Patient interface

Abstract

To provide a medical device used in the diagnosis, amelioration, treatment or prevention of respiratory disorders.SOLUTION: A patient interface is configured to deliver a pressurized flow of respiratory gas to a patient's airways. The patient interface includes a cradle base configured to cradle the patient's nose in use. Two protrusions extend from the cradle base and are configured to be inserted into the patient's nares in use. An opening configured to allow a continuous flow of air therethrough is formed inside each of the protrusions. In addition, a plenum base forms a plenum chamber together with the cradle base. The cradle base is configured such that movement of the cradle base is decoupled from the plenum base.SELECTED DRAWING: Figure 3EE

Description

Technical Field

[0001] 1 Cross - reference to related applications This application claims the benefit of Australian Application No. 2019903362 (filed on September 10, 2019). The entire disclosure of this document is incorporated herein by reference for all purposes.

Background Art

[0002] 2 Background of the technology 2.1 Field of the technology This technology relates to one or more of the detection, diagnosis, treatment, prevention, and amelioration of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

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

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

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

[0006] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

[0007] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by episodes of closure or obstruction of the upper airway during sleep. This is the result of a combination of an abnormally small upper airway and the normal loss of muscle tone in the tongue area, and the normal loss of the soft palate and posterior oropharyngeal wall during sleep. As a result of such a disorder, apneas in affected patients typically last from 30 to 120 seconds, and sometimes the breathing stops 200 to 300 times a night. As a result, excessive daytime sleepiness occurs, which can cause cardiovascular disease and brain damage. This syndrome is a common disorder, particularly common in middle-aged overweight men, but patients are asymptomatic. See U.S. Patent No. 4,944,310 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, in which alternating periods of increasing and decreasing ventilation, known as the CSR cycle, occur periodically. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated sleep arousals, which can cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0009] Respiratory insufficiency is a general term for respiratory disorders and refers to the inability of the lungs to perform adequate oxygen inhalation or adequate CO2 exhalation to meet the patient's needs. Respiratory insufficiency can include some or all of the following diseases.

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

[0011] Obesity hypoventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other clear causes of hypoventilation. Symptoms include dyspnea, headache upon waking, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include an increase in resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in normal elasticity in the lungs. Examples of COPD are emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term that encompasses a number of disorders and diseases that impair muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Some NMD patients are characterized by progressive muscle impairment, which can ultimately lead to inability to walk, confinement to a wheelchair, dysphagia, reduced respiratory muscle strength, and ultimately death due to respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) Characteristics of rapidly progressive diseases: Muscle impairment that worsens over several months and leads to death within a few years (such as amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in the teens, etc.). (ii) Degenerative or slowly progressive diseases: Muscle impairment that worsens over several years but only mildly shortens life expectancy (such as limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Respiratory failure symptoms in NMD include increased general weakness, dysphagia, dyspnea on exertion and at rest, fatigue, sleepiness, headache upon waking, and difficulty with concentration and mood changes.

[0014] Chest wall disorders are a group of thoracic deformities that cause ineffectiveness of the coupling between the respiratory muscles and the thorax. These disorders are mainly characterized by restrictive disorders and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis may develop severe respiratory failure. Symptoms of respiratory failure are listed below: dyspnea on exertion, peripheral edema, orthopnea, recurrent chest infections, headache on waking, fatigue, poor sleep quality, and loss of appetite.

[0015] To treat or improve such diseases, a range of therapies are being used. Additionally, in other respects, healthy individuals can also advantageously utilize preventive therapies for respiratory disorders. However, there are several drawbacks in these.

[0016] 2.2.2 Therapies A variety of therapies (e.g., continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV)) are being used for the treatment of one or more of the above respiratory disorders.

[0017] Continuous positive airway pressure (CPAP) therapy is being used in the treatment of obstructive sleep apnea (OSA). As its mechanism of action, for example, by pushing the soft palate and tongue forward or backward against the posterior oropharyngeal wall, CPAP therapy functions as an air pressure sprint, thereby preventing upper airway closure. Since the treatment of OSA by CPAP therapy can be spontaneous, if such a patient notices one or more of the following regarding the device used for therapy provision, the patient may choose not to comply with the therapy: discomfort, difficulty in use, high cost, lack of aesthetic appeal.

[0018] Non-invasive ventilation (NIV) provides ventilatory assistance to a patient through the upper airway and performs some or all of the respiratory functions to assist the patient's breathing and / or maintain an appropriate oxygen level in the body. The ventilatory assistance is provided via a non-invasive patient interface. NIV is used in the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these therapies can be improved.

[0019] Invasive ventilation (IV) provides ventilatory assistance to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these therapies can be improved.

[0020] 2.2.3 Treatment System These therapies can be provided by a treatment system or device. Such systems and devices can also be used for diagnosis without treating the disease.

[0021] The treatment system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0022] Another form of treatment system is a mandibular repositioning device.

[0023] 2.2.3.1 Patient Interface A patient interface can be used to provide an interface to a breathing apparatus to a wearer, for example, by providing an airflow to an airway inlet. The airflow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface can, for example, form a seal with the area of the patient's face, thereby facilitating gas delivery at a sufficient distributed pressure along with the ambient pressure for therapy execution (e.g., at a positive pressure of about 10 cmH2O relative to the ambient pressure). In other therapy modalities such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas supply to the airway at a positive pressure of about 10 cmH2O.

[0024] Certain other mask systems may be functionally inappropriate in the art. For example, in the case of a mask for purely decorative purposes, it may not be possible to maintain an appropriate pressure. A mask system used for underwater swimming or diving can be configured to protect against water ingress from higher external pressures and not maintain internal air at a pressure higher than the ambient.

[0025] Certain masks may be clinically unfavorable in the present technology (e.g., when the mask blocks airflow through the nose and only allows airflow through the mouth).

[0026] In certain masks, it may be uncomfortable or impractical in the present technology when the patient has to insert a part of the mask structure into the mouth and create and maintain a seal via the lips.

[0027] Certain masks may be impractical for use during sleep (e.g., when sleeping on the side in bed with the head on a pillow).

[0028] In the design of patient interfaces, there are multiple challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly from person to person. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory therapy period.

[0029] Due to these challenges, in some cases of masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the following reasons: overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. If a mask of the wrong size is used, it can lead to a decrease in compliance, comfort, and patient prognosis. Masks designed as part of a pilot's mask, personal protective equipment (e.g., filter mask), SCUBA mask, or anesthesia mask are suitable for their original uses, but in such cases of masks, they may be unacceptably uncomfortable for long-term (e.g., several hours) wearing. Due to such discomfort, the patient's compliance with therapy may decrease. This is especially true when the mask needs to be worn during sleep.

[0030] CPAP therapy is extremely effective in the treatment of certain respiratory disorders when the patient is committed to the therapy. If the mask is uncomfortable or difficult to use, the patient may not commit to the therapy. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's compliance.

[0031] Masks designed for the treatment of sleep apnea may be suitable for other uses in some cases, as masks for other uses (e.g., pilots) may not be suitable for the treatment of sleep apnea.

[0032] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0033] 2.2.3.1.1 Seal-forming structure The patient interface may include a seal-forming structure. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0034] The patient interface may be partially characterized according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure may include a first sub-part for forming a seal around the left nostril and a second sub-part for forming a seal around the right nostril. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils during use. Such a single element may be designed to be placed, for example, on the upper lip region and nasal bridge region of the face. In one form of the patient interface, the seal-forming structure may include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the seal-forming structure may include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces may be known by various names such as nasal masks, full face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0035] A seal-forming structure that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variabilities, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0036] Certain seal-forming structures can be designed for mass production so that one design is suitable for a wide range of different face shapes and sizes and is comfortable and effective. To form a seal, it is necessary to conform one or both of the patient's face shape and the seal-forming structure of the mass-produced patient interface to the extent of the mismatch between them.

[0037] One type of seal-forming structure extends around the perimeter of the patient interface and is intended to seal the patient's face when a force is applied to the patient interface with the seal-forming structure engaged against the patient's face. This seal-forming structure may include an air or fluid-filled cushion or may include a molded or formed surface of an elastic seal element composed of an elastomer such as rubber. With this type of seal-forming structure, if the fit is inappropriate, a gap will occur between the seal-forming structure and the face, and additional force will be required to press the patient interface against the face to achieve a seal.

[0038] Another type of seal-forming structure uses a thin flap seal disposed around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is added within the mask. Similar to the seal-forming portions of the types described above, if the alignment between the face and the mask is not good, additional force may be required to achieve a seal or leakage may occur from the mask. Further, if the shape of the seal-forming structure does not match the patient's shape, creases or buckling may occur in the seal-forming portion during use, causing leakage.

[0039] Another type of seal-forming structure may include friction fit elements inserted into the nostrils, for example, but there are also patients who find these seal-forming portions uncomfortable.

[0040] Another form of seal-forming structure may use an adhesive portion to achieve a seal. Among patients, there are also those who always find it inconvenient to attach or remove the adhesive portion to their face.

[0041] Regarding the technology of a patient interface seal formation structure within a certain range, there is disclosure in the following patent applications assigned to ResMed Limited: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0042] ResMed Limited manufactures the following products using nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask and MIRAGELIBERTY™ Full Face Mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (particularly describing the appearance of ResMed Limited's SWIFT® Nasal Pillow), US Patent Application No. 2009 / 0044808 (particularly describing the appearance of ResMed Limited's SWIFT® LT Nasal Pillow); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (particularly describing the appearance of ResMed Limited's MIRAGE LIBERTY™ Full Face Mask); International Patent Application WO2009 / 052,560 (particularly describing the appearance of ResMed Limited's SWIFT® FX Nasal Pillow).

[0043] 2.2.3.1.2 Positioning and Stabilization The seal formation structure of a patient interface used in positive pressure air therapy is subject to the corresponding forces of air pressure that interfere with the seal. Therefore, various techniques are used to position the seal formation structure and maintain the seal against the appropriate part of the face.

[0044] In one technique, an adhesive part is used. See, for example, US Patent Application Publication US2010 / 0000534. However, when using an adhesive part, there may be discomfort.

[0045] In another technique, one or more straps and / or stabilizing harnesses are used. In the case of a number of such harnesses, one or more of the points such as poor fit, bulky, uncomfortable and difficult to handle apply.

[0046] In a patient interface included in another type of treatment system, a tube or substantially hollow elongated structure for delivering pressurized air to the patient's airway also functions as part of a structure (e.g., a headgear) that positions and stabilizes the appropriate portion of the patient's face against the seal-forming portion of the patient interface. That is, the headgear forms part of the air circuit. For the purposes of this specification, the terms "tube" and "duct" shall be considered to have the same meaning unless the context clearly indicates otherwise.

[0047] When this type of patient interface is referred to as including "headgear tubing" or "tubing headgear", it should be understood as synonymous for the purposes of this specification unless the context clearly indicates otherwise. Using such a patient interface, a duct in the air circuit providing the pressurized air flow from a respiratory pressure therapy device can be provided to the patient interface located at a position other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. 2007 / 0246043. The contents of this document are incorporated herein by reference. In that document, the duct is connected into the patient interface through a port positioned on top of the patient's head during use.

[0048] The Philips DreamWear™ mask includes such conduit headgear / headgear tubing. The length of the DreamWear™ headgear tube cannot be adjusted. Therefore, the DreamWear™ headgear is supplied in three different sizes to accommodate patients with different face sizes. An increase in the number of different sizes can lead to an increase in the complexity and cost of manufacturing the headgear and may lead to larger packaging. Further, when supplying masks of different sizes, the range of patients with different head sizes that can be accommodated may be limited. If a certain number of patients are required to forcibly select an individual size with non-adjustable length, there is a high possibility that the patient may not be able to achieve a fit that the patient himself / herself feels is "comfortable". 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0049] The Respiratory Pressure Therapy (RPT) device can be used for the delivery of one or more of the above-described therapies, for example, by generating an air delivery flow to the airway inlet. This air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0050] Air pressure generators are known in a wide range of applications (e.g., industrial-scale ventilation systems). However, air pressure generators for medical use have specific requirements that cannot be satisfied by more general air pressure generators (e.g., reliability requirements, size requirements, and weight requirements for medical devices). In addition, even a device designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0051] An example of a special requirement for a specific RPT device is acoustic noise.

[0052] Table of noise output levels of conventional RPT devices (measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample). [Table 1]

[0053] As one known RPT device used for the treatment of sleep apnea, there is the S9 sleep therapy system (manufacturer: ResMed Limited). Another example of an RPT device is a ventilator. In the case of a ventilator (e.g., the ResMed Stellar™ series of adult and pediatric ventilators), it can provide assistance for invasive and non-invasive independent breathing for patients for a certain range for the treatment of multiple diseases (including, without limitation, NMD, OHS, and COPD).

[0054] The ResMed Elis Accutronic® 150 ventilator and the ResMed VSIII™ ventilator can provide assistance for invasive and non-invasive dependent breathing suitable for adult or pediatric patients for the treatment of multiple diseases. With these ventilators, volume ventilation modes and pressure ventilation modes using single or double limb circuits can be obtained. The RPT device typically includes a pressure generator (e.g., an electric blower or a compressed gas reservoir) and is configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway with positive pressure. The outlet of the RPT device is connected to the patient interface as described above via an air circuit.

[0055] The device designers can be presented with countless options. Since the design criteria often conflict with each other, certain design options may be far from convention or unavoidable. Furthermore, the comfort and effectiveness of a particular aspect may also be greatly affected by minor changes in one or more parameters.

[0056] 2.2.3.3 Humidifier When air flow delivery is performed without humidification, it can lead to drying of the airway. When a humidifier is used with an RPT device and a patient interface, humidified gas is generated, minimizing drying of the nasal mucosa and increasing patient airway comfort. Additionally, in a cooler climate, generally adding warm air to the facial area around the patient interface increases comfort compared to cold air.

[0057] A range of artificial humidification devices and systems are known, but they do not meet the special requirements of medical humidifiers.

[0058] Medical humidifiers are typically used to increase the humidity and / or temperature of the air flow relative to the ambient air when the patient is asleep or at rest (e.g., in a hospital), if necessary. A medical humidifier placed at the head of the bed may be small. A medical humidifier may be configured to perform only the humidification and / or heating of the air flow delivered to the patient, and not the humidification and / or heating around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can also humidify the air taken into the patient's body by breathing, but in the case of these systems, since the entire room is also humidified and / or heated, it can be uncomfortable for the occupants. Additionally, in the case of medical humidifiers, safety constraints may be more stringent than those of industrial humidifiers.

[0059] Although many medical humidifiers are known, such medical humidifiers can suffer from one or more defects. That is, in the case of such medical humidifiers, some may have inappropriate humidification, while others may be difficult or inconvenient for patients to use.

[0060] 2.2.3.4 Ventilation technology Some forms of treatment systems may include a ventilation section for pushing out exhaled carbon dioxide. This ventilation section enables gas flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings).

[0061] This vent may include an orifice through which gas can flow during mask use. In the case of a number of such vents, the sound is noisy. In other cases, it may become blocked during use, resulting in insufficient extrusion. In the case of some vents, for example due to sound or airflow concentration, it may interfere with the sleep of patient 1000 and co-sleeper 1100.

[0062] ResMed Limited has developed a number of improved mask ventilation technologies. See the following: International Patent Application Publication No. WO1998 / 34,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0063] Table of noise of conventional masks (ISO17510-2:2007, measured at 1 m at a pressure of 10 cmH2O)

Table 2

[0064] (*Measured at 10 cmH2O in CPAP mode using the test method specified in ISO3744 for only 1 sample)

[0065] List the sound pressure values of various subjects as follows

Table 3

Summary of the Invention

Means for Solving the Problems

[0066] 3 Brief Description of the Technology This technology relates to the provision of medical devices used in the diagnosis, improvement, treatment or prevention of respiratory disorders, and these medical devices have one or more of improved comfort, cost, effectiveness, ease of use and manufacturability.

