Patient interface for delivering breathable gas to patient

Abstract

The utility model relates to a patient interface for conveying breathable gas to a patient. The patient interface may include a pressurizable plenum and a seal-forming structure configured to form a seal with an area of the patient's face surrounding an access to the patient's nostrils but not surrounding the patient's mouth. The patient interface may also include a ventilation structure to allow continuous flow of gas exhaled by the patient from the interior of the plenum chamber to the ambient environment. In some forms, the seal-forming structure may include at least one adhesive surface configured to adhere to an area of a patient's face in use to form a seal. The patient interface may also include a mouth closure structure configured to facilitate mouth closure of the patient. An adhesive may be used to connect the seal-forming structure to the plenum. The release liner may cover the adhesive prior to bonding, and the liner may include one or more slits.

Description

Technical Field

[0001] The present technology relates to one or more of the following: screening, diagnosis, monitoring, treatment, prevention, and improvement of breathing-related disorders. The present technology also relates to medical devices or apparatus and uses thereof. The present technology relates to a seal-forming structure for a patient interface that forms a seal with a patient's airway via an adhesive surface. The present technology also relates to a patient interface having a mechanism for promoting mouth closure during use. Background Art

[0002] 1.2 Description of Related Technology

[0003] 1.2.1 Human respiratory system and its diseases

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

[0005] The airway comprises a series of branching tubes, which become narrower, shorter and more numerous as the branching trachea penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and allowing carbon dioxide to move in the opposite direction. The trachea is divided into the left and right main bronchi, which are ultimately divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. Referring to " Respiratory Physiology (Respiratory Physiology)" published by John B.West, Lippincott Williams & Wilkins in 2012, the 9th edition.

[0006] There is a range of respiratory disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

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

[0008] A range of treatments have been used to treat or ameliorate these conditions. Furthermore, such treatments can be used to prevent breathing problems in otherwise healthy individuals. However, these have a number of drawbacks.

[0009] One of the major issues in respiratory therapy is compliance, also known as adherence. Often, patients may be required to wear a patient interface for extended periods of time as part of their respiratory therapy. Bulky and / or obtrusive patient interfaces often cause patients to discontinue respiratory therapy due to discomfort, inconvenience, or disruption to sleep. In particular, it can be difficult to ensure that infants and children do not remove the patient interface during respiratory therapy.

[0010] 1.2.2 Treatment

[0011] Various respiratory therapies, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high flow therapy (HFT), have been used to treat one or more of the above-mentioned respiratory disorders.

[0012] 1.2.2.1 Respiratory pressure therapy

[0013] Respiratory pressure therapy is the application of air to the airway entrance at a controlled target pressure that is nominally positive relative to atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a canister ventilator or chest plate).

[0014] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated with CPAP can be voluntary, so if a patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0015] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to assist the patient's breathing and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, such as OHS, COPD, NMD, and chest wall disease. In some forms, the comfort and effectiveness of these treatments can be improved.

[0016] Non-invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0017] 1.2.3 Respiratory therapy system

[0018] These respiratory therapies can be provided by a respiratory therapy system or device.Such systems and devices can also be used to screen for, diagnose, or monitor a condition without treating it.

[0019] 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 / or data management.

[0020] 1.2.3.1 Patient Interface

[0021] The patient interface can be used to couple the respiratory apparatus to its wearer, for example, by providing a flow of air to an entrance to the airway. The flow of air can be provided into the patient's nose and / or mouth, into the mouth via a tube, or into the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area, such as the patient's face, to facilitate delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment.

[0022] Typically, a mask system is used as a patient interface for delivering airflow. These mask systems typically include an inflatable chamber that is secured to the patient's face via a headgear. The inflatable chamber, together with the patient's face, encloses a volume of space that accommodates the patient's facial features, such as their nose and / or mouth. Typically, the inflatable chamber can be made of a rigid material. These aspects of the design of some conventional patient interfaces can make sleeping while wearing the patient interface inconvenient, uncomfortable, and potentially claustrophobic.

[0023] Mask systems other than those typically used for respiratory therapy may not be functionally suitable for this application. For example, a purely cosmetic mask may not maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to prevent the ingress of higher-pressure water from the outside, but will not maintain the internal air at a pressure higher than ambient pressure.

[0024] Certain masks may be clinically unsuitable for this technology, for example if they block airflow through the nose and only allow it through the mouth.

[0025] Certain masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

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

[0027] As a result of these challenges, some masks suffer from one or more protrusions, are aesthetically undesirable, expensive, poorly fitted, difficult to use, and uncomfortable problems, particularly when worn for extended periods of time or when the patient is unfamiliar with the system. A mask of the wrong size may result in reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks used for the administration of anesthetics may be tolerable for their original applications, but nonetheless, such masks may be undesirably uncomfortable when worn for extended periods of time (e.g., several hours). As previously mentioned, this discomfort may result in reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0028] CPAP therapy is highly effective in treating certain respiratory conditions, provided the patient adheres to the therapy. If the mask is uncomfortable or difficult to use, the patient may not adhere to the therapy.

[0029] Patients are often advised to clean their masks regularly, and if the mask needs cleaning, or if it is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their masks, which may affect patient compliance.

[0030] While a mask used for other applications (such as navigators) may not be suitable for treating sleep-disordered breathing, a mask designed to treat sleep-disordered breathing may be suitable for other applications.

[0031] For these reasons, patient interfaces for delivering CPAP during sleep have emerged as a distinct field.

[0032] 1.2.3.1.1 Sealing structure

[0033] The patient interface may include a seal-forming structure. Since the seal-forming structure is in direct contact with the patient's face, the shape and configuration of the seal-forming structure may directly affect the effectiveness and comfort of the patient interface.

[0034] The patient interface may be characterized in part by the design intent of the seal-forming structure to engage with the face during use. In one form of the patient interface, the seal-forming structure may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to cover, for example, the supra-labial region and / or the nasal bridge region of the face. These different types of patient interfaces may be known by various names by their manufacturers, including nasal pads, nasal pillows, and nasal sprays.

[0035] In one form of patient interface, the seal-forming structure may include an element that surrounds the mouth area when in use, for example by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming structure may include a single element that surrounds the nostrils and mouth area when in use. These patient interfaces may be referred to in the art as oral cushions, oronasal cushions, or full-face cushions.

[0036] A seal-forming structure that is effective in one area of ​​a patient's face may be inadequate in another area, for example, due to different shapes, structures, variability, and sensitive areas of the patient's face. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0037] Certain seal-forming structures may be designed for mass manufacturing so that one design can fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent that there is a mismatch between the shape of the patient's face and the seal-forming structure of a mass-manufactured patient interface, one or both must be modified to form a seal.

[0038] One type of seal-forming structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface with the seal-forming structure in facing engagement with the patient's face. The seal-forming structure may include an air or fluid-filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, if the fit is inadequate, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0039] Another type of seal-forming structure incorporates a flap seal of thin material located around the perimeter of the mask to provide a self-sealing effect against the patient's face when positive pressure is applied within the mask. Similar to the previous types of seal-forming portions, if the fit between the face and the mask is poor, excessive force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the shape of the patient, it may wrinkle or buckle during use, causing leaks.

[0040] Another type of seal-forming structure may include friction-fit elements, for example for insertion into a nostril, however some patients find these uncomfortable.

[0041] Another form of seal-forming structure can use adhesive to achieve the seal.For typical treatment pressures (e.g., up to 20 cmH2O), the seal formed by the adhesive is generally highly effective with little or no leakage.

[0042] The regular application and removal of adhesive-based seal-forming structures can cause skin trauma or irritation. In addition, conventional adhesive-based seal-forming structures require cleaning the skin area to which the seal-forming structure will be adhered before adhering the seal-forming structure. Repeated cleaning (which may include alcohol wipes) can cause skin damage.

[0043] Furthermore, securing adhesive-based seal-forming structures in or around the nose can lead to a weakening of adhesion due to moisture from the patient's breath. In other areas of the face, the skin may also release moisture, which can loosen the adhesion, leading to leaks that can result in ineffective respiratory therapy. Furthermore, when a patient is receiving oxygen therapy, leaks can lead to unnecessary loss of oxygen. Such oxygen leaks can be particularly detrimental in developed countries where medical oxygen is a scarce and expensive resource.

[0044] Adhesive-based seal-forming structures may also leave residue, odor, or color on the patient's skin, sometimes even after the seal-forming structure is removed.

[0045] When placed in contact with a patient's face, adhesive-based seal-forming structures can also wrinkle due to differences between the contours of the patient's face and the natural three-dimensional shape of the seal-forming structure. Wrinkles can provide areas where pressurized gas may leak, potentially causing facial markings or possible discomfort.

[0046] Adhesive-based seal-forming structures may be difficult to apply to a patient's face. For example, a thin seal-forming structure may not retain its shape well and may therefore easily fold or adhere to the intended surface.

[0047] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications assigned to ResMed Pty Ltd: WO 1998 / 004,310; WO 2006 / 074,513; and WO 2010 / 135,785. An example of a patient interface including a seal-forming structure that uses an adhesive to achieve a seal is disclosed in PCT Publication No. WO 2023 / 015340, the contents of which are incorporated herein by reference.

[0048] One form of nasal pillow is found in the Adam circuit manufactured by Puritan-Bennett. Another type of nasal pillow or nasal spray is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0049] ResMed Limited manufactures the following products that incorporate nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFTTM LT nasal pillow mask, SWIFT TM FX Nasal Pillows and MIRAGE LIBERTY TM Full face mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International patent application WO 2004 / 073,778 (describing the ResMed Limited SWIFT TM Other aspects of nasal pillows), U.S. Patent Application 2009 / 0044808 (describing ResMed Limited SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (describing ResMed Limited MIRAGE LIBERTY TM Other aspects of full face masks); International patent application WO 2009 / 052,560 (describing ResMed Limited SWIFT TM Other aspects of the FX nasal pillows).

[0050] 1.2.3.1.2 Positioning and stabilization

[0051] The seal-forming structure of the patient interface for positive air pressure therapy is subjected to the corresponding force of air pressure to destroy the seal. Therefore, various technologies have been used to position the seal-forming structure and keep it in a sealing relationship with the appropriate part of the face.

[0052] One technique is to use adhesives. An example of using adhesives to position and stabilize a patient interface having a seal-forming structure on the face is disclosed in PCT Publication No. WO 2023 / 015340, the contents of which are incorporated herein by reference. One advantage of using adhesives to position and stabilize the seal-forming structure on the patient's face is that it avoids the need for headgear (discussed below), which can be uncomfortable, claustrophobic, and increase manufacturing cost and complexity. However, as previously mentioned, the use of adhesives known in the art has some disadvantages.

[0053] Another technique involves the use of one or more straps and / or stabilizing braces. Many of these straps suffer from one or more of the following issues: poor fit, bulk, discomfort, and inconvenience. They also tend to be less airtight than adhesive-based seal-forming structures. Furthermore, straps and / or stabilizing braces often leave marks on the face when worn overnight.

[0054] 1.2.3.1.3 Pressurized air duct

[0055] In one type of therapy system, a flow of pressurized air is provided to a patient interface via conduits in an air circuit that are fluidly connected to the patient interface such that, when the patient interface is positioned on the patient's face during use, the conduits extend forwardly from the patient's face and out of the patient interface. This may sometimes be referred to as a "tube-down" configuration.

[0056] The tubing connected to the port on the front of the patient's face can sometimes tend to become tangled in bedding.

[0057] 1.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0058] A respiratory pressure therapy (RPT) device can be used alone or as part of a system to deliver one or more of the various therapies described above, for example by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Thus, an RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0059] 1.2.3.3 Air circuit

[0060] An air circuit is a conduit or tube constructed and arranged to allow air flow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inspiration and expiration. In other cases, a single branch air circuit is used for inspiration and expiration.

[0061] 1.2.3.4 Humidifier

[0062] Delivering an air flow without humidification can lead to airway drying. Use of a humidifier with an RPT device and patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air, typically applied to the facial area in and around the patient interface, is more comfortable than cold air.

[0063] 1.2.3.5 Ventilation techniques

[0064] Some forms of therapy systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space of the patient interface, such as a plenum, to the exterior of the patient interface, such as the surrounding environment. Utility Model Content

[0065] The present technology is directed to providing medical devices for screening, diagnosing, monitoring, ameliorating, treating or preventing respiratory disorders with one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0066] A first aspect of the present technology relates to a device for screening, diagnosing, monitoring, ameliorating, treating or preventing a respiratory disorder.

[0067] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0068] One aspect of one form of the present technology is a patient interface that includes a seal-forming structure configured to form a seal with a region of a patient's face surrounding an entrance to the patient's airway.

[0069]

[0011] Another aspect of one form of the present technology is a patient interface comprising a seal-forming structure having an opening such that a flow of breathable gas is delivered to at least one entrance of a patient's nares.

[0070] Another aspect of one form of the present technology is a patient interface comprising a seal-forming structure, the seal-forming structure further comprising at least one adhesive surface configured to adhere to an area of ​​a patient's face surrounding an entrance to the patient's airway to form a seal in use.

[0071] One aspect of one form of the present technology is a patient interface comprising a plenum chamber pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber comprising a plenum inlet port configured to receive a flow of breathable gas at the therapeutic pressure for patient breathing.

[0072] In one form of the present technology, the seal-forming structure is configured to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle in use.

[0073] Another aspect of one form of the present technology is a patient interface having a perimeter shape that is complementary to the perimeter shape of the intended wearer. In one form, the seal-forming structure is configured to have a perimeter shape that is complementary to an area of ​​the patient's face surrounding the patient's airway entrance to form a seal. The area to which the seal-forming structure will adhere can be referred to as a target seal area. In one form, the seal-forming structure is configured so that the area of ​​the patient's face includes an area of ​​the patient's face adjacent to or surrounding the nostrils.

[0074]

[0011] Another aspect of the present technology is a patient interface comprising a mouth closure structure configured to facilitate closure of a patient's mouth.

[0075] According to one aspect of the present technology, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include a plenum chamber that is pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port configured to receive a flow of breathable gas at a therapeutic pressure for the patient to breathe. The patient interface may also include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with an area of ​​the patient's face surrounding the entrances to the patient's nostrils but not surrounding the patient's mouth. The seal-forming structure may have openings therein such that a flow of breathable gas is delivered to the entrances to the patient's nostrils. The seal-forming structure may be configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use. The seal-forming structure may include at least one adhesive surface configured to adhere to an area of ​​the patient's face during use to form the seal. The patient interface may also include a vent structure to allow gas exhaled by the patient to continuously flow from the interior of the plenum chamber to the surrounding environment. The vent structure may be configured to maintain the therapeutic pressure in the plenum chamber during use. The patient interface may also include a mouth closure structure configured to facilitate closure of the patient's mouth.

[0076] In certain forms, the mouth closure structure may include a mouth closure member comprising an adhesive surface configured to adhere to the patient's lips and / or an area of ​​the patient's face proximate the patient's lips during use.

[0077] In certain forms, the mouth closure member may be configured to adhere to an area of ​​the patient's face below the mouth and an area of ​​the patient's face above the mouth.

[0078] In some forms, when the mouth closure member is adhered to the patient's face, the mouth closure member can leave at least a portion of the patient's mouth uncovered. For example, when the mouth closure member is adhered to the patient's face, the mouth closure member can leave the patient's mouth completely uncovered.

[0079] In certain forms, the mouth closure member may be configured to adhere to one or more side-of-the-mouth regions on one or both sides of the patient's mouth and to the lower lip / chin region between the patient's mouth and chin.

[0080] In some forms, the mouth closure member may be configured to span the patient's mouth.

[0081] In certain forms, the mouth closing structure may be integrally connected to the seal-forming structure and / or the inflation chamber.

[0082] In certain forms, the mouth closing structure may be configured to be disconnectable from the seal-forming structure and / or the inflation chamber.

[0083] According to one aspect of the present technology, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include a plenum chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port configured to receive a flow of breathable gas at a therapeutic pressure for the patient to breathe. The patient interface may also include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with a patient's facial area surrounding the entrances of the patient's nostrils but not surrounding the patient's mouth. The seal-forming structure may have openings therein so that the flow of breathable gas is delivered to the entrances of the patient's nostrils. The seal-forming structure may be configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use. The patient interface may also include a vent structure to allow gas exhaled by the patient to continuously flow from the interior of the plenum chamber to the surrounding environment. The vent structure may be configured to maintain the therapeutic pressure in the plenum chamber during use. The patient interface may also include a mouth closure structure configured to facilitate closure of the patient's mouth. The mouth closure structure may be integrally connected to the seal-forming structure and / or the plenum chamber.

[0084] In some forms, the seal-forming structure may include at least one adhesive surface configured to adhere to an area of ​​the patient's face to form the seal in use.

[0085] In some forms, the patient interface may further comprise headgear configured to retain the seal-forming structure in a sealing position on the patient's face in use.

[0086] In some forms, the headgear may include one or more straps configured to maintain the seal-forming structure in a sealing position on the patient's face during use.

[0087] In certain forms, the mouth closure structure may include a mouth closure member comprising an adhesive surface configured to adhere to the patient's lips and / or an area of ​​the patient's face proximate the patient's lips during use.

[0088] In certain forms, the mouth closure member may be configured to adhere to an area of ​​the patient's face below the mouth and an area of ​​the patient's face above the mouth.

