Muffler system for portable / wearable RPT system

Abstract

A respiratory pressure therapy system for treating a patient with a respiratory disorder includes a patient interface, a blower configured to generate a pressurized flow of gas, the blower configured to be connected to the patient interface such that the blower is supported on the patient's head by the patient interface, and a muffler system provided to the patient interface and / or the blower, the muffler system configured and arranged to reduce noise from the blower and / or enhance patient comfort, wherein the muffler system comprises a blower outlet muffler configured to connect to the patient interface and the blower, wherein the blower outlet muffler is configured to form an airflow path to convey the pressurized flow of gas from a blower outlet of the blower to an inlet opening of the patient interface.

Description

MUFFLER SYSTEM FOR PORTABLE / WE ARABLE RPTSYSTEM

[0001] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.1 CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Application No. 63 / 631,507, filed April 9, 2024, which is incorporated herein by reference in its entirety.2 BACKGROUND OF THE TECHNOLOGY2.1 FIELD OF THE TECHNOLOGY

[0003] The present technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention and amelioration of respiratory-related disorders. The present technology also relates to medical devices or apparatus, and their use.2.2 DESCRIPTION OF THE RELATED ART2.2.1 Human Respiratory System and its Disorders

[0004] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the airways of a patient.

[0005] The airways include a series of branching tubes, which become narrower, shorter and more numerous as they penetrate deeper into the lung. The prime function of the lung is gas exchange, allowing oxygen to move from the inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into right and left main bronchi, which further divide eventually into terminal bronchioles. The bronchi make up the conducting airways, and do not take part in gas exchange. Further divisions of the airways lead to the respiratory bronchioles, and eventually to the alveoli. The alveolated region of the lung is where the gas exchange takes place, and is referred to as the respiratory zone. See “ Respiratory Physiology”, by lohn B. West, Lippincott Williams & Wilkins, 9th edition published 2012.

[0006] A range of respiratory disorders exist. Certain disorders may be characterised by particular events, e g. apneas, hypopneas, and hyperpneas.

[0007] Examples of respiratory disorders include Obstructive Sleep Apnea (OSA), Cheyne-Stokes Respiration (CSR), respiratory insufficiency, Obesity Hypoventilation Syndrome (OHS), Chronic Obstructive Pulmonary Disease (COPD), Neuromuscular Disease (NMD) and Chest wall disorders.

[0008] A range of therapies have been used to treat or ameliorate such conditions. Furthermore, otherwise healthy individuals may take advantage of such therapies to prevent respiratory disorders from arising. However, these have a number of shortcomings.2.2.2 Therapies

[0009] Various respiratory therapies, such as Continuous Positive Airway Pressure (CPAP) therapy, Non-invasive ventilation (NIV), Invasive ventilation (IV), and High Flow Therapy (HFT) have been used to treat one or more of the above respiratory disorders.2.2.2.1 Respiratory pressure therapies

[0010] Respiratory pressure therapy is the application of a supply of air to an entrance to the airways at a controlled target pressure that is nominally positive with respect to atmosphere throughout the patient’s breathing cycle (in contrast to negative pressure therapies such as the tank ventilator or cuirass).

[0011] Continuous Positive Airway Pressure (CPAP) therapy has been used to treat Obstructive Sleep Apnea (OSA). The mechanism of action is that continuous positive airway pressure acts as a pneumatic splint and may prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy may be voluntary, and hence patients may elect not to comply with therapy if they find devices used to provide such therapy one or more of: uncomfortable, difficult to use, expensive and aesthetically unappealing.2.2.3 Respiratory Therapy Systems

[0012] These respiratory therapies may be provided by a respiratory therapy system or device. Such systems and devices may also be used to screen, diagnose, or monitor a condition without treating it.

[0013] A respiratory therapy system may comprise a Respiratory Pressure Therapy Device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.2.2.3.1 Patient Interface

[0014] A patient interface may be used to interface respiratory equipment to its wearer, for example by providing a flow of air to an entrance to the airways. The flow of air may be provided via a mask to the nose and / or mouth, a tube to the mouth or a tracheostomy tube to the trachea of a patient. Depending upon the therapy to be applied, the patient interface may form a seal, e.g., with a region of the patient's face, to facilitate the delivery of gas at a pressure at sufficient variance with ambient pressure to effect therapy, e.g., at a positive pressure of about 10 cmHzO relative to ambient pressure. For other forms of therapy, such as the delivery of oxygen, the patient interface may not include a seal sufficient to facilitate delivery to the airways of a supply of gas at a positive pressure of about 10 cmHzO. For flow therapies such as nasal HFT, the patient interface is configured to insufflate the nares but specifically to avoid a complete seal. One example of such a patient interface is a nasal cannula.2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0015] A respiratory pressure therapy (RPT) device may be used individually or as part of a system to deliver one or more of a number of therapies described above, such as by operating the device to generate a flow of air for delivery to an interface to the airways. The flow of air may be pressure-controlled (for respiratory pressure therapies) or flow-controlled (for flow therapies such as HFT). Thus RPT devices may also act as flow therapy devices. Examples of RPT devices include a CPAP device and a ventilator.2.2.3.3 Humidifier

[0016] Delivery of a flow of air without humidification may cause drying of airways. The use of a humidifier with an RPT device and the patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. In addition, in cooler climates, warm air applied generally to the face area in and about the patient interface is more comfortable than cold air.

[0017] While a number of medical humidifiers are known, they can suffer from one or more shortcomings. Some medical humidifiers may provide inadequate humidification, some are difficult or inconvenient to use by patients.2.2.3.4 Vent technologies

[0018] Some forms of treatment systems may include a vent to allow the washout of exhaled carbon dioxide. The vent may allow a flow of gas from an interior space ofa patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.3 BRIEF SUMMARY OF THE TECHNOLOGY

[0019] The present technology is directed towards providing medical devices used in the screening, diagnosis, monitoring, amelioration, treatment, or prevention of respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0020] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0021] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0022] An aspect of certain forms of the present technology is to provide methods and / or apparatus that improve the compliance of patients with respiratory therapy.

[0023] One form of the present technology comprises a patient interface comprising a plenum chamber, a seal-forming structure, and a positioning and stabilising structure.

[0024] One form of the present technology comprises patient interface comprising a plenum chamber pressurisable to a therapeutic pressure of at least 4 cmH20 above ambient air pressure. The plenum chamber includes at least one plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient. The patient interface also comprises a seal-forming structure that is constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s airways. The seal-forming structure has a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient’s nares. The seal-forming structure is constructed and arranged to maintain said therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use. The patient interface also comprises a positioning and stabilising structure to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head.

[0025] One form of the present technology comprises a respiratory pressure therapy (RPT) system that includes a patient interface and a pressure generator (e.g.,blower), wherein the pressure generator is arranged to provide pressurised air to a patient wearing the patient interface.

[0026] Another aspect of one form of the present technology is a respiratory pressure therapy (RPT) system that includes a patient interface and a pressure generator (e g., blower), wherein the pressure generator is supported on the patient’s head in use by the patient interface.

[0027] Another aspect of the present technology relates to a respiratory pressure therapy (RPT) system for treating a patient with a respiratory disorder, the RPT system including a patient interface including a seal forming structure configured to form a seal with a patient’ face, a blower configured to generate a pressurized flow of gas, the blower configured to be connected to the patient interface such that the blower is supported on the patient’s head by the patient interface, and a muffler system provided to the patient interface and / or the blower, the muffler system configured and arranged to reduce noise from the blower and / or enhance patient comfort, wherein the muffler system comprises a blower outlet muffler configured to connect to the patient interface and the blower, wherein the blower outlet muffler is configured to form an airflow path to convey the pressurized flow of gas from a blower outlet of the blower to an inlet opening of the patient interface, wherein the blower outlet muffler includes a main body forming a blower outlet chamber, and wherein the blower outlet muffler includes a noise attenuating material, the main body configured to support at least a portion of the noise attenuating material in the blower outlet chamber.

[0028] In an example, the blower outlet muffler may be configured to removably connect to the patient interface and the blower. In an example, the noise attenuating material may comprise foam. In an example, the noise attenuating material may comprise a heat and moisture exchanger. In an example, the main body may include a first opening and a second opening, the first opening forming an inlet configured to communicate with the blower outlet of the blower, and the second opening forming an outlet configured to communicate with the inlet opening of the patient interface. In an example, the main body may include a side wall surrounding the first opening configured to interface or engage with an outlet tube forming the blower outlet of the blower. In an example, the blower outlet muffler may include an interior wall portion provided within the main body to divide the blower outlet chamber into a first chamber portion and a second chamber portion. In an example, the first chamberportion and the second chamber portion may include different volumes. In an example, each of the first chamber portion and the second chamber portion may include at least one noise attenuating material. In an example, at least the noise attenuating material in the second chamber portion may comprise HME. In an example, the first chamber portion may be arranged adjacent to the first opening and the second chamber portion may be arranged adjacent to the second opening. In an example, the blower outlet muffler may comprise a separate and distinct structure from the blower and the patient interface configured to allow the blower outlet muffler to form a removable component or cartridge. In an example, at least one wall of the main body may include a removable lid configured to allow access to the blower outlet chamber. In an example, the removable lid may comprise a vent for gas washout. In an example, the blower outlet muffler may be configured to directly link the blower to the patient interface. In an example, the muffler system may further comprise a blower inlet muffler arranged upstream of a blower inlet of the blower and configured and arranged to reduce noise emanating from the blower inlet of the blower in use. In an example, the blower inlet muffler may include an enclosure configured to at least partially enclose a blower inlet side of the blower. In an example, the enclosure may include an inlet tube configured to direct air to the blower inlet of the blower. In an example, the seal forming structure may comprise a first seal forming structure configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s mouth, and wherein the seal forming structure comprises a second seal forming structure configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nose. In an example, the patient interface may include a shell, wherein the shell and the seal forming structure at least partially form a plenum chamber configured to receive the pressurized flow of gas. In an example, the shell may be configured to at least partially receive, locate and / or retain the blower. In an example, one or more portions of the shell may comprise an overmolded connection to the blower to secure the blower to the patient interface. In an example, the shell may at least partially form the inlet opening configured to allow the blower outlet muffler to communicate with the plenum chamber. In an example, the patient interface may include a vent for gas washout. In an example, the blower outlet muffler may include a vent for gas washout. In an example, the blower may include a blower inlet aligned with an axis of the blower and the blower outlet is configured to direct the pressurized flow of gas exiting the blowerin a generally tangential direction. In an example, the blower outlet may be formed by an outlet tube oriented in an inferior direction configured to interface with the blower outlet muffler. In an example, the RPT system may further comprise a controller to control the blower. In an example, the controller may be at least partly supported by the patient interface.

