Patient interface

Abstract

To provide a medical device that is used for diagnosis, improvement, treatment or prevention of respiratory illness, and has one or more of improved amenity, cost, efficiency, ease of use and production possibility.SOLUTION: A patient interface comprises: a frame; a head gear; a manifold; and two nose protrusions. The frame is recessed from a face of a patient, and preferably is recessed from the manifold. The manifold can be deformed or moved relative to the face of the patient. The manifold is further configured to follow a direction of engagement to the face of the patient, for example, in an upward direction. By the features, the manifold engages with the face of the patient, for example, engages with an upper lip of the patient, without significant pressure which may give discomfort to the patient. The manifold is also rotatable with respect to the frame, for example by a grip function which is configured to be held by one hand for rotation.SELECTED DRAWING: Figure 3A

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims the benefit of Australian Provisional Application No. AU2014901585, filed May 1, 2014, the entire disclosure of which is incorporated herein by reference. [Background technology]

[0002] Technical Field The present technology relates to one or more of the detection, diagnosis, treatment, prevention and amelioration of respiratory related disorders. Among other things, the present technology relates to medical devices or instruments and uses thereof.

[0003] 2. Description of Related Art 2.2.1 The human respiratory system and its diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrance to a patient's airways.

[0004] The airways contain a series of branches that become narrower, shorter and more numerous the deeper they enter the lungs. The primary function of the lungs is gas exchange, where oxygen is transferred from the air into the venous blood and carbon dioxide is carried out. The trachea divides into the left and right main bronchi, which further branch into the terminal bronchioles. The bronchi make up the conducting airways and do not participate in gas exchange. The airways further divide into the respiratory bronchioles and finally into the alveoli. The alveolar regions of the lungs where gas exchange takes place are called the respiratory regions. See Non-Patent Document 1.

[0005] There is a spectrum of respiratory disorders that can be characterized by specific events, such as apnea, hypopnea, and hyperpnea.

[0006] Obstructive sleep apnea (OSA) is a type of sleep-disordered breathing (SDB) characterized by events involving the closure or obstruction of the upper airway during sleep. It is the result of an abnormally small upper airway combined with the normal loss of muscle tone in the tongue area, soft palate, and posterior oropharyngeal wall during sleep. In this condition, affected patients typically stop breathing for 30 to 120 seconds, sometimes 200 to 300 times per night. Excessive daytime sleepiness is often experienced, which can lead to cardiovascular disease and brain damage. The syndrome is a common disorder, especially in overweight middle-aged men, although affected individuals may not be aware of the problem. See US Pat. No. 5,399,323 (Sullivan).

[0007] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, resulting in alternating rhythmic waxing and waning of breathing, known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repeated hypoxia, CSR can be harmful. In some patients, CSR is associated with repeated arousals during sleep, which results in severe sleep disturbances, increased sympathetic nervous system activity, and increased afterload. See US Patent No. 5,339,993 (Berthon-Jones).

[0008] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic awake hypercapnia in the absence of a known cause for hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0009] Chronic obstructive pulmonary disease (COPD) includes any group of lower airway diseases that share certain characteristics. These include increased resistance to air movement, prolongation of the expiratory phase of breathing, and a decrease in the normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by regular smoking (the primary risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include dyspnea on exertion, chronic cough, and sputum production.

[0010] Neuromuscular diseases (NMD) is a broad term that encompasses many diseases and illnesses that impair muscle function either directly through intrinsic muscle lesions or indirectly through nerve lesions. Some NMD patients are characterized by progressive muscle impairment leading to loss of ambulation, becoming wheelchair bound, having difficulty swallowing, and eventually suffering from respiratory muscle weakness leading to death due to respiratory failure. Neuromuscular diseases can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive diseases are characterized by months of muscle dysfunction and death within a few years (e.g. amyotrophic lateral sclerosis (ALS) and teenage Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive diseases are characterized by worsening over several years and a small reduction in life expectancy (e.g. limb-girdle, facioscapulohumeral muscular dystrophy and myotonic dystrophy). Symptoms of respiratory failure in NMD include progressive generalized weakness, difficulty swallowing, dyspnea on exertion and at rest, fatigue, drowsiness, morning headache, and difficulty concentrating and shifting mood.

[0011] Chest wall disorders are a group of thoracic deformities that lead to inadequate connections between the respiratory muscles and the rib cage. These disorders are usually characterized by restrictive disorders and can lead to long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can lead to severe respiratory failure. Symptoms of respiratory failure include exertional dyspnea, peripheral edema, orthopnea, recurrent pulmonary infections, morning headache, fatigue, poor quality sleep, and loss of appetite.

[0012] In yet another aspect, healthy individuals can take advantage of the systems and devices to prevent the onset of respiratory disorders.

[0013] 2.2.2 Treatment Nasal continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The hypothesis is that CPAP acts as a pneumatic splint, pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall, thereby preventing upper airway obstruction.

[0014] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airway, performing some or all of the work of breathing to help the patient breathe adequately and / or maintain adequate oxygen levels in the body. Ventilatory support is provided via a patient interface. NIV has been used to treat CSR, OHS, COPD, MD, and chest wall disease.

[0015] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own, and is delivered using a tracheostomy tube.

[0016] High flow therapy provides a flow of breathable gas (e.g. air, oxygen or oxygen-enriched air) at a 'high' flow, for example up to 60 L / min. To deliver the required high flow of breathable gas, HFT is typically performed through a nasal cannula. HFT has been used to reduce the work of breathing and enhance gas exchange.

[0017] Ventilators can control the timing and pressure of breaths delivered to the patient and can monitor the breaths the patient is taking. Methods for controlling and monitoring the patient typically include volume-controlled and pressure-cycled methods. Volume-controlled methods include pressure-regulated volume control (PRVC), volume ventilation (VV) and volume-controlled continuous mandatory ventilation (VC-CMV) techniques, among others. Pressure-cycled methods include assistive control (AC), synchronized intermittent mandatory ventilation (SIMV), controlled mechanical ventilation (CMV), pressure-support ventilation (PSV), continuous positive airway pressure (CPAP) or positive end-expiratory pressure (PEEP) techniques, among others. 2.2.3 Treatment system

[0018] The therapy system includes a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface and data management.

[0019] Another form of treatment system is the mandibular repositioning appliance. 2.2.3.1 Patient Interface

[0020] A patient interface can be used to interface a respiratory device to its user, for example by providing an airflow. The airflow can be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy being applied, the patient interface may form a seal, for example to an area of ​​the patient's face, delivering gas at a pressure sufficiently different from ambient pressure for the therapy to be effective, for example at a positive pressure of about 10 cmH2O with respect to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal to allow delivery of gas to the airways at a positive pressure of about 10 cmH2O.

[0021] Patient interface design presents several challenges. The face has a complex three-dimensional shape. Nose size and shape vary considerably between individuals. The head contains bone, cartilage and soft tissue, and different areas of the face respond differently to mechanical forces. The jaw or mandible can move in relation to the other bones of the skull. The entire head can move during respiratory therapy.

[0022] Because of these challenges, some masks suffer from one or more of the following problems: they are occlusive, aesthetically unpleasing, costly, fit poorly, are difficult to use, become worn after extended use, or are uncomfortable when the patient is unfamiliar with the system. For example, masks designed specifically for aviators, masks designed as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks for anesthesia administration may hold up for their intended applications but are undesirably uncomfortable to wear for extended periods of time, e.g., several hours, especially if the mask must be worn while sleeping.

[0023] CPAP therapy is particularly effective in treating certain respiratory conditions, as long as the patient complies with the treatment. If the mask is uncomfortable or difficult to use, the patient may not comply with the treatment. Because patients are often encouraged to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their masks, which affects patient compliance.

[0024] Masks intended for other applications (e.g., for aviators) may not be appropriate for use with sleep-disordered breathing, but masks designed for use with sleep-disordered breathing may be appropriate for other applications.

[0025] For these reasons, patient interfaces for the delivery of nasal CPAP during sleep are a unique field. 2.2.3.1.1 Seal forming part

[0026] The patient interface includes a seal-forming portion that comes into direct contact with the patient's face, and the shape and configuration of the seal-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0027] Patient interfaces are characterized in part by the design intent of where the seal-forming portion will contact the face in use. In one form of patient interface, the seal-forming portion can have two sub-portions, one for each of the left and right nostrils. In one form of patient interface, the seal-forming portion can be a single element that surrounds both nostrils in use. Such a single element can be designed, for example, to cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming portion can comprise an element that surrounds the mouth area in use, for example forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming portion can comprise a single element that surrounds both nostrils and the mouth area in use. These different types of patient interfaces are known by various names given by their manufacturers, including nasal masks, full face masks, nasal pillows, nasal sprays, and oral-nose masks.

[0028] A seal that is effective in one area of ​​a patient's face may not be suitable for another area due to differences in the shape, structure, variability and sensitivities of the patient's face, for example, a seal on swimming goggles that covers the patient's forehead may not be suitable for use on the patient's nose.

[0029] A seal forming part can be designed for mass production so that one design is comfortable and effective for a variety of different face shapes and sizes. Until there is a mismatch between the patient's face shape and the seal forming part of the mass produced patient interface, one or both must be adapted to form a seal.