[0089] In some forms, when the mouth closure member is adhered to the patient's face, the mouth closure member can leave at least a portion of the patient's mouth uncovered. For example, when the mouth closure member is adhered to the patient's face, the mouth closure member can leave the patient's mouth completely uncovered.

[0090] In certain forms, the mouth closure member may be configured to adhere to one or more side-of-the-mouth regions on one or both sides of the patient's mouth and to the lower lip / chin region between the patient's mouth and chin.

[0091] In some forms, the mouth closure member may be configured to span the patient's mouth.

[0092] In certain forms, the mouth closing structure may be integrally connected to the seal-forming structure and / or the inflation chamber.

[0093] In certain forms, the mouth closing structure may be configured to be disconnectable from the seal-forming structure and / or the inflation chamber.

[0094] According to one aspect of the present technology, a patient interface for delivering a breathable gas to a patient is provided. The patient interface may include a seal-forming structure that may be configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway. The seal-forming structure may include at least one adhesive surface configured to adhere to an area of ​​the patient's face to form the seal during use. The seal-forming structure may be configured to have one or more notches formed in an edge of a lateral area of ​​the seal-forming structure.

[0095] According to one aspect of the present technology, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include a plenum chamber that is pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port configured to receive a flow of breathable gas at a therapeutic pressure for the patient to breathe. The patient interface may also include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure may have openings therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nares. The seal-forming structure may be configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use. The patient interface may also include a vent structure to allow gas exhaled by the patient to continuously flow from the interior of the plenum chamber to the surrounding environment. The vent structure is configured to maintain the therapeutic pressure in the plenum chamber during use. The seal-forming structure may include at least one adhesive surface configured to adhere to an area of ​​the patient's face during use to form the seal. The seal-forming structure may be configured to have one or more notches formed in edges of lateral regions of the seal-forming structure.

[0096] In certain forms, at least one of the one or more notches may be formed in a region of the seal-forming structure that is configured to adhere to a patient's nose in use.

[0097] In certain forms, at least one of the one or more notches may be formed in a region of the seal-forming structure that is configured to adhere to the ala of the patient's nose in use.

[0098] In certain forms, at least one of the one or more notches may be formed in a region of the seal-forming structure that is configured to adhere to a patient's cheek in use.

[0099] In some forms, at least one of the one or more recesses can be formed between adjacent regions of the seal-forming structure, the adjacent regions being respectively configured to adhere to the patient's face in use, on either side of the junction between the patient's nose and the patient's cheek.

[0100] In certain forms, at least one of the one or more recesses may be formed in a region of the seal-forming structure that is configured to adhere to a region on the patient's lips in use.

[0101] In certain forms, at least one of the one or more notches may be formed in a region of the seal-forming structure that is configured to adhere to the nasolabial fold region of a patient in use.

[0102] In certain forms, the seal-forming structure may be configured such that at least one of the one or more notches extends substantially laterally inwardly from a lateral edge of the seal-forming structure towards a mid-plane of the patient, in use.

[0103] In certain forms, at least one of the one or more notches may be substantially slit-shaped.

[0104] In some forms, the one or more recesses may include a first recess and a second recess. The first recess may be formed in an area of ​​the seal-forming structure that is configured to be located on one side of the midplane during use. The second recess may be formed in an area of ​​the seal-forming structure that is configured to be located on the other side of the midplane during use.

[0105] According to one aspect of the present technology, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include a plenum chamber that is pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum inlet port configured to receive a flow of breathable gas at a therapeutic pressure for the patient to breathe. The patient interface may also include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure may have openings therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nares. The seal-forming structure may be configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use. The patient interface may also include a vent structure to allow gas exhaled by the patient to continuously flow from the interior of the plenum chamber to the surrounding environment. The vent structure may be configured to maintain the therapeutic pressure in the plenum chamber during use. The seal-forming structure may include at least one adhesive surface configured to adhere to an area of ​​the patient's face during use to form the seal. The seal-forming structure may be configured to have one or more notches formed in an edge of the seal-forming structure, the notches being positioned substantially below the opening during use.

[0106] According to one aspect of the present technology, a patient interface for delivering breathable gas to a patient is provided, the patient interface comprising: a plenum chamber that is pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port, the plenum chamber inlet port being configured to receive a flow of breathable gas at the therapeutic pressure for breathing by the patient; a seal-forming structure provided to the plenum chamber, wherein the seal-forming structure is configured to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having an opening therein so that the flow of breathable gas is delivered to at least the entrance of the patient's nostrils, the seal-forming structure being configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle in use; and a vent structure that allows gas exhaled by the patient to continuously flow from the interior of the plenum chamber to the surrounding environment, the vent structure being configured to maintain the therapeutic pressure in the plenum chamber in use, wherein the seal-forming structure includes at least one adhesive surface, the adhesive surface being configured to adhere to an area of ​​the patient's face to form the seal in use, and wherein the seal-forming structure is configured to have one or more notches formed in an edge of the seal-forming structure, the notches being positioned substantially below the opening during use.

[0107] In certain forms, at least one of the one or more notches may be formed in a region of the seal-forming structure that is configured for adherence to a subnasal point of a patient's nasal septum in use.

[0108] In certain forms, at least one of the one or more notches may be formed in an area of ​​the seal-forming structure configured for adherence to an area on the patient's lips.

[0109] In certain forms, at least one of the one or more recesses may be formed in a region of the seal-forming structure that is configured to adhere to a region of the patient's face located on or near the mid-plane, during use.

[0110] In certain forms, at least one of the one or more recesses may be formed in a region of the seal-forming structure that is configured to adhere, in use, to a region of the patient's face that is transverse to the mid-plane.

[0111] According to one aspect of the present technology, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include a plenum chamber that is pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port configured to receive a flow of breathable gas at a therapeutic pressure for the patient to breathe. The patient interface may further include a seal-forming structure configured to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure may have openings therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nares. The seal-forming structure may be configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use. The seal-forming structure may include at least one adhesive surface configured to adhere to an area of ​​the patient's face during use to form the seal. The patient interface may also include a connecting portion located between the seal-forming structure and the plenum chamber. The connecting portion may be formed to have a thickness that is substantially thinner than adjacent areas of the plenum chamber and the seal-forming structure to allow relative displacement between the seal-forming structure and the plenum chamber. The patient interface may further comprise a vent structure to allow gas exhaled by the patient to continue to flow from the interior of the plenum to the surrounding environment.The vent structure may be configured to maintain a therapeutic pressure in the plenum in use.

[0112] In some forms, the connecting portion may extend around an opening formed in the patient-facing side of the plenum chamber.

[0113] According to one aspect of the present technology, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include a plenum chamber that is pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum chamber inlet port configured to receive a flow of breathable gas at a therapeutic pressure for the patient to breathe. The patient interface may also include a seal-forming structure provided to the plenum chamber. The seal-forming structure may be configured to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure may have openings therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nares. The seal-forming structure may be configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use. The seal-forming structure may include at least one adhesive surface configured to adhere to an area of ​​the patient's face during use to form the seal. The patient interface may also include a vent structure to allow gas exhaled by the patient to continuously flow from the interior of the plenum chamber to the surrounding environment. The vent structure may be configured to maintain the therapeutic pressure in the plenum chamber during use. The patient interface may further include at least one shape retainer configured to facilitate retention of the shape of the seal-forming structure before the seal-forming structure is made to adhere to the patient's face. The at least one shape retainer may include a ring extending around at least a majority of the outer periphery of the seal-forming structure.

[0114] In some forms, at least one shape retainer may comprise an incomplete ring having a first end and a second end separated by a gap.

[0115] In certain forms, the at least one shape retainer may include a tab configured to be grasped by a user to remove the at least one shape retainer from the seal-forming structure.

[0116] In some forms, the tab may extend radially inward from the annular opening.

[0117] In some forms, the tab may extend from the outer region of the ring in a transverse-medial direction.

[0118] In some forms, the tab can be a first tab, and the at least one shape retainer can include a second tab configured to be grasped by a user to remove the at least one shape retainer from the seal-forming structure. In use, the first tab can be located on one side of the patient's mid-plane. In use, the second tab can be located on the other side of the patient's mid-plane.

[0119] According to one aspect of the present technology, a patient interface for delivering breathable gas to a patient is provided. The patient interface may include a plenum chamber that is pressurized to a therapeutic pressure that is at least 6 cmH2O above ambient air pressure. The plenum chamber may include a plenum inlet port configured to receive a flow of breathable gas at a therapeutic pressure for the patient to breathe. The patient interface may also include a seal-forming structure. The seal-forming structure may be configured to form a seal with an area of ​​the patient's face surrounding the entrance to the patient's airway. The seal-forming structure may have openings therein such that the flow of breathable gas is delivered to at least the entrance to the patient's nares. The seal-forming structure may be configured to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle during use. The patient interface may also include a vent structure to allow gas exhaled by the patient to continuously flow from the interior of the plenum chamber to the surrounding environment. The vent structure may be configured to maintain the therapeutic pressure in the plenum chamber during use. The seal-forming structure may include at least one patient-facing adhesive surface configured to adhere to an area of ​​the patient's face during use to form the seal. The seal-forming structure may further include at least one non-patient-facing adhesive surface formed around the opening and configured to adhere to the patient-facing side of the plenum. The seal-forming structure may further include a non-patient-facing removable layer positioned on the non-patient-facing adhesive surface and configured to be removed prior to adhesion of the plenum to the seal-forming structure. A slit may be formed in the non-patient-facing removable layer extending from an edge of the non-patient-facing removable layer.

[0120] In certain forms, the seal-forming structure may further include a patient-facing removable layer positioned on the patient-facing adhesive surface and configured to be removed prior to adhering the seal-forming structure to the patient's face.

[0121] In some forms, the non-patient-facing removable layer may have a hole formed therein. When the non-patient-facing removable layer is positioned on the non-patient-facing adhesive surface, the hole may be substantially aligned with the opening.

[0122] In certain versions, the slit may extend from a radially outer edge of the non-patient-facing removable layer to a radially inner edge of the non-patient-facing removable layer.

[0123] In certain forms, the slits may extend at least partially in an azimuthal direction around the non-patient-facing removable layer.

[0124] In certain forms, the non-patient-facing removable layer may include a tab configured to be grasped by a user to remove the non-patient-facing removable layer from the seal-forming structure.

[0125] In certain forms, the tab may extend outwardly from a non-patient-facing edge of the removable layer substantially opposite the slit.

[0126] In some forms, the slit can be a first slit, and a second slit can be formed in the non-patient-facing removable layer extending from an edge of the non-patient-facing removable layer. The second slit can extend from a radially outer edge of the non-patient-facing removable layer to a radially inner edge of the non-patient-facing removable layer.

[0127] One aspect of some forms of the present technology is a medical device that is easy to use, for example, by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using medical devices of this type.

[0128] Of course, a part of these aspects may form a sub-aspect of the present technology. In addition, each aspect in the sub-aspect and / or aspect may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0129] Other features of the technology will become apparent upon consideration of the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0130] The present technology is illustrated by way of example and not limitation in the accompanying figures and in which like reference numerals indicate similar elements, including:

[0131] Figure 1 A system is shown that includes a patient 1000 wearing a patient interface 3000 receiving a supply of air at positive pressure from a RPT device 4000. The patient sleeps on his side.

[0132] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0133] Figure 2B A view of the human upper airway is shown, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, superior lip, inferior lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0134] Figure 2C It is a frontal view of the face with several surface anatomical features identified, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, inner canthus, nasal ala, nasolabial fold, and corner of the mouth. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0135] Figure 2DIt is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge, nasal prominence, subseptal point, supra-lip, sublip, supra-chin, nasal ridge, apex of the nose, and supra-auricular and subauricular points. The superior-inferior and anterior-posterior directions are also indicated.

[0136] Figure 2E This is another lateral view of the head. The approximate locations of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0137] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, inferior lip, upper vermillion, nostrils, inferior point of the nasal septum, columella, pronasal point, long axis of the nostrils, and the midsagittal plane.

[0138] Figure 2G A side view of the nasal surface features is shown.

[0139] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bones, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0140] Figure 2I The medial anatomy of the nose is shown approximately a few millimeters from the mid-sagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0141] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates, as well as the maxilla and mandible are also indicated.

[0142] Figure 2K A side view of the skull is shown, with the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0143] Figure 2L An anterolateral view of the nose is shown.

[0144] Figure 3 One form of a patient interface in accordance with the present technology is shown, the patient interface being configured to adhere to a flange area of ​​a patient's face.

[0145] Figure 4A Shown is a perspective view of a patient interface adhered to a patient's face in accordance with one form of the present technology.

[0146] Figure 4B Shown Figure 4A Side view of the patient interface.

[0147] Figure 5 is a perspective view of a patient interface adhered to the alar fold area of ​​a patient's face in accordance with one form of the present technology.

[0148] Figure 6 A seal-forming structure according to one form of the present technology is shown.

[0149] Figure 7 is a perspective view of another form of patient interface according to the present technology.

[0150] Figure 8 Shown is a perspective view of a patient interface in accordance with one form of the present technology.

[0151] Figure 9 is a perspective view of another form of patient interface according to the present technology.

[0152] Figure 10 is a perspective view of another form of patient interface according to the present technology.

[0153] Figure 11 is an illustration of a patient interface including a mouth closure structure in accordance with one form of the present technology.

[0154] Figure 12 is an illustration of a patient interface including another form of mouth closure structure in accordance with the present technology.

[0155] Figure 13 is an illustration of a patient interface including another form of mouth closure structure in accordance with the present technology.

[0156] Figure 14 is an illustration of a patient interface including another form of mouth closure structure in accordance with the present technology.

[0157] Figure 15 yes Figure 14 Illustration of a portion of a patient interface is shown.

[0158] Figure 16 yes Figure 14 Illustration of a portion of a patient interface is shown.

[0159] Figure 17 is a perspective illustration of another form of patient interface in accordance with the present technology.

[0160] Figure 18 yes Figure 17 Front view illustration of the patient interface shown.

[0161] Figure 19 When the patient wears Figure 17 Illustration of the patient interface shown.

[0162] Figure 20 is a front view illustration of another form of patient interface according to the present technology.

[0163] Figure 21 yes Figure 20 A perspective view of a patient interface and other components is shown.

[0164] Figure 22A yes Figure 20 An exploded view illustration of a patient interface is shown.

[0165] Figure 22B is an exploded view illustration of another form of patient interface according to the present technology, prior to assembly.

[0166] Figure 23 is an exploded view illustration of another form of patient interface according to the present technology.

[0167] Figure 24 yes Figure 23 A perspective illustration of a patient interface is shown as worn by a patient.

[0168] Figure 25 Shown Figure 23 A portion of a patient interface is shown in the assembled view (top of the figure) and in an exploded view (bottom of the figure).

[0169] Figure 26A is a perspective illustration of another form of patient interface in accordance with the present technology.

[0170] Figure 26B is a plan view illustration of a shape retainer according to one form of the present technology.

[0171] Figure 27 is an exploded view illustration of another form of patient interface according to the present technology, prior to assembly.

[0172] Figures 28A to 28I is a plan view illustration of a non-patient-facing removable layer in accordance with some forms of the present technology. DETAILED DESCRIPTION

[0173] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0174] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any of the examples, any single feature or combination of features may constitute another example.

[0175] 4.1 Treatment

[0176] In one form, the present technology comprises a method for treating a breathing disorder comprising applying positive pressure to an airway entrance of a patient 1000 .

[0177] In some examples of the present technology, a supply of air at positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0178] In some examples of the present technology, mouth breathing is limited, restricted, or prevented.

[0179] 4.2 Respiratory therapy system

[0180] In some forms, such as Figure 1 As shown, the present technology includes a respiratory therapy system 2000 for treating respiratory disorders. Respiratory therapy system 2000 may include an RPT device 4000 for supplying air flow to a patient 1000 via an air circuit 4170 and a patient interface 3000.

[0181] exist Figure 1 In the illustrated form of the technology, the RPT device 4000 is portable and can be carried by the patient 1000, for example attached to the patient's clothing. In an alternative form of the technology (not shown), the RPT device is configured to rest on a nearby surface, such as a bedside table, during use.

[0182] In addition, respiratory therapy system 2000 can include a humidifier to change the absolute humidity of the air or gas delivered to the patient relative to the ambient air. Typically, a humidifier is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0183] 4.3 Patient Interface

[0184] Figure 3-6 and Figure 8-13 A form of technology is shown that provides a patient interface 3000 (or portion thereof) where the patient interface 3000 does not extend into the nostrils of the patient 1000. Figure 7 In the illustrated form of the technology, the patient interface 3000 includes a nasal prong 3250 that engages with and / or extends into the nostrils. These types of patient interfaces will be described in more detail in the following paragraphs.

[0185] According to certain aspects of the present technology, such as Figures 3 to 13 The illustrated patient interface 3000 includes at least some of the following functional aspects: a seal-forming structure 3100 , an inflatable chamber 3200 , a positioning and stabilizing structure 3300 , a vent 3400 , and a mouth closure structure 3910 .

[0186] In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance to the patient's airway so as to maintain positive pressure at the entrance to the patient's 1000 airway. Thus, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0187] The plenum 3200 may be formed from one or more modular components (eg, the cushion module 3150 together with the seal-forming structure 3100) in the sense that it or they may be replaced with different components, such as components of different sizes and / or shapes.

[0188] If a patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0189] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure above ambient, for example at least 2, 4, 6, 10 or 20 cmH20 relative to ambient.