[0029] Another aspect of the present technology relates to muffler system for a respiratory pressure therapy (RPT) system, the muffler system including a blower outlet muffler configured to connect to a patient interface and a blower, wherein the blower outlet muffler is configured to form an airflow path to convey a pressurized flow of gas from a blower outlet of the blower to an inlet opening of the patient interface, wherein the blower outlet muffler includes a main body forming a blower outlet chamber, and wherein the blower outlet muffler includes a noise attenuating material, the main body configured to support at least a portion of the noise attenuating material in the blower outlet chamber.

[0030] An aspect of certain forms of the present technology is a medical device that is easy to use, e g. by a person who does not have medical training, by a person who has limited dexterity, vision or by a person with limited experience in using this type of medical device.

[0031] An aspect of one form of the present technology is a portable RPT device that may be carried by a person, e.g., around the home of the person.

[0032] An aspect of one form of the present technology is a patient interface that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment. An aspect of one form of the present technology is a humidifier tank that may be washed in a home of a patient, e.g., in soapy water, without requiring specialised cleaning equipment.

[0033] Of course, portions of the aspects may form sub-aspects of the present technology. Also, various ones of the sub-aspects and / or aspects may be combined in various manners and also constitute additional aspects or sub-aspects of the present technology.

[0034] Other features of the technology will be apparent from consideration of the information contained in the following detailed description, abstract, drawings and claims.4 BRIEF DESCRIPTION OF THE DRAWINGS

[0035] The present technology is illustrated by way of example, and not by way of limitation, in the figures of the accompanying drawings, in which like reference numerals refer to similar elements including:

[0036] Fig. 1 shows a system including a patient 1000 wearing a patient interface 3000, in the form of a full-face mask, receiving a supply of air at positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000, and passes along an air circuit 4170 to the patient 1000. The patient is sleeping in a side sleeping position.

[0037] Fig. 2 shows a view of a human upper airway including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostril, lip superior, lip inferior, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, oesophagus and trachea.

[0038] Fig. 3 is a schematic diagram of the pneumatic path of an RPT device in accordance with one form of the present technology. The directions of upstream and downstream are indicated with reference to the blower and the patient interface. The blower is defined to be upstream of the patient interface and the patient interface is defined to be downstream of the blower, regardless of the actual flow direction at any particular moment. Items which are located within the pneumatic path between the blower and the patient interface are downstream of the blower and upstream of the patient interface.

[0039] Fig. 4 is a front perspective view of a portable / wearable RPT system including a muffler system according to an example of the present technology.

[0040] Fig. 5 is a bottom perspective view of the portable / wearable RPT system of Fig. 4.

[0041] Fig. 6 is a rear perspective view of the portable / wearable RPT system of Fig. 4.

[0042] Fig. 7 is a perspective view showing the blower outlet muffler removed from the portable / wearable RPT system of Fig. 4.

[0043] Fig. 8 is another perspective view showing the blower outlet muffler removed from the portable / wearable RPT system of Fig. 4.

[0044] Fig. 9 is an exploded view of the of the portable / wearable RPT system of Fig. 4.

[0045] Fig. 10 is a cross-sectional view of the portable / wearable RPT system of Fig. 4.

[0046] Fig. 11 is another cross-sectional view of the portable / wearable RPT system of Fig. 4.

[0047] Fig. 12 is another cross-sectional view of the portable / wearable RPT system of Fig. 4.

[0048] Fig. 13 is a cross-sectional view of the blower and the blower inlet muffler of the portable / wearable RPT system of Fig. 4.

[0049] Fig. 14 is a perspective view of the blower outlet muffler of Fig. 4 according to an example of the present technology.

[0050] Fig. 15 is an exploded view of the blower outlet muffler of Fig. 14.

[0051] Fig. 16 is a front perspective view a front perspective view of a portable / wearable RPT system including a muffler system according to another example of the present technology.

[0052] Fig. 17 is a front view showing the portable / wearable RPT system of Fig. 16 on a patient’s head according to an example of the present technology.

[0053] Fig. 18 is a perspective showing a portion of the portable / wearable RPT system of Fig. 16 according to an example of the present technology.

[0054] Fig. 19 is a perspective showing a portion of the portable / wearable RPT system of Fig. 16, the portable / wearable RPT system including a blower inlet muffler according to an example of the present technology.

[0055] Fig. 20 is a cross-sectional view of the portable / wearable RPT system and blower inlet muffler of Fig. 19.

[0056] Fig. 21 is a cross-sectional view of the blower outlet muffler of the portable / wearable RPT system of Fig. 16 according to an example of the present technology.

[0057] Fig. 22 is an exploded view of the blower outlet muffler of the portable / wearable RPT system of Fig. 16 according to an example of the present technology.

[0058] Fig. 23 is a perspective view of a blower outlet muffler for a portable / wearable RPT system according to an example of the present technology.

[0059] Fig. 24 is a bottom perspective view showing a blower outlet muffler and portable / wearable RPT system according to an example of the present technology.

[0060] Fig. 25 is a schematic view showing a closed loop RPT system according to an example of the present technology.5 DETAILED DESCRIPTION OF EXAMPLES OF THETECHNOLOGY

[0061] Before the present technology is described in further detail, it is to be understood that the technology is not limited to the particular examples described herein, which may vary. It is also to be understood that the terminology used in this disclosure is for the purpose of describing only the particular examples discussed herein, and is not intended to be limiting.

[0062] The following description is provided in relation to various examples which may share one or more common characteristics and / or features. It is to be understood that one or more features of any one example may be combinable with one or more features of another example or other examples. In addition, any single feature or combination of features in any of the examples may constitute a further example.5.1 THERAPY

[0063] In one form, the present technology comprises a system and method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000. The RPT system 6000, e.g., illustrated in Figs. 4 to 25 described below, includes a wearable RPT device wherein the blower is integrated into the patient interface and configured to be mounted on the users head. The RPT device may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

[0064] In certain examples, the supply of air at positive pressure is provided to the nasal passages and mouth of the patient via an interface including a seal-forming structure that covers the nose and mouth. In certain other examples, the patient interface includes a seal-forming structure that covers the nares and / or nose of the patient. In certain other examples of the present technology, a supply of air at positive pressure is provided to the nasal passages of the patient via one or both nares.

[0065] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.5.2 PATIENT INTERFACE

[0066] A non-invasive patient interface 3000, such as that shown in Figs. 4 to 25 described below, in accordance with one aspect of the present technology comprises one or more of the following functional aspects: a seal -forming structure 3100, a plenum chamber 3200, a positioning and stabilising structure 3300, a vent 3400, one form of connection port for connection to air circuit 4170, and a forehead support. In some forms a functional aspect may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use the seal-forming structure 3100 is arranged to surround an entrance to the airways of the patient so as to maintain positive pressure at the entrance(s) to the airways of the patient 1000. The sealed patient interface 3000 is therefore suitable for delivery of positive pressure therapy.5.2.1.1 Nose and Mouth Masks

[0067] In one form, the patient interface 3000 comprises a seal-forming structure 3100 configured to seal around an entrance to the patient’s nasal airways and also around the patient’s mouth. The seal-forming structure 3100 may be configured to seal to the patient’s face proximate a chin region. This patient interface 3000 may deliver a supply of air or breathable gas to both nares and to the mouth of patient 1000. This type of patient interface may be identified as a nose and mouth mask.

[0068] One form of nose-and-mouth mask according to the present technology is what has traditionally been identified as a “full-face mask”, having a seal-forming structure 3100 configured to seal on the patient’s face around the nose, below the mouth and over the bridge of the nose. A nose-and-mouth mask may be generally triangular in shape. In one form the patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use to a patient’s chin-region (which may include the patient’s lip inferior and / or a region directly inferior to the lip inferior), to the patient’s nose bridge or at least a portion of the nose ridge superior to the pronasale, and to cheek regions of the patient's face. The patient interface 3000 shown in Figs. 16 to 20 is of this type. This patient interface 3000 may deliver a supply of air or breathable gas to both nares and mouth of patient 1000 through a single orifice. This type of seal-forming structure 3100 may be referred to as a “nose-and-mouth cushion”.

