Respiratory pressure therapy system with vaporizing humidifier

Abstract

A method of facilitating cleaning of a respiratory pressure therapy (RPT) system, may include: supplying a flow of air at a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder; vaporizing, using a vaporizer, a liquid into the flow of air; detecting a physical phenomenon using a sensor that is positioned on or proximal to the vaporizer; generating a first signal indicative of a first parameter that is associated with the physical phenomenon; determining, using at least one processor and based on the first signal, whether the first parameter exceeds a predetermined threshold; and in response to determination that the first parameter exceeds a predetermined threshold, triggering a responsive action (123)

Description

RESPIRATORY PRESSURE THERAPY SYSTEM WITH VAPORIZINGHUMIDIFIER

[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 the benefit of International Application Nos. PCT / AU2024 / 050820, filed August 1, 2024, and PCT / AU2024 / 050696, filed June 28, 2024, and U.S. Provisional Application No. 63 / 519,643, filed August 15, 2023, the entire contents of which are incorporated herein by reference.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 John 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.2.2.2 Therapies

[0008] 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

[0009] 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).

[0010] 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.

[0011] Non-invasive ventilation (NIV) provides ventilatory support to a patient through the upper airways to assist the patient breathing and / or maintain adequate oxygen levels in the body by doing some or all of the work of breathing. The ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure, in forms such as OHS, COPD, NMD and Chest Wall disorders. In some forms, the comfort and effectiveness of these therapies may be improved.

[0012] Invasive ventilation (IV) provides ventilatory support to patients that are no longer able to effectively breathe themselves and may be provided using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these therapies may be improved.2.2.3 Respiratory Therapy Systems

[0013] 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.

[0014] 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

[0015] 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 cmFFO 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 cmFFO. 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.

[0016] Certain mask systems may be functionally unsuitable for the present field. For example, purely ornamental masks may be unable to maintain a suitable pressure. Mask systems used for underwater swimming or diving may be configured to guard against ingress of water from an external higher pressure, but not to maintain air internally at a higher pressure than ambient.

[0017] Certain masks may be clinically unfavourable for the present technology e.g. if they block airflow via the nose and only allow it via the mouth.

[0018] Certain masks may be uncomfortable or impractical for the present technology if they require a patient to insert a portion of a mask structure in their mouth to create and maintain a seal via their lips.

[0019] Certain masks may be impractical for use while sleeping, e.g. for sleeping while lying on one’s side in bed with a head on a pillow.

[0020] Certain masks may cause some patients a feeling of claustrophobia, unease and / or may feel overly obtrusive.

[0021] The design of a patient interface presents a number of challenges. The face has a complex three-dimensional shape. The size and shape of noses and heads varies considerably between individuals. Since the head includes bone, cartilage and soft tissue, different regions of the face respond differently to mechanical forces. The jaw or mandible may move relative to other bones of the skull. The whole head may move during the course of a period of respiratory therapy.

[0022] Consequently, some masks suffer from being obtrusive, aesthetically undesirable, costly, poorly fitting, difficult to use, and / or uncomfortable especially when worn for long or when a patient is unfamiliar with a system. Wrongly sized masks can give rise to reduced compliance, reduced comfort and poorer patient outcomes. Masks designed solely for aviators, masks designed as part of personal protection equipment (e.g. filter masks), SCUBA masks, or for the administration of anaesthetics may be tolerable for their original application, but nevertheless such masks may be undesirably uncomfortable to be worn for extended periods of time, e.g., several hours. This discomfort may lead to a reduction in patient compliance with therapy, especially if the mask is to be worn during sleep.

[0023] CPAP therapy is highly effective to treat certain respiratory disorders, provided patients comply with therapy. If a mask is uncomfortable, or difficult to use a patient may not comply with therapy. Since it is often recommended that a patient regularly wash their mask, if a mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean their mask and this may impact on patient compliance.

[0024] While a mask for other applications (e.g. aviators) may not be suitable for use in treating sleep disordered breathing, a mask designed for use in treating sleep disordered breathing may be suitable for other applications.

[0025] For these reasons, patient interfaces for delivery of CPAP during sleep form a distinct field.2.2.3.1.1 Seal-forming structure

[0026] Patient interfaces may include a seal-forming structure. Since it is in direct contact with the patient’s face, the shape and configuration of the seal -forming structure can have a direct impact the effectiveness and comfort of the patient interface.

[0027] A patient interface may be partly characterised according to the design intent of where the seal-forming structure is to engage with the face in use. In one form of patient interface, a seal-forming structure may comprise a first sub-portion to form a seal around theleft naris and a second sub-portion to form a seal around the right naris. In one form of patient interface, a seal-forming structure may comprise a single element that surrounds both nares in use. Such single element may be designed to for example overlay an upper lip region and a nasal bridge region of a face. In one form of patient interface a seal -forming structure may comprise an element that surrounds a mouth region in use, e.g. by forming a seal on a lower lip region of a face. In one form of patient interface, a seal -forming structure may comprise a single element that surrounds both nares and a mouth region in use. These different types of patient interfaces may be known by a variety of names by their manufacturer including nasal masks, full-face masks, nasal pillows, nasal puffs and oro-nasal masks.

[0028] A seal-forming structure that may be effective in one region of a patient’s face may be inappropriate in another region, e.g. because of the different shape, structure, variability and sensitivity regions of the patient’s face. For example, a seal on swimming goggles that overlays a patient’s forehead may not be appropriate to use on a patient’s nose.

[0029] Certain seal-forming structures may be designed for mass manufacture such that one design is able to fit and be comfortable and effective for a wide range of different face shapes and sizes. To the extent to which there is a mismatch between the shape of the patient’s face, and the seal-forming structure of the mass-manufactured patient interface, one or both must adapt in order for a seal to form.

[0030] One type of seal -forming structure extends around the periphery of the patient interface, and is intended to seal against the patient's face when force is applied to the patient interface with the seal-forming structure in confronting engagement with the patient's face. The seal-forming structure may include an air or fluid filled cushion, or a moulded or formed surface of a resilient seal element made of an elastomer such as a rubber. With this type of seal-forming structure, if the fit is not adequate, there will be gaps between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face in order to achieve a seal.

[0031] Another type of seal-forming structure incorporates a flap seal of thin material positioned about the periphery of the mask so as to provide a self-sealing action against the face of the patient when positive pressure is applied within the mask. Like the previous style of seal forming portion, if the match between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match that of the patient, it may crease or buckle in use, giving rise to leaks.

[0032] Another type of seal-forming structure may comprise a friction-fit element, e.g. for insertion into a naris, however some patients find these uncomfortable.

[0033] Another form of seal-forming structure may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly apply and remove an adhesive to their face.

[0034] A range of patient interface seal-forming structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0035] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow, or nasal puff is the subject of US Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0036] ResMed Inc. has manufactured the following products that incorporate nasal pillows: SWIFT™ nasal pillows mask, SWIFT™ II nasal pillows mask, SWIFT™ LT nasal pillows mask, SWIFT™ FX nasal pillows mask and MIRAGE LIBERTY™ full-face mask. The following patent applications describe examples of nasal pillows masks: International Patent Application WO 2004 / 073778 (describing amongst other things aspects of the SWIFT™ nasal pillows mask), US Patent Application 2009 / 0044808 (describing amongst other things aspects of the SWIFT™ LT nasal pillows mask); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (describing amongst other things aspects of the MIRAGE LIBERTY™ full-face mask); International Patent Application WO 2009 / 052560 (describing amongst other things aspects of the SWIFT™ FX nasal pillows mask).2.2.3.1.2 Positioning and Stabilising Structure

[0037] A seal -forming structure of a patient interface used for positive air pressure therapy is subject to the corresponding force of the air pressure to disrupt a seal. Thus a variety of techniques have been used to position the seal-forming structure, and to maintain it in sealing relation with the appropriate portion of the face. Several factors may be considered when comparing different positioning and stabilising techniques. These include: how effective the technique is at maintaining the seal-forming structure in the desired position and in sealed engagement with the face during use of the patient interface; how comfortable the interface is for the patient; whether the patient feels intrusiveness and / or claustrophobia when wearing the patient interface; and aesthetic appeal.

[0038] One technique is the use of adhesives, e.g. see US Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some.

[0039] Another technique is the use of one or more straps and / or stabilising harnesses. Many such harnesses suffer from being one or more of ill-fitting, bulky, uncomfortable and awkward to use.2.2.3.1.3 Pressurised Air Conduit

[0040] In one type of treatment system, a flow of pressurised air is provided to a patient interface through a conduit in an air circuit that fluidly connects to the patient interface at a location that is in front of the patient’s face when the patient interface is positioned on the patient’s face during use. The conduit may extend from the patient interface forwards away from the patient’s face.2.2.3.1.4 Pressurised Air Conduit used for Positioning / Stabilising the Seal-Forming Structure

[0041] Another type of treatment system comprises a patient interface in which a tube that delivers pressurised air to the patient’s airways also functions as part of the headgear to position and stabilise the seal-forming portion of the patient interface at the appropriate part of the patient’s face. This type of patient interface may be referred to as having “conduit headgear” or “headgear tubing”. Such patient interfaces allow the conduit in the air circuit providing the flow of pressurised air from a respiratory pressure therapy (RPT) device to connect to the patient interface in a position other than in front of the patient’s face. One example of such a treatment system is disclosed in US Patent Publication No. US 2007 / 0246043, the contents of which are incorporated herein by reference, in which the conduit connects to a tube in the patient interface through a port positioned in use on top of the patient’s head.

[0042] It is desirable for patient interfaces incorporating headgear tubing to be comfortable for a patient to wear over a prolonged duration when the patient is asleep, form an air-tight and stable seal with the patient’s face, while also able to fit a range of patient head shapes and sizes.2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0043] 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.

[0044] Air pressure generators are known in a range of applications, e.g. industrial-scale ventilation systems. However, air pressure generators for medical applications have particular requirements not fulfilled by more generalised air pressure generators, such as the reliability, size and weight requirements of medical devices. In addition, even devices designed for medical treatment may suffer from shortcomings, pertaining to one or more of: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost, and reliability.

[0045] An example of the special requirements of certain RPT devices is acoustic noise.

[0046] Table of noise output levels of prior RPT devices (one specimen only, measured using test method specified in ISO 3744 in CPAP mode at 10 cmH20).

[0047] One known RPT device used for treating sleep disordered breathing is the S9 Sleep Therapy System, manufactured by ResMed Inc. Another example of an RPT device is a ventilator. Ventilators such as the ResMed Stellar™ Series of Adult and Paediatric Ventilators may provide support for invasive and non-invasive non-dependent ventilation for a range of patients for treating a number of conditions such as but not limited to NMD, OHS and COPD.

[0048] The ResMed Elisee™ 150 ventilator and ResMed VS III™ ventilator may provide support for invasive and non-invasive dependent ventilation suitable for adult or paediatric patients for treating a number of conditions. These ventilators provide volumetric and barometric ventilation modes with a single or double limb circuit. RPT devices typically comprise a pressure generator, such as a motor-driven blower or a compressed gas reservoir, and are configured to supply a flow of air to the airway of a patient. In some cases, the flow of air may be supplied to the airway of the patient at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.2.2.3.3 Air circuit

[0049] An air circuit is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components of a respiratory therapy system such as the RPT device and the patient interface. In some cases, there may be separate limbs of the air circuit for inhalation and exhalation. In other cases, a single limb air circuit is used for both inhalation and exhalation.2.2.3.4 Humidifier

[0050] 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.

[0051] A range of artificial humidification devices and systems are known, however they may not fulfil the specialised requirements of a medical humidifier.

[0052] Medical humidifiers are used to increase humidity and / or temperature of the flow of air in relation to ambient air when required, typically where the patient may be asleep or resting (e.g. at a hospital). A medical humidifier for bedside placement may be small. A medical humidifier may be configured to only humidify and / or heat the flow of air delivered to the patient without humidifying and / or heating the patient’s surroundings. Room-based systems (e.g. a sauna, an air conditioner, or an evaporative cooler), for example, may also humidify air that is breathed in by the patient, however those systems would also humidify and / or heat the entire room, which may cause discomfort to the occupants. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers

[0053] 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.2.2.3.5 Vent technologies

[0054] 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 of a patient interface, e.g., the plenum chamber, to an exterior of the patient interface, e.g., to ambient.

[0055] The vent may comprise an orifice and gas may flow through the orifice in use of the mask. Many such vents are noisy. Others may become blocked in use and thus provide insufficient washout. Some vents may be disruptive of the sleep of a bed partner 1100 of the patient 1000, e.g. through noise or focussed airflow.

[0056] ResMed Inc. has developed a number of improved mask vent technologies, e.g. see International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; US Patent No. 6,581,594; US Patent Application Publication No. US 2009 / 0050156; US Patent Application Publication No. 2009 / 0044808.

[0057] Table of noise of prior masks (ISO 17510-2:2007, 10 cmH20 pressure at Im)

[0058] (* one specimen only, measured using test method specified in ISO 3744 inCPAP mode at 10 cmH20)3 BRIEF SUMMARY OF THE TECHNOLOGY

[0059] 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 .

[0060] A first aspect of the present technology relates to apparatus used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0061] Another aspect of the present technology relates to methods used in the screening, diagnosis, monitoring, amelioration, treatment or prevention of a respiratory disorder.

[0062] 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.

[0063] One form of the present technology comprises a positioning and stabilising structure configured to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient’s head. The positioning and stabilising structure includes at least one strap.

[0064] One form of the present technology comprises a patient interface comprising a plenum chamber, a seal -forming structure, and a positioning and stabilising structure.

[0065] 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 toform 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 sealforming 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.

[0066] Another aspect of one form of the present technology is a series of modular elements that may be interconnected in order to form different styles of patient interfaces.

[0067] In one form, there are at least two versions or styles of each modular element. The versions or styles may be interchangeably used with one another in order to form different modular assemblies.