[0190] 4.3.1 Sealing structure

[0191] In one form of the present technology, a patient interface 3000 includes a seal-forming structure 3100 configured to form a seal with an area of ​​a patient's face. The seal-forming structure 3100 is thereby configured to secure a plenum 3200 in sealing engagement relative to the patient's face. The seal-forming structure 3100 may form an opening to allow a flow of breathable gas to be delivered to at least the entrance of the patient's nostrils.

[0192] In one form of the present technology, a target seal-forming area is provided for the seal-forming structure 3100. The target seal-forming area is the area on the seal-forming structure 3100 where sealing is likely to occur. The area where sealing actually occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given course of treatment, depending on a number of factors including, for example, where the patient interface is placed on the face and the shape of the patient's face.

[0193] In some forms of the present technology, the seal-forming structure 3100 is configured so that the shape of the target seal-forming area substantially matches or is similar to the shape of the area of ​​the patient's face to which the seal-forming structure 3100 is attached in use, and / or is configured to be sufficiently flexible so that it can deform to do so. This can promote a greater degree of seal against the patient's face and, in the case of a seal-forming structure adhered to the patient's face, avoid the adhesive surface 3102 pulling on the underlying skin when the patient interface 3000 is in use.

[0194] In some forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material such as silicone rubber.

[0195] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, elastic material, such as silicone or a thermoplastic elastomer (TPE).

[0196] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure 3100 configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large heads but not small heads, and another form of seal-forming structure 3100 that is suitable for small heads but not large heads.

[0197] Further details of seal-forming structures according to certain forms of the present technology are described below. Other aspects of seal-forming structures according to forms of the present technology are described in more detail in PCT Publication No. WO2023 / 015340, the contents of which are incorporated herein by reference.

[0198] 4.3.1.1 Sealing mechanism

[0199] 4.3.1.1.1 Adhesive

[0200] Certain forms of the seal-forming structure 3100 of the present technology are configured to adhere to one or more areas of a patient's face via an adhesive provided on an adhesive surface 3102 of the seal-forming structure 3100 to form a seal with an area of ​​the patient's face surrounding the entrance to one or more of the patient's airways. For example, Figures 3 to 8 、 Figures 11 to 13 、 Figures 17 to 26A and Figure 27 The seal-forming structures 3100 in are each configured to seal around the nasal airways of the patient 1000.

[0201] The adhesive-based attachment of seal-forming structure 3100 to the patient's face allows for a highly airtight seal. A high-quality seal improves the effectiveness of positive pressure respiratory therapy because the desired pressure can be maintained in the patient interface. Furthermore, a high-quality seal reduces the total power required by RPT device 4000 to maintain the pressure of the breathable gas in patient interface 3000. When seal-forming structure 3100 is adhered to the patient's face, an alternative positioning and stabilizing structure, such as a headgear, may not be required.

[0202] 4.3.1.1.2 Other sealing mechanisms

[0203] exist Figure 9 、 Figure 10 and Figures 14 to 16 In the illustrated form, the seal-forming structure includes a sealing flange that utilizes a pressure-assisted sealing mechanism. In use, the sealing flange can readily respond to the system positive pressure acting on its bottom surface within the inflatable chamber 3200, thereby forming a tight sealing engagement with the face. The pressure-assisted mechanism can act in conjunction with the elastic tension in the positioning and stabilizing structure.

[0204] In one embodiment, the seal-forming structure 3100 includes a sealing flange and a support flange. The sealing flange comprises a relatively thin member having a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm, that extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends at least a portion of the path around the periphery. The support flange is or comprises a spring-like element and functions to support the sealing flange and prevent it from buckling during use.

[0205] In one form, the seal-forming structure may include a compression seal portion or a gasket seal portion that is constructed and arranged to be in a compressed state, for example as a result of elastic tension in the positioning and stabilizing structure 3300, in use.

[0206] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is maintained in tension, for example, by an adjacent area of ​​the sealing flange.

[0207] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tensioning portion, and a portion having a tacky or adhesive surface.

[0208] 4.3.1.2 Patient face sealing area

[0209] In some forms of the technology, the seal-forming structure 3100, in use, forms a seal with an area of ​​the patient's face surrounding the entrances to the patient's nostrils. In some forms, the seal-forming structure 3100 forms a seal around the entrances to the patient's nasal airways (i.e., one or both nostrils) but not around the patient's mouth.

[0210] exist Figure 5 、 Figure 9 and Figure 10 In the exemplary form of the technology shown, the seal-forming structure 3100 can be configured to seal against the patient's lips. The patient interface 3000 can leave the patient's mouth uncovered. The patient interface 3000 can deliver air or a supply of breathable gas to both nostrils of the patient 1000 without delivering it to the mouth. This type of patient interface can be identified as a nasal mask.

[0211] One form of a nasal mask in accordance with the present technology is a form conventionally identified as a nasal mask having a seal-forming structure 3100 configured to seal around the nose and over the bridge of the nose on the patient's face. The nasal mask is generally triangular in shape. In one form, the non-invasive patient interface 3000 includes a seal-forming structure 3100 that, in use, forms a seal against the upper lip region (e.g., above the lip), against at least a portion of the nasal ridge in the patient's nose or above the pronasal point, and against the patient's face on each side of the patient's nose, such as near the patient's nasolabial groove. Figure 9 The illustrated patient interface 3000 has this type of seal-forming structure 3100. The patient interface 3000 can deliver air or breathable gas to both nostrils of the patient 1000 through a single orifice.

[0212] Another form of a nasal-only mask may seal around the lower periphery of the patient's nose without engaging the user's nasal ridge. For example, this type of patient interface 3000 may be identified as a "nose support" mask, and the seal-forming structure 3100 may be identified as a "nose support cushion." In one form, for example, Figure 10As shown, the seal-forming structure 3100 is configured to form a seal with the lower surface of the nose around the nostrils during use. The seal-forming structure 3100 can be configured to seal around the patient's nostrils at the lower periphery of the patient's nose, including sealing to the lower and / or front surfaces of the patient's nose in the nasal canthus region and sealing to the patient's nostrils. The seal-forming structure 3100 can seal against the patient's lips. The shape of the seal-forming structure 3100 can be configured to match or closely follow the underside of the patient's nose and may not contact the nasal bridge region or any portion of the patient's nose beyond the nasal canthus. In one form of the nasal cushion, the seal-forming structure 3100 includes a bridging portion that divides the opening into two orifices, each of which supplies air or breathable gas to a corresponding one of the patient's nostrils during use. The bridging portion can be configured to contact or seal with the patient's columella during use. Alternatively, the seal-forming structure 3100 can include a single opening, with both patient nostrils providing airflow or air or breathable gas.

[0213] exist Figure 7 and Figures 14 to 16 In the illustrated form, 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 arranged to form a seal with a corresponding nostril of the patient's nose. Nasal pillows according to one aspect of the present technology include: a frustoconical body, at least a portion of which forms a seal on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible regions can act together to facilitate a universal engagement structure that can adapt to relative movement of both displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0214] A more detailed description of the area of ​​the patient's face to which the seal-forming structure 3100 seals during use will now be described in the context of some forms of technology in which the seal-forming structure is configured to adhere to the patient's face during use.

[0215] exist Figure 3 In the illustrated form of the technology, the seal-forming structure 3100 is configured to adhere to the area of ​​the patient's face immediately surrounding the nostrils. These areas may include (see Figure 2F): the alar region 3141 (i.e., the area of ​​the alar immediately adjacent the nostril and generally facing downward); the uppermost area of ​​the supra-labial region 3142, which may include the nasal septum and / or the area immediately below the nasal septum; and the prenasal region, which is below, e.g., immediately below, the pronotum 3143. In the lateral direction, the seal-forming structure 3100 extends to a region 3144 slightly below the apex of the alar, e.g., an area immediately midway between the junction between the alar roof and the nasolabial groove. In the form of the technology shown, the seal-forming structure 3100 does not adhere to a significant portion of the lateral region of the alar, although in some forms, or for some faces, it may adhere to a lower area of ​​the lateral region of the alar. In addition, Figure 3 The seal-forming structure 3100 does not adhere to the nasal protrusion.

[0216] exist Figure 3 In the illustrated form of the technology, the area of ​​the patient's face to which the seal-forming structure 3100 is adhered is a band that completely surrounds both of the patient's nostrils. The width of the band can be approximately constant around the perimeter of the band.

[0217] It has been found that when the patient 1000 changes his position, Figure 3 The facial area covered by the seal-forming structure 3100 of the illustrated technical form does not substantially change shape because this facial area is primarily composed of cartilage and bone and has relatively little fat tissue compared to the cheek or chin areas. This facial area also typically has no or very little facial hair (for example, some facial hair may be present on the uppermost area of ​​the lip 3142). A seal-forming structure 3100 adhered to this area is particularly advantageous for patients 1000 who have upper lip hair.

[0218] Figure 3 The facial area covered by the seal-forming structure 3100 of the illustrated form of the technology has relatively little variation in shape among patients in a representative population sample, including patients of various ethnicities.

[0219] Furthermore, this area (which may be referred to as the flange area) is smaller in size because it directly surrounds the nostrils.

[0220] In another exemplary form, Figure 4A and Figure 4B As shown, the seal-forming structure 3100 is configured to adhere to a facial area that is smaller than Figure 3 The area shown extends further up and includes the lateral areas of the nose. In some forms, the seal-forming structure 3100 is configured to adhere to the lateral areas of the nose and may also extend radially outward far enough to adhere to the cheek area adjacent to the apex of the nose, such as the area between the nose and the nasolabial groove, during use. The seal-forming structure 3100 may also adhere to the lateral areas of the nose. Figure 3 The area of ​​the surface to which the seal-forming structure adheres. Figure 3 Compared with the sealing structure, Figure 4A and Figure 4B A larger adhesion area of ​​the seal-forming structure in the embodiment may increase adhesion volume and result in less leakage, but may cause more discomfort to the patient.

[0221] In another exemplary form, Figure 5 As shown, the seal-forming structure 3100 is configured to adhere to the patient's face. Figure 3 、 Figure 4A and Figure 4B The area to which the seal-forming structure is adhered is larger. In this form, the seal-forming structure is adhered to an area that extends upwardly to the alar fold area, that is, when the seal-forming structure is adhered to the patient's face, the uppermost portion of the seal-forming structure is adhered to the patient's alar fold. This form of seal-forming structure 3100 may additionally or alternatively be adhered to a major portion of the lip. Furthermore, this form of seal-forming structure 3100 may additionally or alternatively be adhered to the nasal prominence area, which may include a point directly above the nasal prominence. In the lateral direction, this form of seal-forming structure 3100 is adhered to an area of ​​the patient's cheek adjacent to the ala nasi, including the area between the ala nasi and the nasolabial groove, and the seal-forming structure 3100 may completely cover the ala nasi when in use. The seal-forming structure 3100 may also be adhered to Figure 3 、 Figure 4A and / or Figure 4B The area of ​​the face to which the seal-forming structure is adhered. Alternatively, Figure 3 、 Figure 4A and / or Figure 4B The seal forming structure is adhered to some areas compared to Figure 5 The seal-forming structure may be configured to adhere to areas located radially outward from the nostril.

[0222] In some forms of this technology, e.g. Figure 6 In the form of the technology shown in , the seal-forming structure 3100 can be configured to adhere to the columella. For example, the seal-forming structure 3100 can include a septal region 3132 extending between two diametrically opposed regions of the seal-forming structure 3100, the septal region 3132 being configured to adhere to the columella during use.

[0223] Figures 17 to 27 The form of technology shown in is also configured to seal the area of ​​the patient's face around and near the patient's nostrils.

[0224] 4.3.1.3 Composition of the sealing structure

[0225] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a material having one or more of the following properties: biocompatible; soft; flexible; stretchable and optionally elastic. In exemplary forms of the present technology, the seal-forming structure 3100 is formed from silicone or a thermoplastic elastomer (TPE). In other forms, the seal-forming structure 3100 is formed from textiles, fabrics, and / or foam materials.

[0226] In the case of a technique in which an adhesive is used to adhere the seal-forming structure 3100 to the patient's face, any form of adhesive can be used, and the adhesive can be applied to any suitable substrate, which can include materials such as those described above, such as silicone or TPE. For example, a rubber zinc oxide adhesive can be used. In other embodiments, other adhesives can be used, such as acrylic or acrylate adhesives, or silicone adhesives.

[0227] The adhesive may be provided in the form of an adhesive tape 3190, wherein the adhesive is already provided on a substrate (i.e., tape) which may advantageously be used as, or a portion of, the seal-forming structure 3100, or may be readily attached to the seal-forming structure 3100. An example of a suitable tape is 3M TM Nexcare TM In some forms, the material may include a rayon base to which an adhesive is applied. In one form, the seal-forming structure may be made of 3M TM Product No. 2484 (which uses silicone adhesive, "Hi-Tack 3M Medical Silicone Adhesive"), 3M TM Medical tape 9833 (which uses an acrylic / acrylate adhesive) or a similar type of product or a product having a similar structure is formed or can include these products. Multiple layers of tape or product can be used to form the seal-forming structure 3100.

[0228] exist Figure 20 、 Figure 21 、 Figure 22A and Figure 22BIn the illustrated technical form, the seal-forming structure 3100 may include a flange 3105 connected to the patient-facing side (or back side) of the plenum 3200. The flange 3105 may extend radially outward from the opening in the patient-facing side of the plenum 3200 in all directions. The flange 3105 may be formed, for example, by silicone or TPE, and in some forms may be formed by the same material as used to form the plenum 3200, for example, the flange 3105 may be formed integrally with the plenum 3200. In these forms, an adhesive may be applied to the patient-facing side of the flange 3105. In these forms, the entirety or major portion of the adhesive surface 3102 of the seal-forming structure 3100 may be on the patient-facing side of the flange 3105, or aligned therewith. For example, in these forms, the adhesive surface 3102 may not extend radially outward from the flange 3105, contrary to other forms described later.

[0229] In some forms, such as Figure 22A and Figure 22B As shown, the adhesive can be applied to the patient-facing side of the flange 3105 in the form of one or more layers of adhesive tape 3190. Each layer of tape 3190 can cover a majority of the patient-facing side of the flange 3105, such as substantially all of the patient-facing side of the flange 3105.

[0230] In other forms, e.g. Figure 23 、 Figure 24 、 Figure 25 、 Figure 26A and Figure 27 In the illustrated form of the technique, the bonding surface 3102 of the seal-forming structure 3100 may extend radially outward from the flange 3105, or the seal-forming structure 3100 may not include a flange (e.g., Figure 24 For example, Figure 23 and Figure 27 As shown, the flange 3105 may extend radially outward from the opening of the patient-facing side of the plenum chamber 3200 to a lesser extent than the adhesive surface 3102 of the seal-forming structure 3100, for example, to a lesser extent than the adhesive surface 3102 of the seal-forming structure 3100. Figure 22A and Figure 22B In these embodiments, one or more layers of the band 3190 may extend radially outward from the flange 3105.

[0231] Each layer of the strap 3190 can have an aperture formed therein, for example in a central region. The aperture can be sized and shaped to substantially match the opening in the seal-forming structure 3100 and the opening in the patient-facing side of the plenum 3200 so as to align with these openings when the patient interface 3000 is assembled and allow breathable gas to flow through these openings and apertures to the patient's airway. Each layer of the strap 3190 can also be formed with a notch 3110, as described below.

[0232] In some forms, each layer of tape 3190 is formed from a double-sided adhesive tape, i.e., a tape having adhesive on both surfaces of the substrate. The double-sided nature of the tape can be achieved by providing the tape in this form from a supplier, or by applying additional adhesive to the non-adhesive side of the original single-sided adhesive tape.

[0233] exist Figure 22A In the illustrated form, the seal-forming structure 3100 includes a single layer of double-sided adhesive tape 3190. The non-patient-facing side of the layer 3190 is adhered to the patient-facing side of the flange 3105. The patient interface 3000 may include a removable patient-facing layer 3120 that is configured to cover the patient-facing side of the adhesive tape 3190 until the patient is ready to adhere the seal-forming structure 3100 to their face. The removable patient-facing layer 3120 can be removed from the adhesive tape 3190 before the seal-forming structure 3100 is adhered to the face. A replacement portion of the adhesive tape 3190 can be provided to the patient to replace the flange 3105 between each use of the patient interface 3000 or between uses.

[0234] exist Figure 23 In the illustrated form, the seal-forming structure 3100 comprises a single layer of single-sided adhesive tape 3190. The seal-forming structure 3100 may include a ring of adhesive material 3122 for adhering the plenum chamber 3200 to the seal-forming structure 3100. The ring of adhesive material 3122 may be located on the non-patient-facing side of the tape 3190 and surround an opening in the seal-forming structure 3100 through which, in use, breathable gas is delivered to the patient. Similarly, a replacement portion of the adhesive tape 3190 may be provided to the patient to replace with each or every few uses of the patient interface 3000.

