other forms of this technology, part or all of the algorithm 4300 may be implemented by a controller of an external device (e.g., a local external device 4288 or a remote external device 4286). In such a form, data representing input signals and / or intermediate algorithm outputs required for part of the algorithm 4300 executed on the external device may be transmitted to the external device via a local external communication network 4284 or a remote external communication network 4282. In such a form, part of the algorithm 4300 executed on the external device may be represented as a computer program stored on a non-temporary computer-readable storage medium that can access the controller of the external device, including processor control instructions executed by one or more processors. With such a program, the controller of the external device is configured to execute part of the algorithm 4300.

[0426] In this configuration, therapeutic parameters generated by an external device via the therapeutic engine module 4320 (when this configuration forms part of an algorithm 4300 executed by the external device) can be transmitted to the central controller 4230 and sent to the therapeutic control module 4330.

[0427] 4.8 Air Circuit An air circuit 4170 according to one aspect of this technology is a conduit or tube constructed and positioned so that airflow moves between two components (e.g., an RPT device 4000 and a patient interface 3000) during use.

[0428] In particular, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be called an air delivery tube. In some cases, the circuit may have separate branches for inhalation and exhalation. In other cases, a single branch is used.

[0429] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air within the air circuit, for example, to maintain or increase the temperature of the air. The heating elements may take the form of a heated wire circuit and may include one or more transducers, such as temperature sensors. In one embodiment, the heated wire circuit may be spirally wound around the axis of the air circuit 4170. The heating elements may communicate with a controller, such as a central controller 4230. An example of an air circuit 4170 including a heated wire circuit is described in U.S. Patent Application No. 8,733,349, which is incorporated herein by reference in its entirety.

[0430] 4.9 Humidifier 4.9.1 Overview of Humidifiers In one embodiment of this technology, a humidifier 5000 (for example, as shown in Figure 5A) is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and the temperature of the airflow (relative to the ambient air) before delivering the air to the patient's airway.

[0431] The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some embodiments, as shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further comprise a humidifier base 5006 adapted to house the humidifier reservoir 5110 and which may comprise a heating element 5240.

[0432] 4.10 Terminology For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. In other forms of this technology, alternative definitions may apply.

[0433] 4.10.1 Overview Air: In certain forms of this technology, air may be considered to mean the atmosphere, and in other forms of this technology, air may be considered to mean other combinations of some breathable gases, such as oxygen-enriched air.

[0434] Surroundings: In certain forms of this technology, the term surroundings is considered to mean (i) outside the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0435] For example, the ambient humidity for a humidifier may be the humidity of the air adjacent to the humidifier, or the humidity of the room where the patient is sleeping. Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0436] In another example, ambient pressure could be the pressure directly surrounding the body or the pressure outside the body.

[0437] In certain contexts, ambient (e.g., acoustic) noise may be considered as background noise levels within the room where the patient is located, rather than noise generated by, for example, an RPT device or emitted from a mask or patient interface. Ambient noise may originate from sources outside the room.

[0438] Automatic Positive Airway Pressure (APAP) therapy: CPAP therapy that automatically adjusts the therapeutic pressure between a minimum and maximum limit, for example, with each breath, depending on the presence or absence of signs of a short-dose brain event (SDB).

[0439] Continuous positive airway pressure (CPAP) therapy: Respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's entire respiratory cycle. In some forms, the pressure at the airway entrance is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure changes between different respiratory cycles of the patient, for example, increasing in response to the detection of signs of partial upper airway obstruction and decreasing when there are no signs of partial upper airway obstruction.

[0440] Flow rate: The amount (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, a reference to flow rate is to a scalar quantity, i.e., a quantity that has only magnitude. In other cases, a reference to flow rate is to a vector quantity, i.e., a quantity that has both magnitude and direction. The symbol Q may be assigned to flow rate. "Flow rate" is sometimes simply written as "flow" or "airflow".

[0441] In the example of patient respiration, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and negative for the expiratory portion. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface through the air circuit. Vent flow rate Qv is the flow rate of air leaving the vent to allow the expulsion of gas. Leakage flow rate Ql is the flow rate of leakage from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0442] Flow therapy is a respiratory therapy that involves delivering airflow to the airway entrance at a controlled flow rate called therapeutic flow rate, which is typically positive throughout the patient's respiratory cycle.

[0443] Humidifier: The term humidifier is considered to mean a humidifying device that is arranged, installed, or has a physical structure that can provide a therapeutically beneficial amount of water (H2O) vapor to the airflow in order to improve a patient's medical respiratory condition.

[0444] Leakage: The term "leakage" refers to an unintended flow of air. In one example, leakage may occur as a result of an incomplete seal between the mask and the patient's face. In another example, leakage may occur in a swivel elbow to the surroundings.

[0445] Conducted (acoustic) noise: Conducted noise as used herein refers to noise carried to the patient by air pressure paths, such as air circuits and patient interfaces, and the air within them. In one embodiment, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0446] Radiated (acoustic) noise: In this specification, radiated noise refers to noise carried to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the volume / pressure level of the object in question in accordance with ISO 3744.

