Patient interface and seal forming structure therefor

Abstract

The utility model relates to a patient interface and a seal forming structure used for the patient interface. A patient interface includes a seal-forming structure having a mouth portion forming at least a portion of a mouth plenum and configured to seal around a mouth of a patient and a nose portion configured to seal with nostrils of the patient. The nose portion includes a nose plenum chamber positioned to receive pressurized gas from the mouth plenum chamber. The seal-forming structure also includes a clip configured to connect the mouth plenum chamber to the nose plenum chamber and serve as a conduit for the flow of pressurized gas from the mouth plenum chamber to the nose plenum chamber. The clip includes a mouth portion end configured to engage with the mouth, a nose portion end configured to engage with the nose, and a pair of wings projecting from the nose portion end into the nasal plenum chamber such that the wings engage with an inner surface of the nasal plenum chamber.

Description

[0001] This application is a divisional application of the patent application with the application number 202222717210.5, titled "Patient Interface", which was filed on October 14, 2022. Technical Field

[0002] This technology relates to one or more of screening, diagnosing, monitoring, treating, preventing, and improving respiratory-related disorders. This technology also relates to medical devices or equipment and their uses. Background Art

[0003] 1.2 Related Technology Description

[0004] 1.2.1 The Human Respiratory System and Its Disorders

[0005] The respiratory system of the human body facilitates gas exchange. The nose and mouth form the airway entrance of the patient.

[0006] The airway includes a series of branching tubes that become narrower, shorter, and more numerous as the branching bronchi penetrate deeper into the lungs. The main function of the lungs is gas exchange, which allows oxygen to enter venous blood from inhaled air and expel carbon dioxide in the opposite direction. The trachea divides into the left main bronchus and the right main bronchus, which ultimately divide further into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airway leads to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is the region where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology", 9th Edition, published by John B. West, Lippincott Williams & Wilkins in 2012.

[0007] There is a series of respiratory disorders. Some disorders can be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

[0008] Examples of respiratory disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events that include occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway during sleep and the normal loss of muscle tone in the regions of the tongue, soft palate, and posterior oropharyngeal wall. The disorder causes affected patients to stop breathing, typically for periods of 30 seconds to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can result in cardiovascular disease and brain damage. Comorbidities are common disorders, especially in middle-aged overweight men, but affected individuals may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0010] 1.2.2 Treatment

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

[0012] 1.2.2.1 Respiratory pressure therapy

[0013] Respiratory pressure therapy supplies air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient's respiratory cycle (as opposed to negative pressure therapy such as a tank ventilator or a catheter ventilator).

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

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

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

[0017] 1.2.2.2 Flow Therapy

[0018] Not all respiratory therapies are aimed at delivering a prescribed therapeutic pressure. Some respiratory therapies are aimed at delivering a prescribed respiratory volume by delivering an inspiratory flow curve (possibly superimposed on a positive baseline pressure) over a target duration. In other cases, the interface to the patient's airway is "open" (unsealed), and the respiratory therapy can supplement the patient's own spontaneous breathing with a flow of conditioned or enriched gas. In one example, high-flow therapy (HFT) provides a continuous, heated, humidified airflow to the airway inlet through an unsealed or open patient interface at a "therapy flow" that can be maintained substantially constant throughout the respiratory cycle. This therapy flow is nominally set to exceed the patient's peak inspiratory flow. HFT has been used to treat OSA, CSR, respiratory failure, COPD, and other respiratory diseases. One mechanism of action is that the high flow of air at the airway inlet improves ventilation efficiency by flushing or washing out exhaled CO2 from the patient's anatomic dead space. Thus, HFT is sometimes referred to as deadspace therapy (DST procedure). Other benefits can include elevated warmth and humidity (which may be beneficial in secretion management) and the possibility of a modest elevation of airway pressure. As an alternative to a constant flow, the therapy flow can follow a curve that varies during the respiratory cycle.

[0019] 1.2.3 Respiratory Therapy Systems

[0020] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can also be used to screen, diagnose, or monitor a condition without treating it.

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

[0022] 1.2.3.1 Patient Interface

[0023] A patient interface can be used to couple a respiratory device to its wearer, for example by providing an airflow to the entrance of the airway. The airflow can be provided to the patient's nose and / or mouth via a face mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area of the patient's face, for example, to cause gas to be delivered at a pressure that has a sufficient difference from the ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to the ambient pressure) to effect the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of about 10 cmH2O to the airway. For flow therapies such as nasal HFT, the patient interface is configured to puff air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0024] Some other face mask systems may not be functionally suitable for the present field. For example, a purely decorative face mask may not be able to maintain an appropriate pressure. A face mask system for underwater swimming or diving can be configured to prevent water from a higher external pressure from entering, but does not maintain the internal air at a pressure above ambient.

[0025] Some face masks may be clinically disadvantageous for the present technology, for example, in cases where they block airflow through the nose and only allow it through the mouth.

[0026] If some face masks require the patient to insert a portion of the face mask structure into their mouth to create and maintain a seal through their lips, it may be uncomfortable or impractical for the present technology.

[0027] Some face masks may not be achievable for use during sleep, for example, when sleeping on one's side in bed with the head on a pillow.

[0028] The design of the patient interface presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among different individuals. Since the head includes bone, cartilage, and soft tissue, different regions of the face respond differently to mechanical forces. The mandible or lower jawbone can move relative to other bones of the skull. The entire head can move during the course of a respiratory therapy session.

[0029] Due to these challenges, some face masks suffer from one or more of the following problems: obtrusiveness, unsightliness, expense, disproportion, difficulty of use, and discomfort, especially when worn for a long period of time or when the patient is not familiar with the system. A mask of incorrect size can result in reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed as part of personal protective equipment (such as filter masks), SCUBA masks, or masks designed to administer anesthetic agents are acceptable for their original applications, but are not as comfortable as desired for long-term (e.g., several hours) wear. This discomfort can lead to reduced patient compliance with treatment. This is especially true if the mask is worn during sleep.

[0030] Assuming the patient adheres to treatment, CPAP treatment is very effective in treating certain respiratory disorders. If the mask is uncomfortable or difficult to use, the patient may not adhere to treatment. Since patients are typically advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean their mask, which can affect patient compliance.

[0031] While masks for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

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

[0033] 1.2.3.1.1 Seal-forming structure

[0034] The patient interface can include a seal-forming structure. Because of its 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.

[0035] The patient interface can be characterized in part according to the design intent of the seal-forming structure to engage the face during use. In one form of patient interface, the seal-forming structure can include a first sub-part that forms a seal around the left nostril and a second sub-part that forms a seal around the right nostril. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils during use. This single element can be designed to cover, for example, the upper lip region and the bridge of the nose of the face. In one form of patient interface, the seal-forming structure can include an element that surrounds the mouth region during use, e.g., by forming a seal over the lower lip region of the face. In one form of patient interface, the seal-forming structure can include a single element that surrounds both nostrils and the mouth region during use. These different types of patient interfaces can be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0036] A sealing formation structure that may be effective in one area of a patient's face may not be suitable in another area, for example, because of differences in the shape, structure, variability, and sensitive areas of the patient's face. For example, a seal on swimming goggles covering a patient's forehead may not be suitable for use on the patient's nose.

[0037] Certain sealing formation structures can be designed for mass production such that one design is suitable, comfortable, and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the sealing formation structure of a mass-produced patient interface, one or both must adapt to form a seal.

[0038] One type of sealing formation structure extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the sealing formation portion is in face-to-face engagement with the patient's face. The sealing formation structure can include an air or fluid-filled pad, or a molded or formed surface of an elastomeric (e.g., rubber) sealing element. For this type of sealing formation structure, if the fit is inadequate, there will be a gap between the sealing formation structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0039] Another type of sealing formation structure incorporates a sheet seal of thin material around the periphery of the face mask to provide a self-sealing action against the patient's face when positive pressure is applied within the face mask. Similar to the previous type of sealing formation portion, if the match between the face and the face mask is poor, additional force may be required to achieve a seal, or the face mask may leak. Additionally, if the shape of the sealing formation structure does not match the shape of the patient, it may wrinkle or bend during use, causing leakage.

[0040] Another type of sealing formation structure can include friction fit elements, such as for insertion into the nostrils, however some patients find these uncomfortable.

[0041] Another form of sealing formation structure can use an adhesive to achieve a seal. Some patients may find it inconvenient to regularly apply and remove the adhesive on their face.

[0042] A series of patient interface sealing formation structure techniques are disclosed in the following patent applications assigned to ResMed Limited: WO 98 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0043] One form of nasal pillows is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0044] ResMed manufactures the following products that include nasal pillows: SWIFTTM Nasal Pillow Cushion, SWIFTTM II Nasal Pillow Mask, SWIFTTM LT Nasal Pillow Mask, SWIFTTM FX Nasal Pillow Mask, and MIRAGE LIBERTYTM Full Face Mask. The following patent applications assigned to ResMed describe examples of nasal pillow masks: International Patent Application WO2004 / 073,778 (which describes additional aspects of ResMed's SWIFTTM Nasal Pillow), U.S. Patent Application 2009 / 0044808 (which describes additional aspects of ResMed's SWIFTTM LT Nasal Pillow); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (which describe aspects of ResMed's MIRAGE LIBERTYTM Full Face Mask); International Patent Application WO 2009 / 052560 (which describes additional aspects of ResMed's SWIFTTM FX Nasal Pillow).

[0045] 1.2.3.1.2 Positioning and stabilization

[0046] The seal-forming structure of a patient interface for positive pressure therapy is subject to corresponding forces from the air pressure that would break the seal. Accordingly, various techniques have been used to position the seal-forming structure and maintain its sealed relationship with the appropriate portion of the face.

[0047] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication US 2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0048] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of being ill-fitting, bulky, uncomfortable, and inconvenient to use.

[0049] 1.2.3.2 Respiratory Pressure Therapy (RPT) devices

[0050] Respiratory Pressure Therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the above-mentioned various therapies, for example, by operating the device to generate an air flow for delivery to an airway interface. The air flow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapies such as HFT). Thus, the RPT device can also be used as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0051] 1.2.3.3 Air Circuit

[0052] The air circuit is a conduit or tube that is constructed and arranged to allow an air flow to travel between two components of a respiratory therapy system, such as an RPT device and a patient interface, in use. In some cases, there may be separate branches for the air circuit for inhalation and exhalation. In other cases, a single branched air circuit is used for both inhalation and exhalation.

[0053] 1.2.3.4 Humidifier

[0054] Delivering an air flow without humidification can cause airway dryness. Using a humidifier with an RPT device and a patient interface produces humidified gas, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Additionally, in colder climates, warm air that is typically applied to the interior of the patient interface and the facial area around the patient interface is more comfortable than cold air.

[0055] 1.2.3.5 Venting Technology

[0056] Some forms of therapy systems can include vents to allow flushing of exhaled carbon dioxide. The vents can allow gas to flow from the interior space of the patient interface (such as an inflation chamber) to the exterior space of the patient interface, for example, to the environment.

[0057] The vent can include an orifice and gas can flow through the orifice in the use of a mask. Many such vent holes are noisy. Others may become blocked during use, providing insufficient flushing. Some vents can, for example, disturb the sleep of the patient 1000's bed partner 1100 through noise or aggregated air flow.

[0058] Resmed Limited has developed many improved mask venting technologies. See International Patent Application Publication No. WO1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. 2009 / 0044808.

[0059] Noise table of existing masks (ISO 17510-2:2007, pressure of 10 cmH2O at 1 m)

[0060]

[0061]

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

[0063] The sound pressure values of various objects are listed below

[0064] Summary of the Invention

[0065] The present technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders, which have one or more of improved comfort, cost, efficacy, ease of use, and manufacturability.

[0066] The first aspect of the present technology relates to devices for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0067] Another aspect of the present technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0068] One aspect of certain forms of the present technology is methods and / or devices for providing improved patient compliance with respiratory therapy.

[0069] One form of the present technology includes a patient interface having a sealing portion configured to seal the patient's face.

[0070] Another aspect of the present technology includes a mouth gasket configured to seal around the patient's mouth and a nose gasket configured to seal around the patient's nostrils.

[0071] Another aspect of the present technology includes a mouth gasket configured to seal around the patient's mouth and a nose gasket configured to seal against the inner side of the patient's nostrils.

[0072] Another aspect of the present technology includes a nose gasket configured to seal the patient's nasal airway.

[0073] Another aspect of the present technology includes a headband having an air delivery conduit configured to support the patient interface on the patient's head.

[0074] Another aspect of the technology includes a vent for the patient interface, the vent including a surface having at least one vent hole.

[0075] One aspect of the present technology relates to a patient interface that includes: a mouth inflation chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure, the mouth inflation chamber including an inflation chamber inlet port, the size and structure of the inflation chamber inlet port being designed to receive an air flow for the patient to breathe at the treatment pressure, a seal-forming structure that is configured and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet, the seal-forming structure having an aperture therein such that the air flow at the treatment pressure is delivered to at least one inlet of the patient's nostrils, the seal-forming structure being configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's breathing cycle during use, the seal-forming structure including: a mouth portion that forms at least a part of the mouth inflation chamber and is configured to seal around the patient's mouth; a nose portion that is configured to seal with the patient's nostrils, the nose portion including a nose inflation chamber that is positioned to receive pressurized gas from the mouth inflation chamber; and a clip that is configured to connect the mouth inflation chamber to the nose inflation chamber and act as a conduit for the flow of the pressurized gas from the mouth inflation chamber to the nose inflation chamber, the clip including: a mouth portion end that is configured to engage the mouth portion; a nose portion end that is configured to engage the nose portion; and a pair of wings that project from the nose portion end into the interior of the nose inflation chamber such that the wings engage the inner surface of the nose inflation chamber, the base of each wing being positioned on opposite lateral sides of the clip, a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tie that is configured and arranged such that in use at least a part of it covers an area of the patient's head that is above the supra-aural reference point of the patient's head; a ventilation structure that is configured to allow the gas exhaled by the patient to continuously flow from the interior of the inflation chamber to the surrounding environment, the size and shape of the ventilation structure being set to maintain the treatment pressure in the inflation chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of a pressurized air flow through the inflation chamber inlet port.

[0076] In the example, (a) the wings can be separated from each other and be different, (b) the height of each wing can be the distance that each wing projects from the nose portion end of the clip, and the maximum height of each wing can be at the laterally farthest point on the wing, (c) the height of each wing can vary such that the height of each wing increases towards the laterally farthest point on the wing, (d) the height of each wing can gradually vary to form a smooth curve, and the height of each wing can decrease to a zero value towards the central region of the nose portion end of the clip, (e) the nose inflation chamber can include an inlet opening, and the clip can include a nose end flange and an intermediate flange, and these flanges together can form a nose end channel that is configured to receive the edge of the inlet opening of the nose inflation chamber, and the nose end flange can be configured to be inserted into the inlet opening of the nose inflation chamber, (f) the pair of wings can extend from the nose end flange, (g) the mouth inflation chamber can include an outlet opening, and the clip can include a mouth end flange that together forms a mouth end channel that can receive the edge of the outlet opening of the mouth inflation chamber, (h) the mouth end flange can be configured to be inserted into the mouth inflation chamber, (i) the edge of the outlet opening of the mouth inflation chamber can include a tab and there can be a notch in the mouth end flange of the clip, and the notch can be positioned to receive the tab when the nose portion is connected to the mouth portion in the correct orientation, (j) the tab can be configured to prevent the nose portion from being fixed to the mouth portion in the wrong orientation, (k) the outer surface of the mouth portion can include a first printed mark, and the outer surface of the nose portion can include a second printed mark, and the second printed mark aligns with the first printed mark when the nose portion is connected to the mouth portion in the correct orientation, and (l) the nose portion can include a flexible base and a pair of nasal pillows attached to the flexible base, and the nasal pillows can be configured to seal with the interior of the patient's nostrils.

[0077] In another example, (a) the mouthpiece portion may include a flange having an inner surface and an outer surface, and the flange may include a target seal-forming region located on its outer surface, (b) the outer surface may include a lip region configured to have a lip-saddle region, (c) at a point where an intermediate contact plane on the outer surface of the mouthpiece portion contacts the target seal-forming region, the curvature of the lip-saddle region in the inferior-superior direction may have a negative sign and a magnitude greater than the magnitude of the curvature of the lip-saddle region in the left-right direction, (d) the outer surface may include a left corner region and a right corner region, (e) the outer surface may be configured to have a first convex dome-shaped region in the left corner region, (f) the outer surface may be configured to have a second convex dome-shaped region in the right corner region, (g) the outer surface of the flange may have an inner edge, the aperture may be defined by the inner edge, and the inner edge may include an inner edge lip region, (h) the inner edge of the flange may be configured such that a space curve on the outer surface of the flange at the inner edge in the left corner region may have a left-handed positive twist, (i) the inner edge of the flange may be configured such that a space curve on the outer surface of the flange at the inner edge in the right corner region has a right-handed positive twist, (j) the mouth inflation chamber may be partially formed by a housing having an inner housing surface and an outer housing surface, the inner housing surface may be arranged to be at the treatment pressure in use, and the outer housing surface may be arranged to be at the ambient pressure in use, (k) the housing may be configured to be rigid when subjected to an internal pressure higher than the ambient pressure and less than about 30 cmH2O, (l) the housing may be made of a rigid plastic material, (m) the housing may be made of a transparent material, (n) the inner housing surface may be configured to include a concave dome-shaped region, (o) the positioning and stabilization structure may include a second tie, the second tie being constructed and arranged such that at least a portion of its upper edge passes below the inferior auricular base point of the patient's head and covers or lies under the occipital bone of the patient's head (p) the positioning and stabilization structure may include low-profile sides configured to be positioned under the patient's head when the patient is lying in a lateral position (q) the mouth inflation chamber may be constructed of a transparent material, (r) the patient interface may be configured such that no part of the patient interface structure enters the oral cavity during use, or (s) the patient interface may be constructed and arranged such that the mouth inflation chamber does not cover the eyes during use.

[0078] Another aspect of the present technology relates to a patient interface that includes: a mouth inflation chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure, the mouth inflation chamber including an inflation chamber inlet port, the size and structure of the inflation chamber inlet port being designed to receive an air stream for a patient to breathe at the treatment pressure, a seal-forming structure that is configured and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet, the seal-forming structure having a hole therein such that the air stream at the treatment pressure is delivered to at least one inlet of the patient's nostrils, the seal-forming structure being configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use, the seal-forming structure including: a nasal portion that is configured to seal with the patient's nostrils, the nasal portion including a nasal inflation chamber that is positioned to receive pressurized gas from the mouth inflation chamber; and a clip that is configured to connect the mouth inflation chamber to the nasal inflation chamber and act as a conduit for the flow of the pressurized gas from the mouth inflation chamber to the nasal inflation chamber, the clip including: a mouth portion end that is configured to engage the mouth portion outside the mouth inflation chamber; and a nasal portion end that is configured to engage the nasal portion, the clip being configured to increase the rigidity of the lateral side of the nasal inflation chamber such that when the clip is attached to the nasal inflation chamber, the lateral side of the nasal inflation chamber is more rigid than the central portion of the nasal inflation chamber; a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; a ventilation structure that is configured to allow gas exhaled by the patient to continuously flow from the interior of the inflation chamber to the surrounding environment, the size and shape of the ventilation structure being set to maintain the treatment pressure in the inflation chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of a pressurized air stream passing through the inflation chamber inlet port.