[0068] An aspect of the present technology is directed to a patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to seal with a region of the patient’s face surrounding an entrance to the patient’s airways, the seal-forming structure having a hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, and the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; 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, the positioning and stabilising structure comprising a tie, the tie being constructed and arranged so that at least a portion overlies a region of the patient’s head superior to an otobasion superior of the patient’s head in use; a connection port configured to be connected to an air circuit to receive the flow of air at the therapeutic pressure and direct the flow of air at the therapeutic pressure to the plenum chamber for breathing by the patient; a vaporizer configured to contain water and comprising a heating element configured to vaporize water contained in the vaporizer; and a vent structure comprising one or more vent holes configured to allow a continuous flow of gases exhaled by the patient from an interior of the plenum chamber to ambient, the one or more vent holes being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; wherein the patient interface is configured to leave the patient’s mouth uncovered, or if the seal-forming structure is configured to seal around the patient’s nose and mouth, thepatient interface is configured to allow the patient to breath from ambient in the absence of a flow of pressurised air through the plenum chamber inlet port.

[0069] An aspect of the present technology is directed to a patient interface comprising: a plenum chamber; a seal-forming structure; a positioning and stabilising structure; a connection port; a vaporizer and a heating element configured to vaporize water contained in the vaporizer; and a vent structure.

[0070] In examples of the aspects of the two preceding paragraphs: (a) at least a portion of the vaporizer may be positioned inside the plenum chamber to vaporize water into the flow of air at the therapeutic pressure in the plenum chamber, (b) at least a portion of the vaporizer may be positioned inside the connection port to vaporize water into the flow of air at the therapeutic pressure in the plenum chamber, (c) a first sensor may be positioned on the plenum chamber and exposed to the interior of the plenum chamber to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the plenum chamber, (d) a second sensor may be positioned on the connection port and exposed to the interior of the connection port to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the connection port, (e) the positioning and stabilizing structure may comprise a pair of tubes, each of the tubes being fluidly connected at a distal end to the connection port and at a proximal end to the plenum chamber to direct the flow of air at the therapeutic pressure to the plenum chamber for breathing by the patient, and a third sensor may be positioned on at least one of the tubes and is exposed to the interior of the corresponding tube to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the corresponding tube, (f) a reservoir may be configured to store water, the reservoir being in fluid communication with the vaporizer to provide water for vaporization during use, (g) the reservoir may be permanently attached to the vaporizer or the reservoir may be removably attached to the vaporizer, (h) a wicking material may be configured to transport water from the reservoir to the vaporizer, (i) the reservoir may be constructed from rubber or polymer and may be configured to collapse when empty or filled to less than a maximum volume, (j) the vaporizer may comprise a first porous material configured to contain water and thermally connected to the heating element to be heated by the heating element to vaporize water in the porous material, (k) the first porous material may be any one of ceramic, metal, sintered metal, quartz, a polymer, or a fibrous material, (1) the first porous material may be structured to transport water via capillary force, (m) the vaporizer may comprise a second porous material configured to contain water and fluidly connected to the first porous material totransport water from the second porous material to the first porous material, (n) the second porous material may be any one of ceramic, metal, sintered metal, quartz, a polymer, or a fibrous material, (o) the second porous material may be structured to transport water via capillary force, (p) the heating element may be an electric resistance heater, (q) a power supply may be configured to power the heating element, (r) the power supply may be a battery, (s) the heating element may be configured to be electrically connected to an RPT device comprising a blower to pressurize the flow of air to the therapeutic pressure, and the heating element may be configured to be powered by the RPT device, (t) a heat and moisture exchanger (HMX) may be positioned on the plenum chamber or the connection port and between the seal-forming structure and the vent structure along a flow path from the sealforming structure to the vent structure such that the HMX is exposed to the flow of air at the therapeutic pressure to absorb heat and moisture from exhaled gases from the patient in use, (u) the HMX may be fluidly connected to the vaporizer to transport water absorbed from exhaled gases from the patient to the vaporizer, (v) the vaporizer may be permanently attached to the plenum chamber or the vaporizer may be removably attached to the plenum chamber, and / or (w) the vaporizer may be permanently attached to the connection port or the vaporizer may be removably attached to the connection port.

[0071] An aspect of the present technology is directed to a vaporizing device for use with a respiratory pressure therapy (RPT) device comprising a blower to pressurize a flow of air to a therapeutic pressure above atmospheric pressure to treat a respiratory disorder. The vaporizing device comprising: a vaporization device comprising: a vaporization module comprising a vaporizer configured to contain water and a heating element configured to heat the vaporizer to vaporize water contained in the vaporizer; and a reservoir attached to the vaporization module above the vaporization module in an operational orientation, and the reservoir being configured to store water in fluid contact with the vaporizer to provide water via gravity to the vaporizer for vaporization during use; a vaporization passage configured to direct the flow of air at the therapeutic pressure through the vaporization device, and the vaporizer being exposed to the flow of air at the therapeutic pressure within the vaporization passage; an inlet tube configured to receive the flow of air at the therapeutic pressure pressurized by the blower and direct the flow of air at the therapeutic pressure into the vaporization passage; and an outlet tube configured to receive the humidified flow of air at the therapeutic pressure from the vaporization passage and direct the humidified flow of air at the therapeutic pressure to a patient interface.

[0072] An aspect of the present technology is directed to a vaporizing device for use with a respiratory pressure therapy (RPT) device comprising a blower to pressurize a flow of air to a therapeutic pressure above atmospheric pressure to treat a respiratory disorder. The vaporizing device comprising: a vaporization device comprising: a vaporization module comprising a vaporizer and a heating element; and a reservoir attached to the vaporization module, and the reservoir being configured to store water; and a vaporization passage configured to direct the flow of air at the therapeutic pressure through the vaporization device.

[0073] In examples of the aspects of the two preceding paragraphs: (a) the vaporization module may be positioned above the vaporization passage in the operational orientation such that vaporized water from the vaporizer travels downward into the to the flow of air at the therapeutic pressure within the vaporization passage, (b) the reservoir and the vaporization module may be permanently or removably attached, (c) the vaporization passage and the vaporization module may be permanently or removably attached, (d) the vaporization module may not include a wicking material, (e) the reservoir may be constructed from rubber or polymer and may be configured to collapse when empty or filled to less than a maximum volume, (f) the vaporizer may comprise a first porous material configured to contain water and thermally connected to the heating element to be heated by the heating element to vaporize water in the porous material, (g) the first porous material may be any one of ceramic, metal, sintered metal, quartz, a polymer, or a fibrous material, (h) the first porous material may be structured to transport water via capillary force, (i) the vaporizer may comprise a second porous material configured to contain water and fluidly connected to the first porous material to transport water from the second porous material to the first porous material, (j) the second porous material may be any one of ceramic, metal, sintered metal, quartz, a polymer, or a fibrous material, (k) the second porous material may be structured to transport water via capillary force, (1) the heating element may be an electric resistance heater, (m) a power supply may be configured to power the heating element, (n) the power supply may be a battery, and / or (o) the heating element may be configured to be electrically connected to the RPT device to power the heating element.

[0074] An aspect of the present technology is directed to a respiratory pressure therapy(RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the RPT system comprising: a component that at least partly forms a passage for the flow of air at the therapeutic pressure, the component being one of the patient interface configured to direct theflow of air at the therapeutic pressure to the patient, a flow generator comprising a blower to pressurize the flow of air to the therapeutic pressure, an air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, or a humidifier comprising a water reservoir and a heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure; and a vaporization device comprising: a vaporization module comprising a vaporizer configured to contain water and a heating element configured to heat the vaporizer to vaporize water contained in the vaporizer; and a reservoir attached to the vaporization module, and the reservoir being configured to store water and provide water to the vaporizer for vaporization during use, wherein at least a portion of the vaporizer is exposed to the passage for the flow of air at the therapeutic pressure.

[0075] An aspect of the present technology is directed to a respiratory pressure therapy (RPT) system comprising: a component that at least partly forms a passage, the component being one of a patient interface, a flow generator, an air circuit, or a humidifier; and a vaporization device comprising: a vaporization module comprising a vaporizer and a heating element; and a reservoir attached to the vaporization module.

[0076] In examples of the aspects of the two preceding paragraphs: (a) the component may be one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, or the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, and the RPT system may further comprise the others of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, and the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface that are not the component, (b) the humidifier may be included and comprise the water reservoir and the heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure, (c) a first sensor may be positioned on the component upstream relative to the vaporization device along the passage for the flow of air at the therapeutic pressure, the first sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the first sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the vaporization device or a controller external of thevaporization device, (d) a second sensor may be positioned on the component downstream relative to the vaporization device along the passage for the flow of air at the therapeutic pressure, the second sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the second sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the vaporization device or a controller external of the vaporization device, (e) a heat and moisture exchanger (HMX) may be exposed to the flow of air at the therapeutic pressure to absorb heat and moisture from exhaled gases from the patient in use, (f) the HMX may be positioned upstream relative to the vaporization device along the passage for the flow of air at the therapeutic pressure to desorb moisture into the flow of air at the therapeutic pressure before the flow of air at the therapeutic pressure reaches the vaporization device, (g) the first sensor may be positioned between the HMX and the vaporization device along the passage for the flow of air at the therapeutic pressure, (h) a third sensor may be positioned on the component upstream relative to the HMX along the passage for the flow of air at the therapeutic pressure, the third sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the third sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the vaporization device or a controller external of the vaporization device, (i) a vent may be positioned on the component upstream relative to the HMX along the passage for the flow of air at the therapeutic pressure, the vent being configured to allow air from with the component to travel to atmosphere (j) the vent may be configured to at least one of: open and / or close in response to the air flowing through the component; open and / or close or in response to a characteristic of the air flowing through the component; open when the user exhales and / or when the heating element is powered off and close when the patient inhales and / or when the heating element is powered on; and open or close based on the humidity of the air flowing through the component, (k) the vent may comprise or more holes that remains open to atmosphere continuously throughout the patient’s breathing cycle, (1) the vaporization device may further comprise a heat sink thermally connected to the vaporizer to absorb heat from the vaporizer and release heat into the flow of air at the therapeutic pressure in the passage, (m) the heat sink may be positioned within the passage for the flow of air at the therapeutic pressure, (n) the entire vaporization device may be positioned within the passage for the flow of air at thetherapeutic pressure, (o) the vaporizer may comprise a first surface through which water is vaporized into the flow of air at the therapeutic pressure and a second surface spaced from the first surface, and the heat sink being positioned on the second surface, (p) the heat sink may be constructed from metal, (q) the heat sink may comprise a plurality of fins, (r) the vaporization device may comprise a bridge that thermally connects the vaporizer and the heat sink to transfer heat from the vaporizer to the heat sink, (s) the bridge may be constructed from metal, (t) the bridge may be positioned upstream relative to the HMX along the passage for the flow of air at the therapeutic pressure, (u) the first sensor may be positioned upstream relative to the HMX along the passage for the flow of air at the therapeutic pressure, (v) the first sensor may be positioned proximal to the heat sink, (w) a recirculation passage from the patient interface to the HMX that is separate from the air circuit may be included, and the recirculation passage being configured to direct the flow of air at the therapeutic pressure to the HMX, and / or (x) the recirculation path may not include a vent.

[0077] An aspect of the present technology is directed to a patient interface comprising: a plenum chamber pressurisable to a therapeutic pressure of at least 6 cmH20 above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient; a seal-forming structure constructed and arranged to seal with a region of the patient’s face surrounding an entrance to the patient’s airways, the seal-forming structure having a hole therein such that the flow of air at the therapeutic pressure is delivered to at least an entrance to the patient’s nares, and the seal-forming structure constructed and arranged to maintain the therapeutic pressure in the plenum chamber throughout the patient’s respiratory cycle in use; 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, the positioning and stabilising structure comprising a tie, the tie being constructed and arranged so that at least a portion overlies a region of the patient’s head superior to an otobasion superior of the patient’s head in use; a connection port configured to be connected to an air circuit to receive the flow of air at the therapeutic pressure and direct the flow of air at the therapeutic pressure to the plenum chamber for breathing by the patient; a cartridge assembly coupled to the plenum chamber or the connection port and comprising: a reservoir configured to contain a liquid; and a vaporizer in fluid communication with the reservoir to receive the liquid from the reservoir, the vaporizer being configured to contain the liquid, and the vaporizer comprising a heating element configured to vaporize water contained in the vaporizer; and a vent structure comprising one or more vent holes configured to allow a continuous flow of gases exhaled bythe patient from an interior of the plenum chamber to ambient, the one or more vent holes being sized and shaped to maintain the therapeutic pressure in the plenum chamber in use; wherein the patient interface is configured to leave the patient’s mouth uncovered, or if the seal -forming structure is configured to seal around the patient’s nose and mouth, the patient interface is configured to allow the patient to breath from ambient in the absence of a flow of pressurised air through the plenum chamber inlet port.

[0078] An aspect of the present technology is directed to a patient interface comprising: a plenum chamber; a seal-forming structure; a positioning and stabilising structure; a connection port; a cartridge assembly comprising: a reservoir; and a vaporizer comprising a heating element configured to vaporize water contained in the vaporizer; and a vent structure.

[0079] In examples of the aspects of the two preceding paragraphs: (a) the cartridge assembly may be removably coupled to the plenum chamber such that at least a portion of the vaporizer is positioned inside the plenum chamber to vaporize water into the flow of air at the therapeutic pressure in the plenum chamber, (b) the cartridge assembly may be removably coupled to the connection port such that at least a portion of the vaporizer is positioned inside the connection port to vaporize water into the flow of air at the therapeutic pressure in the plenum chamber, (c) a first sensor may be positioned on the plenum chamber and exposed to the interior of the plenum chamber to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the plenum chamber, (d) a second sensor may be positioned on the connection port and exposed to the interior of the connection port to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the connection port, (e) the positioning and stabilizing structure may comprise a pair of tubes, each of the tubes being fluidly connected at a distal end to the connection port and at a proximal end to the plenum chamber to direct the flow of air at the therapeutic pressure to the plenum chamber for breathing by the patient, and a third sensor may be positioned on at least one of the tubes and is exposed to the interior of the corresponding tube to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the corresponding tube, (f) at least one of a porous wicking material, an aerogel, or a hydrogel may be positioned inside the reservoir to store the liquid, (g) the reservoir may be permanently attached to the vaporizer or the reservoir is removably attached to the vaporizer, (h) the reservoir may be constructed from rubber or polymer and is configured to collapse when empty or filled to less than a maximum volume, (i) the cartridge assembly may be configured to be removably coupled to the plenum chamber or the connection port with a snap fit or a friction fit, (j) the vaporizer may comprisea first porous material configured to contain water and thermally connected to the heating element to be heated by the heating element to vaporize water in the first porous material, (k) the first porous material may be any one of ceramic, metal, sintered metal, quartz, a polymer, or a fibrous material, (1) the first porous material may be structured to transport water via capillary force, (m) the vaporizer may comprise a second porous material configured to contain water and fluidly connected to the first porous material to transport water from the second porous material to the first porous material, (n) the second porous material may be any one of ceramic, metal, sintered metal, quartz, a polymer, or a fibrous material, (o) the second porous material may be structured to transport water via capillary force, (p) the heating element may be an electric resistance heater, (q) a power supply may be configured to power the heating element, (r) the power supply may be a battery, (s) the heating element may be configured to be electrically connected to an RPT device comprising a blower to pressurize the flow of air to the therapeutic pressure, and the heating element being configured to be powered by the RPT device, (t) a heat and moisture exchanger (HMX) may be positioned on the plenum chamber or the connection port and between the seal-forming structure and the vent structure along a flow path from the seal-forming structure to the vent structure such that the HMX is exposed to the flow of air at the therapeutic pressure to absorb heat and moisture from exhaled gases from the patient in use, (u) the HMX may be fluidly connected to the vaporizer to transport water absorbed from exhaled gases from the patient to the vaporizer, (v) the plenum chamber or the connection port may comprise an opening, and the cartridge assembly being configured to be removably coupled to the plenum chamber or the connection port at the opening, and at least one seal may be configured to seal between the cartridge assembly and the plenum chamber or the connection port, (w) the at least one seal may be positioned on the cartridge assembly, the at least one seal may be positioned on the plenum chamber or the connection port, or a first seal may be positioned on the cartridge assembly and a second seal is positioned on the plenum chamber or the connection port, (x) the cartridge assembly is removably coupled to the plenum chamber or the connection port, or the cartridge assembly may be permanently coupled to the plenum chamber or the connection port.