[0447] Ventilation (acoustic) noise: In this specification, ventilation noise refers to noise generated by airflow through any ventilation opening, such as a vent in the patient interface.

[0448] Oxygen-enriched air: Air with an oxygen concentration higher than atmospheric concentration (21%), such as at least approximately 50%, at least approximately 60%, at least approximately 70%, at least approximately 80%, at least approximately 90%, at least approximately 95%, at least approximately 98%, or at least approximately 99% oxygen. "Oxygen-enriched air" is sometimes abbreviated as "oxygen."

[0449] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0450] A patient is a person, regardless of whether or not they are suffering from respiratory problems.

[0451] Pressure: Force per unit area. Pressure is expressed as cmH2O, gf / cm². 2 It can be expressed in a variety of units, including hectopascals. 1 cmH2O is 1 g-f / cm³. 2 This is equivalent to approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m³). 2 (=1 millibar to 0.001 atm). Unless otherwise specified in this specification, pressure is given in units of cmH2O.

[0452] The pressure within the patient interface is denoted by the symbol Pm, and the therapeutic pressure, which represents the target value achieved by the interface pressure Pm at the current moment, is denoted by the symbol Pt.

[0453] Respiratory pressure therapy involves supplying air to the airway entrance at a processing pressure that is typically positive relative to atmospheric pressure.

[0454] A ventilator is a mechanical device that provides pressure support to a patient to perform some or all of the breathing function.

[0455] 4.10.1.1 Material Silicone or silicone elastomer: synthetic rubber. In this specification, reference to silicone refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products marketed under this trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45, as measured by ASTM D2240.

[0456] Polycarbonate is a thermoplastic polymer of bisphenol A carbonate.

[0457] 4.10.1.2 Mechanical properties Elasticity: The ability of a material to absorb energy when it undergoes elastic deformation and release that energy when the load is removed.

[0458] Elasticity: When unloaded, virtually all energy is released. This includes, for example, certain silicones and thermoplastic elastomers.

[0459] Hardness: The ability of a material itself to resist deformation (e.g., expressed by Young's modulus or an indentation hardness scale measured on a standardized sample size). ● "Soft" materials may include silicone or thermoplastic elastomer (TPE) and can be easily deformed, for example, under finger pressure. ● "Hard" materials may include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0460] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment (e.g., compression, tension, bending, or torsion). A structure or component may provide different resistances in different directions. The opposite of rigidity is flexibility.

[0461] Floppy structure or component: A structure or component whose shape changes (e.g., bends) within a relatively short period of time (e.g., 1 second) when it is able to support its own weight.

[0462] Rigid structures or components: Structures or components whose shape does not substantially change when subjected to loads typically encountered during use. An example of such an application is setting and maintaining a patient interface in a sealing relationship with the entrance to the patient's airway, for example, under a pressure load of approximately 20-30 cmH2O.

[0463] For example, an I-beam may exhibit different bending stiffness (resistance to bending load) in the first direction compared to the second orthogonal direction. In another example, a structure or component may be floppy in the first direction and rigid in the second direction.

[0464] 4.10.2 Respiratory Cycle Apnea: According to some definitions, apnea occurs when airflow falls below a predetermined threshold for a certain period, for example, 10 seconds. Obstructive apnea occurs when, despite the patient's effort, a partial obstruction of the airway prevents airflow. Central apnea occurs when apnea is detected due to decreased or absent respiratory effort, despite the airway remaining patent. Mixed apnea occurs when decreased or absent respiratory effort coincides with an obstructed airway.

[0465] Respiratory rate: This is the rate of a patient's spontaneous breathing, usually measured as respiratory rate per minute.

[0466] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0467] Effort (breathing): This refers to the effort a person puts into breathing, which is a voluntary action.

[0468] The exhalation portion of the respiratory cycle: This is the period from the start of the exhalation flow to the start of the inhalation flow.

[0469] Flow limitation: Flow limitation is considered a situation in a patient's respiration where an increase in the patient's effort does not result in a corresponding increase in flow rate. When flow limitation occurs during the inspiratory portion of the respiratory cycle, it may be described as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, it may be described as expiratory flow limitation.

[0470] Types of flow-limiting inspiratory waveforms: (i) Flattening: An upward trend continues, followed by a relatively flat period, and then a downward trend follows. (ii) M-shaped: It has a total of two local peaks, one on the leading edge and one on the trailing edge, with a relatively flat section between these two peaks. (iii) Chair shape: It has a single local peak, which is located on the leading edge and is followed by a relatively flat section. (iv) Reverse chair shape: A relatively flat area is followed by a single local peak, which is located on the trailing edge.