[0030] One type of seal-forming portion extends around the periphery of the patient interface, where the seal-forming portion is intended to engage the patient's face and seal against the patient's face when force is applied to the patient interface. The seal-forming portion may include an air or liquid filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal formation, if the fit is not proper, there will be a gap between the seal-forming portion and the face, requiring additional force to be applied to the patient interface against the face to form a seal.

[0031] Another type of seal-forming section includes a flap seal made of a thin material located near the periphery of the mask that self-seals against the patient's face when positive pressure is applied within the mask. As with the previous type of seal-forming section, if the fit between the face and the mask is not good, additional force is required to create a seal or the mask will leak unintentionally. Furthermore, if the shape of the seal-forming section does not match that of the patient, it may wrinkle or bend during use, resulting in unintentional leakage.

[0032] Another type of seal-forming portion may include a mating element, such as an insertion into the nostril.

[0033] Another form of seal-forming part uses an adhesive to achieve the seal, and some patients find it inconvenient to constantly apply and remove adhesive from the face.

[0034] Various patient interface seal forming technologies are disclosed in the following patent applications assigned to ResMed Limited: US Pat. No. 5,399,413; US Pat. No. 5,499,413; and US Pat. No. 5,523,341.

[0035] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennet. Another nasal pillow or nasal spray is the subject of US Pat. No. 5,399,323 (Trimble et al.), assigned to the Puritan-Bennet Corporation.

[0036] ResMed Limited manufactured the following products incorporating nasal pillows: the SWIFT nasal pillows mask, the SWIFTII nasal pillows mask, the SWIFTLT nasal pillows mask, the SWIFTFX nasal pillows mask, and the LIBERTY full face mask. Nasal pillows masks are described in the following patent applications assigned to RedMed: US Pat. No. 5,393,663 (depicting, among other things, features of the RedMed SWIFT nasal pillows); US Pat. No. 5,493,663 (depicting, among other things, features of the RedMed SWIFTLT nasal pillows); US Pat. No. 5,493,663 (depicting, among other things, features of the ResMed LIBERTY full face mask); US Pat. No. 5,593,663 (depicting, among other things, features of the ResMed SWIFT TM (Describes the features of the FX nasal pillow). 2.2.3.1.2 Positioning and stabilization

[0037] Seal-forming portions of patient interfaces used in positive air therapy are subject to the corresponding force of air pressure tending to collapse the seal.

[0038] Thus, various techniques have been used to position the seal-forming portion and maintain it in sealing relationship with the appropriate portion of the face.

[0039] One technique involves the use of adhesives, see for example US Pat.

[0040] Another technique involves the use of one or more straps and a stabilizing harness. Many such harnesses suffer from one or more of the problems of poor fit, bulk, discomfort and awkwardness.

[0041] For either or both sealing (nasal pillows) and / or non-sealing (e.g., nasal cannula) types, it is desirable to maintain the patient interface in its operative orientation and / or position during use, which in turn enables the patient interface to maintain a seal and / or effectively deliver breathable gas (e.g., oxygen) to the patient.

[0042] During use, the patient interface may be subjected to forces that tend to displace it from its operative orientation and / or position. For example, during use, the patient interface may be pulled by one or more of the following: its own weight, the weight of the air circuit, tension in the air circuit, and friction between the patient interface and another object, such as the surface of a bed.

[0043] In this manner, the positioning and stabilising structure is used to maintain the seal and / or maintain the patient interface in its operative orientation and / or position. 2.2.3.1.3 Venting Technology

[0044] Some forms of patient interface systems may include a vent for cleaning of exhaled carbon dioxide. The vent may allow gas flow from an interior volume of the patient interface, e.g., a plenum chamber, to the exterior of the patient interface, e.g., to the atmosphere. The vent includes an orifice through which gas passes during use of the mask. Many such vents are noisy. Others become clogged during use and are inadequately cleaned. Some vents may disturb the sleep of the patient's 1000 bed partner 1100 due to noise or focusing of the airflow.

[0045] ResMed Limited has developed a number of improved mask vent technologies, see US Pat. Nos. 5,993, 6,133, 6,141, 6,152, 6,166, 6,171, and 6,182, 6,193.

[0046] Previous mask noise table (ISO 17510-2:2007, pressure 10cmH2O at 1m)

[0047] [Table 1]

[0048] (*Measured using only one sample in CPAP mode at 10cmH2O using the test method specified in ISO3744)

[0049] The sound pressure levels of various objects are given below.

[0050] [Table 2]

[0051] Some forms of patient interfaces do not include a vent. An example of a non-vented patient interface includes those designed for use with dual limb air circuits, which include an expiratory limb that transports exhaled gases (e.g., carbon dioxide) away from the patient. Another example is a non-sealing patient interface, such as a nasal cannula. In some nasal cannulas, exhaled gases are carried away through one or more gaps created between the patient interface and the patient's airway. 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0052] One known RPT used to treat sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed. Another example of an RPT device is a ventilator. The ResMed Stellar Adult and Pediatric Ventilators TM Ventilators such as the series can provide invasive and non-invasive independent ventilatory support for a variety of patients treating many diseases such as (but not limited to) NMD, OHS and COPD.

[0053] ResMed Elisee TM 150 Ventilators and ResMed VSIII TM The ventilators can provide invasive and non-invasive ventilation suitable for the treatment of multiple conditions in adult and pediatric patients. These ventilators provide volumetric and pressure ventilation modes with single or dual limb circuits.

[0054] The RPT device typically consists of a pressure generator, such as a motor-driven blower or compressed gas reservoir, and is configured to deliver a flow of air to the patient's airway. In some cases, the airflow can be delivered to the patient's airway at positive pressure. The outlet of the RPT device is connected to the patient interface via an air circuit.

[0055] RPT devices also typically include an inlet filter, various sensors, and a microprocessor-based controller. The blower includes a servo-controlled motor, volute, and impeller. Optionally, a brake for the motor is incorporated to overcome the inertia of the motor and impeller and reduce the blower speed more quickly. Braking allows the blower to achieve a low pressure state more quickly in time to synchronize with exhalation despite inertia. Optionally, the pressure generator can include a valve that allows the generated air to be discharged to atmosphere as a means of varying the pressure delivered to the patient, as an alternative to controlling the motor speed. Sensors measure motor speed, mass flow rate, and outlet pressure, such as by a pressure transducer, among others. The controller can include data storage capacity with or without integrated data retrieval and display capabilities.

[0056] Table of noise output of previous RPT devices (measured using the test method specified in ISO3744 in CPAP mode at 10cmH2O, for one sample only)

[0057] [Table 3] 2.2.3.3 Humidifier

[0058] Delivering the airflow without humidification can dry out the airways. Medical humidifiers are used to increase the humidity and / or temperature of the airflow relative to the ambient air, if desired, typically while the patient is sleeping or resting (e.g., in hospitals). As a result, medical humidifiers can be small, placed next to a bed, and configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surroundings. For example, room-based systems (e.g., saunas, air conditioners, evaporative coolers) can also humidify the air breathed by the patient, but these systems can humidify and / or heat the entire room, causing discomfort to the occupant.

[0059] The use of a humidifier with the RPT device and patient interface produces humidified gases, which minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in cool climates, warm air applied broadly to the face in and around the patient interface is much more comfortable than cold air.

[0060] There are various forms of respiratory humidifiers, some standalone and connected to the RPT device via an air circuit, some built into the RPT device, and some configured to be directly connected to an associated RPT device. While known passive humidifiers can provide some relief, heated humidifiers generally provide sufficient humidity and temperature for patient comfort. Humidifiers typically include a water reservoir or tub with a capacity of several hundred milliliters (ml), a heating element to heat the water in the reservoir, a control device to vary the level of humidification, a gas inlet to receive gas from a flow generator or RPT device, and a gas outlet adapted to be connected to an air circuit to deliver humidified gas to a patient interface. [Prior art documents] [Patent documents]

[0061] [Patent Document 1] U.S. Pat. No. 4,944,310 [Patent Document 2] U.S. Patent No. 6,532,959 [Patent Document 3] International Publication No. 1998 / 004310 [Patent Document 4] International Publication No. 2006 / 074513 [Patent Document 5] International Publication No. 2010 / 135785 [Patent Document 6] U.S. Pat. No. 4,782,832 [Patent Document 7] International Publication No. 2004 / 073778 [Patent Document 8] US Patent Application No. 2009 / 0044808 [Patent Document 9] International Publication No. 2005 / 063328 [Patent Document 10] International Publication No. 2006 / 130903 [Patent Document 11] International Publication No. 2009 / 052560 [Patent Document 12] U.S. Patent Application No. 2010 / 0000534 [Patent Document 13] International Publication No. 1998 / 034665 [Patent Document 14] International Publication No. 2000 / 078381 [Patent Document 15] U.S. Patent No. 6,581,594 [Patent Document 16] US Patent Application No. 2009 / 0050156 [Patent Document 17] US Patent Application No. 2009 / 0044808 [Non-patent literature]

[0062] [Non-Patent Document 1] Respiratory Physiology by John B. West, Lippoincott Williams & Wilkins, 9th edition 2011 Summary of the Invention [Means for solving the problem]

[0063] The present technology provides medical devices for use in the diagnosis, amelioration, treatment or prevention of respiratory disorders having one or more improved comfort, cost, effectiveness, ease of use and manufacturability.