[0080] An aspect of the present technology is directed to a respiratory pressure therapy (RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the RPT system comprising: a component that at least partly forms a passage for the flow of air at the therapeutic pressure, the component being one of the patient interface configured to direct theflow of air at the therapeutic pressure to the patient, a flow generator comprising a blower to pressurize the flow of air to the therapeutic pressure, an air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, or a humidifier comprising a water reservoir and a heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure; and a first cartridge assembly coupled to the component and comprising: a first reservoir configured to contain a first liquid; and a first vaporizer in fluid communication with the first reservoir to receive the first liquid from the first reservoir, the first vaporizer being configured to contain the first liquid, and the first vaporizer comprising a first heating element configured to heat the first vaporizer to vaporize the first liquid contained in the first vaporizer; wherein at least a portion of the first vaporizer is exposed to the passage for the flow of air at the therapeutic pressure.

[0081] An aspect of the present technology is directed to a respiratory pressure therapy (RPT) system comprising: a component that at least partly forms a passage for the flow of air; and a first cartridge assembly coupled to the component and comprising: a first reservoir; and a first vaporizer comprising a first heating element configured to heat the first vaporizer to vaporize the first liquid contained in the first vaporizer.

[0082] In examples of the aspects of the two preceding paragraphs: (a) the component is one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, or the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, and wherein the RPT system may comprise the others of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, and the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface that are not the component, (b) the humidifier may comprise the water reservoir and the heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure, (c) a first sensor may be positioned on the component upstream relative to the first cartridge assembly along the passage for the flow of air at the therapeutic pressure, the first sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the first sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the first cartridge assembly or a controller external of the first cartridgeassembly, (d) a second sensor may be positioned on the component downstream relative to the first cartridge assembly along the passage for the flow of air at the therapeutic pressure, the second sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the second sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the first cartridge assembly or a controller external of the first cartridge assembly, (e) the first cartridge assembly may be removably coupled to the component, or the first cartridge assembly may be permanently coupled to the component, (f) at least one of a porous wicking material, an aerogel, or a hydrogel may be positioned inside the first reservoir to store the first liquid, (g) a surface of the first vaporizer may be exposed to the flow of air in the passage is approximately flush with a surface of the component that is adjacent to the first vaporizer, (h) a surface of the first vaporizer may be exposed to the flow of air in the passage extends above a surface of the component that is adjacent to the first vaporizer and extends into the passage, (i) the first cartridge assembly may be removably coupled to the component, or the first cartridge assembly may be permanently coupled to the component, (j) a reservoir may be attached to the component, and the reservoir being configured to capture excess of the first liquid that is not absorbed into the flow of air at the therapeutic pressure, (h) a second cartridge assembly may be coupled to the component and may comprise: a second reservoir configured to contain a second liquid; and a second vaporizer in fluid communication with the second reservoir to receive the second liquid from the second reservoir, the second vaporizer being configured to contain the second liquid, and the second vaporizer comprising a second heating element configured to heat the second vaporizer to vaporize the second liquid contained in the second vaporizer; wherein at least a portion of the second vaporizer is exposed to the passage for the flow of air at the therapeutic pressure.

[0083] An aspect of the present technology is directed to a cartridge assembly for a respiratory pressure therapy (RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the cartridge assembly comprising: a reservoir configured to contain a liquid; and a vaporizer in fluid communication with the reservoir to receive the liquid from the reservoir, the vaporizer being configured to contain the liquid, and the vaporizer comprising a heating element configured to vaporize water contained in the vaporizer.

[0084] In examples of the aspects of the preceding paragraph: (a) at least one of a porous wicking material, an aerogel, or a hydrogel may be positioned inside the reservoir to store the liquid, (b) the reservoir may be constructed from rubber or polymer and is configured to collapse when empty or filled to less than a maximum volume, (c) the cartridge assembly may be configured to be removably coupled to a plenum chamber or a connection port of a patient interface of the RPT system with a snap fit or a friction fit, (d) the plenum chamber or the connection port may comprises an opening, and the cartridge assembly may be configured to be removably coupled to the plenum chamber or the connection port at the opening, (e) at least one seal may be configured to seal between the cartridge assembly and the plenum chamber or the connection port, (f) the at least one seal may be positioned on the cartridge assembly, (g) the vaporizer may comprise a first porous material configured to contain water and thermally connected to the heating element to be heated by the heating element to vaporize water in the first porous material, (h) the first porous material may be any one of ceramic, metal, sintered metal, quartz, a polymer, or a fibrous material, (i) the first porous material may be structured to transport water via capillary force, (j) the vaporizer may comprise a second porous material configured to contain water and fluidly connected to the first porous material to transport water from the second porous material to the first porous material, (k) the second porous material may be any one of ceramic, metal, sintered metal, quartz, a polymer, or a fibrous material, (1) the second porous material may be structured to transport water via capillary force, (m) the heating element may be an electric resistance heater.

[0085] An aspect of the present technology is directed to a respiratory pressure therapy (RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the RPT system comprising: a component that at least partly forms a passage for the flow of air at the therapeutic pressure, the component being one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, a flow generator comprising a blower to pressurize the flow of air to the therapeutic pressure, an air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, or a humidifier comprising a water reservoir and a heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure; a first cartridge assembly coupled to the component and comprising: a first reservoir configured to contain a first liquid; and a first vaporizer in fluid communication with the first reservoir to receive the first liquid from the first reservoir, the first vaporizer being configured to contain the firstliquid, and the first vaporizer comprising a first heating element configured to heat the first vaporizer to vaporize the first liquid contained in the first vaporizer; a vaporizer sensor positioned on or proximal to the first vaporizer and configured to detect a physical phenomenon and generate a first signal indicative of a first parameter; and a controller configured to receive the first signal from the vaporizer sensor, the controller configured to determine whether the first parameter exceeds a predetermined threshold, wherein at least a portion of the first vaporizer is exposed to the passage for the flow of air at the therapeutic pressure.

[0086] An aspect of the present technology is directed to a respiratory pressure therapy (RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the RPT system comprising: a component that at least partly forms a passage for the flow of air at the therapeutic pressure; a first cartridge assembly coupled to the component and comprising: a first reservoir configured to contain a first liquid; and a first vaporizer in fluid communication with the first reservoir; a vaporizer sensor; and a controller.

[0087] In examples of the aspects of the two preceding paragraphs: (a) the component may be one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, or the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, and the RPT system may comprise the others of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, and the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface that are not the component, (b) the humidifier may comprise the water reservoir and the heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure, (c) a first sensor may be positioned on the component upstream relative to the first cartridge assembly along the passage for the flow of air at the therapeutic pressure, the first sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the first sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressureinside the passage to the first cartridge assembly or a controller external of the first cartridge assembly, (d) a second sensor may be positioned on the component downstream relative to the first cartridge assembly along the passage for the flow of air at the therapeutic pressure, the second sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the second sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the first cartridge assembly or a controller external of the first cartridge assembly, (e) the first cartridge assembly may be removably coupled to the component, or the first cartridge assembly may be permanently coupled to the component, (f) the first cartridge assembly may be removably coupled to the component, or the first cartridge assembly may be permanently coupled to the component, (g) the physical phenomenon may include one or more of temperature, presence or absence of moisture, weight, light, electrical power, and time, (h) the controller may be configured to instruct the first heating element to generate heat in response to a determination that the first parameter exceeded the predetermined threshold, (i) the controller may be configured to cause a notification to be generated in response to a determination that the first parameter exceeded the predetermined threshold, (j) the vaporizer sensor may be configured to repeatedly generate the first signal during therapy, (k) the controller may be configured to receive the first signal from the vaporizer sensor and determine whether the first parameter exceeds a predetermined threshold continuously during therapy, (1) an ultrasonic transducer may be positioned on or proximal to the first cartridge assembly or the first vaporizer, and the ultrasonic transducer being configured to vibrate in response to an instruction from the controller, and / or (m) the controller may be configured to trigger the instruction based on determination that the first parameter exceeded the predetermined threshold.

[0088] An aspect of the present technology is directed to a respiratory pressure therapy (RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the RPT system comprising: a component that at least partly forms a passage for the flow of air at the therapeutic pressure, the component being one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, a flow generator comprising a blower to pressurize the flow of air to the therapeutic pressure, an air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, or a humidifier comprising a water reservoir and a heater plate configured to heat water stored inthe water reservoir to humidify the flow of air at the therapeutic pressure; a vaporization device comprising: a vaporization module comprising a vaporizer configured to contain water and a heating element configured to heat the vaporizer to vaporize water contained in the vaporizer; and a reservoir attached to the vaporization module, and the reservoir being configured to store water and provide water to the vaporizer for vaporization during use; a vaporizer sensor positioned on or proximal to the vaporizer and configured to measure a physical phenomenon and generate a first signal indicative of a first parameter; and a controller configured to receive the first signal from the vaporizer sensor, the controller being configured to determine whether the first parameter exceeds a predetermined threshold, wherein at least a portion of the vaporizer is exposed to the passage for the flow of air at the therapeutic pressure.

[0089] An aspect of the present technology is directed to a respiratory pressure therapy (RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the RPT system comprising: a component that at least partly forms a passage for the flow of air at the therapeutic pressure; a vaporization device comprising: a vaporization module comprising a vaporizer configured to contain water and a heating element; and a reservoir attached to the vaporization module; a vaporizer sensor; and a controller.

[0090] In examples of the aspects of the two preceding paragraphs: (a) the component may be one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, or the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, and the RPT system may comprise the others of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, and the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface that are not the component, (b) the humidifier may comprise the water reservoir and the heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure, (c) a first sensor may be positioned on the component upstream relative to the vaporization device along the passage for the flow of air at the therapeutic pressure, the first sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the first sensor being configured to communicate the detectedpressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the vaporization device or a controller external of the vaporization device, (d) a second sensor may be positioned on the component downstream relative to the vaporization device along the passage for the flow of air at the therapeutic pressure, the second sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the second sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the vaporization device or a controller external of the vaporization device, (e) the physical phenomenon includes one or more of temperature, presence or absence of moisture, weight, light, electrical power, and time, (f) the controller may be configured to instruct the heating element to generate heat in response to a determination that the first parameter exceeded the predetermined threshold, (g) the controller may be configured to instruct the RPT system to generate a notification in response to a determination that the first parameter exceeded the predetermined threshold, (h) the vaporizer sensor may be configured to measure the physical phenomenon and generate the first signal repeatedly during therapy, (i) the controller may be configured to receive the first signal from the vaporizer sensor and determine whether the first parameter exceeds a predetermined threshold repeatedly during therapy, (j) an ultrasonic transducer may be positioned on or proximal to the vaporizer, and the ultrasonic transducer being configured to vibrate in response to an instruction from the controller, and / or (k) the controller may be configured to trigger the instruction based on determination that the first parameter exceeded the predetermined threshold.

[0091] An aspect of the present technology is directed to a method facilitating cleaning of a respiratory pressure therapy (RPT) system, the method comprising: supplying a flow of air at a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder; vaporizing, using a vaporizer, a liquid into the flow of air; detecting a physical phenomenon using a sensor that is positioned on or proximal to the vaporizer; generating a first signal indicative of a first parameter that is associated with the physical phenomenon; determining, using at least one processor and based on the first signal, whether the first parameter exceeds a predetermined threshold; and in response to determination that the first parameter exceeds a predetermined threshold, triggering a responsive action.

[0092] An aspect of the present technology is directed to a method of facilitating cleaning of a respiratory pressure therapy (RPT) system, the method comprising: supplying a flow of air at a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder; vaporizing, using a vaporizer, a liquid into the flow of air; detecting a physical phenomenon using a sensor that is positioned on or proximal to the vaporizer; generating a first signal indicative of a first parameter that is associated with the physical phenomenon; determining, using at least one processor and based on the first signal, whether the first parameter exceeds a predetermined threshold; and in response to determination that the first parameter exceeds a predetermined threshold, triggering a responsive action.

[0093] In examples of the aspect of the preceding paragraph: (a) the physical phenomenon may include one or more of temperature, presence or absence of moisture, weight, light, electrical power, and time, (b) the responsive action may include causing an increase in heat generated by the vaporizer, (c), the responsive action may include generating a notification, (d) the method may comprise repeatedly generating the first signal and detecting the physical phenomenon, (e) the method may comprise repeatedly determining whether the first parameter exceeds the predetermined threshold during therapy, (f) the RPT system may comprise an ultrasonic transducer positioned on or proximal to the vaporizer, and the responsive action may include causing the ultrasonic transducer to vibrate.

[0094] Another aspect of one form of the present technology is a patient interface that is moulded or otherwise constructed with a perimeter shape which is complementary to that of an intended wearer.

[0095] An aspect of one form of the present technology is a method of manufacturing apparatus.