[0079] In the example, (a) the clip may include a pair of lateral wings extending from one end of the clip, each lateral wing may be located on opposite sides of a lumen in the clip and may be configured to increase the stiffness of the nasal inflation chamber when the clip is attached to the nasal inflation chamber, (b) the height of each wing may be the distance that each wing projects from the end of the clip, and the maximum height of each wing may be at the laterally farthest point on the wing, (c) the height of each wing may vary such that the height of each wing increases toward the laterally farthest point on the wing, (d) the height of each wing may decrease to a zero value toward a central region at the nasal portion end of the clip, (e) the nasal portion may include a nasal base and a pair of nasal pillows extending from the nasal base, (f) the nasal base may form the nasal inflation chamber, (g) the nasal base and the nasal pillows may be formed of a flexible material, (h) the clip may be made of a material that is more rigid than the nasal portion and the mouth portion, (i) the wings may be configured to be inserted into the nasal inflation chamber when the clip is attached to the nasal portion, (j) when the clip is connected to the nasal inflation chamber, the wings may be configured to abut against the interior of the nasal inflation chamber, (k) the clip may be removed from the mouth inflation chamber, (l) the clip may be removed from the nasal inflation chamber.

[0080] Another aspect of the present technology relates to a patient interface that includes: a mouth inflation chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure, the mouth inflation chamber including an inflation chamber inlet port, the size and structure of the inflation chamber inlet port being designed to receive an air flow for the patient to breathe at the treatment pressure, a seal-forming structure that is configured and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet, the seal-forming structure having a hole therein such that the air flow at the treatment pressure is delivered to at least one inlet of the patient's nostrils, the seal-forming structure being configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's breathing cycle during use, the seal-forming structure including: a nasal portion that is configured to seal with the patient's nostrils, the nasal portion including a nasal inflation chamber that includes an air inlet configured to receive pressurized gas from the mouth inflation chamber; and a clip that is configured to connect the mouth inflation chamber to the nasal inflation chamber and act as a conduit for the flow of the pressurized gas from the mouth inflation chamber to the nasal inflation chamber, the clip including: a mouth portion end that is configured to engage the mouth portion outside the mouth inflation chamber; a nasal portion end that is configured to engage the nasal portion; a lumen extending from the mouth portion to the nasal portion; and a pair of wings that project from the nasal portion end into the interior of the nasal inflation chamber, the wings being anchored to the nasal portion end at respective bases located on opposite lateral sides of the lumen, each wing extending laterally away from the lumen and terminating in a free end, the distance between the free ends of the wings being greater than the diameter of the air inlet of the nasal inflation chamber; and a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. A ventilation structure that is configured to allow the gas exhaled by the patient to continuously flow from the interior of the inflation chamber to the surrounding environment, the size and shape of the ventilation structure being set to maintain the treatment pressure in the inflation chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of a pressurized air flow through the inflation chamber inlet port.

[0081] In an example, (a) the wings can engage an inner surface of the nasal inflation chamber, (b) the clip can be configured such that the force necessary to insert the clip into the nasal inflation chamber is less than the force necessary to remove the clip from the nasal inflation chamber, (c) the force necessary to remove the clip from the nasal inflation chamber can be between 19 N and 20 N, (d) after the clip is secured to the nasal inflation chamber, each wing can be movable relative to an inner surface of the nasal inflation chamber base, (e) the wings can prevent the clip from being removed from the nasal inflation chamber, (f) the clip can include a nasal flange and an intermediate flange that together form a nasal passage, the nasal passage being configured to receive an edge of an air inlet of the nasal inflation chamber, the nasal flange being configurable to be inserted into an inlet opening of the nasal inflation chamber, (g) a pair of wings can extend from the nasal flange, the oral inflation chamber can include an outlet opening, and the clip can include an oral portion end flange, the oral portion end flange together forming an oral portion end passage that receives an edge of the outlet opening of the oral inflation chamber, (h) the oral portion end flange can be configured to be inserted into the oral inflation chamber.

[0082] Another aspect of the present technology relates to a patient interface that includes: a mouth inflation chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure, the mouth inflation chamber including an inflation chamber inlet port, the size and structure of the inflation chamber inlet port being designed to receive an air flow for the patient to breathe at the treatment pressure, a seal forming structure that is constructed and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet, the seal forming structure having an aperture therein such that the air flow at the treatment pressure is delivered to at least one inlet of the patient's nostrils, the seal forming structure being constructed and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's breathing cycle during use, the seal forming structure including: a mouth portion that forms at least a part of the mouth inflation chamber and is configured to seal around the patient's mouth; the mouth portion including a container having an outlet opening and a pair of mouth portion magnets located on opposite sides of the outlet opening; and a nose portion that is configured to seal with the patient's nostrils, the nose portion including a nose inflation chamber that has an inlet opening and a pair of nose portion magnets located on opposite sides of the inlet opening, the nose inflation chamber being configured to be received within the container and the nose portion magnets being positioned such that when the nose inflation chamber is received within the container, the two nose portion magnets are located between the mouth portion magnets; and a positioning and stabilizing structure that provides a force to hold the seal forming structure in a therapeutically effective position on the patient's head. A ventilation structure, the ventilation structure being configured to allow the gas exhaled by the patient to continuously flow from the interior of the inflation chamber to the surrounding environment, the size and shape of the ventilation structure being set to maintain the treatment pressure in the inflation chamber during use; wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth without a pressurized air flow passing through the inflation chamber inlet port.

[0083] In the example, (a) the container may include at least one sidewall extending from the base, and the mouth magnets may be positioned on the at least one sidewall, (b) the nose inflation chamber may include at least one sidewall and the nose section magnets may be positioned on the at least one sidewall, (c) the nose section magnets may be on a lateral side of the nose inflation chamber, (d) the mouth section magnets may be on a lateral side of the container, (e) the nose section magnets may be oriented to present different polarities toward the mouth section magnets, (f) the mouth section magnets may be oriented to present different polarities toward the nose section magnets, (g) the nose section magnets and the mouth section magnets may be oriented to repel each other when the nose inflation chamber is inserted into the container in the wrong orientation, (h) the nose section magnets and the mouth section magnets may be configured to connect two flexible bodies, (i) the nose section magnets may be molded to the nose inflation chamber and the mouth section magnets may be molded to the container, (j) the bottom of the edge of the inlet opening in the nose inflation chamber may include a lip seal, (k) the lip seal may be configured to engage the edge of the outlet opening of the container when the nose inflation chamber may be fixed within the container, (l) the lip seal may be positioned below the nose section magnets, (m) the nose section magnets may face each other (n) the mouth section magnets may face each other.

[0084] Another aspect of the present technology relates to a patient interface that includes: a mouth inflation chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure, the mouth inflation chamber including an inflation chamber inlet port, the size and structure of the inflation chamber inlet port being designed to receive an air stream for the patient to breathe at the treatment pressure, a seal-forming structure that is configured and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet, the seal-forming structure having an aperture therein such that the air stream at the treatment pressure is delivered to at least one inlet of the patient's nostrils, the seal-forming structure being configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's breathing cycle during use, the seal-forming structure including: a mouth portion that forms at least a part of the mouth inflation chamber and is configured to seal around the patient's mouth; and a nose portion that is configured to seal with the patient's nostrils, the nose portion including a nose inflation chamber having an inlet opening, the nose inflation chamber being configured to be received within the container; and a positioning and stabilizing structure that provides a force to hold the seal-forming structure in a therapeutically effective position on the patient's head. A ventilation structure that is configured to allow the gas exhaled by the patient to continuously flow from the interior of the inflation chamber to the surrounding environment, the size and shape of the ventilation structure being set to maintain the treatment pressure in the inflation chamber during use; the ventilation structure includes: a body configured to be fixed to the mouth portion, the body including a ventilation wall having a plurality of ventilation holes, a container, and a pair of anchor containers located on opposite sides of the container; a cover that includes a pair of studs on the lateral sides of the cover, the studs being configured to be inserted into the anchor containers to fix the cover to the body; and a diffuser received within the container between the anchor containers, the diffuser being sandwiched between the body and the cover, wherein the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth in the absence of pressurized air flowing through the inflation chamber inlet port.

[0085] In the example, (a) the anchoring container can be keyed to the plug such that only a plug having the same shape as the anchoring container can be received within the anchoring container, (b) the anchoring container can be tapered such that the plug is wedged into the anchoring container when the cap is fixed to the body, (c) the body can include a first flange and a second flange that forms a passage with the first flange. The nozzle portion can include a vent opening, and when the body is fixed to the nozzle portion, an edge of the vent opening can be received within the passage, (d) the anchoring container can extend deeper than the passage, (e) the vent wall can enclose one end of the interior of the container closest to the nozzle inflation chamber, (f) the diffuser can be spaced apart from the vent hole, (g) each anchoring container can have a different size, (h) each anchoring container can have a different shape, (i) the anchoring container can be configured to prevent the cap from being fastened to the body in a wrong orientation, (j) the perimeter of the cap can be smaller than the perimeter of the body such that a gap can be formed between the body and the cap when the cap is fastened to the body, (k) the vent hole can be tapered such that the vent hole narrows in a direction towards the diffuser, (l) opposite sides of the inner wall of each vent hole can form a taper angle of 10 to 35 degrees, (m) the taper angle can be about 10 degrees, (n) the taper angle can be about 35 degrees, (o) the base of each vent hole can be flared, (p) the flared portion of the vent hole can have a radius of curvature of 0.2 mm to 0.4 mm, (q) the radius of curvature can be about 0.25 mm, (r) the radius of curvature can be about 0.3 mm, (s) the minimum diameter of each vent hole can be 0.5 mm to 2.0 mm, (t) the minimum diameter can be 0.89 mm, (u) the minimum diameter can be 0.98 mm, (v) the minimum diameter can be 1.01 mm, (w) the minimum diameter can be 1.17 mm.

[0086] Another aspect of the present technology relates to a patient interface, the patient interface comprising: a mouth inflation chamber that can be pressurized to a treatment pressure higher than the ambient air pressure by at least 6 cmH2O, the mouth inflation chamber including an inflation chamber inlet port, the size and structure of the inflation chamber inlet port being designed to receive an air flow for the patient to breathe at the treatment pressure; a seal forming structure that is configured and arranged to form a seal with an area of the patient's face surrounding the patient's airway inlet, the seal forming structure having an aperture therein such that the air flow at the treatment pressure is delivered to at least one inlet of the patient's nostrils, the seal forming structure being configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's breathing cycle during use, the seal forming structure including: a mouth portion that forms at least a part of the mouth inflation chamber and is configured to seal around the patient's mouth; and a nose portion that is configured to seal with the patient's nostrils, the nose portion including a nose inflation chamber having an inlet opening, the nose inflation chamber being configured to be received within the container; and a positioning and stabilizing structure that provides a force to hold the seal forming structure in a therapeutically effective position on the patient's head. A ventilation structure that is configured to allow the gas exhaled by the patient to continuously flow from the interior of the inflation chamber to the surrounding environment, the size and shape of the ventilation structure being set to maintain the treatment pressure in the inflation chamber during use; the ventilation structure including: a ventilation wall having a plurality of ventilation openings and a groove on an outer surface completely surrounding the ventilation openings; at least one side wall extending from the ventilation wall; and a flange that extends from an end of the at least one side wall such that an edge of the ventilation wall, an outer surface of the at least one side wall, and the flange together form a channel that is configured to receive an edge surrounding the ventilation opening in the mouth portion, the flange being configured to be received within the mouth inflation chamber. Wherein, the patient interface is configured to allow the patient to breathe from the surrounding environment through their mouth without a pressurized air flow passing through the inflation chamber inlet port.

[0087] In an example, (a) the outward-facing surface of the ventilation wall can be convex and the inward-facing surface of the ventilation wall opposite the outward-facing surface can be convex, (b) the ventilation holes can be tapered such that the ventilation holes narrow in the direction towards the outward-facing surface of the ventilation wall, (c) opposite sides of the inner wall of each ventilation hole can form a taper angle of 10 to 35 degrees, (d) the taper angle can be about 10 degrees, (e) the taper angle can be about 35 degrees, (f) the base of each ventilation hole can be flared, (g) the flared portion of the ventilation hole can have a radius of curvature of 0.2 mm to 0.4 mm, (h) the radius of curvature can be about 0.25 mm, (i) the radius of curvature can be about 0.3 mm, (j) the minimum diameter of each ventilation hole can be 0.5 mm to 2.0 mm, (k) the minimum diameter can be 0.89 mm, (l) the minimum diameter can be 0.98 mm, (m) the minimum diameter can be 1.01 mm, (n) the minimum diameter can be 1.17 mm.

[0088] In yet another aspect of the present technology, there is provided a respiratory therapy system comprising: a patient interface according to any aspect of the present technology discussed above; a respiratory pressure therapy device configured to generate an air flow at a therapeutic pressure; and an air circuit configured to direct the air flow at the therapeutic pressure from the respiratory pressure therapy device to the patient interface.

[0089] Another aspect of one form of the present technology is a patient interface that is molded or otherwise configured to have a peripheral shape complementary to the peripheral shape of an intended wearer.

[0090] One aspect of one form of the present technology is a method of manufacturing a device.

[0091] One aspect of certain forms of the present technology is an easy-to-use medical device, for example, for a person without medical training, a person with clumsiness, limited vision, or limited experience in using this type of medical device.

[0092] One aspect of one form of the present technology is a portable RPT device that can be carried by a person (e.g., a person in their home).

[0093] One aspect of one form of the present technology is a patient interface that can be cleaned, for example, in soapy water in a patient's home, without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier chamber that can be washed, for example, in soapy water in a patient's home, without the need for specialized cleaning equipment.

[0094] The described methods, systems, devices, and apparatuses can be implemented to improve the functionality of a processor, such as a processor of a dedicated computer, a respiratory monitor, and / or a respiratory treatment device. Additionally, the described methods, systems, devices, and apparatuses can provide improvements in the technical field of the automated management, monitoring, and / or treatment of respiratory conditions, such as sleep disordered breathing.

[0095] Of course, some of these aspects can form sub - aspects of the present technology. The various aspects within the sub - aspects and / or aspects can be combined in various ways and also constitute other aspects or sub - aspects of the present technology.

[0096] Other features of the present technology will become apparent in view of the information contained in the following detailed description, abstract, drawings, and claims. BRIEF DESCRIPTION OF THE DRAWINGS

[0097] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings, in which like reference numerals refer to like elements and include:

[0098] 3.1 Respiratory Therapy System

[0099] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of nasal pillows receives an air supply under positive pressure from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and conveyed along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine position.

[0100] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives an air supply under positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and conveyed along the air circuit 4170 to the patient 1000.

[0101] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a full face mask receives an air supply under positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and conveyed along the air circuit 4170 to the patient 1000. The patient is sleeping in a lateral position.

[0102] 3.2 Respiratory System and Facial Anatomy

[0103] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity, oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0104] Figure 2B Shows a view of the human upper airway including the nasal cavity, nasal bone, external nasal cartilage, major alar cartilage, nostril, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0105] Figure 2C Is a front view of the face with several identified surface anatomical features, including the upper lip, vermilion border of the upper lip, vermilion border of the lower lip, lower lip, mouth width, inner canthus, alae nasi, nasolabial fold, and oral commissure. The upper, lower, radially inward, and radially outward directions are also indicated.

[0106] Figure 2D Is a lateral view of the head with several identified surface anatomical features, including the glabella, nasion, nasal prominence, subnasale, upper lip, lower lip, supramentale, nasal ridge, alar apex, superior auricular point, and inferior auricular point. The up-down and front-back directions are also indicated.

[0107] Figure 2E Is a lateral view of the other side of the head. The approximate positions of the Frankfurt horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0108] Figure 2F Shows a bottom view of the nose with several identified features, including the nasolabial fold, lower lip, vermilion border of the upper lip, nostril, subnasale, columella, nasal prominence, long axis of the nostril, and the central sagittal plane.

[0109] Figure 2G Shows a lateral view of the surface features of the nose.

[0110] Figure 2H Shows the subcutaneous structure of the nose, including the lateral cartilage, septal cartilage, major alar cartilage, minor alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0111] Figure 2I Shows a medial view of the nose approximately a few millimeters from the central sagittal plane, showing, among other things, the medial crura of the septal cartilage and the major alar cartilage.

[0112] Figure 2J Shows a front view of the skull, including the frontal bone, nasal bone, and zygomatic bone. The nasal concha, as well as the maxilla and mandible, are also indicated.

[0113] Figure 2K Shows a lateral view of the skull with the surface contour of the head and several muscles. The following bony parts are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0114] Figure 2L Shows an anterolateral view of the nose.

[0115] 3.3 Patient interface

[0116] Figure 3A Shows a patient interface in the form of a nasal mask according to one form of the present technology.

[0117] Figure 3B Shows a schematic view of a cross-section through the structure at a point. The outward normal at the point is indicated. The curvature at that point has a positive sign and has a relatively large magnitude when compared with Figure 3C the magnitude of the curvature shown.

[0118] Figure 3C Shows a schematic view of a cross-section through the structure at a point. The outward normal at the point is indicated. The curvature at that point has a positive sign and has a relatively small magnitude when compared with Figure 3B the magnitude of the curvature shown.

[0119] Figure 3D Shows a schematic view of a cross-section through the structure at a point. The outward normal at the point is indicated. The curvature at that point has a zero value.

[0120] Figure 3E Shows a schematic view of a cross-section through the structure at a point. The outward normal at the point is indicated. The curvature at that point has a negative sign and has a relatively small magnitude when compared with Figure 3F the magnitude of the curvature shown.

[0121] Figure 3F Shows a schematic view of a cross-section through the structure at a point. The outward normal at the point is indicated. The curvature at that point has a negative sign and has a relatively large magnitude when compared with Figure 3E the magnitude of the curvature shown.

[0122] Figure 3G Shows a cushion for a mask including two pillows. The outer surface of the cushion is indicated. The edge of the surface is shown. The vault and saddle regions are shown.

[0123] Figure 3H Shows a cushion for a mask. The outer surface of the cushion is indicated. The edge of the surface is shown. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle regions and a dome region are indicated.

[0124] Figure 3I Shows the surface of a structure having a one-dimensional hole on the surface. The illustrated planar curve forms the boundary of the one-dimensional hole.

[0125] Figure 3J Shows a cross-section throughFigure 3I Cross-section of the structure. The surface shown is Figure 3I In the structure defines a two-dimensional hole.

[0126] Figure 3K Shows Figure 3I Perspective view of the structure, including a two-dimensional hole and a one-dimensional hole. Also shown is in Figure 3I The surface that defines the two-dimensional hole in the structure.

[0127] Figure 3L Shows a face mask with an inflatable airbag as a cushion.

[0128] Figure 3M Shows through Figure 3L Cross-section of the face mask, and shows the inner surface of the airbag. The inner surface defines the two-dimensional hole in the mask.

[0129] Figure 3N Shows through Figure 3L Another cross-section of the mask. The inner surface is also marked.

[0130] Figure 3O Shows the left-hand rule.

[0131] Figure 3P Shows the right-hand rule.

[0132] Figure 3Q Shows the left ear, including the left ear helix.

[0133] Figure 3R Shows the right ear, including the right ear helix.

[0134] Figure 3S Shows the right-handed helix.

[0135] Figure 3T Shows a view of the face mask, including the sign of the twist of the space curve defined by the edge of the sealing film in different regions of the face mask.

[0136] Figure 3U Shows a view of the inflatable chamber 3200, showing the sagittal plane and the intermediate contact plane.