[0471] Respiratory depression: According to some definitions, respiratory depression is considered a decrease in flow rate, but not a complete cessation of flow. In one form, respiratory depression may be said to have occurred when the flow rate decreases and falls below a threshold rate for a certain period of time. When respiratory depression is detected due to a decrease in respiratory effort, it is said to have occurred. In one form in adults, any of the following may be considered respiratory depression: (i) A 30% reduction in patient respiration for at least 10 seconds, and associated 4% desaturation; or (ii) A decrease in patient respiration for at least 10 seconds (but less than 50%), and associated desaturation or excitation of at least 3%.

[0472] Hyperventilation: An increase in blood flow to a higher level than normal.

[0473] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0474] Patency (airway): The degree to which the airway is open, or the extent to which the airway is open. A patent airway is open. Airway patency can be quantified, for example, as a value of 1 when it is patent, and as a value of 0 when it is closed (obstructed).

[0475] Positive end-expiratory pressure (PEEP): This is the pressure in the lungs at the end of exhalation that is greater than the atmospheric pressure.

[0476] Peak flow rate (Q peak): This is the maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0477] Respiratory flow rate, patient airflow rate, respiratory airflow rate (Qr): These terms may be understood to refer to estimates of respiratory flow rate by an RPT device, distinct from "true respiratory flow rate" or "true respiratory flow rate." "True respiratory flow rate" or "true respiratory flow rate" is the actual respiratory flow rate experienced by the patient, usually expressed in liters per minute.

[0478] Tidal volume (Vt): This is the volume of air inhaled or exhaled during normal breathing, without any extra effort. In principle, the inspiratory volume Vi (volume of inhaled air) is equal to the expiratory volume Ve (volume of exhaled air), so a single tidal volume Vt can be defined as being equal to either of these volumes. In practice, tidal volume Vt is estimated as some combination (for example, the average of inspiratory volume Vi and expiratory volume Ve).

[0479] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0480] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0481] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0482] Typical recent ventilation: Ventilation values ​​where recent ventilation values ​​tend to cluster together over a given time scale (i.e., the degree of clustering of recent ventilation values).

[0483] Upper airway obstruction (UAO): This includes both partial and complete upper airway obstruction. This can be associated with a flow-limiting condition in which flow may increase slightly or even decrease as the pressure difference across the upper airway increases (behavior of Stirling resistance).

[0484] Ventilation: A measure of the amount of gas exchanged by a patient's respiratory system. Measures of ventilation may include either or both inspiratory and expiratory flow rates per unit time. When expressed as volume per minute, this amount is often called "minute ventilation." Minute ventilation is sometimes simply given as volume and is understood as volume per minute.

[0485] 4.10.3 Respirator Adaptive servo ventilators (ASVs) are servo ventilators that have a changeable target ventilation rather than a fixed one. The changeable target ventilation can be learned from certain characteristics of the patient, such as the patient's respiratory characteristics.

[0486] Backup rate: A ventilator parameter that sets the minimum number of breaths (typically breaths per minute) that the ventilator will provide to the patient if not triggered by spontaneous respiratory effort.

[0487] Cycled: This refers to the end of the inspiratory phase of a ventilator. When a ventilator is delivering breath to a patient who is breathing spontaneously, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to cycle to stop delivering breath.

[0488] Positive expiratory airway pressure (EPAP): This is the base pressure that generates the desired interface pressure that a ventilator attempts to achieve in a given time, through the application of varying pressures during respiration.

[0489] End-expiratory pressure (EEP): This is the desired interface pressure that a ventilator attempts to achieve at the end of the expiratory portion of exhalation. When = 1, and the pressure waveform template ( ) is set to zero at the end of exhalation, i.e., ( ) = 0, then EEP is equal to EPAP.

[0490] Positive Inspiratory Airway Pressure (IPAP): This is the maximum desired interface pressure that a ventilator attempts to achieve during the inspiratory portion of respiration.

[0491] Pressure support: A numerical value indicating that the inspiratory pressure of a ventilator has risen above the expiratory pressure of a ventilator. It essentially represents the pressure difference between the maximum inspiratory pressure and the base pressure (e.g., PS = IPAP - EPAP). In some situations, pressure support refers to the difference the ventilator is trying to achieve, rather than the difference it actually achieves.

[0492] Servo ventilator: A ventilator that measures patient ventilation, has a target ventilation level, and adjusts the level of pressure support to guide patient ventilation toward the target ventilation.

[0493] Spontaneous / Timed (S / T): This is a mode of ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. If the device does not detect breathing within a predetermined period, the device automatically starts delivering air.

[0494] Swing: This term is equivalent to pressure support.

[0495] Trigger: A trigger is when a ventilator or other respiratory therapy device (such as an RPT device or portable oxygen concentrator) delivers a certain amount of breathable gas to a spontaneously breathing patient. Due to the patient's efforts, triggers usually occur at or near the start of the respiratory portion of the respiratory cycle.

[0496] 4.10.4 Biological Structure 4.10.4.1 Biological structure of the face Nasal ala: The outer wall of each nostril or "wing" (complex number: alar)

[0497] Alar angle:

[0498] Nasal alae: The outermost point on the alae of the nose.