[0096] Another aspect of one form of the present technology is a method of assembling a modular system comprising selecting a positioning and stabilising structure, and connecting the positioning and stabilising structure to either a first cushion or a second cushion.

[0097] 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.

[0098] 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.

[0099] 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 cleaningequipment. 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.

[0100] The methods, systems, devices and apparatus described may be implemented so as to improve the functionality of a processor, such as a processor of a specific purpose computer, respiratory monitor and / or a respiratory therapy apparatus. Moreover, the described methods, systems, devices and apparatus can provide improvements in the technological field of automated management, monitoring and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0101] 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.

[0102] 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

[0103] 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:4. 1 RESPIRATORY THERAPY SYSTEMS

[0104] Figs. 1A and IB each illustrate various configurations of a respiratory therapy system in use.4.2 RESPIRATORY SYSTEM AND FACIAL ANATOMY

[0105] Fig. 2A shows an overview of a human respiratory system including the nasal and oral cavities, the larynx, vocal folds, oesophagus, trachea, bronchus, lung, alveolar sacs, heart and diaphragm.

[0106] Fig. 2B 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.

[0107] Fig. 2C is a front view of a face with several features of surface anatomy identified including the lip superior, upper vermilion, lower vermilion, lip inferior, mouth width, endocanthion, a nasal ala, nasolabial sulcus and cheilion. Also indicated are the directions superior, inferior, radially inward and radially outward.

[0108] Fig. 2D is a side view of a head with several features of surface anatomy identified including glabella, sellion, pronasale, subnasale, lip superior, lip inferior, supramenton, nasal ridge, alar crest point, otobasion superior and otobasion inferior. Also indicated are the directions superior & inferior, and anterior & posterior.

[0109] Fig. 2E is a further side view of a head. The approximate locations of the Frankfort horizontal and nasolabial angle are indicated. The coronal plane is also indicated.

[0110] Fig. 2F shows a base view of a nose with several features identified including naso-labial sulcus, lip inferior, upper Vermilion, naris, subnasale, columella, pronasale, the major axis of a naris and the midsagittal plane.

[0111] Fig. 2G shows a side view of the superficial features of a nose.

[0112] Fig. 2H shows subcutaneal structures of the nose, including lateral cartilage, septum cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla and fibrofatty tissue.

[0113] Fig. 21 shows a medial dissection of a nose, approximately several millimeters from the midsagittal plane, amongst other things showing the septum cartilage and medial crus of greater alar cartilage.

[0114] Fig. 2J shows a front view of the bones of a skull including the frontal, nasal and zygomatic bones. Nasal concha are indicated, as are the maxilla, and mandible.

[0115] Fig. 2K shows a lateral view of a skull with the outline of the surface of a head, as well as several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal and occipital. The mental protuberance is indicated. The following muscles are shown: digastricus, masseter, sternocleidomastoid and trapezius.

[0116] Fig. 2L shows an anterolateral view of a nose.4.3 PATIENT INTERFACE

[0117] Fig. 3 A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.

[0118] Fig. 3B shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively large magnitude when compared to the magnitude of the curvature shown in Fig. 3C.

[0119] Fig. 3C shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a positive sign, and a relatively small magnitude when compared to the magnitude of the curvature shown in Fig. 3B.

[0120] Fig. 3D shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a value of zero.

[0121] Fig. 3E shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively small magnitude when compared to the magnitude of the curvature shown in Fig. 3F.

[0122] Fig. 3F shows a schematic of a cross-section through a structure at a point. An outward normal at the point is indicated. The curvature at the point has a negative sign, and a relatively large magnitude when compared to the magnitude of the curvature shown in Fig. 3E.

[0123] Fig. 3G shows a cushion for a mask that includes two pillows. An exterior surface of the cushion is indicated. An edge of the surface is indicated. Dome and saddle regions are indicated.

[0124] Fig. 3H shows a cushion for a mask. An exterior surface of the cushion is indicated. An edge of the surface is indicated. A path on the surface between points A and B is indicated. A straight line distance between A and B is indicated. Two saddle regions and a dome region are indicated.

[0125] Fig. 31 shows the surface of a structure, with a one dimensional hole in the surface. The illustrated plane curve forms the boundary of a one dimensional hole.

[0126] Fig. 3J shows a cross-section through the structure of Fig.31. The illustrated surface bounds a two dimensional hole in the structure of Fig. 31.

[0127] Fig. 3K shows a perspective view of the structure of Fig. 31, including the two dimensional hole and the one dimensional hole. Also shown is the surface that bounds a two dimensional hole in the structure of Fig. 31.

[0128] Fig. 3L shows a mask having an inflatable bladder as a cushion.

[0129] Fig. 3M shows a cross-section through the mask of Fig. 3L, and shows the interior surface of the bladder. The interior surface bounds the two dimensional hole in the mask.

[0130] Fig. 3N shows a further cross-section through the mask of Fig. 3L. The interior surface is also indicated.

[0131] Fig. 30 illustrates a left-hand rule.

[0132] Fig. 3P illustrates a right-hand rule.

[0133] Fig. 3Q shows a left ear, including the left ear helix.

[0134] Fig. 3R shows a right ear, including the right ear helix.

[0135] Fig. 3S shows a right-hand helix.

[0136] Fig. 3T shows a view of a mask, including the sign of the torsion of the space curve defined by the edge of the sealing membrane in different regions of the mask.

[0137] Fig. 4A shows a patient interface in the form of a nasal mask in accordance with one form of the present technology.

[0138] Fig. 4B shows a patient interface in the form of a nasal cannula in accordance with one form of the present technology.

[0139] Fig. 4C shows a patient interface having conduit headgear, in accordance with one form of the present technology.4.4 RPT DEVICE

[0140] Fig. 5A shows an RPT device in accordance with one form of the present technology.

[0141] Fig. 5B 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.4.5 HUMIDIFIER

[0142] Fig. 6A shows an isometric view of a humidifier in accordance with one form of the present technology.

[0143] Fig. 6B shows an isometric view of a humidifier in accordance with one form of the present technology, showing a humidifier reservoir 5110 removed from the humidifier reservoir dock 5130.

[0144] Fig. 6C shows a schematic of a humidifier in accordance with one form of the present technology.4.6 BREATHING WAVEFORMS

[0145] Fig. 7A shows a model typical breath waveform of a person while sleeping.

[0146] Fig. 7B shows selected polysomnography channels (pulse oximetry, flow rate, thoracic movement, and abdominal movement) of a patient during non-REM sleep breathing normally over a period of about ninety seconds.

[0147] Fig. 7C shows polysomnography of a patient before treatment.4.7 EXAMPLES OF PATIENT INTERFACE AND VAPORIZATION DEVICE

[0148] Fig. 8A is a front view of a patient wearing a heads-up configuration of a patient interface.

[0149] Fig. 8B is a front view of a patient wearing a tube-down configuration of a patient interface.

[0150] Fig . 8C is a front view of a patient wearing a tube-up configuration of a patient interface.

[0151] Fig. 8D is a front view of a patient wearing an alternative tube-down configuration of a patient interface.

[0152] Fig. 9A is a top-down view of an exemplary configuration of a vaporization device.

[0153] Fig. 9B is a side view of the vaporization device shown in Fig. 9A.

[0154] Fig. 10 is an exemplary schematic of an alternative vaporization device.

[0155] Fig. 11 is another exemplary schematic of an alternative vaporization device.

[0156] Fig. 12 is another exemplary schematic of an alternative vaporization device.

[0157] Fig. 13 is an exemplary schematic of a further alternative vaporization device.

[0158] Fig. 14 is an exemplary schematic of a further alternative vaporization device.

[0159] Fig. 15 is a schematic of an exemplary configuration of a cartridge module.

[0160] Fig. 16 is a schematic of an alternative exemplary configuration of a cartridge module.

[0161] Fig. 17 is a schematic of an exemplary configuration of an alternative cartridge module.

[0162] Fig. 18 is a schematic of an exemplary configuration of a vaporization device cartridge module that may include a sensor and / or an ultrasonic transducer.

[0163] Fig. 19 is a schematic of a vaporization device that may include a sensor and / or an ultrasonic transducer.

[0164] Fig. 20 is a graph depicting power applied to a vaporization device on the x-axis and temperature of the vaporization device on the y-axis.

[0165] Fig. 21 is a flow chart depicting data monitoring and cleaning functions for a vaporization device.5 DETAILED DESCRIPTION OF EXAMPLES OF THE TECHNOLOGY

[0166] 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 mayvary. 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.

[0167] 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

[0168] In one form, the present technology comprises a method for treating a respiratory disorder comprising applying positive pressure to the entrance of the airways of a patient 1000.

[0169] In certain 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.

[0170] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.5.2 RESPIRATORY THERAPY SYSTEMS

[0171] In one form, the present technology comprises a respiratory therapy system for treating a respiratory disorder. The respiratory therapy system may comprise an RPT device 4000 for supplying a flow of air to the patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0172] Fig. 1A shows a respiratory therapy system including a patient 1000 wearing a patient interface 3000, in the form of nasal mask, receiving a supply of air at positive pressure from an RPT device 4000. In some examples, air from the RPT device 4000 is humidified in a conventional humidifier 5000, and passes along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient is sleeping in a supine sleeping position. As will be discussed in further detail below, an alternative to humidifier 5000 may be used in some examples.

[0173] For example, as will be discussed in further detail below, the respiratory therapy system may include a vaporization device 1105 instead of or in addition to a conventional humidifier 5000 for humidifying the pressurized flow of air. The vaporization device 1105 may be coupled to one or more components of the respiratory therapy system so that it is exposed to the pressurized flow of air to increase humidity in the pressurized flow of air. Vaporization device 1105 may include a capillary force vaporizer or a heating element tovaporize liquid, e.g., water and / or other substances such as medication, stored in the vaporization device 1105 or elsewhere in the respiratory therapy system. The vaporization device 1105 may be configured to vaporize liquid, e.g., water and / or other substances such as medication, in order to introduce the vaporized liquid and / or other substances into the pressurized air flow. Vaporization device 1105 may further include a reservoir that stores the liquid, e.g., water and / or other substances such as medication, to be vaporized during therapy. Alternatively, or additionally, the respiratory therapy system may include a reservoir for the liquid that is separate from the vaporization device 1105 and fluidly connected thereto. The vaporization device 1105 may be able to vaporize the liquid more efficiently than a conventional humidifier 5000, and therefore the vaporization device 1105 may be able to function with a smaller reservoir as compared to a conventional humidifier 5000. That is, the amount of liquid required to adequately humidify pressurized air for the entire duration of a night’s sleep, or other therapy period, is less than what a conventional humidifier 5000 requires because the vaporization device 1105 is capable of more precisely and efficiently vaporizing liquid in correlation with what is intended by the clinician and / or the patient. Accordingly, vaporization device 1105 may be substantially smaller in terms of volume, internal and / or external, and whether it is integrated with or separate from the vaporization device 1105, compared to the reservoir of a conventional humidifier 5000.

[0174] Conventional positive airway pressure (PAP) systems may utilize a pass over humidification system, which typically includes a water reservoir. Water in the water reservoir is heated to a warm, but not boiling, temperature, and the increased warmth from heating accelerates evaporation beyond what would otherwise occur in ambient conditions to humidify pressurized air as it passes through the reservoir and over the heated water. Conventional humidifiers of the pass-over type function by keeping a reservoir of water constantly heated, which requires a substantial amount of water, since water is constantly being lost to evaporation (e.g., regardless of breathing phase of the patient because humidifying pressurized air may not be necessary during the exhalation phase when the patient would not be exposed to the added humidity, also because in many therapy types there is continuous venting of the pressurized air to atmosphere so that exhaled carbon dioxide does not build up within the system). Further, the constant heating of water throughout the therapy period (e.g., eight hours of sleep) requires constantly energizing the heating element, and there is a longer start-up time (i.e., time to reach temperature within the humidifier before evaporation occurs at the desired rate) when turning on the humidifier due to the larger thermal mass. Maintaining a larger reservoir of water also increases the likelihood of spills,as compared to a smaller reservoir. Furthermore, a larger volume of water is more capable of damaging components of the respiratory therapy system, if spilled, as compared to a smaller volume. Thus, conventional humidifiers are also sized beyond the volume of water intended to be carried to include structures that prevent, or at least limit, the amount of water that can escape the reservoir if moved out of the intended operational orientation, e.g., accidentally knocked off of a nightstand. By comparison, the vaporization device 1105, may require a significantly smaller reservoir as a result of its efficient, and the much higher temperatures that the vaporization device 1105, as compared to conventional humidifiers, can achieve may also necessitate a much smaller volume of water to provided adequate humidity for an entire therapy period.

[0175] The vaporization device 1105 may convert a liquid into a vapor or gas form, which is then distributed into the pressurized air flow of a respiratory therapy system for inhalation by the patient. Vaporization device 1105 may be more efficient in increasing humidity levels as compared to conventional pass-over humidifiers, because vaporizers may disperse moisture more quickly, increasing humidity levels faster. The vaporization device 1105 is designed to increase or maximize the surface area to volume ratio between the heating element of vaporization device 1105 and the water. As a result, humidification may occur at much greater speeds when using vaporization device 1105. Further, the smaller footprint of vaporization device 1105, relative to conventional humidifiers, may allow for quicker start-up time of the vaporizer (e.g., on the order of tens or hundreds of milliseconds). As a result, vaporization device 1105 may be turned on and off quickly so that use of vaporization device 1105 is timed with a patient’s breathing. In other words, vaporization device 1105 may only be turned on to vaporize liquid when the system detects inhalation or predicts that inhalation will occur, as is discussed in greater detail below. This may decrease the amount of water needed to supply vaporization device 1105, relative to conventional humidifiers, thereby allowing for use of the smaller reservoir, relative to conventional humidifiers, and may decrease, relative to conventional humidifiers, the amount of power required by the vaporization device 1105 to vaporize the liquid.

[0176] The vaporization device 1105 of the present technology is differs from a nebulizer, which converts liquid into a mist or aerosol. Nebulizers typically use ultrasonic transducers, compressed air or oxygen to break down liquid into droplets, which are then inhaled by a patient. The vaporization device 1105 of the present technology, on the other hand, may use heat to convert liquid into its gaseous state. Thus, the vaporization device 1105of the present technology operates by changing the phase of the liquid to a gas, rather than to a fine droplet mist like a nebulizers.