[0137] Figure 3V Shows Figure 3U View of the rear of the inflatable chamber. The direction of this view is perpendicular to the intermediate contact plane. Figure 3V The sagittal plane in bisects the inflatable chamber into a left side and a right side.

[0138] Figure 3W Shows through Figure 3V Cross-section of the inflatable chamber, the cross-section is at Figure 3VTaken at the sagittal plane shown. The "mid-contact" plane is shown. The mid-contact plane is perpendicular to the sagittal plane. The orientation of the mid-contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and contacts the gasket of the inflatable chamber at just two points on the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the gasket in this region, the mid-contact plane can be the tangent at the upper and lower points.

[0139] Figure 3X is shown Figure 3U The position of the inflatable chamber 3200 for use on the face. When the inflatable chamber is in the use position, the sagittal plane of the inflatable chamber 3200 generally coincides with the median sagittal plane of the face. When the inflatable chamber is in the use position, the mid-contact plane generally corresponds to the 'facial plane'. In Figure 3X where the inflatable chamber 3200 is the inflatable chamber of a nasal mask, and the upper point 3220 is located approximately on the root of the nose and the lower point 3230 is located on the upper lip.

[0140] Figure 3Y is shown a patient interface in the form of a nasal cannula according to one form of the present technology.

[0141] 3.4 RPT device

[0142] Figure 4A is shown an RPT device according to one form of the present technology.

[0143] Figure 4B is a schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. The upstream and downstream directions are indicated with reference to the blower and the patient interface. The blower is defined as upstream of the patient interface and the patient interface is defined as downstream of the blower, regardless of the actual flow direction at any particular moment. Articles within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0144] 3.5 Humidifier

[0145] Figure 5A is shown an isometric view of a humidifier according to one form of the present technology.

[0146] Figure 5B is shown an isometric view of a humidifier according to one form of the present technology, which shows the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0147] 3.6 Examples of the present technology

[0148] Figure 6 is shown an exemplary patient interface according to one form of the present technology.

[0149] Figure 7Shows Figure 7 an exploded view of a patient interface.

[0150] Figure 8 Shows Figure 7 a rear view of the body of the patient interface.

[0151] Figure 9 Shows a cross-sectional view of a nasal pillow module according to one aspect of the present technology.

[0152] Figure 9A - 9C Shows a cross-sectional view of the flange of the nasal pillow module.

[0153] Figures 10 - 12 Shows different views of an exemplary gasket clip.

[0154] Figure 13 Shows a cross-sectional view of a nasal pillow module according to another aspect of the present technology.

[0155] Figures 14 - 16 Shows different views of another exemplary gasket clip.

[0156] Figure 17 Shows a cross-sectional view of the body of the patient interface.

[0157] Figure 18 Shows another view of the gasket clip.

[0158] Figure 19 Shows an exploded view of another exemplary patient interface.

[0159] Figure 20 Shows a nasal pillow module according to another aspect of the present technology.

[0160] Figure 21 Shows Figure 20 another view of the nasal pillow module.

[0161] Figure 22 Shows Figure 19 a cross-sectional view of the patient interface.

[0162] Figure 23 Shows an enlarged view of the connection between the nasal module and the mouth gasket.

[0163] Figure 24 Shows an exemplary magnet according to one aspect of the present technology.

[0164] Figure 25 Shows an exploded view of an exemplary vent assembly.

[0165] Figure 26 Shows Figure 25 the vent assembly in an assembled form.

[0166] Figure 27 shows the Figure 25 main body of the vent assembly.

[0167] Figure 28 shows the Figure 27 cross-sectional view of the main body.

[0168] Figure 29 and 30 shows a detailed view of the anchoring container of the vent assembly.

[0169] Figure 31 shows the Figure 25 another exploded view of the vent assembly.

[0170] Figure 32 shows the main body of the vent assembly according to another aspect of the present technology.

[0171] Figure 33 shows the Figure 32 cross-sectional view of the main body.

[0172] Figure 34 and 35 shows a detailed view of the anchoring container of the vent assembly.

[0173] Figure 36 shows a rear view of the vent according to another aspect of the present technology.

[0174] Figure 37 shows the Figure 36 another view of the vent.

[0175] Figure 38 shows the Figure 36 cross-sectional view of the vent.

[0176] Figure 39 shows the vent according to another aspect of the present technology.

[0177] Figure 40 shows the Figure 39 cross-sectional view of the vent. Detailed Description

[0178] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, and the specific examples described herein may be changed. It should also be understood that the terms used in this disclosure are only for the purpose of describing the specific examples described herein and are not intended to be limiting.

[0179] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Additionally, in any of the examples, any single feature or combination of features may form additional examples.

[0180] 4.1 Treatment

[0181] In one form, the present technology includes a method for treating a respiratory disorder, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0182] In certain examples of the present technology, an air supply under positive pressure is provided to the nasal passages of the patient via one or both nostrils.

[0183] In certain examples of the present technology, mouth breathing is defined, restricted or prevented.

[0184] 4.2 Respiratory Therapy System

[0185] In one form, the present technology includes a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may include an RPT device 4000 for supplying an air stream to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0186] 4.3 Patient Interface

[0187] The non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflation chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 in one form for connection to the air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the inlet of the patient's airway so as to maintain positive pressure at the airway inlet of the patient 1000. The sealed patient interface 3000 is thus suitable for the delivery of positive pressure therapy.

[0188] An unsealed patient interface 3800 in the form of a nasal cannula includes nasal tips 3810a, 3810b that can deliver air to the respective nostrils of a patient 1000 via respective orifices in their tips. Such nasal cannulas typically do not form a seal with the inner or outer skin surfaces of the nostrils. This type of interface results in one or more gaps that are present by design (intentional) during use, but they are typically not fixed in size such that they may vary unpredictably during use due to movement. Different from other types of mask-based respiratory therapy systems, this can provide complex pneumatic variables for a respiratory therapy system when implementing pneumatic control and / or assessment. Air can be delivered to these nasal cannulas via one or more air supply lumens 3820a, 3820b coupled to the nasal cannula-type unsealed patient interface 3800. The lumens 3820a, 3820b lead from the nasal cannula-type unsealed patient interface 3800 to a respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivering flow therapy, where the RPT device generates an air flow at a controlled flow rate rather than a controlled pressure. At the "vent" or gap at the unsealed patient interface 3800, excess air flow escapes to the surrounding environment through this vent, which is a passage leading to the atmosphere via the patient's nostrils between the ends of the cannulas 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800.

[0189] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0190] A patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 6 cm H2O relative to the environment.

[0191] A patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 10 cm H2O relative to the environment.

[0192] A patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 20 cm H2O relative to the environment.

[0193] 4.3.1 Seal-forming structure

[0194] In one form of the present technology, a seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The area where the actual seal occurs - the actual seal surface - can vary from day to day and from patient to patient during a given treatment course, depending on a series of factors, including for example the position where the patient interface is placed on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0195] In one form, the target seal-forming region is located on the outer surface of the seal-forming structure 3100.

[0196] In certain forms of the present technology, the seal-forming structure 3100 is composed of a biocompatible material such as silicone rubber.

[0197] The seal-forming structure 3100 according to the present technology can be constructed from a soft, flexible and resilient material such as silicone.

[0198] In certain forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each seal-forming structure being configured to correspond to a different range of sizes and / or shapes. For example, the system can include one form of seal-forming structure 3100 that is suitable for a large-sized head but not for a small-sized head, and another that is suitable for a small-sized head but not for a large-sized head.

[0199] 4.3.1.1 Sealing mechanism

[0200] In one form, the seal-forming structure includes a seal flange that utilizes a pressure-assisted sealing mechanism. In use, the seal flange can readily respond to the system positive pressure acting on its bottom surface inside the inflatable chamber 3200, thereby making a tight sealing engagement with the face. This pressure-assisted mechanism can act together with the elastic tension in the positioning and stabilizing structure.

[0201] In one form, the seal-forming structure 3100 includes a seal flange and a support flange. The seal flange includes a relatively thin member having a thickness less than about 1 mm, for example about 0.25 mm to about 0.45 mm, that extends around the perimeter of the inflatable chamber 3200. The support flange can be relatively thicker than the seal flange. The support flange is disposed between the seal flange and the edge of the inflatable chamber 3200 and extends around at least a portion of the perimeter path. The support flange is or includes a spring-like element and serves to support the seal flange against bending in use.

[0202] In one form, the seal-forming structure can include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged to be in a compressed state, for example as a result of the elastic tension in the positioning and stabilizing structure.

[0203] In one form, the seal-forming structure includes a tensioning portion. In use, the tensioning portion is kept in tension, for example, by adjacent regions of the seal flange.

[0204] In one form, the seal-forming structure includes a region having a sticky or adhesive surface.

[0205] In some forms of the present technology, the seal-forming structure may include one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tensioning portion, and a portion having a sticky or adhesive surface.

[0206] 4.3.1.2 Upper lip region

[0207] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0208] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip region of the patient's face during use.

[0209] 4.3.1.3 Chin region

[0210] In one form, the non-invasive patient interface 3000 includes a seal-forming structure that forms a seal on the chin region of the patient's face during use.

[0211] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the chin region of the patient's face during use.

[0212] 4.3.1.4 Nasal pillows

[0213] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal jets or nasal pillows, each nasal jet or nasal pillow being configured and arranged to form a seal with a respective nostril of the patient's nose.

[0214] The nasal pillow according to one aspect of the present technology includes: a frustum of a cone that forms a seal on at least a portion of the bottom surface of the patient's nose; a stem; a flexible region on the bottom surface of the frustum of the cone that connects the frustum of the cone to the stem. In addition, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the bottom of the stem. The flexible regions may act together to facilitate a universal engagement structure that is capable of accommodating relative movement in both displacement and angle between the frustum of the cone and the structure to which the nasal pillow is connected. For example, the position of the frustum of the cone may be axially moved towards the structure to which the stem is connected.

[0215] 4.3.2 Inflatable chamber

[0216] In the region that forms a seal during use, the inflatable chamber 3200 has a perimeter that is shaped to complement the surface profile of an average human face. In use, the bounding edge of the inflatable chamber 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend along the entire perimeter of the inflatable chamber 3200 during use. In some forms, the inflatable chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous sheet of material.

[0217] In certain forms of the technology, the inflatable chamber 3200 does not cover the patient's eyes during use. In other words, these eyes are outside of the pressurized volume defined by the inflatable chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with the treatment.

[0218] In certain forms of the technology, the wall 3211 that defines at least a portion of the inflatable chamber 3200 is constructed of a transparent material (e.g., clear polycarbonate). The use of a transparent material can reduce the profile of the patient interface and help improve compliance with the treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functioning.

[0219] In certain forms of the technology, the wall 3211 that defines at least a portion of the inflatable chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the profile of the patient interface and help improve compliance with the treatment.

[0220] 4.3.3 Body

[0221] Figure 6 An exemplary patient interface 3000 is shown in accordance with one aspect of the technology. As shown, the patient interface includes a body 3010 and a positioning and stabilization structure 3300 that supports the body 3010. It should be understood that the patient interface 3000 can also be referred to as a patient interface assembly. When the patient interface 3000 is referred to as a patient interface assembly, the body 3010 can be referred to as the patient interface.

[0222] See Figure 7 , the body 3010 can include a seal-forming structure 3100 and a wall 3211 that defines the inflatable chamber 3200. It is contemplated that the body 3010 can also be referred to as the core of the patient interface 3000. The body 3010 can also be referred to as a gasket and housing assembly, a gasket and frame assembly, or a gasket / frame, where the seal-forming structure 3100 forms the gasket portion and the wall 3211 forms the housing or frame portion. It is contemplated that the wall 3211 can also be referred to as a frame or housing.

[0223] The wall 3211 may form at least a portion of the front side of the inflatable chamber 3200. Additionally, the positioning and stabilization structure 3300 may be connected to the main body 3010 at the wall 3211. In particular, the wall 3211 may include a pair of upper headband connectors 3221 and a pair of lower headband connectors 3231, which are located at positions below the upper headband connectors 3221.

[0224] The upper headband connectors 3221 may be located on opposite lateral sides of the center of the main body 3010. Additionally, the upper headband connectors 3221 may be configured to connect to corresponding upper headband straps and / or conduits of the positioning and stabilization structure 3300. The upper headband connectors 3221 may be in the form of openings in the wall 3211 and may serve as gas or air inlets for the inflatable chamber 3200. In other words, pressurized breathing gas from the RPT device 4000 may enter the main body 3010 through the upper headband connectors 3221. Additionally, the upper headband connectors 3221 may form part of a magnetic connection and / or a mechanical connection with the corresponding upper headband straps and / or conduits.

[0225] The lower headband connectors 3231 may be located on opposite lateral sides of the center of the main body 3010. Additionally, the lower headband connectors may be configured to correspond to the lower headband straps and / or conduits of the positioning and stabilization structure 3300. The lower headband connectors 3231 may have a different structure and may be connected to the positioning and stabilization structure 3300 differently from the upper headband connectors 3221. The lower headband connectors 3231 may form part of a magnetic connection and / or a mechanical connection with the corresponding lower headband straps and / or conduits. Additionally, it is contemplated that the lower headband connectors 3231 may be rotatable and / or elastically flexible. Additionally, although the lower headband connectors 3231 are shown as components on the wall 3211 (see Figure 6 and 7 ), it is contemplated that the lower headband connectors 3231 may be openings in the wall 3211.

[0226] In some configurations, the upper headband connectors 3221 or the lower headband connectors 3231 may be omitted. In a configuration having only the lower headband connectors 3231, the lower headband connectors 3231 may be openings in the wall 3211, which serve as air / gas inlets into the inflatable chamber 3200. It is also contemplated that the structures of the upper headband connectors 3221 and the lower headband connectors 3231 may be interchanged. That is, the lower headband connectors 3231 may be openings in the wall 3211, and the upper headband connectors 3221 may be located on the wall 3211.

[0227] It is contemplated that the wall 3211 may have any number of shapes. An exemplary shape is shown in Figure 6 and 7 . Figure 6 and 7The exemplary shape of the wall 3211 has a lower side and an upper side that are farther apart at the lateral sides than at the central portion. It is also contemplated that the wall 3211 can be curved such that the inner side of the wall 3211 (i.e., the side facing the inflation chamber 3200) is concave while the outer side of the wall 3211 (i.e., the side facing away from the inflation chamber 3200) is convex. Thus, the entire outer surface of the wall 3211 can be dome-shaped.

[0228] The seal forming structure 3100 can be in the form of a flexible mouth-nose gasket that can include a mouth (or oral) portion 3105 configured to seal around the patient's mouth and can include a nasal portion 3110 configured to seal the patient's nostrils.

[0229] The mouth portion 3105 can cooperate with the wall 3211 to form the inflation chamber 3200. Additionally, the mouth portion 3105 can include a first opening 3115 that receives the wall 3211. The lower side and the upper side of the first opening 3115 can be farther apart at the lateral sides than at the central portion. The wall 3211 can be fixed to the mouth portion 3105 by sonic welding, adhesives, mechanical bonding, or mechanical fasteners. It is also contemplated that the wall 3211 can be molded onto the mouth portion 3105.

[0230] The mouth portion 3105 can include a continuous target seal forming area around the patient's mouth that is configured to engage the patient's upper lip and the patient's chin. The mouth portion 3105 can include a seal flap on the rear side that forms an edge around a second opening 3120 (see Figure 8 ). The second opening 3120 can be positioned such that pressurized breathing gas flowing through the second opening 3120 is discharged directly into the patient's mouth during use.

[0231] Furthermore, it is contemplated that the seal flap can be saddle-shaped in the region where it intersects the plane that bisects the body 3010 into a right side and a left side (or the sagittal plane of the patient). That is, both the central upper side and the central lower side of the seal flap can be saddle-shaped. Additionally, each saddle-shaped portion of the seal flap can be positioned between dome-shaped regions. Additionally, the lateral sides of the seal flap can have a cylindrical shape and can be positioned between opposing dome-shaped regions.

[0232] It is contemplated that the mouth 3105 can include a third opening 3125 configured to receive the vent assembly 3400. The third opening 3125 can be located on the forward-facing side of the mouth portion 3105. The vent assembly 3400 will be described in more detail later. It is contemplated that the surface of the mouth portion 3105 around the third opening can be dome-shaped.

[0233] The superior (or upper) surface of the mouth portion 3105 may form a receiving portion 3130 configured to receive the nose portion 3110. The container 3130 may be in the form of a recess in the mouth portion 3105 and may be referred to as any type of recess, such as a pocket, notch, bowl, slot, basin, trough.

[0234] The container 3130 may include a base 3135 at the base of the container 3130 and at least one side wall 3140 extending from the base 3135, the at least one side wall 3140 terminating at an outer rim 3145 of the container 3130. The base 3135 and the at least one side wall 3140 may form a receiving space 3150 for receiving the nose portion 3110. The receiving space 3150 may be shaped such that the perimeter of the container 3130 at the outer edge 3145 is greater than the perimeter of the container 3130 at the base 3135. Additionally, the receiving space 3150 may be separated from the inflation chamber 3200 by the base 3135 and the at least one side wall 3140. Further, a fourth opening 3155 of the mouth portion 3105 may be located in the base 3135. Pressurized breathing gas in the inflation chamber 3200 may be discharged through the fourth opening 3155 into the nose portion 3110.

[0235] Figure 8 A substantially trapezoidal fourth opening 3155 is shown. However, the fourth opening 3155 may have any shape that allows the flow of pressurized breathing gas to discharge from the inflation chamber 3200. Additionally, it is contemplated that the edge surrounding the fourth opening 3155 may be saddle-shaped, while the outer edge 3145 may include alternating cylindrical and domed regions. A groove may be formed between the saddle-shaped edge and the domed and cylindrical outer edges. Alternatively, the base 3135 of the container 3130 may be flat and / or planar such that the container 3130 does not have a groove. The shape of the container 3130 may allow the nose portion 3110 to be positioned closer to the central portion of the body 3010 to form a more compact structure when the nose portion 3110 is secured to the mouth portion 3105.

[0236] It is contemplated that a wall 3211 (or housing) may extend over the upper side of the mouth portion 3105 such that the wall 3211 forms the receiving portion 3130 and includes the fourth opening 3155. The above-described shape also applies to the fourth opening 3155 and the container 3130 formed by the wall 3211.

[0237] The nasal portion 3110 may include a nasal base 3160 and a pair of nasal pillows 3165 extending from the nasal base 3160. The nasal base 3160 may be a hollow body forming a nasal inflation chamber 3170. In addition, at least a portion of the nasal base 3160 may have a shape complementary to the shape of at least one side wall 3140 of the container 3130. It is contemplated that the nasal base 3160 may be made of a soft, flexible, elastic material, such as silicone. Accordingly, the nasal base 3160 may be configured to conform to the shape of at least one side wall 3140 of the receiving portion 3130 when the nasal base 3160 is received in the receiving portion 3130.

[0238] The central portion of the nasal base 3160 (including the portion between the nasal pillows 3165) may have a saddle shape. In addition, the sides of the nasal base 3160 may be dome-shaped.

[0239] The inlet 3175 may be located on the side of the nasal base 3160 opposite the nasal pillows 3165. It is contemplated that the inlet 3175 may have a shape and size similar to or the same as the fourth opening 3155 in the mouth portion 3105. In addition, when the nasal portion 3110 is fixed to the mouth portion 3105, the inlet opening 3175 may be aligned with the fourth opening 3155 such that the pressurized breathing gas in the inflation chamber 3200 can flow through the fourth opening 3155 to the inlet opening 3175 and enter the nasal inflation chamber 3170. In addition, the surface of the nasal base 3160 surrounding the inlet 3175 may be planar or flat.