[0235] In other forms, for example Figure 22B and Figure 27As shown, the seal-forming structure 3100 includes multiple layers of adhesive tape 3190, such as two layers formed by tapes 3190a and 3190b. When the seal-forming structure 3100 is assembled, the non-patient-facing side of the first tape 3190a can be adhered to the patient-facing side of the flange 3105, the non-patient-facing side of the second tape 3190b can be adhered to the patient-facing side of the first tape 3190a, and when the patient interface 3000 is in use, the patient-facing side of the second tape 3190b can be adhered to the patient's face. Prior to assembling the seal-forming structure 3100, the non-patient-facing side of the first tape 3190a can be covered by a non-patient-facing removable layer 3180 to protect the adhesive prior to assembly, and the patient-facing side of the second tape 3190b can be covered by a patient-facing removable layer 3120 to protect the adhesive prior to assembly. This layered assembly of multiple layers (e.g., layers 3180, 3190a, 3190b, and 3120) can be provided to the plenum chamber 3200 separately. Furthermore, a plurality of such layered assemblies may be provided, and the patient may replace the layered assemblies for different uses of the patient interface 3000, for example the layered assemblies may be replaced every night or every few nights.

[0236] In some versions, the second tape 3190b may be a tape particularly suitable for adhering to a patient's skin, such as medical tape, while the first tape 3190a may be more suitable for adhering to the flange 3105. In some versions, the medical tape used as the second tape 3190b may not be double-sided, so that the double-sided first tape 3190a may be used to adhere the medical tape to the plenum chamber 3200.

[0237] exist Figure 22B In the illustrated form, each layer of straps 3190a and 3190b may be sized and shaped similarly to the size and shape of the patient-facing side of flange 3105 such that each layer of strap 3190 covers a majority of the patient-facing area of ​​flange 3105 but does not extend radially outward from the edge of the flange.

[0238] exist Figure 27 In the illustrated form, the size and shape of the first band 3190a can be similar to the size and shape of the flange 3105, for example, annular. The first band 3190a can be double-sided. The second band 3190b can have a larger area than the first band 3190a and can extend radially outward from the first band 3190a and, therefore, radially outward from the flange 3105. The second band 3190b can be single-sided and can be a medical tape suitable for adhering to the patient's skin. The size and shape of the non-patient-facing removable layer 3180 can match the size and shape of the first band 3190a, and the size and shape of the patient-facing removable layer 3120 can match the size and shape of the second band 3190b.

[0239] In some forms, the fluid adhesive may be applied to the surface of the seal-forming structure 3100, for example in the form of a spray.

[0240] In some forms, the seal-forming structure 3100 can be attached to the patient's face using one or more action-releasing adhesives. One or more action-releasing adhesives can be configured so that their adhesive strength decreases when an action is achieved. The reduction in adhesive strength can be sufficient to allow the seal-forming structure 3100 to be easily removed from the patient's face while causing an acceptable level of discomfort. In some forms, the action can be some changes or effects applied to the adhesive or to a component of the adhesive (e.g., the seal-forming structure 3100). For example, the patient interface 3000 can include a seal-forming structure 3100 having an adhesive surface 3102, wherein the adhesive strength of the adhesive surface 3102 can be reduced by deformation of the adhesive surface 3102. The deformation can be a stretching action, i.e., the adhesive surface 3102 can have a stretch-releasing adhesive or be formed by a stretch-releasing adhesive. A stretch-releasing adhesive can have certain adhesive properties only when the adhesive surface 3102 is substantially unstretched. The adhesive surface 3102 can be configured to have reduced adhesive properties and / or no adhesive properties when the adhesive surface 3102 is stretched. In some forms, acrylate-based adhesives may be used as stretch release adhesives for adhesive surface 3102, such as Fixomul TM or 3M TM Stretch the release tape.

[0241] 4.3.1.4 Notch

[0242] In some forms of this technology, e.g. Figures 17 to 27 As shown, the seal-forming structure 3100 may be configured with one or more notches 3110. The notches may be formed at the edges of the seal-forming structure 3100, i.e., at the outer periphery of the seal-forming structure 3100. The notches 3110 may be used to inhibit or prevent the seal-forming structure 3100 from forming wrinkles when adhered to the patient's face. Such wrinkling may occur due to differences between the patient's facial contours and the natural three-dimensional shape of the seal-forming structure 3100. Because such wrinkling may provide areas where pressurized gas may leak, avoiding these wrinkles may be beneficial in providing treatment. Moreover, after extended use, such as overnight, wrinkling may mark the patient's skin and / or cause it to be uncomfortable.

[0243] When the seal-forming structure 3100 is adhered to the patient's face, wrinkles may occur in certain areas of the seal-forming structure 3100, such as areas configured to adhere to the patient's face, that have areas of a substantially non-planar shape, such as abrupt changes in orientation. In some forms, notches 3110 may be formed in one or more areas of the seal-forming structure 3100 that are configured to adhere to the patient's face. In some forms, the areas of the patient's face may be on, around, or near the patient's nose.

[0244] Certain exemplary forms of the technology in which the seal-forming structure 3100 is configured with one or more notches 3110 will be described in the following paragraphs and with reference to the accompanying drawings. These forms have notches 3110 at certain locations on the seal-forming structure 3100. In addition, the different shapes and sizes of the notches 3110 are described with respect to different forms of the technology. It should be understood that these exemplary forms are not limited to the technology, and other forms not explicitly shown or described may have notches 3110 in different locations and / or different combinations of notches 3110 of different shapes and / or sizes. For example, in other forms, the location, shape and / or size of the notches of one form may be applied to the notches of another form. Other forms may omit the notches 3110 described in the exemplary forms.

[0245] In the case where the seal-forming structure 3100 is formed of a plurality of layers, for example Figure 22A and Figure 22B , each layer of the seal-forming structure 3100 may include recesses of appropriate size, shape, and positioning so that when the layers are assembled together, recesses 3110 as described herein are formed. For simplicity in the description and drawings, not all recesses of each individual layer are described and labeled.

[0246] Figure 17 and Figure 18 The plenum chamber 3200 and seal-forming structure 3100 of an exemplary patient interface 3000 are shown, wherein the seal-forming structure 3100 is configured with a plurality of notches 3110a, 3110b, 3110c, and 3110d disposed at different locations in the outer edge of the seal-forming structure. Figure 19 is shown with the seal-forming structure 3100 adhered to the patient's face.

[0247] A notch 3110a is formed in a region of the seal-forming structure 3100, the notch 3110a being configured to adhere to the patient's nasal prominence when the seal-forming structure 3100 is adhered to the patient's face. The notch 3110a may be formed in an upper edge of a region of the seal-forming structure 3100 that, in use, may be located in the mid-plane of the patient, i.e., the notch 3110a may be located laterally in the middle of the seal-forming structure 3100.

[0248] Two further notches 3110b and 3110c may be formed in areas of the seal-forming structure 3100 that, in use, is configured to adhere to or proximate to the nose of a patient, such as Figure 19 As shown. Notches 3110b and 3110c can be located at the upper edge of the seal-forming structure 3100. When the seal-forming structure 3100 is positioned in use, notches 3110b and 3110c can be located laterally on either side of the midplane, i.e., notch 3110b is formed in an area of ​​the seal-forming structure 3100 configured to be located on one side of the midplane during use, while notch 3110c is formed in an area of ​​the seal-forming structure 3100 configured to be located on the other side of the midplane during use. Notches 3110b and 3110c can be located centrally inward from the lateral edges of the seal-forming structure 3100, for example, notches 3110b and 3110c can be located approximately halfway between the inner (or central) area and the lateral outer edges of the seal-forming structure 3100.

[0249] The recesses 3110a, 3110b, and 3110c can be generally V-shaped. This allows the recess 3110 to be further opened or further closed when adhered to an area of ​​the patient's face, depending on the contours of that area. In the illustrated form, the recess 3110a can be formed into a wider V-shape than the recesses 3110b and 3110c, but in other forms, the recess 3110a can be formed into a narrower V-shape, or each of the recesses 3110a, 3110b, and 3110c can be formed into a similar V-shape.

[0250] Figure 17 and Figure 18The seal-forming structure 3100 shown in FIG also forms a notch 3110d formed in an area configured to adhere to an area above the patient's lips during use. Notch 3110d can be located at the lower edge of the seal-forming structure 3100. Notch 3110d can be formed in an area of ​​the seal-forming structure that is configured to adhere to an area of ​​the patient's face located at or near a mid-plane during use. For example, notch 3110d can be located at the patient's mid-plane during use. In some embodiments, such as shown in the figures, notch 3110d is relatively wider than the other notches 3110a-3110c. For example, it can extend laterally across the patient's face, approximately the width of the patient's mouth. In other words, the seal-forming structure 3100 can be configured such that the width of notch 3110d is approximately equal to or greater than the width of a typical patient. In this embodiment, when the seal-forming structure 3110 is in an operative position during use, notch 3110d can be described as spanning the patient's mid-plane. This size of the recess 3110d can help position the seal-forming structure 3100 around the patient's mouth without adhering to the upper red lip (see FIG. Figure 2C ), which can be uncomfortable.

[0251] Figure 17-19 The seal-forming structure shown in FIG30 can be formed so that the lateral edges of the seal-forming structure 3100 extend laterally far enough so that they adhere to the patient's cheeks during use. Alternatively, the side edges of the seal-forming structure 3100 can extend laterally far enough so that they adhere to the patient's nasolabial fold area during use.

[0252] In an alternative form of the technology, the patient interface 3000 includes a seal-forming structure 3100, such as Figure 20 -22. In this form, an upper notch 3110a is formed in a region of the seal-forming structure 3100 that is configured to adhere to the patient's nose, such as the prona nasalis, in use. Figure 20 The seal-forming structure 3100 shown in FIG. 22 may further include a lower recess 3110d disposed on a lower edge of a middle region of the seal-forming structure 3100, the lower recess 3110d being located substantially below the opening 3202. The lower recess 3110d may be formed in a region of the seal-forming structure 3100 that, during use, is configured to adhere to a region above the patient's lips, such as at or substantially near a lower point of the patient's nasal septum.

[0253] Figure 20 The seal-forming structure 3100 shown in FIG. 22 may further define first and second lateral notches 3110b and 3110c. These notches may extend from the lateral edges of the seal-forming structure 3100 toward the mid-plane of the patient substantially laterally inwardly toward the mid-plane of the patient during use.

[0254] Transverse notches 3110b and 3110c can be substantially slit-shaped. For example, notches 3110b and 3110c can have edges that are substantially parallel to one another. This can allow notches 3110 to open further or close further when adhered to an area of ​​the patient's face, depending on the contours of that area. The seal-forming structure 3100 can also be formed so that the lead to each notch 3110b and 3110c is curved. This can avoid sharp corners on the seal-forming structure that could be uncomfortable or prone to peeling from the patient's face during use.

[0255] Figure 20 The seal-forming structure 3100 shown in FIG. 22 can be configured such that, when adhered to the patient's face, the area of ​​the seal-forming structure 3100 immediately above the recesses 3110b and 3110c adheres to the patient's corresponding nasal alar, while the area of ​​the seal-forming structure 3100 immediately below the recesses 3110b and 3110c adheres to an area of ​​the patient's upper lip region adjacent to and below the nasal alar. That is, the area of ​​the seal-forming structure 3100 adjacent to the recesses 3110b and 3110c can adhere to the patient's nasal alar apex (see FIG. 22 ). Figure 2C Thus, the presence of lateral notches 3110b and 3110c may help the seal-forming structure 3100 seal across the folds between the nose and the lip.

[0256] Forms of the technology are not limited to the number of notches 3110 formed in the seal-forming structure 3100 thereof. However, in certain forms, the number of notches 3110 is not so large that the seal-forming structure 3100 becomes unwieldy, making it difficult to position the seal-forming structure 3100 on the face without wrinkling or folding the seal-forming structure 3100, such as in the areas of the seal-forming structure 3100 between the notches 3110. The permissible number of notches 3110 may vary depending on the configuration of the patient interface 3000, including the size and shape of the notches 3110. For example, longer notches 3110 will tend to allow for a greater amount of flexibility in the seal-forming structure 3100 than shorter notches 3110, and therefore fewer longer notches 3110 may be permissible.

[0257] In some forms, such as Figure 20 In the form of the technology shown in FIG-22, the seal-forming structure 3100 can be formed to be substantially symmetrical about an axis that is oriented in a transverse-medial direction when the seal-forming structure 3100 is adhered to the patient's face during use. Figure 20AA is shown in FIG. Explained another way, when the seal-forming structure 3100 is adhered to the patient's face, the axis can be perpendicular to the patient's midsagittal plane. One advantage of this is that the seal-forming structure 3100 can be applied to the patient's face in two different orientations, i.e., it does not matter whether the patient orients the seal-forming structure 3100 in one direction or the other.

[0258] 4.3.1.5 Shape retainer

[0259] In some forms of the technology, the patient interface 3000 may include one or more shape retainers 3170. The one or more shape retainers may be configured to facilitate retention of the shape of the seal-forming structure 3100 before the seal-forming structure is made to adhere to the patient's face, e.g., to an extent sufficient to prevent the seal-forming structure 3100 from wrinkling, folding, or sagging in a manner that makes it difficult for the patient 1000 to attach the seal-forming structure 3100 to their face.

[0260] The one or more shape retainers 3170 may be one or more components, assemblies, or structures formed with a shape and / or made of a material to provide a predetermined level of stiffness suitable for promoting a desired level of shape retention of the seal-forming structure 3100. In some forms, the one or more shape retainers 3170 are included as part of the seal-forming structure 3100. In other forms, the shape retainers 3170 may be attached to the seal-forming structure 3100 to promote retention of the shape of the seal-forming structure 3100, such as by stiffening one or more regions of the seal-forming structure 3100.

[0261] In some forms, the plenum 3200 may be formed to be more rigid than the seal-forming structure 3100, and the provision of the seal-forming structure 3100 to the plenum 3200 may serve to help maintain the shape of the seal-forming structure 3100. The area of ​​the seal-forming structure 3100 connected to the plenum 3200 may maintain its shape by the relatively rigid plenum 3200, and this may also help maintain the shape of other portions of the seal-forming structure 3100.

[0262] In other forms, e.g. Figure 20 22, removable layer 3120 can be used to help maintain the shape of seal-forming structure 3100 prior to removal of removable layer 3120. To function in this manner, removable layer 3120 can be formed to be relatively rigid compared to seal-forming structure 3100, e.g., removable layer 3120 can be formed from a relatively rigid material and / or shape.

[0263] exist Figure 23-27The exemplary patient interface 3000 shown in FIGURE 1 is another form of the technology in which the patient interface 3000 includes at least one shape retainer 3170 configured to facilitate retention of the shape of the seal-forming structure 3100 before the seal-forming structure 3100 is made to adhere to the patient's face. In these forms, the shape retainer 3170 comprises a ring extending around a major portion of the outer periphery of the seal-forming structure 3100. The shape retainer 3170 is used to provide shape retention to a radially outer region of the seal-forming structure 3100, thereby urging all of the seal-forming structure 3100 to maintain its shape until the shape retainer 3170 is removed.

[0264] Figure 23-27 The shape retainer 3170 can be formed of a material and / or have a shape so as to make the shape retainer 3170 more rigid than the seal-forming structure 3100. For example, the shape retainer 3170 can be formed of a material that is thicker than the material used to form the seal-forming structure 3100. Additionally or alternatively, the shape retainer 3170 can be formed of a material that is harder than the material used to form the seal-forming structure 3100. In some exemplary forms, the shape retainer 3170 can be provided with additional rigid structures to provide additional rigidity, such as rigid ribs. The shape retainer 3170 may not be rigid so that its shape cannot be changed by the patient, such that when the patient interface 3000 is adhered to their face, the patient can still bend the shape retainer 3170 and the seal-forming structure 3100. In this regard, the shape retainer 3170 can be described as semi-rigid. In one example, the shape retainer 3170 can be formed of paper, such as kraft paper.

[0265] exist Figure 23-27In the illustrated embodiment, the shape retainer 3170 is configured to be located on the non-patient-facing side of the seal-forming structure 3100. For example, the shape retainer 3170 may be adhered to the non-patient-facing side of the seal-forming structure 3100. In some embodiments, the shape retainer 3170 may be adhered to the seal-forming structure 3100 using an adhesive. In such embodiments, the adhesive may be applied to the patient-facing side of the shape retainer 3170, the non-patient-facing side of the seal-forming structure 3100, or both. The strength of the adhesive may be relatively low to enable the shape retainer 3170 to be easily removed from the seal-forming structure 3100 by the patient. In other embodiments, the shape retainer 3170 may be weakly held in place relative to the seal-forming structure 3100 by the natural adhesion between the seal-forming structure 3100 and the shape retainer 3170. An advantage of positioning the shape retainer 3170 on the non-patient-facing side of the seal-forming structure 3100 is that the patient can position the seal-forming structure 3100 on their face while the shape retainer 3170 is still in place. The shape retainer 3170 can then be removed when the seal-forming structure 3100 is adhered to the face, as in Figure 24 appears in the example.

[0266] In other forms, the shape retainer 3170 may be located on the patient-facing side of the seal-forming structure 3100. The retaining mechanism of these forms may be the same or similar to the forms described above in which the shape retainer 3170 is located on the non-patient-facing side of the seal-forming structure 3100. An advantage of this form is that the same adhesive surface of the seal-forming structure 3100 that is used to adhere the seal-forming structure 3100 to the patient's face can be used to hold the shape retainer 3170 in place until it is removed.

[0267] exist Figure 23-27 In the illustrated form, the shape retainer 3170 comprises a ring extending around a major portion of the outer periphery of the seal-forming structure 3100. In some forms, the shape retainer 3170 is positioned around the radially outermost portion of the seal-forming structure 3100, while in other forms, the shape retainer 3170 is positioned in the form of a ring around the radially outermost portion of the seal-forming structure 3100, but is not necessarily provided to the outermost portion around the entire periphery of the seal-forming structure 3100.