[0069] In another form the patient interface 3000 comprises a seal-forming structure 3100 that forms a seal in use on a patient’s chin region (which may includethe patient’s lip inferior and / or a region directly inferior to the lip inferior), to an inferior and / or an anterior surface of a pronasale portion of the patient’s nose, to the alae of the patient’s nose and to the patient’s face on each lateral side of the patient’s nose, for example proximate the nasolabial sulci. The seal-forming structure 3100 may also form a seal against a patient’s lip superior. A patient interface 3000 having this type of seal-forming structure may have a single opening configured to deliver a flow of air or breathable gas to both nares and mouth of a patient, may have an oral hole configured to provide air or breathable gas to the mouth and a nasal hole configured to provide air or breathable gas to the nares, or may have an oral hole for delivering air to the patient’s mouth and two nasal holes for delivering air to respective nares. This type of patient interface 3000 may have a nasal portion and an oral portion, the nasal portion sealing to the patient’s face at similar locations to a nasal cradle mask. The patient interface 3000 shown in Figs. 4 to 12 is of this type.

[0070] In a further form of nose and mouth mask, the patient interface 3000 may comprise a seal-forming structure 3100 having a nasal portion comprising nasal pillows and an oral portion configured to form a seal to the patient’s face around the patient’s mouth.

[0071] In some forms, the seal-forming structure 3100 may have a nasal portion that is separate and distinct from an oral portion. In other forms, a seal-forming structure 3100 may form a contiguous seal around the patient’s nose and mouth.

[0072] It is to be understood that the above examples of different forms of patient interface 3000 do not constitute an exhaustive list of possible configurations. In some forms a patient interface 3000 may comprise a combination of different features of the above described examples of nose-only and nose and mouth masks.5.2.2 Plenum chamber

[0073] The plenum chamber 3200 has a perimeter that is shaped to be complementary to the surface contour of the face of an average person in the region where a seal will form in use. In use, a marginal edge of the plenum chamber 3200 is positioned in close proximity to an adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend in use about the entire perimeter of the plenum chamber 3200. In some forms, the plenum chamber 3200 and the seal -forming structure 3100 are formed from a single homogeneous piece of material.

[0074] In certain forms of the present technology, the plenum chamber 3200 does not cover the eyes of the patient in use. In other words, the eyes are outside the pressurised volume defined by the plenum chamber. Such forms tend to be less obtrusive and / or more comfortable for the wearer, which can improve compliance with therapy.

[0075] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, e.g. a transparent polycarbonate. The use of a transparent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy. The use of a transparent material can aid a clinician to observe how the patient interface is located and functioning.

[0076] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. The use of a translucent material can reduce the obtrusiveness of the patient interface, and help improve compliance with therapy.

[0077] In some forms, the plenum chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the sealforming structure.

[0078] In some forms, the plenum chamber 3200 is constructed from a flexible material (e.g., constructed from a soft, flexible, resilient material like silicone, textile, foam, etc.). For example, in examples then may be formed from a material which has a Young's modulus of 0.4 GPa or lower, for example foam. In some forms of the technology the plenum chamber 3200 may be made from a material having Young's modulus of 0. IGPa or lower, for example rubber. In other forms of the technology the plenum chamber 3200 may be made from a material having a Young's modulus of 0.7MPa or less, for example between 0.7MPa and 0.3MPa. An example of such a material is silicone.5.2.3 Positioning and stabilising structure

[0079] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be held in sealing position in use by the positioning and stabilising structure 3300. The positioning and stabilising structure 3300 may comprise and function as “headgear” since it engages the patient’s head in order to hold the patient interface 3000 in a sealing position. Examples of a positioning and stabilising structure may be shown in Figs. 16 and 17.5.2.3.1 Headgear straps

[0080] In some forms, the positioning and stabilising structure 3300 may include headgear 3302 with at least one strap which may be worn by the patient in order to assist in properly orienting the seal-forming structure 3100 against the patient’s face (e g., in order to limit or prevent leaks).

[0081] Some forms of the headgear 3302 may be constructed from a textile material, which may be comfortable against the patient’s skin. The textile may be flexible in order to conform to a variety of facial contours. Although the textile may include rigidisers along a selected length, which may limit bending, flexing, and / or stretching of the headgear 3302.

[0082] In certain forms, the headgear 3302 may be at least partially extensible. For example, the headgear 3302 may include elastic, or a similar extensible material. For example, the entire headgear 3302 may be extensible or selected portions may be extensible (or more extensible than surrounding portions). This may allow the headgear 3302 to stretch while under tension, which may assist in providing a sealing force for the seal-forming structure 3100.

[0083] In some forms, the headgear may comprise a four-point headgear or a two-point headgear, e.g., Figs. 16 and 17 show four point headgear configured to connect to four separate places on a frame connected to the plenum chamber 3200.5.2.4 Vent

[0084] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the washout of exhaled gases, e.g. carbon dioxide.

[0085] In certain forms the vent 3400 is configured to allow a continuous vent flow from an interior of the plenum chamber 3200 to ambient whilst the pressure within the plenum chamber is positive with respect to ambient. The vent 3400 is configured such that the vent flow rate has a magnitude sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure in the plenum chamber in use.

[0086] One form of vent 3400 in accordance with the present technology comprises a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0087] The vent 3400 may be located in the plenum chamber 3200, e.g., see Figs. 16 to 20. Alternatively, the vent is located in a decoupling structure, e.g., a swivel.5.2.5 Decoupling structure(s)

[0088] In one form the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.5.2.6 Connection port

[0089] Connection port allows for connection to the air circuit 4170.5.2.7 Forehead support

[0090] In one form, the patient interface 3000 includes a forehead support.5.2.8 Anti-asphyxia valve

[0091] In one form, the patient interface 3000 includes an anti-asphyxia valve.5.2.9 Ports

[0092] In one form of the present technology, a patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form this allows a clinician to supply supplementary oxygen. In one form, this allows for the direct measurement of a property of gases within the plenum chamber 3200, such as the pressure.5.2.10 Modularity

[0093] As described above, the cushion, headgear, and sleeves may come in different styles, which may correspond to different uses (e g., mouth breathing, nasal breathing, etc.). A patient or clinician may select certain combinations of cushions, headgear, and sleeves in order to optimize the effectiveness of the therapy and / or the individual patient’s comfort An example of this sort of modular design is described in PCT / SG2022 / 050777 filed 28 October 2022, incorporated herein by reference in its entirety.5.3 RPT DEVICE

[0094] An RPT device 4000 in accordance with one aspect of the present technology comprises mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms, such as any of the methods, in whole or in part, described herein. The RPT device 4000 may be configured to generate a flow of air for delivery to a patient’s airways, such as to treat one or more of the respiratory conditions described elsewhere in the present document.

[0095] In one form, the RPT device 4000 is constructed and arranged to be capable of delivering a flow of air in a range of -20 L / min to +150 L / min whilemaintaining a positive pressure of at least 4 cmH20, or at least 10cmH2O, or at least 20 cmH20.

[0096] In the illustrated example, the RPT device is wearable in which the blower is integrated into the patient interface and configured to be mounted on the patient’s head.

[0097] The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 capable of supplying air at positive pressure (e.g., a blower 4142), an outlet muffler 4124 and one or more transducers 4270, such as pressure sensors and flow rate sensors (e.g., see Fig. 3).

[0098] The RPT device 4000 may have an electrical power supply, one or more input devices, a central controller, a therapy device controller, a pressure generator, one or more protection circuits, memory, transducers, data communication interface and one or more output devices. Electrical components may be mounted on a single Printed Circuit Board Assembly (PCBA). In an alternative form, the RPT device 4000 may include more than one PCBA.5.3.1 RPT device mechanical & pneumatic components

[0099] An RPT device may comprise one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be located as respective separate units.5.3.1.1 Air filter(s)

[0100] An RPT device in accordance with one form of the present technology may include an air fdter 4110, or a plurality of air filters 4110.

[0101] In one form illustrated in Fig. 3, an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.

[0102] In one form illustrated in Fig. 3, an outlet air filter 4114, for example an antibacterial filter, is located between an outlet of the pneumatic block 4020 and a patient interface 3000.5.3.1.2 Muffler(s)

[0103] An RPT device in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0104] In one form of the present technology (see e.g., Fig. 3), an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.

[0105] In one form of the present technology, an outlet muffler 4124 is located in the pneumatic path between the pressure generator 4140 and a patient interface 3000.5.3.1.3 Pressure generator

[0106] In one form of the present technology, a pressure generator 4140 for producing a flow, or a supply, of air at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 with one or more impellers. The impellers may be located in a volute. The blower may be capable of delivering a supply of air, for example at a rate of up to about 120 litres / minute, at a positive pressure in a range from about 4 cmH20 to about 20 cmH20, or in other forms up to about 30 cmH20 when delivering respiratory pressure therapy. The blower may be as described in any one of the following patents or patent applications the contents of which are incorporated herein by reference in their entirety: U.S.Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO 2013 / 020167.

[0107] The pressure generator 4140 may be under the control of the therapy device controller.

[0108] In other forms, a pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high pressure source (e.g. compressed air reservoir), or a bellows.5.3.1.4 Transducer(s)

[0109] Transducers may be internal of the RPT device, or external of the RPT device. External transducers may be located for example on or form part of the air circuit, e.g., the patient interface. External transducers may be in the form of noncontact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.

[0110] In one form of the present technology (see e.g., Fig. 3), one or more transducers 4270 are located upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to generate signals representing properties of the flow of air such as a flow rate, a pressure or a temperature at that point in the pneumatic path.

[0111] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000.

[0112] In one form, a signal from a transducer 4270 may be filtered, such as by low-pass, high-pass or band-pass filtering.5.3.2 RPT device electrical components5.3.2.1 Power supply

[0113] A power supply may be located internal or external of the external housing of the RPT device 4000.