[0240] The pair of nasal pillows 3165 may form a seal with the interior of the patient's nostrils and / or the underside of the patient's nose. Additionally, the pair of nasal pillows 3165 may be integrally formed with the nasal base 3160. Alternatively, each nasal pillow 3165 may be detachable from the nasal base 3160. In yet another alternative configuration, the nasal pillows 3165 may be removed from the nasal base 3160 as a unit.

[0241] The nasal pillow 3165 may include an opening through which the pressurized breathing gas may be discharged into the patient's nasal passage. The surface (edge) surrounding the opening in the nasal pillow 3165 may be saddle-shaped. Moreover, it is contemplated that the nasal pillow may have a double-wall structure (as shown in Figure 9 , 13 , 21 and 22) or a single-wall structure (not shown).

[0242] The nasal portion 3110 may be fixed to the mouth portion 3105 by any number of methods. For example, the nasal portion 3110 may be fixed to the mouth portion 3105 by a clip or a magnetic connection.

[0243] 4.3.3.1 Clip connection

[0244] In Figures 9 - 18In one aspect of the disclosed technology, the nasal portion 3110 can be fixed to the oral portion 3105 by a clip (or gasket clip) 6000. The clip 6000 can be in the form of a tubular structure with open ends. The clip 6000 can have a cavity (or aperture) 6005 that extends from one end to the other and forms an airflow path through the clip 6000. The lumen can have a central longitudinal axis 6007. Additionally, the clip can be formed of a rigid and / or molded material, such as plastic. Alternatively, the clip 6000 can be formed of a flexible material, such as silicone.

[0245] The clip 6000 can be fixed to the nasal base 3160 by an interference fit, where the structures on the clip 6000 and the nasal base 3160 can interlock. For example, a portion of the clip 6000 can be inserted inside the nasal base 3160 such that one or more features on the outer surface of the clip 6000 can interlock with one or more features on the inner surface of the nasal base 3160. It is contemplated that the clip 6000 can be fixed to the nasal base 3160 by any other method, such as a threaded connection, a bayonet connection, a magnetic connection, a snap-fit connection, etc. The clip 6000 can also be fixed to the nasal base 3160 by any combination of the above connection types. Additionally, for configurations where the clip 6000 is permanently attached to the nasal base 3160, the clip 6000 can be attached to the nasal base 3160 by an adhesive, chemical bonding, co-molding, or any other permanent connection method.

[0246] It is contemplated that in some configurations, the edge of the inlet opening 3175 of the nasal base 3160 can form part of the interference fit and can be in the form of an inwardly projecting flange (or lip) 3180. The flange 3180 can taper towards the free end of the flange 3180 such that the flange 3180 is thickest closest to its base at the sidewall 3182 and thinnest at its free end.

[0247] Additionally, as can be seen in Figure 9A the flange 3180 can have an asymmetric cross-sectional shape. Specifically, the flange 3180 can have a first side 3185 facing the nasal pillow 3165 and a second side 3190 facing away from the nasal pillow 3165. The first side 3185 can form a first angle α with a line 3195 that extends through the furthest extent of the flange 3180 and is perpendicular to the sidewall 3182. The second side 3190 can form a second angle β with the line 3195. The angle α can be less than the angle β such that the taper of the second side 3190 is greater than the taper of the first side 3185.

[0248] Clip 6000 can be bisected by an intermediate flange 6010 on the outer surface of clip 6000 that is remote from the lumen 6005 and extends radially around the perimeter of clip 6000. Additionally, clip 6000 can include a first end flange (or nose end flange) 6015 on one side of intermediate flange 6010 and a second end flange (or mouth end flange) 6020 on the other side of intermediate flange 6010. Intermediate flange 6010 and first end flange 6015 together can form a first channel (or first groove or first trough) 6025 that is configured to receive flange 3180 of nasal base 3160. Additionally, intermediate flange 6010 and second end flange 6020 together can form a second channel (or second groove or second trough) 6030 that is configured to receive a portion of container 3130.

[0249] Intermediate flange 6010 can be a continuous structure that completely surrounds lumen 6005. Alternatively, intermediate flange 6010 can be a discontinuous structure and / or can only partially extend around lumen 6005 (e.g., partially around lumen 6005). Additionally, intermediate flange 6010 can taper towards the free end of intermediate flange 6010. Thus, intermediate flange 6010 can be thickest at its closest point to lumen 6005 and thinnest at its free end.

[0250] As Figure 9B shown, intermediate flange 6010 can have an asymmetric cross-sectional shape. Specifically, intermediate flange 6010 can have a first side (or nose-facing side) 6035 that forms part of first channel 6025. Intermediate flange 6010 can have a second side (or mouth portion-facing side) 6040 that forms part of second channel 6030. First side 6035 can form an angle γ with a line 6045 that extends through the free end of intermediate flange 6010 and is perpendicular to the sidewall 6047 of lumen 6005. Second side 6040 can form an angle δ with line 6045. Angle γ can be greater than angle δ such that the taper of first side 6035 is greater than the taper of second side 6040.

[0251] Similar to intermediate flange 6010, first end flange 6015 can also be tapered ( Figure 9C ). Specifically, the channel side 6050 of first end flange 6015 can form an angle φ with a line 6055 that extends through the furthest extension of first end flange 6015 and is perpendicular to sidewall 6047. The taper angle of channel side 6050 can match the taper angle of the first side 3185 of flange 3180. Additionally, the taper angle of the first side 6035 of intermediate flange 6010 can match the taper angle of the second side 3190 of flange 3180. In this way, the shape of the first channel 6025 of clip 6000 can be complementary to the shape of flange 3180.

[0252] When the clip 6000 is inserted into the nasal base 3160 to connect the clip 6000 to the nasal base 3160, the flange 3180 can be received within the first channel 6025. Since the shape of the first channel 6025 can be complementary to the shape of the flange 3180, the flange 3180 can form an airtight seal with the first end flange 6015 and the intermediate flange 6010. In addition, the flange 3180 can resist movement of the clip 6000 relative to the nasal base 3160 along the central longitudinal axis 6007 (i.e., axial movement of the clip 6000).

[0253] It should be understood that the asymmetric cross-section of the flange 3180 allows the clip 6000 to be pushed into the nasal base 3160 with a force less than the force required to remove the clip 6000 from the nasal base 3160. In other words, the flange 3180 can provide greater resistance to removing the clip 6000 from the nasal base 3160 than to inserting the clip 6000 into the nasal base 3160. Specifically, the larger taper angle of the second side 3190 of the flange 3180 can provide less resistance to the insertion (inward movement) of the first end flange 6015 of the clip 6000 than the first side 3185 provides to the removal (outward movement) of the first end flange 6015 of the clip 6000.

[0254] It is contemplated that the clip 6000 can optionally include a pair of wings (or extensions or auxiliary flanges) 6060, which can enhance the holding force for keeping the clip 6000 fixed to the nasal base 3160. In one example, a form of the clip 6000 without the wings 6060 can have a holding force between 10 N and 12 N. In other words, at least 10 to 12 N is required to remove the clip 6000 without the wings 6060 from the nasal base 3160. On the other hand, a form of the clip 6000 with the wings 6060 can have a holding force between 19 N and 20 N. In other words, at least 19 to 20 N may be required to remove the clip 6000 with the wings 6060 from the nasal base 3160. Thus, in the example provided above, the wings 6060 increase the holding force for keeping the clip 6000 fixed to the nasal base 3160 by up to 100% (i.e., double the holding force).

[0255] As Figure 14As shown, each wing 6060 can extend from the nasal pillow facing side 6065 of the first end flange 6015. Additionally, the wings 6060 can be positioned on opposite lateral sides of the clip 6000 such that the lumen 6005 is between the two wings 6060. The base 6070 of each wing 6060 can extend around one side of the lumen 6005 from the front side of the first end flange 6015 to the rear side of the first end flange 6015. Thus, the end 6075 of the base 6070 can be closest to the central longitudinal axis 6007 of the lumen 6005, while the middle of the base 6070 can be farthest from the central longitudinal axis 6007 of the lumen 6005. Further, the extent to which each wing 6060 projects from the first end flange 6015 can gradually increase from each end 6075 of the base 6070 to a maximum distance at the middle portion of the wing 6060.

[0256] Each wing 6060 can be oriented such that each wing 6060 extends from the first end flange 6015 in both the axial and lateral directions such that each wing 6060 extends beyond the first end flange 6015 in both the lateral and axial directions. Additionally, the outer surface of the wing 6060 can engage the lateral side of the inner surface of the nasal inflation chamber 3170. It is contemplated that the shape of the outer surface of the wing 6060 can be complementary to the shape of the inner surface of the nasal inflation chamber 3170. Further, even after the clip 6000 is secured to the nasal inflation chamber 3170, the wings 6060 can remain unsecured (i.e., movable) relative to the sides of the nasal inflation chamber 3170. For example, if the nasal inflation chamber 3170 is compressed and portions of the inner surface of the nasal inflation chamber 3170 move or fold due to the compression of the nasal inflation chamber 3170, the wings 6060 can slide along the inner surface of the nasal inflation chamber 3170.

[0257] The wing 6060 can increase rigidity and provide support to the lateral sides of the nasal inflation chamber 3170, such that the lateral sides of the nasal inflation chamber 3170 have greater rigidity than the central front and rear sides. The height of the wing 6060 measured from the first end flange 6015 can increase towards the lateral sides of the clip 6000 and can decrease towards the central rear and central front sides of the clip 6000, such that the maximum height can be at the furthest lateral extent of the wing 6060. It is contemplated that the increase in height can be gradual and can form a curved shape at the edges of the wing 6060. In this way, the nasal inflation chamber 3170 is softer in the central region than on the lateral sides. By restricting the wing 6060 to the lateral sides of the nasal inflation chamber 3170 and by varying the height of the wing 6060, patient comfort can be maintained while also strengthening the connection between the nasal portion 3110 and the clip 6000. In particular, if the wing 6060 is positioned towards the central portion of the nasal inflation chamber 3170, or if the maximum height of the wing 6060 is positioned towards the central portion of the nasal inflation chamber 3170, then if the nasal inflation chamber 3170 is compressed, the wing 6060 will be more likely to press against the patient's upper lip or the tip of the nose. However, since the wing 6060 is located on the lateral sides of the nasal inflation chamber 3170, the wing 6060 is aligned on either side of the patient's nose and is less likely to press against any sensitive parts of the patient's face.

[0258] As Figure 17 shown, the clip 6000 can be similarly fixed to the mouth portion 3105 by an interference fit, where the structures on the clip 6000 and the container 3130 can be interlocked. For example, a portion of the clip 6000 can be inserted into the inflation chamber 3200 such that one or more features on the outer surface of the clip 6000 can be interlocked with one or more features on the surface of the container 3130. It is contemplated that the clip 6000 can be fixed to the mouth portion 3105 by any other method, such as a threaded connection, a bayonet connection, a magnetic connection, a snap-fit connection, etc. Additionally, the clip 6000 can be fixed to the mouth portion 3105 by any combination of the above connection types.

[0259] It is contemplated that in some configurations, the edge of the fourth opening 3155 of the container 3130 can form part of the interference fit and can be in the form of an inwardly projecting flange (or lip) 3197. The flange 3197 can taper towards the free end of the flange 3197 such that the flange 3197 is thickest at its base closest to at least one side wall 3140 and thinnest at its free end.

[0260] 4.3.3.2 Magnetic connection

[0261] In Figures 19 - 23In another aspect of the technology shown, the nasal portion 3110 can be fixed to the oral portion 3105 by a magnetic connection. The magnetic connection can be in the form of a pair of nasal module magnets 7000 located on the nasal base 3160 and a pair of container magnets 7005 located in the container 3130. Different from the clip connection, the magnetic connection can eliminate the rigid body between the flexible body of the nose 3110 and the mouth 3105. In other words, the magnetic connection can be a direct connection between flexible bodies.

[0262] As Figure 20 and 21 shown, the nasal module magnets 7000 can be located on opposite lateral sides of the nasal base 3160 such that the lumen 6005 is between the nasal module magnets 7000. Additionally, the nasal module magnets 7000 can be arranged such that one side of one magnet 7000 having a first polarity (i.e., north or south pole) faces generally the direction of the side of the other magnet 7000 having an opposite polarity. This will help position the nasal portion in the correct orientation when the nasal portion 3110 is attached to the oral portion 3105.

[0263] Furthermore, the edge around the inlet opening 3175 can include a lip seal 7010 that is configured to sealingly engage the base 3135 of the container 3130. It is contemplated that the nasal module magnets 7000 can be overmolded onto the side walls 3182 of the nasal base 3160. Alternatively, the nasal module magnets 7000 can be fixed to the nasal base 3160 by an adhesive, mechanical fasteners, or any other method that can secure the nasal module magnets 7000 to the nasal base 3160.

[0264] As Figure 22 and 23 shown, the container magnets 7005 can be located on opposite lateral sides of the container 3130 such that when the nasal portion 3110 is received within the container 3130, the nasal base 3160 is between the container magnets 7005. Additionally, similar to the nasal module magnets 7000, the container magnets 7005 can be arranged such that one side of one magnet 7005 having a first polarity (i.e., north or south pole) faces generally the direction of the side of the other magnet 7005 having an opposite polarity. This will help position the nasal portion 3110 in the correct orientation when the nasal portion 3110 is attached to the oral portion 3105.

[0265] Furthermore, the shape of the receiving space 3150 and the shape of the nasal base 3160 can be complementary such that when the nasal base 3160 is received in the receiving space 3150 in the correct orientation, each nasal module magnet 7000 automatically aligns with a corresponding one of the container magnets 7005.

[0266] It is contemplated that the container magnets 7005 can be overmolded onto at least one sidewall 3140 of the container 3130. Alternatively, these container magnets 7005 can be fixed to the mouth portion 3105 by an adhesive, mechanical fasteners, or any other method that can secure these container magnets 7005 to the mouth portion 3105.

[0267] When the nasal base 3160 is fully received within the container 3130, the lip seal 7010 can engage the edge of the fourth opening 3155 to form a seal. When the nasal base 3160 is fully received within the container 3130, the lip seal 7010 can be beneath the nasal module magnet 7000 and the container magnet 7005. Additionally, the nasal module magnet 7000 can be positioned between the container magnets. It should be understood that the magnetic force between the nasal module magnet 7000 and the container magnet 7005 can be sufficient to overcome the air pressure in the inflation chamber 3200 and maintain the lip seal 7010 in a sealed engagement with the edge of the fourth opening 3155.

[0268] As Figure 24 shown, the magnets 7000, 7005 can have a core 7015 in the form of an annular magnet. The outer diameter od of the core 7015 can be about 7 mm. The inner diameter id of the core 7015 can be approximately 2.5 mm. Additionally, the thickness t of the core 7015 can be about 2 mm. Although the core 7015 is shown as an annular magnet, the core 7015 can have other shapes, such as a disk, plate, or any other shape that allows for a sealed attachment of the nose portion 3110 to the mouth portion 3105. Additionally, the magnets 7000, 7005 can have a silicone rubber covering 7020 overmolded onto the core 7015. The silicone rubber covering 7020 can have a thickness of about 0.5 mm. It should be understood that the term "about" used to describe the above dimensions allows for manufacturing tolerances.

[0269] It is contemplated that each nasal module magnet 7000 can have a different polarity. Similarly, each container magnet 7005 can have a different polarity. Thus, if the nose portion 3110 is inserted into the container 3130 in the wrong direction, the repulsive magnetic force will prevent the nose portion 3110 from being fixed to the mouth portion 3105. It is contemplated that the magnets can be polarized and magnetized before or after being overmolded onto the nose portion 3110 or the mouth portion 3105.

[0270] 4.3.3.3 Alignment Indicator

[0271] As Figure 6 shown, the mouth portion 3105 can have a printed mark 8000 located near the edge of the container 3130. Meanwhile, the nasal base 3160 can have a printed mark 8005 that is positioned to align with the printed mark 8000 when the nose portion 3110 is correctly oriented within the container 3130.

[0272] It is contemplated that the clip 6000 may have a key connection with the container 3130. In particular, the clip 6000 may have a notch or recess 8010 that is complementary in shape to a protrusion or rib 8015 located on the edge of the fourth opening 3155. If the nose portion 3110 is positioned within the container 3130 in the wrong orientation, the tab 8015 may prevent the clip 6000 from being fixed to the container 3130. Alternatively, the rib 8015 may be located on the clip 6000 and the notch 8010 may be in the edge of the fourth opening 3155.

[0273] 4.3.4 Positioning and stabilizing structure

[0274] The seal-forming structure 3100 of the patient interface 3000 of the present technology can be maintained in a sealed state during use by the positioning and stabilizing structure 3300.

[0275] In one form, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the effect of the positive pressure in the inflation chamber 3200 to lift off the face.

[0276] In one form, the positioning and stabilizing structure 3300 provides a holding force to overcome the effect of gravity on the patient interface 3000.

[0277] In one form, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential impact of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0278] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a smaller side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0279] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to not be so large and bulky as to prevent the patient from lying in a supine sleeping position, where the back region of the patient's head is on the pillow.

[0280] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured to not be so large and bulky as to prevent the patient from lying in a side sleeping position, where the side region of the patient's head is on the pillow.

[0281] In one form of the present technology, the positioning and stabilization structure 3300 is provided with a decoupling portion between the front portion of the positioning and stabilization structure 3300 and the rear portion of the positioning and stabilization structure 3300. The decoupling portion does not resist compression and can be, for example, a flexible band or a soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, the presence of the decoupling portion prevents the force acting on the rear portion from being transmitted along the positioning and stabilization structure 3300 and breaking the seal.

[0282] In one form of the present technology, the positioning and stabilization structure 3300 includes a strap constructed of a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer includes a loop material for engaging with a hook material portion.

[0283] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap that is extendable, such as elastically extendable. For example, the strap can be constructed to be in a tensioned state during use and to direct forces to cause the seal forming structure to make sealing contact with a portion of the patient's face. In an example, the strap can be configured as a lace.

[0284] In one form of the present technology, the positioning and stabilization structure includes a first lace that is constructed and arranged such that in use, at least a portion of the lower edge of the first lace passes over the upper ear base of the patient's head and covers a portion of the parietal bone without covering the occipital bone.

[0285] In one form of the present technology applicable to a nasal mask only or a full face mask, the positioning and stabilization structure includes a second lace that is constructed and arranged such that in use, at least a portion of the upper edge of the second lace passes under the lower ear base of the patient's head and covers or is located under the occipital bone of the patient's head.

[0286] In one form of the present technology applicable to a nasal mask only or a full face mask, the positioning and stabilization structure includes a third lace that is constructed and arranged to interconnect the first lace and the second lace to reduce the tendency of the first lace and the second lace to separate from each other.

[0287] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap that is bendable and, for example, non-rigid. The advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0288] In certain forms of the present technology, the positioning and stabilization structure 3300 includes a strap constructed to be breathable to allow moisture to be transmitted through the strap.

[0289] In certain forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each positioning and stabilizing structure being configured to provide a holding force corresponding to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads and not for large-sized heads.