[0177] Vaporization device 1105 may reduce the risk of bacterial growth when compared with nebulizers or conventional pass-over humidifiers. The heating element in vaporization device 1105 may kill or inhibit the growth of microorganisms, facilitating the production of relatively clean vapor, e.g., due to the higher temperatures produced by the vaporization device 1105 during operation thus reducing cleaning maintenance.

[0178] The smaller vaporization device 1105 may be incorporated in, on, or adjacent to various components of the respiratory therapy system, for example, one or more of a patient interface, RPT device 4000, air circuit 4170, or other components. For example, as shown in FIG. 1A, vaporization device 1105 may be included in or on or coupled to a portion of the air circuit 4170. In other examples, vaporization device 1105 may be located between components of the respiratory therapy system, for example, between RPT device 4000 and air circuit 4170, or between air circuit 4170 and a patient interface 3000. Additionally, one or more sensors 1110 may be coupled to one or more components of the respiratory therapy system. The function of vaporization device 1105 may or may not be affected by data detected by one or more sensors 1110. If incorporated, one or more sensors 1110 may be incorporated on the same or different, or the same and different in the case of multiple sensors 1110, component as vaporization device 1105. As illustrated in FIG. 1A, one or more sensors 1110 may be disposed on patient interface 3000 and / or air circuit 4170. Information from one or more sensors 1110 may be used to at least partially affect the operation of vaporization device 1105, as discussed further below.

[0179] Fig. IB shows a further alternative configuration of the respiratory therapy 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. As will be discussed in further detail below, an alternative to humidifier 5000 may be used in some examples.

[0180] Additionally, as will be discussed in further detail below, the respiratory therapy system shown in Fig. IB may include vaporization device 1105. For example, vaporization device 1105 may be coupled to a portion of the air circuit 4170. Additionally, one or more sensors 1110 may be coupled to one or more components of the respiratory therapy system. As illustrated, one or more sensors 1110 may be disposed on air circuit 4170, for example,proximal and / or distal to vaporization device 1105. One or more sensors 1110 may be used to at least partially affect the operation of vaporization device 1105.

[0181] As will be discussed in greater detail below, a cartridge assembly 1120 may be used with the respiratory therapy systems shown in Figs. 1A and IB. Cartridge assembly 1120 may be configured to receive or contain a vaporization device 1105. Vaporization device 1105 may be a capillary force vaporizer configured to vaporize liquid, e.g., water, or other substances in order to introduce the vaporized liquid and / or substances into the air flow.

[0182] Cartridge assembly 1120 may include a housing that forms a reservoir that is fluidly coupled to vaporization device 1105 to provide water or another substance to vaporization device 1105 to vaporize. Vaporization device 1105 may be configured for operation with a smaller reservoir as compared to a conventional humidifier 5000 that heats water stored in a reservoir. Cartridge assembly 1120 may be used in place of a conventional humidifier 5000, or in addition to a conventional humidifier 5000, and may be coupled to one or more components of the respiratory therapy system. Cartridge assembly 1120 and vaporization device 1105 will be described in more detail below and may be substantially smaller compared to a conventional humidifier 5000. The smaller cartridge assembly 1120 may be incorporated in, on, or adjacent to various components of the respiratory therapy system, for example, one or more of a patient interface, RPT device 4000, air circuit 4170, or other components. Further, cartridge assembly 1120 and / or one or more components of cartridge assembly 1120 (e.g., vaporization device 1105 and / or an associated reservoir or filter) may be removably coupled to one or more components within the respiratory therapy system. In other examples, cartridge assembly 1120 and / or vaporization device 1105 may be removably coupled between components of the respiratory therapy system, for example, between RPT device 4000 and air circuit 4170, or between air circuit 4170 and a patient interface. The removability of cartridge assembly 1120 and / or components of cartridge assembly 1120 may facilitate replacement, cleaning, refilling, etc., of cartridge assembly 1120.

[0183] As will be discussed in further detail below, cartridge assembly 1120 may be configured to receive vaporization device 1105. Vaporization device 1105 is configured to convert a liquid into a vapor or gas form, which can be incorporated into the air flow of a respiratory therapy system for inhalation by the patient. Vaporization device 1105 may be more efficient in increasing humidity levels as compared to conventional pass-over humidifiers, because capillary force vaporizers, as an example, may disperse moisture more quickly, increasing humidity levels faster. Vaporization device 1105 is designed to increaseor maximize the surface area to volume ratio between the heating element of vaporization device 1105 and the water. As a result, humidification may occur at much greater speeds when using vaporization device 1105. Further, the smaller footprint of vaporization device 1105 and / or cartridge assembly 1120 may allow for quicker start-up time of the vaporizer (e.g., on the order of tens or hundreds of milliseconds). As a result, vaporization device 1105 may be turned on and off quickly so that use of vaporization device 1105 is timed with a patient’s breathing. In other words, vaporization device 1105 may only be turned on when a patient inhales, as is discussed in greater detail below. This may decrease the amount of water needed to supply vaporization device 1105, allowing for use of the smaller reservoir, and may decrease the amount of power needed to supply vaporization device 1105.

[0184] For example, as shown in FIG. 1A, cartridge assembly 1120 may be included in or on or coupled to a portion of the air circuit 4170. Additionally, in some examples, one or more sensors 1110 may be coupled to one or more components of the respiratory therapy system. The function of cartridge assembly 1120 may or may not be affected by data detected by one or more sensors 1110. If incorporated, one or more sensors 1110 may be incorporated on the same or different components, or the same and different components in the case of multiple sensors 1110. For example, multiple sensors 1110 may be incorporated on or in the component in which cartridge assembly 1120 is incorporated in and / or multiple sensors 1110 may be incorporated on or in the same component in which cartridge assembly 1120 is incorporated in. As illustrated in FIG. 1A, one or more sensors 1110 may be disposed on patient interface 3000 and / or air circuit 4170. Information from one or more sensors 1110 may be used to at least partially affect the operation of cartridge assembly 1120, as discussed further below.

[0185] In some examples, vaporization device 1105 may be configured to humidify the air flowing through the respiratory therapy system. Additionally or alternatively, vaporization device 1105 may be configured to deliver a substance into the air flowing through the respiratory therapy system. The substance may be a liquid, a gel, a gas, a vapor, or any combination thereof. In such a way, at least a portion of cartridge assembly 1120 and / or vaporization device 1105 may be exposed to the air flow path such that air flowing through the illustrated respiratory therapy system also flows through, in, or over vaporization device 1105.

[0186] By way of example, cartridge assembly 1120 is illustrated as being disposed along air circuit 4170, between patient interface 3000 and RPT device 4000 in Figs. 1A and IB. However, the positioning of cartridge assembly 1120 and vaporization device 1105 aremerely exemplary. For example, cartridge assembly 1120 and vaporization device 1105 may be disposed anywhere along the air flow path, such as, for example, on or within RPT device 4000, on or within air circuit 4170, and / or on or within patient interface 3000. In some examples, cartridge assembly 1120 may be disposed between components of the respiratory therapy system, for example, between RPT device 4000 and air circuit 4170, or between air circuit 4170 and a patient interface.

[0187] One or more sensors 1110 may additionally be used with the respiratory therapy systems shown in Figs. 1A and IB. The one or more sensors 1110 may be exposed to air flowing through the respiratory therapy system. In such a way, the one or more sensors 1110 may be disposed on or in any of the components comprising the respiratory therapy system. For example, in reference to Fig. IB, a first sensor 1110 may be disposed proximal to the patient relative to cartridge assembly 1120 along air circuit 4170. In referring to Fig. IB, a first sensor 1110 may be disposed proximal to the patient relative to cartridge assembly 1120. A second sensor 1110 may be disposed distal to the patient relative to cartridge assembly 1120 along the air flow path. Additional sensors (e.g., a third sensor, a fourth sensor, etc.) may be disposed elsewhere along the air flow path, proximally or distally to the patient relative to cartridge assembly 1120. Each sensor of the one or more sensors 1110 may be a temperature sensor, a humidity sensor, a pressure sensor, a flow rate sensor, etc. The one or more sensors 1110 may be configured to transmit information to RPT device 4000 and / or to cartridge assembly 1120 and / or a controller operatively coupled to cartridge assembly 1120.

[0188] The relative size, shape, and / or position of cartridge assembly 1120 and / or the one or more sensors 1110 described herein are merely exemplary. For example, cartridge assembly 1120 may be larger, and / or the one or more sensors may be positioned elsewhere along the air flow path of the respiratory therapy system. Further, multiple cartridge assemblies 1120 may be incorporated within the respiratory therapy system, either in different locations in the system or adjacent one another in the respiratory therapy system.5.3 PATIENT INTERFACE

[0189] A non-invasive patient interface 3000, such as that shown in Fig. 3A, in accordance with one aspect of the present technology comprises 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 3600 for connection to air circuit 4170, and a forehead support 3700. 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 anentrance 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.

[0190] As will be discussed in further detail below, a vaporizer 3105 may be included in, or on, or coupled to, the connection port 3600 or a decoupling structure 3500, for example, between the connection port 3600 and the air circuit 4170. In such a way, air may flow from the air circuit 4170, into, past, and / or through the vaporizer 3105, and through the connection port 3600 to the patient. In some examples, one or more sensors 3110 may be coupled to the plenum chamber 3200 and / or the seal -forming structure 3100 and exposed to the breathing chamber therein. One or more sensors 3110 may be disposed within the air flow path and configured to transmit information to vaporizer 3105 or a controller in the RPT device 4000. Vaporizer 3105 is configured to vaporize water into the air flowing through patient interface 3000, thereby providing humidification to the air flow.

[0191] An example of an unsealed patient interface 3800, in the form of a nasal cannula, is shown in Fig. 4B, which may be used with high-flow therapies discussed above and below. Patient interface 3800 includes nasal prongs 3810a, 3810b which can deliver air to respective nares of the patient 1000 via respective orifices in their tips. Such nasal prongs do not generally form a seal with the inner or outer skin surface of the nares. This type of interface results in one or more gaps that are present in use by design (intentional) but they are typically not fixed such that they may vary unpredictably by movement during use. This can present a complex pneumatic variable for a respiratory therapy system when pneumatic control and / or assessment is implemented, unlike other types of mask-based respiratory therapy systems. The air to the nasal prongs may be delivered by one or more air supply lumens 3820a, 3820b that are coupled with the nasal cannula-type unsealed patient interface 3800. The lumens 3820a, 3820b lead from the nasal cannula-type unsealed patient interface 3800 to a respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivery of flow therapies, in which the RPT device generates the flow of air at controlled flow rates rather than controlled pressures. The “vent” or gap at the unsealed patient interface 3800, through which excess airflow escapes to ambient, is the passage between the end of the prongs 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800 via the patient’s nares to atmosphere.

[0192] If a patient interface is unable to comfortably deliver a minimum level of positive pressure to the airways, the patient interface may be unsuitable for respiratory pressure therapy.

[0193] The patient interface 3000 in accordance with one form of the present technology is constructed and arranged to be able to provide a supply of air at a positive pressure above the ambient, for example at least 2, 4, 6, 10, or 20 cmH20 with respect to ambient.

[0194] In the configuration shown in Fig. 4B, vaporizer 3105 may be included in or on or coupled to patient interface 3800. In such a way, air may flow from one or more air supply lumens 3820a, 3820b, into, past, and / or through vaporizer 3105, and through prongs 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800. One or more sensors 3110 may be coupled to one or more components. For example, one or more sensors 3110 may be disposed within the air flow path and data received from sensors 3110 may be used to at least partially affect the operation of vaporizer 3105. Vaporizer 3105 may vaporize a liquid into the air flowing through patient interface 3800. In some aspects, two vaporization devices 3105 may be incorporated on patient interface 3800, e.g., one on each prong 3810a and 3810b. In such an example, different doses of vaporized substances, e.g., water vapor, may be delivered to each nostril. The differences in doses may depend, at least in part, on the nasal cycle and / or patency of one or both nostrils.

[0195] As shown in Fig. 4C, a non-invasive patient interface 3000 in accordance with another aspect of the present technology comprises the following functional aspects: a sealforming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400 and one form of connection port 3600 for connection to an air circuit (such as the air circuit 4170 shown in Figs. 1A and IB). The plenum chamber 3200 may be formed of one or more modular components (e.g., a cushion module 3150 together with the seal-forming structure 3100) in the sense that it or they can be replaced with different components, for example components of a different size.

[0196] As will be discussed in further detail below, vaporizer 3105 may be included in or on or coupled to connection port 3600, for example, between connection port 3600 and an elbow joint 3610. In such a way, air may flow through connection port 3600, into, past, and / or through vaporizer 3105, and through elbow joint 3610 to the patient. Elbow joint 3610 may include a vent 3615. One or more sensors 3110 may be coupled to plenum chamber 3200 and / or the seal-forming structure 3100 and exposed to the breathing chamber therein. One or more sensors 3110 may be disposed within the air flow path and data received from sensors 3110 may be used to at least partially affect the operation of vaporizer 3105. Vaporizer 3105 may be configured to vaporize a liquid (e.g., water) into the air flowing through patient interface 3000. In some examples, vaporizer 3105 may be integrally formed with elbow joint 3610 or otherwise coupled to elbow joint 3610. Integration of vaporizer3105 with elbow joint 3610 may be suitable, for example, due to the location and / or design of vent 3615 on elbow joint 3610, among other reasons.

[0197] As will be discussed in further detail below, cartridge assembly 1120 may be included in or on or coupled to connection port 3600, for example, between connection portion 3600 and an elbow joint 3610. Cartridge assembly 1120 may include vaporization device 1105. In such a way, air may flow through connection port 3600, into and through cartridge assembly 1120, and through elbow joint 3610 to the patient. One or more sensors 1110 may be coupled to plenum chamber 3200. One or more sensors 1110 may be disposed within the air flow path and configured to transmit information to cartridge assembly 1120 and / or a controller operatively coupled to cartridge assembly 1120. Vaporization device 1105 may be configured to deliver water and / or a substance (e.g., a liquid, a material, a compound, a medicine, etc.) into the air flowing through patient interface 3000, thereby providing humidification to the air flow and / or dosing the air flow with a substance. Although cartridge assembly 1120 is depicted in one location and sensor 1110 is depicted on plenum chamber 3200, one or more sensors or cartridge assembly 1120 may be incorporated in any suitable location on patient interface 3000. Further, the location of the one or more sensors 1110 and / or cartridge assembly 1120 may depend, at least in part, on the type of patient interface (e.g., full face mask, nasal cannula, etc.) on which it is coupled to or adjacent to.