[0114] In one form of the present technology, power supply provides electrical power to the RPT device 4000 only.5.4 HUMIDIFIER5.4.1 Humidifier overview

[0115] In one form of the present technology there is provided a humidifier 5000 to change the absolute humidity of air or gas for delivery to a patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and increase the temperature of the flow of air (relative to ambient air) before delivery to the patient’s airways.5.5 PORTABLE / WE AR AB LE RPT SYSTEM INCLUDING MUFFLER SYSTEM WITH HME

[0116] Figs. 4 to 15 illustrate a portable / wearable RPT system 6000 including a muffler system 7000 according to an example of the present technology. As described in greater detail below, the muffler system 7000 comprises a blower outlet muffler 7100 that is connectable to the RPT system 6000 and configured to reduce noise from the blower 4142 and enhance patient comfort. In some forms, the blower outlet muffler is removably connected to the RPT system. Alternatively, the blower outlet muffler may form a non-removable connection to the RPT system.

[0117] In the illustrated example, the portable / wearable RPT system 6000 includes a patient interface 3000, a blower 4142 configured to generate air at positive pressure, and the muffler system 7000. In the illustrated example, the blower outlet muffler 7100 of the muffler system 7000 is connected to the patient interface 3000 and the blower 4142. In use, the blower 4142 generates a supply of pressurized air (e g., 2-30 cmH20) that is delivered to the patient interface 3000 via the blower outlet muffler 7100. Accordingly, the blower outlet muffler 7100 is configured to form an airflow path to convey the pressurized flow of gas from the blower 4142 to the patient interface 3000. That is, the blower outlet muffler 7100 directly links the blower 4142 to the patient interface 3000 such that the RPT system does not need air deliverytubing (i.e., air delivery tube or a short tube) to connect the blower 4142 and the patient interface 3000.Patient Interface

[0118] The patient interface or mask 3000 may have suitable configurations as is known in the art, e.g., full-face mask, nasal mask, oro-nasal mask, etc.

[0119] In the illustrated example of Figs. 4 to 15, the patient interface 3000 is an oro-nasal patient interface configured to seal around both the patient's nasal airways and oral airway. The patient interface 3000 includes a seal forming structure 3100 comprising a first seal forming structure 3101 connected to an oral portion 3201 of the plenum chamber 3200 and constructed and arranged to form seal with a region of the patient’s face surrounding an entrance to the patient’s mouth, and a second sealforming structure 3102 connected to a nasal portion 3202 of the plenum chamber 3200 constructed and arranged to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nose. In an example, the second seal forming structure 3102 may be configured to contact the patient's face below the bridge of the nose or below the pronasale. In an example, the second seal forming structure 3102 may include at least one nasal aperture 3135 (e g., two nasal apertures 3135 as shown in Fig. 6) configured to deliver the flow of air at a therapeutic pressure to an entrance to the patient’s nares. In an example, the seal-forming structure 3100 may be constructed from a soft, flexible, resilient material such as silicone.

[0120] In the illustrated example, the plenum chamber 3200 is at least partially formed by a shell 3250. In some forms of the technology, the shell 3250 may be made from a rigid material such as polycarbonate. However, in other forms of the technology, the shell 3250, or portions of the shell 3250, may be somewhat flexible. In examples, the shell 3250 and one or both of the first and second seal forming structures 3101, 3102 may be formed from the same material (e.g., silicone).

[0121] In the illustrated example, the shell 3250 includes an opening or recess 3255 configured to at least partially receive, locate and / or retain the blower 4142. The opening or recess 3255 may be substantially circular in shape and may be centered on the oral portion 3201 of the plenum chamber 3200. However, it should be appreciated that the opening or recess may include other suitable shapes and positioning on the plenum chamber in order to interface with and retain the blower 4142.

[0122] The shell 3250 also at least partly forms an inlet opening 3260 that is spaced apart and inferior to the opening or recess 3250. The inlet opening 3260 is configured to allow the blower outlet muffler 7100 to communicate with the plenum chamber 3200 when the blower outlet muffler 7100 is coupled to the patient interface 3000, i.e., the inlet opening 3260 is configured to allow the supply of pressurized air from the blower to be delivered to the patient interface 3000.

[0123] A shroud 3350 (constructed from a rigid or semi-rigid material) is coupled to the plenum chamber 3200 and assists in maintaining the therapeutically effective position of the seal-forming structure 3100. In some forms, the shroud 3350 provides at least one connection point, which may assist in connecting headgear straps of headgear to the plenum chamber 3200 and / or seal-forming structure 3100. For example, the shroud 3350 may include upper headgear connectors 3352 and lower headgear connectors 3354. Each upper headgear connector 3352 includes an elongated arm and a slot or receiving hole at the free end of the arm configured to receive a respective headgear strap, and each lower headgear connector 3351 includes an abbreviated arm and a clip magnet configured to be removably coupled with a headgear clip associated with a respective headgear strap.

[0124] In some forms, one or more aspects of the patient interface 3000 shown in Figs. 4 to 15 may be similar to the patient interface described in WO 2022 / 191776, which is incorporated herein by reference in its entirety.

[0125] Figs. 16 to 20 show another example of the present technology, in which the patient interface 3000 is a full-face patient interface configured to seal around both the patient's nose and mouth. The patient interface includes a shell 3250 (e.g., constructed from a rigid material such as polycarbonate) and a seal-forming structure or cushion 3100 (e.g., constructed from a soft, flexible, resilient material such as silicone) configured to form a seal with the patient's nose and mouth in use (e.g., generally along nasal bridge, cheek, and lower lip / chin regions of the patient’s face). In an example, the seal-forming structure 3100 is removable connected to the shell 3250. The plenum chamber 3200 is at least partially formed by the shell 3250 and the cushion 3100. A shroud 3350 is connected to the shell 3250 and is structured to attach headgear 3302 to the patient interface 3000. Upper headgear connectors 3352 extend from each side of the top end of the shroud 3350, and lower headgear connectors 3354 extend from each side of the lower end of the shroud 3350. Each upper headgear connector 3352 includes an elongated arm and a slot or receiving holeat the free end of the arm configured to receive a respective headgear strap of headgear 3302, and each lower headgear connector 3354 includes an abbreviated arm and a clip receptacle configured to be removably interlocked with a headgear clip associated with a respective headgear strap of headgear 3302. In an embodiment, soft fabric sleeves 3355 may be mounted on the upper and / or lower headgear connectors, e.g. to increase comfort and / or guide / hide one or more wires / cables associated with a controller / battery for the blower 4142.

[0126] In the illustrated example of Figs. 16 to 20, the shell 3250 includes a recess 3255 (e.g., substantially circular in shape) configured to at least partially receive, locate and / or retain the blower 4142. Also, the shell 3250 at least partly forms an inlet opening configured to allow the blower outlet muffler 7100 to communicate with the plenum chamber 3200 when the blower outlet muffler 7100 is coupled to the patient interface 3000.

[0127] In the illustrated example of Figs. 16 to 20, the shell 3250 includes a vent 3400 for gas washout. As illustrated, the vent 3400 is spaced apart and superior to the recess 3255, and the vent 3400 includes a plurality of vent holes for gas washout that are arranged so that the exhausted air is directed away from the patient in use. It should be appreciated that the vent 3400 may include other suitable arrangements, e.g., different number of holes, hole arrangement, positioning on shell.

[0128] In some forms, one or more aspects of the patient interface 3000 shown in Figs. 16 to 20 may be similar to patient interfaces described in WO 2009 / 108995 and WO 2011 / 060479, each of which is incorporated herein by reference in its entirety.Blower

[0129] In the illustrated example, the blower 4142 is portable and configured to be worn and supported on the patient’s head such that it is wearable or earned by the patient, is configured to be built into or incorporated into the patient interface or mask 3000, and is small, compact, and lightweight such that it is comfortable to wear and carry around.

[0130] In an example, the blower 4142 may comprise a single stage, centrifugal blower that is operable to draw a supply of gas into the blower housing 4146 through a blower inlet 4143 and provide a pressurized flow of gas at a blower outlet 4145. In the illustrated example, the blower housing 4146 is generally cylindrical with the blower inlet 4143 aligned with an axis of the blower 4142 and the blower outlet 4145is configured to direct gas exiting the blower in a generally tangential direction. In the illustrated example, the blower outlet 4145 is formed by an outlet tube 4148 that extends outwardly from the blower housing 4146.

[0131] In some forms, the blower 4142 may be similar to the blower described in WO 2008 / 051534 and WO 2011 / 062633, which is incorporated herein by reference in its entirety.

[0132] In the illustrated example, the blower housing 4146 includes a substantially cylindrical shape and is configured to be received and retained within the substantially circular opening or recess 3255 in the patient interface 3000. As illustrated, the blower 4142 is positioned and arranged such that the outlet tube 4148 is oriented in an inferior direction configured to interface with the the blower outlet muffler 7100.

[0133] In some forms of the technology, the blower 4142 may be releasably connectable to the shell 3250, e.g., snap-fit connection, interference fit. In an example, additional retention features may be provided to retain the blower 4142 to the shell 3250, e.g., retaining clip to retain the blower to the shell.

[0134] Additionally or alternatively, one more components of the blower 4142 may be permanently connected to the shell 3250, e.g., by bonding and / or overmolding. For example, one or more portions of the shell 3250 may be overmolded to the blower housing 4146 of the blower 4142 to secure the blower 4142 to the patient interface 3000.