[0290] 4.3.4.1 Headband Tube

[0291] In some forms of the present technology, the positioning and stabilizing structure 3300 includes one or more tubes 3350 that convey pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through the body 3010. Figure 6 In the form of the present technology shown, the positioning and stabilizing structure 3300 includes two tubes 3350 that convey air from the air circuit 4170 to the seal-forming structure 3100. The tubes 3350 can be an integral part of the positioning and stabilizing structure 3300 of the patient interface 3000 to position and stabilize the seal-forming structure 3100 of the patient interface to an appropriate part of the patient's face (e.g., the nose and / or mouth). This allows a conduit of the air circuit 4170 that provides a pressurized air flow to be connected to a connection port 3600 of the patient interface, which is located at a position outside the patient's face, which may be unaesthetic for some people. While a pair of tubes 3350 has some advantages (described below), in some examples, the positioning and stabilizing structure 3300 may include only a single tube 3350 configured to cover one side of the patient's head. A strap or other stabilizing component can be provided on the other side of the patient's head between the top end of the single tube 3350 and the seal-forming structure 3100 to provide a balanced force on the seal-forming structure 3100.

[0292] Since air can be contained and passed through the headband tube 3350 to convey pressurized air from the air circuit 4170 to the patient's airway, the positioning and stabilizing structure 3300 can be described as inflatable. It can be understood that not all components of the inflatable positioning and stabilizing structure 3300 need to be inflatable. For example, Figure 6 in the example shown, the positioning and stabilizing structure 3300 includes an inflatable headband tube 3350 and a non-inflatable strap 3310.

[0293] In certain forms of the present technology, the patient interface 3000 may include a connection port 3600 located near the top, side, or rear of the patient's head. For example, Figure 6In the form of the present technology shown, the connection port 3600 is located at the top of the patient's head. In this example, the patient interface 3000 includes an elbow 3610, and the connection port 3600 is set to the elbow. The elbow 3610 can rotate relative to the positioning and stabilizing structure 3300 so as to separate the movement of the catheter connected to the connection port 3600 from the positioning and stabilizing structure 3300. Additionally or alternatively, the catheter connected to the connection port 3600 can rotate relative to the elbow 3610. In the example shown, the elbow 3610 includes a rotating catheter connector, and the catheter of the air circuit 4170 can be connected to the connection port, such that the catheter can rotate around its longitudinal axis relative to the elbow 3610.

[0294] Patient interfaces in which the connection port is not positioned in front of the patient's face may be advantageous because some patients find catheters connected to patient interfaces in front of the face to be unaesthetic and protruding. For example, catheters connected to patient interfaces in front of the face may be prone to tangling in bedding or sheets, especially if the catheter extends downward from the patient interface during use. Forms of the technology using patient interfaces with connection ports can make the patient more comfortable or easier in one or more of the following positions: lying on the side or in the lateral position; lying on the back (i.e., lying on the back with the face up); and lying face down (i.e., lying prone). In addition, connecting the catheter to the front of the patient interface exacerbates a problem called tube resistance, where the catheter can provide an undesirable resistance on the patient interface, resulting in displacement away from the face.

[0295] In Figure 6 In the form of the present technology shown, the positioning and stabilizing structure 3300 includes two tubes 3350, each tube 3350 is positioned on a different side of the patient's head during use and extends across the corresponding cheek area, above the corresponding ear (above the supraauricular base point of the patient's head) to the elbow 3610 on the top of the patient 1000's head. This form of technology may be advantageous because if the patient sleeps on their side and one of the tubes is compressed to block or partially block the gas flow along that tube, the other tube remains open to supply pressurized gas to the patient. In other examples of the technology, the patient interface 3000 can include a different number of tubes, such as one tube, or three or more tubes. In one example, where the patient interface has a tube 3350, the single tube 3350 is positioned on one side of the patient's head during use (e.g., across one cheek area) and the strap forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another area) to help fix the patient interface 3000 to the patient's head.

[0296] In Figure 6In the illustrated embodiment, two tubes 3350 are fluidly connected to each other at their upper ends and fluidly connected to a connection port 3600. In one embodiment, the two tubes are integrally formed, while in other embodiments, the tubes are separate components that are connected together in use and can be disconnected, for example, for cleaning or replacement. In the case of using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-shaped conduit having two conduit arms, each conduit arm being fluidly connected to a tube 3350, and a third conduit arm or opening serving as the connection port 3600 and being connectable in use to an air circuit 4170. The connection port 3600 can include an elbow 3610 fluidly received at the center of the two integrally formed tubes 3350.

[0297] The tubes 3350 can be formed of a semi-rigid material, such as an elastomeric material, such as silicone. For example, the tube 3350 extending from a non-extendable tube section 3363 on the left side to a non-extendable tube section 3363 on the right side can be formed (e.g., by molding) from a single homogeneous sheet of material (e.g., silicone). The tube can have a natural preformed shape and be capable of bending or moving into another shape if a force is applied to the tube. For example, the tube can be generally bow-shaped or curved, with a shape approximating the contour of the head between the top of the patient's head and the nose or oral region.

[0298] As described in U.S. Patent No. 6,044,844, the content of which is incorporated herein, if the tube 3350 is flattened during use (e.g., if it is flattened between the patient's face and a pillow), the tube can be crush-resistant to avoid the flow of breathable gas through the tube. In all cases, a crush-resistant tube may not be necessary because the pressurized gas in the tube can act as a splint to prevent or at least limit the crushing of the tube 3350 during use. A crush-resistant tube may be advantageous in the case where only a single tube 3350 is present, as in the event that the single tube becomes blocked during use, the flow of gas will be restricted and the therapeutic efficacy will cease or be reduced.

[0299] In some forms of the technology, one or more portions of tube 3350 can be rigidified by one or more rigidifying or stiffening elements. Examples of stiffening elements include: sections of tube 3350 that are relatively thicker than other sections; sections of tube 3350 formed from a material that is relatively more rigid than the material forming other sections; and rigid members that are attached to the interior, exterior, or embedded within sections of the tube. The use of such rigidifying elements helps to control how the positioning and stabilization structure 3300 functions in use, for example in situations where tube 3350 is more likely to deform when a force is applied to it and in situations where tube 3350 is more likely to maintain its shape when a force is applied. Thus, choosing the location within tube 3350 at which such a rigidifying element is positioned can help to improve comfort when wearing the patient interface 3000 and can help to maintain a good seal at the seal-forming structure 3100 during use. The rigidifying or stiffening element can be located within the positioning and stabilization structure 3300, which is configured to support a relatively heavy seal-forming structure, such as a full-face or nasal-oral cushion assembly.

[0300] Figure 6 The lengths of tubes 3350 in the illustrated forms of the technology are between 15 and 30 cm, respectively, such as between 20 and 27 cm, respectively. In one example, each tube is approximately 26 cm long. In another example, each tube is approximately 23 cm long. The length of the tube is chosen to be suitable for the size of a typical patient's head, such as the distance between the region near the top of the head where the upper end of tube 3350 is located and the region near the patient's airway opening when following a generally arcuate path down the sides of the head and through the patient's cheek region (such as Figure 6 as shown), where the lower end of tube 3350 is connected to the inflatable chamber 3211 at this opening. As described in more detail below, the patient interface 3000 is configured such that the length of tube 3350 can vary in some forms of the technology, and the above lengths can apply to the tube in a contracted, stretched, or neutral state. It should be understood that the length of tube 3350 will depend on the lengths of other components within the patient interface 3000, such as the length of the arm of the T-shaped conduit to which the upper end of tube 3350 is connected and / or the size of the inflatable chamber 3200.

[0301] 4.3.4.2 Headband Straps

[0302] In some forms of the present technology, the positioning and stabilization structure 3300 includes at least one headband strap in addition to tube 3350 for positioning and stabilizing the seal-forming structure 3100 in the sealed position at the patient airway inlet. As Figure 6As shown, the patient interface 3000 includes a strap 3310 that forms part of the positioning and stabilizing structure 3300. For example, the strap 3310 may be referred to as a back strap or a rear head strap. In other examples of the present technology, one or more additional straps may be provided. For example, the patient interface 3000 having a full face or nasal-oral cushion module according to an example of the present technology may have a second lower strap configured to cover the back of the patient's neck.

[0303] 4.3.5 Ventilation port

[0304] In one form, the patient interface 3000 includes a ventilation port 3400 that is constructed and arranged to allow the flushing of exhaled gases such as carbon dioxide.

[0305] In some forms, the ventilation port 3400 is configured to allow a continuous ventilation flow from the interior of the inflation chamber 3200 to the surrounding environment while the pressure in the inflation chamber is positive relative to the surrounding environment. The ventilation port 3400 is configured such that the ventilation port flow rate has an amplitude sufficient to reduce the patient's rebreathing of exhaled CO2 while maintaining the therapeutic pressure in the inflation chamber during use.

[0306] One form of the ventilation port 3400 according to the present technology includes a plurality of holes, for example, from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0307] The ventilation port 3400 may be located in the inflation chamber 3200. Alternatively, the ventilation port 3400 is located in a decoupling structure such as a rotary joint.

[0308] 4.3.5.1 Disposable ventilation port

[0309] In Figure 6 、 7 In one aspect of the technology shown in FIGS. 19 and 25 - 36, the ventilation port 3400 may allow the flushing of exhaled gases through a third opening 3125 in the mouth portion 3105. Additionally, the ventilation port 3400 may be located away from any air inlets into the inflation chamber 3200. For example, the ventilation port 3400 may be located within the third opening 3125 of the mouth portion 3105. Alternatively, the ventilation port 3400 may be located in another opening (not shown) in the wall 3211 that may allow the flushing of exhaled gases through the wall 3211. Preferably, the ventilation port 3400 may be configured to be permanently held within the third opening 3125. However, it is contemplated that the ventilation port 3400 may be removed from the third opening 3125 for cleaning.

[0310] The ventilation port 3400 may be an assembly including a body 3405, a lid 3410, and a diffuser 3415 sandwiched between the body 3405 and the lid 3410.

[0311] The body 3405 can be formed of a rigid material such as plastic and can be the portion of the vent 3400 that secures the vent 3400 to the mouthpiece portion 3105. The body 3405 can include a frame 3420 having features for securing the vent 3400 to the mouthpiece portion 3105 and a container (or holding portion) 3425 having a receiving space defined by the frame 3420.

[0312] The frame 3420 can include a first flange 3430 extending around the perimeter of the frame 3420. A second flange 3435 can be positioned opposite the first flange 3430. The first flange 3430 and the second flange 3435 can together form a channel 3440. When the vent 3400 is assembled to the mouthpiece portion 3105, at least a portion of the edge of the third opening 3125 can be received within the channel 3440 such that the first flange 3430 and the second flange 3435 can hold the frame 3420 in place within the third opening 3125. Additionally, the engagement of the first flange 3430 and the second flange 3435 with the edge of the third opening 3125 can form a seal such that exhaled gas can flow through the vent 3400 without flowing around the vent 3400.

[0313] Furthermore, it is contemplated that one or more gaps (or notches) 3445 can be present in the first flange 3430 and / or the second flange 3435. The gaps 3445 can be positioned, sized, and shaped to be complementary to tabs 3450 extending from the edge of the third opening 3125. When the frame 3420 is in the correct orientation, the tabs 3450 can be received by a corresponding one of these gaps 3445. When the frame 3420 is in the incorrect orientation, the tabs 3450 can prevent the frame 3420 from being received within the third opening 3125. It should be understood that the positions of the gaps 3445 and the tabs 3450 can be interchanged such that the gaps 3445 are located on the edge of the third opening 3125 and the tabs 3450 are located on the first flange 3430 and / or the second flange 3435. It is also contemplated that the vent 3400 can have other alignment indicators, such as printed markings.

[0314] The container 3425 can include a vent wall 3455 having a plurality of vent holes 3460. The container 3425 can also include one or more side walls 3465 that extend from the perimeter of the vent wall 3455 toward the second flange 3435. Additionally, a pair of fixing blocks 3470 can be located on opposite lateral sides of the container 3425.

[0315] It is contemplated that the profile of the vent wall 3455 is such that the side of the vent wall 3455 facing the interior of the container 3425 has a convex shape while the opposite side of the vent wall 3455 is concave. The plurality of vent holes 3460 can be arranged in any pattern. For example, as Figure 33As shown, the vent wall 3455 may include 16 vent holes 3460 arranged in two rows.

[0316] Each vent hole 3460 can be tapered toward the convex side of the vent wall 3455 (i.e., the side facing the container 3425 and away from the plenum 3200). In other words, when the exhausted gas is further away from the plenum 3200, the cross-sectional area of ​​the ventilation path through each vent hole 3460 can be reduced. Therefore, each vent hole 3460 can have a cross-sectional area larger than the cross-sectional area on the concave side of the vent wall 3455 (i.e., the side facing the plenum 3200) of the vent wall 3455. The cone angle θ of each vent hole 3460 (the angle formed by the side wall of the vent hole 3460) can be between 10 degrees and 35 degrees. For example, the cone angle θ can be 30.4 degrees or 14.0 degrees. In addition, the diameter D of each vent hole 3460 at the smaller end can be between 0.5 and 2 mm. For example, the diameter D can be 0.89, 0.98, 1.17 mm or 1.01 mm. The thickness H of the vent wall 3455 (and the height of each vent hole 3460) may be between 1.5 mm and 2.5 mm. For example, the thickness H may be 2.0 mm.

[0317] like Figure 28 As shown, each vent hole may flare outwardly on the larger side (ie, the side adjacent to the plenum 3200). The flared portion of the vent hole 3460 may have a radius of curvature R between 0.2 mm and 0.4 mm. For example, the radius of curvature may be 0.25 mm or 0.3 mm.

[0318] The cover 3410 can be secured to the body 3405 at the anchor block 3470. The cover 3410 can be secured by a friction fit, a snap fit, an adhesive, a mechanical fastener, or any other fastening method.

[0319] Each anchor block 3470 can be located on a lateral side of the body 3405 and can include a docking surface 3475 located inside the receptacle 3425 and offset from the vent wall 3455. The docking surface 3475 can have an anchor hole (receptacle) 3480 that receives a corresponding anchor peg (or anchor post) 3485 extending from the cover 3410. The anchor hole 3480 can be keyed to the sleeve peg 3485. In other words, the shape of the anchor hole 3480 can be complementary to the shape of the sleeve peg 3485. It is contemplated that the anchor hole 3480 can extend into the anchor block 3470 until the channel 3440 ( Figure 30 It is also contemplated that the anchor hole 3480 may extend beyond the channel 3440 and may narrow toward the bottom of the anchor hole 3480 ( Figure 36) Extending and narrowing the anchoring holes 3480 can allow for more surface contact and can allow the studs 3485 of the lid 3410 to fit more tightly and become more seated within the anchoring holes 3480, thereby increasing the holding force acting on the studs 3485. Additionally, each anchoring hole 3480 can have a different shape and / or size such that the stud 3485 cannot be inserted into the anchoring hole 3480 unless the lid 3410 is in the correct orientation.

[0320] As Figure 27 and 33 shown, the vent wall 3455 can include a first support strip 3490 that spans the lateral length of the vent wall 3455. The first support strip 3490 can extend from one anchoring block 3470 to another anchoring block 3470. A pair of second support strips 3495 can be positioned on opposite sides of the first support strip 3490 and can extend in a direction perpendicular to the first support strip 3490. When the diffuser 3415 is received within the container 3425, the diffuser 3415 can rest on the first support strip 3490 and the second support strips 3495. Accordingly, the diffuser 3415 can be spaced apart from the vent wall 3455 such that a space is maintained between the diffuser 3415 and the vent wall 3455. The first support strip 3490 and the pair of support strips 3495 can also have the effect of splitting the air flow as the expelled gas exits the vent holes 3460.

[0321] Because exhaled gas has a certain humidity, the diffuser 3415 tends to become wet when exhaled gas flows through it. Spacing the diffuser from the vent wall 3455 can allow the diffuser 3415 to dry between treatments, which in turn can prevent the growth of mold, bacteria, or other undesirable contaminants.

[0322] It is contemplated that the diffuser 3415 can be a continuum made of any porous material (such as open-cell foam, cotton, or any other fibrous material). It is also contemplated that the diffuser 3415 can be hydrophobic or hydrophilic.

[0323] As Figure 25 、 27As shown in FIGS. 31 and 32, the fixing block 3470 extends continuously or almost continuously to the second flange 3435. It is conceivable that the depth of the anchor block 3470 may be equal to or greater than the thickness of the diffuser 3415. In this way, attaching the cover 3410 to the body 3405 will not compress the diffuser 3415 or will not compress the diffuser beyond the desired and / or predetermined threshold, such that the air path within the diffuser 3415 is not restricted beyond the desired or predetermined limit. Additionally, the lateral sides of the diffuser 3415 may be shaped to complement the shape of the anchoring block 3470, such that the lateral sides of the diffuser 3415 may abut and / or conform to the anchoring block 3470 without being compressed beyond the desired and / or predetermined amount. In this way, the fixing block 3470 can prevent lateral movement of the diffuser 3415. Therefore, the size of the diffuser 3415 can be maximized and the diffuser 3415 can be fixed in place without compressing the diffuser 3415 or compressing the diffuser 3415 beyond the desired and / or predetermined amount.

[0324] After the diffuser 3415 has been received in the container 3425, the cover may be positioned on the body 3405 and the anchor holes 3480 may receive the bolts 3485 to fix the cover 3410 to the body 3405, thereby locking the diffuser 3415 in place. It should be understood that the cover 3410 may be anchored to the body 3405 at the lateral sides of the body 3405 such that the diffuser 3415 is positioned between the anchor points (or attachment mechanisms) that fix the cover 3410 to the body 2405.

[0325] The lid 3410 can have a solid surface without holes and can be smaller than the container 3425. Thus, when the lid 3410 is fixed to the body 3405, a gap 3497 is formed between the perimeter of the container 3425 and the perimeter of the lid 3410. The underside of the lid 3410 can also have a plurality of protrusions 3499. One protrusion 3499 can extend longitudinally across the central portion of the lid 3410. A pair of protrusions 3499 can extend transversely across the lateral sides of the lid 3410 (or perpendicular to the longitudinal protrusion 3499). It is contemplated that the longitudinal protrusion 3499 can extend from one lateral protrusion 3499 to the other lateral protrusion 3499. Additionally, the longitudinal protrusion 3499 can extend across the centerline of the lid 3410. The protrusions 3499 can have the effect of compressing the diffuser 3415 to a predetermined degree, thereby compressing the air path through the diffuser 3415. The protrusions 3499 can also act as flow splitters for the air flowing through the diffuser 3415. Thus, the flow path of the exhaled gas from the inflation chamber 3200 can flow through the vent holes 3460, through the diffuser 3415, and around the perimeter of the lid 3410. It is contemplated that the protrusions 3499 can have any cross-sectional shape. For example, the cross-sectional shape of the protrusions 3499 can be triangular. It is also contemplated that different protrusions 3499 can have different cross-sectional shapes or the same cross-sectional shape.

[0326] 4.3.5.2 Multi-purpose vent

[0327] In Figures 37 - 40 In another aspect of the technology shown, the vent 3400 can allow the flushing of exhaled gas through the third opening 3125 of the mouthpiece portion 3105. Additionally, the vent 3400 can be positioned away from any air inlets into the inflation chamber 3200. For example, the vent 3400 can be positioned within the third opening 3125 of the mouthpiece portion 3105. Alternatively, the vent 3400 can be positioned in another opening (not shown) in the wall 3211, which can allow the flushing of exhaled gas through the wall 3211. Preferably, in this configuration, the vent 3400 can be configured to be removable from the third opening 3125 for cleaning. However, it is contemplated that the vent hole 3400 can be permanently retained within the third opening 3125.