[0067] The first aspect of the present technology relates to an apparatus used for the diagnosis, improvement, treatment, or prevention of respiratory disorders.

[0068] Another aspect of the present technology relates to a method used in the diagnosis, improvement, treatment, or prevention of respiratory disorders.

[0069] One aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0070] One aspect of the present technology relates to a patient interface. The patient interface includes a plenum structure, a seal-forming structure, and a positioning and stabilization structure configured to support the seal-forming structure and the plenum structure on the patient's head. The patient interface may include a ventilation system.

[0071] Another aspect of the present technology relates to a patient interface configured to deliver a pressurized respiratory gas flow to a patient's airway. The patient interface may include a cradle base configured to cradle support a patient's nose during use, and two protrusions extending from the cradle base and configured to be inserted into the patient's nostrils during use.

[0072] Another aspect of the present technology relates to a seal-forming structure for a patient interface configured to form a seal with a patient's nostrils. The seal-forming structure may include a base and two protrusions provided on the base, wherein an opening configured to allow a continuous air flow to pass therethrough is formed inside each of the protrusions. In an exemplary form of the present technology, the protrusions are structured and arranged to be inserted or partially inserted into each of the patient's nostrils during use. The protrusions may be structured and arranged to seal the inner peripheral edge of each nostril during use. The protrusions may include an end portion configured to seal the inner peripheral edge of each nostril during use.

[0073] In an example, the base further includes a lateral extension that extends laterally outwardly on either side of one of the two protrusions, and each lateral extension is configured to seal the lateral or lower portion of each of the patient's nasal wings during use.

[0074] In an example, the base is formed such that when there is no force acting on the base, the base has a positive curvature in the lateral direction, and when the base engages with the nose during wearing by the patient, the positive curvature of the base decreases.

[0075] One aspect of the present technology relates to a seal-forming structure for a patient interface configured to form a seal with the patient's nostrils. The seal-forming structure may include a base and at least one opening within the base configured to allow a continuous airflow to pass therethrough. In an exemplary form of the present technology, the base is provided in a plenum chamber. One or more folds may be formed by a portion of the base and / or a portion of the plenum chamber. In an example, the seal-forming structure includes two protrusions provided on the base, and within each of the protrusions, one of the openings is formed.

[0076] One aspect of the present technology is a patient interface, which is a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O exceeding the ambient air pressure. The plenum chamber includes a plenum chamber inlet port sized and structured to receive an air flow for breathing by the patient at the treatment pressure. A seal-forming structure constructed and arranged to form a seal with a region of the patient's face that surrounds the entrance to the patient's airway. The seal-forming structure is constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use. And a ventilation structure that enables the gas exhaled by the patient to continuously flow from the inside of the plenum chamber to the surroundings. The ventilation structure is sized and shaped to maintain the treatment pressure within the plenum chamber during use. The seal-forming structure further includes a base and two protrusions provided on the base. Inside each of the protrusions, an opening is formed that is configured to allow a continuous air flow to pass through. The protrusions are structured and arranged to be inserted or partially inserted into each of the patient's nostrils during use to provide an air flow to the patient's nostrils at the treatment pressure. It relates to a patient interface.

[0077] One aspect of the present technology is a patient interface, comprising a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive an airflow for breathing by a patient at the treatment pressure; a seal-forming structure constructed and arranged to form a seal with a region of the patient's face that surrounds an inlet to the patient's airway, the seal-forming structure being constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use; and a ventilation structure that enables a gas exhaled by the patient to flow continuously from the interior of the plenum chamber to the surroundings, the ventilation structure being sized and shaped to maintain the treatment pressure within the plenum chamber during use. The seal-forming structure includes a base and at least one opening within the base configured to provide an airflow at the treatment pressure to the patient's nostrils during use. The base is provided on the plenum chamber, and one or more folds are formed by a part of the base and / or a part of the plenum chamber. In an example, the seal-forming structure includes two protrusions provided on the base, and within each of the protrusions, one of the openings is formed.

[0078] In an example, the base further includes a lateral extension that extends laterally outward on either side of either of the two protrusions, the lateral extension being configured to seal the lateral or lower part of each of the patient's alae nasi during use.

[0079] In an example, the base is formed such that it has a positive curvature when no force acts on the base, and when the base engages with the nose during wearing by the patient, the positive curvature of the base decreases.

[0080] In an example, the patient interface further includes a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. In one example, the positioning and stabilization structure includes a strap, and the strap is constructed and arranged such that at least a portion thereof covers a region of the patient's head above the upper ear base point of the patient's head during use. In another example, the positioning and stabilization structure includes at least one gas delivery tube constructed and arranged to contact at least a region of the patient's head above the upper ear base point of the patient's head during use, and a portion of the gas delivery tube above the upper ear base point of the patient's head includes or is provided with a connection port configured to receive an air flow from the air circuit and deliver the air flow to the inlet of the patient's airway through the seal-forming structure.

[0081] Another aspect of one form of the present technology is a patient interface molded or otherwise constructed with a peripheral shape that is complementary to the shape of the intended wearer.

[0082] One aspect of one form of the present technology is a method of manufacturing the device.

[0083] One aspect of a particular form of the present technology is an easy-to-use medical device for, for example, a person who has not received medical training, a person who is not very dexterous or lacks insight, or a person with limited experience in using this type of medical device.

[0084] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning device is required. One aspect of one form of the present technology is a humidifier tank that can be cleaned, for example, with soapy water in the patient's home, and no special cleaning device is required.

[0085] Another aspect of the technology includes a patient interface configured to deliver a pressurized breathing gas flow to a patient's airway. The patient interface may include a cradle base configured to cradle support a patient's nose in use. Two projections may extend from the cradle base and may be configured to be inserted into a patient's nostrils in use. Within each of the projections, an opening may be formed that is configured to allow a continuous air flow to pass therethrough. The plenum base may form a plenum chamber together with the cradle base. The cradle base may be configured such that movement of the cradle base is decoupled from the plenum base.

[0086] The projections may be structured and arranged to seal the inner peripheral edge of each nostril in use. Additionally, the projections may include an end portion that seals the inner peripheral edge of each nostril in use.

[0087] The cradle base may include lateral extensions that extend laterally outwardly on either side of either of the two projections. Each of the lateral extensions may be configured to seal the lateral or lower portion of each of the patient's alae nasi in use. Additionally, the cradle base may be configured to flex outwardly by the patient's nose when worn by the patient.

[0088] The projections may have a frustoconical shape. Additionally, the opening of the projection may be angled relative to the portion of the cradle base surface where the extension of the projection begins.

[0089] The plenum base may include a pair of air inlets on opposing lateral sides. Additionally, the plenum base and the cradle base may be inflatable.

[0090] The buffer or damper between the cradle base and the plenum base can be configured to decouple the movement of the cradle base from the plenum base. The buffer or damper may not be configured to decouple the movement between two sealing surfaces. Also, the buffer or damper may not be configured to decouple the movement between the nose seal and the mouth seal. The patient interface may not include a mouth seal. Also, the protrusion may not include a stem portion.

[0091] Another aspect of the present technology includes a patient interface configured to deliver a pressurized breathing gas flow to a patient's airway. The patient interface may include a plenum base and a cradle base attached to the plenum base. The plenum base can be configured to cradlingly support a patient's nose during use. A plenum chamber can be formed by both the plenum base and the cradle base. Channels in the surface of the plenum base adjacent to the cradle base can be configured to decouple the movement of the cradle base from the plenum base. Additionally, a pair of protrusions can extend from the cradle base. The pair of protrusions can be configured to be inserted into a patient's nostrils during use. The pair of protrusions can form a gas flow path from the plenum chamber to the patient's airway during use.

[0092] The channels can completely surround the cradle base. Additionally, the cradle base can be U-shaped or V-shaped. The plenum base and the cradle base can be inflatable. Also, the lateral portions of the cradle base can be configured to flex in a proximal and a distal direction relative to the plenum base.

[0093] Each protrusion can extend from a respective lateral portion of the cradle base. The lateral portions of the cradle base can extend laterally beyond each protrusion.

[0094] The plenum base can include a pair of gas inlets. Each gas inlet can be disposed at each lateral side portion of the plenum base.

[0095] Each protrusion may be configured to seal the inside of the patient's nostril. At the same time, the cradle base may be configured to seal the outer surface of the patient's nostril.

[0096] Another aspect of the technology includes a patient interface configured to deliver a pressurized breathing gas flow to the patient's airway. The patient interface may include a plenum base that can be pressurized to at least a therapeutic pressure of 6 cmH2O above ambient air pressure. The plenum base may include a plenum chamber inlet port sized and structured to receive an air flow for breathing by the patient at the therapeutic pressure. The seal-forming structure may be constructed and arranged to surround the patient's nasal cavity in the patient's face and form a seal with the area inside the patient's nasal cavity. The seal-forming structure may be constructed and arranged to maintain the therapeutic pressure within the plenum chamber throughout the patient's breathing cycle during use. A spring or damper may be disposed between the plenum chamber and the seal-forming structure. The spring or damper may be configured to decouple the movement of the seal-forming structure from the plenum base. The seal-forming structure may further include a cradle base and two protrusions provided on the cradle base. Inside each of the protrusions, an opening may be formed that is configured to allow a continuous air flow to pass therethrough. The protrusions may be structured and arranged to be inserted or partially inserted into each of the patient's nostrils during use so that the air flow is provided to the patient's nostrils at the therapeutic pressure.

[0097] The protrusions may be configured to form a seal with the inside of the patient's nostril. Additionally, the cradle base may be configured to cradle support the patient's nose and form a seal with the surface outside the patient's nostril during use.

[0098] Only the central portion of the cradle base can be attached to the plenum base. The side portions of the cradle base can be flexible in the proximal and distal directions relative to the plenum base. Additionally, the protrusion can be angled relative to the surface of the cradle base where the extension of the protrusion begins.

[0099] Another aspect of the technology includes a patient interface configured to deliver a pressurized breathing gas flow to a patient's airway. The patient interface can include a plenum base that can be pressurized to at least a therapeutic pressure of 6 cmH2O above ambient air pressure. The plenum base can include an inlet port sized and structured to receive an air flow for breathing by the patient at the therapeutic pressure. The seal-forming structure can be constructed and arranged to surround the patient's nasal apertures of the patient's face and form a seal with the area inside the patient's nasal apertures. The seal-forming structure can also be constructed and arranged to maintain the therapeutic pressure within the plenum base throughout the patient's breathing cycle during use. The seal-forming structure can include a cradle base and a pair of protrusions extending from the cradle base. Inside each protrusion, an opening can be formed that is configured to convey an air flow at the therapeutic pressure to the patient's nostril during use. Each protrusion can be configured to be inserted into or partially inserted into one of the patient's nostrils during use. The cradle base can be supported on a portion of the plenum base and / or a portion of the plenum base can form one or more folds configured to decouple the movement of the cradle base from the plenum base.

[0100] One or more of the folds can be part of a concertina structure. Additionally, the cradle base can further include a lateral extension that extends laterally outwardly on either side of any of the protrusions. The lateral extension can be configured to seal the lateral or lower portions of each of the patient's nasal wings during use.

[0101] The patient interface may further include a positioning and stabilization structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilization structure may include straps constructed and arranged such that at least a portion thereof covers a region of the patient's head above the upper ear canal points of the patient's head during use. The positioning and stabilization structure may also include at least one gas delivery tube constructed and arranged to contact at least a region of the patient's head above the upper ear canal points of the patient's head during use. The portion of the gas delivery tube above the upper ear canal points of the patient's head includes or is provided with a connection port configured to receive an air flow from the air circuit and deliver the air flow to the inlet of the patient's airway via the seal-forming structure.

[0102] Of course, some of the above aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and / or aspects can be variously combined to form further aspects or sub-aspects of the present technology.

[0103] Other features of the present technology will become apparent in view of the information contained in the following detailed description, summary, drawings, and claims.

[0104] 4 Brief Description of the Drawings The present technology is illustrated by way of example and not limitation in the accompanying drawings, in which like reference numerals include the following like elements:

Brief Description of the Drawings

[0105]

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 2C

Figure 2D

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Figure 2F

Figure 2G

Figure 2H

Figure 2I

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Figure 2K

Figure 2L

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 3F

Figure 3G

Figure 3H

Figure 3I

Figure 3J

Figure 3K

Figure 3L

Figure 3M

Figure 3N

Figure 3O

Figure 3P

Figure 3Q

Figure 3R

Figure 3S

Figure 3T

Figure 3U

Figure 3V

Figure 3W

Figure 3X

Figure 3Y

Figure 3Z

Figure 3AA

Figure 3BB

Figure 3CC

Figure 3DD

Figure 3EE

Figure 3FF

Figure 4A

Figure 4B

Figure 5A

Figure 5B

Figure 6A

DETAILED DESCRIPTION OF THE INVENTION

[0106] 5 DETAILED DESCRIPTION OF EXAMPLES OF THE PRESENT TECHNOLOGY Before explaining the present technology in more detail, it should be understood that the present technology is not limited to the different specific examples described herein. It should also be understood that the terms used in the present disclosure are for the purpose of explaining the specific examples described herein and are not limiting.

[0107] The following description is provided in relation to various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, any single feature or combination of features in any of these examples may constitute a further example.

[0108] 5.1 Therapy In one form, the technology includes a method of treating a respiratory disorder. The method includes the step of applying positive pressure to the entrance of the airway of patient 1000.

[0109] In certain examples of the technology, an air supply at positive pressure is provided to the nasal passage of the patient via one or both of the nostrils.

[0110] In certain examples of the technology, mouth breathing is restricted, limited, or prevented.

[0111] 5.2 Treatment System In one form, the technology includes an apparatus or device for the treatment of a respiratory disorder. The apparatus or device may include an RPT device 4000 that supplies pressurized air to patient 1000 via an air circuit 4170 to a patient interface 3000.

[0112] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of the technology includes the following functional modalities: a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a ventilation portion 3400, a form of connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional modalities may be provided by one or more physical components. In some forms, one physical component may provide one or more functional modalities. In use, the seal-forming structure 3100 is arranged to surround the entrance to the patient's airway so as to facilitate the supply of air at positive pressure to the airway.

[0113] If the patient interface cannot comfortably deliver the lowest level of positive pressure to the airway, the patient interface may be inappropriate for respiratory pressure therapy.

[0114] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to the surroundings.

[0115] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to the surroundings.

[0116] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to the surroundings.

[0117] 5.3.1 Seal formation structure In one form of the present technology, the seal formation structure 3100 may provide a target seal formation area and further provide a cushioning function. The target seal formation area is an area where sealing can occur in the seal formation structure 3100. The area where sealing actually occurs (i.e., the actual sealing surface) may vary daily by the patient in a given treatment session depending on a range of factors (e.g., the placement position of the patient interface on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face).

[0118] In one form, the target seal formation area is disposed on the outer surface of the seal formation structure 3100.

[0119] In a particular form of the present technology, the seal formation structure 3100 is constructed from a biocompatible material (e.g., silicone rubber).

[0120] The seal formation structure 3100 according to the present technology may be constructed from a soft, flexible and elastic material (e.g., silicone).

[0121] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100. Each seal-forming structure 3100 is configured to accommodate different size and / or shape ranges. For example, the system may include one form of a seal-forming structure 3100 suitable for a large-sized head rather than a small-sized head and another suitable for a small-sized head rather than a large-sized head.