[0268] In the form of a ring, the shape retainer 3170 forms a hole on the radially inner side of the ring. Furthermore, when the shape retainer 3170 is mounted to the seal-forming structure 3100, an area of ​​the non-patient-facing side of the seal-forming structure 3100 may not be covered by the shape retainer 3170, i.e., a gap may exist between the patient-proximal periphery of the plenum 3200 and the radially inner edge of the shape retainer 3170. It has been found that this form of shape retainer may be more advantageous than a shape retainer 3170 that covers all or most of the non-patient-facing side of the seal-forming structure 3100, because in the latter case, the shape retainer 3170 may provide too much rigidity to the seal-forming structure 3100, making it difficult to apply to the face.

[0269] exist Figure 23 and Figure 25 In the exemplary form shown, the patient interface 3000 can include a ring of adhesive material 3122 on the non-patient-facing side for adhering the plenum 3200 to the seal-forming structure 3100. The ring of adhesive material 3122 can be covered by a non-patient-facing removable layer 3180 to protect the adhesive prior to contact between the plenum 3200 and the ring of adhesive material 3122. In this form, an annular gap exists between the ring of adhesive material 3122 and the shape retainer 3170, and due to this gap, an annular region of the non-patient-facing side of the seal-forming structure 3100 can be uncovered by the shape retainer 3170.

[0270] The shape retainer 3170 may have a constant radial thickness around the ring, or as Figure 23 、 Figure 25 , Figure 26 and Figure 27 As shown, the radial thickness of the shape retainer 3170 can vary around the ring. The radial thickness of the shape retainer 3170 can be thicker in areas that would benefit from a greater amount of shape retention. For example, the lateral areas of the shape retainer 3170 disposed in the lateral regions of the seal-forming structure 3100 (from the perspective of the position of the seal-forming structure 3100 on the patient's face) can be radially thicker than other areas, such as the lower and upper middle areas of the shape retainer 3170. The lateral areas of the seal-forming structure 3100 can benefit from more shape retention in the form shown because these areas have a larger area than the lower and upper middle areas of the seal-forming structure 3100 and are therefore more prone to lifting or wrinkling when the patient adheres the seal-forming structure 3100 to their face.

[0271] In some forms, such as Figure 25 、 Figure 26B and Figure 27In the form shown in FIG, a discontinuity 3174 can be formed in the shape retainer 3170 that can extend from the inner edge to the outer edge of the shape retainer. In some forms, such as Figures 26B-27 As shown, the discontinuity 3174 can be a slit (e.g., a cut having substantially no width), while in other forms, such as Figure 25 As shown, the interruption 3174 can be a gap in the shape retainer 3170. In the latter form, the shape retainer 3170 can form an incomplete ring with a first end 3170A and a second end 3170B, with a gap between the first end 3170A and the second end 3170B. The gap can be very small so that the first end 3170A can be close to the second end 3170B in use, for example, the circumferential width of the gap can be significantly smaller than the circumference of the ring. In some forms, the circumferential width of the gap can be a few millimeters or less. In use, the patient can grab the shape retainer 3170 on one side of the interruption 3174 (for example, the first end 3170A or the second end 3170B) to remove the shape retainer 3170 from the seal-forming structure 3100.

[0272] In alternative forms of this technology, such as Figure 23 26, the ring of the shape retainer 3170 may be continuous without any discontinuities. In other forms of the technology, the ring of the shape retainer 3170 may have a plurality of discontinuities 3174, which may be slits and / or gaps.

[0273] In some forms of this technology, e.g. Figure 26A 、 Figure 26B and 27 As shown, the shape retainer 3170 may include one or more tabs 3172 configured to be grasped by a user to remove the shape retainer 3170 from the seal-forming structure 3100. A tab may be an area of ​​the shape retainer 3170 that protrudes outward from an edge of another portion of the shape retainer 3170 to facilitate grasping. Figure 26A 、 Figure 26B and Figure 27 As shown, at least one tab 3172 can extend radially inward from an opening in the annulus of the shape retainer 3170 toward the seal-forming structure 3100 for delivering breathable gas to the patient. An advantage of this configuration is that the tab 3172 does not extend outward from the footprint of the seal-forming structure 3100 and, therefore, cannot be inadvertently caught and pulled away from the seal-forming structure 3100. In an alternative form, the tab 3172 can extend radially outward from the annulus of the shape retainer 3170.

[0274] One or more tabs may be located at any one or more circumferential locations around the ring of the shape retainer 3170. For example, the tabs 3172 may extend radially inward from the outer region of the ring such that when the seal-forming structure 3100 is in place on the patient's face, the tabs 3172 extend in a transverse-medial direction. Figure 26A In the illustrated form, the shape retainer 3170 includes a first tab 3172a and a second tab 3172b that, in use, are located on either side of the patient's mid-plane. The first tab 3172a and the second tab 3172b can be configured to extend radially inwardly from the ring of the shape retainer 3170.

[0275] 4.3.1.6 Non-patient-facing removable layers

[0276] It has been described that in certain forms of the technology, the seal-forming structure 3100 may include a non-patient-facing removable layer 3180 to protect an adhesive, such as a strip 3190, on the non-patient-facing side of the seal-forming structure's layer prior to adhering the seal-forming structure's layer to the patient-facing side of the flange 3105 or to the inflatable chamber 3200. Figure 22B 、 Figure 25 、 Figure 27 and 28A to 28I Shown is an exemplary form of the non-patient-facing removable layer 3180. The non-patient-facing removable layer 3180 may also be referred to as a "release liner."

[0277] exist Figure 25 and Figure 27 In an example, the non-patient-facing side of the strap 3190 may carry a loop of adhesive material 3122 for adhering the strap 3190 to the flange 3105 or the plenum 3200. The loop of adhesive material 3122 may be covered by a non-patient-facing removable layer 3180 to protect the adhesive before the plenum 3200 comes into contact with the loop of adhesive material 3122. In such an example, the non-patient-facing removable layer 3180 may similarly be annular so as to completely cover the loop of adhesive material 3122, but it may not cover other areas of the non-patient-facing side of the strap 3190. That is, the non-patient-facing removable layer 3180 may have an aperture formed therein. When the non-patient-facing removable layer 3180 is positioned to cover the loop of adhesive material 3122, the aperture may substantially align with the aperture in the strap 3190, i.e., the opening in the seal-forming structure 3100 through which breathable gas is delivered to the patient when the patient interface 3000 is in use.

[0278] 4.3.1.6.1 Slit

[0279] In some forms, the non-patient-facing removable layer 3180 has one or more slits 3182 formed therein. Different forms of this technology may have the slits 3182 in different locations and orientations, some examples of which are described below.

[0280] The presence of one or more slits 3182 of the type described below can help a user remove the non-patient-facing removable layer 3180 without causing undesirable effects on certain portions of the seal-forming structure 3100, particularly on the layered assembly additionally formed by the one or more layers of tape 3190, the patient-facing removable layer 3120, and the optional shape retainer 3170. When the non-patient-facing removable layer 3180 is removed, for example by a peeling action, tension on the non-patient-facing removable layer 3180 can be transmitted to the layered assembly, causing it to bend in the direction of the tension. In some cases, such bending can cause exposed areas of adhesive on the layered assembly to contact and adhere to another area of ​​the layered assembly. This can be undesirable and can be difficult for the user to undo and / or can result in wrinkling of the layered assembly if undoing occurs, which can make it difficult to ultimately adhere the seal-forming structure 3100 to the patient's face or can adversely affect the strength of the adhesion on the patient's face. Additionally, or alternatively, the action of pulling the non-patient-facing removable layer 3180 away may cause the patient-facing removable layer 3120 to delaminate from the patient-facing side of the strap 3190 to form a form where the patient-facing removable layer 3120 is present. If such delamination occurs before the user desires it, this may cause difficulty for the user in manipulating the seal-forming structure 3100 or adversely affect the adhesion of the seal-forming structure 3100 to the patient's face, similar to the problematic effects described above.

[0281] In exemplary forms, each slit 3182 may extend from an edge of the non-patient-facing removable layer 3180, i.e., from an edge region to a central region of the non-patient-facing removable layer 3180. In some forms, the one or more slits 3182 may extend from a radially outer edge of the non-patient-facing removable layer to a radially inner edge of the non-patient-facing removable layer, i.e., the slit may extend through the annular non-patient-facing removable layer 3180 between the aperture and the outer circumference. In some forms, the one or more slits 3182 may extend at least partially in an azimuthal direction around the non-patient-facing removable layer 3180.

[0282] 28A to 28I Various forms of exemplary non-patient-facing removable layers 3180 are shown.

[0283] Figure 27 and Figure 28AThe illustrated form of the non-patient-facing removable layer 3180 has two slits 3182a and 3182b formed therein. The first slit 3182a extends from the radially outer edge to the radially inner edge of the non-patient-facing removable layer. The first slit 3182a can be located on the side of the non-patient-facing removable layer 3180 opposite the tab 3184 (described below), but offset from being directly opposite, such as at an azimuth angle of approximately 120-160° relative to the tab 3184, although the slits can be located in other positions relative to the tab 3184 in other forms. The second slit 3182b extends inwardly from the radially outer edge of the non-patient-facing removable layer 3180. The location at which the second slit 3182b begins on the outer edge can be on the side of the non-patient-facing removable layer 3180 opposite the tab 3184, but offset from being directly opposite, such as at an azimuth angle of approximately 120°-160° from the tab 3184 in a direction opposite to the azimuth direction of the tab's first slit 3182. That is, the second slit 3182b can intersect the outer periphery of the non-patient-facing removable layer 3180 at an azimuth angle of approximately 40-120° from the first slit 3182. The second slit 3182b can extend generally radially inward from the outer edge of the non-patient-facing removable layer 3180 and then turn to extend azimuthally around the non-patient-facing removable layer 3180. The end of the second slit 3182b can be in a central region of the non-patient-facing removable layer 3180 and can be proximal to the first slit 3182a.

[0284] Figure 28B The form of the non-patient-facing removable layer 3180 shown has a single slit 3182 formed therein extending from a radially outer edge to a radially inner edge of the non-patient-facing removable layer.

[0285] Figure 28C The form of the non-patient-facing removable layer 3180 shown has a single slit 3182 formed therein extending from the radially outer edge to the radially inner edge of the non-patient-facing removable layer. The slit 3182 is azimuthally adjacent to the tab 3184.

[0286] Figure 28D The non-patient-facing removable layer 3180 is shown in a form in which there are no holes. A slit 3182 extends from one radially outer edge of the non-patient-facing removable layer 3180 to the other radially outer edge and may pass through a central region of the non-patient-facing removable layer 3180. In this form, the slit 3182 may be curved in shape, for example, to define one or more tabs 3184 for a user to grasp to remove the non-patient-facing removable layer 3180.

[0287] In some forms, such as Figure 28E As shown, the slit (e.g. Figure 28EThe slits 3182a and 3182b in the tab 3184 can extend radially through the central portion of the tab 3184. In the illustrated form, the slits 3182a and 3182b each extend from the radially outer edge to the radially inner edge of the non-patient-facing removable layer. The slits 3182a and 3182b are diametrically opposed to each other, although they can be arranged at different locations in other forms.

[0288] In some forms, such as Figure 28F As shown, the slit 3182 can extend horizontally around all or most of the circumference of the non-patient-facing removable layer 3180. In the illustrated form, one end of the slit 3182 is located at the radially outer edge of the non-patient-facing removable layer 3180, while the other end of the slit is located at the radially inner edge, with both ends being approximately similarly located in azimuth. Figure 28F The radially inner end of the case can be positioned adjacent to the tab 3184.

[0289] Figure 28G The non-patient facing removable layer 3180 is shown in a form without slits but with tabs 3184 .

[0290] exist Figure 28H In the illustrated form of the non-patient-facing removable layer 3180, there are two slits 3182a and 3182b that terminate at an edge of the non-patient-facing removable layer 3180, such as at the radially inner edge, on a side of the non-patient-facing removable layer 3180 opposite the tab 3184, but offset from being directly opposite, such as at an azimuth angle of approximately 120-160° from the tab 3184 in a direction opposite each other. Each slit extends outwardly from the inner edge of the non-patient-facing removable layer 3180 at a non-zero angle relative to the radial direction and then curves to extend in an azimuth direction around the non-patient-facing removable layer 3180. The slits may curve toward each other such that the ends of the two slits are proximate to each other.

[0291] exist Figure 28IIn the form of the non-patient-facing removable layer 3180 shown, there are a plurality of slits 3182. The slits 3182 are collectively located on a side of the non-patient-facing removable layer 3180 opposite the tab 3184. One of the slits 3182 may extend from a radially outer edge to a radially inner edge of the non-patient-facing removable layer. In the example shown, the slit is positioned radially opposite the tab 3184. The non-patient-facing removable layer 3180 may have two sets of slits formed therein: a first set extending radially inward from the radially outer edge of the non-patient-facing removable layer 3180 and a second set extending radially outward from the radially inner edge of the non-patient-facing removable layer 3180. The first set of slits may be staggered with the second set of slits such that, azimuthally around the non-patient-facing removable layer 3180, the slits alternate between the first set of slits and the second set of slits. These slits may be symmetrically disposed on either side of a central slit, in a form as shown in the illustration in which such slits are present.

[0292] It has been discovered that in some circumstances, the arrangement of the slits 3182, whereby, when the non-patient-facing removable layer 3180 is peeled off the strap 3190 beginning at the tab 3184, the last portion of the non-patient-facing removable layer 3180 to be removed from the strap 3190 has a relatively small area adhered to the strap 3190, e.g., is relatively thin, is advantageous in helping to prevent some or all of the above-mentioned adverse effects that may occur when peeling off some other forms of the non-patient-facing removable layer 3180.

[0293] 4.3.1.6.2 Tabs

[0294] As described above, the non-patient-facing removable layer 3180 can include one or more tabs 3184. Each tab 3184 can be configured to be grasped by a user for removing the non-patient-facing removable layer 3180 from the seal-forming structure 3100, for example, away from the strap 3190.

[0295] In some forms, such as Figure 27 、 Figure 28A 、 Figure 28G 、 Figure 28H and Figure 28I As shown, the tab 3184 may extend radially outward from the radially outer edge of the non-patient-facing removable layer 3180. In other forms, for example, Figure 28C 、 Figure 28E and Figure 28F As shown, the tab 3184 can extend radially inward from the radially inner edge of the non-patient-facing removable layer 3180 .

[0296] In some forms, such as Figure 27 、 Figure 28A 、 Figure 28H and Figure 28IIn the example shown, the tab 3184 may extend outwardly from the edge of the non-patient-facing removable layer 3180 that is generally opposite the one or more slits 3182. For example, the tab 3184 may be located radially opposite the one or more slits 3182. In other forms, for example Figure 28C In the form shown, the slit 3182 can be positioned azimuthally adjacent to the tab 3184.

[0297] 4.3.2 Inflatable chamber

[0298] The plenum chamber 3200 of some forms of the present technology is configured to receive a flow of breathable gas at a therapeutic pressure for patient breathing from the air circuit 4170. The plenum chamber can be formed to be pressurizable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, and in some forms to a pressure of approximately 20 cmH2O or 30 cmH2O.

[0299] In one form, the plenum 3200 has a perimeter shaped to complement the surface contours of an average person's face in the area where the seal is formed when in use. The complementary shape of the perimeter of the plenum 3200 can be configured to facilitate correct positioning of the patient interface 3000 against the patient's face when in use.

[0300] Alternatively, in some forms, the plenum 3200 may be shaped in a custom manner for an individual patient. Alternatively, the plenum 3200 of the patient interface 3000 may be selected from one of a plurality of possible forms of plenum 3200, with the appropriate plenum for the individual patient being selected as best suited for them.

[0301] In use, the boundary edge of the inflatable chamber 3200 is positioned in close proximity to the adjacent surface of the face. The seal-forming structure 3100 can provide actual contact with the surface. The seal-forming structure 3100 can extend along the entire periphery of the inflatable chamber 3200 in use.

[0302] The plenum chamber 3200 may include at least two openings. One opening, which may be formed in the patient-facing or rear side of the plenum chamber 3200, allows pressurized gas to flow from the interior volume of the plenum chamber 3200 to the patient's airway through the seal-forming structure 3100. The opening may also allow exhaled gas from the patient to flow into the plenum chamber 3200. Another opening, which may be referred to as a plenum inlet port 3202, is configured to allow breathable gas to flow from the air circuit 4170 into the plenum chamber 3200. In some forms, the plenum inlet port 3202 may be arranged on the side of the plenum chamber 3200 that faces away from the patient in use, i.e., the front side of the plenum chamber 3200. In other forms, the patient interface may include one or more plenum inlet ports 3202 arranged on the sides (e.g., left and right sides) of the plenum chamber 3200.

[0303] In some forms, such as Figure 17 、 Figure 18 、 Figure 20-24 and Figure 26A In the forms shown in , the plenum chamber 3200 can be configured such that the opening in the patient-facing side of the plenum chamber 3200 is sized and shaped to cover both of the patient's nostrils when the patient interface 3000 is in use. In these forms, the opening can be sized and shaped to generally match the area on the underside of the patient's nose formed by the patient's nostrils and the patient's columella and, in use, be positioned adjacent that area (see FIG. Figure 2F The opening may be formed by a rim 3210 on the rear side of the plenum chamber 3200, and the plenum chamber 3200 may be configured such that, in use, the rim 3210 is located adjacent to and in front of the lateral, rear, and front edges of the patient's nostrils.