[0198] In the configuration shown in Fig. 4B, cartridge assembly 1120, including vaporization device 1105, may be included in or on or coupled to patient interface 3800. In such a way, air may flow from one or more air supply lumens 3820a, 3820b, past or through cartridge assembly 1120 and / or vaporization device 1105, and through prongs 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800. One or more sensors 1110 may be coupled to one or more components. For example, one or more sensors 1110 may be disposed within the air flow path and data received from sensors 1110 may be used to at least partially affect the operation of cartridge assembly 1120 and / or vaporization device 1105. Vaporization device 1105 may be configured to deliver a liquid into the air flowing through patient interface 3800.

[0199] As will be discussed in further detail below, cartridge assembly 1120, including vaporization device 1105, may be coupled to connection port 3600, for example, between connection portion 3600 and an elbow joint 3610. In such a way, air may flow through connection port 3600, into and through cartridge assembly 1120, and through elbow joint 3610 to the patient. One or more sensors 1110 may be coupled to plenum chamber 3200. One or more sensors 1110 may be disposed within the air flow path and data received fromsensors 1110 may be used to at least partially affect the operation of cartridge assembly 1120 and / or vaporization device 1105. Vaporization device 1105 may be configured to deliver water or a substance (e.g., a liquid, a material, a compound, a medicine, etc.) into the air flowing through patient interface 3000.

[0200] Furthermore, as illustrated in Figs. 8A-8D, cartridge assembly 1120, vaporization device 1105, and / or sensor(s) 1110 may each be included in or on or coupled to various aspects of the different patient interfaces. For example, cartridge assembly 1120 and / or vaporization device 1105 may be disposed between two components of the patient interface. Sensor(s) 1110 may be coupled to the patient interfaces, elsewhere along the fluid flow path. In any of the configurations described above, cartridge assembly 1120 and / or vaporization device 1105 may be configured such that cartridge assembly 1120 and / or vaporization device 1105 is / are at least partially exposed to the air flowing through the patient interface.Additionally, sensor(s) 1110 may be configured such that sensors(s) 1110 is / are at least partially exposed to the air flowing through the patient interface. Sensor(s) 1110 may be configured to detect and transmit (e.g., wirelessly or via at least one wire) information that may be used to at least partially affect the operation or cartridge assembly 1120 and / or vaporization device 1105. The information may pertain to the air flow or any other aspect of the therapy being delivered.5.3.1 Seal-forming structure

[0201] In one form of the present technology, a seal-forming structure 3100 provides a target seal-forming region, and may additionally provide a cushioning function. The target seal -forming region is a region on the seal -forming structure 3100 where sealing may occur. The region where sealing actually occurs- the actual sealing surface- may change within a given treatment session, from day to day, and from patient to patient, depending on a range of factors including for example, where the patient interface was placed on the face, tension in the positioning and stabilising structure and the shape of a patient’s face.

[0202] In one form the target seal-forming region is located on an outside surface of the seal -forming structure 3100.

[0203] In certain forms of the present technology, the seal-forming structure 3100 is constructed from a biocompatible material, e.g. silicone rubber.

[0204] A seal -forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible, resilient material such as silicone.

[0205] In certain forms of the present technology, a system is provided comprising more than one a seal -forming structure 3100, each being configured to correspond to a different size and / or shape range. For example the system may comprise one form of a seal-forming structure 3100 suitable for a large sized head, but not a small sized head and another suitable for a small sized head, but not a large sized head.5.3.2 Plenum chamber

[0206] 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.

[0207] 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.

[0208] 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.

[0209] 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.

[0210] In some forms, the plenum chamber 3200 is constructed from a rigid material such as polycarbonate. The rigid material may provide support to the seal -forming structure.

[0211] 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 amaterial 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.5.3.3 Positioning and stabilising structure

[0212] 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. 3 A and 3A-1.

[0213] In one form the positioning and stabilising structure 3300 provides a retention force at least sufficient to overcome the effect of the positive pressure in the plenum chamber 3200 to lift off the face (i.e., Fpienum).

[0214] In one form the positioning and stabilising structure 3300 provides a retention force to overcome the effect of the gravitational force on the patient interface 3000.

[0215] The positioning and stabilising structure 3300 provides a force Fpss that assists in maintaining the plenum chamber 3200 in the sealing position on the patient’s face. The positioning and stabilising force Fpss may be the resultant force from the various forces of the different elements of the positioning and stabilising structure 3300. For example, headgear straps may individually provide a strap force Fstra in order to hold the seal-forming structure 3100 against the patient’s face. The force Fstrap may also be directed at least partially in the superior direction in order to overcome the gravitational force Fg. The gravitational force Fgmay be specifically shown for the seal -forming structure 3100 and the plenum chamber 3200, but gravity would act on the entirely of the patient interface 3000 (i.e., in the same direction as the illustrated gravitational force Fg).

[0216] The gravitational force Fgmay be opposed by a frictional force Ff, which may act in a direction directly opposite of the gravitational force Fg. As gravity pulls the seal-forming structure 3100 and the plenum chamber 3200 in the inferior direction, the frictional force Ff would act in the superior direction (e.g., against a patient’s face). For example, the patient may experience the frictional force Ff against his lip superior (and / or other surfaces of the patient’s face in contact with the seal-forming structure 3100) in order to oppose the motion in the inferior direction (which may help to stabilising the cushion in place). Although the frictional force Ff is shown specifically opposing the gravitational force Fgof the sealforming structure 3100 and the plenum chamber 3200, components of an overall frictionalforce (not shown) would also oppose the gravitational force Fgassociated with the positioning and stabilising structure 3300 and any other portions of the patient interface 3000. A force of friction can act along any place where the patient interface 3000 contacts the patient’s skin (or hair). The frictional force Ff extends in the opposite direction of the gravitational force Fgand along the patient’s skin (or hair). In some forms the gravitiational force Fgmay also be countered by vertical components of the reaction force from the patient’s face acting on the seal-forming structure 3100, for example at the nose ridge and chin regions of the patient’s face, for example.

[0217] In some forms, the sum of the various forces may equal zero so that the patient interface 3000 is at equilibrium (e.g., not moving along the patient’s face while in use). Specifically, the gravitational force Fgand the blowout force Fpienum tend to move the sealforming structure 3100 away from the desired sealing position. The positioning and stabilising force Fpss is applied in order to counteract the gravitational force Fgand the blowout force Fpienum (as well as any frictional forces Ff) and keep the seal-forming structure 3100 properly situated. Although the positioning and stabilising force Fpss may exceed the sum of the gravitational force Fgand the blowout force Fpienum (with any additional positioning and stabilising force Fpss being balanced by reaction force from the patient’s head acting on the portions of patient interface 3000) and still maintain the seal -forming structure 3100 in an appropriate sealing position, patient comfort may be sacrificed. Maximum patient comfort may be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilising force Fpss is exactly strong enough to achieve this. In some examples the positioning and stabilising structure 3300 may be adjustable such that when fitted the positioning and stabilising force Fpss is greater than required to exactly balance the gravitational force Fgand the blowout force Fpienum to hold the patient interface 3000 against the patient’s head tightly enough that disruptive forces which may be experienced in use (such as tube drag or lateral shunting of the plenum chamber 3200 during side sleeping) do not disrupt the seal. As described below, various positions of the patient’s head while using the patient interface 3000 may determine the positioning and stabilising force Fpss necessary to achieve equilibrium.

[0218] In one form the positioning and stabilising structure 3300 provides a retention force as a safety margin to overcome the potential effect of disrupting forces on the patient interface 3000, such as from tube drag, or accidental interference with the patient interface.

[0219] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured in a manner consistent with being worn by a patient whilesleeping. In one example the positioning and stabilising structure 3300 has a low profile, or cross-sectional thickness, to reduce the perceived or actual bulk of the apparatus. In one example, the positioning and stabilising structure 3300 comprises at least one strap having a rectangular cross-section. In one example the positioning and stabilising structure 3300 comprises at least one flat strap.

[0220] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a supine sleeping position with a back region of the patient’s head on a pillow.

[0221] In one form of the present technology, a positioning and stabilising structure 3300 is provided that is configured so as not to be too large and bulky to prevent the patient from lying in a side sleeping position with a side region of the patient’s head on a pillow.

[0222] In one form of the present technology, a positioning and stabilising structure 3300 is provided with a decoupling portion located between an anterior portion of the positioning and stabilising structure 3300, and a posterior portion of the positioning and stabilising structure 3300. The decoupling portion does not resist compression and may be, e.g. a flexible or floppy strap. The decoupling portion is constructed and arranged so that when the patient lies with their head on a pillow, the presence of the decoupling portion prevents a force on the posterior portion from being transmitted along the positioning and stabilising structure 3300 and disrupting the seal.

[0223] In one form of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed from a laminate of a fabric patient-contacting layer, a foam inner layer and a fabric outer layer. In one form, the foam is porous to allow moisture, (e.g., sweat), to pass through the strap. In one form, the fabric outer layer comprises loop material to engage with a hook material portion.

[0224] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is extensible, e.g. resiliently extensible. For example the strap may be configured in use to be in tension, and to direct a force to draw a seal-forming structure into sealing contact with a portion of a patient’s face. In an example the strap may be configured as a tie.

[0225] In one form of the present technology, the positioning and stabilising structure comprises a first tie, the first tie being constructed and arranged so that in use at least a portion of an inferior edge thereof passes superior to an otobasion superior of the patient’s head and overlays a portion of a parietal bone without overlaying the occipital bone.

[0226] In one form of the present technology suitable for a nasal-only mask or for a fullface mask, the positioning and stabilising structure includes a second tie, the second tie being constructed and arranged so that in use at least a portion of a superior edge thereof passes inferior to an otobasion inferior of the patient’s head and overlays or lies inferior to the occipital bone of the patient’s head.

[0227] In one form of the present technology suitable for a nasal-only mask or for a fullface mask, the positioning and stabilising structure includes a third tie that is constructed and arranged to interconnect the first tie and the second tie to reduce a tendency of the first tie and the second tie to move apart from one another.

[0228] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap that is bendable and e.g. non-rigid. An advantage of this aspect is that the strap is more comfortable for a patient to lie upon while the patient is sleeping.

[0229] In certain forms of the present technology, a positioning and stabilising structure 3300 comprises a strap constructed to be breathable to allow moisture vapour to be transmitted through the strap,

[0230] In certain forms of the present technology, a system is provided comprising more than one positioning and stabilising structure 3300, each being configured to provide a retaining force to correspond to a different size and / or shape range. For example the system may comprise one form of positioning and stabilising structure 3300 suitable for a large sized head, but not a small sized head, and another, suitable for a small sized head, but not a large sized head.5.3.3.1 Conduit headgear5.3.3.1.1 Conduit headgear tubes

[0231] In some forms of the present technology, the positioning and stabilising structure 3300 comprises one or more headgear tubes 3350 that deliver pressurised air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient’s airways, for example through the plenum chamber 3200 and seal -forming structure 3100The positioning and stabilising structure 3300 comprises two tubes 3350 that deliver air to the plenum chamber 3200 from the air circuit 4170. The tubes 3350 are configured to position and stabilise the seal-forming structure 3100 of the patient interface 3000 at the appropriate part of the patient’s face (for example, the nose and / or mouth) in use. This allows the conduit of air circuit 4170 providing the flow of pressurised air to connect to a connection port 3600 of the patient interface in a position other than in front of the patient’s face, for example on top of the patient’s head.

[0232] The positioning and stabilising structure 3300 comprises two tubes 3350, each tube 3350 being positioned in use on a different side of the patient’s head and extending across the respective cheek region, above the respective ear (superior to the otobasion superior on the patient’s head) to the elbow 3610 on top of the head of the patient 1000. This form of technology may be advantageous because, if a patient sleeps with their head on its side and one of the tubes 3350 is compressed to block or partially block the flow of gas along the tube 3350, the other tube 3350 remains open to supply pressurised gas to the patient. In other examples of the technology, the patient interface 3000 may comprise a different number of tubes, for example one tube, or two or more tubes.

[0233] In one example in which the patient interface has one tube 3350, the single tube 3350 is positioned on one side of the patient’s head in use (e.g. across one cheek region) and a strap forms part of the positioning and stabilising structure 3300 and is positioned on the other side of the patient’s head in use (e.g. across the other region) to assist in securing the patient interface 3000 on the patient’s head. For example, the tube 3350 and the strap may each be under tension in use in order to assist in maintaining the seal -forming structure 3100 in a sealing position.

[0234] In one form, the tube 3350 may be at least partially extensible so that the tube 3350 and the strap may adjust substantially equal lengths when worn by a patient. This may allow for substantially symmetrical adjustments between the tube 3350 and the strap so that the seal-forming structure remains substantially in the middle.

[0235] The two tubes 3350 are fluidly connected at superior ends to each other and to the connection port 3600. In some examples, the two tubes 3350 are integrally formed while in other examples the tubes 3350 are formed separately but are connected in use and may be disconnected, for example for cleaning or storage. Where separate tubes are used, they may be indirectly connected together, for example each may be connected to a T-shaped connector. The T-shaped connector may have two arms / branches each fluidly connectable to a respective one of the tubes 3350. Additionally, the T-shaped connector may have a third arm or opening providing the connection port 3600 for fluid connection to the air circuit 4170 in use. The opening may be an inlet 3332 (see e.g., 7C) for receiving the flow of pressurized air.

[0236] In some forms, the third arm of the T-shaped connector may be substantially perpendicular to each of the first two arms.

[0237] In some forms, the third arm of the T-shaped connector may be obliquely formed with respect to each of the first two arms.

[0238] In some forms, a Y-shaped connector may be used instead of the T-shaped connector. The first two arms may be oblique with respect to one another, and the third arm may be oblique with respect to the first two arms. The angled formation of the first two arms may be similar to the shape of the patient’s head in order to conform to the shape.

[0239] In some forms, at least one of the arms of the T-shaped connector (or Y-shaped connector) may be flexible. This may allow the connector to bend based on the shape of the patient’s head and / or a force in the positioning and stabilising structure 3300.

[0240] In some forms, at least one of the arms of the T-shaped connector (or Y-shaped connector) may be at least partially rigidised. This may assist in maintaining the shape of the connector so that bending of the connector does not close the airflow path.