[0122] 5.3.1.1 Sealing mechanism In one form, the seal-forming structure includes a sealing flange that uses a pressure-assisted sealing mechanism. In use, the sealing flange can act on its underside in easy response to the system positive pressure within the plenum chamber 3200 to form a tight sealing engagement with the surface. The pressure-assisted mechanism can act together with the elastic tension in the positioning and stabilizing structure.

[0123] In one form, the seal-forming structure may include a compression seal or a gasket seal. In use, the compression seal or the gasket seal is constructed and arranged to be in a compressed state, for example, due to the elastic tension in the positioning and stabilizing structure.

[0124] In one form, the seal-forming structure includes a tension portion. In use, the tension portion is held in a taut state, for example, by an adjacent region of the sealing flange.

[0125] In one form, the seal-forming structure includes a region having an adhesive surface or an adherent surface.

[0126] In certain forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted sealing flange, a compression seal, a gasket seal, a tension portion, and a portion having an adhesive surface or an adherent surface.

[0127] 5.3.1.2 Nasal seal Figures 3Y through 3CC illustrate a patient interface 3000 that includes a seal forming structure 3100 and a plenum base 3105 according to another aspect of the present technique. A damper or buffer 3106 may be disposed between the seal forming structure 3100 and the plenum base 3105 to decouple the movement of the seal forming structure 3100 from the plenum base 3105.

[0128] The seal forming structure 3100 of the patient interface 3000 may be a nasal cradle and may include an anchoring portion configured to anchor the nasal cradle to the patient's nostrils. Each seal forming structure 3100 may include a pair of protrusions 3110 extending from a cradle base 3120. The protrusions 3110 may be constructed and arranged to form a seal with each nostril of the patient's nose. Alternatively, the protrusions 3110 may engage only a portion of the patient's nostrils and may not form a seal with the nostrils of the patient's nose.

[0129] The protrusions 3110 may be structured and arranged to be inserted or partially inserted into each of the patient's nostrils during use. Each protrusion 3110 may be hollow and may have an opening 3130 at the end of the protrusion 3110. Each protrusion 3110 may be configured to allow a pressurized breathing gas flow to pass therethrough internally, such that the pressurized breathing gas flow may flow into the patient's nostrils when the patient interface 3000 is worn.

[0130] In some forms of the present technology, each projection 3110 can be configured to extend partially into each of the patient's nostrils. For example, each projection 3110 can be structured and arranged to engage and seal (or engage only) with the inner peripheral edge of each nostril during use. The height of each projection 3110 can be less than that of a conventional nasal pillow patient interface. For example, the height of each projection 3110 from the cradle base 3120 can be less than 2 cm. It is contemplated that the height of each projection 3110 from the cradle base 3120 can be less than 1 cm. It is further contemplated that the height of the projection 3110 from the cradle base 3120 can be less than 0.5 cm. The end (or edge) of each projection 3110 forming the opening 3130 can be configured to engage and seal with the inner peripheral edge of each nostril (or to perform only sealing).

[0131] Each projection 3110 can have a proximal end 3140 adjacent to the cradle base 3120 and an outlet end 3150 opposite the proximal end 3140. The opening 3130 can be provided at the outlet end 3150. Since the projection 3110 has a hollow structure, a gas passage for the pressurized breathing gas flow can be formed by the peripheral wall 3160 of the projection 3110.

[0132] Since each projection 3110 can be tapered, the proprietary area of the projection 3110 is maximized at the proximal end 3140 and minimized at the outlet end 3150. The structure of the projection 3110 can be made different from that of a conventional nasal pillow by removing a thinner stem portion between the widest part and a base that allows substantial deflection and / or bending relative to the base of the nasal pillow. Removal of the stem portion can minimize the relative movement between the projection 3110 and the surface of the cradle base 3120 from which the extension of the projection 3110 begins, thus facilitating the anchor fixing action by the projection 3110.

[0133] The protrusion 3110 is contemplated to have a frustoconical shape or a similar shape. For example, as shown in FIGS. 3Y and 3Z, while the peripheral wall 3160 of the protrusion 3110 can be tapered as it approaches the outlet end 3150 from the base end 3140, the cross-sectional shape of the protrusion 3110 can be elliptical rather than circular. It is further contemplated that the shape of the protrusion 3110 is not limited to that shown in FIGS. 3Y and 3Z. For example, the cross-sectional shape of the protrusion 3110 can be circular, rectangular, triangular, or any combination thereof. It is contemplated that this cross-sectional shape can be open at least on one side. For example, the cross-sectional shape can be C-shaped. In a configuration where the cross-sectional shape is open at least on one side, the protrusion 3110 may not form part of the gas flow path. Instead, the protrusion 3110 can solely serve the function of anchoring the seal-forming structure 3100 to the patient's nose.

[0134] Alternatively, the peripheral wall 3160 of the protrusion 3110 may not be tapered, and the exclusive area of the protrusion 3110 is invariant from the base end 3140 to the outlet end 3150. It is also contemplated that more than one peripheral wall 3160 (depending on the cross-sectional shape of the protrusion 3110) can be provided.

[0135] As shown in FIG. 3BB, the opening 3130 may extend along the surface 3170. In addition, the protrusion 3110 may have a longitudinal axis 3175 that is perpendicular to the surface 3170 and extends through the proximal end 3140 and the outlet end 3150 of the protrusion 3110. In addition, the peripheral wall 3160 may be tapered at an angle α with respect to the longitudinal axis 3175. The taper angle α may vary in a direction perpendicular to the longitudinal axis 3175. For example, the taper angle α of the peripheral wall 3160 may be minimized at the protrusion 3110 on the central facing side 3180 (i.e., the side of the protrusion 3110 closest to the other protrusion 3110). At the same time, the taper angle α of the peripheral wall 3160 may be maximized at the side 3190 facing outward of the protrusion 3110 (i.e., the side of the protrusion 3110 farthest from the other protrusion 3110). In this configuration, the length of the peripheral wall 3160 from the proximal end 3140 to the outlet end 3150 may be maximized at the central facing side 3180 and minimized at the side 3190 facing outward.

[0136] By changing the taper angle α, the protrusion 3110 and the opening 3130 can be angled relative to the portion of the cradle base 3120 where the extension of the protrusion 3110 begins. The portion of the cradle base 3120 where the extension of the protrusion 3110 begins can be angled relative to the opening in the patient's nasal cavity. Thus, by angling the protrusion 3110 and the opening 3130 relative to the cradle base 3120, the protrusion 3110 can be aligned with the patient's nasal cavity so that the entire outlet end 3150 is received within the patient's nasal cavity.

[0137] Alternatively, the taper angle α may be invariant in a direction perpendicular to the longitudinal axis 3175. In this configuration, the length of the peripheral wall 2160 from the proximal end 3140 to the outlet end 3150 may be the same at the central facing side 3180 and the side 3190 facing outward.

[0138] Since the opening 3130 may have an elliptical shape, it is contemplated that it can be easily adapted to the shape of the patient's nostril. However, it should be understood that the opening 3130 can be any other shape (e.g., circular shape).

[0139] The protrusion 3110 can improve the seal stability. For example, during use, the protrusion 3110 can be arranged in contact with the outer periphery of the patient's nostril and function to position the cradle base 3120 (and thus the patient interface 3000 at the intended position on the patient's face) and to maintain the patient interface 3000 at that position during use. In other words, the protrusion 3110 can be configured to avoid a situation where the patient interface 3000 moves laterally across the patient's face during use.

[0140] To perform the function of anchoring the cradle base 3120 to the patient's nasal cavity, each protrusion 3110 only needs to engage the rim of the opening with the patient's nasal airway. Thus, the protrusion 3110 only needs to be of sufficient length to engage the rim of the opening with the patient's nasal airway or its adjacent part. In other words, the protrusion 3110 can be designed not to penetrate as deeply into the patient's nasal passage as a conventional nasal prong or even a conventional nasal pillow.

[0141] It may be preferable that the protrusion 3110 does not extend beyond (or far beyond) the rim of the opening of the patient's nasal airway, which leads to an increase in the area of the opening 3140 at the end of the protrusion 3110. Specifically, the patient's nasal airway becomes smaller as it extends into the patient's nose. Therefore, in the case of a conventional nasal prong, in order to fit into the patient's nasal airway, it is necessary to reduce the diameter towards the distal end, thereby reducing the size of the opening at the distal end of the nasal prong. By restricting the range in which the protrusion 3110 extends into the patient's nasal airway, the opening 3140 at the end of the protrusion 3110 can be made larger than in the normal case of a conventional nasal prong. The increase in the size of the opening 3140 can reduce the flow restriction, minimize the jetting, and improve the breathing comfort.

[0142] Alternatively, the projection 3110 may be designed to enter deep into the patient's nasal passage (i.e., beyond the adjacent portion of the rim of the opening to the patient's nasal airway), similar to a conventional nasal prong or nasal pillow.

[0143] The cradle base 3120 and the projection 3110 may be formed from the same material and, in certain configurations, are contemplated to be formed as a one-piece (e.g., integrally molded). It is further contemplated that the projection 3110 and the cradle base 3120 may be made of a flexible material (e.g., silicone).

[0144] The cradle base 3120 may include a central portion 3240 between a pair of side portions 3250. Since each projection 3110 may be disposed on each side portion 3250, the projections 3110 are provided on opposite side portions of the central portion 3240. Additionally, a sealing surface 3260 that may be included in the cradle base 3120 extends into the space between the projections 3110 and surrounds the proximal end portions 3140 of the projections 3110. Thus, a portion of the sealing surface 3260 of the cradle base 3120 may extend beyond the exclusive area of the projections 3110 and may form a rim 3270 around the projections 3110. The size and orientation of the sealing surface 3260 may be such that, when the patient interface 3000 is worn, the sealing surface 3260 (and the rim 3270) can engage the patient's skin and form a seal against the lateral and / or lower portions of the patient's nasal wings.

[0145] Thus, the patient interface 3000 may form a first seal and a second seal against the patient's nose (e.g., a first seal between the inner wall of the patient's nostril and the projection 3110 and a second seal between the sealing surface 3260 (and the rim 3270) and the outside of the patient's nose). Thereby, the quality of the overall seal between the patient interface 3000 and the patient's face (or nose) may be improved, and the seal-forming structure during use may also be stabilized, thereby reducing the risk of compromise of the overall seal during use.

[0146] The cradle base 3120 can be flexible and can generally have a cradle-like, cup-like, U-shaped or V-shaped form that cradles the patient's nose during use. Due to the flexibility of the cradle base 3120, the side portions 3250 can flex relative to the central portion 3240, whereby the side portions 3250 (and the protrusions 3110) can be movable relative to each other in the proximal and distal directions.

[0147] As can be seen from FIG. 3CC, the side portions 3250 can be oriented at an angle β relative to a plane 3280 that bisects the patient interface 3000 between the protrusions 3110. At rest (or when not engaged with the patient's nose), the side portions 3250 can be oriented at a pre-set (or rest) angle β. However, when the patient wears the patient interface 3000, the side portions 3250 can flex outwards (along with the protrusions 3110) due to the patient's nose, causing the angle β to increase. Since the cradle base 3120 can have elastic properties, the side portions 3250 can be biased towards the pre-set angle β. Due to this biasing force, the side portions 3250 can be pressed (or urged) against the patient's nose, thereby maintaining a seal against the patient's nose and stabilizing the patient interface 3000 on the patient's face.

[0148] It is contemplated that the cradle base 3120 can be hollow. Since the material of the cradle base 3120 can be expandable and / or flexible, it is further contemplated that when pressurized breathing gas is supplied into the interior of the cradle base 3120, the cradle base 3120 can expand (i.e., the chambers within the cradle base 3120 expand). When the cradle base 3120 expands, the sealing surface 3260 can be pressed against the patient's nose, thereby maintaining a seal against the patient's nose and assisting in stabilizing the patient interface 3000 on the patient's face.

[0149] Since the different cradle bases 3120 can be sized differently, it is contemplated that the different sized cradle bases 3120 can have different rest angles β. By utilizing the different sized cradle bases 3120 and different rest angles β, it may be possible to improve the design flexibility for accommodating patients with different sized and / or shaped noses and / or faces. For example, a cradle base 3120 having a larger rest angle β may be more suitable for patients with larger, wider and / or lower noses.

[0150] As shown in FIGS. 3AA and 3DD, the seal forming structure 3100 may optionally include a foam layer 3285 on the sealing surface 3260. The foam layer 3285 can extend across the entire sealing surface 3260 and can include openings 3286 for the protrusions 3110. The foam layer 3285 can improve the comfort of the seal forming structure 3100 and can be made of an open cell foam or a closed cell foam. It is contemplated that the seal forming structure 3100 can include the foam layer 3285 without the lower sealing surface 3260. It is further contemplated that a layer made of a textile material may be used instead of the foam layer 3285. Alternatively, the foam layer may be encapsulated within a textile material skin. These materials are each known to improve tactile comfort as compared to elastomeric silicone.

[0151] The foam layer 3285 can be configured to support a seal between the patient interface 3000 and the patient's face. For example, the foam layer 3285 can be adapted to apply a compression seal against the user's face. The compression seal provided by the foam layer 3285 can cooperate with the lower sealing surface 3260 to provide seal improvement. When the seal forming structure 3100 is pressurized from within, the lower sealing surface 3260 can bias the foam layer against the user's face. This sealing mechanism can function by a combination of compression of the foam material provided within the foam layer 3285 and can be further supported by internal pressurization of the seal forming structure 3100. The foam layer 3285 can also improve patient comfort.

[0152] The foam layer 3285 may be permanently attached to the cradle base 3120 or may be removable from the cradle base 3120. It is contemplated that the foam layer 3285 can be fixed to the cradle base 3120 by clips, snaps, adhesives, hook and loop arrangements or bonding. Also, the foam layer 3285 may optionally take the form of a sleeve and surround the entire cradle base 3120 together with the protrusion 3110 extending through the opening 3286. The foam layer 3285 may optionally have one or more flaps 3287. While a part of the fixing mechanism (e.g., hook, loop, clip) may be disposed on the flap 3287, the other part of the fixing mechanism (e.g., hook, loop, clip) may be provided at a corresponding position on the cradle base 3120.

[0153] In FIG. 3DD, four flaps 3287 are shown, but any number of flaps 3287 (e.g., 1, 2, 3, 4) may be used depending on what is necessary to fix the foam layer 3285 above the cradle base 3120. Additionally, the position of the flaps 3287 is not limited to that shown in FIG. 3DD. The flaps 3287 may be arranged in any manner along the perimeter of the foam layer 3285.

[0154] It is further contemplated that the foam layer 3285 can be held in place by the protrusion 3110. Specifically, since the diameter (or exclusive area) of the opening 3286 may be slightly smaller than the exclusive area of the base end portion 3140 of the protrusion 3110, the opening 3286 can be stretched by the protrusion 3110 when attached to the cradle base 3120 and can be held in place by the friction between the protrusion 3110 and the rim of the opening 3286.

[0155] The cradle base 3120 is contemplated to generally be U-shaped when viewed from the front side during use. The curvature of the cradle base 3120 in the front-to-back direction (i.e., the sagittal plane) can be positive, negative, or zero. When the curvature of the cradle base 3120 in the lateral direction is positive, the protrusions 3110 can be provided for each nostril, and a portion of the cradle base 3120 between the protrusions 3110 can be further disposed in the forward direction, thereby avoiding contact with the patient's nasal column.

[0156] The configuration of the cradle base 3120 is such that when there is no force acting on the cradle base 3120, the cradle base 3120 can have a certain amount of positive curvature in the lateral direction, so that during wearing by the patient, the positive curvature of the cradle base 3120 can be reduced due to the engagement between the cradle base 3120 and the nose. That is, the "natural" or "resting" curvature of the cradle base 3120 can be greater than the curvature of the cradle base 3120 during wearing. In an example where the cradle base 3120 is formed from an elastic material or is configured to elastically return to its original shape when not in use, the lateral portion 3250 of the cradle base 3120 can be forced inward against the patient's nose during wearing of the patient interface 3000. This can assist in forming a seal against the nose and stabilizing the patient interface 3000 in the desired position.