[0064] A first aspect of the present technology relates to an apparatus for use in the diagnosis, amelioration, treatment or prevention of respiratory disease.

[0065] Another aspect of the technology relates to methods used in the diagnosis, amelioration, treatment or prevention of respiratory disorders.

[0066] One form of the present technology includes a patient interface for delivering an airflow to one or more nares of a patient, the patient interface comprising: a plenum chamber configured to receive the airflow; a protrusion for delivering the airflow from the plenum chamber to the patient's nares; and a frame coupled to the plenum chamber, the frame adapted to engage the patient's head which, in use, locates the plenum chamber relative to the patient's nares, wherein a portion of the frame is recessed forwardly from at least a portion of the plenum chamber such that a portion of the plenum chamber is displaced forwardly into the recess.

[0067] In accordance with one form of the present technology, the portion of the frame is recessed from a central portion of the plenum chamber.

[0068] In accordance with one form of the present technology, the portion of the frame is constructed to be rigid.

[0069] According to one form of the present technology, a central portion of the plenum chamber is configured to engage the patient's upper lip during use.

[0070] In accordance with one form of the present technology, the plenum chamber is substantially tubular.

[0071] According to one form of the present technology, the plenum chamber is oriented substantially perpendicular to the sagittal plane during use.

[0072] According to one form of the present technology, a frame engages a first end and a second end of a plenum chamber.

[0073] According to one form of the present technology, the plenum chamber includes an opening configured to connect to an air circuit to receive the flow of air.

[0074] According to one form of the present technology, the plenum chamber comprises a resilient and flexible material.

[0075] According to one form of the present technology, protrusions extend outwardly from the plenum chamber towards the patient's nares.

[0076] According to one form of the present technology, the prongs are configured to be inserted into the patient's nostrils.

[0077] In accordance with one form of the present technology, the protrusion is formed integrally with the plenum chamber.

[0078] According to one form of the present technology, the protrusions extend superiorly and posteriorly towards the patient.

[0079] According to one form of the present technology, the protrusions are curved.

[0080] According to one form of the present technology, a frame includes a rigid portion adapted to engage the patient's face during use.

[0081] According to one form of the present technology, the rigid portion is adapted to engage the patient's upper jaw during use.

[0082] One form of the present technology further includes headgear coupled to the frame.

[0083] According to one form of the present technology, the headgear is elastic.

[0084] According to one form of the present technology, headgear includes a top strap and a back strap.

[0085] According to one form of the present technology, the headgear is bifurcated.

[0086] One form of the present technology includes a patient interface for delivering an airflow to an entrance of a patient's airway, the patient interface including a plenum chamber configured to receive the airflow; one or more protrusions configured to deliver the airflow from the plenum chamber to the entrance of the patient's airway; a rigid frame configured to engage the patient's cheek in use; and headgear coupled to the rigid frame and configured to engage the patient's head to seek out the one or more protrusions in use, wherein the rigid frame includes a central portion extending forwards and rearwards away from and beyond the plenum chamber.

[0087] According to one form of the present technology, the central portion includes a plurality of bracing members.

[0088] According to one aspect of the present technology, multiple brace members are connected at an angle.

[0089] According to one form of the present technology, a plurality of bracing members form a triangular structure.

[0090] In accordance with one form of the present technology, a portion of the frame extends substantially across a width of the plenum chamber.

[0091] According to one form of the present technology, the locations of engagement between the central portion and the plenum chamber include left and right ends of the plenum chamber.

[0092] According to one form of the present technology, the central portion includes a curved surface.

[0093] According to one form of the present technology, the central section is curved across the width of the plenum chamber.

[0094] In accordance with one form of the present technology, the plenum chamber has negligible impact on the stiffness of the patient interface.

[0095] One form of the present technology includes two prongs.

[0096] According to one form of the present technology, the plenum chamber is cylindrically shaped.

[0097] In accordance with one form of the present technology, the plenum chamber is a substantially straight cylinder.

[0098] In accordance with one form of the present technology, the plenum chamber comprises silicon.

[0099] In accordance with one form of the present technology, the plenum chamber and the one or more protrusions are integrally formed.

[0100] According to one form of the present technology, a rigid frame includes a left portion and a right portion.

[0101] According to one form of the present technology, a rigid frame is formed by molding.

[0102] One form of the present technology further includes a header.

[0103] One form of the present technology relates to a respiratory treatment comprising a respiratory treatment device configured to generate a flow of breathable gas; a humidifier coupled to the treatment device and configured to humidify the flow of breathable gas; an air circuit that delivers the flow of breathable gas; and a patient interface according to the present technology.

[0104] Of course, portions of the embodiments form sub-embodiments of the present technology. Furthermore, the sub-embodiments and / or various aspects of the embodiments may be combined in various ways to form additional embodiments or sub-embodiments of the present technology.

[0105] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, summary, drawings, and claims. [Brief description of the drawings]

[0106] The present technology is illustrated by way of example, and not by way of limitation, in the accompanying drawings in which like reference numerals refer to like elements and in which: 4.1 Treatment system [Figure 1A] Figure 1A shows a system including a patient 1000 wearing a patient interface 3000 in the form of nasal pillows that receives a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and supplied to the patient 1000 through an air circuit 4170. A bed partner 1100 is also shown. [Figure 1B] 1B shows a system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask that receives a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and supplied to the patient 1000 through an air circuit 4170. [Figure 1C] Figure 1C shows a system including a patient 1000 wearing a patient interface 3000 in the form of a full face mask that receives a supply of air at positive pressure from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and supplied to the patient 1000 through an air circuit 4170. 4.2 Respiratory System and Facial Anatomy [Figure 2A] FIG. 2A shows an overview of the human respiratory system, including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] FIG. 2B shows an overview of the human upper respiratory tract, including the nasal cavity, nasal bones, lateral nasal cartilages, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea. [Figure 2C] Figure 2C is a front view of the face showing some features of the surface anatomy identified as upper lip, upper vermilion, lower vermilion, lower lip, mouth width, endocanthion, alae of the nose, nasolabial folds and cheilion, as well as superior, inferior, medial and lateral radial directions. [Figure 2D]Figure 2D is a lateral view of the head showing several features of the surface anatomy including the glabella, therion, pronasal, subnasal point, upper lip, lower lip, supramenton, nasal ridge, alar crest point, superior and inferior temporal points, and also shows the superior and inferior directions and the anterior and posterior directions. [Figure 2E] Figure 2E is a further lateral view of the head, with the Frankfort horizontal and nasolabial angle also identified. The frontal plane is also shown. [Figure 2F] Figure 2F is a bottom view of the nose showing some of the features that were identified, including the nasolabial fold, lower lip, upper vermilion, nostrils, inferior nasal point, columella, pronasal passage, and the major and sagittal axes of the nostrils. [Figure 2G] FIG. 2G is a side view of the nasal surface features. [Figure 2H] FIG. 2H shows the subcutaneous structures of the nose, including the lateral cartilage, septum cartilage, larger alar cartilage, smaller alar cartilage, sesamoid cartilage, nasal bones, epithelium, adipose tissue, frontal process of the maxilla, and fibroadipose tissue. [Figure 2I] Figure 2I shows the medial anatomy of the nose approximately a few millimeters from the sagittal plane, specifically showing the septal cartilage and medial crus of the greater alar cartilage. [Figure 2J] Figure 2J is a frontal view of the bones of the head, including the frontal nasal and zygomatic bones, with the nasal conchae shown as the upper and lower jaws. [Figure 2K] Figure 2K shows a lateral view of the skull with the surface of the head outlined along with some of the muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital bones. The mental protuberance is shown. The following muscles are shown: digastric, masseter, sternocleidomastoid and trapezius. [Figure 2L] Figure 2L shows an anterolateral view of the nose. 4.3 Patient Interface [Figure 3A] FIG. 3A shows a side perspective view of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 3B] FIG. 3B shows an exploded side view of a patient interface in the form of a nasal cannula and air circuit in accordance with one form of the present technology. [Figure 3C]FIG. 3C shows a rear view of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 3D] FIG. 3D shows a side view of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 3E] FIG. 3E shows a top view of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 3F] FIG. 3F shows a top view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 3G] FIG. 3G shows a rear perspective view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 3H] FIG. 3H shows a front perspective view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 3I] 3I shows a front perspective view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology, with the nasal prongs, manifold and barrel shown exploded from the cannula frame. [Figure 3J] FIG. 3J shows a side view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology in a typical operative position and orientation on the patient's head. [Figure 3K] FIG. 3K shows a front perspective view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4A] FIG. 4A shows a side perspective view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4B] FIG. 4B shows a side exploded view of a patient interface in the form of a nasal cannula and air circuit according to one form of the present technology. [Figure 4C] FIG. 4C is a side view of a patient interface in the form of a nasal cannula in accordance with one form of the present technology, with the cross section shown in FIG. 4D. [Figure 4D] FIG. 4D is a top view of a patient interface in the form of a nasal cannula in accordance with one form of the present technology, showing the cross section shown in FIG. 4C. [Figure 4E] FIG. 4E shows a front view of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4F] FIG. 4F shows a rear view of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4G] FIG. 4G shows a side perspective view of a frame of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4H] FIG. 4H shows a side perspective view of a frame of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4I] FIG. 4I shows a side view of a patient interface in the form of a nasal cannula placed on a patient's head in accordance with one form of the present technology. [Figure 4J] FIG. 4J shows a plan view (top view) of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4K] FIG. 4K shows a perspective view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4L] FIG. 4L shows a rear view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. [Figure 4M] FIG. 4M shows a side perspective view of a portion of a patient interface in the form of a nasal cannula in accordance with one form of the present technology. 4.4 RPT Device [Figure 5A] FIG. 5A shows an RPT device according to one form of the present technology. 4.5 Humidifier [Figure 6A] FIG. 6A shows an isometric view of a humidifier in accordance with one form of the present technology. [Figure 6B] FIG. 6B shows an isometric view of a humidifier with the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130 in accordance with one form of the present technology. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0107] Detailed Description of the Technical Embodiments Before describing the present technology in further detail, it is to be understood that the present technology is not limited to the specific embodiments described herein, which may vary, and the terminology used in this disclosure is for the purpose of describing only the specific embodiments discussed herein, and is not intended to be limiting. 5.1 Treatment