[0328] The vent 3400 can be an integral body having a body 3405 integrally formed with the lid 3410. In this configuration, the diffuser can be omitted. The vent 3400 can be formed from a rigid material (such as plastic). The body 3405 can be the portion of the vent 3400 that secures the vent 3400 to the mouthpiece portion 3105.

[0329] The body 3405 may include a first flange 3430 extending around the perimeter of the body 3405. A second flange 3435 may be positioned opposite the first flange 3430. The first flange 3430 and the second flange 3435 may together form a passage 3440. When the vent 3400 is assembled to the mouth portion 3105, at least a portion of the edge of the third opening 3125 may be received within the passage 3440 such that the first flange 3430 and the second flange 3435 may hold the body 3405 in place within the third opening 3125. Additionally, the engagement of the first flange 3430 and the second flange 3435 with the edge of the third opening 3125 may form a seal such that exhaled gas may flow through the vent 3400 without flowing around the vent 3400.

[0330] In addition, it is contemplated that one or more gaps (or notches) 3445 may be present in the first flange 3430 and / or the second flange 3435. The gaps 3445 may be positioned, sized, and shaped to be complementary to tabs 3450 extending from the edge of the third opening 3125. When the frame 3420 is in the correct orientation, the tabs 3450 may be received by a corresponding one of these gaps 3445. When the frame 3420 is in the incorrect orientation, the tabs 3450 may prevent the frame 3420 from being received within the third opening 3125. It should be understood that the positions of the gaps 3445 and the tabs 3450 may be interchanged such that the gaps 3445 are located on the edge of the third opening 3125 and the tabs 3450 are located on the first flange 3430 and / or the second flange 3435. It is also contemplated that the vent 3400 may have other alignment indicators, such as printed markings.

[0331] The cover 3410 may include a vent wall 3455 having a plurality of vent holes 3460. Additionally, the vent 3400 may include one or more sidewalls 3465 extending from the perimeter of the vent wall 3455 towards the first flange 3430. Thus, when the vent 3400 is secured to the mouth portion 3105, the cover 3410 may be spaced apart from the third opening 3125.

[0332] It is contemplated that the vent wall 3455 may be shaped such that the side of the vent wall 3455 facing the interior of the vent 3400 has a concave shape and the opposite side of the vent wall 3455 is convex. The plurality of vent holes 3460 may be arranged in any pattern. For example, as Figure 37 shown, the vent wall 3455 may include 20 vent holes 3460, where 16 vent holes 3460 are arranged in two rows and two additional rows of vent holes 3460 (two vent holes 3460 per row) are positioned on opposite sides of the two rows of 16 vent holes 3460.

[0333] Each vent hole 3460 may taper towards the convex side of the vent wall 3455 (i.e., the side facing away from the third opening 3125). In other words, as the discharged gas moves further away from the inflation chamber 3200, the cross-sectional area of the vent path passing through each vent hole 3460 may decrease. Thus, each vent hole 3460 may have a larger cross-sectional area on the concave side of the vent wall 3455 than on the convex side of the vent wall 3455 (i.e., the side facing the inflation chamber 3200). The taper angle θ (the angle formed by the side walls of the vent hole 3460) of each vent hole 3460 may be between 10 degrees and 35 degrees. For example, the taper angle θ may be 30.4 degrees or 14.0 degrees. Additionally, the diameter D of each vent hole 3460 at the smaller end may be between 0.5 and 2 mm. For example, the diameter D may be 0.89, 0.98, 1.17 mm, or 1.01 mm. The thickness of the vent wall 3455 (and the height of each vent hole 3460) H may be between 1.5 mm and 2.5 mm. For example, the thickness H may be 2.0 mm.

[0334] As Figure 38 shown, each vent hole may flare outwards on the larger side (i.e., the side adjacent to the inflation chamber 3200). The flared portion of the vent hole 3460 may have a radius of curvature R between 0.2 mm and 0.4 mm. For example, the radius of curvature may be 0.25 mm or 0.3 mm.

[0335] As described above, the cover 3410 may be integrally formed with the body 3405. In one configuration, the cover 3410 may have a smooth continuous surface. However, in another configuration, the outer surface of the cover 3410 may have a channel 3498 that completely surrounds the vent hole 3460. The channel 3498 may help reduce sink marks that may form during the manufacturing process.

[0336] 4.3.6 Decoupling Structure

[0337] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel axis or a ball and socket joint.

[0338] 4.3.7 Connection Port

[0339] The connection port 3600 allows connection to the air circuit 4170.

[0340] 4.3.8 Anti-Suffocation Valve

[0341] In one form, the patient interface 3000 includes an anti-suffocation valve.

[0342] 4.3.9 Port

[0343] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one form, this enables a clinician to supply supplemental oxygen. In one form, this enables the properties of the gas within the inflation chamber 3200, such as pressure, to be directly measured.

[0344] 4.4 RPT device

[0345] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300, such as all or part of the methods described herein. The RPT device 4000 can be configured to generate an air flow for delivery to a patient airway, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0346] In one form, the RPT device 4000 is constructed and arranged to be able to deliver an air flow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0347] The RPT device may have an external housing 4010 that consists of two parts: an upper part 4012 and a lower part 4014. Additionally, 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.

[0348] The pneumatic path of the RPT device 4000 may include one or more air path components, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air under positive pressure, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0349] One or more air path components may be provided within a detachable separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the external housing 4010. In one form, the pneumatic block 4020 is supported by the chassis 4016 or forms a part thereof.

[0350] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. 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.

[0351] 4.4.1 Mechanical and pneumatic components of the RPT device

[0352] 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 provided as separate units.

[0353] 4.4.1.1 Air filter

[0354] The RPT device according to one form of the present technology may include one air filter 4110, or multiple air filters 4110.

[0355] In one form, the inlet air filter 4112 is positioned at the starting point of the pneumatic path upstream of the pressure generator 4140.

[0356] In one form, the outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0357] 4.4.1.2 Silencer

[0358] The RPT device according to one form of the present technology may include one silencer 4120, or multiple silencers 4120.

[0359] In one form of the present technology, the inlet silencer 4122 is positioned in the pneumatic path upstream of the pressure generator 4140.

[0360] In one form of the present technology, the outlet silencer 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0361] 4.4.1.3 Pressure generator

[0362] In one form of the present technology, the pressure generator 4140 for generating an air flow or air supply under positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. These impellers may be located in a volute. The blower may deliver an air supply at a rate of, for example, up to about 120 liters per minute and at a positive pressure in the range of about 4 cm H2O to about 20 cm H2O or up to about 30 cm H2O in other forms, such as when delivering respiratory pressure therapy. The blower may be as 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 No. WO 2013 / 020167.

[0363] The pressure generator 4140 may be controlled by the therapy device controller 4240.

[0364] In other words, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0365] 4.4.1.4 Anti-backflow valve

[0366] In one form of the present technology, the anti-backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0367] 4.4.2 RPT device algorithms

[0368] As described above, in some forms of the present technology, the central controller 4230 may be configured to implement one or more algorithms 4300 represented as a computer program stored in a non-transitory computer-readable storage medium (such as the memory 4260). The algorithms 4300 are generally grouped into sets called modules.

[0369] In other forms of the present technology, some or all of algorithm 4300 can be implemented by a controller of an external device such as local external device 4288 or remote external device 4286. In such form, data representing input signals and / or intermediate algorithm outputs required for portions of algorithm 4300 to be executed at the external device can be transmitted to the external device via local external communication network 4284 or remote external communication network 4282. In such form, the portions of algorithm 4300 to be executed at the external device can be represented as a computer program stored in a non-transitory computer-readable storage medium accessible by the controller of the external device, such as processor control instructions executed by one or more processors. Such a program configures the controller of the external device to execute portions of algorithm 4300.

[0370] In such form, treatment parameters generated by the external device via treatment engine module 4320 (if such form a part of the portion of algorithm 4300 to be executed by the external device) can be transmitted to central controller 4230 for delivery to treatment control module 4330.

[0371] 4.5 Air Circuit

[0372] Air circuit 4170 according to one aspect of the present technology is a conduit or tube which, in use, is constructed and arranged to permit air flow to travel between two components such as RPT device 4000 and patient interface 3000 or 3800.

[0373] Specifically, air circuit 4170 can be in fluid connection with the outlet of pneumatic block 4020 and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches for the inhalation and exhalation circuits. In other cases, a single branch is used.

[0374] In some forms, air circuit 4170 can include one or more heating elements configured to heat the air in the air circuit, for example to maintain or raise the temperature of the air. The heating element can be in the form of a heating wire circuit and can include one or more transducers such as temperature sensors. In one form, the heating wire circuit can be helically wound around the axis of air circuit 4170. The heating element can be in communication with a controller such as central controller 4230. An example of air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which patent application is incorporated herein by reference in its entirety.

[0375] 4.6 Humidifier

[0376] 4.6.1 Humidifier Overview

[0377] In one form of the present technology, a humidifier 5000 is provided (e.g., as Figure 5A(as shown) to change the absolute humidity of the air or gas to be delivered to the patient relative to the ambient air. Generally, the humidifier 5000 is used to increase the absolute humidity of the air stream and increase the temperature of the air stream (relative to the ambient air) before it is delivered to the patient's airway.

[0378] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving the air stream, and a humidifier outlet 5004 for delivering the humidified air stream. In some forms, as Figure 5A and Figure 5B shown, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0379] 4.6.2 Humidifier Components

[0380] 4.6.2.1 Water Reservoir

[0381] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a liquid (e.g., water) volume to be evaporated for humidifying the air stream. The water reservoir 5110 may be configured to hold a predetermined maximum water volume to provide sufficient humidification for at least the duration of a breathing session, such as one night of sleep. Generally, the reservoir 5110 is configured to hold 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 such as a building's water supply system.

[0382] According to one aspect, the water reservoir 5110 is configured to increase the humidity of the air stream from the RPT device 4000 as the air stream travels through it. In one form, the water reservoir 5110 may be configured to facilitate the air stream traveling in a curved path through the reservoir 5110 while in contact with the water volume therein.

[0383] According to one form, the reservoir 5110 may be removed from the humidifier 5000, for example, in a lateral direction as shown in Figure 5A and Figure 5B shown.

[0384] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any orifice and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation. Since the air stream to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to avoid losses in pneumatic pressure due to leakage and / or flow impedance.

[0385] 4.6.2.2 Conductive part

[0386] According to one arrangement, the reservoir 5110 includes a conductive part 5120 configured to allow efficient transfer of heat from the heating element 5240 to the liquid volume in the reservoir 5110. In one form, the conductive part 5120 may be arranged as a plate, but other shapes may also be equally applicable. All or part of the conductive part 5120 may be made of a heat-conductive material such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm or 3 mm), another heat-conductive metal or some plastics. In some cases, appropriate heat conductivity may be achieved using a material with a lower conductivity and an appropriate geometry.

[0387] 4.6.2.3 Humidifier reservoir dock

[0388] In one form, the humidifier 5000 may include a humidifier reservoir dock 5130 (as Figure 5B shown), which is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may include a locking structure, such as a locking lever 5135 configured to hold the reservoir 5110 in the humidifier reservoir dock 5130.

[0389] 4.6.2.4 Water level indicator

[0390] The humidifier reservoir 5110 may include a water level indicator 5150 as Figures 5A - 5B shown. In some forms, the water level indicator 5150 may provide one or more indications to a user (such as the patient 1000 or a caregiver) regarding the amount of water volume in the humidifier reservoir 5110. One or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75% or a volume such as 200 ml, 300 ml or 400 ml.

[0391] 4.6.2.5 Heating element

[0392] In some cases, the heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more of the water volume in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 may include a heat-generating component, such as a resistive electric heating rail. A suitable example of the heating element 5240 is a laminated heating element, such as the laminated heating element described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0393] In some forms, the heating element 5240 may be disposed within the humidifier base 5006, where heat may be provided to the humidifier reservoir 5110 primarily by conduction as shown in Figure 5B .

[0394] 4.7 Terms

[0395] For purposes of implementing the present disclosure, one or more of the following definitions may be applied in certain forms of the present technology. In other forms of the present technology, alternative definitions may be applied.

[0396] 4.7.1 General

[0397] Air: In certain forms of the present technology, air may be considered to mean ambient air, and in other forms of the present technology, air may be considered to refer to some other combination of breathable gases, such as oxygen-enriched air.

[0398] Environment: In certain forms of the present technology, the term environment may have the following meanings (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0399] For example, the environment with respect to a humidifier Humidity may be the humidity of the air directly surrounding the humidifier, such as the humidity within the room in which the patient is sleeping. This environmental humidity may be different from the humidity outside the room in which the patient is sleeping.

[0400] In another example, the ambient pressure may be the pressure directly surrounding the body or outside the body.

[0401] In certain forms, environmental (e.g., acoustic) noise may be considered to be the background noise level in the room in which the patient is located, apart from, for example, noise generated by the RPT device or from the mask or patient interface. Environmental noise may be generated by a sound source outside the room.

[0402] Auto Positive Airway Pressure (APAP) Therapy: A CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum, e.g., varying with each breath, depending on whether an indication of an SBD event is present.

[0403] Continuous Positive Airway Pressure (CPAP) Therapy: A respiratory pressure therapy in which the therapy pressure may be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, e.g., increasing in response to detection of an indication of partial upper airway obstruction and decreasing in the absence of an indication of partial upper airway obstruction.

[0404] Flow: The volume (or mass) of air delivered per unit time. Flow can refer to an instantaneous quantity. In some cases, a reference to flow will be a reference to a scalar, i.e., a quantity having only magnitude. In other cases, a reference to flow will be a reference to a vector, i.e., a quantity having both magnitude and direction. Flow can be given the symbol Q. 'Flow' is sometimes simply abbreviated to 'flux' or 'airflow'.

[0405] In an example of patient breathing, the flow can be nominally positive for the inspiratory part of the patient's breathing cycle and thus negative for the expiratory part of the patient's breathing cycle. The device flow Qd is the air flow leaving the RPT device. The total flow Qt is the flow of air and any supplemental gas reaching the patient interface via the air circuit. The ventilation flow Qv is the air flow leaving the vent to allow flushing of exhaled gas. The leak flow Ql is the leak flow from the patient interface system or elsewhere. The respiratory flow Qr is the air flow received into the patient's respiratory system.

[0406] Flow therapy: A respiratory therapy that includes delivering an air stream to the airway inlet at a controlled flow rate known as the therapy flow, which is typically positive throughout the patient's breathing cycle.

[0407] Humidifier: The term humidifier will be considered to refer to a humidifying device that is constructed and arranged or configured with a physical structure that is capable of providing a therapeutically beneficial amount of water (H2O) vapor to an air stream to improve the patient's medical breathing condition.

[0408] Leak: The word leak will be considered an undesired air flow. In one instance, a leak can occur due to an incomplete seal between the mask and the patient's face. In another example, a leak can occur in a swivel elbow to the surrounding environment.

[0409] Noise, conducted (acoustic): Conducted noise in this document refers to noise brought to the patient through a pneumatic path such as the air circuit and the patient interface and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0410] Noise, radiated (acoustic): Radiated noise in this document refers to noise brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0411] Noise, ventilated (acoustic): Ventilated noise in this document refers to noise generated by the air flow through any vent such as the vent of the patient interface.

[0412] Oxygen-rich air: Air with an oxygen concentration greater than that of ambient air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. "Oxygen-rich air" is sometimes abbreviated to "oxygen".

[0413] Medical oxygen: Medical oxygen is defined as oxygen-rich air with an oxygen concentration of 80% or higher.

[0414] Patient: A person, whether or not they have a respiratory condition.

[0415] Pressure: Force per unit area. Pressure can be expressed in units including cmH2O, g-f / cm 2 , hectopascal. 1 cmH20 is equal to 1 g-f / cm 2 and is approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atmosphere (atm)). In this specification, unless otherwise stated, pressure is given in cm H2O units.

[0416] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained at the current moment through the interface pressure Pm.

[0417] Respiratory pressure therapy: Applying an air supply to the airway inlet at a treatment pressure that is typically positive relative to the atmosphere.

[0418] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0419] 4.7.1.1 Materials and Their Properties

[0420] (Indentation hardness (indentation hardness): A material property measured by the indentation of an indenter (e.g., as measured according to ASTM D2240).

[0421] "Soft" materials can include silicone or thermoplastic elastomer (TPE), and can be easily deformed, for example, under finger pressure.

[0422] "Hard" materials can include polycarbonate, polypropylene, steel, or aluminum, and are not easily deformed, for example, under finger pressure.

[0423] Silicone or silicone elastomer: a synthetic rubber. In this specification, reference to silicone refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (including the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is the Wacker Group. Unless otherwise specified to the contrary, an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of approximately 35 to approximately 45.

[0424] Polycarbonate: a transparent thermoplastic polymer that is a bisphenol A carbonate.

[0425] 4.7.1.2 Mechanics

[0426] Axis:

[0427] a. Neutral axis: the axis in the cross-section of a beam or plate where there is no longitudinal stress or strain.

[0428] b. Longitudinal axis

[0429] c. Circumferential axis

[0430] d. Radial axis

[0431] Deformation: the process by which the original geometry of a member changes when subjected to a force (such as a force in a direction relative to an axis). This process can include stretching or compression, bending, and twisting.

[0432] Stiffness: the ability of a structure or component to resist deformation in response to an applied load. A structure or component can have axial stiffness, bending stiffness, and torsional stiffness. A structure or component is considered rigid when it is not easily deformed when subjected to mechanical forces. The stiffness of a structure or component is related to its material properties and its shape. The reciprocal of stiffness is flexibility.

[0433] Elasticity: the ability of a material to return to its original geometry after deformation.

[0434] Viscosity: the ability of a material to resist flow.

[0435] Viscoelasticity: the ability of a material to exhibit both elastic and viscous behavior during deformation.

[0436] Yield: the situation when a material no longer returns to its original geometry after deformation.

[0437] 4.7.1.3 Structural elements

[0438] Thin structures:

[0439] a. Beams,

[0440] b. Membranes, plates, and shells

[0441] Thick structure: solid

[0442] Shell: A shell will be considered to mean a curved and relatively thin structure having bendable, stretchable, and compressible stiffness. For example, the curved structural wall of a face mask can be a shell. In some forms, the shell can be polyhedral. In some forms, the shell can be airtight. In some forms, the shell can not be airtight.

[0443] Membrane: A membrane will be considered to mean a typically thin element that preferably has substantially no resistance to bending but has resistance to stretching.

[0444] Load transfer member: A structural member that transfers a load from one location to another member.

[0445] Load support member: A structural member that transfers a load from one location to a non-structural item (such as a surface).

[0446] Tensile member: A structural element that resists tension

[0447] Tie (noun): A structure for resisting tension.

[0448] Compression member: A structural element that resists compressive forces.

[0449] Support: A support will be considered to be a structural part designed to increase the compressive resistance of another part in at least one direction. Reinforcement

[0450] Reinforcement: A reinforcement will be considered to mean a structural part designed to increase the bending resistance of another part in at least one direction.

[0451] Elbow: An elbow is an example of a structure that directs the axis of an air flow passing through it to change direction by a certain angle. In one form, the angle can be about 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have an approximately circular cross-section. In another form, the elbow can have an elliptical or rectangular cross-section. In certain forms, the elbow can rotate relative to a mating part, such as about 360 degrees. In certain forms, the elbow can be removable from the mating part, for example, via a snap connection. In certain forms, the elbow can be snap-assembled to the mating part during manufacturing but cannot be removed by the patient.