[0157] It is understood that different patient interfaces 3000 can include different amounts of positive curvature of the cradle base 3120 in the "resting" state to accommodate patients with different sizes and / or shapes of noses and / or faces.

[0158] The plenum base 3105 may support the cradle base 3120 and the protrusion 3110. Additionally, a composite plenum chamber for receiving a pressurized respiratory gas flow may be formed by both the plenum base 3105 and the cradle base 3120. A portion of the plenum base 3105 may have a surface shaped complementary to the contour of an average person's face in use. In some forms, the plenum base 3105 and the seal-forming structure 3100 may be formed from a single homogenous piece of material (e.g., silicone).

[0159] In certain forms of the technology, the plenum base 3105 may be constructed of a transparent material (e.g., a transparent polycarbonate or silicone material). Alternatively, the plenum base 3105 may be constructed of a translucent material.

[0160] In certain forms of the technology, the plenum base 3105 may be formed of the same material as the seal-forming structure 3100 and may be integrally formed.

[0161] One or more positioning and stabilization structure connectors (or headgear connectors) 3290 may be provided on the plenum base 3105. The positioning and stabilization structure connector 3290 is configured to connect to the positioning and stabilization structure 3300 in use. The positioning and stabilization connector 3290 may be disposed on opposing lateral sides of the plenum base 3105. It is contemplated that the positioning and stabilization structure connector 3290 may include a clip, buckle, or any other connector capable of or connected to the positioning and stabilization structure 3300 (e.g., a headgear strap and headgear conduit).

[0162] The positioning and stabilization structure connector 3290 can take the form of an inlet tube 3310 protruding from the side of the plenum base 3105 or can include an inlet tube 3310 protruding from the lateral side of the plenum base 3105. The inlet tube 3310 can be configured to receive pressurized breathing gas from one or more air delivery tubes and / or one or more conduits within the positioning and stabilization structure (or headgear) 3300. If a headgear conduit is included in the positioning and stabilization structure (or headgear) 3300, it is contemplated that the inlet tube 3310 can be connected to the air delivery conduit while simultaneously connecting the plenum base 3105 (and patient interface 3000) to the positioning and stabilization structure (or headgear) 3300.

[0163] A damper or buffer 3106 can be interposed between the cradle base 3120 and the plenum base 3105. The damper or buffer 3106 can decouple the movement of the cradle base 3120 (and the movement of the protrusion 3110) from the plenum base 3105. The damper or buffer 3106 can completely surround the cradle base 3120 or can only partially surround the cradle base 3120. It is contemplated that the lateral portion 3250 of the cradle base 3120 can extend beyond the damper or buffer 3106. Additionally, the damper or buffer 3106 can take the form of a channel (FIG. 3Z), a concertina (FIG. 3AA), a bellows, a spring, or other structure between the cradle base 3120 and the plenum base 3105 that is capable of decoupling the movement of the cradle base 3120 from the plenum base 3105.

[0164] The buffer or damper 3106 can absorb a side load acting on the cradle base 3120 (before the side load is transmitted to the plenum base 3105). It is contemplated that the buffer or damper 3106 may enable the lateral portion 3250 of the cradle base 3120 to flex or move (independently of the plenum base 3105). It is further contemplated that due to internal pressurization within the plenum chamber formed by the cradle base 3120 and the plenum base 3105, the plenum base 3105 may expand together with the buffer or damper 3106. The expansion of the plenum base 3105 and the channel 3320 may bias the protrusion 3110 and the sealing surface 3260 against the patient's nose, thereby further supporting the seal formed by the protrusion 3110 and the sealing surface 3260.

[0165] In addition, since the lateral portion 3250 of the cradle base 3120 can project in a direction away from the plenum base 3105 and the buffer or damper 3106, only the central portion 3240 is directly attached to the plenum base 3105. It is contemplated that the portion of the lateral portion 3250 closest to the central portion 3240 may be directly attached to the plenum base 3105. Thus, at least a portion of the lateral portion 3250 may be separated from the plenum base 3105 and the buffer or damper 3106, whereby the surface 3330 on the opposite side of the sealing surface 3260 of the lateral portion 3250 may face the surface of the buffer or damper 3106 and / or the plenum base 3105. The flexibility of the buffer or damper 3106 may enable the surface 3330 to move in proximal and distal directions relative to the surface of the plenum base 3105. Such flexible movement may assist in maintaining the seal against the patient's nose during use.

[0166] The buffer or damper 3106 can be an independent component. Alternatively, the buffer or damper 3106 can form part of the cradle base 3120 and / or part of the plenum base 3105 of the seal-forming structure 3100. As a concertina or bellows structure, the buffer or damper 3106 can form one or more folds. For example, one or more folds 3340 can be provided in a part of the cradle base 3120 that connects to and / or is adjacent to the plenum base 3105. Additionally (or alternatively), one or more folds 3340 can be provided in a part of the plenum base 3105 that connects to and / or is adjacent to the cradle base 3120. As a channel structure, the buffer or damper 3106 can form a recess within the surface of the plenum base 3105.

[0167] As shown in FIGS. 3Y to 3CC, the cradle base 3120 can connect to the plenum base 3015 along a generally elliptical or elongated region (extending in a range smaller than the outer range of the cradle base 3120). Additionally, the buffer or damper 3106 can project inwardly towards the interior of a portion of the plenum chamber formed by the plenum base 3105. In other forms, the buffer or damper 3106 can project outwardly in a separating direction from a portion of the plenum chamber formed by the plenum base 3105. If the buffer or damper 3106 includes a concertina or bellows structure, a part of the buffer or damper 3106 can project inwardly and another part can project outwardly.

[0168] The buffer or damper 3106 may function to at least partially decouple the movement of the cradle base 3120 from the plenum base 3105 during use. Additionally or alternatively, the buffer or damper 3106 may enable the seal-forming structure 3100 to conform to the facial structures of different patients. Additionally or alternatively, since the buffer or damper 3106 may function like a spring, when the patient wears the patient interface 3000 and the cradle base 3120 is pressed against the plenum base 3105, the buffer or damper 3106 may bias the cradle base 3120 towards the patient's face, thereby assisting in maintaining the sealing engagement between the seal-forming structure 3100 and the patient's face. Additionally or alternatively, the buffer or damper 3106 may be configured to expand or partially expand when pressurized air enters the plenum base 3105 and / or the seal-forming structure 3100. Such expansion may assist in biasing the cradle base 3120 towards the patient's face, thereby assisting in maintaining the sealing engagement between the seal-forming structure 3100 and the patient's face.

[0169] The plenum base 3105 may include a vent portion that includes one or more openings. Additionally, the patient interface 3000 may not include an oral seal or cushion (e.g., a cushion configured to seal around the patient's mouth). Also, the buffer or damper 3106 may not be configured to decouple movement between two sealing surfaces. The buffer or damper 3106 may not be configured to decouple movement between an oral seal and a nasal seal.

[0170] 5.3.1.3 Nasal Pillow Figures 3EE and 3BB show another patient interface 3000 including a seal formation structure 3100 according to an example of the present technology. In these examples, the seal formation structure of the non-invasive patient interface 3000 includes a pair of nasal pillows 7100. These nasal pillows 7100 can be or can be called nasal pillows. Each nasal pillow or nasal pillow 7100 is constructed and arranged to form a seal with each nostril of the patient's nose.

[0171] The nasal pillow 7100 according to a form of the present technology includes protrusions 7120. These protrusions 7120 are structured and arranged to be inserted into or partially enter each of the patient's nostrils during use. The opening 7140 formed inside each nasal pillow 7100 is configured such that a continuous airflow passes through the inside, whereby the airflow moves into the patient's nostrils when the patient interface 3000 is worn.

[0172] In a particular form of the present technology, each of the protrusions 7120 is configured to partially extend into each of the patient's nostrils. For example, each protrusion 7120 can be structured and arranged to seal the inner peripheral edge of each nostril during use. Therefore, the height of each protrusion 7120 is lower than that of the protrusions 7120 on a conventional nasal pillow patient interface. The edge of each protrusion 7120 forming the opening 7140 is configured to seal the inner peripheral edge of each nostril.

[0173] Each protrusion 7120 can be formed in a frustum of a cone shape.

[0174] During use, the protrusions 7120 can be arranged in contact with the outer periphery of the patient's nostrils and function to position the patient interface 3000 at the intended position on the patient's face and to maintain the patient interface 3000 at that position during use.

[0175] The protrusions 7120 can be formed such that the openings 7140 are angled so as to conform to the angle of the patient's nostrils. That is, the openings 7140 formed by the angles of the edges of each protrusion 7120 have an orientation that is aligned or substantially aligned with the surface formed by the inner peripheral edge of each nostril.

[0176] 5.3.1.3.1 Seal-forming structure with a base In the exemplary patient interface 3000 shown in FIGS. 3EE and 3FF, the nasal pillow 7100 includes a base 7160 provided with protrusions 7120. The protrusions extend rearward from the base 7160. The base 7160 and the protrusions 7120 can be formed from the same material and, in certain configurations, are formed as a one-piece, for example, integrally molded.

[0177] As shown in FIGS. 3EE and 3FF, in some forms of the technology, the lateral extensions 7180 included in the base 7160 extend outward from the base of the protrusions 7120 at the lateral sides of each protrusion 7120. The size and orientation of the lateral extensions 7180 are such that each lateral extension seals the lateral or lower portion of one of the patient's nasal wings when the patient interface 3000 is worn. This improves the quality of the seal, stabilizes the seal-forming structure during use, and reduces the risk of compromise to the seal during use.

[0178] The base 7160 is formed to generally have a positive curvature in the lateral direction. For example, the base 7160 can generally be U-shaped when viewed from the front side during use. The curvature of the base in the front-to-back direction (i.e., the sagittal plane) can be positive, negative, or zero. When the base 7160 has a positive curvature in the lateral direction, protrusions 7120 are provided for each nostril, and the base 7160 between the protrusions 7120 is further positioned in the forward direction to avoid contact with the patient's nasal septum.

[0179] The base 7160 is configured such that, when there is no force acting on the base 7160, the base 7160 has a certain amount of positive curvature in the lateral direction, so that when worn by the patient, the positive curvature of the base 7160 is reduced by the engagement of the base and the nose. That is, the "natural" or "resting" curvature of the base 7160 is greater than the curvature of the base 7160 during wear. In an example where the base 7160 is formed from an elastic material or is configured to elastically return to its original shape when not in use, the lateral portions of the base are forced to move inwardly relative to the patient's nose when the patient interface is worn. This aids in the generation of a seal against the nose and the stabilization of the patient interface at the desired position.

[0180] Since different patient interfaces can include bases with different amounts of positive curvature in the "resting" state, it is understood that they can accommodate patients with different sizes and / or shapes of noses and / or faces. For example, the base 7160 shown in FIG. 3EE has a lower positive curvature than the base 7160 shown in FIG. 3FF and is thus more suitable for patients with larger, wider and / or flatter noses.

[0181] 5.3.1.3.2 Prenum Chamber The prenum chamber 3200 has a perimeter that is complementary to the surface profile of an average person's face in the region where the seal is formed during use. During use, the peripheral edge of the prenum chamber 3200 is positioned close to the adjacent surface of the face. The actual contact with the face is provided by the seal formation structure 3100. The seal formation structure 3100 can extend around the entire perimeter of the prenum chamber 3200 during use. In some forms, the prenum chamber 3200 and the seal formation structure 3100 are formed from a single homogeneous piece of material.

[0182] In certain forms of the technology, the plenum chamber 3200 is constructed from a transparent material (e.g., clear polycarbonate). Use of the transparent material can reduce the constrictiveness of the patient interface and can assist in improving compliance with therapy. Use of the transparent material can assist a clinician in viewing the placement and function of the patient interface.

[0183] In certain forms of the technology, the plenum chamber 3200 is constructed from a translucent material. Use of the translucent material can reduce the constrictiveness of the patient interface and can assist in improving compliance with therapy.

[0184] In certain forms of the technology, the plenum chamber 3200 is formed from the same material as the seal-forming structure 3100. In the forms of the technology shown in FIGS. 3EE and 3FF, the plenum chamber 3200 and the seal-forming structure 3100 are integrally formed.

[0185] One or more positioning and stabilization structure connectors 7500 can be provided on the plenum chamber 3200. The positioning and stabilization structure connectors 7500 are configured to connect to the positioning and stabilization structure 3300 during use. In one form, the positioning and stabilization structure connectors 7500 can include clips, buckles, or any other connector (e.g., a headgear strap) capable of connecting to or being connected by the positioning and stabilization structure 3300.

[0186] In the configurations of the technology shown in FIGS. 3EE and 3FF, the positioning and stabilization structure connector 7500 includes a tube 7520 that protrudes laterally, outwardly, and rearwardly from the lateral side of the plenum chamber 3200. In the positioning and stabilization structure 3300, in the configuration where one or more gas delivery tubes for delivering an air flow to the plenum chamber (i.e., the "duct headgear") are included, the gas delivery tubes of the positioning and stabilization structure 3300 are fluidly connected to the tube 7520 that protrudes outwardly from the plenum chamber 3200. The tube 7520 is fluidly connected to the plenum chamber 3200 so as to deliver the gas flow from the gas delivery tubes of the positioning and stabilization structure 3300 to the plenum chamber 3200.

[0187] 5.3.1.3.3 Crease for Release of Bonding in Seal Forming Structure / Plenum Chamber In a particular configuration of the present technology, one or more creases 7220 are formed by a part of the base 7160 of the seal forming structure 3100 and / or a part of the plenum chamber 3200. For example, one or more creases 7220 may be provided in a part of the base 7160 that connects to and / or is adjacent to the plenum chamber 3200. Alternatively, one or more creases 7220 may be provided in a part of the plenum chamber 3200 that connects to and / or is adjacent to the base 7160. Alternatively, one or more creases 7220 may form a part of a portion connected between the base 7160 and the plenum chamber 3200.

[0188] In the configurations of the technology shown in FIGS. 3EE and 3FF, the patient interface 3000 includes a single crease 7220 between the base 7160 and the plenum chamber 3200. The base 7160 connects to the plenum chamber 3200 along a generally elliptical or elongated region (smaller than the outer extent of the base 7160). That is, the crease 7220 is an inner crease. In other configurations, one or more creases may include outer creases. In other configurations, one or more creases may include at least one inner and at least one outer crease (e.g., in a concertina or bellows configuration).

[0189] In the form of the technology shown in FIGS. 3EE and 3FF, the fold line 7220 extends around the entire periphery of the base 7160. In other forms, one or more fold lines 7220 may extend only around a portion of the periphery of the base 7160. That is, the periphery of the base 7160 may include one or more portions having one or more fold lines 7220 and one or more portions without fold lines.

[0190] One or more fold lines 7220 may function to at least partially decouple the movement of the base 7160 from the plenum chamber 3200 during use. Additionally or alternatively, one or more fold lines 7220 may enable the seal forming structure 7100 to conform to different patient face structures. Additionally or alternatively, since one or more fold lines 7220 may function like a spring, when a patient wears the patient interface 3000 and presses the base 7160 against the plenum chamber 3200, the one or more fold lines 7220 tend to bias the base 7160 against the patient's face, assisting in maintaining the sealing engagement of the seal forming structure 3100 with the patient's face. Additionally or alternatively, one or more fold lines 7220 may be configured to expand or partially expand (when pressurized air enters the plenum chamber 3200 and / or the seal forming structure 3100). Such expansion may assist in biasing the base 7160 against the patient's face and assist in maintaining the sealing engagement of the seal forming structure 3100 with the patient's face.