[0135] In some forms, a gasket (e.g., constructed of an elastomeric material) may be arranged between the blower 4142 and the shell 3250 to secure the blower 4142 in position. The inherent flexibility of the gasket provides a flexible connection to decouple the blower 4142 from the shell 3250 and reduce any blower vibration directly transmitting to the patient interface 3000.

[0136] As illustrated, the blower 4142 has a substantially compact design capable of fitting into a small space at the front of the patient interface 3000. Additionally, the compact design results in a light-weight blower, which is beneficial for using with the patient interface supported on the patient’s head. Thus, the portable / wearable RPT system 6000 provides a lightweight (e.g., less than about 300g, less than 250g, about 200g) and low intrusive design. Also, the light weight of the design requires less headgear tension to support the patient interface on the patient’s face and prevent mask leaks.

[0137] In the illustrated example, the blower 4142 is mounted on the top of the shell 3250, i.e., directly adjacent the patient interface, and communicated with the patient interface 3000 via the blower outlet muffler 7100 which provides minimum impedance in the flow path. The blower 4142 may be operated at lower speed, and the blower may generate less pressure swings and require less power consumption (e g., longer battery life when powered by a battery).

[0138] In some forms, the blower 4142 is provided to the patient interface 3000 such that at least a portion of the blower housing 4146 forms at least a portion of the plenum chamber 3200. For example, as shown in Figs. 11 and 12, the blower 4142 may be supported and retained within the substantially circular opening or recess 3255 such that a rear wall of the blower housing 4146 (e.g., opposite to the blower inlet 4143) forms at least a portion of the plenum chamber 3200 along with the shell 3250 and seal forming structure 3100. In other forms, as best shown in Fig. 20, the blower 4142 may be supported by a recess or recessed wall portion 3255 of the shell 3250 such that the blower 4142 is arranged outside the plenum chamber 3200 and does not form a portion of the plenum chamber 3200.

[0139] In some forms, the blower 4142 may be controllable to adjust the speed and / or duration of operation (e.g., by a controller located on the patient interface and / or by a remote controller (e.g., a cell phone or computer (e.g., Bluetooth / wireless remote communication))). For example, Figs. 16 and 17 show an example of a sleek and compact controller 4230 with a display configured to display, e.g., one or more of usage / compliance, settings and clinical data. In the illustrated example, the controller 4230 (e.g., control box) may be secured to the patient interface 3000 (e.g., clip-on type connection to the shroud or headgear) and one or more wires / cables 4235 may connect the controller 4230 to the blower 4142. As illustrated, the one or more wires / cables 4235 may be at least partially guided / hidden by a fabric sleeve 3355 provided to the upper headgear connector 3352. In other forms, the wires / cables may be arranged between laminated materials of the patient interface.

[0140] In some forms, a power supply may be provided to the blower and / or patient interface to power the blower. For example, the control box including the controller 4230 may include a battery, e g., rechargeable battery charged by induction.Muffler System

[0141] An aspect of the present technology relates to a wearable RPT system 6000 including a muffler system 7000 with at least one muffler structured and arranged to reduce noise output of the blower 4142 in use. In the illustrated example, the muffler system 7000 includes a blower outlet muffler 7100 arranged downstream of the blower outlet 4145 of the blower 4142 and / or a blower inlet muffler 7200 (e.g., see Figs. 19-20) arranged upstream of the blower inlet 4143 of the blower 4142. The blower outlet muffler 7100 is configured and arranged to reduce a noise output generated by the blower and emanating from the blower outlet of the blower in use, and the blower inlet muffler 7200 is configured and arranged to reduce a noise output generated by the blower and emanating from the blower inlet of the blower in use. The blower outlet muffler 7100 and / or the blower inlet muffler 7200 may comprise a noise attenuating material. In an example, the noise attenuating material of the blower outlet muffler 7100 may also function as a heat and moisture exchanger (HME).

[0142] In the illustrated example, the blower outlet muffler 7100 is arranged in the pneumatic path between the blower outlet 4145 of the blower 4142 and the inlet opening 3260 of the patient interface 3000. The blower outlet muffler 7100 comprises space / volume as well as a noise attenuating material that absorbs energy of the sound waves exiting the blower outlet 4145 of the blower 4142 in use to reduce noise, i.e., expansion and absorption muffler design.

[0143] In the illustrated example, air is pressurized inside the blower 4142 such that a flow of air at positive pressure is provided at the blower outlet 4145 of the blower 4142. This pressurized air is then passed into the blower outlet chamber 7110 (forming at least part of the blower outlet muffler 7100) and on to the patient interface 3000. That is, the volume forming the blower outlet chamber 7110 is bounded between the blower outlet 4145 and the inlet opening 3260 of the patient interface 3000.

[0144] The blower outlet muffler 7100 comprises a main body 7105 forming the blower outlet chamber 7110 located downstream of the blower outlet 4145 of the blower 4142. The main body 7105 includes a first opening 7120 and a second opening 7130. The first opening 7120 forms an inlet to the blower outlet muffler 7100 configured to communicate with the blower outlet 4145 of the blower 4142. The second opening 7120 forms an outlet from the blower outlet muffler 7100 configured to communicate with the inlet opening 3260 of the patient interface 3000.The side wall surrounding the first opening 7120 is configured to interface or engage with the outlet tube 4148 forming the blower outlet 4145, e.g., with a snap-fit, interference-fit. In addition, the second opening 7120 is configured to align with and interface or engage with the inlet opening 3260 of the patient interface 3000. In some forms, additional retention features may be provided to blower, the patient interface and / or the blower outlet muffler 7100 in order to retain the blower outlet muffler 7100 in an operative position.

[0145] In an example, the first opening 7120 and / or the second opening 7120 of the main body 7105 may include a seal (e.g., constructed of an elastomeric material) configured to seal the air path for pressurized air entering and / or exiting the blower outlet muffler 7100.

[0146] In the illustrated example, the main body 7105 includes one or more walls or wall portions that cooperate to form the blower outlet chamber 7110. In an example, the main body 7105 may comprise a relatively rigid, plastic material (e.g., polypropylene, polyethylene, or other suitable polymers).

[0147] In the illustrated example, an interior wall portion 7150 is provided within the main body 7105 to divide the blower outlet chamber 7110 into a first chamber portion 7110.1 and a second chamber portion 7110.2. As illustrated, the first chamber portion 7110.1 forms a muffler chamber adjacent the first / inlet opening 7120 and the second chamber portion 7110.2 forms an expansion muffler chamber adjacent the second / outlet opening 7130. In an example, the first and second chamber portions may be non-symmetrical (e.g., different volumes to prevent standing waves and resonance noise). For example, the volume of the second chamber portion 7110.2 may be larger than the volume of the first chamber portion 7110.1), with the second chamber portion configured and arranged to attenuate high frequency noise from the blower 4142. In some forms, the first and second chamber portions may be symmetrical (e.g., similar volumes).

[0148] In an example, noise attenuating material (e.g., one or more portions or pieces of foam or other sound absorptive material) may be provided to the blower outlet muffler 7100 to improve the function or performance of the blower outlet muffler 7100. For example, the noise attenuating material (e.g., foam) provides an absorptive-type muffler (resonance peak damping) and the volume of the blower outlet chamber 7110 provides an expansion-type muffler (muffles via expansion ofvolume) along the air flow path. These two methods of attenuating noise work together to reduce acoustic output and minimise the effect of acoustic resonances.

[0149] In the illustrated example, each of the first chamber portion 7110 1 and the second chamber portion 7110.2 includes at least one or more portions or pieces of noise attenuating material. For example, a single one-piece noise attenuating material 7160.1 (e.g., foam block) is supported and retained within the space formed by the first chamber portion 7110.1, and a single one-piece noise attenuating material 7160.2 (e g., foam block) is supported and retained within the space formed by the second chamber portion 7110.2.

[0150] In the illustrated example, each noise attenuating material is arranged such that at least some of the air flow along the air flow path encounters the noise attenuating material and at least some of the air flow along the air flow path is unobstructed by the noise attenuating material.

[0151] Each noise attenuating material 7160.1, 7160.2 is configured to absorb noise, e.g., from the blower and / or the patient interface. For example, noise from the blower is projected towards the noise attenuating material to reduce conducted noise from the blower. In an example, the noise attenuating material may also function as a heat and moisture exchanger (HME). For example, in the illustrated example, at least the noise attenuating material 7160.2 adjacent the second / outlet opening 7130 (communicated with the inlet opening 3260 of the patient interface 3000) functions as a HME. In an example, the noise attenuating material 7160.1, 7160.2 may be similar to one another, or may be different than one another (e.g., noise attenuating material 7160.1 comprises foam and noise attenuating material 7160.2 comprises HME.

[0152] The HME 7160.2 (e g., constructed of foam, sponge, fabric, ceramic, gel, filter material, paper, or a substance capable of acting as a condensation and absorption surface) is arranged in direct fluid communication with the entrance of the patient’s airways, and configured to at least partially retain heat and moisture present in exhaled gas from the patient’s airways. The retained heat and moisture from the HME is returned to the flow of air for humidification. Thus, the HME can provide moisture and humidity to patients during therapy. For example, as shown in Figs. 13 and 21, expired air can flow into the second chamber portion 7110.2 (via the opening 7130) and through the HME 7160.2 so that heat and moisture within the expired air can be captured and retained in the HME for redelivery to the patient during inspiration.