[0304] The rear side of the plenum 3200 can be shaped to complement the shape of the underside of the patient's nose and, in use, the plenum 3200 can be positioned against the patient's nose. Figure 17 、 Figure 18 、 Figure 20-24 and Figure 26A In the illustrated form, the rear side of the plenum 3200 can be formed by a rim 3210 surrounding the opening on the patient-facing side of the plenum 3200. In some examples, the rear side of the plenum 3200 can be located on a saddle-shaped surface, where "saddle-shaped" herein refers to a geometric surface where the lines on the surface are convex in one direction and concave in another direction orthogonal to the first direction. More specifically, the rear side of the plenum 3200 can be concave in a lateral direction relative to the patient's face such that the patient's columella extends into a concave groove, as shown. Figure 24 The rear side of the plenum 3200 may be convex in the anterior-posterior direction such that the peak of the convexity extends toward the lateral edge of the patient's nostril, again as shown. Figure 24 shown.

[0305] When the seal-forming structure 3100 is assembled with the plenum 3200, the seal-forming structure 3100, which may be formed of a flexible material, may be deformed into a shape similar to the plenum 3200. As shown in the figure, for example, Figures 20 to 24 and Figure 26A In the embodiment of the present invention, the seal-forming structure 3100 can have a saddle-shaped patient-facing surface before sealing contact with the patient's face.

[0306] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface and help improve compliance with therapy.

[0307] In some versions, the plenum 3200 is constructed of a rigid material such as polycarbonate. The rigid material can provide support to the seal-forming structure.

[0308] In some forms, the plenum 3200 is constructed of a flexible material (e.g., a soft, flexible, elastic material such as silicone, fabric, foam, etc.). For example, in an example, it can be formed of a material having a Young's modulus of 0.4 GPa or less, such as foam. In some forms of the technology, the plenum 3200 can be made of a material having a Young's modulus of 0.1 GPa or less, such as rubber. In other forms of the technology, the plenum 3200 can be made of a material having a Young's modulus of 0.7 MPa or less, such as between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0309] In some forms, the plenum 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material, such as silicone or TPE.

[0310] 4.3.3 Connection between the gas-filled chamber and the sealing structure

[0311] The plenum 3200 may be coupled to the seal-forming structure 3100. In some forms, the plenum 3200 is directly coupled to the seal-forming structure 3100. For example, the plenum 3200 may be coupled to the seal-forming structure 3100 with an adhesive via a mechanical joint, or the plenum 3200 and seal-forming structure 3100 may be integrally formed. In other forms, the plenum 3200 may be indirectly coupled to the seal-forming structure 3100, for example via another component.

[0312] 4.3.3.1 Connection part

[0313] In some forms of this technology, e.g. Figure 20-23 As shown, the patient interface 3000 includes a connecting portion 3160 located between the plenum 3200 and the seal-forming structure 3100. In these forms, the connecting portion 3160 is formed to have a thickness that is significantly thinner than adjacent areas of the plenum 3200 and the seal-forming structure 3100. The relative thicknesses can be configured such that the connecting portion 3160 allows flexibility in movement of the patient interface 3000 because it allows relative displacement between the seal-forming structure 3100 and the plenum 3200.

[0314] In some forms, the connecting portion 3160 can be thin enough that it is substantially flexible to allow relative displacement between the seal-forming structure 3100 and the inflatable chamber 3200.

[0315] In other forms, the connecting portion 3160 can be formed into a structure that enables the seal-forming structure 3100 to move relative to the inflatable chamber 3200. For example, the connecting portion 3160 can include a plurality of folds. For example, the connecting portion 3160 can have an accordion-like configuration.

[0316] The connecting portion 3160 may allow for some displacement between the seal-forming structure 3100 and the plenum 3200, such as translation, rotation, or both.

[0317] If a force is applied to the air circuit 4170, the force may be transmitted to the seal-forming structure 3100 via the plenum 3200. Since the seal-forming structure 3100 is configured to adhere to the patient 1000 via an adhesive surface, such a force transmitted directly to the seal-forming structure 3100 may cause the patient's skin to be pulled, thereby causing discomfort to the patient 1000 or causing the seal-forming structure 3100 to be removed. Therefore, the connecting portion 3160 allows a greater amount of movement of the air circuit 4170 without these effects.

[0318] In some forms, e.g. Figure 20-23 In the form shown in , the connecting portion 3160 extends most of the way around the opening formed in the patient-facing side of the inflatable chamber 3200, for example, the connecting portion 3160 may extend all the way around the opening. Thus, the connecting portion 3160 can have an annular shape around the patient-proximal end of the inflatable chamber 3200. In other forms, the connecting portion 3160 may extend only a portion of the way around the annular joint between the inflatable chamber 3200 and the seal-forming structure 3100. In some forms, the connecting portion 3160 can include multiple regions that are substantially thinner than adjacent regions of the inflatable chamber 3200 and the seal-forming structure 3100. Each region can be separated from the other regions by a thicker region. In this way, the nature of the flexibility between the inflatable chamber 3200 and the seal-forming structure 3100 can be controlled.

[0319] 4.3.3.2 Adhesive connection

[0320] In some forms, the plenum 3200 may be attached to the seal-forming structure 3100 using an adhesive. Examples of this are shown in FIG. Figures 23 to 27 . It has been described above that the adhesive on the non-patient-facing side of the seal-forming structure 3100 can be adhered to the patient-facing side of the inflatable chamber 3200, such as the edge 3210. Alternatively, the flange 3105, which can be considered a part of the seal-forming structure 3100, can be integrally formed with the inflatable chamber 3200, and other portions of the seal-forming structure 3100 can be adhered to the flange 3105, as previously described.

[0321] 4.3.4 Positioning and stabilizing the structure

[0322] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed position during use by a positioning and stabilizing structure 3300. Because the positioning and stabilizing structure 3300 engages the patient's head to maintain the patient interface 3000 in a sealed position, the positioning and stabilizing structure 3300 may comprise and function as a "headgear." Figure 9 and Figure 10 An example of a positioning and stabilizing structure is shown in .

[0323] In one form, the positioning and stabilising structure 3300 provides a retaining force that is at least sufficient to overcome the positive pressure in the plenum 3200 to lift off the face.

[0324] In one form, the positioning and stabilising structure 3300 provides a retaining force to overcome the effects of gravity on the patient interface 3000 .

[0325] In one form, the positioning and stabilising structure 3300 provides a retaining force as a safety margin to overcome the potential effects of damaging forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0326] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a supine sleeping position with the back region of the patient's head resting on a pillow. In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured so as not to be too large and bulky to prevent a patient from lying in a side sleeping position with the side region of the patient's head resting on a pillow.

[0327] As already explained, in certain forms of the technology, the patient interface 3000 includes a seal-forming structure 3100 that is configured to adhere to the patient's face in order to form a seal and maintain the patient interface 3000 in position on the patient's face. In such forms, the seal-forming structure 3100 may be considered to additionally serve as a positioning and stabilizing structure 3300 through the action of the adhesive.

[0328] In other forms, the patient interface 3000 may include another form of positioning and stabilizing structure 3300. For example, in some forms, the positioning and stabilizing structure 3300 may include headgear 3302 having one or more straps that may be worn by the patient to help properly orient the seal-forming structure 3100 against the patient's face (e.g., to limit or prevent leakage).

[0329] Some versions of the headgear 3302 can be constructed from a fabric material that can fit comfortably against the patient's skin. The fabric can be flexible to conform to various facial contours. Although the fabric can include stiffeners along selected lengths, it can limit bending, flexing, and / or stretching of the headgear 3302.

[0330] In some embodiments, the headgear 3302 can be at least partially stretchable. For example, the headgear 3302 can include elastic or a similar stretchable material. For example, the entire headgear 3302 can be stretchable, or selected portions can be stretchable (or more stretchable than surrounding portions). This can allow the headgear 3302 to stretch under tension, which can help provide a sealing force to the seal-forming structure 3100.

[0331] exist Figure 10 In an exemplary form, the headgear 3302 can be a two-point connection headgear. This means that the headgear 3302 can be connected to two separate locations.

[0332] In some forms, e.g. Figure 9 As shown, headgear 3302 may include one or more straps constructed and arranged such that, during use, at least a portion of its lower edge passes above the ear of the patient's head and covers a portion of the parietal bone while not covering the occipital bone. In some embodiments, headgear 3302 may additionally or alternatively include one or more straps constructed and arranged such that, during use, at least a portion of its upper edge passes below the ear of the patient's head and covers or lies below the occipital bone of the patient's head. One or more additional straps may also be provided, for example, to interconnect other straps to reduce the tendency of the other straps to move apart during use.

[0333] 4.3.4.1 Catheter head cover

[0334] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more head cuffs 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, such as through the plenum 3200 and seal-forming structure 3100. Figure 10 In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the plenum chamber 3200. The tubes 3350 are configured to position and stabilize the seal-forming structure 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., nose and / or mouth) during use. This allows the conduit of the air circuit 4170, which provides the pressurized air flow, to be connected to a connection port 3600 of the patient interface that is located other than at the front of the patient's face, such as at the top of the patient's head.

[0335] exist Figure 10 and Figure 14 In the illustrated form of the present technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 being located on a different side of the patient's head in use and extending above the respective ear (above the supraauricular point on the patient's head), through the respective cheek region, to an elbow 3610 at the top of the head of the patient 1000. This form of technology can be advantageous because if the patient sleeps with their head on their side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 can include a different number of tubes, such as one tube, or two or more tubes.

[0336] In one form, the tube 3350 can be at least partially extendable so that the tube 3350 and the strap can be adjusted to substantially equal lengths when worn by the patient. This can allow for substantially symmetrical adjustment between the tube 3350 and the strap so that the seal-forming structure remains substantially centered. For example, Figure 10 The patient interface 3000 shown in FIG. 33 includes a tube 3350 having an upper portion comprising extendable tube segments, each of which is in the form of an extendable accordion-like structure 3362. The lower portion of the tube 3350 may be a non-extendable tube segment 3363.

[0337] exist Figure 10 and Figure 14 In the technical form shown, the two tubes 3350 are fluidically connected to each other and to the connection port 3600 at their upper ends.

[0338] Tube 3350 can be formed from a flexible material, such as an elastomer, such as silicone or TPE, and / or one or more fabrics and / or foam materials. Tube 3350 can have a pre-formed shape and bend or move into another shape when a force is applied, but return to its original pre-formed shape when the force is absent. Tube 3350 can be generally arcuate or curved, with its shape approximating the contours of the patient's head between the top of the head and the nasal or oral regions.

[0339] Each tube 3350 can be configured to receive air flow from a connection port 3600 on the top of the patient's head and deliver the air flow to the seal-forming structure 3100 at the entrance to the patient's airway. Figure 10In the example shown, each tube 3350 is located on a path that extends from the inflatable chamber 3200 through the patient's cheek area and reaches the curved tube 3610 above the patient's ear during use. For example, the portion of each tube 3350 near the inflatable chamber 3200 can cover the maxillary area of ​​the patient's head during use. Another portion of each tube 3350 can cover an area of ​​the patient's head that is above the supra-auricular point of the patient's head. Each tube 3350 can also be located on the patient's sphenoid bone and / or temporal bone and one or both of the patient's frontal bone and parietal bone. The curved tube 3610 can be located on the patient's parietal bone, on the frontal bone and / or on the junction between them (e.g., the coronal suture) during use.

[0340] In some forms of the present technology, the positioning and stabilizing structure 3300 includes at least one headgear strap that, in addition to the tube 3350, serves to position and stabilize the seal-forming structure 3100 at the patient's airway entrance. Figure 10 In the example shown, the strap 3310 of the positioning and stabilizing structure 3300 is connected between two tubes 3350, which are located on each side of the patient's head and pass around the back of the patient's head, for example, over or lying under the occipital bone of the patient's head during use. The strap 3310 is connected to each tube above the patient's ear. Figure 10 , the positioning and stabilizing structure 3300 includes a pair of tabs 3320. In use, the strap 3310 can be connected between the tabs 3320. The strap 3310 can be flexible enough to pass around the back of the patient's head and rest comfortably against the patient's head, even when under tension during use. In other examples of the present technology, one or more additional straps can be provided. For example, a patient interface 3000 with a naso-oral cushion according to examples of the present technology can have a second lower strap configured to rest against the patient's head near the patient's neck and / or against a posterior surface of the patient's neck.

[0341] As described above, in some examples of the present technology, the patient interface 3000 includes a seal-forming structure 3100 in the form of a cushion that is generally positioned under the nose and seals to the lower periphery of the nose (e.g., an under-nose cushion). The positioning and stabilizing structure 3300 (including the tube 3350) can be constructed and arranged to draw the seal-forming structure 3100 under the patient's nose using a sealing force in a posterior and superior direction (e.g., a posterior-superior direction). The sealing force having a posterior-superior direction can cause the seal-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and forward-facing surfaces of the patient's face, such as on either side of the patient's nose and the patient's lips.

[0342] 4.3.5 Forehead support

[0343] In some forms, such as Figure 9 As shown, the patient interface 3000 may include a forehead support 3700 .

[0344] 4.3.6 Vent

[0345] In some forms of the technology, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide. The vent 3400 may be implemented by a vent structure that may be formed or provided in any one or more components of the patient interface 3000.

[0346] In some forms, the vent 3400 is configured to allow continuous ventilation flow from the interior of the plenum chamber 3200 to the surrounding environment while the pressure within the plenum chamber is positive relative to the surrounding environment. The vent 3400 is configured to allow ventilation flow of a sufficient magnitude to reduce rebreathing of exhaled CO2 by the patient while maintaining a therapeutic pressure in the plenum chamber during use.

[0347] One form of a vent 3400 in accordance with the present technology includes a plurality of holes, for example, from about 5 to about 80 holes, or from about 10 to about 40 holes, or from about 20 to about 25 holes.

[0348] In some forms of this technology, e.g. Figure 5 and 9 As shown, vent 3400 may be located in plenum chamber 3200 .

[0349] Alternatively, vent 3400 may be located in air circuit 4170 that delivers the flow of breathable gas from RPT device 4000 to plenum 3200 , such as in a portion of air circuit 4170 located near plenum 3200 .

[0350] 4.3.6.1 Port

[0351] In some forms of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In some forms, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0352] 4.3.6.2 Breathing - atmospheric ventilation

[0353] In certain forms of the technology, the patient interface 3000 may include a vent 3400 that is configured to be capable of adopting at least two configurations. In one configuration, which may be referred to as an open configuration, the vent 3400 allows the patient to inhale and exhale through the vent 3400 without significant impedance, or with an impedance level that is largely unnoticeable to the patient. In another configuration, which may be referred to as a closed configuration, the vent 3400 is more obstructed than in the open configuration. In some forms, in the closed configuration, the vent 3400 allows exhaled gas to be flushed from the interior of the plenum 3200 to the surrounding environment while substantially maintaining the pressure within the plenum 3200 positive relative to the surrounding environment. In other forms, in the closed configuration, the vent may substantially block all gas flushing through the vent, and instead, exhaled gas is discharged through a separate vent structure. Such a vent 3400 may be referred to as a "breath-to-atmosphere" vent (BTA vent).

[0354] Whether the BTA vent adopts an open or closed configuration can be based on the pressure of the breathable gas supply provided from RPT device 4000 to patient interface 3000. The BTA vent can be configured to adopt an open configuration when no breathable gas is being supplied, or when the flow of breathable gas is being supplied at a pressure below a certain threshold, for example, below a therapeutic pressure level such as 6 cmH2O. The BTA vent can be configured to adopt a closed configuration when the flow of breathable gas is being supplied at a pressure above a certain threshold, for example, above a therapeutic pressure level such as 6 cmH2O.

[0355] Further description of a patient interface system including a vent that may be considered to function in the manner of a BTA vent as described above is provided in PCT Application No. PCT / US2012 / 055148, the contents of which are incorporated herein by reference.

[0356] In one application, a BTA vent can be used in a patient interface system, where the BTA vent is configured to adopt an open configuration when a patient first puts on the patient interface 3000 and when the RPT device 4000 detects that the patient is awake. In this configuration, the RPT device may not provide a flow of breathable gas, or may be configured to provide a small flow of breathable gas to help flush exhaled CO2 from the plenum chamber 3200. Once the RPT device 4000 detects that the patient has fallen asleep, a flow of breathable gas at a therapeutic pressure may be provided, which causes the BTA vent to adopt a closed configuration.

[0357] 4.3.6.2.1 Anti-suffocation valve

[0358] One form of BTA vent is an anti-asphyxia valve (AAV), which is commonly used in patient interfaces that cover the nose and mouth as a measure to mitigate the risk of suffocation. In the event of an interruption in the supply of breathable gas to the plenum chamber 3200 and / or the airway of the patient 1000, the AAV ensures ventilation of the airway of the patient 1000. In certain forms of the present technology, the patient interface 3000 may include a conventional design of an AAV that functions as a BTA vent, as described above.

[0359] For example, in Figure 8 In the illustrated form of the technology, the patient interface 3000 includes a vent 3400 that, in use, functions as a BTA vent in the manner described above. The BTA vent may be in the form of an anti-asphyxia valve 3402. In the illustrated form of the technology, the anti-asphyxia valve 3402 is located at or near one end of an air circuit 4170 that is connected to an inlet port 3202 of the plenum chamber 3200. In other forms, the AAV may be located in another location, such as within the plenum chamber 3200, or in a tube connected between the air circuit 4170 and the plenum chamber 3200.