[0191] 5.3.2 Positioning and Stabilization Structure The seal forming structure 3100 of the patient interface 3000 of the present technology may be held in a sealed position by a positioning and stabilization structure 3300 during use.

[0192] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face.

[0193] In one form, the positioning and stabilization structure 3300 provides a holding force sufficient to overcome the gravitational force on the patient interface 3000.

[0194] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to eliminate the possibility of destructive effects (e.g., due to tubing drag or accidental interference with the patient interface) on the patient interface 3000.

[0195] In one form of the present technology, the positioning and stabilization structure 3300 is configured such that the patient is positioned while being worn during sleep. In one example, the positioning and stabilization structure 3300 has a non - obtrusive profile or cross - sectional thickness so as to reduce the perceived or actual bulk of the device. In one example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross - section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0196] In one form of the present technology, there is provided a positioning and stabilization structure 3300 configured such that when the patient lies in the supine sleep position with the back of the patient's head resting on a pillow, it does not have an overly large or bulky size that would interfere.

[0197] In one form of the present technology, there is provided a positioning and stabilization structure 3300 configured such that when the patient lies in the lateral sleep position with the side of the patient's head resting on a pillow, it does not have an overly large or bulky size that would interfere.

[0198] In one form of the present technology, the positioning and stabilization structure 3300 includes a decoupling portion disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. This decoupling portion is not resistant to compression and can be, for example, a flexible or slippery strap. The decoupling portion is constructed and arranged so that when the patient lies with their head on the pillow, the presence of the decoupling portion can avoid a situation where the force on the rear portion is transmitted along the positioning and stabilization structure 3300 and the seal is obstructed.

[0199] 5.3.2.1 Headgear Strap(s) In one form of the present technology, the positioning and stabilization structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous such that moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0200] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is stretchable (e.g., stretchable with elasticity). For example, the strap can be configured to be taut during use and direct a force to seal a seal-forming structure against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0201] In one form of the present technology, the positioning and stabilization structure includes a first tie, and the first tie is constructed and arranged such that at least a portion of its lower edge moves upward and passes over the upper ear base point of the patient's head during use and covers a portion of the parietal bone without covering the occipital bone.

[0202] In a particular form of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and, for example, non-rigid. An advantage of this aspect is that the strap is more comfortable when the patient lies on their side during sleep.

[0203] In certain forms of the technology, the positioning and stabilization structure 3300 includes straps constructed to be breathable such that water vapor can pass through them internally.

[0204] In certain forms of the technology, a system is provided that includes more than one positioning and stabilization structure 3300. Each positioning and stabilization structure 3300 is configured to provide a holding force for accommodating different sizes and / or ranges of shapes. For example, the system may include a form of the positioning and stabilization structure 3300 suitable for a large-sized head rather than a small-sized head and another form suitable for a small-sized head rather than a large-sized head.

[0205] 5.3.2.2 Gas Delivery Tube(s) In some forms of the technology, one or more conduits in the form of gas delivery tubes provided in the positioning and stabilization structure 3300 deliver pressurized air received from the air circuit 4170 to the patient's airway from the RPT device (e.g., through the plenum chamber 3200 and the seal-forming structure 3100). In these forms, the positioning and stabilization structure 3300 may be referred to as a conduit headgear and, in addition to delivering pressurized air to the airway, has the function of positioning and stabilizing the seal-forming structure 3100 of the patient interface against an appropriate portion of the patient's face. As used herein, unless specified otherwise in the context, the terms "tube" and "conduit" should be understood to be synonymous. In these forms, the conduit headgear contacts at least the region of the patient's head above the upper ear base point of the patient's head. As shown in Figure 2D, the upper ear base point is a point on the side of the patient's head that leads to the top of the ear.

[0206] In one example, the tube can be substantially cylindrical. However, in other examples, the tube can be formed with a variety of cross-sectional shapes. For example, a substantially D-shaped cross-sectional profile can be used, in which case the flat side of this profile can contact the patient's face during wear and may be more comfortable than a semi-circular profile.

[0207] In some forms of the present technology, a pair of tubes included in the conduit headgear deliver pressurized air from the downstream end of the air circuit to the seal-forming structure. As an example, these tubes can be joined to a crown connector at the upper end. This crown connector supports a connection port to be in fluid engagement with the downstream end of the air circuit and forms an integral part of the positioning and stabilization structure of the patient interface. These tubes can be separated, for example, for cleaning or storage.

[0208] In some forms of the present technology, the conduit headgear includes a left tube and a right tube. These left and right tubes are in fluid engagement with or otherwise connected to the patient interface 3000 at the lower end for delivery of pressurized air to the seal-forming structure. A connection port for engagement with the downstream end of the air circuit 4170 is provided at the upper part of the conduit headgear where the two arms of the tube meet. In this example, the conduit headgear is a substantially integral structure.

[0209] In a particular example, the connection port is disposed mainly at the top of the patient's head when the conduit headgear is worn. However, it should be understood that the connection port can be provided at different positions according to the shape of the conduit headgear. For example, instead of meeting across the top of the patient's head, these tubes can be arranged to meet further back on the patient's head. Thereby, the connection port is provided in the vicinity of a part at the back (not the top) of the patient's head. Alternatively, the connection port can be provided at another location (for example, one of the two tubes) where the tubes do not meet.

[0210] In certain examples of the present technology, the conduit headgear is formed of a suitable spring material that provides sufficient stabilizing force to accurately position the patient interface in a sealing arrangement on the patient's head. In other specific examples, the positioning and stabilizing structure includes a mechanism for connecting a headgear strap or other stabilizing component to the headgear tube. The headgear strap can reinforce the stabilizing force provided by the conduit headgear and assist in accurately positioning the patient interface in a sealing arrangement on the patient's head.

[0211] In these examples, the headgear strap can be connected directly or indirectly to the headgear tube. In the case of one form of patient interface, tabs configured to connect to a backstrap generally project in a direction away from the tube in the rearward direction. These tabs have slits internally that receive the strap ends.

[0212] The backstrap can be secured to itself (e.g., by hook and loop fastening material) after passing through the slit in the tab. Thus, it becomes possible to adjust the backstrap to fit around heads of different sizes. In some forms of the present technology, by providing more than one tab on the tube, a range of alternative arrangements of the backstrap can be provided to the patient. Doing so can be useful in ensuring the addition of sealing force to the face.

[0213] In some examples, the tube of the conduit headgear can be formed from a textile, spacer fabric, and / or foam material. The portion of the tube that contacts the patient can be formed with a textile or fabric for improved patient comfort. In some examples, the tube can be formed of a semi-rigid material (e.g., an elastomeric material such as silicone). In these examples, these tubes can include a thin sleeve coated by a fabric or textile. These sleeves can be more comfortable against the patient's face than tubes that are not coated at all.

[0214] In some examples, the tubes of the conduit headgear can have a natural preformed shape that conforms to the general shape of the patient's head. In some examples, these tubes can be deformable when a force is applied to the tubes or can have at least some ability to conform to the patient's head. For example, these tubes can generally take on an arcuate or curvilinear shape that resembles the outer contour of the patient's head between the upper head and the nose or mouth region.

[0215] Since it is possible to contain air and send it through the tubes of the conduit headgear for delivery of pressurized air from the air circuit 4170 to the patient's airway, the conduit headgear can be described as being inflatable. In the case of an inflatable conduit headgear, it is understood that it is not necessary to make all components of the conduit headgear inflatable. For example, if the headgear tubes and backstraps are included in the positioning and stabilizing structure, the headgear tubes are inflatable and the backstraps are non-inflatable.

[0216] 5.3.3 Ventilation section In one form, the patient interface 3000 includes a ventilation section 3400 that is constructed and arranged to allow the expulsion of exhaled gas (e.g., carbon dioxide).

[0217] In certain forms, the ventilation section 3400 is configured to allow a continuous ventilation flow from the interior of the plenum chamber 3200 to the ambient when the pressure in the plenum chamber is positive relative to the ambient. The ventilation section 3400 is configured such that, while maintaining the therapeutic pressure in the plenum chamber during use, the magnitude of the ventilation flow rate is large enough to reduce the rebreathing of exhaled CO2 by the patient.

[0218] One form of the ventilation section 3400 according to the present technology includes a plurality of holes (e.g., about 20 to about 80 holes or about 40 to about 60 holes or about 45 to about 55 holes).

[0219] The ventilation part 3400 can be arranged inside the plenum chamber 3200. Alternatively, the ventilation part 3400 is arranged inside a disconnection structure (e.g., a swivel).

[0220] The ventilation part 3400 provided in the plenum chamber 3200 may include a plurality of openings 3402. The openings 3402 may be arranged in two groups that are symmetric with respect to the center line of the plenum chamber 3200. The plurality of openings 3402 can reduce noise and diffuse the concentration of the ventilation flow.

[0221] The openings 3402 may be arranged close enough to the center line of the plenum chamber 3200 so that the openings 3402 are not blocked when the patient lies down and sleeps. To avoid weakening of the chassis in the relatively narrow part, the openings 3402 may be spaced apart from the center line.

[0222] The openings 3402 may have a circular profile.

[0223] In the example of the patient interface shown in FIGS. 3EE and 3FF, the ventilation part 3400 can be provided in front of the plenum chamber 3200. For example, the plenum chamber 3200 may include an opening 7300 on the front side (configured to receive the ventilation part 3400 during use). The ventilation part 3400 can be provided as a ventilation module and can be removed and reinserted into the opening 7300 (e.g., when cleaning and / or replacing the ventilation part 3400).

[0224] 5.3.4 Disconnection structure(s) In one form, the patient interface 3000 includes at least one decoupling structure 3500 (e.g., a swivel or ball and socket). The decoupling structure 3500 can take the form of an elbow. The decoupling structure 3500 can include a swivel connected to the air circuit 4170 and a patient interface connector connected to the patient interface 3000. The patient interface connector can enable the tube of the decoupling structure 3500 to rotate relative to the patient interface 3000. The decoupling structure 3500 can also include a vent 3400. The vent 3400 of the decoupling structure 3500 can include at least one opening through a portion of the patient interface connector and / or through a portion of the tube.

[0225] In one form of the present technology, the decoupling structure can be connected to the opening 7300 in front of the plenum chamber 3200 during use.

[0226] In another form of the present technology, the decoupling structure can be connected to the connection port 3600 during use. The connection port 3600 is included in or provided in one or more gas delivery tubes provided as part of the positioning and stabilization structure 3300 and is disposed adjacent to a region of the patient's head above the upper ear point of the patient's head during use.

[0227] 5.3.5 Connection Port The connection port 3600 enables connection to the air circuit 4170.

[0228] In a particular form of the present technology, the connection port 3600 can be the opening 7300 on the front side of the plenum chamber 3200. The connection port 3600 can be configured to connect to the air circuit 4170 and / or the decoupling structure 3500 (e.g., an elbow provided in the air circuit 4170).

[0229] In an alternative form of the present technology that employs the patient interface 3000 shown, for example, in FIGS. 3EE and 3FF, the patient interface includes or is provided with connection ports included in or provided on one or more gas delivery tubes provided as part of the positioning and stabilization structure 3300. In such an example, the connection ports can be arranged adjacent to a region of the patient's head above the upper ear base point of the patient's head during use. In such an example, the airflow is delivered to the seal forming structure 3100 via the connection ports and gas delivery tubes included as part of the positioning and stabilization structure 3300.

[0230] 5.3.6 Ports In one form of the present technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables direct measurement of the characteristics (e.g., pressure) of the gas within the plenum chamber 3200.

[0231] 5.4 RPT Device The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway, for example, for the treatment of one or more of the respiratory diseases described in any one of the items in this document.

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

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

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

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

[0236] The RPT device 4000 can have a power supply 4210, one or more input devices 4220, a central controller, a therapy device controller, a pressure generator 4140, one or more protection circuits, a memory, a transducer 4270, a data communication interface, and one or more output devices. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0237] 5.4.1 RPT Device Mechanical and Pneumatic Components The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be arranged as separate individual units.

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

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

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

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

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

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

[0244] 5.4.1.3 Pressure generator In one form of the technology, the pressure generator 4140 that generates an air flow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers housed within a volute. The blower can deliver an air supply at a speed of, for example, up to about 120 liters per minute, at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are hereby incorporated by reference in their entirety: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479, and PCT Patent Application Publication WO2013 / 020167.

[0245] The pressure generator 4140 is under the control of a therapy device controller.

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

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

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

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

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

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

[0252] In one aspect, a signal indicating the flow rate from the flow sensor is received by the central controller.

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

[0254] In one aspect, a signal from the pressure sensor may be received by the central controller.

[0255] 5.4.1.4.3 Motor Speed Transducer In one aspect of the technology, a motor speed transducer may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer may be provided to the therapy device controller. The motor speed transducer may be, for example, a speed sensor (e.g., a Hall effect sensor).

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

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

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

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

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

[0261] 5.4.2.3 Central Controller In one form of the present technology, the central controller is one or more processors suitable for controlling the RPT device 4000.

[0262] Suitable processors can include x86 INTEL processors, which are processors based on the ARM (trademark) Cortex (trademark)-M processors from ARM Holdings (e.g., the S (trademark) 32 series of microcontrollers from STMicroelectronics). In certain alternative forms of the present technology, 32-bit RISC CPUs (e.g., the STR9 series of microcontrollers from STMicroelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of microcontrollers manufactured by Texas Instruments) may also be suitable.

[0263] In one form of the present technology, the central controller is a dedicated electronic circuit.

[0264] In one form, the central controller is an application-specific integrated circuit. In another form, the central controller includes individual electronic components.

[0265] The central controller can be configured to receive input signal(s) from one or more transducers 4270, one or more input devices 4220, and the humidifier 5000.

[0266] The central controller can be configured to provide output signal(s) to one or more of an output device, a therapy device controller, a data communication interface, and the humidifier 5000.

[0267] In some forms of the present technology, the central controller is configured to implement one or more of the methods described herein (e.g., one or more algorithms expressed as a computer program recorded in a non-transitory computer-readable recording medium (e.g., memory)). In some forms of the present technology, the central controller may be integrated with the RPT device 4000. However, in some forms of the present technology, some of the methods may be performed by remotely located devices. For example, a remotely located device may determine control settings for a ventilator or detect respiratory-related events by analyzing recorded data (e.g., from any of the sensors described herein).

[0268] 5.5 Air Circuit An air circuit 4170 according to one aspect of the present technology is a conduit or tube constructed and arranged such that, in use, an air flow moves between two components (e.g., the RPT device 4000 and the patient interface 3000).

[0269] Specifically, the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0270] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (e.g., to maintain or increase the air temperature). The heating element may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one form, the heating wire circuit may be wound helically around the axis of the air circuit 4170. The heating element may communicate with a controller (e.g., the central controller). An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. 8,733,349. The entire disclosure of this document is incorporated herein by reference for all purposes.

[0271] 5.5.1 Oxygen Delivery In one form of the technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic path (e.g., upstream of the pneumatic block 4020), the air circuit 4170, and / or the patient interface 3000.

[0272] 5.6 Humidifier 5.6.1 Overview of the Humidifier In one form of the technology, a humidifier 5000 is provided for varying the absolute humidity of air or gas to be delivered to a patient relative to ambient air (e.g., as shown in FIG. 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to ambient air) and the temperature of an air stream before it is delivered to the patient's airway.

[0273] The humidifier 5000 can include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air stream, and a humidifier outlet 5004 for delivering the humidified air stream. In some forms, such as shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 can be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 can further include a humidifier base 5006. The humidifier base 5006 can be adapted to receive the humidifier reservoir 5110 and can include a heating element 5240.