[0499] Alar curvature (or apex of the nasal ala): The last point on the bending baseline of each nasal ala, located at the fold formed where the nasal ala meets the cheek.

[0500] Auricle: The entire part of the ear that is visible from the outside.

[0501] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nose of the frontal bone.

[0502] (Nasal) cartilage skeleton: The cartilage skeleton of the nose includes the nasal septum, lateral cartilage, major cartilage, and accessory cartilage.

[0503] Columella: The band of skin that separates the nostrils, extending from the front nostril to the upper lip.

[0504] Columella angle: The angle between a line passing through the midpoint of the nostril and a line intersecting the infranasal point and perpendicular to the Frankfurt plane.

[0505] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left tragus. The tragus is the deepest point of the depression above the tragus of the atrial appendage.

[0506] Glabella: Located on soft tissue, it is the most prominent point in the midline sagittal plane of the forehead.

[0507] Lateral nasal cartilage: Generally a triangular cartilage plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0508] Lip, lower side (lower lip: labrale inferius):

[0509] Lip, upper side (upper lip: labrale superius):

[0510] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. The greater alar cartilage curves around the anterior part of the nostril. Its posterior end connects to the frontal process of the maxilla by a tough fibrous membrane containing 3-4 small cartilages of the nasal ala.

[0511] Nostrils: The nearly elongated pores that form the entrance to the nasal cavity. The singular form of nostrils (nares) is naris (nostril). The nostrils are separated by the nasal septum.

[0512] Nasolabial folds or grooves: Folds or grooves of skin that extend from both sides of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0513] Nasolabial angle: The angle between the columella and the upper lip, which intersects with the subnasal point.

[0514] Superior base of the ear: The highest point where the auricle attaches to the skin of the face.

[0515] The highest point where the auricle attaches to the skin of the face at the base of the ear.

[0516] Nasal tip: The most prominent point or tip of the nose, which can be identified in a lateral view of the rest of the head.

[0517] Philtrum: The groove that runs from the lower edge of the nasal septum to the tip of the upper lip.

[0518] Pogonion: Located in soft tissue, it is the anterior midpoint of the jaw.

[0519] Nasal ridge: The nasal ridge is a projection along the midline of the nose, extending from the selion to the nasal tip.

[0520] Sagittal plane: The vertical plane from the front (front) to the back (back). The median sagittal plane is the sagittal plane that divides the body into left and right halves.

[0521] Serion: The most recessed point located on soft tissue, covering the area of ​​the anterior nasal suture.

[0522] Nasal septal cartilage (nose): The nasal septal cartilage forms part of the nasal septum and separates the anterior part of the nasal cavity.

[0523] Paranasal alae: Points located on the lower edge of the base of the nasal ala, where the base of the nasal ala connects to the skin of the upper lip.

[0524] Infranasal point: Located on soft tissue, this is the point where the columella connects to the upper lip in the midline sagittal plane.

[0525] The most concave point on the midline of the lower lip between the suprachin point (midpoint of the lower lip) and the soft tissue pogonion.

[0526] Biological structure of the skull

[0527] Frontal bone: The frontal bone contains a large vertical section called the frontal squamous region, which corresponds to the area known as the forehead.

[0528] Mandible: The mandible forms the lower jaw. The mental protuberance is a bony projection of the mandible that forms the jaw.

[0529] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbit. The frontal process of the maxilla projects upward through the side of the nose and forms part of its lateral boundary.

[0530] Nasal bones: The nasal bones are two small, oval-shaped bones that vary in size and shape from individual to individual. The nasal bones are located side by side in the central and lateral parts of the face, and their joint forms the "ridge" of the nose.

[0531] Nasion: The area of ​​depression between the eyes and just above the bridge of the nose, at the intersection of the frontal bone and the two nasal bones.

[0532] Occipital bone: The occipital bone is located in the lower posterior part of the skull. It contains an oval-shaped opening called the greater occipital foramen, which leads the cranial cavity into the vertebral canal. The curved plate behind the greater occipital foramen is the occipital squama.

[0533] Orbit: The cavity in the skull that houses the eyeball.

[0534] Parietal bone: The parietal bone is the bone that, when joined together, forms the top and sides of the skull.

[0535] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the temples of the face.

[0536] Cheekbones: The face includes two cheekbones located on the upper and sides of the face, forming the cheek prominences.

[0537] 4.10.4.2 Structure of the Respiratory System Diaphragm: A sheet of muscle that spans the bottom of the thoracic cavity. 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, drawing air into the lungs.

[0538] Larynx: The larynx, or vocal organ, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0539] Lungs: The human respiratory system. The conduction region of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory region includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0540] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space located in the center of the face, above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On either side of the nasal cavity are three horizontal extensions called the nasal conchae (singular "concha") or nasal conchae (turbinates). Anterior to the nasal cavity is the nose, whose dorsal portion merges with the nasopharynx via the posterior nostrils.