[0241] The tubes 3350 may be formed from a flexible material, such as an elastomer, e.g. silicone or TPE, and / or from one or more textile and / or foam materials. The tubes 3350 may have a preformed shape and may be able to be bent or moved into another shape upon application of a force but may return to the original preformed shape in the absence of said force. The tubes 3350 may be generally arcuate or curved in a shape approximating the contours of a patient’s head between the top of the head and the nasal or oral region.

[0242] In some examples, the one or more tubes 3350 are crush resistant to resist being blocked if crushed during use, for example if squashed between a patient’s head and pillow, especially if there is only one tube 3350. The tubes 3350 may be formed with a sufficient structural stiffness to resist crushing or may be as described in US Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0243] Each tube 3350 may be configured to receive a flow of air from the connection port 3600 on top of the patient’s head and to deliver the flow of air to the seal -forming structure 3100 at the entrance of the patient’s airways. Each tube 3350 lies in use on a path extending from the plenum chamber 3200 across the patient’s cheek region and superior to the patient’s ear to the elbow 3610. For example, a portion of each tube 3350 proximate the plenum chamber 3200 may overlie a maxilla region of the patient’s head in use. Another portion of each tube 3350 may overlie a region of the patient’s head superior to an otobasion superior of the patient’s head. Each of the tubes 3350 may also lie over the patient’s sphenoid bone and / or temporal bone and either or both of the patient’s frontal bone and parietal bone. The elbow 3610 may be located in use over the patient’s parietal bone, over the frontal bone and / or over the junction therebetween (e.g. the coronal suture).

[0244] In certain forms of the present technology the patient interface 3000 is configured such that the connection port 3600 can be positioned in a range of positions across the top ofthe patient’s head so that the patient interface 3000 can be positioned as appropriate for the comfort or fit of an individual patient. In some examples, the headgear tubes 3350 are configured to allow movement of an upper portion of the patient interface 3000 (e.g. a connection port 3600) with respect to a lower portion of the patient interface 3000 (e.g. a plenum chamber 3200). That is, the connection port 3600 may be at least partially decoupled from the plenum chamber 3200. In this way, the seal-forming structure 3100 may form an effective seal with the patient’s face irrespective of the position of the connection port 3600 (at least within a predetermined range of positions) on the patient’s head.

[0245] As described above, in some examples of the present technology the patient interface 3000 comprises a seal -forming structure 3100 in the form of a cradle cushion which lies generally under the nose and seals to an inferior periphery of the nose (e.g. an under-the- nose cushion). The positioning and stabilising structure 3300, including the tubes 3350 may be structured and arranged to pull the seal -forming structure 3100 into the patient’s face under the nose with a sealing force in a posterior and superior direction (e.g. a posterosuperior direction). A sealing force with a posterosuperior direction may cause the seal -forming structure 3100 to form a good seal to both the inferior periphery of the patient’s nose and anterior-facing surfaces of the patient’s face, for example on either side of the patient’s nose and the patient’s lip superior.

[0246] Conduits forming part of the positioning and stabilising structure 3300, like headgear straps, may provide a force that contributes to the positioning and stabilising force Fpss. The positioning and stabilising force Fpss may be the resultant force from the various forces of the different elements of the positioning and stabilising structure 3300. For example, each conduit may provide a force FCOnduit directed in the posterior and respective lateral direction in order to hold the seal-forming structure 3100 against the patient’s face (into the upper lip and sealing under the nose) and oppose the effect of the positive pressure in the plenum chamber 3200 to lift off the face (i.e., F ienum). The force FCOnduit directed may also be directed at least partially in the superior direction in order to overcome the gravitational force Fg.

[0247] In some forms, the conduits may provide a force directed into the patient’s head when the conduits are filled with pressurized air. The force may assist in gripping the patient’s head. The force may be caused by the inflation of the conduits during normal use. In some forms, the force may provide a cushioning effect to the patient’s head. The conduits may be designed in order to limit expansion in order to prevent over-gripping the patient’s head.

[0248] The position of the patient’s head may also change the gripping force of the conduits. For example, if the patient is sleeping on his side, the weight of the patient’s head may compress one conduit, and the other conduit (e.g., the lateral portion not between the patient’s head and a sleeping surface, like a pillow) may additionally expand in order to keep substantially the same flow rate of pressurized air.

[0249] The gravitational force Fgmay be opposed by a frictional force Ff, which may act in a direction directly opposite of the gravitational force Fg. As gravity pulls the seal-forming structure 3100 and the plenum chamber 3200 in the inferior direction, the frictional force Ff would act in the superior direction (e.g., against a patient’s face). For example, the patient may experience the frictional force Ff against his lip superior (and / or other surfaces of the patient’s face in contact with the seal-forming structure 3100) in order to oppose the motion in the inferior direction (which may help to stabilising the cushion in place). Although the frictional force Ff is shown specifically opposing the gravitational force Fgof the sealforming structure 3100 and the plenum chamber 3200, components of an overall frictional force (not shown) would also oppose the gravitational force Fgassociated with the positioning and stabilising structure 3300 and any other portions of the patient interface 3000. A force of friction can act along any place where the patient interface 3000 contacts the patient’s skin (or hair). The frictional force Ff extends in the opposite direction of the gravitational force Fgand along the patient’s skin (or hair).

[0250] In some forms, the sum of the various forces may equal zero so that the patient interface 3000 is at equilibrium (e.g., not moving along the patient’s face while in use). Specifically, the gravitational force Fgand the blowout force Fpienum tend to move the sealforming structure 3100 away from the desired sealing position. The positioning and stabilising force Fpss is applied in order to counteract the gravitational force Fgand the blowout force Fpienum (as well as any frictional forces Ff) and keep the seal-forming structure 3100 properly situated. Although the positioning and stabilising force Fpss may exceed the sum of the gravitational force Fgand the blowout force Fpienum (with any additional positioning and stabilising force Fpss being balanced by reaction force from the patient’s head acting on the portions of patient interface 3000) and still maintain the seal -forming structure 3100 in an appropriate sealing position, patient comfort may be sacrificed. Maximum patient comfort may be achieved when the net force on the patient interface 3000 is zero and the positioning and stabilising force Fpss is exactly strong enough to achieve this. In some examples the positioning and stabilising structure 3300 may be adjustable such that when fitted the positioning and stabilising force Fpss is greater than required to exactly balance thegravitational force Fgand the blowout force Fpienum to hold the patient interface 3000 against the patient’s head tightly enough that disruptive forces which may be experienced in use (such as tube drag or lateral shunting of the plenum chamber 3200 during side sleeping) do not disrupt the seal. As described below, various positions of the patient’s head while using the patient interface 3000 may determine the positioning and stabilising force Fpss necessary to achieve equilibrium5.3.3.1.2 Extendable and non-extendable tube portions

[0251] In some examples of the present technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may comprise one or more extendable tube sections, for example formed by an extendable concertina structure. In some forms, the patient interface 3000 may comprise a positioning and stabilising structure 3300 including at least one gas delivery tube comprising a tube wall having an extendable concertina structure. The patient interface 3000 comprises tubes 3350, the superior portions of which comprise extendable tube sections each in the form of an extendable concertina structure 3362.

[0252] In some forms, the extendable concertina structure 3328 may be formed as a series of ridges and grooves on the surface of the tubes 3350. The concertina structure 3328 may be biased toward a retracted position, and may move to an expanded position when the patient dons the positioning and stabilising structure 3300. Because portions of the tubes 3350 may be substantially inextensible (e.g., non-extendable tube sections 3363), the concertina structures 3328 permit the positioning and stabilising structure 3300 to stretch in order to fit different sized heads. This may allow a single sized tube 3350 to be used with multiple sized heads. For example, the positioning and stabilising structure 3300 may be “one-size-fits-all” as a result of the concertina structure 3328. Alternatively, the tubes 3350 may be manufactured in multiple sizes (e.g., small, medium, large). The patient may select a length that most closely conforms to their head, and the concertina structures 3328 may make small adjustments in order to tailor the fit to the individual patient.

[0253] In some forms, the inlet 3332 may be disposed in the middle of the conduit 6320. For example, the tubes 3350 may be symmetric about the inlet 3332 through at least one axis.

[0254] The cross-sectional shape of the non-extendable tube sections 3363 of the tubes 3350 may be circular, elliptical, oval, D-shaped or a rounded rectangle, for example as described in US Patent No. 6,044,844. A cross-sectional shape that presents a flattened surface of tube on the side that faces and contacts the patient’s face or other part of the head may be more comfortable to wear than, for example a tube with a circular cross-section.

[0255] In some examples of the present technology, the non-extendable tube sections 3363 connects to the plenum chamber 3200 from a low angle. The headgear tubes 3350 may extend inferiorly down the sides of the patient’s head and then curve anteriorly and medially to connect to the plenum chamber 3200 in front of the patient’s face. The tubes 3350, before connecting to the plenum chamber 3200, may extend to a location at the same vertical position as (or, in some examples, inferior to) the connection with the plenum chamber 3200. That is, the tubes 3350 may project in an at least partially superior direction before connecting with the plenum chamber 3200. A portion of the tubes 3350 may be located inferior to the plenum chamber 3200 and / or the seal forming structure 3100. The tubes 3350 may contact the patient’s face below the patient’s cheekbones, which may be more comfortable than contact on the patient’s cheekbones and may avoid excessively obscuring the patient’s peripheral vision.5.3.3.1.3 Conduit headgear connection port

[0256] In certain forms of the present technology, the patient interface 3000 may comprise a connection port 3600 located proximal to a superior, lateral or posterior portion of a patient’s head. For example, the connection port 3600 is located on top of the patient’s head (e.g. at a superior location with respect to the patient’s head). In this example the patient interface 3000 comprises an elbow 3610 forming the connection port 3600. The elbow 3610 may be configured to fluidly connect with a conduit of an air circuit 4170. The elbow 3610 may be configured to swivel with respect to the positioning and stabilising structure 3300 to at least partially decouple the conduit from the positioning and stabilising structure 3300. In some examples the elbow 3610 may be configured to swivel by rotation about a substantially vertical axis and, in some particular examples, by rotation about two or more axes. In some examples the elbow may comprise or be connected to the tubes 3350 by a ball-and-socket joint. The connection portion 3600 may be located in the sagittal plane of the patient’s head in use.

[0257] Patient interfaces having a connection port that is not positioned anterior to the patient’s face may be advantageous as some patients may find a conduit that connects to a patient interface anterior to their face to be unsightly and / or obtrusive. For example, a conduit connecting to a patient interface anterior to the patient’s face may be prone to interference with bedclothes or bed linen, particularly if the conduit extends inferiorly from the patient interface in use. Forms of the present technology comprising a patient interface having a connection port positioned superiorly to the patient’s head in use may make it easier or more comfortable for a patient to he or sleep in one or more of the following positions: a side-sleeping position, a supine position (e.g. on their back, facing generally upwards) or in a prone position (e.g. on their front, facing generally downwards). Moreover, connecting a conduit to an anterior portion of a patient interface may exacerbate a problem known as tube drag in which the conduit exerts an undesired force upon the patient interface during movement of the patient’s head or the conduit, thereby causing dislodgement away from the face. Tube drag may be less of a problem when force is received at a superior location of the patient’s head than anterior to the patient’s face proximate to the seal-forming structure (where tube drag forces may be more likely to disrupt the seal).5.3.3.1.4 Headgear Tube Fluid Connections

[0258] The two tubes 3350 are fluidly connected at their inferior ends to the plenum chamber 3200. In certain forms of the technology, the connection between the tubes 3350 and the plenum chamber 3200 is achieved by connection of two rigid connectors. The tubes 3350 and plenum chamber 3200 may be configured to enable the patient to easily connect the two components together in a reliable manner. The tubes 3350 and plenum chamber 3200 may be configured to provide tactile and / or audible feedback in the form of a ‘re-assuring click’ or a similar sound, so that the patient may easily know that each tube 3350 has been correctly connected to the plenum chamber 3200. In one form, the tubes 3350 are formed from a silicone or textile material and the inferior end of each of the silicone tubes 3350 is overmolded to a rigid connector made, for example, from polypropylene, polycarbonate, nylon or the like. The rigid connector on each tube 3350 may comprise a female mating feature configured to connect with a male mating feature on the plenum chamber 3200. Alternatively, the rigid connector on each tube 3350 may comprise a male mating feature configured to connect to a female mating feature on the plenum chamber 3200. In other examples the tubes 3350 may each comprise a male or female connector formed from a flexible material, such as silicone or TPE, for example the same material from which the tubes 3350 are formed.

[0259] In other examples a compression seal is used to connect each tube 3350 to the plenum chamber 3200. For example, a resiliently flexible (e.g. silicone) tube 3350 without a rigid connector may be configured to be squeezed to reduce its diameter so that it can be compressed into a port in the plenum chamber 3200 and the inherent resilience of the silicone pushes the tube 3350 outwards to seal the tube 3350 in the port in an air-tight manner. Alternatively, in a hard-to-hard type engagement between the tube 3350 and the plenum chamber 3200, each tube 3350 and / or plenum chamber 3200 may comprise a pressure activated seal, for example a peripheral sealing flange. When pressurised gas is suppliedthrough the tubes 3350 the sealing flange may be urged against the join between the tubes and a circumferential surface around a port or connector of the plenum chamber 3200 to form or enhance a seal between the tube 3350 and plenum chamber 3200.5.3.3.2 Headgear straps

[0260] 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).

[0261] As described above, 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.

[0262] 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.

[0263] Two forms of the headgear, four-point headgear 3302-1 and two-point headgear 3302-2, are discussed in more detail below as illustrative examples.5.3.3.2.1 Four-point connection

[0264] Some forms of the headgear 3302-1 may be a four-point connection headgear. This means that the headgear 3302-1 may connect to four separate places on the plenum chamber 3200, on a frame connected to the plenum chamber 3200, and / or on arms connected to the plenum chamber 3200. The headgear 3302-1 may include four different straps providing a tensile force to help maintain the seal-forming structure 3100 in a sealing position. The positioning and stabilising structure 3300 of Fig. 8A may also be considered a four-point connection headgear.