[0153] In the illustrated example, the blower outlet muffler 7100 comprises a separate and distinct structure from the blower 4142 and the patient interface 3000. For example, the blower outlet muffler 7100 is separate and distinct from the blower housing of the blower 4142 and arranged outside the volute of the blower 4142, and the blower outlet muffler 7100 is separate and distinct from the patient interface 3000 and arranged outside the plenum chamber 3200 of the patient interface 3000. In an example, the blower outlet muffler 7100 forms a removable component or cartridge, e.g., to allow easy removal from the patient interface / blower for cleaning and / or replacement of the noise attenuating material 7160.1, 7160.2. That is, a muffler and HME are combined in a component or cartridge, which is configured to be removably plugged onto the blower / patient interface and provide a low impedance air flow connection between the blower 4142 and the patient interface 3000. In forms, the blower outlet muffler 7100 may form a non-removable connection to the patient interface and the blower.

[0154] In an example, e.g., see Fig. 15, at least one wall of the main body 7105 may include a removable end wall or lid 7140 configured to allow the user to open and access the inside of the blower outlet chamber 7110, e.g., for cleaning the chamber and / or for removal / replacement / cleaning of the noise attenuating material 7160.1, 7160.2. In an example, the only part that the user needs to disassemble regularly to clean the whole system is the lid. In an example, the lid 7140 may have an interference fit to the main body 7105. In an example, the noise attenuating material, e.g., HME, could be a disposable or reusable type. In an example, the lid 7140 may support and / or comprise a vent 3400.

[0155] In an alternative example, the main body 7105 may not include removable lid, and the noise attenuating material may be removed via the first opening 7120 and / or the second opening 7120, e.g., see Fig. 22.

[0156] In the example of Figs. 4 to 15, the HME 7160.2 is arranged between the patient’s airways and the vent 3400 so that expired air flows through the HME 7160.2 prior to exiting through the vent 3400, e g., to ensure maximum performance of the HME by minimizing moisture loss during venting.

[0157] In some forms, the vent 3400 is provided to the blower outlet muffler 7100 to allow for the washout of exhaled gases. For example, in the example of Figs. 4 to 15, the vent 3400 is provided to the removable lid 7140 arranged at the bottom of the blower outlet muffler. In the example of Figs. 23 and 24, the main body 7105does not include removable lid and the vent 3400 is provided to a bottom wall of the blower outlet muffler 7100. In each of these examples, the vent 3400 is configured and arranged such that vent flow is oriented to flow in a generally inferior direction, i.e., away from the patient to prevent vent flow disturbing the patient and / or bed partner. In other forms, e.g., see Figs. 16 to 20, the vent 3400 may be provided to the patient interface 3000, and therefore a vent may not be provided to the blower outlet muffler 7100.

[0158] In the example of Figs. 4 to 15, the vent 3400 may comprise a constant flow vent (CFV) assembly 3410 configured to limit the vent flow. As illustrated, the CFV assembly 3410 includes a generally cylindrical geometry with an assembly of parts (e.g., vent base, membrane, vent cap) configured and arranged such that changes in pressure of the gas in the blower outlet chamber causes the membrane to flex. The varying flex in the membrane varies at least a portion of the membrane relative to the vent cap, which controls vent flow through vent outlets formed in the vent cap. In some forms, such CFV assembly 3410 is configured so that the vent flow rate from the chamber through the CFV assembly 3410 to ambient is substantially constant for a range of pressures inside the chamber in use. In the illustrated example, the CFV assembly 3410 is configured to be received and retained within a substantially circular opening 7142 in the lid 7140.

[0159] In some forms, the CFV assembly 3410 may be similar to vent examples described in WO 2023 / 049966, which is incorporated herein by reference in its entirety.

[0160] In other forms, the vent 3400 may comprise a plurality of vent holes 3420 for gas washout, e.g., about 10 to about 80 holes. In some forms, the vent holes 3420 may be provided the patient interface 3000, e.g., see example of Figs. 16 to 20 in which the shell 3250 includes a vent holes 3420 for gas washout. In some forms, the vent holes 3420 may be provided to a non-removable bottom wall of the blower outlet muffler 7100, e.g., see Figs. 23 and 24. In some forms, the vent holes 3420 may be provided to a removable lid 7141 of the blower outlet muffler 7100, e.g., see Fig. 9. In some forms, the lid 7141 with the vent holes 3420 may be used in combination with the lid 7140 with the CFV assembly 3410, e.g., vent holes 3420 arranged upstream of the CFV assembly 3410. In some forms, the blower outlet muffler 7100 may be used with a selected one of the lid 7140 with the CFV assembly 3410 and the lid 7141 with the vent holes 3420. It should be appreciated that the vent holes 3420may include other suitable arrangements, e g., different number of holes, hole arrangement, positioning on shell / lid.

[0161] In an example, the muffler system 7000 may include a blower inlet muffler 7200 configured and arranged to reduce a noise output generated by the blower 4142 and emanating from the blower inlet 4143 of the blower 4142 in use, e.g., see Figs. 19-20. In some forms, the blower inlet muffler 7200 may include an enclosure 7205 that may at least partially enclose a blower inlet side of the blower 4142, e.g., enclosure at least partly forms a blower inlet chamber arranged upstream of the blower inlet wherein the volume of the blower inlet chamber provides an expansion-type muffler (muffles via expansion of volume). For example, the enclosure 7205 may be provided to the blower inlet side of the blower 4142 to muffle noise and limit disturbances caused to the patient and / or the bed partner by directing any noise from the blower inlet 4143 away from the patient and / or the bed partner. As illustrated, the enclosure 7205 may include an inlet tube 7210 oriented away from the patient interface 3000 and configured to direct air toward to the blower inlet 4143 of the blower 4142. In some forms, the enclosure 7205 may be retained in position via the blower housing 4146 of the blower 4142 and / or the shell 3250 patient interface 3000.

[0162] In the illustrated example, the blower 4142 includes a single blower inlet 4143 and a single blower outlet 4145. It should be appreciated that the muffler system according to examples of the present technology may be applicable to wearable PAP systems with alternative blower configurations, e.g., blower including one or more blower inlets and / or one or more blower outlets which may be arranged in alternative configurations with respect to one another.

[0163] In some forms, as shown in Fig. 25, the portable / wearable RPT system 6000 and muffler system 7000 thereof may form a closed loop system, e.g., since the blower 4142 is located so close to the patient interface or mask 3000 and the blower outlet muffler 7100 interconnects the blower 4142 and the patient interface 3000 which eliminates the need for air delivery tubing connecting the patient interface to the blower. In some forms, the close loop system may be energy efficient, and the blower may be configured to operate at lower speeds to deliver therapeutic pressure (since the blower inlet pressure would be higher than the atmospheric pressure). This would allow the blower to be smaller sized and would reduce vent noise. In some forms, the closed loop system may be configured to receive at least some air from thepatient interface to input to the blower inlet of the blower. Since system is closed loop, additional volume of air intake would be same as the volume of vent flow, e g., VI = V5 (L / min). In the example shown in Fig. 25, V2 is the blower output, and it would be substantially similar to the mask input V3. In the example shown in Fig. 25, at least a portion of air flow from the mask V6 is fed into the blower input VI . In the example shown in Fig. 25, V5 is the vent flow, and the total blower input V2 is VI + V6.

[0164] In the illustrated examples, the RPT system is configured for respiratory pressure therapy to treat OSA. It should be appreciated that the system according to examples of the present technology may be applicable for other uses. For example, the system may be used as a snore prevention device by combining a low mask pressure with a MRD (mandibular repositioning device). In an example, the MRD may be attached to the patient interface. In another example, the system may monitor mask pressure and flow with sensors in the mask. In some forms, the mask may have an alarm when It detects any abnormalities in breathing.5.6 GLOSSARY

[0165] For the purposes of the present technology disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, alternative definitions may apply.5.6.1 General

[0166] Air. In certain forms of the present technology, air may be taken to mean atmospheric air, and in other forms of the present technology air may be taken to mean some other combination of breathable gases, e.g. oxygen enriched air.

[0167] Ambient: In certain forms of the present technology, the term ambient will be taken to mean (i) external of the treatment system or patient, and (ii) immediately surrounding the treatment system or patient.

[0168] For example, ambient humidity with respect to a humidifier may be the humidity of air immediately surrounding the humidifier, e.g. the humidity in the room where a patient is sleeping. Such ambient humidity may be different to the humidity outside the room where a patient is sleeping.

[0169] In another example, ambient pressure may be the pressure immediately surrounding or external to the body.

[0170] In certain forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room where a patient is located, other than for example, noise generated by an RPT device or emanating from a mask or patient interface. Ambient noise may be generated by sources outside the room.

[0171] Automatic Positive Airway Pressure (APAP) therapy . C P AP therapy in which the treatment pressure is automatically adjustable, e.g. from breath to breath, between minimum and maximum limits, depending on the presence or absence of indications of SDB events.

[0172] Continuous Positive Airway Pressure (CPAP) therapy . Respiratory pressure therapy in which the treatment pressure is approximately constant through a respiratory cycle of a patient. In some forms, the pressure at the entrance to the airways will be slightly higher during exhalation, and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, being increased in response to detection of indications of partial upper airway obstruction, and decreased in the absence of indications of partial upper airway obstruction.

[0173] Flow rate '. The volume (or mass) of air delivered per unit time. Flow rate may refer to an instantaneous quantity. In some cases, a reference to flow rate will be a reference to a scalar quantity, namely a quantity having magnitude only. In other cases, a reference to flow rate will be a reference to a vector quantity, namely a quantity having both magnitude and direction. Flow rate may be given the symbol Q. ‘Flow rate’ is sometimes shortened to simply ‘flow’ or ‘airflow’.