[0274] 5.6.2 Humidifier Components 5.6.2.1 Water Reservoir According to one arrangement configuration, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the air flow. The water reservoir 5110 may be configured to contain a predetermined maximum amount of water to provide adequate humidification over at least a respiratory therapy session (e.g., overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0275] According to one aspect, the water reservoir 5110 is configured to humidify the air flow from the RPT device 4000 as the air flow passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to facilitate the movement of the air flow along a serpentine path in the reservoir 5110 while the air flow is in contact with a certain amount of water in the reservoir 5110.

[0276] According to one form, the reservoir 5110 may be removable from the humidifier 5000 in a lateral direction as shown, for example, in FIGS. 5A and 5B.

[0277] The reservoir 5110 may also be configured to suppress liquid discharge from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating orientation (e.g., through any aperture and / or between its sub-components). Since the air flow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent air pressure loss through leakage and / or flow impedance.

[0278] 5.6.2.2 Conductive portion According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a fixed amount of liquid in the reservoir 5110. In one form, the conductive portion 5120 can be arranged as a plate, although other shapes may also be suitable. All or part of the conductive portion 5120 can be composed of a thermally conductive material such as aluminum (e.g., with a thickness of approximately 2 mm (e.g., 1 mm, 1.5 mm, 2.5 mm or 3 mm)), another thermally conductive metal or some plastic. In some cases, appropriate thermal conductivity can be achieved by a lower conductivity material with an appropriate geometry.

[0279] 5.6.2.3 Humidifier Reservoir Dock In one form, the humidifier 5000 can include a humidifier reservoir dock 5130 configured to receive the humidifier reservoir 5110 (as shown in FIG. 5B). In some arrangements, the humidifier reservoir dock 5130 can include a locking function (e.g., a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0280] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 can include a water level indicator 5150 as shown in FIGS. 5A - 5B. In some forms, the water level indicator 5150 can provide one or more indications to a user such as the patient 1000 or caregiver regarding the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 can include notification of the maximum predetermined amount of water, any part thereof (e.g., 25%, 50% or 75% or an amount (e.g., 200 ml, 300 ml or 400 ml)).

[0281] 5.6.2.5 Heating Element In some cases, the heating element 5240 can be provided to the humidifier 5000 that provides heat input to one or more of the amount of water in the humidifier reservoir 5110 and / or the amount of water to the air flow. The heating element 5240 can include a heat generating component such as an electrical resistance heating track. One suitable example of the heating element 5240 is, for example, the layered heating element described in PCT Patent Application Publication No. WO2012 / 171072. In this specification, the entire document is incorporated herein by reference.

[0282] In some forms, the heating element 5240 can be provided into the humidifier base 5006. In the humidifier base 5006, heat can be sent to the humidifier reservoir 5110 mainly by conduction as shown in FIG. 5B.

[0283] 5.7 Respiratory waveform FIG. 6 shows a model of a typical respiratory waveform of a human during sleep. The horizontal axis is time and the vertical axis is respiratory flow rate. Since the parameter values can vary, a typical respiration can have the following approximate values: tidal volume, Vt, 0.5 L, inspiratory time, Ti, 1.6 s, peak inspiratory flow rate, Qpeak, 0.4 L / s, expiratory time, Te, 2.4 s, peak expiratory flow rate, Qpeak, -0.5 L / s. The total duration of respiration Ttot is about 4 seconds. A human typically breathes about 15 times per minute (BPM), and the ventilation Vent is about 7.5 L / min. The ratio of a typical duty cycle, Ti to Ttot, is about 40%.

[0284] 5.8 Glossary For the purposes of the disclosure of this technology, in certain forms of this technology, one or more of the following definitions may apply. In other forms of this technology, other definitions may also apply.

[0285] 5.8.1 General Air: In certain forms of this technology, air can mean the atmosphere, and in other forms of this technology, air can mean a combination of other breathable gases (e.g., an atmosphere rich in oxygen).

[0286] Surroundings: In certain forms of the present technology, the term "surroundings" should be taken to mean (i) outside the treatment system or the patient, and (ii) that which directly surrounds the treatment system or the patient.

[0287] For example, the ambient humidity for a humidifier can be the humidity of the air that directly surrounds the humidifier (e.g., the humidity inside the room where the patient is sleeping). Such ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0288] In another example, the ambient pressure can be the pressure directly surrounding or outside the body.

[0289] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the room where the patient is located, other than the noise generated from, for example, the RPT device or the noise generated from the mask or patient interface. Ambient noise can be generated from sources outside the room.

[0290] Automated Positive Airway Pressure (APAP) Therapy: A form of CPAP therapy that can automatically adjust the treatment pressure between a minimum and a maximum, for example, in response to the presence or absence of signs of SDB during the breathing cycle.

[0291] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the treatment pressure is substantially constant throughout the patient's breathing cycle. In some forms, the pressure at the airway inlet rises slightly during exhalation and drops slightly during inhalation. In some forms, the pressure varies between different breathing cycles of the patient (e.g., increased in response to detection of signs of partial upper airway obstruction and reduced in the absence of notification of partial upper airway obstruction).

[0292] Flow rate: The instantaneous amount (or mass) of air delivered per unit time. The flow rate can refer to the instantaneous amount. In some cases, when referring to the flow rate, it may refer to a scalar quantity (i.e., a quantity having only magnitude). In other cases, when referring to the flow rate, it may refer to a vector quantity (i.e., a quantity having both magnitude and direction). The flow rate may be given the symbol Q. The "flow rate" may also be abbreviated as "flow" for simplicity.

[0293] In an example of a patient's breathing, the flow rate can be nominally positive pressure for the inhalation part of the patient's breathing cycle and thus negative for the exhalation part of the patient's breathing cycle. The total flow rate Qt is the flow rate of air exiting the RPT device. The ventilation flow rate Qv is the flow rate of air exiting through the ventilation holes to allow the outflow of the exhaled gas. The leakage flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The breathing flow rate Qr is the flow rate of air received in the patient's respiratory system.

[0294] Humidifier: The term "humidifier" is interpreted to mean a humidifying device constructed, arranged, or configured with a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air flow to improve a patient's medical respiratory condition.

[0295] Leakage: The term "leakage" is taken as an unintended air flow. In one example, leakage can occur due to an incomplete seal between the mask and the patient's face. In another example, leakage can occur at a swivel elbow to the surroundings.

[0296] Noise conduction (acoustic): In this document, conduction noise refers to noise conveyed to the patient through an air pressure path (e.g., an air circuit and the patient interface and the air within it). In one form, conduction noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0297] Noise Emission (Acoustic): In this document, emitted noise refers to noise conveyed to the patient by the surrounding air. In one form, emitted noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744.

[0298] Noise Ventilation (Acoustic): In this document, ventilation noise refers to noise generated by an air flow through any ventilation (e.g., ventilation holes in a patient interface).

[0299] Patient: A person who has or does not have a respiratory disease.

[0300] Pressure: Force per unit area. Pressure can be expressed in various units (e.g., cmH2O, g-f / cm 2 , and hectopascal). 1 cmH2O is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascal. In this specification, unless otherwise specified, pressure is given in the unit of cmH2O.

[0301] The pressure in the patient interface is denoted by the symbol Pm, and the treatment pressure representing the target value to be achieved by the mask pressure Pm at the current time is denoted by the symbol Pt.

[0302] Respiratory Pressure Therapy (RPT): Addition of an air supply to the airway inlet at a treatment pressure that is typically positive pressure with respect to the atmosphere.

[0303] Ventilator: A mechanical device that provides pressure assistance when a patient performs some or all of the breathing movements.

[0304] 5.8.1.1 Materials Silicone or silicone elastomer: A synthetic rubber. As used herein, when referring to silicone, it refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). As one form of commercially available LSR, there is SILASTIC manufactured by Dow Corning (included in the product group sold under this trademark). Another LSR manufacturer is Wacker. Unless otherwise stated, the Shore A (or Type A) indentation hardness of the exemplary form of LSR, when measured by ASTM D2240, is in the range of about 35 to about 45.

[0305] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0306] 5.8.1.2 Mechanical Properties Elasticity: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0307] Elastic: Substantially all energy is released during unloading. For example, it includes certain silicones and thermoplastic elastomers.

[0308] Hardness: The ability of a material to resist deformation of itself (e.g., as described by the Young's modulus or an indentation hardness scale measured on a standardized sample size). - "Soft" materials may include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure. - "Hard" materials may include polycarbonate, polypropylene, steel or aluminum, and cannot be easily deformed, for example, under finger pressure.

[0309] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation when subjected to a load. The load can be a force or a moment (e.g., compression, tension, bending or torsion). The structure or component may provide different resistances in different directions.

[0310] Flabby structure or component: A structure or component that changes (e.g., bends) its shape within a relatively short period (e.g., 1 second) when supported under its own weight.

[0311] Rigid structure or component: A structure or component that undergoes substantially no shape change when subjected to the loads typically encountered during use. As an example of such an application, a patient interface may be set up and maintained in a sealed manner against a patient's airway inlet under a pressure load of, for example, approximately 20 - 30 cmH2O.

[0312] As an example, an I - beam may include different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In another example, a structure or component may be flabby in a first direction and rigid in a second direction.

[0313] 5.8.2 Respiratory cycle Apnea: According to some definitions, apnea is said to occur when a flow below a predetermined threshold persists for a continuous period, for example, 10 seconds. Obstructive apnea is said to occur when, despite the patient's effort, air flow is not permitted due to some airway obstruction. Central apnea refers to a state where apnea is detected due to a decrease or absence of respiratory effort despite the airway being open. Mixed apnea refers to a state where a decrease or absence of respiratory effort occurs simultaneously with airway obstruction.

[0314] Respiratory rate: The patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0315] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0316] Effort (respiratory): Respiratory effort is said to refer to the movement performed by a person's spontaneous breathing while trying to breathe.

[0317] Expiratory portion of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0318] Flow limitation: Flow limitation is construed as a situation in a patient's breathing where an increase in the patient's effort does not cause a corresponding increase in the flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, the flow limitation can be referred to as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, the flow limitation can be referred to as expiratory flow limitation.

[0319] Types of waveforms of inspiratory flow limitation: (i) Flattening: After an ascent, a relatively flat portion follows, and then a descent occurs. (ii) M-shaped: Having one local peak at the rise and one local peak at the fall, and a relatively flat portion between these two peaks. (iii) Chair-shaped: Having a single local peak, which occurs at the rise portion, followed by a relatively flat portion. (iv) Inverse chair-shaped: A single local peak follows a relatively flat portion, and this peak occurs at the fall portion.

[0320] Hypopnea: According to some definitions, hypopnea means a decrease in flow rather than an interruption of flow. In one form, when a flow decrease below a threshold velocity continues over a duration, it is said that hypopnea has occurred. When hypopnea is detected due to a decrease in respiratory effort, it is said that central hypopnea has occurred. In one form in adults, any of the following may occur and be regarded as hypopnea: (i) A 30% decrease in the patient's breathing for at least 10 seconds + associated 4% desaturation, or, (ii) A decrease (less than 50%) in the patient's breathing for at least 10 seconds, with associated desaturation of at least 3% or arousal occurring.

[0321] Hyperpnea: The flow increases to a level higher than the normal flow.

[0322] Inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is taken as the inspiratory portion of the respiratory cycle.

[0323] Patency (airway): The degree to which the airway is open or the range over which the airway is open. The airway patency is an opening. The quantification of the airway patency can be performed, for example, with a value (1) indicating patency and a value (0) indicating closure (obstruction).

[0324] Positive end-expiratory pressure (PEEP): A pressure that exceeds the atmospheric pressure in the lungs and exists at the end of expiration.

[0325] Peak flow (Qpeak): The maximum flow value in the inspiratory portion of the respiratory flow waveform.

[0326] Respiratory gas flow rate, air flow rate, patient's air flow rate, respiratory gas air flow rate (Qr): These terms can be understood to refer to the estimation of the respiratory flow rate of the RPT device and are used in contrast to the "true respiratory flow rate" or the actual respiratory flow rate of the patient, which is usually expressed in liters per minute.

[0327] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort.

[0328] (Inspiration) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0329] (Expiration) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0330] (Total) time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0331] Typical recent ventilation: The ventilation value (i.e., the degree of tendency of the center of the most recent values of ventilation) for which the most recent values of ventilation Vent tend to cluster over a given time scale.

[0332] Upper airway obstruction (UAO): Includes both partial upper airway obstruction and total upper airway obstruction. It may be associated with a state of flow limitation where flow may either slightly increase or decrease along with an increase in the pressure difference across the upper airway (Starling resistor behavior).

[0333] Ventilation (Vent): Measurement of the rate of gas exchange performed by a patient's respiratory system. Measurement of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation may simply be given as a volume and is understood as volume per minute.

[0334] 5.8.3 Ventilation Adaptive servo - ventilator (ASV): A servo - ventilator with a changeable rather than a fixed target ventilation. The changeable target ventilation can be learned from some characteristic of the patient (e.g., the patient's respiratory characteristics).

[0335] Backup rate: A parameter of a ventilator that establishes the minimum respiratory rate (typically, breaths per minute) delivered from the ventilator to the patient (when not triggered by spontaneous breathing efforts).

[0336] Cycle: The end of the inspiratory phase of a ventilator. When delivering a breath from a ventilator to a patient who is breathing spontaneously, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to cycle to stop breath delivery.

[0337] Expiratory positive airway pressure (EPAP): The baseline pressure to which a pressure that varies within a breath is added for the generation of a desired mask pressure that the ventilator attempts to achieve at a given time.

[0338] End - expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion of a breath. If the pressure waveform template Π(Φ) has a value of zero at the end of expiration (i.e., Π(Φ)=0 when Φ = 1), EEP is equal to EPAP.

[0339] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory part of breathing.

[0340] Pressure support: A number indicating the pressure increase during ventilator inspiration compared to during ventilator expiration, mainly meaning the pressure difference between the maximum value during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure support means the difference that the ventilator attempts to achieve (rather than the difference that the ventilator actually achieves).

[0341] Servo ventilator: A ventilator with patient ventilation and target ventilation, which adjusts the pressure support level to bring patient ventilation closer to the target ventilation.

[0342] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of breathing in a spontaneously breathing patient. However, if the device cannot detect breathing within a predetermined period, the device automatically starts breath delivery.

[0343] Swing: A term corresponding to pressure support.

[0344] Trigger: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be triggered to deliver the breath when the patient himself / herself starts the breathing part of the breathing cycle.

[0345] Typical recent ventilation: The typical recent ventilation Vtyp is a range of values where recent ventilation measurements tend to cluster over a certain predetermined time scale. For example, a measurement of the central tendency of ventilation measurements over the recent history can be an appropriate value for the typical recent ventilation.

[0346] 5.8.4 Anatomical Structure 5.8.4.1 Facial Anatomical Structure Ala: The outer wall or the "wing" of each nasal cavity (plural: alar)

[0347] Alar angle:

[0348] Alare: The outermost point on the ala.

[0349] Alar curvature (or alar summit) point: The most posterior point on the curvilinear reference line of each ala, seen at the crease formed by the junction of the ala and the cheek.

[0350] Auricle: The entire visible part of the ear.

[0351] (Nasal) skeleton: The nasal skeleton includes the nasal bones, the frontal processes of the maxillae, and the nasal part of the frontal bone.

[0352] (Nasal) cartilage skeleton: The nasal cartilage skeleton includes the septal cartilage, the lateral cartilages, the major cartilages, and the minor cartilages.

[0353] Columella: A skin flap that separates the nostrils and extends from the tip of the nose to the upper lip.