[0360] Anti-asphyxia valve 3402 may include a flap that, when valve 3402 is in a closed configuration, is configured to cover an opening in a wall of air circuit 4170 and, in use, prevent or limit leakage of gas contained in plenum chamber 3200. When the valve is in an open configuration, such as in the event that the flow of breathable gas to plenum chamber 3200 is interrupted or reduced, or if the pressure of breathable gas supplied by RPT device 4000 has not increased (e.g., if the patient is detected to be still awake), the flap is in a position where the opening is less obstructed to allow patient 1000 to breathe directly to and from ambient atmosphere.

[0361] 4.3.6.3 Exhalation resistance valve

[0362] In some forms of the technology, the positive pressure within the plenum 3200 may be generated in a manner other than by supplying air from the RPT device 4000 into the plenum 3200. For example, in one form of the respiratory therapy system 2000, the positive pressure in the plenum 3200 is generated by the flow of gas exhaled by the patient. Such a system may be referred to as an expiratory positive pressure (EPAP) system. An EPAP system according to some forms of the present technology may not include the RPT device or air circuit described herein. Alternatively, the EPAP system may include a vent that is configured to generate and maintain a therapeutic pressure in the plenum from the flow of gas exhaled by the patient.

[0363] 4.3.7 Mouth closure structure

[0364] In some forms of the technology, the patient interface 3000 includes a mouth closure structure 3910. The mouth closure structure 3910 is a structure that may be formed from a component or assembly of components that is configured to facilitate closure of the patient's mouth when the patient interface is worn by the patient.

[0365] In some forms of this technology, e.g. Figures 11 to 13 , a mouth closure structure 3910 may be included as part of a patient interface 3000 that includes a seal-forming structure 3100 configured to adhere to the patient's face to form a seal. In other forms of the technology, for example Figures 14 to 16 , the mouth closure structure 3910 can be included as part of a patient interface 3000 that includes a seal-forming structure 3100 that forms a seal with the patient's face by an alternative mechanism, such as by using a headgear to hold the seal-forming structure 3100 on the patient's face.

[0366] It should be understood that even if only one form of mouth closure structure 3910 is described in the context of a patient interface 3000 including one type of seal-forming structure 3100, in another form of the technology, the same form of mouth closure structure 3910 may be used in a patient interface 3000 having another type of seal-forming structure 3100 even if that combination is not explicitly described.

[0367] 4.3.7.1 Mouth closure structure function

[0368] The mouth closure structure 3910 is used to facilitate closure of the patient's mouth when the patient interface is being worn by the patient and when the patient interface is receiving respiratory therapy.

[0369] In certain forms, the mouth closure structure 3910 may be configured to facilitate closure of the patient's mouth by providing resistance to the patient opening their mouth. For example, the structure may be configured such that when the patient's mouth is closed, little or no force is applied to the patient's mouth, but if the patient attempts to open their mouth, resistance is applied and tends to prevent or inhibit opening of the mouth.

[0370] In some forms, the mouth closure structure 3910 may alternatively or additionally be configured to urge the patient's mouth to close by applying a mouth closure force on a portion of the patient's face, for example, by applying a force on a portion of the patient's face proximal to the mouth to facilitate closure of the patient's mouth. In some embodiments, the mouth closure structure 3910 may apply a force in a generally upward direction on the patient's lower jaw, pushing the lower jaw toward the upper jaw, thereby urging the mouth to close.

[0371] In some forms, the mouth closure structure 3910 can be configured to facilitate closure of the patient's mouth so as to seal the mouth and substantially prevent gas from flowing through the patient's mouth opening. This can be achieved, for example, by the mouth closure structure 3910 being used to press the patient's lips together sufficiently tightly to form a seal. Alternatively (or additionally), this can occur by positioning the mouth closure structure 3910 across the patient's mouth so as to seal the mouth opening itself.

[0372] However, in other forms, the mouth closure structure 3910 does not seal the patient's mouth, and it should be understood that reference to the patient's mouth "closing" does not necessarily require that the patient's mouth be completely closed, i.e., sealed to prevent air from entering or exiting the mouth opening. The mouth closure structure 3910 may be configured to prevent the mouth from opening further than a particular position that allows for approximate closure, and / or may be configured to urge the mouth to a more closed state, even if not a fully closed state.

[0373] Certain versions of the mouth closure structure 3910 may be configured to allow a patient to open their mouth, or a portion thereof, under certain conditions, such as when a sufficient degree of force is applied to the mouth closure structure 3910. This may be desirable in situations where a patient needs to open their mouth to breathe, such as when their nasal air passages are blocked, when there is a malfunction in the RPT device, or if the patient is panicking and feels the need to breathe through their mouth for comfort.

[0374] 4.3.7.2 Bonding nozzle closure structure

[0375] In some forms of this technology, e.g. Figures 11 to 16 , the mouth closure structure 3910 includes at least one mouth closure member 3912 that includes an adhesive surface. The adhesive surface is on a side of the mouth closure member 3912 that faces the patient during use, i.e., the rear side of the mouth closure member 3912. The adhesive surface of the mouth closure member 3912 is configured to adhere to the patient's lips and / or an area of ​​the patient near the patient's lips during use. For example, in Figure 11 、 Figure 12 and Figures 14 to 16 In the form shown, the mouth closure member 3912 is adhered to the area of ​​the patient's face near the patient's mouth and also adheres to the patient's lips. Depending on the patient's preference and the shape of the mouth, the mouth closure member 3912 may be adhered to both the lower lip and the upper lip, or to only one of the upper lips, during use. Figure 13 In the exemplary form shown, the mouth closure member 3912 adheres around the patient's mouth but does not adhere directly to the patient's lips. Figures 11 to 16In each of the forms shown, the mouth closure member 3912 is adhered to the area below the mouth of the patient's face and also adhered to the area above the mouth of the patient's face. This provides a support effect between the upper and lower parts of the mouth, providing resistance to the mouth opening.

[0376] In some forms of this technology, for example Figures 11 to 16 In those forms shown in , the mouth closure member 3912 is configured such that when the mouth closure member 3912 is adhered to the patient's face, the mouth closure member 3912 leaves at least a portion of the patient's mouth uncovered. Figure 11 、 Figure 12 and Figures 13 to 16 In the case of the patient interface 3000 shown, when the mouth closure member 3912 is adhered to the patient's face, the side areas of the patient's mouth remain uncovered by the mouth closure member. Figure 13 In the case of the patient interface 3000 shown, the patient's mouth remains completely uncovered when the mouth closure member 3912 is positioned and adhered to the patient's face. The mouth closure member 3912 may be designed to allow at least a portion of the mouth to be open during use as a safety measure, so that if the supply of breathable gas to the nostrils is stopped, or if they feel the urgency to do so, the patient is able to breathe through their mouth without having to overcome the resistance of the mouth closure member 3912. Leaving at least a portion of the mouth uncovered may also be a psychological preference of the patient. As in Figure 13 In the example of FIG, by leaving the mouth completely uncovered, the patient is able to speak or consume food or drink while wearing the patient interface 3000.

[0377] exist Figure 11 、 Figure 12 and Figures 13 to 16 In the form shown, the mouth closure member 3912 is adhered to the patient's upper and lower lips (see Figures 2B to 2D ) and across the patient's mouth. In both versions, the mouth closure member 3912 comprises an elongated strip with one end of the strip adhered to the patient's lips and the other end of the strip adhered beneath the lips. Figure 11 In the example of FIG, the mouth closure structure 3910 includes two mouth closure members 3912 in the form of elongated strips that cross each other at overlapping central regions (ie, the mouth closure members are arranged in a cross shape). Figure 12 In the example of , the mouth closing structure 3910 includes a single mouth closing member 3912 in the form of an elongated strip, which is arranged in the up-down direction. Figures 14 to 16In the examples of FIG. 3 , the mouth closure structure 3910 includes a mouth closure member 3912 in the form of an elongated strip arranged in an up-down direction, with the lower end of the strip containing a fork, each arm of the fork extending downwardly and laterally from the upper portion of the strip. In each of these cases, when adhered in place during use, the mouth closure member 3912 covers the central area of ​​the patient's mouth.

[0378] Techniques in which the mouth closure member 3912 adheres to the patient's mouth and / or facial areas proximate to the patient's mouth may be more convenient than other techniques in which the mouth closure member 3912 may adhere to facial areas where, for example, a beard grows. Figure 13 The adhesive may not adhere effectively to hairy areas of the patient's face and may be uncomfortable to remove from these areas. Figures 14 to 16 In the illustrated form, the forked shape of the lower end of the mouth closure structure 3910 can be used to prevent the lower tip of the mouth closure member 3912 from adhering to the upper, central portion under the patient's lip, which can be difficult to adhere to, particularly for patients with facial hair growth in this area. For some patients, they may have less facial hair growth in the area immediately outside of the upper, central portion under the patient's lip.

[0379] exist Figure 13 In the illustrated form of the technology, the mouth closure member 3912 is configured to adhere to one or more side areas of the patient's mouth on one or both sides, and to the lower lip / chin area between the patient's mouth and chin. Furthermore, as previously described, when the mouth closure member 3912 in this form is positioned and adhered to the patient's face, the patient's mouth is fully opened. In the example shown, the mouth closure member 3912 can be generally U-shaped. When the adhesive surface of the mouth closure member 3912 is considered in addition to the adhesive surface 3102 of the seal-forming structure 3100, in this form of the technology, the adhesive surface completely surrounds the patient's mouth.

[0380] In some forms of the technology, the mouth closure structure 3910 may include one or more tabs that the patient can use to remove the mouth closure structure 3910. For example, the tabs may be formed as one or more areas of the mouth closure member 3912 where no adhesive is applied on the patient-facing side. Thus, such one or more areas do not adhere to the patient's face and can be easily grasped by the patient to remove the mouth closure member 3912. Figure 12 In one form of the patient interface 3000 shown, for example, the lower end of the mouth closure member 3912 may form such a tab. In other forms, the tab may be a region extending laterally outwardly from a strip-shaped mouth closure member.

[0381] The mouth closure member 3912 may be formed from any of the materials and adhesives described above in connection with forming the adhesive seal structure 3100 .

[0382] In some forms of the technology, the mouth closure structure 3910 may be integrally connected to the seal-forming structure 3100 and / or the plenum chamber 3200. For example, in Figures 11 to 13 In the exemplary form shown, the mouth closure member 3912 of the mouth closure structure 3910 can be integrally connected to the seal-forming structure 3100. For example, the seal-forming structure 3100 and the mouth closure member 3912 can be formed from the same sheet of material, such as adhesive tape or any of the materials previously described with respect to the adhesive seal-forming structure 3100. This can also be Figure 14 In other forms, the mouth closure member 3912 may be formed as a separate body but permanently connected to the seal-forming structure 3100 and / or the plenum chamber 3200. Such an integral connection may make manufacturing and / or donning the patient interface 3000 easier than in forms in which the mouth closure structure 3910 is a separate component from other parts of the patient interface.

[0383] In some forms of the technology, the mouth closure structure 3910 may be adhered to the seal-forming structure 3100 and / or the plenum 3200. For example, an upper region of the mouth closure member 3912 may be adhered to a lower region of the seal-forming structure 3100 and / or the plenum 3200. In some forms, a surface of the mouth closure member 3912 that faces away from the patient during use is adhered to a surface of the seal-forming structure 3100 and / or the plenum 3200 that faces toward the patient during use. In other forms, a surface of the mouth closure member 3912 that faces toward the patient during use may be adhered to a surface of the seal-forming structure 3100 and / or the plenum 3200 that faces away from the patient during use.

[0384] In some forms of the technology, the mouth closure structure 3910 can be configured to be detachable from the seal-forming structure 3100 and / or the inflatable chamber 3200. For example, the mouth closure member 3912 can be connected to the seal-forming structure 3100 in a manner that allows the patient to easily disconnect the mouth closure member 3912. In one example, a perforation can be formed at the junction between the mouth closure member 3912 and the seal-forming structure 3100, and the patient can easily tear the mouth closure member 3912 along the perforation line. In another example, the mouth closure member 3912 can be connected to the seal-forming structure 3100 by a neck of material that can be easily torn by the patient. The patient interface 3000 can be provided with the mouth closure structure 3910 connected to the seal-forming structure 3100 and / or the inflatable chamber 3200 in such a manner that the patient can choose to easily remove the mouth closure structure 3910 if they prefer not to use it. In some forms, the patient interface 3000 may include a plurality of mouth closure members 3912, each configured to be detachable from the seal-forming structure 3100 and / or the inflatable chamber 3200. In such forms, the patient may select which mouth closure member 3912 they wish to leave in place, and which (if any) mouth closure member 3912 they wish to remove. Thus, the patient may be able to customize the form of the mouth closure structure 3910 to suit their preferences. For example, the patient interface 3000 may have Figures 11 to 13 Any two or more forms of mouth closure members 3912 are shown, connected to the seal-forming structure 3100 in a manner that allows them to be easily disconnected.

[0385] exist Figures 14 to 16 In the illustrated form of the technology, the mouth closure structure 3910 includes a mouth closure structure base 3914 and a mouth closure member 3912. The mouth closure member 3912 is connected to the mouth closure structure base 3914, for example the mouth closure member 3912 and the mouth closure structure base 3914 can be integrally formed from the same body of material. The mouth closure structure base 3914 can be configured to be connected to the seal-forming structure 3100, and the mouth closure member 3912 can extend downwardly from the mouth closure structure base 3914 when in use. The mouth closure structure base 3914 can include one or more mouth closure structure openings 3916, which can be engaged with a portion of the seal-forming structure 3100, or otherwise engaged with a portion of the inflatable chamber 3200, to connect the mouth closure structure 3910 to the seal-forming structure 3100 or the inflatable chamber 3200. Figures 14 to 16In the form shown, the mouth closure structure 3910 may be configured for use with a patient interface 3000 in which the seal-forming structure 3100 includes a nasal prong. In this form, the mouth closure structure opening 3916 may be of a suitable size and shape so that the nasal prong of the seal-forming structure 3100 may protrude through the mouth closure structure opening 3916 so as to hold the mouth closure structure 3910 in position relative to the seal-forming structure 3100. Once assembled in this manner, the mouth closure structure base 3914 is positioned around the neck of the nasal prong in the manner of a collar. In the form shown, to achieve this, the mouth closure structure openings 3916 are positioned laterally adjacent and symmetrically in the mouth closure structure base 3914. In this form, the mouth closure structure 3910 is capable of being completely removed from the rest of the patient interface 3000 and can be replaced, for example, after use. In addition, mouth closure structures of different shapes and / or sizes may be provided for use with the same patient interface 3000 so that the patient can select the mouth closure structure 3910 that best suits their needs. Although Figures 14 to 16 The type of mouth closure structure 3910 shown is one in which the mouth closure member 3912 has a forked lower tip, as described above, and in other forms the mouth closure structure 3910 may have a mouth closure member 3912 of a different shape, such as one of the other types / shapes described herein.

[0386] 4.3.7.3 Other forms of mouth closure structures

[0387] In other forms of the technology, the mouth closure structure 3910 may facilitate closure of the patient's mouth when the patient is wearing the patient interface in different ways. In some examples, the mouth closure structure 3910 may include a chin strap, i.e., a strap that passes under the patient's chin during use. The chin strap may be positioned and configured to exert sufficient force on the chin, such as the undersurface of the chin, to push the patient's mouth upwardly and facilitate closure of the patient's mouth by making it difficult for the patient to open their mouth. In some forms, the chin strap may be configured such that when the patient attempts to open their mouth from a closed position, force is exerted only on the patient's chin.

[0388] In one embodiment, the mouth closure structure 3910 includes a chin strap having two ends and a central portion located between the two ends. Each end is configured to connect to a corresponding portion of the patient interface positioned laterally, such as a portion of the positioning and stabilizing structure 3300 that covers a corresponding cheek area of ​​the patient. The central portion can be configured to be positioned under the patient's chin during use. In another embodiment, the ends of the chin strap can be configured to adhere to the patient's face, such as to opposing cheek areas of the patient's face, to secure them in place during use.

[0389] 4.3.7.4 Benefits of mouth closure structure

[0390] It may be advantageous to breathe through the nasal passages as the primary or sole channel for breathing while sleeping. Various health benefits are thought to result from nasal breathing, and keeping the mouth closed may also prevent snoring.

[0391] These benefits can be achieved by keeping the patient's mouth closed while they receive respiratory therapy. Furthermore, when respiratory therapy is delivered to the patient's nasal passages rather than their mouth, keeping the patient's mouth closed ensures that the patient is only able to breathe the air delivered during the respiratory therapy and not the surrounding air, thereby "short-circuiting" the respiratory therapy.

[0392] For patients who sleep with their mouths open, the options for patient interfaces through which they can receive respiratory therapy may be limited to those that supply breathable gas to the mouth (e.g., pressurized breathable gas in the case of CPAP therapy) so that they cannot breathe ambient air through their mouths. That is, these patients may be limited to choosing patient interfaces that cover their mouths. Such patient interfaces may be bulkier and less comfortable than patient interfaces that supply air only to the nasal passages. In addition, such patient interfaces may come into contact with a larger area of ​​the patient's face during use than smaller masks, which may result in a greater amount of skin irritation or facial markings. By including features that facilitate mouth closure during use of the patient interface, patients in such situations may have a greater choice of patient interfaces that they can effectively use. For example, some nasal masks, nasal pad masks, and / or nasal pillow masks can be effectively used by patients who breathe through their mouths while sleeping if they include mouth closure features as described herein.