[0541] The pharynx is a part of the throat located directly below the nasal cavity, above the esophagus and larynx. The pharynx is usually divided into three parts: the nasopharynx (the nasal part of the pharynx), the mesopharynx (the oral part of the pharynx), and the hypopharynx.

[0542] 4.10.5 Patient Interface Anti-asphyxiation valve (AAV): A component or subassembly of a mask system that reduces the risk of a patient rebreathing carbon monoxide (CO2) by releasing into the atmosphere in a fail-safe manner.

[0543] Elbow: An elbow is an example of a structure that guides an airflow axis to change direction at an angle. In one embodiment, the angle may be approximately 90 degrees. In another embodiment, the angle may be greater than or less than 90 degrees. An elbow may have a substantially circular cross-section. In another embodiment, an elbow may have an elliptical or rectangular cross-section. In certain embodiments, an elbow may be rotatable, for example, about 360 degrees relative to a mating component. In certain embodiments, an elbow may be detachable from a mating component, for example, via a snap connection. In certain embodiments, an elbow may be assembled to a mating component via a one-time snap during manufacturing, but cannot be detached by the patient.

[0544] Frame: The term "frame" is taken to mean a mask structure that supports tensile loads between two or more points connecting the headgear. The mask frame can be an airtight load-supporting structure within the mask. However, some forms of mask frames may be airtight.

[0545] Functional dead space:

[0546] Headgear: Headgear is a positioning and stabilizing structure designed for the head. For example, headgear may include a set of one or more struts, ties, and reinforcements configured to position and hold a patient interface on the patient's face for respiratory therapy. Some ties may be formed from a flexible, pliable, and resilient material, such as a laminated composite of foam and fabric.

[0547] Membrane: The term "membrane" is typically used to mean a thin-walled element, preferably one that offers little resistance to bending and little resistance to stretching.

[0548] Plenum Chamber: The term "mask plenum chamber" is taken to mean a part of the patient interface having a wall that at least partially encloses the volume of space, where the air in the volume is pressurized to exceed atmospheric pressure when in use. A shell may form part of the wall of the mask plenum chamber.

[0549] Seal: When used as a noun ("seal"), it can refer to a structure; when used as a verb ("to seal"), it can refer to its effect. Two elements can be constructed and / or arranged to achieve a "seal" or a "seal" between them, without requiring a separate "seal" element itself.

[0550] Shell: The term "shell" is used to mean a curved, relatively thin-walled structure with bending, tensile, and compressive rigidity. For example, the curved structural walls of a mask can be a shell. In some forms, a shell can be faceted. In some forms, a shell can be airtight. In some forms, a shell may not be airtight.

[0551] Stiffener: The term "stiffener" is understood to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0552] Support: The term "support" is used to mean a structural component designed to increase the compressive strength of another component in at least one direction.

[0553] Swivel (noun): A subassembly of a component configured to rotate preferably independently and preferably under low torque around a common axis. In one embodiment, the swivel may be configured to rotate at an angle of at least 360 degrees. In another embodiment, the swivel may be configured to rotate at an angle of less than 360 degrees. When used in connection with a delivery tube, the subassembly of the component preferably includes a pair of cylindrical conduits. During use, there may be little to no leakage of airflow from the swivel.

[0554] Thai (noun): A structure designed to resist tension.

[0555] Ventilation section (noun): A structure that allows airflow from inside the mask or conduit to the surrounding air, clinically effective in flushing out exhaled gases. For example, in clinically effective exhalation, flow rates of approximately 10 liters / min to 100 liters / min may be used, depending on the mask design and treatment pressure.

[0556] 4.10.6 Structure Shape Products based on this technology may include one or more three-dimensional mechanical structures, such as a mask cushion or an impeller. The three-dimensional structure may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels to describe the orientation, position, function or any other characteristic of the associated surfaces. 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, a seal-forming structure may include a face-contact (e.g., outer) surface and separate non-face-contact (e.g., bottom or inner) surfaces. In yet another example, the structure may include a first surface and a second surface.

[0557] To facilitate the description of the three-dimensional structure and surface shape, we first consider a cross-section that crosses the surface of the structure at point p. Figures 3B to 3F show examples of cross-sections at point p on the surface and the resulting planar curves. Figures 3B to 3F also show the outward normal vector at p. The outward normal vector at p points away from the surface. In some examples, the inventors describe the surface from the perspective of a hypothetical small person standing upright on the surface.

[0558] 4.10.6.1 Curvature in one dimension The curvature of a plane curve at p can be described as having a sign (e.g., positive, negative) and magnitude (e.g., the radius of the circle that touches the curve at 1 / p).

[0559] Positive curvature: If a curve at point p curves towards its outer normal, the curvature at that point is considered positive (if a hypothetical small person leaves point p, they would have to walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C) and Figure 3C (relatively small positive curvature compared to Figure 3B). Such curves are generally called concave curves.

[0560] Zero curvature: If the curve at point p is a straight line, the curvature is considered zero (a hypothetical small person leaving point p can walk horizontally without going up or down). See Figure 3D.