[0354] Columella angle: The angle between a line drawn through the midpoint of the nasal aperture and a line drawn perpendicular to the Frankfurt horizontal while intersecting the subnasale point.

[0355] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the left auricular point. The auricular point is the deepest point from the upper notch to the tragus of the auricle.

[0356] Glabella: A point located in the soft tissue and most prominent in the mid-sagittal plane of the forehead region.

[0357] Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper peripheral edge is attached to the nasal bones and the frontal processes of the maxillae, and its lower peripheral edge is connected to the major alar cartilages.

[0358] Lip, lower (Labrale inferius):

[0359] Lip, upper (Labrale superius):

[0360] Greater alar cartilage: A plate of cartilage that is located inferior to the lateral nasal cartilages. It curves around the anterior portion of the nostrils. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that includes three or four alar minor cartilages.

[0361] Nostrils (nares): Generally oval-shaped openings that form the entrances to the nasal cavities. The singular form of nares is naris. These nares are separated by the nasal septum.

[0362] Nasolabial groove or fold: A crease or groove in the skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0363] Nasolabial angle: The angle between the columella and the upper lip, which intersects with the subnasale point.

[0364] Lower ear attachment point: The lowest point of attachment of the auricle to the facial skin.

[0365] Upper ear attachment point: The highest point of attachment of the auricle to the facial skin.

[0366] Tip of the nose point: The most prominent point or tip of the nose, which can be identified in a side view of the remaining part of the head portion.

[0367] Philtrum: A midline groove that extends from the inferior border of the nasal septum to the upper part of the lip in the upper lip region.

[0368] Pogonion: The most anterior midpoint of the jaw, located on the soft tissue.

[0369] (Nasal) dorsum: The nasal dorsum is a midline ridge of the nose that extends from the sellion to the tip of the nose.

[0370] Midsagittal plane: A vertical plane that extends from the front (anterior) to the back (posterior) and divides the body into a right and a left half.

[0371] Sellion: The most concave point on the area of the fronto-nasal suture, located on the soft tissue.

[0372] Septal cartilage (nose): The septal cartilage is part of the septum and divides the front part of the nasal cavity.

[0373] Lowest alar point: The point at the lower margin of the alar base, where the alar base joins the skin of the upper (superior) lip.

[0374] Subnasal point: The point located on the soft tissue where the columella joins the upper lip in the median sagittal plane.

[0375] Stomion: The most concave point in the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

[0376] 5.8.4.2 Anatomical structure of the skull Frontal bone: The frontal bone includes the frontal squama, which is a large vertical part corresponding to the region known as the forehead.

[0377] Mandible: The mandible forms the lower jaw. The mental eminence is a bony prominence of the jaw that forms the chin.

[0378] Maxilla: The maxilla forms the upper jaw and is located below the lower jaw and below the eye socket. The frontal process of the maxilla projects upward by the side of the nose and forms part of its outer boundary.

[0379] Nasal bone: The nasal bones are two small rectangular bones, varying in size and shape among individuals. The nasal bones are arranged side by side in the middle and upper parts of the face, and their junction forms the "bridge" of the nose.

[0380] Nasion: The intersection of the frontal bone and the two nasal bones, which is a concave area directly provided between the eyes and the upper side of the nasal bridge.

[0381] Occipital bone: The occipital bone is located on the back and lower part of the skull. The occipital bone includes the foramen magnum, which is an elliptical hole through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0382] Orbit: A bony cavity in the skull that contains the eyeball.

[0383] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0384] Temporal bone: The temporal bones are located on the base and sides of the skull and support the part of the face known as the temple.

[0385] Cheekbone: The two cheekbones that are part of the face are located in the upper and lateral parts of the face and form the cheek prominences.

[0386] 5.8.4.3 Anatomical Structure of the Respiratory System Diaphragm: A sheet of muscle that extends over the lower part of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0387] Larynx: The larynx or voice box that houses the vocal folds and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0388] Lung: The respiratory organ in humans. The conductive zone of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0389] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called nasal conchae (singular "concha") or nasal turbinate bones. In front of the nasal cavity is the nose, and behind it leads into the nasopharynx through the posterior nares.

[0390] Pharynx: The part of the throat located directly below the nasal cavity (downward) and above the esophagus and larynx. The pharynx has traditionally been divided into the following three parts: the nasopharynx (upper pharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0391] 5.8.5 Patient Interface Aspiration prevention valve (AAV): A component or sub - assembly of a mask system that reduces the risk of excessive CO2 re - breathing by the patient through an opening to the atmosphere in a fail - safe mode.

[0392] Elbow: An elbow is an example of a structure that directs the axis of the air flow moving inside and changes the direction through an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a substantially circular cross - section. In another form, the elbow can have an elliptical or rectangular cross - section. In a particular form, the elbow can be rotatable, for example, about 360 degrees with respect to an engaging component. In a particular form, the elbow can be removable from an engaging component, for example, via a snap connection. In a particular form, the elbow can be assembled to an engaging component via a one - time snap during manufacture, while being non - removable by the patient.

[0393] Frame: The frame is taken to mean a mask structure that supports the tensile load between two or more points connecting the headgear. The mask frame can be a non - airtight load - supporting structure in the mask. However, some forms of the mask frame can be airtight.

[0394] Functional dead space:

[0395] Headgear: Headgear is taken to mean a form of positioning and stabilization structure designed to be used on the head. For example, the headgear can include a collection of one or more struts, ties, and supplementary rigid materials configured to position and hold a patient interface at a predetermined position on the patient's face for the delivery of respiratory therapy. Some ties are formed of a soft, flexible elastic material (e.g., a laminated composite of foam and fabric).

[0396] Membrane: The membrane is typically taken to mean a thin element, preferably substantially resistant to bending and resistant to stretching and contraction.

[0397] Plenum chamber: The mask plenum chamber is taken to mean a part of a patient interface having a wall that at least partially encloses the volume of space, and the air in the volume is pressurized to exceed atmospheric pressure during use. The shell may form part of the wall of the mask plenum chamber.

[0398] Seal: When used as a noun ("seal"), it may refer to the structure, and when used as a verb ("seal"), it may refer to its effect. Two elements may be constructed and / or arranged to "seal" or obtain a "sealing" effect between them without the need for separate "seal" elements themselves.

[0399] Shell: The shell is taken to mean a relatively thin, curved structure having bending, tensile, and compressive rigidity. For example, the curved structure wall of a mask may be a shell. In some forms, the shell may be faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0400] Reinforcing member: The reinforcing member is taken to mean a structural component designed to increase the stiffness or flexibility of another component in at least one direction.

[0401] Strut: The strut is taken to mean a structural component designed to increase the compressive resistance of another component in at least one direction.

[0402] Swerl (noun): A sub-assembly of components that is configured to rotate preferably independently and preferably under low torque about a common axis. In one form, the swerl can be constructed to rotate at an angle of at least 360 degrees. In another form, the swerl can be constructed to rotate at an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably includes a pair of cylindrical conduits in combination. In use, there is little leakage of air flow from the swerl.

[0403] Ty (noun): A structure designed to resist tension.

[0404] Ventilation: (noun) A structure that allows air flow to the ambient air inside a mask or conduit, enabling a clinically effective washout of the exhaled gas. For example, in a clinically effective washout, a flow rate of about 10 liters / minute to about 100 liters / minute can be used depending on the mask design and the treatment pressure. 5.8.6 Shape of the Structure

[0405] The product according to the present technology may include one or more three-dimensional mechanical structures (e.g., a mask cushion or an impeller). The three-dimensional structure can be bounded by two-dimensional surfaces. These surfaces can be distinguished using labels to describe the direction, position, function, or some other property of the associated surface. For example, the structure can include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure can include a face contact (e.g., outer) surface and a separate non-face contact (e.g., lower or inner) surface. In another example, the structure can include a first surface and a second surface.

[0406] To facilitate the description of the shape and surface of the three-dimensional structure, first consider the cross-section at point p through the surface of the structure. Refer to FIGS. 3B to 3F. FIGS. 3B to 3F show an example of a cross-section at point p on the surface and an example of the resulting planar curve. FIGS. 3B to 3F also show the outward normal vector at p. The outward normal vector at p extends in the direction away from the surface. In some examples, this surface is described from the perspective of a fictional small person standing upright on the surface.

[0407] 5.8.6.1 Curvature in One Dimension The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., 1 / radius of the circle tangent to the curve at p).

[0408] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is taken to have a positive value (when this fictional small person leaves point p, they need to walk uphill). Refer to FIG. 3B (relatively large positive curvature compared to FIG. 3C) and FIG. 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often called concave.

[0409] Zero curvature: When the curve at p is a straight line, the curvature is taken as zero (when this fictional small person leaves point p, they can walk on a horizontal plane that is neither upward nor downward). Refer to FIG. 3D.

[0410] Negative curvature: When the curve at p bends in the direction away from the outward normal, the curvature at that point and in that direction is taken to have a negative value (when this fictional small person leaves point p, they need to walk downhill). Refer to FIG. 3E (relatively small negative curvature compared to FIG. 3F) and FIG. 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often called convex.

[0411] 5.8.6.2 Curvature of a Two-Dimensional Surface The description of the shape at a given point on a two-dimensional surface according to this technique may include a plurality of vertical cross-sections. The plurality of cross-sections may cut the surface in a plane including the outward normal (the "normal plane"), and each cross-section may be taken in a different direction. As a result of each cross-section, a planar curve with a corresponding curvature is obtained. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have a magnitude (e.g., relatively small). The planar curves in FIGS. 3B-3F may be examples of such a plurality of cross-sections at a particular point.

[0412] Principal curvatures and directions: The directions of the normal planes in which the curvature of the curve takes its maximum and minimum values are called the principal directions. In the examples of FIGS. 3B-3F, since the maximum curvature occurs in FIG. 3B and the minimum in FIG. 3F, FIGS. 3B and 3F are cross-sections in the principal directions. The principal curvatures at p are the curvatures in the principal directions.

[0413] Region of the surface: A set of connected points on the surface. This set of points within the region may have similar characteristics (e.g., curvature or sign).

[0414] Saddle region: A region in which the principal curvatures at each point have opposite signs (i.e., one positive and the other negative) depending on the direction in which an imaginary person walking on the uphill or downhill could face.

[0415] Dome region: A region in which the principal curvatures at each point have the same sign (both positive ("concave dome") or both negative ("convex dome")).

[0416] Cylindrical region: A region in which one principal curvature is zero (or zero within manufacturing tolerances, for example), and the other principal curvature is non-zero.

[0417] Planar region: A region of the surface in which both principal curvatures are zero (or zero within manufacturing tolerances, for example).

[0418] Edge of the surface: The boundary or limit of the surface or region.

[0419] Path: In a particular form of the present technology, "path" is taken to mean a path in the mathematical-topological sense (e.g., a continuous space curve from f(0) to f(1) on a surface). In a particular form of the present technology, "path" can be described as a route or course including, for example, a set of points on a surface. (The path of a fictional person is a place to walk on a surface and is similar to a garden path).

[0420] Path length: In a particular form of the present technology, "path length" is taken to refer to the distance from f(0) to f(1) along the surface (i.e., the distance along the path on the surface). There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of a fictional person is the distance walked along the path on the surface).

[0421] Straight-line distance: The straight-line distance is the distance between two points on a surface, without considering the surface. On a planar region, there is a distance along the edge of the surface that has the same path length as the straight-line distance between two points on the surface. In the case of a non-planar surface, there may not be a path with the same path length as the straight-line distance between two points. (In a fictional person, this straight-line distance corresponds to a "straight-line" distance).

[0422] 5.8.6.3 Space curve Space curve: Unlike a planar curve, a space curve does not necessarily lie in any particular plane. A space curve can be closed, i.e., it has no endpoints. A space curve can be considered as a one-dimensional piece of three-dimensional space. A fictional person walking along the strand of a DNA helix walks along a space curve. A typical human left ear contains a left-handed helix (see Fig. 3Q). A typical human right ear contains a right-handed helix (see Fig. 3R). Fig. 3S shows a right-handed helix. The edge of a structure (e.g., the edge of a membrane or an impeller) can follow a space curve. In general, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of the way a curve deviates from a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with respect to the tangent vector, the normal vector, and the binormal vector at that point.

[0423] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction and a magnitude from that point. The tangent unit vector is the unit vector that points in the same direction as the curve at that point. If a fictional person is flying along a curve and falls out of their vehicle at a particular point, the direction of the tangent vector is the direction in which the person should be moving.

[0424] Unit normal vector: When a fictional person is moving along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the direction in which the tangent vector is changing is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0425] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (e.g., see Fig. 3P) or, alternatively, the left-hand rule (Fig. 3O).

[0426] Contact plane: The plane that contains the unit tangent vector and the unit principal normal vector. See Figs. 3O and 3P.

[0427] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures the degree of deviation from the osculating plane of the curve. The torsion of a space curve lying in a plane is zero. When the deviation from the osculating plane of a space curve is relatively small, the magnitude of the torsion of that space curve is relatively small (e.g., a gently sloping helical path). When the deviation from the osculating plane of a space curve is relatively large, the magnitude of the torsion of that space curve is relatively large (e.g., a steeply sloping helical path). Referring to Fig. 3S, since T2 > T1, the magnitude of the torsion near the upper coil of the helix in Fig. 3S is greater than the magnitude of the torsion of the lowermost coil of the helix in Fig. 3S.

[0428] Referring to the right - hand rule of Fig. 3P, a space curve that bends in the direction of the right - hand binormal can be regarded as having a positive torsion in the right - hand direction (e.g., a right - hand helix as shown in Fig. 3S). A space curve that points in the separating direction from the right - hand binormal direction can be regarded as having a negative torsion of the right - hand (e.g., a left - hand helix).

[0429] Similarly, referring to the left - hand rule (see Fig. 3O), a space curve that points in the left - hand binormal direction can be regarded as having a positive torsion of the left - hand (e.g., a left - hand helix). Thus, the positive direction of the left - hand corresponds to the negative direction of the right - hand. Refer to Fig. 3T.

[0430] 5.8.6.4 Holes A surface can have one - dimensional holes (e.g., holes bounded by a planar curve or a space curve). In the case of a thin - walled structure (e.g., a membrane) containing holes, this structure can be described as having one - dimensional holes. For example, refer to the state where the one - dimensional holes in the surface of the structure shown in Fig. 3I are bounded by a planar curve.

[0431] The structure may have a two-dimensional hole (e.g., a hole bounded by a surface). For example, an inflatable tire has a two-dimensional hole bounded by the inner surface of the tire. In another example, a bladder with a cavity for air or gel may have a two-dimensional hole. See, for example, the cushion of FIG. 3L and the exemplary cross-sections of FIG. 3L in FIGS. 3M and 3N where the inner surface bounding the two-dimensional hole is shown. In yet another example, a conduit may include a one-dimensional hole (e.g., at its inlet or its outlet) and may include a two-dimensional hole bounded by the inner surface of the conduit. See also the two-dimensional hole bounded by a surface as shown through the structure of FIG. 3K and as illustrated.

[0432] 5.9 Other Considerations Part of the disclosure of this patent document contains content that is given copyright protection. The copyright owner has no objection if anyone reproduces this patent document or this patent disclosure by fax, provided it is for the purpose of what is described in the patent file or record of the Patent Office, but retains all copyrights for other purposes.

[0433] Unless otherwise clearly apparent from the context and unless a range of values is provided, it is understood that each intervening value between the lower limit of 1 / 10 of the unit of the lower limit, between the upper and lower limits of the range, and any other stated value or intervening value in the stated range of the description is encompassed by the technology. Even if the upper and lower limits of these intervening ranges independently included within the intervening range particularly exceed the limitations in the stated range, they are still encompassed by the technology. If the stated range includes one or both of these limitations, ranges exceeding either or both of these stated limitations are also encompassed by the technology.