[0393] 4.4 Air circuit

[0394] In one form, patient interface 3000 may be included as part of a patient interface system 5000 that also includes an air circuit 4170. Air circuit 4170 is configured to deliver breathable gas to patient interface 3000 for delivery to the airway of patient 1000. For example, Figure 1 The air circuit 4170 of the illustrated form of technology delivers breathable gas from the RPT device 4000 to the plenum chamber 3200.

[0395] A first end of the air circuit 4170 may be connected to the plenum inlet port 3202. A second end of the air circuit 4170, which may be opposite the first end, may be connected to the RPT device 4000.

[0396] In an exemplary form of the present technology, the air circuit 4170 is flexible.

[0397] In certain forms, the geometry of air circuit 4170 may depend on the flow parameters of the breathable gas provided to the patient from RPT device 4000. For example, the diameter of air circuit 4170 may be relatively small in the case of an RPT device 4000 configured to provide a supply of breathable gas at a relatively low pressure (e.g., 2 to 6 cmH2), i.e., low-pressure therapy. The diameter of air circuit 4170 may be relatively large for use with an RPT device 4000 configured to supply breathable gas at a higher pressure (e.g., 6 to 20 cmH2O).

[0398] 4.4.1 Air circuit positioning

[0399] The patient interface 3000 described with respect to various forms of technology herein can accommodate positioning of the air circuit 4170 relative to the patient in a variety of arrangements.

[0400] In some forms, the air circuit 4170 can be configured to be directed to the patient interface 3000 from substantially above a transverse plane configured to pass through the patient's nose and / or mouth region, such as at the Frankfurt level (see FIG. Figure 2E ). In this form, the patient interface 3000 may include a positioning structure configured to maintain a portion of the air circuit 4170 in a desired position relative to the patient's head, for example, the portion of the air circuit 4170 may be maintained in a position above a point above the patient's ear. For example, the positioning structure may include one or more straps configured to be worn on the patient's head and engage the air circuit 4170. In one form, the air circuit 4170 may be configured to pass over the top and / or back of the patient's head. Alternatively or additionally, the air circuit 4170 may be configured to pass behind and / or near the back of the patient's neck when the patient interface system 5000 is in use.

[0401] In another form, the air circuit 4170 may be configured to reach the patient interface 3000 from substantially below a transverse plane configured to pass through the patient's nose and / or mouth region, such as the Frankfurt horizontal plane. Figure 3 、 Figure 4A 、 Figure 4B and Figure 10 In this form, the patient interface 3000 may not require any locating structures to secure the air circuit 4170 in place.

[0402] In one form, the air circuit 4170 may be arranged around and / or proximate to one or both ears of the patient 1000. For example, the air circuit 4170 may branch into two conduits prior to the end of the air circuit 4170 connecting to the patient interface 3000. Each conduit may be configured to be passed behind a respective ear of the patient 1000 during use.

[0403] 4.5RPT device

[0404] An RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms, such as all or part of any of the methods described herein. The RPT device 4000 can be configured to generate an air flow for delivery to a patient's airway, such as for treating one or more respiratory conditions described elsewhere in this document.

[0405] In some forms, the RPT device 4000 can be configured to deliver air flow to the patient interface 3000 at a positive pressure relative to the ambient environment. The RPT device 4000 can be configured to deliver air at a therapeutic pressure, such as at least 6 cmH2O relative to the ambient environment. A conventional RPT device 4000 can be used for this purpose.

[0406] In other forms, the RPT device 4000 can be configured to deliver fluid or air to the patient interface 3000 at a lower pressure (but still at a positive pressure relative to the ambient environment), such as 2 to 6 cmH2O relative to the ambient environment. A respiratory therapy system including an RPT device 4000 that delivers airflow at such a pressure can be used to provide low-level therapy. For example, such a system can be used to treat or ameliorate snoring or other mild respiratory conditions. Compared to RPT devices capable of delivering air at higher pressures, such as those suitable for treating obstructive sleep apnea, such systems can be cheaper to manufacture, use less power, and be more compact in size.

[0407] Figure 1 A respiratory therapy system 2000 is shown that includes an RPT device 4000 of the type just described. Figure 1 In the illustrated form, breathable gas is delivered to a patient interface 3000. The RPT device 4000 is compact in size and thus portable, i.e., capable of being carried by the patient during use, such as by attaching it to the patient's person or clothing. For example, during use, the RPT device 4000 may be strapped around the patient's neck or arm, or carried in a pocket.

[0408] Breathable gas from the RPT device 4000 can be delivered to the patient interface 3000 via an air circuit 4170. The inlet port 3202 of the plenum chamber 3200 can be connected to one end of the air circuit 4170, with the other end of the air circuit 4170 connected to the RPT device. Because the flow rate and / or pressure of the air supply can be lower than that of a conventional RPT device 4000 (e.g., a CPAP device), the air circuit 4170 can have a reduced diameter compared to conventional air circuits. For example, in certain embodiments, the air circuit 4170 can have a diameter in the range of 5-15 mm, such as 10 mm. A smaller diameter tube provides greater resistance to air flow than a larger diameter tube, but this may be acceptable if the flow rate and / or pressure to be delivered are also lower. A smaller diameter tube may be desirable because it is less bulky and unobtrusive, easier to store or package, and less expensive to manufacture.

[0409] 4.6 Glossary

[0410] For purposes of this technical disclosure, in some forms of the technology, one or more of the following definitions may apply. In other forms of the technology, alternative definitions may apply.

[0411] 4.6.1 General

[0412] Air: in some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0413] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0414] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the room that the patient is sleeping in. This ambient humidity can be different from the humidity outside the room that the patient is sleeping.

[0415] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0416] In some forms, ambient (e.g., acoustic) noise can be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or emanating from a mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0417] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjusted between a minimum and a maximum limit, eg, breath-by-breath, depending on whether there is an indication of an SBD (Sleep Disordered Breathing) event.

[0418] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is approximately constant throughout a patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of a patient, for example, increasing in response to detecting an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0419] Flow rate: The volume (or mass) of air transported per unit time. Flow rate can refer to an instantaneous quantity. In some cases, reference to flow rate will be to a scalar quantity, i.e., a quantity having only magnitude. In other cases, reference to flow rate will be to a vector quantity, i.e., a quantity having both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated to 'flow' or 'air flow'.

[0420] Flow therapy: Respiratory therapy involves delivering air flow to the entrance of the airway at a controlled flow rate called the therapy flow, which is usually positive throughout the patient's respiratory cycle.

[0421] Humidifier: The term humidifier will be deemed to refer to a humidifying device constructed and arranged or configured with a physical structure capable of providing therapeutically beneficial amounts of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0422] Leakage: The word leakage is considered to be undesirable air flow. In one example, a leak may occur due to an incomplete seal between the mask and the patient's face. In another example, a leak may occur in the swivel elbow to the surrounding environment.

[0423] Noise, Conducted (Acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0424] Noise, radiated (acoustic): Radiated noise in this document refers to the noise that reaches the patient through the ambient air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0425] Noise, Ventilation (Acoustics): Ventilation noise in this document refers to the noise generated by the flow of air through any vent, such as the vent of a patient interface.

[0426] Oxygen-enriched air: Air with an oxygen concentration greater than atmospheric air (21%), e.g., at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-enriched air" is sometimes shortened to "oxygen."

[0427] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or greater.

[0428] Patient: A person, whether or not they have a respiratory condition.

[0429] Pressure: Force per unit area. Pressure can be expressed in a range of units, including cmH2O, gf / cm2, and hectopascals. 1 cmH2O is equal to 1 g-f / cm2 and is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m2 = 1 millibar ~ 0.001 atmosphere). Throughout this specification, pressure is given in cmH2O unless otherwise specified.

[0430] The pressure in the patient interface is given the symbol Pm, while the treatment pressure is given the symbol Pt, which represents the target value to be achieved by the interface pressure Pm at the current moment.

[0431] Respiratory Pressure Therapy: The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0432] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0433] 4.6.1.1 Materials

[0434] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0435] Polycarbonate: is a thermoplastic polymer of bisphenol A carbonate.

[0436] 4.6.1.2 Mechanical properties

[0437] Resilience: The ability of a material to absorb energy during elastic deformation and release that energy when unloaded.

[0438] Elastic: Will release substantially all of its energy when unloaded. Includes, for example, certain silicones and thermoplastic elastomers.

[0439] Hardness: The ability of a material to resist deformation (as described, for example, by Young's modulus or the indentation hardness scale measured on a standardized sample size).

[0440] • "Soft" materials may include silicone or thermoplastic elastomers (TPEs) and may deform easily, for example, under finger pressure.

[0441] • "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and may not deform easily, for example under finger pressure.

[0442] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component may offer different resistance in different directions. The inverse of stiffness is flexibility.

[0443] Flexible structure or component: A structure or component that will change shape (eg, bend) when made to support its own weight for a relatively short period of time, eg, within 1 second.

[0444] Rigid structure or component: A structure or component that does not substantially change shape when subjected to loads typically encountered in use. An example of such use may be placing and maintaining a patient interface in sealing relationship with the entrance to a patient's airway, for example, under a load of a pressure of about 20 to 30 cmH2O.

[0445] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction than in a second orthogonal direction.In another example, a structure or component may be flexible in a first direction and rigid in a second direction.

[0446] 4.6.2 Dissection

[0447] 4.6.2.1 Facial anatomy

[0448] Ala: The outer lining or "wing" of each nostril (plural: alar).

[0449] Alar tip: The outermost point on the wing of the nose.

[0450] Alar bend (or alar apex) point: The most posterior point in the base of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0451] Pinna: The entire external, visible part of the ear.

[0452] (Nose) Skeleton: The nasal skeleton includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0453] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0454] Columella: The strip of skin that separates the nostrils and extends from the protruding point of the nose to the upper lip.

[0455] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (where both lines intersect at the lower point of the nasal septum).

[0456] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left cochlea, which is the deepest point in the notch above the tragus of the auricle.

[0457] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0458] External nasal cartilage: A cartilage plate that is essentially triangular in shape. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the greater alar cartilage.

[0459] Lip, lower (midpoint of lower lip):

[0460] Lip, upper (midpoint of upper lip):

[0461] The greater alar cartilage is a cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that contains three or four smaller cartilages of the alar.

[0462] Nares (Nostrils): The roughly oval-shaped openings that form the entrance to the nasal cavity. The singular form of nares is naris (nostril). The nostrils are separated by the nasal septum.

[0463] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0464] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0465] Subauricular point: The lowest point where the auricle attaches to the facial skin.

[0466] Supraauricular point: The highest point where the auricle attaches to the facial skin.

[0467] Nasal protuberance: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0468] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0469] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0470] The nasal ridge is the midline protrusion of the nose extending from the nasal bridge to the nasal protuberance.

[0471] Sagittal plane: A vertical plane running from anterior (front) to posterior (back). The midsagittal plane is the sagittal plane that divides the body into right and left halves.

[0472] Nasal bridge point: The most concave point on the soft tissue covering the forehead and nasal suture area.

[0473] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal cavity.

[0474] Posterior superior lateral: The point at the inferior edge of the alar base where the alar base joins the skin of the upper (superior) lip.

[0475] Subnasal point: The point on the soft tissue where the columella and upper lip meet in the midsagittal plane.

[0476] Supramental point: The point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue chin.

[0477] Skull anatomy

[0478] Frontal Bone: The frontal bone includes a large vertical portion (the squama) that corresponds to the area called the forehead.

[0479] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0480] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of its lateral border.

[0481] Nasal bones: The nasal bones are two small, oval bones that vary in size and form among different individuals; they lie side by side in the middle and upper parts of the face and form the "bridge" of the nose at their junction.

[0482] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0483] Occipital bone: The occipital bone is located at the back and bottom of the skull. It contains an oval hole (the foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0484] Orbit: The bony cavity in the skull that houses the eyeball.

[0485] Parietal bones: The parietal bones are the bones that, when joined together, form the roof and sides of the skull.

[0486] Temporal bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0487] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the prominence of the cheeks.

[0488] 4.6.3 Patient interface

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

[0490] Elbow: An elbow is an example of a structure that directs the axis of air flow traveling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be greater than or less than 90 degrees. The elbow may have a cross-section that is approximately circular. In another form, the elbow may have an oval or rectangular cross-section. In some forms, the elbow may be rotatable relative to the mating component, for example, approximately 360 degrees. In some forms, the elbow may be removable from the mating component, for example, via a snap connection. In some forms, the elbow may be assembled to the mating component via a one-time snap connection during manufacturing, but may not be removed by the patient.

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

[0492] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0493] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls at least partially enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the walls of the mask plenum.

[0494] Seal: This can be a noun referring to a structure ("seal") or a verb referring to that effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or achieve a 'seal' between them without requiring a separate 'seal' element itself.

[0495] Shell: Shell will be understood to mean a curved, relatively thin structure with bendable, extendable, and compressible stiffness. For example, the curved structural wall of a mask can be the shell. In some forms, the shell can be multi-faceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0496] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0497] Struts: Struts will be considered structural components designed to increase the compression resistance of another component in at least one direction.

[0498] Swivel (noun): A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel can be configured to rotate through an angle of at least 360 degrees. In another form, the swivel can be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of components preferably comprises a pair of matching cylindrical conduits. There can be little or no air flow leakage from the swivel during use.

[0499] Lacera (noun): A structure used to resist tension.

[0500] Vent: (noun): A structure that allows air flow from the interior of a mask or conduit to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the therapy pressure.

[0501] 4.7 Other Notes

[0502] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in the Patent Office file or records, but otherwise reserves all copyright rights whatsoever.

[0503] Unless the context clearly indicates otherwise and a numerical range is provided, it is understood that each intervening value between the upper and lower limits of that range, to the tenth of the unit of the lower limit, and any other stated or intervening value in that stated range are broadly encompassed within the present technology. The upper and lower limits of these intermediate ranges (which may independently be included in the intermediate ranges) are also encompassed within the present technology, subject to any specifically excluded limits in the stated ranges. Where the stated range includes one or both limits, ranges excluding either or both of those included limits are also encompassed within the present technology.

[0504] Furthermore, where one or more values ​​are stated herein as being implemented as part of a technology, it should be understood that such values ​​may be approximate unless otherwise stated, and that such values ​​may be used with any suitable significant figures to the extent practical technical implementation may allow or require it.

[0505] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0506] When a particular material is provided for use in constructing a component, obvious alternative materials having similar properties may be used as substitutes. Furthermore, unless specified to the contrary, any and all components described herein should be understood to be capable of being manufactured, and thus may be manufactured together or separately.

[0507] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly dictates otherwise.

[0508] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosures prior to the filing date of the present application. This paper should not be construed as admitting that the present technology is not entitled to disclose earlier than this type of disclosure due to prior invention. In addition, the publication date provided may be different from the actual publication date, which may require independent confirmation.

[0509] The terms "comprises" and "comprising" should be understood to refer to elements, components or steps in a non-exclusive manner, indicating that the marked elements, components or steps may be present or utilized, or in combination with other elements, components or steps that are not marked.

[0510] The subject headings used in the detailed description are included only for the convenience of the reader and should not be used to limit the subject matter found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.

[0511] Although the technology herein has been described with reference to specific examples, it should be understood that these examples only illustrate the principles and applications of the technology. In some cases, the terms and symbols may imply specific details that are not required for practicing the technology. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to represent any order, but may be used to distinguish different elements. In addition, although the process steps in the method can be described or shown in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects thereof can be performed simultaneously or even synchronously.

[0512] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

Claims

1. A patient interface for delivering breathable gas to a patient, characterized in that The patient interface comprises: a plenum chamber pressurizable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber comprising a plenum inlet port configured to receive a flow of breathable gas at the therapeutic pressure for breathing by a patient; a seal-forming structure provided to the plenum chamber, wherein the seal-forming structure is configured to form a seal with a region of the patient's face surrounding an entrance to the patient's airway, the seal-forming structure having openings therein to allow a flow of breathable gas to be delivered to at least the entrance to the patient's nares, the seal-forming structure being configured, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's breathing cycle; and a vent structure that allows gas exhaled by the patient to continue to flow from the interior of the plenum chamber to the surrounding environment, the vent structure being configured to maintain the therapeutic pressure in the plenum chamber in use, wherein the seal-forming structure comprises at least one adhesive surface configured to adhere to an area of ​​the patient's face in use to form the seal, and Wherein the seal-forming structure is configured to have one or more notches formed in an edge of the seal-forming structure, the notches being positioned substantially below the opening during use.

2. The patient interface according to claim 1, wherein At least one of the one or more notches is formed in a region of the seal-forming structure that is configured for adherence to a subnasal point of the patient's nasal septum in use.

3. The patient interface according to claim 1, wherein At least one of the one or more recesses is formed in a region of the seal-forming structure that is configured for adherence to a region on the patient's lips.

4. The patient interface according to any one of claims 1 to 3, characterized in that At least one of the one or more recesses is formed in a region of the seal-forming structure that is configured, in use, to adhere to a region of the patient's face that is located on or near a mid-plane.

5. The patient interface according to any one of claims 1 to 3, characterized in that At least one of the one or more recesses is formed in a region of the seal-forming structure that is configured, in use, to adhere to a region of the patient's face that is transverse to the mid-plane.

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