[0561] Negative curvature: If the curve at point p deviates from its outer normal, the curvature at that point in that direction is considered negative (if a hypothetical small person leaves point p, they must walk downhill). See Figure 3E (relatively small negative curvature compared to Figure 3F) and Figure 3F (relatively large negative curvature compared to Figure 3E). Such curves are generally called convex curves.

[0562] 4.10.6.2 Curvature of a two-dimensional surface The description of the shape at a given point on a two-dimensional surface using this technique may include multiple normal cross-sections. These cross-sections may cut the surface in a plane containing an outward normal ("normal plane"), and each cross-section may be taken in a different direction. Each cross-section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same or different signs. Each curvature at that point has a magnitude (e.g., relatively small). The planar curves in Figures 3B to 3F may be examples of such multiple cross-sections at a particular point.

[0563] 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 example in Figures 3B to 3F, the maximum curvature occurs in Figure 3B and the minimum occurs in Figure 3F; therefore, Figures 3B and 3F are cross-sections in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0564] A region on a surface: A series of connected points on a surface. A set of points within a region may have similar properties, such as curvature or sign.

[0565] Saddle region: A region where the principal curvatures have opposite signs at each point (i.e., one is positive and the other is negative) (a hypothetical person could walk uphill or downhill depending on the direction they are facing).

[0566] Dome region: A region where the principal curvatures have the same sign at each point (for example, both are positive ("concave dome"), or both are negative ("convex dome")).

[0567] Cylindrical region: A region where one principal curvature is zero (or zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0568] Planar region: A region of a surface where both principal curvatures are zero (or zero, for example, within manufacturing tolerances).

[0569] Surface edge: The boundary or limit of a surface or area.

[0570] Path: In certain forms of this technology, “path” is interpreted as a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In certain forms of this technology, “path” can be described, for example, as a route or course involving a set of points on a surface. (For a hypothetical person, a path is where they walk on the surface, similar to a garden path).

[0571] Path Length: In certain forms of this technology, “path length” is interpreted to mean the distance along the surface from f(0) to f(1) (i.e., the distance along the path on the surface). There can be more than one path between two points on the surface, and such paths may have different path lengths. (For a hypothetical person, the path length is the distance that person should walk along the path on the surface).

[0572] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. On a planar region, there is a distance on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there can be no path with the same path length as the straight-line distance between two points. (For a hypothetical person, straight-line distance corresponds to the distance a crow "flies".)

[0573] 4.10.6.3 Space curve Spatial curves: Unlike plane curves, spatial curves do not necessarily lie on a specific plane. Spatial curves can be closed; that is, they have no endpoint. Spatial curves can be thought of as one-dimensional pieces of three-dimensional space. A hypothetical person walking along a DNA helix would be walking along a spatial 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 structures (e.g., the edges of a membrane or impeller) can follow a spatial curve. In general, a spatial curve can be described by its curvature and torsion at each point on the curve. Torsion is a measure of the manner in which a curve originates from a plane. Torsion has a sign and magnitude. Torsion at a point on a spatial curve can be characterized by referring to the tangent, normal, and binormal vectors at that point.

[0574] Tangent Unit Vector (or Unit Tangent Vector): For each point on a curve, the vector at that point specifies the direction and amplitude from that point. A tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a hypothetical person flies along a curve and falls out of a car at a specific point, the direction of the tangent vector will be the direction in which she is moving.

[0575] Unit Normal Vector: When a hypothetical figure moves along a curve, the tangent vector itself also changes. The unit vector that points in the same direction as the changing tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0576] Binormal Unit Vector: The binormal unit vector is perpendicular to the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P) or the left-hand rule (see Figure 3O).

[0577] Contact plane: A plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0578] Twist of a spatial curve: The twist of a spatial curve at a point is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation of the curve from the tangent plane. A spatial curve lying in the plane has zero twist. If the deviation of the spatial curve from the tangent plane is relatively small, the magnitude of the twist of the spatial curve is relatively small (e.g., a gently sloping spiral path). If the deviation of the spatial curve from the tangent plane is relatively large, the magnitude of the twist of the spatial curve is relatively large (e.g., a steeply sloping spiral path). Referring to Figure 3S, since T2 > T1, the amount of twist near the upper coil of the spiral in S in Figure 3 is greater than the amount of twist of the lower coil of the spiral in Figure 3S.

[0579] Referring to the right-hand rule in Figure 3P, a spatial curve curving toward the direction of the right-hand binormal can be considered to have a positive twist in the right-hand direction (e.g., a right-hand spiral as shown in Figure 3S). A spatial curve pointing away from the direction of the right-hand binormal can be considered to have a negative right-hand twist (e.g., a left-hand spiral).

[0580] Similarly, referring to the left-hand rule (see Figure 3O), a spatial curve pointing in the direction of the left-hand binormal can be considered to have a positive left-hand twist (e.g., a left-hand spiral). Thus, the positive direction of the left hand corresponds to the negative direction of the right hand. See Figure 3T.