[0434] Furthermore, when a value (singular or plural) is embodied as part of the technology in this specification, unless otherwise specified, it is understood that such a value may be approximated and such a value may be used to any appropriate significant digits up to the extent permitted or required by the actual technical implementation.

[0435] Unless otherwise noted, all technical and scientific terms used in this specification 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 in this specification can be used in the practice or testing of this technology, only a limited number of exemplary methods and materials are described herein.

[0436] Although specific materials are described as being preferably used in the construction of components, obvious alternative materials with similar properties can be used as substitutes. Further, unless stated to the contrary, any and all components described herein are understood to be manufacturable and can be manufactured either collectively or individually.

[0437] As used in this specification and the appended claims, note that the singular forms "a," "an," and "the" include their plural equivalents unless the context clearly indicates otherwise.

[0438] All of the publications described herein are hereby incorporated by reference for their disclosure and description of the methods and / or materials that are the subject of these publications. The publications described herein are provided only for their disclosure prior to the filing date of this application. Nothing in this specification should be construed as an admission that the technology described herein does not antedate such publications by virtue of prior invention. Further, the dates of the publications described may be different from the actual publication dates and may need to be individually verified.

[0439] The terms "comprises" and "comprising" are to be interpreted as referring to elements, components, or steps in a non-exclusive sense, indicating that the recited elements, components, or steps can be present, utilized, or combined with other elements, components, or steps not expressly recited.

[0440] The headings used in the detailed description are for the convenience of the reader and should not be used to limit the content found throughout the present disclosure or the entire scope of the claims. These headings should not be used in the interpretation of the scope of the claims or the limitations of the claims.

[0441] Although the techniques in this specification have been described with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the technology. In some cases, the terms and symbols may indicate specific details that are unnecessary for the implementation of the technology. For example, terms such as "first" and "second" (etc.) are used, but unless otherwise specified, these terms are not intended to indicate any order and are used to distinguish separate elements. Further, when describing or exemplifying the process steps in this method, they may be presented in an ordered manner, but such an order is not necessary. One skilled in the art will recognize that such an order can be changed and / or that the aspects can be performed simultaneously or even synchronously.

[0442] Therefore, it should be understood that numerous variations are possible in the exemplary examples without departing from the spirit and scope of the technology, and other arrangements can be devised.

Description of Reference Numerals

[0443] 1000 Patient 1100 Roommate 3000 Patient Interface 3100 Seal Forming Structure 3105 Plenum Base 3106 Damper 3110 Protrusion 3120 Cradle Base 3130 Opening 3140 Base End 3150 Outlet End 3160 Peripheral Wall 3170 Plane 3175 Longitudinal axis 3180 Central opposing side 3190 Side facing outwards 3200 Plenum chamber 3210 Tendon 3220 Upper point 3230 Lower point 3240 Central part 3250 Lateral part 3260 Sealing surface 3270 Rim 3280 Plane 3285 Buffer or damper 3290 Positioning and stabilization structure connector 3300 Positioning and stabilization structure 3310 Inlet pipe 3330 Surface 3400 Ventilation part 3500 Disconnection structure 3600 Connection port 3700 Forehead support part 4000 RPT device 4010 External housing 4012 Upper part 4014 Part 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic block 4110 Air filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Outlet muffler 4140 Pressure generator 4142 Blower 4144 Motor 4160 Anti-spillback valve 4170 Air circuit 4180 Supplementary oxygen 4200 Electrical component 4202 PCBA 4210 Power supply 4220 Input device 4270 Converter 5000 Humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier base 5110 Reservoir 5120 Conductive part 5130 Humidifier reservoir dock 5135 Lock lever 5150 Water level indicator 5240 Heating element 7100 Nasal puff / pillow 7120 Protrusion 7140 Opening 7160 Base 7180 Lateral extension 7220 One or more folds 7300 Opening 7500 Positioning and stabilization structure connector 7520 Tube

Claims

1. 1. A patient interface configured to deliver a pressurized flow of respiratory gas to an airway of a patient, the patient interface comprising: a cradle base configured, in use, to cradle support the patient's nose; two prongs extending from the cradle base and configured to be inserted into the patient's nares in use, each prong defining an opening therein configured to allow a continuous flow of air therethrough; and a plenum base forming a plenum chamber with said cradle base; A patient interface, wherein the cradle base is configured such that movement of the cradle base decouples from the plenum base.

2. The patient interface of claim 1 , wherein the protrusions are constructed and arranged to seal against an inner periphery of each of the nostrils in use.

3. 3. A patient interface according to claim 1 or 2, wherein the protrusions include ends that, in use, seal against an inner periphery of each of the nostrils.

4. 4. A patient interface according to claim 1, wherein the cradle base includes lateral extensions extending laterally outwardly on either side of the two protrusions, each of the lateral extensions being configured to seal against a lateral or lower portion of each of the patient's nasal alars in use.

5. A patient interface according to any preceding claim, wherein the cradle base is configured to be deflected outwardly by the patient's nose when worn by the patient.

6. A patient interface according to any preceding claim, wherein the protrusion has a frusto-conical shape.

7. A patient interface according to any preceding claim, wherein the opening of the projection is angled relative to a surface of the cradle base from which the projection begins to extend.

8. A patient interface according to any preceding claim, wherein the plenum base includes a pair of air inlets on opposing lateral sides.

9. The patient interface of any one of claims 1 to 8, wherein the plenum base and the cradle base are inflatable.

10. A patient interface according to any preceding claim, wherein a buffer or damper between the cradle base and the plenum base is configured to decouple movement of the cradle base from the plenum base.

11. A patient interface according to any one of claims 1 to 10, wherein the buffer or damper is not configured to decouple movement between the two sealing surfaces.

12. The patient interface of claim 10 or 11, wherein the buffer or damper is not configured to decouple movement between the nose seal and the mouth seal.

13. A patient interface according to any preceding claim, wherein the patient interface does not include a mouth seal.

14. A patient interface according to any preceding claim, wherein the projection does not include a stem.

15. 1. A patient interface configured to deliver a pressurized flow of respiratory gas to an airway of a patient, the patient interface comprising: Plenum base; a cradle base attached to the plenum base and configured to cradle support the patient's nose in use, the plenum base and the cradle base together defining a plenum chamber; a channel in a surface of the plenum base adjacent the cradle base, the channel configured to decouple movement of the cradle base from the plenum base; and a pair of protrusions extending from the cradle base, the pair of protrusions including a pair of protrusions configured to be inserted into the patient's nares in use; A patient interface, wherein the pair of protrusions, in use, define a gas flow path from the plenum chamber to the patient's airway.

16. The patient interface of claim 15 , wherein the channel completely surrounds the cradle base.

17. 17. The patient interface of claim 15 or 16, wherein the cradle base is U-shaped or V-shaped.

18. The patient interface of any one of claims 15 to 17, wherein the plenum base and the cradle base are inflatable.

19. The patient interface of any one of claims 15 to 18, wherein the sides of the cradle base are configured to flex proximally and distally relative to the plenum base.

20. The patient interface of claim 19 , wherein each of the projections extends from a respective side portion of the cradle base.

21. The patient interface of claim 20 , wherein a lateral portion of the cradle base extends laterally beyond each of the projections.

22. A patient interface according to any one of claims 15 to 21, wherein the plenum base includes a pair of gas inlets, one gas inlet located on each lateral side of the plenum base.

23. A patient interface according to any one of claims 15 to 22, wherein each protrusion is configured to seal inside a nostril of the patient.

24. A patient interface according to any one of claims 15 to 23, wherein the cradle base is configured to seal against the outer surfaces of the patient's nares.

25. 1. A patient interface configured to deliver a pressurized flow of respiratory gas to an airway of a patient, the patient interface comprising: At least 6 cmH above ambient air pressure ２ a plenum base pressurizable to a therapeutic pressure of O, said plenum base including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by the patient; a seal-forming structure constructed and arranged to surround the patient's nostrils and form a seal with areas of the patient's face that are interior to the patient's nostrils, the seal-forming structure constructed and arranged to maintain the treatment pressure within the plenum base throughout the patient's respiratory cycle, in use; and a spring or damper between the plenum chamber and the seal-forming structure, the spring or damper configured to decouple movement of the seal-forming structure from the plenum base; a patient interface, the seal-forming structure further comprising a cradle base and two protrusions provided on the cradle base, each of the protrusions having an opening formed therein configured to pass a continuous flow of air therethrough, the protrusions being constructed and arranged to be inserted or partially inserted into each of the patient's nares in use to provide the air flow at the treatment pressure to the patient's nares.

26. 26. The patient interface of claim 25, wherein the protrusions are configured to form a seal with the inside of the patient's nares.

27. 27. A patient interface according to claim 25 or 26, wherein the cradle base is configured to cradle the patient's nose and form a seal with outer surfaces of the patient's nares in use.

28. 28. A patient interface according to any one of claims 25 to 27, wherein only a central portion of the cradle base is attached to the plenum base.

29. A patient interface according to any one of claims 25 to 28, wherein the sides of the cradle base are flexible in proximal and distal directions relative to the plenum base.

30. 30. A patient interface according to any one of claims 25 to 29, wherein the protrusion is angled relative to a surface of the cradle base from which the protrusion begins to extend.

31. 1. A patient interface configured to deliver a pressurized flow of respiratory gas to an airway of a patient, the patient interface comprising: At least 6 cmH above ambient air pressure ２ a plenum base pressurizable to a therapeutic pressure of O, said plenum base including an inlet port sized and configured to receive an airflow at said therapeutic pressure for breathing by said patient; and a seal-forming structure constructed and arranged to surround the patient's nostrils and form a seal with areas of the patient's face that are interior to the patient's nostrils, the seal-forming structure constructed and arranged to maintain the treatment pressure within the plenum base throughout the patient's respiratory cycle, in use; the seal-forming structure includes a cradle base and a pair of prongs extending from the cradle base, each prong having an opening formed therein configured to convey the air flow at the treatment pressure in use to a nares of the patient, each prong being configured to be inserted or partially inserted into one of the patient's nares in use; A patient interface, wherein the cradle base is supported on the plenum base and a portion of the cradle base and / or the portion of the plenum base forms one or more folds configured to decouple movement of the cradle base from the plenum base.

32. 32. The patient interface of claim 31 , wherein the one or more folds are part of a concertina structure.

33. 33. A patient interface according to claim 31 or 32, wherein the cradle base further includes lateral extensions extending laterally outwardly on either side of the protrusion, the lateral extensions being configured to seal against the lateral or inferior portions, respectively, of each of the patient's nasal alars in use.

34. 34. A patient interface according to any one of claims 31 to 33, further comprising a positioning and stabilising structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

35. 35. The patient interface of claim 34, wherein the positioning and stabilizing structure includes a tie, the tie constructed and arranged to, in use, at least partially cover an area of ​​the patient's head above an upper ear-base point of the patient's head.

36. 35. The patient interface of claim 34, wherein the positioning and stabilizing structure includes at least one gas delivery tube constructed and arranged to, in use, contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head, and a portion of the gas delivery tube above the upper ear-base point of the patient's head includes or is provided with a connection port configured to receive the air flow from an air circuit and deliver the air flow through the seal-forming structure to an entrance of the patient's airway.

37. 1. A patient interface configured to deliver a pressurized flow of respiratory gas to an airway of a patient, the patient interface comprising: a cradle base configured, in use, to cradle support the patient's nose; and A patient interface including: two prongs extending from the cradle base and configured to be inserted into the patient's nares in use.

38. 1. A seal-forming structure for a patient interface configured to form a seal with a nares of a patient, the seal-forming structure comprising: Base; and two protrusions on the base, each protrusion defining an opening configured to allow a continuous air flow therethrough; The protrusions are constructed and arranged to be inserted or partially inserted into each of the patient's nostrils in use.

39. 40. The seal-forming structure of claim 38, wherein the projections are constructed and arranged to seal against an inner periphery of each of the nostrils in use.

40. 40. The seal-forming structure of claim 38 or 39, wherein the projections include ends that, in use, seal against an inner periphery of each of the nostrils.

41. 41. The seal-forming structure of any one of claims 38 to 40, wherein the base further includes lateral extensions extending laterally outward on either side of the two protrusions, each of the lateral extensions configured to seal against a lateral or lower portion of each of the patient's nasal alars in use.

42. 42. The seal-forming structure of any one of claims 38 to 41, wherein the base is formed such that in the absence of any force acting on the base, the base has a positive curvature in the lateral direction, and when worn by the patient, the positive curvature of the base decreases when the base engages the nose.

43. 1. A seal-forming structure for a patient interface configured to form a seal with a nares of a patient, the seal-forming structure comprising: plenum chamber; a base disposed in the plenum chamber; and at least one opening in the base configured to allow a continuous air flow therethrough; A seal-forming structure, wherein one or more folds may be formed by a portion of the base and / or a portion of the plenum chamber.

44. 44. The seal-forming structure of claim 43, wherein the seal-forming structure includes two projections disposed on the base, each of the projections having one of the openings formed therein.

45. 1. A patient interface, comprising: At least 6 cmH above ambient air pressure ２ a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a vent structure to allow continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; a patient interface, the seal-forming structure further comprising a base and two protrusions provided on the base, each of the protrusions having an opening formed therein configured to pass a continuous flow of air therethrough, the protrusions being constructed and arranged to be inserted or partially inserted into each of the patient's nares in use to provide the air flow at the treatment pressure to the patient's nares.

46. 1. A patient interface, comprising: At least 6 cmH above ambient air pressure ２ a plenum chamber pressurizable to a therapeutic pressure of O, said plenum chamber including a plenum chamber inlet port sized and configured to receive a flow of air at said therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to form a seal with an area of ​​the patient's face surrounding an entrance to the patient's airway, the seal-forming structure constructed and arranged, in use, to maintain the therapeutic pressure in the plenum chamber throughout the patient's respiratory cycle; and a vent structure to allow continuous flow of gases exhaled by the patient from within the plenum chamber to the surroundings, the vent structure being sized and shaped to maintain the therapeutic pressure within the plenum chamber in use; a patient interface, the patient interface including a base and at least one opening in the base configured to, in use, provide the air flow at the treatment pressure to the patient's nares, the base being disposed in a plenum chamber, and one or more folds being formed by a portion of the base and / or a portion of the plenum chamber.

47. 47. The patient interface of claim 46, wherein the seal-forming structure includes two projections on the base, each of the projections having one of the openings formed therein.

48. 48. A patient interface according to any one of claims 45 to 47, wherein the base further includes lateral extensions extending laterally outwardly on either side of the two protrusions, the lateral extensions being configured to seal against the lateral or inferior portions, respectively, of each of the patient's nasal alars in use.

49. 49. The patient interface of any one of claims 45 to 48, wherein the base is formed such that in the absence of any force acting on the base, the base has a positive curvature, and when worn by the patient, the positive curvature of the base decreases when the base engages the nose.

50. 50. A patient interface according to any one of claims 45 to 49, further comprising a positioning and stabilising structure providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head.

51. 51. The patient interface of claim 50, wherein the positioning and stabilizing structure includes a tie, the tie constructed and arranged to, in use, at least partially cover an area of ​​the patient's head above an upper ear-base point of the patient's head.

52. 52. The patient interface of claim 51 , wherein the positioning and stabilizing structure includes at least one gas delivery tube constructed and arranged to, in use, contact at least an area of ​​the patient's head above an upper ear-base point of the patient's head, and a portion of the gas delivery tube above the upper ear-base point of the patient's head includes or is provided with a connection port configured to receive the air flow from an air circuit and deliver the air flow through the seal-forming structure to an entrance of the patient's airway.

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