[0174] In the example of patient respiration, a flow rate may be nominally positive for the inspiratory portion of a breathing cycle of a patient, and hence negative for the expiratory portion of the breathing cycle of a patient. Device flow rate, Qd, is the flow rate of air leaving the RPT device. Total flow rate, Qt, is the flow rate of air and any supplementary gas reaching the patient interface via the air circuit. Vent flow rate, Qy, is the flow rate of air leaving a vent to allow washout of exhaled gases. Leak flow rate, QI, is the flow rate of leak from a patient interface system or elsewhere. Respiratory flow rate, Qr, is the flow rate of air that is received into the patient’s respiratory system.

[0175] Flow therapy. Respiratory therapy comprising the delivery of a flow of air to an entrance to the airways at a controlled flow rate referred to as the treatment flow rate that is typically positive throughout the patient’s breathing cycle.

[0176] Humidifier . The word humidifier will be taken to mean a humidifying apparatus constructed and arranged, or configured with a physical structure to be capable of providing a therapeutically beneficial amount of water (H2O) vapour to a flow of air to ameliorate a medical respiratory condition of a patient.

[0177] Leak'. The word leak will be taken to be an unintended flow of air. In one example, leak may occur as the result of an incomplete seal between a mask and a patient’s face. In another example leak may occur in a swivel elbow to the ambient.

[0178] Noise, conducted (acoustic) '. Conducted noise in the present document refers to noise which is carried to the patient by the pneumatic path, such as the air circuit and the patient interface as well as the air therein. In one form, conducted noise may be quantified by measuring sound pressure levels at the end of an air circuit.

[0179] Noise, radiated (acoustic). Radiated noise in the present document refers to noise which is carried to the patient by the ambient air. In one form, radiated noise may be quantified by measuring sound power / pressure levels of the object in question according to ISO 3744.

[0180] Noise, vent (acoustic) '. Vent noise in the present document refers to noise which is generated by the flow of air through any vents such as vent holes of the patient interface.

[0181] Oxygen enriched air '. Air with a concentration of oxygen greater than that of atmospheric air (21%), for example at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen enriched air” is sometimes shortened to “oxygen”.

[0182] Medical Oxygen'. Medical oxygen is defined as oxygen enriched air with an oxygen concentration of 80% or greater.

[0183] Patient: A person, whether or not they are suffering from a respiratory condition.

[0184] Pressure. Force per unit area. Pressure may be expressed in a range of units, including cmFFO, g-f / cm2and hectopascal. 1 cmFFO is equal to 1 g-f / cm2and is approximately 0.98 hectopascal (1 hectopascal = 100 Pa = 100 N / m2= 1 millibar ~ 0.001 atm). In this specification, unless otherwise stated, pressure is given in units of crnFFO.

[0185] The pressure in the patient interface is given the symbol Pm, while the treatment pressure, which represents a target value to be achieved by the interface pressure Pm at the current instant of time, is given the symbol Pt.

[0186] Respiratory Pressure Therapy. The application of a supply of air to an entrance to the airways at a treatment pressure that is typically positive with respect to atmosphere.

[0187] Ventilator. A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.5.6.1.1 Materials & their properties

[0188] Hardness'. Refers to durometer or indentation hardness, which is a material property measured by indentation of an indentor (e.g., as measured in accordance with ASTM D2240).• ‘ Soft’ materials may include silicone or thermo-plastic elastomer (TPE), and may, e.g. readily deform under finger pressure.• ‘Hard’ materials may include polycarbonate, polypropylene, and may not e.g. readily deform under finger pressure.

[0189] Silicone or Silicone Elastomer'. A synthetic rubber. In this specification, a reference to silicone is a reference to liquid silicone rubber (LSR) or a compression moulded 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 manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, an exemplary form of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0190] Polycarbonate', a thermoplastic polymer of Bisphenol-A Carbonate.5.6.1.2 Mechanics

[0191] Axes: a. Neutral axis: An axis in the cross-section of a beam or plate along which there are no longitudinal stresses or strains. b. Longitudinal axis: An axis extending along the length of a shape. The axis generally passes through a center of the shape.c. Circumferential axis'. An axis oriented perpendicularly with respect to the longitudinal axis. The axis may be specifically present in pipes, tubes, cylinders, or similar shapes with a circular and / or elliptical cross section.

[0192] Deformation '. The process where the original geometry of a member changes when subjected to forces, e.g. a force in a direction with respect to an axis. The process may include stretching or compressing, bending and, twisting.

[0193] Elasticity '. The ability of a material to return to its original geometry after deformation.

[0194] Floppy structure or component: A stmcture or component that will change shape, e.g. bend, when caused to support its own weight, within a relatively short period of time such as 1 second.

[0195] Resilience'. Ability of a material to absorb energy when deformed elastically and to release the energy upon unloading.

[0196] Resilient'. Will release substantially all of the energy when unloaded. Includes e.g. certain silicones, and thermoplastic elastomers.

[0197] Rigid structure or component: A structure or component that will not substantially change shape when subject to the loads typically encountered in use. An example of such a use may be setting up and maintaining a patient interface in sealing relationship with an entrance to a patient’s airways, e.g. at a load of approximately 20 to 30 cmH20 pressure.

[0198] As an example, an I-beam may comprise a different bending stiffness (resistance to a bending load) in a first direction in comparison to a second, orthogonal direction. In another example, a structure or component may be floppy in a first direction and rigid in a second direction.

[0199] Stiffness (or rigidity) of a structure or component: The ability of the structure or component to resist deformation in response to an applied load. The load may be a force or a moment, e.g. compression, tension, bending or torsion. The structure or component may offer different resistances in different directions. The inverse of stiffness is flexibility.

[0200] Viscous: The ability of a material to resist flow.

[0201] Visco-elasticity. The ability of a material to display both elastic and viscous behaviour in deformation.

[0202] Yield: The situation when a material can no longer return back to its original geometry after deformation.5.6.1.3 Structural Elements

[0203] Compression member: A structural element that resists compression forces.

[0204] Elbow. An elbow is an example of a structure that directs an axis of flow of air travelling therethrough to change direction through an angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be more, or less than 90 degrees. The elbow may have an approximately circular cross-section. In another form the elbow may have an oval or a rectangular cross-section. In certain forms an elbow may be rotatable with respect to a mating component, e.g. about 360 degrees. In certain forms an elbow may be removable from a mating component, e.g. via a snap connection. In certain forms, an elbow may be assembled to a mating component via a one-time snap during manufacture, but not removable by a patient.

[0205] Frame'. Frame will be taken to mean a mask structure that bears the load of tension between two or more points of connection with a headgear. A mask frame may be a non-airtight load bearing structure in the mask. However, some forms of mask frame may also be air-tight.

[0206] Membrane'. Membrane will be taken to mean a typically thin element that has, preferably, substantially no resistance to bending, but has resistance to being stretched.

[0207] Tie (noun)'. A structure designed to resist tension.

[0208] Thin structures: a. Beams,A beam may be relatively long in one dimension compared to the other two dimensions such that the smaller dimensions are comparatively thin compared to the long dimension b. Membranes,Relatively long in two dimensions, with one thin dimension. Readily deforms in response to bending forces. Resists being stretched, (might also resist compression). c. Plates & ShellsThese may be relatively long in two directions, with one thin dimension. They may have bending, tensile, and / or compressive stiffness.

[0209] Thick structures: Solids

[0210] Seal'. May be a noun form ("a seal") which refers to a structure, or a verb form (“to seal”) which refers to the effect. Two elements may be constructed and / orarranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate ‘seal’ element per se.

[0211] Shell. A shell will be taken to mean a curved, relatively thin structure having bending, tensile and compressive stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, a shell may be faceted. In some forms a shell may be airtight. In some forms a shell may not be airtight.

[0212] Stiffener '. A stiffener will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0213] Strut'. A strut will be taken to be a structural component designed to increase the compression resistance of another component in at least one direction.

[0214] Swivel (noun) '. A subassembly of components configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be constructed to rotate through an angle of at least 360 degrees. In another form, the swivel may be constructed to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably comprises a matched pair of cylindrical conduits. There may be little or no leak flow of air from the swivel in use.5.6.2 Patient interface

[0215] Anti-asphyxia valve (AAV): The component or sub-assembly of a mask system that, by opening to atmosphere in a failsafe manner, reduces the risk of excessive CO2 rebreathing by a patient.

[0216] Headgear: Headgear will be taken to mean a form of positioning and stabilising structure designed to hold a device, e.g., a mask, on a head.

[0217] Plenum chamber: a mask plenum chamber will be taken to mean a portion of a patient interface having walls at least partially enclosing a volume of space, the volume having air therein pressurised above atmospheric pressure in use. A shell may form part of the walls of a mask plenum chamber.

[0218] Seal: May be a noun form (“a seal”) which refers to a structure, or a verb form (“to seal”) which refers to the effect. Two elements may be constructed and / or arranged to ‘seal’ or to effect ‘sealing’ therebetween without requiring a separate ‘seal’ element per se.