[0108] In one form, the present technology comprises a method of treating a respiratory disorder comprising the step of applying positive pressure to an entrance of the airways of a patient 1000.

[0109] In one embodiment of the present technology, air at positive pressure is delivered to the patient's nasal cavity through one or both nostrils.

[0110] In some embodiments of the present technology, mouth breathing is limited, inhibited or prevented. 5.2 Treatment system

[0111] In one form, the technology comprises an apparatus or device for treating a respiratory disorder, the apparatus or device including an RPT device 4000 that delivers pressurized breathing gas, such as air, to a patient 1000 via an air circuit 4170 to a patient interface 3000. 5.3 Patient Interface 3000

[0112] A non-invasive patient interface 3000 in accordance with one aspect of the present technology has the following functional aspects: air directing structures, positioning and stabilizing structures 3300, and a connection port 3600 for connection to an air circuit 4170. Some forms of the functional aspects can be provided by one or more physical components. In some forms, one physical component can provide one or more functional aspects. 5.3.1 Air Directing Structure

[0113] The air directing structure may direct the flow of air received by the patient interface 3000 to the patient's airway via at least one of the nose or mouth.

[0114] In some configurations, the air directing structure can include one or more walls (e.g., nasal pillows, a nasal mask as shown in Figures 1A-1C, or a full-face mask) configured to form a sealed conduit to the patient's airway, thereby directing the airflow toward the patient's airway, such as the mouth or nostrils.

[0115] In other configurations, the air directing structure may direct air to one or more nostrils without forming a sealed conduit. For example, a nasal cannula may deliver a stream of air to the patient 1000, where prongs of the nasal cannula are placed near or within the patient's nares without forming a seal.

[0116] According to one aspect of the present technology, the air directing structure includes one or more nasal prongs 3100 as shown in FIG. 3A configured to direct the airflow into one or more nostrils of the patient 1000.

[0117] In one configuration, the nasal prongs 3100 are configured to be inserted into the nasal passages of the patient 1000. In the embodiment shown in Figure 4I, a portion of the nasal prongs 3100 is shown in dashed lines to indicate that it is inserted into the nasal passages of the patient 1000. In other configurations, the nasal prongs 3100 may be located outside the nasal passages of the patient 1000 and direct air into one or more nostrils of the patient 1000.

[0118] The nasal protrusion 3100 according to one form of the present technology is shaped to direct airflow into the patient's nares to minimize patient discomfort during use. Because the nasal protrusion 3100 may be inserted into the patient's nares during use in some cases (see FIG. 4I where a portion of the protrusion 3100 in the patient's nasal cavity is shown in dashed lines), the nasal protrusion 3100 is shaped to reduce the chance of the nasal protrusion 3100 contacting the patient via the skin or inner surface of the nasal cavity. Preventing or reducing contact between the nasal protrusion 3100 and the patient advantageously improves the patient's comfort using the patient interface.

[0119] For example, the nasal protrusion 3100 is configured to prevent contact with the inner surface(s) of the patient's nasal cavity or upper lip (see FIG. 2C) during use. In one form, the nasal protrusion 3100 approximates the curvature of the nasal cavity towards the nostril and extends in an anterior and posterior direction towards the patient 1000. Examples of suitable shapes may include arcs as shown in FIG. 3H or 4C, although straight protrusions or protrusions comprised of multiple sections (of various curvatures, shapes and / or orientations) are also suitable.

[0120] In one form, the nasal prongs 3100 may be coupled to a plenum chamber (such as a manifold 3200) configured to receive air from one or more air circuits 4170. An example of a nasal prong 3100 coupled to a manifold 3200 is shown in Figure 3A.

[0121] The manifold 3200 may include one or more openings for connection to one or more air circuits. For example, the manifold 3200 includes an opening coupled to a connection port 3600 for connection to an air circuit. In some forms, the manifold 3200 is configured to connect to multiple air circuits, such as one or more circuits for an inhalation flow and one or more air circuits for an exhalation flow. The manifold 3200 can be connected to an air circuit having multiple limbs, such as an inspiratory limb and an expiratory limb.

[0122] It will be appreciated that the protrusions 3100 and manifold 3200 can be constructed of a resilient, flexible, biologically compatible material such as silicone, although numerous other materials are suitable. In one form, the protrusions 3100 and manifold 3200 can be molded, such as by injection molding.

[0123] The protrusions 3100 and / or manifold 3200 may be flexible to reduce discomfort to the patient when the protrusions and / or manifold come into contact with the patient, as described in more detail below.

[0124] The projection 3100 and / or manifold 3200 may include relatively thin sections. For example, the projection 3100 and / or manifold 3200 may be constructed by injection molding and have a wall thickness of about 0.5 mm. Of course, it will be appreciated that other thicknesses, such as about 0.2 mm to 1 mm, about 0.3 mm to 0.8 mm, or about 0.4 mm to 0.6 mm, are also suitable. It will also be appreciated that one portion of the projection 3100 and / or manifold 3200 may also include a different wall section thickness than another portion according to the structural requirements of the projection 3100 and / or manifold 3200.

[0125] In some configurations, the manifold 3200 can be formed integrally with the nasal prongs 3100, as shown in the exploded views of the patient interface 3000 in Figure 3B or 4B. In other configurations, the manifold 3200 is formed separately from the nasal prongs 3100 and coupled thereto by any number of known methods, such as at least one of mechanical fasteners, adhesives, or an interference fit.

[0126] Where nose protrusions 3100 are coupled to manifold 3200, protrusions 3200 are removably coupled to manifold 3200. That is, one or more of protrusions 3100 are movable relative to manifold 3200, such as, for example, translation about or to one or more axes. In one form, each protrusion 3100 is independently movable relative to manifold 3200 (and relative to the other protrusions 3100), such as, for example, rotation as shown in FIG. 3K.

[0127] In this manner, the patient may move (e.g., rotate) one or more of the protrusions 3100 relative to the manifold 3200 to orient them according to the patient's preferences, e.g., to suit the facial structure and / or nasal passages of the patient. For example, one or more of the protrusions 3100 may be moved to a patient-preferred operating orientation and / or position.

[0128] The patient interface 3000 may be configured in a manner that results in improved patient comfort or improved delivery of airflow to the patient's airways.

[0129] The manifold 3200 can provide structural support to the nasal protrusions 3100. For example, the manifold 3200 can help maintain the protrusions 3100 in the proper location and / or orientation during use. The manifold 3200 can include a cylinder-like shape to provide some structural support to the protrusions 3100. The manifold 3200 can be configured as a straight cylinder, for example.

[0130] The position and / or orientation of the protrusions 3100 during use may include within or near one or more nostrils of the patient 1000 .

[0131] During use, the manifold 3200 is positioned adjacent or on the patient interface to effectively maintain the protrusions 3100 in a preferred operative position and / or orientation relative to the patient's nares. For example, the manifold 3200 can be positioned adjacent the upper lip of the patient 1000 with the protrusions 3100 oriented toward the patient's nares and / or nasal passages.

[0132] In configurations of the patient interface 3000 where the manifold 3200 is in close proximity to the patient's upper lip (and nostrils), effective airflow to the patient's airway can be achieved with a relatively short projection 3100, such as the length between the nostrils and the manifold. In turn, the short distance advantageously increases the stiffness of the projection 3100, helping the projection 3100 maintain a predetermined configuration relative to the manifold 3200.

[0133] In some cases, when the manifold 3200 is close to the patient's upper lip, the manifold can exert pressure (or force) on the patient 1000 during use of the patient interface 3000. Such pressure (or force) can cause at least some discomfort to the patient 1000 during use of the patient interface 3000 due to a tactile sensation of pressure. Additionally, while the upper lip area provides an approximate protrusion for looking 3100 with respect to the patient's nostrils, for many patients this is also typically a sensitive area of ​​the face.