[0452] Frame: A frame will be considered to mean a face mask structure that bears the tension load between two or more connection points with a headband. The face mask frame can be a non-airtight load-bearing structure in the face mask. However, some forms of face mask frames can also be airtight.

[0453] Seal: It can refer to the noun form of the structure (seal), or the verb form of the effect (seal). Two components can be constructed and / or arranged to 'seal' or achieve 'sealing' therebetween without the need for a separate 'seal' component itself.

[0454] Swivel shaft (noun): A sub-component of a component configured to rotate about a common axis, preferably independently, preferably at low torque. In one form, the swivel shaft can be configured to rotate through an angle of at least 360 degrees. In another form, the swivel shaft can be configured to rotate through an angle of less than 360 degrees. When used in the case of an air delivery conduit, the sub-assembly of the component preferably includes a pair of matching cylindrical conduits. There can be little or no air flow leakage from the swivel shaft during use.

[0455] 4.7.2 Respiratory cycle

[0456] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a continuous period (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air flow even with the patient's efforts. Central apnea is considered to occur when apnea is detected despite the airway being open, but due to a reduction or absence of respiratory effort. Mixed apnea is considered to occur when a reduction or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0457] Respiratory rate: The rate of the patient's spontaneous breathing, which is typically measured as the number of breaths per minute.

[0458] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0459] Effort (respiratory): The work done by a spontaneous breather in attempting to breathe.

[0460] Expiratory part of the respiratory cycle: The time period from the start of expiratory flow to the start of inspiratory flow.

[0461] Flow limitation: Flow limitation will be considered a state in the patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. In the case where flow limitation occurs during the inspiratory part of the respiratory cycle, it can be described as inspiratory flow limitation. In the case where flow limitation occurs during the expiratory part of the respiratory cycle, it can be described as expiratory flow limitation.

[0462] Type of inspiratory waveform of flow limitation:

[0463] (i) Flattened: Having one rise, followed by a relatively flat part, and then a decline.

[0464] (ii) M-shaped: having two local peaks, one at the leading edge and one at the trailing edge, and having a relatively flat portion between the two peaks.

[0465] (iii) Chair-shaped: having a single local peak, the peak being at the leading edge and then a relatively flat portion.

[0466] (iv) Reverse chair-shaped: having a relatively flat portion and then a single local peak, the peak being located at the trailing edge.

[0467] Hypopnea: According to some definitions, hypopnea will be considered a decrease in flow rather than a cessation of flow. In one form, hypopnea can be considered to occur when the flow drops below a threshold rate for a period of time. Central hypopnea is considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following can be considered hypopnea:

[0468] (i) The patient's respiration decreases by 30% for at least 10 seconds plus associated 4% desaturation; or

[0469] (ii) The patient's respiration decreases (but less than 50%) for at least 10 seconds, accompanied by associated desaturation or arousal of at least 3%.

[0470] Hyperpnea: The flow increases to a level higher than normal.

[0471] Inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0472] Openness (of the airway): The degree to which the airway is open or the extent to which the airway is open. An open airway is unobstructed. Airway openness can be quantified, for example, with a value of (1) for open and a value of zero (0) for closed (obstructed).

[0473] Positive end-expiratory pressure (PEEP): The pressure in the lungs at the end of expiration that is above atmospheric pressure.

[0474] Peak flow (Qpeak): The maximum value of the flow during the inspiratory portion of the respiratory flow waveform.

[0475] Respiratory flow, patient air flow, respiratory air flow (Qr): These synonymous terms can be understood to refer to the estimation of respiratory flow by the RPT device, as opposed to "true respiratory flow" or "actual respiratory flow", which is the actual respiratory flow experienced by the patient, typically expressed in liters per minute.

[0476] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing when no additional effort is applied. In principle, the inspiratory volume Vi (the volume of inhaled air) is equal to the expiratory volume Ve (the volume of exhaled air), so a single tidal volume Vt can be defined as equal to either quantity. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, such as an average.

[0477] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0478] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0479] (Total) time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0480] Typical recent ventilation volume: The ventilation value around which the recent ventilation values Vent tend to cluster within some predetermined time range, that is, a measure of the central tendency of the recent ventilation values.

[0481] Upper airway obstruction (UAO): Includes partial and complete upper airway obstruction. This may be associated with a state of flow limitation where flow increases only slightly or even decreases as the pressure difference across the upper airway increases (Starling impedance behavior).

[0482] Ventilation volume (Vent): A measure of the rate of gas exchange by the patient's respiratory system. The measured value of the ventilation volume can include one or both of the inspiratory and expiratory flows (per unit time). When expressed as a volume per minute, this quantity is often referred to as "minute ventilation". The minute ventilation is sometimes simply given as a volume and is understood to be the volume per minute.

[0483] 4.7.3 Ventilation

[0484] Adaptive servo-ventilator (ASV): A servo-ventilator with a variable rather than a fixed target ventilation volume. The variable target ventilation volume can be derived from some characteristics of the patient, such as the patient's respiratory characteristics.

[0485] Backup rate: A parameter of the ventilator that determines the minimum respiratory rate (usually in breaths per minute) that the ventilator will deliver to the patient if not triggered by a spontaneous breathing effort.

[0486] Cycling: The termination of the inspiratory phase of the ventilator. When the ventilator delivers breaths to a spontaneously breathing patient, at the end of the inspiratory portion of the respiratory cycle, the ventilator is considered to cycle to stop delivering breaths.

[0487] Expiratory Positive Airway Pressure (EPAP): The base pressure to which a changing pressure within the breath is added to produce the desired interface pressure that the ventilator will attempt to achieve at a given time.

[0488] End-Expiratory Pressure (EEP): The desired interface pressure that the ventilator attempts to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Φ) is zero at the end of expiration, i.e., Π(Φ) = 0 when Φ = 1, then EEP is equal to EPAP.

[0489] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to achieve during the inspiratory portion of the breath.

[0490] Pressure Support: A number indicating that the pressure during inspiration by the ventilator increases beyond the pressure during expiration by the ventilator, and generally means the pressure difference between the maximum value during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator is intended to achieve, rather than the difference actually achieved.

[0491] Servo Ventilator: A ventilator that measures the patient's ventilation volume, has a target ventilation volume, and adjusts the level of pressure support to bring the patient's ventilation volume to the target ventilation volume.

[0492] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of a breath of a spontaneously breathing patient. However, if the device does not detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0493] Swing: A term equivalent to pressure support.

[0494] Trigger: When a ventilator or other respiratory therapy device (e.g., an RPT device or a portable oxygen concentrator) delivers a certain volume of breathable gas to a spontaneously breathing patient, it is said to be triggered to do so. Triggering usually occurs when the patient makes an effort to initiate the breathing portion of the respiratory cycle or near it.

[0495] 4.7.4 Anatomy

[0496] 4.7.4.1 Anatomy of the Face

[0497] Ala (Alar): The outer outer wall or "wing" of each nostril (plural: alae (alar))

[0498] Ala Angle:

[0499] Ala Tip: The outermost point on the ala.

[0500] Ala Bend (or Ala Crest) Point: The most posterior point in the curved baseline of each ala, which is found in the fold formed by the junction of the ala and the cheek.

[0501] Auricle: The entire visible outer part of the ear.

[0502] (Nasal) Skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0503] (Nasal) Cartilaginous Skeleton: The nasal cartilaginous skeleton includes the septum, lateral, major, and minor cartilages.

[0504] Columella: A strip of skin that separates the nostrils and extends from the nasal tip to the upper lip.

[0505] Columella Angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (where the two lines intersect at the subnasale point).

[0506] Frankfurt Horizontal Plane: A line extending from the lowest point on the edge of the eye socket to the left cochlea. The cochlea is the deepest point in the notch in the upper tragus of the auricle.

[0507] Glabella: Located on the soft tissue, the most prominent point in the median sagittal plane of the forehead.

[0508] External Nasal Cartilage: A cartilaginous plate that is generally triangular in shape. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the major alar cartilage.

[0509] Lip, Lower (Midpoint of Lower Lip):

[0510] Lip, Upper (Midpoint of Upper Lip):

[0511] Major Alar Cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that includes three or four small cartilages of the ala.

[0512] Nostril (Naris): An approximately oval-shaped opening that forms the entrance to the nasal cavity. The singular form of nostril is naris. The nares are separated by the nasal septum.

[0513] Nasolabial Groove or Nasolabial Fold: A skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0514] Nasolabial Angle: The angle between the columella and the upper lip (where they intersect at the subnasale point).

[0515] Inferior Auricular Base Point: The lowest point where the auricle attaches to the facial skin.

[0516] Superior Auricular Base Point: The highest point where the auricle attaches to the facial skin.

[0517] Nasal Tip Point: The most prominent point or tip of the nose, which can be identified in a lateral view of the rest of the head.

[0518] Philtrum: The midline groove extending from the lower border of the nasal septum to the top of the upper lip in the upper lip region.

[0519] Gnathion: Located on the soft tissue, the midpoint of the most anterior part of the chin.

[0520] Ridge (nose): The nasal ridge is the midline prominence of the nose extending from the nasion to the rhinion.

[0521] Sagittal plane: The vertical plane from anterior (front) to posterior (back). The median sagittal plane is the sagittal plane that divides the body into a right half and a left half.

[0522] Nasion: Located on the soft tissue, the most concave point covering the fronto-nasal suture area.

[0523] Septal cartilage (nose): The septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0524] Posterior-superior lateral crura: The point at the lower edge of the base of the alae nasi, where the base of the alae nasi joins the skin of the upper (superior) lip.

[0525] Subnasale: Located on the soft tissue, the point at the intersection of the columella and the upper lip in the median sagittal plane.

[0526] Gnathion alveolare: The point of maximum concavity in the midline of the lower lip between the midpoint of the lower lip and the gnathion of the soft tissue.

[0527] 4.7.4.2 Anatomical structure of the skull

[0528] Frontal bone: The frontal bone includes a large vertical part (frontal squama), which corresponds to the area called the forehead.

[0529] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony prominence of the mandible that forms the chin.

[0530] Maxilla: The maxilla forms the upper jaw and is located above the mandible and below the orbits. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral border.

[0531] Nasal bones: The nasal bones are two small oval bones, which vary in size and form in different individuals; they are located side by side in the middle and upper part of the face, and form the "beam" of the nose through their junction points.

[0532] Nasion: The intersection of the frontal bone and the two nasal bones, directly between the eyes and in the concave area above the nasal bridge of the nose.

[0533] Occipital bone: The occipital bone is located at the posterior and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0534] Orbit: The bony cavity in the skull that houses the eyeball.

[0535] Parietal bone: The parietal bones are the bones that, when joined together, form the roof and sides of the skull.

[0536] Temporal bone: The temporal bones are located at the base and sides of the skull and support that part of the face known as the temples.

[0537] Zygomatic bone: The face includes two zygomatic bones, which are located in the upper and lateral parts of the face and form the prominences of the cheeks.

[0538] 4.7.4.3 Anatomical Structure of the Respiratory System

[0539] Diaphragm: A sheet of muscle that extends across the bottom of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0540] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0541] Lung: The organ of respiration in humans. The conducting zone of the lung contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0542] Nasal cavity: The nasal cavity (or nasal fossa) is the large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical fin called the nasal septum. There are three horizontal branches on the sides of the nasal cavity, which are called nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, and the back joins the nasopharynx via the internal nares.

[0543] Pharynx: The part of the throat that lies immediately below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three segments: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (midpharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0544] 4.7.5 Patient Interface

[0545] Anti-asphyxia valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

[0546] Functional dead space:

[0547] Headband: The headband will be understood as a form of positioning and stabilizing structure designed to hold a device such as a mask on the head.

[0548] Inflatable chamber: The mask inflatable chamber will be considered to mean the part of the patient interface having a wall that at least partially encloses a volume of space that, in use, has air pressurized therein to a pressure above atmospheric pressure. The housing may form part of the wall of the mask inflatable chamber.

[0549] Vent (noun): A structure that allows air flow from inside the mask or catheter to ambient air, for example, for effective flushing of exhaled gas. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and treatment pressure.

[0550] 4.7.6 Shape of Structures

[0551] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask gasket or a pusher. The three-dimensional structures may be joined by two-dimensional surfaces. These surfaces may be differentiated using markings to describe the relevant surface orientation, position, function, or some other characteristic. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a sealing-forming structure may include a surface (e.g., an outer surface) that contacts the face and a separate surface (e.g., a lower side or an inner surface) that does not contact the face. In another example, the structure may include a first surface and a second surface.

[0552] To assist in describing the shape of three-dimensional structures and surfaces, first consider a cross-section through a point p on the surface of the structure, see Figures 3B to 3F , which show cross-sections at point p on the surface and examples of the resulting planar curves. Figures 3B to 3F Also shown is the outward normal vector at p. The outward normal vector at p points in the direction away from the surface. In some examples, the surface is described from the viewpoint of an imaginary little person standing upright on the surface.

[0553] 4.7.6.1 One-Dimensional Curvature

[0554] The curvature of a planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0555] Positive curvature: If the curve at p turns towards the outward normal, the curvature at that point will be taken as positive (if the imaginary little person leaves point p, they must walk uphill). See Figure 3B (relatively large positive curvature compared to Figure 3C ) and Figure 3C (relatively small positive curvature compared to Figure 3B ). Such curves are generally referred to as concave.

[0556] Zero curvature: If the curve at p is a straight line, the curvature will be taken as zero (if the imaginary little people leave point p, they can walk horizontally, without going up or down). See Figure 3D .

[0557] Negative curvature: If the curve at p turns away from the outward normal, the curvature in the direction at the point will be taken as negative (if the imaginary little people leave point p, they must walk downhill). See Figure 3E (Compared with Figure 3F relatively small negative curvature) and Figure 3F (Compared with Figure 3E relatively large negative curvature). Such curves are usually called convex.

[0558] 4.7.6.2 Curvature of two-dimensional surfaces

[0559] The description of the shape at a given point on a two-dimensional surface according to the present technology may include a plurality of normal sections. The plurality of cross-sections may cut the surface in a plane including the outward normal ("normal plane"), and each cross-section may be intercepted in a different direction. Each cross-section produces a plane curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a magnitude, for example a relatively small magnitude. Figures 3B to 3F The plane curves in

[0560] Principal curvature and principal direction: The directions of the normal planes in which the curve curvature takes its maximum and minimum values are called the principal directions. In Figures 3B to 3F example, the maximum curvature occurs in Figure 3B and the minimum curvature occurs in Figure 3F , so Figure 3B and Figure 3F are cross-sections in the principal directions. The principal curvature at P is the curvature in the principal direction.

[0561] Region of the surface: A connected set of points on the surface. The set of points in the region may have similar characteristics, such as curvature or sign.

[0562] Saddle-shaped region: A region where the principal curvatures have opposite signs at each point, i.e., one sign is positive and the other sign is negative (depending on the direction in which the imaginary individual turns, they can walk up or down).

[0563] Dome region: A region where the principal curvatures have the same sign at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0564] Cylindrical region: A region where one of the principal curvatures is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0565] Planar region: A surface region where both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0566] Surface edge: The boundary or limit of a surface or region.

[0567] Path: In some forms of the present technology, a 'path' will be considered to mean a path in the mathematical-topological sense, such as a continuous space curve on a surface from f(0) to f(1). In some forms of the present technology, a 'path' can be described as a route or course, including, for example, a set of points on a surface. (The path of an imaginary person is where they walk on the surface and is analogous to a garden path).

[0568] Path length: In some forms of the present technology, 'path length' will be considered to be the distance along a surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length of an imaginary person will be the distance they have to walk along the path on the surface).

[0569] Straight-line distance: The straight-line distance is the distance between two points on a surface, but without considering the surface. On a planar region, there will be a path on the surface with the same path length as the straight-line distance between the two points on the surface. On a non-planar surface, there may not be a path with the same path length as the straight-line distance between the two points. (For an imaginary individual, the straight-line distance will correspond to the distance as a'straight line').

[0570] 4.7.6.3 Space curve

[0571] Space curve: Different from a planar curve, a space curve does not have to 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 segment of three-dimensional space. An imaginary person walking on one strand of a DNA helix walks along a space curve. A typical human left ear includes a helix, which is a left-handed helix, see Figure 3Q .. A typical human right ear includes a helix, which is a right-handed helix, see Figure 3R . Figure 3S A right-handed helix is shown. The edge of a structure, such as the edge of a membrane or an impeller, can follow a space curve. Generally, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of how the curve turns out of a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with reference to the tangent vector, the normal vector, and the binormal vector at that point.

[0572] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point specifies a direction and magnitude starting from that point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If a hypothetical person is flying along the curve and drops from their vehicle at a particular point, the direction of the tangent vector is the direction in which she will travel.

[0573] Unit normal vector: As the hypothetical person moves along the curve, this tangent vector itself changes. The unit vector that points in the direction of the change of the tangent vector is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0574] 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 Figure 3P ) or optionally by the left-hand rule ( Figure 3O ).

[0575] Osculating plane: The plane that contains the unit tangent vector and the unit principal normal vector. See Appendix Figure 3O and 3P .

[0576] 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. It measures how much the curve deviates from the osculating plane. A space curve that lies in a plane has zero torsion. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torsion (e.g., a gently sloping helical path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torsion (e.g., a steeply sloping helical path). See Figure 3S , since T2 > T1, the amount of torsion near the top coil of the helix in Figure 3 is greater than Figure 3S the amount of torsion of the bottom coil of the helix.

[0577] Referring to Figure 3P the right-hand rule, a space curve that is oriented towards the right-hand side binormal direction can be considered to have a right-handed positive torsion (e.g., the right-handed helix shown in Figure 3S ). A space curve that turns away from the right-hand binormal direction can be considered to have a right-handed negative torsion (e.g., a left-handed helix).

[0578] Similarly, referring to the left-hand rule (see Figure 3O ), a space curve that is oriented towards the left-hand binormal direction can be considered to have a left-handed positive torsion (e.g., a left-handed helix). Thus left-handed positive is equivalent to right-handed negative. See Figure 3T .

[0579] 4.7.6.4 Hole

[0580] The surface may have one-dimensional pores, such as pores bounded by a planar curve or by a space curve. A thin structure (e.g., a film) having pores can be described as having one-dimensional pores. See, for example Figure 3I One-dimensional pores in the surface of the structure shown bounded by a planar curve.

[0581] The structure may have two-dimensional pores, such as pores bounded by a surface. For example, an inflated tire has a two-dimensional pore bounded by the inner surface of the tire. In another example, a bladder having a cavity for air or gel may have a two-dimensional pore. See, for example Figure 3L the gasket of Figure 3M and Figure 3N the exemplary cross-sections in Figure 3K where an inner surface bounding a two-dimensional pore is shown. In yet another example, a conduit may include one-dimensional pores (e.g., at its inlet or at its outlet) and a two-dimensional pore bounded by the inner surface of the conduit. Also see

[0582] 4.8 Other Remarks

[0583] Part of the disclosure of this patent document contains copyrighted material. The copyright owner does not object to the reproduction by anyone of the patent documents or patent disclosures in the form in which they appear in the patent office files or records, but reserves all copyright rights otherwise.

[0584] Unless the context clearly dictates otherwise and a numerical range is provided, it should be understood that each intermediate value between the upper and lower limits of the range, to one-tenth of the unit of the lower limit, and any other stated value or intermediate value within the range is broadly included in the present technology. The upper and lower limits of these intermediate ranges may independently be included in the intermediate range and also in the present technology, subject to any explicit exclusionary bounds within the range. In cases where the range includes one or both of the limiting values, ranges excluding any one or both of the included limiting values are also included in the present technology.