[0581] 4.10.6.4 holes A surface may have one-dimensional holes (e.g., holes bounded by planar or spatial curves). In the case of a thin structure containing holes (e.g., a film), this structure can be described as having one-dimensional holes. See, for example, the way one-dimensional holes in the surface of the structure shown in Figure 3I are bounded by planar curves.

[0582] A structure may 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 may have a two-dimensional hole. See, for example, the cushion in Figure 3L, and the exemplary cross-section of Figure 3L in Figures 3M and 3N, where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or outlet) and a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole that passes through the structure shown in Figure 3K and is bounded by a surface as shown.

[0583] 4.11 Other Notes Some of the disclosures in this patent document include material protected by copyright. The copyright holder will not object if someone reproduces this patent document or the patent disclosures, provided that such reproductions are included in the patent files or records of the Patent Office, but otherwise, all copyrights are reserved.

[0584] Unless otherwise explicitly indicated in the context, if a range of values ​​is provided, it is understood that each value intervening between the upper and lower limits of that range, up to one-tenth of the lower limit unit, and any other stated or intervening values ​​within that stated range, are included in this technique. The upper and lower limits of these intervening ranges, which may be independently contained within an intervening range, are also included in this technique, subject to any specifically excluded limits within the stated range. If the stated range includes one or both of the limits, the range excluding one or both of those included limits is also included in this technique.

[0585] Furthermore, where a value(s) is described herein as being implemented as part of the Art, unless otherwise stated, such value(s) may be approximations and may be used with any appropriate number of significant digits to the extent permitted or required in the practical technical implementation.

[0586] Unless otherwise specified, all technical and scientific terms used herein have the same meaning as those generally understood by those skilled in the art to which this art pertains. Any methods and materials similar to or equivalent to those described herein may also be used in the implementation or testing of this art, although this specification describes only a limited number of exemplary methods and materials.

[0587] While certain materials are described as suitably used in the construction of components, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, all components described herein are understood to be manufacturable and therefore may be manufactured together or separately.

[0588] Note that, as used herein and in the appended claims, the singular forms ("a," "an," and "the") include their plural equivalents unless explicitly indicated otherwise in the context.

[0589] All publications mentioned herein are incorporated herein in their entirety by reference to disclose and describe the methods and / or materials that are the subject matter of those publications. Publications discussed herein are provided solely for their disclosure prior to the filing date of this application. Nothing herein should be construed as an admission that the present art does not have prior rights to such publications by prior invention. Furthermore, the dates of the publications provided may differ from the actual publication dates, and publication dates may need to be independently verified.

[0590] The terms “comprises” and “comprising” should be interpreted as referring to an element, component, or step in a non-exclusive manner, indicating that the referenced element, component, or step may exist, be used, or be combined with other elements, components, or steps that are not explicitly referenced.

[0591] The subject matter titles used in the detailed descriptions are included solely for the convenience of reader reference and should not be used to limit the subject matter found throughout this disclosure or the claims. The subject matter titles should not be used in interpreting the claims or the limitations of the claims.

[0592] While the techniques described herein have been explained with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some instances, terms and symbols may suggest certain details that are not necessary for the implementation of the techniques. For example, the terms “first” and “second” may be used, but unless otherwise specified, these terms are not intended to indicate any order and may be used to distinguish distinct elements. Furthermore, process steps in a methodology may be described or illustrated in order, but such ordering is not required. Those skilled in the art will recognize that such ordering may be changed, and / or that such changes may occur simultaneously or even synchronously.

[0593] Therefore, it should be understood that numerous modifications may be made to the examples, and other configurations may be devised, without deviating from the spirit and scope of this technology. [Explanation of symbols]

[0594] 1000 patients 1100 Companion 3000 Patient Interfaces 3100 Seal-forming structure 3110 holes 3150 Action Module 3200 Plenum Chamber 3210 Frame Section 3211 Front 3212 Lateral protruding connection part 3213 Side 3214 connector 3220 Entrance 3230 recess 3240 Opening 3300 Positioning and stabilization structure 3310 Headgear Strap 3310a Raised part 3312 Buttonhole 3320 Conduit section 3330 Rigidizer Arm 3332 Opening 3350 Tube 3350a Ventilation section facing side 3352 tabs 3354 Tube section 3356 Opening 3358 Connector 3360 frames 3360a Ventilation section facing side 3362 Opening 3364 Connector 3364a slot 3366 Arm 3400 Ventilation structure 3400A Other ventilation structures 3410 Ventilation hole 3412 Ventilation wall 3412a Side view 3414 Rotating part 3420 Ventilation Module 3430 Rib 3500 Deflector 3512 side wall 3512a Ventilation section facing side 3512b Air permeable portion 3512c Air-impermeable portion 3512d opening 3514 Deflector rear wall 3516 Deflector Upper Wall 3518 Deflector lower wall 3520 Gap 3530 Spacer 3600 connection ports 3800 connector 3810 Protrusion 3820 slots 3900 Diffuser 4000 RPT devices 4010 External Housing 4012 Top 4014 Lower 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic Block 4100 Blower Housing 4110 Air Filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Entrance muffler 4124 Exhaust muffler 4140 Pressure Generator 4142 Blower 4144 Motor