[0134] Thus, a patient interface 3000 in accordance with the present technology can be configured to be positioned adjacent to or on the patient 1000 and provide a flow of breathable gas to the patient 1000. Further advantageously, the patient interface 3000 can also minimize pressure (or force) applied to sensitive areas of the patient 1000, such as the upper lip and / or under the nose.

[0135] In one embodiment, the patient face 3000 can be positioned such that the manifold 3200 conforms to the direction of engagement with the patient's face (e.g., forward), for example, by the inclusion of certain fold joints or regions of low stiffness in the manifold 3200. Stiffness is sometimes expressed as a spring rate, and thus the manifold 3200 can be said to have a low spring rate.

[0136] In another embodiment, the manifold 3200 can be flexibly coupled (e.g., at least anteriorly) to the frame of the patient interface 3000. The manifold 3200 in such an arrangement can reduce pressure (or force) applied to areas of the patient's face that are in contact with the manifold 3200.

[0137] The pressure (or force) generated by deformation of the object is a function of the stiffness of the deflected object. A manifold 3200 configured to comply at least forward in this manner is advantageous because if the manifold 3200 is displaced forward and comes into contact with the patient 1000, the resulting pressure (or force) exerted on the patient in the area of ​​contact is reduced.

[0138] For example, a displacement or deformation of the manifold 3200 occurs when the manifold 3200 comes into contact with the patient's face (e.g., at or near the upper lip or under the nose). Displacement or deformation of the manifold 3200 from the rest state occurs when the patient interface 3000 is placed on the patient in its activated configuration. The displacement or deformation occurs in the forward direction, where the resulting pressure (or force) on the patient 1000 is a function of the stiffness of the manifold 3200 in the forward direction. Thus, by reducing the stiffness of the manifold 3200 in the forward direction, the pressure (or force) on the upper lip or under the nose of the patient 1000 is reduced improving patient comfort. Similarly, the manifold can be configured to readily displace or deflect (e.g., with reduced stiffness) in one or more other directions, thus improving patient comfort.

[0139] Thus, one aspect of the present technology relates to a patient interface 3000 that includes a reduced stiffness portion. Some embodiments of the present technology include a manifold 3200 that includes a central portion having reduced stiffness compared to one or more other portions of the manifold 3200, such as adjacent portions or the entire manifold 3200. The reduced stiffness portion includes reduced stiffness at least in the anterior portion.

[0140] A reduced stiffness portion comprises a reduced stiffness by one or more mechanisms, such as geometric or material means, compared to another portion of the manifold 3200. For example, a reduced stiffness portion may comprise a reduced wall thickness, comprise a material with a low modulus of elasticity, and / or comprise a geometry with a reduced stiffness (e.g., bending) relative to other portions of the manifold 3200.

[0141] In some forms, the low stiffness section can include a connection between adjacent sections. For example, a first section of the manifold 3200 can be connected to an adjacent section of the manifold 3200 by a low stiffness section, such as a reduced wall thickness, a material stiffness such as a hinge section, or a low stiffness geometry.

[0142] The manifold 3200 can include a cylindrically shaped body, for example as shown in Figure 3 A. Alternatively, the manifold 3200 can include a curved body, as shown in Figures 4B and 4D, where the body is curved to approximate the curvature of the patient's face.

[0143] In one form, as shown in Figures 4B-4D, the manifold 3200 includes one or more 'grooves' such as anterior indentations 3200fi and posterior indentations 3200ri. The one or more grooves are configured to include reduced stiffness as previously described. The one or more indentations 3200fi and 3200ri extend substantially along the sagittal plane (as shown in Figure 4D) and perpendicular to the anterior direction. The grooves may thereby reduce the anterior stiffness of the manifold 3200. The indentations 3200fi and 3200ri provide additional conformance to the manifold 3200 when the manifold 3200 is displaced or deformed anteriorly (or posteriorly) due to movement of the patient's upper lip or attachment of the patient interface 3000 to the patient's face. The indentations 3200fi and 3200ri may additionally or alternatively include reduced wall thickness compared to adjacent portions of the patient interface 3000, such as the remainder of the manifold 3200.

[0144] For example, the grooves help prevent the manifold 3200 from becoming taut. If the manifold 3200 becomes taut, the resistance (effective spring constant) on the manifold will be reduced, e.g., further displacement or deformation will present a greater reaction force to the patient's face.

[0145] In reduced stiffness sections of the manifold, such as those containing indentations 3200fi and 3200ri, the cross-sectional width (as viewed from the front) is, for example, about 50% of the typical width of the adjacent sections (see FIG. 4D). In other configurations, the cross-sectional width is about 40-60%, or 25-75% of the typical width. As described elsewhere, it will be appreciated that other aspects of the material or geometry can be varied to achieve an appropriate reduction in stiffness.

[0146] According to one embodiment, the base of the manifold 3200 includes a raised central portion as shown in FIG 4L. The raised central portion includes an indentation in the base of the manifold 3200, for example, having a length L1 and a height H1 as shown in FIG 4L. The raised central portion improves patient comfort by reducing interference between the patient's face (e.g., upper lip) and the manifold 3200.

[0147] In one embodiment, the raised central portion has a span of about 30 mm and is raised about 6 mm, as shown in Figure 4L. In other configurations, the raised central portion spans between 25 mm and 35 mm, and alternatively between 15 mm and 45 mm. Additionally or alternatively, the raised central portion is raised between 5 mm and 7 mm, or between 4 mm and 8 mm, or between 3 mm and 9 mm.

[0148] It will be appreciated by those skilled in the art that any number of other methods and / or mechanisms may be employed while still achieving the goal of reducing pressure and / or force on sensitive areas of the face, such as the upper lip or under the nose. For example, one or more reduced local wall thicknesses, folded sections, use of different materials (e.g., softer materials), flexible joints, or curved geometries may be used to reduce the effective spring rate of the manifold 3200 in the direction of engagement with the face.

[0149] The patient interface 3000 can include one or more caps 3210 configured to couple to an end of the manifold 3200. The manifold caps 3210 can couple to an end of the manifold 3200 and close to form a wall. In some configurations, the manifold caps 3210 include a connection port 3600 through which the manifold 3200 can be connected to the air circuit 4170 to receive or discharge airflow. The manifold caps 3210 can be inserted into the manifold 3200 to ensure a secure fit, although many other connection configurations are suitable.

[0150] In the configuration shown in FIG. 4B , the manifold 3200 can be connected to a manifold cap 3210 configured to close a first end of the manifold 3200 and a second manifold cap 3210 including a connection port 3600 for connecting to the air circuit 4170.

[0151] The manifold cap 3210 further includes a connection means for positioning the manifold 3200 and / or securing the manifold 3200 to the positioning and stabilizing structure 3300. The connection means may be a latch as shown in Figure 4B or 4K. The manifold cap 3210 is configured to fit into the positioning and stabilizing structure 3300 shown in Figures 4B and 4K via terminals 3335ep.

[0152] End 3335ep includes a receiver portion of the latch as shown in FIG. 4K, although many other configurations are suitable. The latch includes a lead-in portion to facilitate quick assembly and prevent disassembly of manifold cap 3210.

[0153] According to another embodiment, the nasal prongs 3100 can be configured to be movable relative to the positioning and stabilizing structure 3300 of the patient interface 3000. In one form, the manifold 3200 can be coupled to a rotating barrel 3250 as shown in Figures 3A-3B, where the barrel 3150 rotatably fits into the positioning and stabilizing structure 3300 or a portion thereof, such as the front clamp as shown in Figures 3H-3I.

[0154] The barrel 3150 and front catch 3320 are rotatably fitted together such that the relative rotational adjustment can be discretely variable (e.g., by a notch 3152 and protrusion 3322 shown in Figures 3H and 3I) or continuously variable, for example, by a sliding friction fit (not shown).

[0155] The barrel 3150 in one form includes a grip 3150gr to allow easy rotation of the barrel 3150 with one hand. The grip 3150gr includes one or more indentations configured to receive one or more fingers of the patient 1000 (or another user) or a high friction surface to improve the fit of the fingers in the grip 3150gr.

[0156] The barrel 3150 includes one or more ends, each configured to close an end of the manifold 3200 or provide a connection port 3600. For example, the exemplary barrel 3150 shown in Figure 3B includes a first closed end configured to form a wall at a first end of the manifold 3200 and a second open end configured to connect to the connection port 3600. The first end of the barrel 3150 shown in Figure 3B includes a grip 3150gr, which may be located in some manner at the second end.