[0219] Vent: (noun): A structure that allows a flow of air from an interior of the mask, or conduit, to ambient air for clinically effective washout of exhaled gases. For example, a clinically effective washout may involve a flow rate of about 10 litres per minute to about 100 litres per minute, depending on the mask design and treatment pressure.5.6.3 Shape of structures

[0220] Products in accordance with the present technology may comprise one or more three-dimensional mechanical structures, for example a mask cushion or an impeller. The three-dimensional structures may be bounded by two-dimensional surfaces. These surfaces may be distinguished using a label to describe an associated surface orientation, location, function, or some other characteristic. For example a structure may comprise one or more of an anterior surface, a posterior surface, an interior surface and an exterior surface. In another example, a seal-forming structure may comprise a face-contacting (e.g. outer) surface, and a separate non-face- contacting (e g. underside or inner) surface. In another example, a structure may comprise a first surface and a second surface.5.6.3.1 Curvature of two dimensional surfaces

[0221] A description of the shape at a given point on a two-dimensional surface in accordance with the present technology may include multiple normal crosssections. The multiple cross-sections may cut the surface in a plane that includes the outward normal (a “normal plane”), and each cross-section may be taken in a different direction. Each cross-section results in a plane curve with a corresponding curvature. The different curvatures at that point may have the same sign, or a different sign. Each of the curvatures at that point has a magnitude, e.g. relatively small.

[0222] Principal curvatures and directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values are called the principal directions.

[0223] Region of a surface: A connected set of points on a surface. The set of points in a region may have similar characteristics, e.g. curvatures or signs.

[0224] Saddle region: A region where at each point, the principal curvatures have opposite signs, that is, one is positive, and the other is negative (depending on the direction to which the imaginary person turns, they may walk uphill or downhill).

[0225] Dome region: A region where at each point the principal curvatures have the same sign, e g. both positive (a “concave dome”) or both negative (a “convex dome”).

[0226] Cylindrical region: A region where one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is non-zero.

[0227] Planar region: A region of a surface where both of the principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0228] Edge of a surface: A boundary or limit of a surface or region.

[0229] Path: In certain forms of the present technology, ‘path’ will be taken to mean a path in the mathematical - topological sense, e.g. a continuous space curve from f(0) to f(l) on a surface. In certain forms of the present technology, a ‘path’ may be described as a route or course, including e.g. a set of points on a surface. (The path for the imaginary person is where they walk on the surface, and is analogous to a garden path).

[0230] Path length: In certain forms of the present technology, ‘path length’ will be taken to mean the distance along the surface from f(0) to f(l), that is, the distance along the path on the surface. There may be more than one path between two points on a surface and such paths may have different path lengths. (The path length for the imaginary person would be the distance they have to walk on the surface along the path).

[0231] Straight-line distance: The straight-line distance is the distance between two points on a surface, but without regard to the surface. On planar regions, there would be a path on the surface having the same path length as the straight-line distance between two points on the surface. On non-planar surfaces, there may be no paths having the same path length as the straight-line distance between two points. (For the imaginary person, the straight-line distance would correspond to the distance ‘as the crow flies’ .)5.7 OTHER REMARKS

[0232] A portion of the disclosure of this patent document contains material which is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure, as it appears in Patent Office patent files or records, but otherwise reserves all copyright rights whatsoever.

[0233] Unless the context clearly dictates otherwise and where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit, between the upper and lower limit of that range, 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, which may be independently included in the intervening ranges, are also encompassed within the technology, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either or both of those included limits are also included in the technology.

[0234] Furthermore, where a value or values are stated herein as being implemented as part of the technology, it is understood that such values may be approximated, unless otherwise stated, and such values may be utilized to any suitable significant digit to the extent that a practical technical implementation may permit or require it.

[0235] Furthermore, “approximately”, “substantially”, “about”, or any similar term used herein means + / - 5-10% of the recited value.

[0236] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present technology, a limited number of the exemplary methods and materials are described herein.

[0237] When a particular material is identified as being used to construct a component, obvious alternative materials with similar properties may be used as a substitute. Furthermore, unless specified to the contrary, any and all components herein described are understood to be capable of being manufactured and, as such, may be manufactured together or separately.

[0238] It must be noted that as used herein and in the appended claims, the singular forms “a”, “an”, and “the” include their plural equivalents, unless the context clearly dictates otherwise.

[0239] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials which are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein isto be construed as an admission that the present technology is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates, which may need to be independently confirmed.

[0240] The terms “comprises” and “comprising” should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced.

[0241] The subject headings used in the detailed description are included only for the ease of reference of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The subject headings should not be used in construing the scope of the claims or the claim limitations.

[0242] Although the technology herein has been described with reference to particular examples, it is to be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terminology and symbols may imply specific details that are not required to practice the technology. For example, although the terms “first” and “second” may be used, unless otherwise specified, they are not intended to indicate any order but may be utilised to distinguish between distinct elements. Furthermore, although process steps in the methodologies may be described or illustrated in an order, such an ordering is not required. Those skilled in the art will recognize that such ordering may be modified and / or aspects thereof may be conducted concurrently or even synchronously.

[0243] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the technology.5.8 REFERENCE SIGNS LIST

Claims

6 CLAIMS1. A respiratory pressure therapy (RPT) system for treating a patient with a respiratory disorder, the RPT system comprising: a patient interface including a seal forming structure configured to form a seal with a patient’ face; a blower configured to generate a pressurized flow of gas, the blower configured to be connected to the patient interface such that the blower is supported on the patient’s head by the patient interface; and a muffler system provided to the patient interface and / or the blower, the muffler system configured and arranged to reduce noise from the blower and / or enhance patient comfort, wherein the muffler system comprises a blower outlet muffler configured to connect to the patient interface and the blower, wherein the blower outlet muffler is configured to form an airflow path to convey the pressurized flow of gas from a blower outlet of the blower to an inlet opening of the patient interface, wherein the blower outlet muffler includes a main body forming a blower outlet chamber, and wherein the blower outlet muffler includes a noise attenuating material, the main body configured to support at least a portion of the noise attenuating material in the blower outlet chamber.

2. The RPT system according to claim 1, wherein the blower outlet muffler is configured to removably connect to the patient interface and the blower.

3. The RPT system according to any one of claims 1 to 2, wherein the noise attenuating material comprises foam.

4. The RPT system according to any one of claims 1 to 3, wherein the noise attenuating material comprises a heat and moisture exchanger.

5. The RPT system according to any one of claims 1 to 4, wherein the main body includes a first opening and a second opening, the first opening forming an inlet configured to communicate with the blower outlet of the blower, and the second opening forming an outlet configured to communicate with the inlet opening of the patient interface.

6. The RPT system according to claim 5, wherein the main body includes a side wall surrounding the first opening configured to interface or engage with an outlet tube forming the blower outlet of the blower.

7. The RPT system according to any one of claims 5 to 6, wherein the blower outlet muffler includes an interior wall portion provided within the main body to divide the blower outlet chamber into a first chamber portion and a second chamber portion.

8. The RPT system according to claim 7, wherein the first chamber portion and the second chamber portion include different volumes.

9. The RPT system according to any one of claims 7 to 8, wherein each of the first chamber portion and the second chamber portion includes at least one noise attenuating material.

10. The RPT system according to claim 9, wherein at least the noise attenuating material in the second chamber portion comprises HME.

11. The RPT system according to any one of claims 7 to 10, wherein the first chamber portion is arranged adjacent to the first opening and the second chamber portion is arranged adjacent to the second opening.

12. The RPT system according to any one of claims 1 to 11, wherein the blower outlet muffler comprises a separate and distinct structure from the blower and the patient interface configured to allow the blower outlet muffler to form a removable component or cartridge.

13. The RPT system according to any one of claims 1 to 12, wherein at least one wall of the main body includes a removable lid configured to allow access to the blower outlet chamber.

14. The RPT system according to claim 13, wherein the removable lid comprise a vent for gas washout.

15. The RPT system according to any one of claims 1 to 14, wherein the blower outlet muffler is configured to directly link the blower to the patient interface.

16. The RPT system according to any one of claims 1 to 15, wherein the muffler system further comprises a blower inlet muffler arranged upstream of a blower inlet of the blower and configured and arranged to reduce noise emanating from the blower inlet of the blower in use.

17. The RPT system according to claim 16, wherein the blower inlet muffler includes an enclosure configured to at least partially enclose a blower inlet side of the blower.

18. The RPT system according to claim 17, wherein the enclosure includes an inlet tube configured to direct air to the blower inlet of the blower.

19. The RPT system according to any one of claims 1 to 18, wherein the seal forming structure comprises a first seal forming structure configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s mouth, and wherein the seal forming structure comprises a second seal forming structure configured to form a seal with a region of the patient’s face surrounding an entrance to the patient’s nose.

20. The RPT system according to any one of claims 1 to 19, wherein the patient interface includes a shell, wherein the shell and the seal forming structure at least partially form a plenum chamber configured to receive the pressurized flow of gas.

21. The RPT system according to claim 20, wherein the shell is configured to at least partially receive, locate and / or retain the blower.

22. The RPT system according to any one of claims 20 to 21, wherein one or more portions of the shell comprises an overmolded connection to the blower to secure the blower to the patient interface.

23. The RPT system according to any one of claims 20 to 22, wherein the shell at least partially forms the inlet opening configured to allow the blower outlet muffler to communicate with the plenum chamber.

24. The RPT system according to any one of claims 1 to 23, wherein the patient interface includes a vent for gas washout.

25. The RPT system according to any one of claims 1 to 23, wherein the blower outlet muffler includes a vent for gas washout.

26. The RPT system according to any one of claims 1 to 25, wherein the blower includes a blower inlet aligned with an axis of the blower and the blower outlet is configured to direct the pressurized flow of gas exiting the blower in a generally tangential direction.

27. The RPT system according to claim 26, wherein the blower outlet is formed by an outlet tube oriented in an inferior direction configured to interface with the blower outlet muffler.

28. The RPT system according to any one of claims 1 to 27, further comprising a controller to control the blower.

29. The RPT system according to claim 28, wherein the controller is at least partly supported by the patient interface.

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