[0585] Furthermore, in cases where one or more values described herein are implemented as part of the present technology, it should be understood that such values may be approximate unless otherwise stated, and such values may be used to any appropriate significant digits to the extent that the practical technology implementation permits or requires them.

[0586] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein may also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

[0587] When a particular material is identified for constructing a component, obvious alternative materials with similar properties can be used as substitutes. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0588] It must be noted that, unless the context clearly dictates otherwise, as used herein and in the appended claims, the singular forms "a", "an", and "the" include their plural equivalents.

[0589] All publications mentioned herein are hereby incorporated by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. This application should not be construed as an admission that the present technology is not entitled to antedate such disclosure by virtue of a prior invention. Additionally, the publication dates provided may be different from the actual publication dates, which may require independent verification.

[0590] The terms "comprises" and "comprising" are to be understood to mean that each element, each component, or each step in a non-exclusive manner, indicating that the marked element, component, or step may be present or utilized, or a combination with other elements, components, or steps that are not marked.

[0591] The subject headings used in the detailed description are for the convenience of the reader only and should not be used to limit the subject matter that can be found throughout the present disclosure or the claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.

[0592] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments merely illustrate the principles and applications of the present technology. In some cases, the terms and symbols may imply specific details that are not required for the practice of the technology. For example, although the terms "first" and "second" may be used, unless otherwise stated, they are not intended to denote any order but may be used to distinguish different elements. Additionally, although the process steps in a method may be described or illustrated in sequence, such sequence is not required. Those skilled in the art will recognize that such sequence can be modified and / or aspects thereof can be performed simultaneously or even synchronously.

[0593] Therefore, it should be understood that numerous adjustments can be made to the exemplary embodiments and that other arrangements can be designed without departing from the spirit and scope of the present technology.

[0594] 4.9 List of Reference Numerals

[0595]

[0596]

[0597]

[0598]

[0599]

Claims

1. A patient interface comprising: A mouth inflation chamber that can be pressurized to a treatment pressure that is at least 6 cmH2O higher than the ambient air pressure. The mouth inflation chamber includes an inflation chamber inlet port sized and configured to receive an air flow for patient breathing at the treatment pressure; And A seal-forming structure configured and arranged to form a seal around the area of the patient's airway inlet and the patient's face. The seal-forming structure has a hole such that an air flow at the treatment pressure is at least delivered to the inlet of the patient's nostrils, Characterized in that the seal-forming structure includes: A mouth portion that forms at least a part of the mouth inflation chamber and is configured to seal around the patient's mouth. The mouth portion includes a container and a pair of mouth portion magnets. The container has an outlet opening at the base of the container, and the mouth portion magnets are positioned inside the container on opposite sides of the outlet opening; and A nose portion configured to seal with the patient's nostrils. The nose portion includes a nose inflation chamber having an inlet opening and a pair of nose portion magnets positioned on opposite sides of the inlet opening. The nose inflation chamber is configured to be received inside the container, and the nose portion magnets are positioned such that when the nose inflation chamber is received inside the container, the nose portion magnets are both between the mouth portion magnets, Wherein the seal-forming structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's breathing cycle during use.

2. The patient interface according to claim 1, wherein, The mouth portion includes a sealing flange having an inner surface, an outer surface, and a target seal-forming area located on the outer surface thereof.

3. The patient interface according to claim 2, wherein, The outer surface of the sealing flange includes a lip-shaped area configured to have a lip saddle-shaped area at a point where a middle contact plane on the outer surface of the mouth portion contacts the target seal-forming area. The curvature of the lip saddle-shaped area in the up-down direction has a negative sign and its magnitude is greater than the magnitude of the curvature of the lip saddle-shaped area in the left-right direction.

4. The patient interface according to claim 3, wherein, The outer surface includes a left corner area and a right corner area and is configured to have a first convex dome-shaped area in the left corner area and a second convex dome-shaped area in the right corner area.

5. The patient interface according to claim 4, wherein, The outer surface of the sealing flange has an inner edge, and the hole is defined by the inner edge.

6. The patient interface according to claim 5, wherein, The inner edge of the sealing flange is configured such that the space curve on the outer surface of the sealing flange at the inner edge in the left corner area has a left-handed positive twist, and such that the surface of the sealing flange at the inner edge in the right corner area has a right-handed positive twist.

7. The patient interface according to claim 1, wherein, The mouth inflation chamber is partially formed by a housing having a housing inner surface and a housing outer surface. The housing inner surface is arranged to be at the treatment pressure during use, and the housing outer surface is arranged to be at the ambient pressure during use.

8. The patient interface according to claim 7, wherein, The housing is configured to be rigid when subjected to an internal pressure that is less than about 30 cmH2O higher than the ambient pressure.

9. The patient interface according to claim 7, wherein, The housing is made of a transparent rigid plastic material.

10. The patient interface according to claim 7, wherein, The inner surface of the housing is configured to include a concave dome-shaped region.

11. The patient interface according to claim 1, wherein, The patient interface is configured such that no part of the patient interface enters the mouth during use, and such that the mouth inflation chamber does not cover the patient's eyes during use.

12. The patient interface according to claim 1, Among them, The mouth portion includes a sealing flange having an inner surface, an outer surface, and a target seal-forming region located on the outer surface of the sealing flange, wherein the outer surface of the sealing flange includes a lip region configured to have a lip saddle region at a point where an intermediate contact plane on the outer surface of the mouth portion contacts the target seal-forming region, the lip saddle region having a negative curvature in the up-down direction and a magnitude greater than the magnitude of the curvature of the lip saddle region in the left-right direction, wherein the outer surface includes a left corner region and a right corner region and is configured to have a first convex dome-shaped region in the left corner region and a second convex dome-shaped region in the right corner region, wherein the outer surface of the sealing flange has an inner edge, and the aperture is defined by the inner edge, wherein the inner edge of the sealing flange is configured such that a space curve on the outer surface of the sealing flange at the inner edge in the left corner region has a left-handed positive twist, and such that the surface of the sealing flange at the inner edge in the right corner region has a right-handed positive twist, wherein the mouth inflation chamber is partially formed by the housing having an inner housing surface and an outer housing surface, the inner housing surface being arranged to be at the treatment pressure during use and the outer housing surface being arranged to be at the ambient pressure during use, wherein the housing is configured to be rigid when subjected to an internal pressure that is less than about 30 cmH2O higher than the ambient pressure, wherein the housing is made of a transparent rigid plastic material, wherein the inner surface of the housing is configured to include a concave dome-shaped region, and wherein the patient interface is configured such that no part of the patient interface enters the mouth during use, and such that the mouth inflation chamber does not cover the patient's eyes during use.

13. The patient interface according to claim 1, further comprising: a positioning and stabilization structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head; and a ventilation structure for allowing the patient's exhaled gas to flow continuously from the interior of the patient interface to the environment, the ventilation structure being sized and shaped to maintain the treatment pressure in the patient interface during use.

14. The patient interface according to claim 13, wherein, The positioning and stabilization structure includes a strap configured and arranged such that at least a portion of its upper edge passes under the ear base below the patient's head and covers or is located below the occipital bone of the patient's head.

15. The patient interface according to claim 13, wherein, The positioning and stabilization structure includes a low-profile side configured to be positioned under the patient's head while the patient is lying on their side.

16. The patient interface according to claim 1, wherein, The patient interface is configured to allow the patient to breathe from the ambient environment through their mouth without a pressurized air flow through the inlet port of the inflation chamber.

17. The patient interface according to claim 1, Among them, the mouth portion magnet and the nose portion magnet are configured to fix the nose portion to the mouth portion when the nose inflation chamber is received within the container in the mouth portion.

18. The patient interface according to claim 1, wherein, The container includes at least one sidewall extending from the base of the container, and the mouth portion magnet is positioned on the at least one sidewall.

19. The patient interface according to claim 1, wherein, The nose inflation chamber includes at least one sidewall, and the nose portion magnet is positioned on the at least one sidewall of the nose inflation chamber.

20. The patient interface according to claim 1, wherein, The nose portion magnet is on a lateral side of the nose inflation chamber, and wherein, the mouth portion magnet is on a lateral side of the container.

21. The patient interface according to claim 1, wherein, The nose portion magnet is oriented to present a different polarity towards the mouth portion magnet.

22. The patient interface according to claim 21, wherein, The mouth portion magnet is oriented to present a different polarity towards the nose portion magnet.

23. The patient interface according to claim 22, wherein, The nose portion magnet and the mouth portion magnet are oriented to repel each other when the nose inflation chamber is inserted into the container in the wrong orientation.

24. The patient interface according to claim 1, wherein, The nose portion magnet and the mouth portion magnet are configured to connect two flexible bodies.

25. The patient interface according to claim 1, wherein, The nose portion magnet is molded to the nose inflation chamber, and the mouth portion magnet is molded to the container.

26. The patient interface according to claim 1, wherein, The bottom of the edge of the inlet opening in the nose inflation chamber includes a lip seal.

27. The patient interface according to claim 26, wherein, The lip seal is configured to engage the edge of the outlet opening of the container when the nose inflation chamber is fixed within the container.

28. The patient interface according to claim 27, wherein, The lip seal is positioned below the nose portion magnet.

29. The patient interface according to claim 1, wherein, The nose portion magnets face each other, and wherein, the mouth portion magnets face each other.

30. The patient interface according to claim 1, wherein, The container includes at least one sidewall extending from the base of the container, and the mouth portion magnet is positioned on the at least one sidewall, wherein, the nose inflation chamber includes at least one sidewall, and the nose portion magnet is positioned on the at least one sidewall of the nose inflation chamber, wherein, the nose portion magnet is on a lateral side of the nose inflation chamber, wherein, the mouth portion magnet is on a lateral side of the container, wherein, the nose portion magnet is oriented to present a different polarity towards the mouth portion magnet, wherein, the mouth portion magnet is oriented to present a different polarity towards the nose portion magnet, wherein, the nose portion magnet and the mouth portion magnet are oriented to repel each other when the nose inflation chamber is inserted into the container in the wrong orientation, wherein, the nose portion magnet and the mouth portion magnet are configured to connect two flexible bodies, wherein, the nose portion magnet is molded to the nose inflation chamber, and the mouth portion magnet is molded to the container, wherein, the bottom of the edge of the inlet opening in the nose inflation chamber includes a lip seal, wherein, the lip seal is configured to engage the edge of the outlet opening of the container when the nose inflation chamber is fixed within the container, wherein the lip seal is positioned below the nasal portion magnet, wherein the nasal portion magnets face each other, and wherein the mouth portion magnets face each other.

31. A patient interface comprising: a mouth inflation chamber that can be pressurized to a therapeutic pressure that is at least 6 cmH2O higher than ambient air pressure, the mouth inflation chamber including an inflation chamber inlet port sized and configured to receive an air flow at the therapeutic pressure for a patient to breathe; a seal-forming structure configured and arranged to form a seal around a patient airway inlet and a patient facial region, the seal-forming structure having a hole such that an air flow at the therapeutic pressure is at least delivered to an inlet leading to a patient's nostrils, the seal-forming structure configured and arranged to maintain the therapeutic pressure in the inflation chamber during the entire respiratory cycle of the patient in use; and a ventilation structure configured to allow a patient's exhaled gas to continuously flow from the interior of the inflation chamber to the ambient, the ventilation structure sized and shaped to maintain the therapeutic pressure in the inflation chamber in use, characterized in that the ventilation structure comprises: a body configured to be fixed to a mouth portion of the seal-forming structure, the body including a ventilation wall having a plurality of ventilation holes, a container, and a pair of anchoring containers located on opposite lateral sides of the container; a lid including a pair of pegs located on a lateral side of the lid, the pegs configured to be inserted into the anchoring containers to fix the lid to the body; and a diffuser received in the container between the anchoring containers, the diffuser being sandwiched between the body and the lid, wherein the patient interface is configured to allow a patient to breathe from the surrounding environment through their mouth in the absence of a pressurized air flow through the inflation chamber inlet port condition.

32. The patient interface according to claim 31, wherein, The anchoring containers are keyed to the pegs such that only pegs having the same shape as the anchoring containers can be received in the anchoring containers.

33. The patient interface according to claim 31, wherein, The anchoring containers are tapered such that when the lid is fixed to the body, the pegs are wedged into the anchoring containers.

34. The patient interface according to claim 31, wherein, The body includes a first flange and a second flange that forms a channel with the first flange, the mouth portion including a ventilation opening, wherein when the body is fixed to the mouth portion, an edge of the ventilation opening is configured to be received in the channel.

35. The patient interface according to claim 34, wherein, The anchoring containers extend deeper than the channel.

36. The patient interface according to claim 31, wherein, The ventilation wall surrounds an end of the container closest to the interior of the mouth inflation chamber.

37. The patient interface according to claim 31, wherein, The diffuser is spaced apart from the ventilation holes.

38. The patient interface according to claim 31, wherein, Each anchoring container has a different size and / or shape.

39. The patient interface according to claim 31, wherein The anchoring containers are configured to prevent the lid from being fixed to the body in the wrong direction.

40. The patient interface according to claim 31, wherein, The perimeter of the lid is smaller than the perimeter of the body such that a gap is formed between the body and the lid when the lid is fixed to the body.

41. The patient interface according to claim 31, wherein, The ventilation holes are tapered such that the ventilation holes narrow in a direction towards the diffuser.

42. The patient interface according to claim 31, wherein, On opposite sides of the inner wall of each vent hole, a taper angle of 10 degrees to 35 degrees is formed.

43. The patient interface according to claim 42, wherein, The taper angle is about 10 degrees or about 35 degrees.

44. The patient interface according to claim 31, wherein, The base of each vent hole is flared.

45. The patient interface according to claim 44, wherein, The flared portion of the vent hole has a radius of curvature of 0.2 mm to 0.4 mm.

46. The patient interface according to claim 45, wherein, The radius of curvature is about 0.25 mm or about 0.3 mm.

47. The patient interface according to claim 31, wherein, The minimum diameter of each vent hole is 0.5 mm to 2.0 mm.

48. The patient interface according to claim 47, wherein, The minimum diameter is about 0.89 mm, about 0.98 mm, about 1.01 mm or about 1.17 mm.

49. The patient interface according to claim 31, wherein, The anchoring container is keyed to the stud such that only a stud having the same shape as the anchoring container can be received within the anchoring container, wherein the anchoring container is conical such that when the cap is fixed to the body, the stud becomes wedged within the anchoring container, wherein the body includes a first flange and a second flange, the second flange and the first flange form a passage, the mouth portion includes a vent opening, wherein an edge of the vent opening is configured to be received within the passage when the body is fixed to the mouth portion, wherein the anchoring container extends deeper than the passage, wherein the vent wall surrounds an end of the container that is closest to the interior of the mouth inflation chamber, wherein the diffuser is spaced apart from the vent hole, wherein each anchoring container has a different size and / or shape, wherein the anchoring container is configured to prevent the cap from being fixed to the body in the wrong direction, wherein the perimeter of the cap is less than the perimeter of the body such that a gap is formed between the body and the cap when the cap is fixed to the body, wherein the vent hole is conical such that the vent hole narrows in a direction towards the diffuser, On opposite sides of the inner wall of each vent hole, a taper angle of 10 degrees to 35 degrees is formed, wherein the base of each vent hole is flared, wherein the flared portion of the vent hole has a radius of curvature of 0.2 mm to 0.4 mm, and wherein the minimum diameter of each vent hole is 0.5 mm to 2.0 mm.

50. The patient interface according to claim 31, further comprising: A positioning and stabilizing structure for providing a force to hold the seal-forming structure in a therapeutically effective position on the patient's head, wherein the seal-forming structure includes: The mouth portion, the mouth portion forming at least a part of the mouth inflation chamber and being configured to seal around the patient's mouth; and A nose portion, the nose portion being configured to seal with the patient's nostrils, the nose portion including a nose inflation chamber having an inlet opening, the nose inflation chamber being configured to be received within the container.

51. A patient interface, comprising: A mouth inflation chamber, the mouth inflation chamber being capable of being pressurized to a therapeutic pressure that is at least 6 cmH2O higher than the ambient air pressure, the mouth inflation chamber including an inflation chamber inlet port, the size and structure of the inflation chamber inlet port being set to receive an air flow at the therapeutic pressure for the patient to breathe; A seal-forming structure that is configured and arranged to form a seal around a patient airway inlet and a patient facial region, the seal-forming structure having an aperture such that an airflow at the treatment pressure is delivered at least to an inlet leading to the patient's nostrils, the seal-forming structure being configured and arranged to maintain the treatment pressure in the inflation chamber during the entire respiratory cycle of the patient in use, and a ventilation structure that is configured to allow exhaled gas from the patient to flow continuously from the interior of the inflation chamber to the environment, the ventilation structure being sized and shaped to maintain the treatment pressure within the inflation chamber in use, characterized in that the ventilation structure comprises: a ventilation wall having a plurality of ventilation openings and grooves on an outward-facing surface that completely surrounds the ventilation openings; at least one side wall extending from the ventilation wall; and a flange extending from an end of the at least one side wall such that an edge of the ventilation wall, an outer surface of the at least one side wall, and the flange together form a channel that is configured to receive an edge around the ventilation openings in a mouth portion surrounding the seal-forming structure, the flange being configured to be received within the mouth portion.

52. The patient interface according to claim 51, wherein, The outward-facing surface of the ventilation wall is convex, and an inward-facing surface of the ventilation wall opposite the outward-facing surface is convex.

53. The patient interface according to claim 51, wherein, The ventilation openings are tapered such that the ventilation apertures narrow in a direction towards the outward-facing surface of the ventilation wall.

54. The patient interface according to claim 51, wherein, The base of each ventilation opening is flared.

55. The patient interface according to claim 51, further comprising: a positioning and stabilizing structure for providing a force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, wherein the seal-forming structure comprises: the mouth portion that forms at least a part of the mouth inflation chamber and is configured to seal around the patient's mouth; and a nasal portion that is configured to seal with the patient's nostrils, the nasal portion including a nasal cavity inflation chamber having an inlet opening, the nostril inflation chamber being configured to be received within a container in the mouth portion.

56. A seal-forming structure for a patient interface, the seal-forming structure being configured to deliver a therapeutic pressure of at least 6 cmH2O above ambient air pressure to a patient's airway, the seal-forming structure being constructed and arranged to form a seal around an entrance of the patient's airway and an area of the patient's face, characterized in that, The seal-forming structure comprises: a mouth portion that cooperates with a wall to form an inflation chamber and is configured to seal around the patient's mouth, the mouth portion including an outlet opening and a pair of container magnets; and a nasal portion that is configured to seal the patient's nostrils, the nasal portion including a nasal base having an inlet opening and a pair of nasal module magnets, wherein the nasal portion and the mouth portion are configured to be fixed to each other by way of a magnetic connection between the pair of container magnets and the pair of nasal module magnets.

57. The seal forming structure according to claim 56, wherein, The mouth portion includes a container that is configured to receive the nasal portion.

58. The sealing formation structure according to claim 57, wherein, The container is a recess in the mouth portion.

59. The seal forming structure according to claim 58, wherein, The pair of nasal module magnets are positioned on opposite sides of the nasal base, and wherein the pair of nasal module magnets are positioned such that when the nasal base is fully received within the container, both of the pair of nasal module magnets are between the pair of container magnets.

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