[0157] Each nasal prong 3100 includes one or more openings 3110 that deliver flow or air to the patient's airways. In one embodiment, the openings 3110 are configured in an oval shape as shown in Figure 3C, although it will be understood by one of ordinary skill in the art that other shapes or configurations are suitable. 5.3.2 Positioning and stabilizing structures 3300

[0158] The air directing structure of the patient interface 3000 of the present technology is held in an operative position by a positioning and stabilizing structure 3300. In one form, the positioning and stabilizing structure 3300 includes a frame (e.g., two side fasteners 3310 and a front fastener 3320) and headgear (e.g., a rear strap 3350 and a top strap 3340). The positioning and stabilizing structure is configured to hold the air directing structure in its open position and / or orientation during use, minimizing potential disturbance to the patient. In one form, the positioning and stabilizing structure 3300 is configured to exert minimal pressure on the upper lip (upper lip) or subnasal area of ​​the patient 1000, as will be described in more detail below. 5.3.2.1 Frames

[0159] The patient interface 3000 is configured to act as a skeleton to the patient interface 3000, such as by maintaining the shape and / or configuration of the patient interface 3000 in one or more orientations or aspects. The frame is configured to engage the face of the patient 1000, such as the left or right cheek of the patient 1000, during use. In some forms, the frame can be made, for example, by molding, from polypropylene or polycarbonate.

[0160] The positioning and stabilizing structure 3300, in some configurations, includes a frame configured to engage at least the patient's cheek when the patient interface 3000 is in an operative position and / or orientation, such as in use.

[0161] The frame is further configured such that the stiffness of the frame in one direction (e.g., anteriorly) is greater than the stiffness at another location of the patient interface 3000. For example, the stiffness of the frame in a position engaged with the patient's cheek(s) is greater than the stiffness of the patient interface (e.g., manifold 3200) for engaging the upper lip.

[0162] In a typical configuration, the force (support load) applied to the patient 1000 by the positioning and stabilizing structure 3300 to position and support the patient interface (particularly the nasal prongs 3100) favorably reacts primarily to the cheeks, which are therefore generally less sensitive than, for example, the patient's upper lip.

[0163] The patient interface 3000 in the cheek engagement region is stiffer in at least one direction (e.g., anteriorly) than the upper lip engagement portion by one of several possible ratios. For example, the cheek engagement region is about 2 times, 5 times, 10 times, or 20 times stiffer. It will be appreciated that this ratio will vary depending on the particular configuration of the patient interface. Some typical aspects that affect this ratio include the amount of contact area of ​​the cheek engagement region and / or upper lip engagement portion or whether the upper lip mating engagement region is in constant contact with the upper lip while the patient interface 3000 is in use, as opposed to the upper lip engagement region (e.g., manifold) always being engaged to the upper lip.

[0164] In one form, each side fastener 3310 includes a curved cheek-engaging region 3310ch, as shown in Figure 3E. The side fasteners 3310 are configured to be rigid so that support loads are transferred to (and react against) the patient's cheek (where the side fastener 3310 is engaged to the cheek). For example, the side fasteners 3310 are configured to be rigid with respect to the manifold 3200 and / or the protrusions 3100 constructed of a soft material such as silicone.

[0165] To allow the side fasteners 3310 to bend and follow the contours of the face, the side fasteners 3310 are relatively thin in directions that run along the surface of the face, but in other directions (e.g., vertically) the side fasteners 3310 are thicker to resist deformation. This arrangement allows one shape of the side fasteners 3310 to suit multiple patient facial shapes. In some forms, the frame (e.g., the side fasteners 3310) is pre-bent to curve (e.g., as shown in Figures 3D-3E) to match the typical curvature of the face, while providing sufficient flexibility for adjustability if shape variability is desired.

[0166] According to another embodiment, the patient interface 3000 further includes a rigid front section, such as the front bracket 3320 shown in Figures 3A-3B, which connects to the two side brackets 3310. The front section may be in addition to the manifold 3200, which may also be between the two side brackets. However, the manifold 3200 is configured to be structurally decoupled from the frame, such as the front bracket 3320 and / or the side brackets 3310.

[0167] Thus, in some configurations, the patient interface 3000 includes a rigid front portion (e.g., front brace 3320) and a manifold 3200, both of which extend across the face (perpendicular to the sagittal plane). The manifold 3200 is positioned close to the patient's face for efficient delivery of breathable gas, while the front portion is configured to connect to the left and right sides of the patient interface.

[0168] In some forms, the front portion is recessed away from the face of the patient 1000 (e.g., relative to the upper lip). Thus, the front catch 3320 is recessed in a front direction (see FIG. 2D for orientation) from the patient 1000 as shown in FIG. 3E.

[0169] In one form, the front fastener 3320 includes a central portion 3325 and one or more side portions 3327. The central portion 3325 extends across the patient's face and is recessed from the manifold 3200. The one or more side portions 3327 (e.g., a left portion and a right portion) are configured to snap into and / or attach to the side fastener(s) 3310.

[0170] The front portion is rigidly constructed and / or rigidly connected to the cheek engaging portions of the frame (e.g., side fasteners 3310) to help maintain the cheek engaging portions in their desired operative position and / or orientation during use.

[0171] In the embodiment shown (see FIG. 3E), the front fasteners 3320 are engaged with the side fasteners 3310 such that the frame is rigidly restrained generally laterally (ie, across the sagittal plane).

[0172] The front of the frame is configured to reduce discomfort caused by the nasal protrusions 3100 and manifold 3200 on the patient 1000 .

[0173] The front catch 3320 includes a recess with respect to the manifold 3200 in one or more directions (e.g., forward) such that the interface of the manifold 3200 with the patient's face (e.g., upper lip) may cause forward deformation or displacement of the manifold as described above.

[0174] 3E and 3F, the front catch 3320 is shown to include a recess 3323 forwardly (e.g., toward the center of the central portion 3325) between the manifold 3200 and the front catch 3320. The recess 3323 thus provides a space into which the manifold 3200 transitions upon forward deformation or displacement that occurs upon contact with the upper lip of the patient 1000.

[0175] Advantageously, a deformed or displaced manifold 3200 will not come into contact with the front catch 3320 because the deformation and / or displacement occurs into the recess. Thus, the resistance force on the patient's face in this configuration is reduced compared to a configuration in which the manifold 3200 is pushed against a rigid boundary such as the front catch 3320.

[0176] Additionally, providing such a recess between the manifold 3200 and the front catch 3320 allows the front catch 3320 to displace the manifold 3200 forward without collapsing (e.g., resulting in a significant reduction in cross-sectional area), preventing potential blockage of the airflow path, which is further advantageous by reducing any potential changes to the delivery of airflow to the patient 1000.

[0177] The provision of one or more recesses as described above provides further advantages in the attachment of the patient interface 3000 to the patient 1000. It is well known that head and face shapes vary from patient to patient, creating a range of applications that the patient interface 3000 must accommodate. The patient interface 3000 as described above, including one or more recesses, helps to accommodate the variations in head and face shapes of the patient 1000.

[0178] For example, one or more recesses may allow the manifold 3200 and nasal prongs 3100 to move relative to the face of the patient 1000 while maintaining a relatively constant pressure on sensitive areas of the face, thus reducing sensitivity to changes in the degree of discomfort to the face.

[0179] The recess between the manifold 3200 and the front fastener 3320 is, for example, between about 1-4 mm, such as 2-3 mm, 2.5 mm, etc. It will be appreciated that in some configurations the recess may be larger or smaller and the size of the recess may vary from the examples discussed herein depending, for example, on the particular arrangement and / or configuration of the patient interface 3000.

[0180] In one form of the present technology, the positioning and stabilizing structure 3300 includes a fastener 3300 as shown in Fig. 4B. The fastener 3300 includes a central portion 3335 as described in more detail herein.

[0181] The central portion 3335 includes one or more bracing members 3335st as shown in Figure 4G. The bracing members 3335st of the central portion 3335 are configured to surround the manifold 3200 as shown in Figure 4H. The central portion 3335 at least partially surrounds an air directing structure such as the manifold 3200 as shown in Figures 4B and 4G.

[0182] In one form, one or more bracing members may be joined together to create a triangular section. In some embodiments, one or more sides of the triangular structure may be curved into a substantially teardrop-shaped cavity. The structure may be substantially non-planar, but still be considered 'triangulated.'

[0183] The example central portion 3335 shown in FIG. 4G can be said to include two out-of-plane, teardrop shaped structures that can still be said to be triangular.

[0184] As shown in Figures 4G and 4H, the central portion 3335 includes two triangular structures that extend anteriorly and posteriorly across the manifold, connected by bracing members 3335st that wrap around to a common anchor portion 3335 shown in Figures 4G and 4H at or near the sagittal plane.

[0185] A plurality of brace members 3335st thus extend from at least the height width of the manifold 3200 to another anchor portion 3335an. In some configurations, four brace members 3335st join the central anchor portion 3335 at an angle to create a lightweight, yet vertically rigid triangular structure, as shown in Figures 4G and 4H.

[0186] Each set of brace members is joined at a distal end to another portion 3335an at a terminal portion 3335ep to form a triangular looped structure. The terminal portion 3335ep is formed complementary to the manifold 3200 and includes a curved portion that surrounds the manifold 3200. Thus, the embodiment shown in FIG. 4H shows the manifold 3200 traversing the triangular structure of the central portion 3335.

[0187] It should be noted that while in Figures 4G and 4H the central portion 3335 is shown to include two triangular portions, other configurations are possible. It should be noted that while in the illustrated embodiment the anchor portions 3335an, the bracing members 3335st and / or the terminal portions 3335ep are integrally formed with one another, other arrangements are possible.