Claims

1. It is a patient interface, At least 6 cmH higher than ambient air pressure ２ A plenum chamber pressurized to high therapeutic pressure, comprising a plenum chamber including an inlet configured to receive an airflow at therapeutic pressure for the patient to breathe, A seal-forming structure configured to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, and configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use; A ventilation structure configured to allow gases exhaled by a patient to flow from the inside of the plenum chamber to the surrounding area, and configured to maintain the therapeutic pressure within the plenum chamber during use, A positioning and stabilizing structure, including at least one headgear strap, provides force to hold the seal-forming structure in an effective position for treatment on the patient's head, It is equipped with, At least one of the headgear straps includes a diffuser, The diffuser is positioned to diffuse the gas flow from the ventilation structure during use, in a patient interface.

2. The plenum chamber includes an inner portion and a front portion, The aforementioned inner portion is positioned so that the patient's median sagittal plane passes through the inner portion during use. The patient interface according to claim 1, wherein the entrance is located in the front and inner portions.

3. The patient interface according to claim 1 or 2, wherein the ventilation structure is located in the portion of the patient interface to the side of the inlet and is configured to ventilate the gas flow substantially laterally from inside the plenum chamber when in use.

4. The ventilation structure is a first ventilation structure configured to ventilate the first gas flow exhaled by the patient from inside the plenum chamber outwards in a first substantially lateral direction during use. The patient interface includes a second ventilation structure configured to ventilate the second gas flow exhaled by the patient from inside the plenum chamber outwards in a second substantially lateral direction during use. The patient interface according to any one of claims 1 to 3, wherein the first substantially lateral direction is generally opposite to the second substantially lateral direction.

5. The first ventilation structure is located on one side of the patient interface, to the side of the inlet. The patient interface according to claim 4, wherein the second ventilation structure is located on the other side of the patient interface, lateral to the inlet.

6. The patient interface according to any one of claims 1 to 5, comprising a deflector configured to redirect a considerable amount of gas flow ventilated laterally in a direction having a forward component relative to the patient when in use.

7. At least one of the headgear strap coverings covers at least a portion of the ventilation structure when in use. The patient interface according to any one of claims 1 to 6, wherein the diffuser is optionally placed in the covering portion.

8. It is a patient interface, At least 6 cmH higher than ambient air pressure ２ A plenum chamber pressurized to high therapeutic pressure, comprising a plenum chamber including an inlet configured to receive an airflow at therapeutic pressure for the patient to breathe, A seal-forming structure configured to form a seal with the area of ​​the patient's face surrounding the entrance to the patient's airway, and configured to maintain the therapeutic pressure within the plenum chamber throughout the patient's entire respiratory cycle during use; A ventilation structure configured to allow gases exhaled by a patient to flow from the inside of the plenum chamber to the surroundings for ventilation, and configured to maintain the therapeutic pressure within the plenum chamber during use, A positioning and stabilizing structure that provides force to hold the seal-forming structure in a position effective for treatment on the patient's head, It is equipped with, The positioning and stabilization structure includes a component that includes a ventilation-facing surface positioned in the path of the ventilation gas flow from the ventilation structure during use, A diffuser is arranged on the ventilation-facing side of the component. The diffuser is positioned in a patient interface to diffuse the ventilation gas flow from the ventilation structure when in use.

9. The patient interface according to claim 8, wherein the component includes a frame configured to facilitate indirect attachment of the plenum chamber to at least one headgear strap of the positioning and stabilizing structure.

10. The patient interface according to claim 9, wherein the diffuser is detachably attached to the frame.

11. The patient interface according to claim 9 or 10, wherein the frame includes a pair of connectors for facilitating the attachment of the frame to at least one of the headgear straps.

12. The component includes at least one tube, At least one of the tubes is configured to, when in use, deliver airflow from an air circuit fluidly connected to at least one of the tubes into the interior of the plenum chamber via the inlet. The patient interface according to claim 8, wherein the diffuser is optionally detachably attached to at least one of the tubes.

13. The aforementioned component includes a rigidizer arm, The rigidizer arm is configured to stiffen at least one headgear strap of the positioning and stabilizing structure. The patient interface according to claim 8, wherein the diffuser is optionally detachably attached to the rigidizer arm.

14. A positioning and stabilizing structure for holding a patient interface in a position effective for treatment on the patient's head, Includes at least one headgear strap, At least one of the headgear straps includes a diffuser, which is a positioning and stabilizing structure configured to diffuse a gas flow ventilated from inside the patient interface into the surrounding area via a ventilation structure configured on the patient interface.

15. At least one of the headgear strap coverings covers at least a portion of the ventilation structure when in use. The positioning and stabilization structure according to claim 14, wherein the diffuser is optionally positioned on the covering portion.

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