[0188] Additionally or alternatively, central portion 3335 includes a curve. Central portion 3335 is curved in one or more planes when viewed in a vertical plane upward (e.g., from above the head when worn by a patient, such as in the orientation shown in FIG. 4J). As shown in FIG. 4D, central portion 3335 includes a curve with a radius of about 30 mm.

[0189] It will be appreciated that other radii are of course suitable, for example in the ranges of 20-50 mm, 25-40 mm, 30-35 mm, or other radii. The appropriate radius will be selected depending on many other parameters such as the intended patient population, the stiffness of other portions of the patient interface 3000, the size of the manifold 3200, or the type of patient interface 3000.

[0190] The central portion 3335 is configured to be more rigid in one direction than in another direction, hi one embodiment the central portion 3335 comprises a higher bending stiffness in one direction than in a second, orthogonal direction.

[0191] For example, the central portion 3335 is significantly stiffer in response to bending moments caused by upward forces than bending moments caused by forward forces. Such a configuration advantageously allows the patient interface 3000 to conform better to the patient's face without exerting significant forces and / or pressures (and thus discomfort) on the patient 1000.

[0192] In one form, this mismatch in stiffness is accomplished at least in part by configuring the central portion to be triangular in one direction (e.g., when viewed from the front) but not in a second, orthogonal direction (e.g., when viewed from above). For example, reviewing Figures 4E, 4G and 4J shows that the patient interface 3000 is triangular in one direction (as shown in Figure 4E) but not in the orthogonal direction (e.g., Figure 4J).

[0193] At least some portion of the central portion 3335 extends beyond the exterior of the manifold 3200, as seen in Figures 4K and 4L. The central portion 3335 extends forward and rearward beyond the exterior of the manifold, for example, as shown in Figure 4J.

[0194] The central section 3335 may be detached from the manifold 3200. Upon detachment, the manifold 3200 may deform and / or displace while maintaining a low stiffness to reduce forces and / or pressures on the patient, as described in more detail elsewhere herein.

[0195] The central portion 3335 extends across at least a portion of the plenum chamber, such as across the manifold from left to right, for example spanning at least a portion of the width of the manifold 3200. In some forms, the central portion 3335 spans (left to right) across the entire width of the plenum chamber and only engages the plenum chamber at limited locations.

[0196] For example, the central portion 3335 engages the plenum chamber via end protrusions 3335ep at the left and right ends of the plenum chamber as shown in Figures 4H, 4J and 4K.

[0197] The central portion 3335 in some forms overlaps the manifold 3200 when viewed from above (eg, as shown in FIG. 4J), however, at least a portion of the overlapping portion of the central portion 3335 and the manifold 3200 do not engage each other.

[0198] The portion of the central portion 3335 that extends around and beyond the manifold 3200 is curved, as shown in FIG. 4D, although other configurations and shapes are possible.

[0199] By extending around and / or beyond the exterior of the manifold 3200 without engaging it, the central portion 3335 provides a rigid structure to the patient interface 3000. At the same time, the manifold 3200 comprises a relatively low stiffness, thereby reducing discomfort to the patient 1000 during use.

[0200] In one embodiment, the central portion 3335 and manifold 3200 are configured such that the stiffness of the patient interface 3000 is negligible due to the presence of the manifold 3200. For example, the manifold 3200 may comprise a substantially cylindrical thin silicone structure as described herein, while the central portion 3335 may comprise a plurality of triangular braces.

[0201] In this manner, only the curved portion of the central portion 3335 engages the manifold 3200, as do the ends of the curved portion. It should be noted that in some configurations of this technology, only a portion of the central portion 3335 is bent.

[0202] Additionally or alternatively, the patient interface 3000 includes a forward recess 3323 (e.g., as shown in FIG. 4J) between the central portion 3335 and the manifold 3200. The central portion 3335 is configured in some forms such that the recess between the central portion 3335 and the manifold 3200 varies in size across the sagittal plane. Thus, as the manifold 3200 deflects or deforms, for example as a function of the deflection of the manifold 3200 in the forward direction, the manifold 3200 comes increasingly into contact with the central portion 3335. This has the effect of progressively increasing the forward stiffness of the patient interface 3000, providing a controlled increase in stiffness along with feedback to the patient.

[0203] As mentioned above (as shown in FIG. 3B), the frame includes multiple parts such as a pair of side fasteners 3310 and side fasteners 3310. However, it should be understood that the frame can include any number of parts such as one part or a number of parts beyond the configuration shown. In some forms, the frame also includes a skeleton portion (3310sk in FIG. 3B or 3330sk in FIG. 4B) made of a rigid material and a cover portion made of a soft material (e.g., silicone or fabric) where the frame rests against the patient's skin to increase patient comfort. The cover portion may be a silicone outer covering (3310om) as shown in FIG. 3B or a fabric covering (3330tc) as shown in FIG. 4B. 5.3.2.2 Headgear

[0204] Preferably, headgear is provided to engage the patient's head and assist in positioning the nasal prongs 3100 relative to the patient's nostrils. Various types and arrangements of headgear are known in the art and it will be appreciated that there are many suitable configurations of headgear.

[0205] 3A-3J, the headgear includes rear straps 3350 and top straps 3340 that can be attached to the frame using one of many known methods such as adhesives, sewing, overmolding, etc. In other configurations, the headgear is integrally formed with the frame.

[0206] Some forms of headgear (not shown) engage the patient's ears for support with one or more headgear sections, each of which loops or bends around the base of the ear. Some forms of headgear (not shown) include a single strap to include only the rear strap. Other forms of headgear (not shown) include one or more straps, each of which may be bifurcated, for example.

[0207] It will be appreciated that at least some forms of headgear previously known in the art can be combined with aspects of the current technology, for example the bifurcated straps disclosed in International Patent Application WO / 2014 / 015382 can be combined with the frames, manifolds and protrusions of the present technology. 5.3.3 Connection port 3600

[0208] The connection port 3600 allows for connection to an air circuit 4170. In one form, the connection port 3600 can be located on the frame (FIGS. 3A or 4A), but the connection port 3600 can be located at the end of the air circuit 4170 for connection to another air circuit 4170 as shown in FIG. 5.4 RPT device 4000

[0209] A preferred RPT device 4000 according to one embodiment of the present technology includes mechanical and pneumatic components 4100, electrical components 4200, and is programmed to execute one or more algorithms 4300. The RPT device preferably has an outer housing 4010, preferably formed in two sections, an upper section 4012 and a lower section 4014. The outer housing 4010 further includes one or more panel(s) 4015. The RPT device 4000 preferably includes a chassis 4016 that supports one or more internal components of the RPT device 4000. In one form, a pneumatic block 4020 is supported by or formed as part of the chassis 4016. The RPT device 4000 includes a handle 4018.

[0210] The airway of the RPT device 4000 preferably includes an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (preferably a blower 4142) capable of supplying air at positive pressure, an air block 4020, and an outlet muffler 4124. One or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274, are included in the airway.

[0211] The preferred air block 4020 is located within the outer housing 4010 and includes a portion of the air passageway that can house a pressure generator 4140 .

[0212] The RPT device 4000 preferably includes a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 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 embodiment, the RPT device 4000 includes one or more PCBAs 4202. 5.5 Humidifier 5000 5.5.1 Humidifier Overview

[0213] In one form of the present technology, a humidifier 5000 (as shown in Figures 6A and 6B) is provided to modify the absolute humidity of the air or gas delivered to a patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and raise the temperature (relative to the ambient air) before the airflow is delivered to the patient's airways.

[0214] The humidifier 5000 includes a humidifier reservoir 5110, a humidifier inlet 5002 that receives an air flow, and a humidifier outlet 5004 that outputs a humidified air flow. In some forms, as shown in Figures 6A and 6B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006 adapted to mount the humidifier reservoir 5110 and including a heating element 5240. 5.6 Glossary

[0215] For purposes of disclosure of this technology, one or more of the following definitions may apply in some embodiments of this technology. In other embodiments of this technology, alternative definitions may apply. 5.6.1 General

[0216] Air: In some forms of the present technology, air means atmospheric air, and in other forms of the present technology, air means some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0217] Ambient: In certain forms of the present technology, the term ambient means: (i) external to the treatment system or patient; (ii) immediately surrounding the treatment system or patient.

[0218] For example, surroundings related to humidifiers humidity is the humidity immediately surrounding the humidifier, such as the humidity in the room in which the patient is sleeping. Such ambient humidity may differ from the humidity outside the room in which the patient is sleeping.

[0219] In another embodiment, the periphery pressure is the pressure immediately surrounding or outside the body.

[0220] In some forms, the surrounding noise (e.g., acoustics) may be considered the background noise level in the room the patient is in, excluding, for example, noise generated by the RPT device or noise emanating from the mask or patient interface. Ambient noise originates from sources outside the room. 5.6.2 Facial anatomy

[0221] Frankfort horizontal plane: a line extending from the lowest part of the orbital rim to the left auricular point, which is the deepest point in the notch of the auricle above the tragus.

[0222] Nostrils (nares): roughly oval openings that form the entrance to the nasal cavity. The singular form of nostril (nares) is naris. The nostrils are separated by the nasal septum. 5.6.3 Materials

[0223] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, silicone refers to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark) manufactured by Dow Corning. Another company that manufactures LSR is Wacker. Unless otherwise stated, the preferred form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to 45, measured according to ASTM D2240.

[0224] Polycarbonate: A typically transparent thermoplastic polymer of bisphenol-A carbonate. 5.6.4 Patient Interface Aspects

[0225] Frame: Frame means the mask structure that bears the load of tension between two or more connection points with the headgear. The mask frame may be a non-airtight load-bearing structure in the mask, but some forms of mask frames may also be airtight.

[0226] Headgear: Headgear may be taken to mean any form of positioning and stabilizing structure designed for use on the head. Preferably, the headgear includes one or more braces, retainers and stiffeners configured to position and hold the patient interface in the proper location on the patient's face for delivery of respiratory therapy. Some retainers are formed of a soft, flexible, elastic material such as a laminated composite of foam and fabric.

[0227] Plenum Chamber: Mask plenum chamber is taken to mean a portion of the patient interface that has walls that enclose a volumetric space, the volume before being exhaled through the air directing portion. In some configurations, a shell or frame can form part of the wall of the plenum chamber. 5.6.5 Terminology used in relation to patient interfaces 5.7 Other notes

[0228] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to anyone making a facsimile reproduction of the patent document or patent disclosure so long as it remains in the Patent and Trademark Office patent file or records. Otherwise, all copyrights whatsoever are reserved.

[0229] Unless otherwise clearly stated by context, and unless a range of values ​​is stated, each intervening value, between the upper and lower limits of that range, to one-tenth of the unit of the lower limit, and any other stated or intervening value in that stated range, is encompassed within the technology. The upper and lower limits of these intervening ranges may be independently included in the intervening ranges, subject to any specifically excluded limit in the stated range, and are encompassed within the technology. When a stated range includes one or both limits, ranges excluding either or both of those included limits are also encompassed within the technology.

[0230] Furthermore, where one or more values ​​are described as being incorporated herein as part of the technology, unless otherwise specified, it will be understood that such values ​​may be approximated and that such values ​​may utilize any suitable significant digits to the extent practical technology implementation permits or requires.

[0231] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods or materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of exemplary methods and materials are described herein.

[0232] Where a particular material is identified as being preferably used to construct a component, obviously alternative materials having similar properties may be used as a substitute. Further, unless specifically noted to the contrary, it is understood that any and all components described herein are manufacturable and therefore may be manufactured together or separately.

[0233] It should be noted that, as used in this specification and the appended claims, the singular forms "a," "an," and "the" include the plural forms unless the context clearly dictates otherwise.

[0234] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of such publications. The publications discussed herein are provided for their disclosure prior to the filing date of this application. Nothing contained herein should be construed as an admission that the present technology is entitled to antedate such publications by virtue of prior invention. Further, the publication dates provided may be different from the actual publication dates and each must be independently confirmed.

[0235] Moreover, when interpreting this disclosure, all terms should be interpreted in the broadest reasonable manner consistent with the context. In particular, the words "comprises" and "comprising" should be interpreted in a non-exclusive manner when referring to elements, components, or steps such that the referenced element, component, or step may be present or utilized or may be combined with other elements, components, or steps not expressly referenced.

[0236] The subject headings used in the detailed description are included solely for the reader's ease of reference and should not be used to limit the subject matter found throughout the disclosure or claims. The subject headings should not be used to construe the scope of the claims or claim limitations.

[0237] Although the technology described herein has been described with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details that are not required to practice the technology. For example, the terms "first" and "second" are used unless otherwise noted, but they are not intended to indicate any order and may be used to distinguish distinct elements. Furthermore, although process steps in a methodology may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order may be modified and / or that features may be performed simultaneously or synchronously.

[0238] It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the technology. [Explanation of symbols]

[0239] 5.8 List of quotation marks

[0240] [Table 4]

[0241]

Table 5

Claims

1. 1. A patient interface for delivering a flow of air to one or more nostrils of a patient, the patient interface comprising: a plenum chamber configured to receive an air flow; protrusions for directing the flow of air from the plenum chamber to the patient's nares; and a frame coupled to the plenum chamber, the frame adapted to engage a patient's head in use for positioning the plenum chamber relative to the patient's nares; A patient interface comprising: a portion of the frame recessed forward from at least a portion of the plenum chamber such that said portion of the plenum chamber is displaced into the forward recess.

2. 2. A patient interface according to claim 1, wherein said portion of the frame is recessed from a central portion of the plenum chamber.

3. A patient interface according to claim 1 or 2, wherein said portion of the frame is constructed rigidly.

4. 4. A patient interface according to claim 2 or 3, wherein a central portion of the plenum chamber is configured to engage the patient's upper lip in use.

5. 5. A patient interface according to any one of claims 1 to 4, wherein the plenum chamber is substantially tubular.

6. 6. A patient interface according to any one of claims 1 to 5, wherein the plenum chamber is oriented in use to be substantially perpendicular to the sagittal plane.

7. 7. A patient interface according to any one of claims 1 to 6, wherein the frame engages the first and second ends of the plenum chamber.

8. 8. A patient interface according to any one of claims 1 to 7, wherein the plenum chamber includes an opening configured to be connected to an air circuit receiving a flow of air.

9. 9. A patient interface according to any one of claims 1 to 8, wherein the plenum chamber comprises a resilient, flexible material.

10. 10. A patient interface according to any one of claims 1 to 9, wherein the protrusions extend outwardly from the plenum chamber towards the patient's nares.

11. 11. A patient interface according to any one of claims 1 to 10, wherein the prongs are configured for insertion into the patient's nares.

12. 12. A patient interface according to any one of claims 1 to 11, wherein the protrusion is integrally formed with the plenum chamber.

13. 13. A patient interface according to any one of claims 1 to 12, wherein the protrusions extend upwardly and downwardly towards the patient.

14. 14. A patient interface according to any one of claims 1 to 13, wherein the protrusions are curved.

15. A patient interface according to any one of claims 1 to 14, wherein the frame includes a rigid portion adapted to engage the patient's face in use.

16. 16. A patient interface according to claim 15, wherein the rigid portion is adapted to engage the patient's upper jaw in use.

17. 17. A patient interface according to any one of claims 1 to 16, further comprising headgear connected to the frame.

18. 20. A patient interface according to claim 17, wherein the headgear is resilient.

19. 19. A patient interface according to claim 17 or 18, wherein the headgear includes a top strap and a rear strap.

20. 20. A patient interface according to any one of claims 17 to 19, wherein the headgear is bifurcated.

21. 1. A patient interface for delivering a flow of air to an airway entrance of a patient, the patient interface comprising: a plenum chamber configured to receive the flow of air; one or more protrusions configured to deliver a flow of air from the plenum chamber to an entrance of the patient's airway; a rigid frame configured to engage the patient's cheek in use; headgear coupled to the rigid frame and configured to engage a patient's head to seek out one or more protrusions during use; A patient interface according to any one of claims 1 to 7, wherein the rigid frame includes a central portion detached from the plenum chamber and extending forward and rearward beyond the plenum chamber.

22. 22. A patient interface according to claim 21, wherein the central portion comprises a plurality of bracing members.

23. 23. A patient interface according to claim 22, wherein the brace members are connected at an angle.

24. 24. A patient interface according to claim 22 or 23, wherein the plurality of bracing members form a triangular structure.

25. 25. A patient interface according to any one of claims 22 to 24, wherein the portion of the frame extends substantially across a width of the plenum chamber.

26. 26. A patient interface according to claim 25, wherein the points of engagement between the central portion and the plenum chamber are located at left and right ends of the plenum chamber.

27. 27. A patient interface according to any one of claims 21 to 26, wherein the central portion comprises a curve.

28. 28. A patient interface according to claim 27, wherein the central portion is curved across the width of the plenum chamber.

29. 29. A patient interface according to any one of claims 21 to 28, wherein the plenum chamber has negligible effect on the stiffness of the patient interface.

30. 30. A patient interface according to any one of claims 21 to 29, comprising two prongs.

31. 31. A patient interface according to any one of claims 21 to 30, wherein the plenum chamber is cylindrical.

32. 32. A patient interface according to any one of claims 21 to 31, wherein the plenum chamber is a substantially straight cylinder.

33. 33. A patient interface according to any one of claims 21 to 32, wherein the plenum chamber is made from silicone.

34. 34. A patient interface according to any one of claims 21 to 33, wherein the plenum chamber and the one or more protrusions are integrally formed.

35. 35. A patient interface according to any one of claims 21 to 34, wherein the rigid frame includes a left side and a right side.

36. 36. A patient interface according to claim 35, wherein the rigid frame is formed by molding.

37. 37. A patient interface according to any one of claims 21 to 36, further comprising headgear.

38. 1. A respiratory treatment system comprising: A respiratory treatment device configured to generate a flow of breathable gas; a humidifier configured to be coupled to the respiratory treatment device for humidifying the flow of breathable gas; a circuit for delivering a flow of breathable gas; and 38. A respiratory treatment system including a patient interface according to any one of claims 21 to 37.

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