[0265] In some forms, the headgear 3302-1 may include inferior straps 3304-1, which may connect to an inferior portion of the cushion 3050-1. The inferior straps 3304-1 may extend along the patient’s cheek toward a posterior region of the patient’s head. For example, the inferior straps 3304-1 may overlay the masseter muscle on either side of the patient’s face. The inferior straps 3304-1 may therefore contact the patient’s head below the patient’sears. The inferior straps 3304-1 may meet at the posterior of the patient’s head, and may overlay the occipital bone and / or the trapezius muscle.

[0266] The headgear 3302-1 may also include superior straps 3305-1, which may overlay the temporal bones, parietal bone, and / or occipital bone. The superior straps 3305-1 may also connect to the tubes 3350 (e.g., by interfacing with the tabs 3320).

[0267] A rear strap 3307-1 may extend between the superior straps 3305-1 and between the inferior straps 3304-1. The inferior and superior straps 3304-1, 3305-1 on a given side (e.g., left or right) may also be connected to the rear strap 3307-1 adjacent to one another. The height of the rear strap 3307-1 may therefore be approximately the combined height of the inferior and superior strap 3304-1, 3305-1. The rear strap 3307-1 may overlay the occipital bone and / or the pariental bone in use. This may allow the rear strap 3307-1 to assist in anchoring the headgear 3302-1 to the patient’s head.

[0268] In the illustrated example, the headgear 3302-1 may be formed with a substantially X-shape. The inferior and superior straps 3304-1, 3305-1 may be connected to a rear strap 3307-1 using stitching, ultrasonic welding, or any similar process.

[0269] In some forms, the inferior straps 3304-1 are connected to a magnetic member 3306-1. For example, each inferior straps 3304-1 may be threaded through a magnetic member 3306-1, so that a length of each inferior strap 3304-1 may be adjusted. The magnetic members 3306-1 may removably connect to the magnets 3370-1 (described below), so that the inferior straps 3304-1 may be disconnected from the plenum chamber 3200, but the length of the inferior straps 3304-1 may not be affected.

[0270] In some forms, the superior straps 3305-1 may be connected directly to the tabs 3320 of the tubes 3350. The superior straps 3305-1 may be threaded through the tabs 3320 in order to adjust the length and control the tensile force of each superior strap 3305-1.

[0271] In some forms, the headgear 3302-1 may be used only with the nose and mouth cushion 3050-1 (e.g., because the nose-only cushion 3050-1 does not have four connection points). However, the headgear 3302-1 may be used interchangeably with the tubes 3350 and the rigidiser arms 3340.5.3.3.2.2 Two-point conn ection

[0272] As shown in Fig. 8C, some forms of the headgear 3302-2 may be a two-point connection headgear. This means that the headgear 3302-2 may connect to two separate places.

[0273] In some forms, the headgear 3302-2 may be formed from a continuous piece of material. In other words, the headgear 3302-2 may not be formed from multiple strapsconnected (e.g., stitched) together. This may be comfortable for a patient as they will not be in contact with any seams or joints connecting different straps. In other forms, the headgear 3302-2 may be formed from multiple straps (e.g., two superior straps, a rear strap, etc.) that are connected together (e.g., with stitching, ultra-sonic welding, etc.).

[0274] In certain forms of the present technology, the positioning and stabilising structure 3300 comprises at least one headgear strap acting in addition to the tubes 3350 to position and stabilise the seal -forming structure 3100 at the entrance to the patient’s airways. The patient interface 3000 may comprises a strap 3307-2 forming part of the positioning and stabilising structure 3300. The strap 3307-2 may be known as a back strap or a rear headgear strap, for example. The rear strap 3307-2 may overlay the temporal bones, parietal bone, and / or occipital bone. In other examples of the present technology, one or more further straps may be provided. For example, patient interfaces 3000 according to examples of the present technology having a nose-and-mouth cushion may have a second, lower, strap configured to lie against the patient’s head proximate the patient’s neck and / or against posterior surfaces of the patient’s neck.

[0275] The strap 3310 of the positioning and stabilising structure 3300 is connected between the two tubes 3350 positioned on each side of the patient’s head and passing around the back of the patient’s head, for example overlying or lying inferior to the occipital bone of the patient’s head in use. The strap 3310 connects to each tube above the patient’s ears. The positioning and stabilising structure 3300 comprises a pair of tabs 3320. In use a strap 3310 may be connected between the tabs 3320. The strap 3310 may be sufficiently flexible to pass around the back of the patient’s head and he comfortably against the patient’s head, even when under tension in use.

[0276] Some forms of the headgear 3302-2 may be at least partially bifurcated. For example, a rear strap 3307-2 of the headgear 3302-2 (e.g., configured to contact the posterior portion of the patient’s head) may be wider than the surrounding portions of the headgear 3302-2. An intermediate section 3308-2 of the rear strap 3307-2 may include a slit 3309-2. A superior section of the rear strap 3307-2 may therefore be movable relative to the inferior section as a result of the slit 3309-2. This may allow the patient to have a larger strap coverage on the posterior region of their head, which may assist in better anchoring the headgear 3302-2 to the patient’s head since there is no inferior strap (e.g., 3304-1).

[0277] In some forms, the headgear 3302-2 may be used only with the nasal cushion 3050-2 (e.g., because the nose and mouth cushion 3050-1 does not have four connectionpoints). However, the headgear 3302-2 may be used interchangeably with the tubes 3350 and the rigidiser arms 3340.5.3.3.3 Rigidiser Arm

[0278] As shown in Fig. 8D, a rigidiser arm 3340 may be an elongated, rigid member that assists in maintaining the cushion (e.g., the nose and mouth cushion 3050-1 or the nasal cushion 3050-2) in an operating position. The rigidiser arm 3340 may contact a side of the patient’s head and provide a force to limit slipping of the seal-forming structure 3100 from the patient’s nose and / or mouth.

[0279] In some forms, the rigidiser arm 3340 is constructed from a rigid material (e.g., plastic). The rigid material may not permit the rigidiser arm 3340 to stretch. Additionally, the rigidiser arm 3340 may be substantially inflexible and may be unable to bend. The rigidiser arm 3340 may be pre-molded into a desired shape in order to fit a patient’s head. For example, the rigidiser arms 3340 may be molded with a curved shape to substantially correspond to the shape of the side of the patient’s head (e.g., overlaying the masseter muscle and / or the temporal bone).

[0280] In certain forms, the rigidiser arm 3340 may be molded in order to conform to a specific patient’s head (e.g., the rigidiser arm 3340 is customized).

[0281] In some forms, the rigidiser arm 3340 may be flexible along at least one direction. For example, the rigidiser arm 3340 may be flexible about its width and may be inflexible along its length. In other words, the rigidiser arm 3340 may be bendable about an axis along the width of the rigidiser arm 3340, but may be unable to bend about an axis perpendicular to the rigidiser arm 3340. This may allow an individual patient to adjust the rigidiser arm 3340 in order to better fit their individual head.

[0282] In certain forms, the rigidiser arm 3340 may remain in the new position after being bent. This may allow a patient adjust the shape of the rigidiser arm 3340 for their specific head and then the rigidiser arm 3340 will keep the desired shape while in use in order to promote patient comfort.

[0283] In some forms, a first end 3342 of the rigidiser arm 3340 may be a free end and a second end 3344 (e.g., opposite of the first end 3342) of the rigidiser arm 3340 may be fixed. The first end 3342 may be curved in order to minimize sharp edges that could cause patient discomfort. The first end 3342 may also overlay the patient’s head proximate to the temporal bone, in use. The second end 3344 may be fixed to an arm connection structure 3504.

[0284] In some forms, the arm connection structure 3504 may be similar to the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduitconnection structure 3500 may have substantially the same shape. This may allow either the conduit connection structure 3500 or the arm connection structure 3504 to fit into the groove (e.g., 3266-1 or 3266-2) and connect to the plenum chamber inlet port 3254. The arm connection structure 3504 may connect to the nose and mouth cushion 3050-1 or the nose- only cushion 3050-2 in substantially the same way as the conduit connection structure 3500 (e.g., via a snap fit, press fit, friction fit, etc.).

[0285] In some forms, the arm connection structure 3504 may act as a plug for the plenum chamber inlet port 3254 (e.g., either 3254-1 and / or 3254-2). Unlike the tubes 3350, the rigidiser arm 3340 does not convey pressurized air to the plenum chamber 3200. The rigidised arm 3340 may be used with a “tube down” configuration, where a hose is connected to the vent opening 3402 (e.g., either 3402-1 and / or 3402-2), and conveys air into the plenum chamber 3200 through the vent opening 3402. In this example, air does not need to travel into or out of the plenum chamber inlet openings 3254. Thus, the arm connection structure 3504 may form a seal with the plenum chamber inlet opening 3254 in order to limit airflow into or out of the plenum chamber 3200.5.3.4 Vent

[0286] 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.

[0287] 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.

[0288] 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.

[0289] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure, e.g., a swivel.5.3.5 Decoupling structure(s)

[0290] In one form the patient interface 3000 includes at least one decoupling structure, for example, a swivel or a ball and socket.5.3.6 Connection port

[0291] Connection port 3600 allows for connection to the air circuit 4170.5.3.7 Forehead support

[0292] In one form, the patient interface 3000 includes a forehead support 3700.5.3.8 Anti-asphyxia valve

[0293] In one form, the patient interface 3000 includes an anti-asphyxia valve.5.3.9 Ports

[0294] 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.5.4 RPT DEVICE

[0295] Referring to Figs. 5A and 5B, 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 4300, 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.

[0296] 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 while maintaining a positive pressure of at least 4 cmH20, or at least 10cmH2O, or at least 20 cmH20.

[0297] The RPT device may have an external housing 4010, formed in two parts, an upper portion 4012 and a lower portion 4014. Furthermore, the external housing 4010 may include one or more panel(s) 4015. The RPT device 4000 comprises a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0298] The pneumatic path of the RPT device 4000 may comprise one or more air path items, e.g., an inlet air fdter 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 4272 and flow rate sensors 4274.

[0299] One or more of the air path items may be located within a removable unitary structure which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be located within the external housing 4010. In one form a pneumatic block 4020 is supported by, or formed as part of the chassis 4016.

[0300] As will be discussed in further detail below, a vaporization device 4105 may be included in or on or coupled to blower 4142. One or more sensors 4111 may be coupled to blower 4142 or to other components of RPT device 4000. One or more sensors 4111 and vaporization device 4105 may be disposed within or exposed to the air flow path. Sensor(s) 4111 may be configured to detect data, and data received from sensors 4111 may be transmitted to a controller of RPT device 4000 and used to at least partially affect the operation of vaporization device 4105. Vaporization device 4105 may be configured to vaporize a liquid into the air flowing through RPT device 4000 to the patient.

[0301] As will be discussed in further detail below, a cartridge assembly 4130, including vaporization device 4105, may be included in or on, or coupled to blower 4142. One or more sensors 4111 may be coupled to blower 4142 or to other components of RPT device 4000. One or more sensors 4111 and cartridge assembly 4130 may be disposed within the air flow path. Sensor(s) 4111 may be configured to detect data, and data received from sensors 4111 may be used to at least partially affect the operation of cartridge assembly 4130. Vaporization device 4105 may be configured to deliver a liquid into the air flowing through RPT device 4000 to the patient.5.4.1 RPT device mechanical & pneumatic components

[0302] 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.5.4.1.1 Air filter(s)

[0303] An RPT device in accordance with one form of the present technology may include an air filter 4110, or a plurality of air filters 4110.

[0304] In one form illustrated in Fig. 5B, an inlet air filter 4112 is located at the beginning of the pneumatic path upstream of a pressure generator 4140.

[0305] In one form illustrated in Fig. 5B, 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 or 3800.5.4.1.2 Muffler(s)

[0306] An RPT device in accordance with one form of the present technology may include a muffler 4120, or a plurality of mufflers 4120.

[0307] In one form of the present technology (see e.g., Fig. 5B), an inlet muffler 4122 is located in the pneumatic path upstream of a pressure generator 4140.

[0308] 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 or 3800.5.4.1.3 Pressure generator

[0309] 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.

[0310] The pressure generator 4140 may be under the control of the therapy device controller 4240.

[0311] 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.5.4.1.4 Transducer(s)

[0312] 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 non-contact sensors such as a Doppler radar movement sensor that transmit or transfer data to the RPT device.

[0313] In one form of the present technology (see e.g., Fig. 5B), 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.

[0314] In one form of the present technology, one or more transducers 4270 may be located proximate to the patient interface 3000 or 3800.

[0315] In one form, a signal from a transducer 4270 may be filtered, such as by low-pass, high-pass or band-pass filtering.5.4.1.5 Anti-spill back valve

[0316] As shown in Fig. 5B, one form of the present technology, an anti-spill back valve 4160 is located between the humidifier 5000 and the pneumatic block 4020. The anti-spill back valve is constructed and arranged to reduce the risk that water will flow upstream from the humidifier 5000, for example to the motor 4144.5.4.2 RPT device electrical components5.4.2.1 Power supply

[0317] A power supply 4210 may be located internal or external of the external housing 4010 of the RPT device 4000.

[0318] In one form of the present technology, power supply 4210 provides electrical power to the RPT device 4000 only. In another form of the present technology, power supply 4210 provides electrical power to both RPT device 4000 and vaporization device 4105 and / or cartridge assembly 4130.5.4.2.2 Input devices

[0319] In one form of the present technology, an RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches or dials to allow a person to interact with the device. The buttons, switches or dials may be physical devices, or software devices accessible via a touch screen. The buttons, switches or dials may, in one form, be physically connected to the external housing 4010, or may, in another form, be in wireless communication with a receiver that is in electrical connection to the central controller 4230.

[0320] In one form, the input device 4220 may be constructed and arranged to allow a person to select a value and / or a menu option.5.4.2.3 Controller

[0321] In one form of the present technology, RPT device 4000 includes a controller. Any or all of the controllers discussed herein may comprise one or a plurality of hardware processors . Illustrative hardware processors may include an x86 INTEL processor, a processor based on ARM® Cortex®-M processor from ARM Holdings such as an STM32 series microcontroller from ST MICROELECTRONIC. In certain alternative forms of the present technology, a 32-bit RISC CPU, such as an STR9 series microcontroller from ST MICROELECTRONICS or a 16-bit RISC CPU such as a processor from the MSP430 family of microcontrollers, manufactured by TEXAS INSTRUMENTS may also be used. In some examples, a controller may be a dedicated electronic circuit. In some examples, a controller may be an application-specific integrated circuit (ASIC). In some examples, a controllercomprises discrete electronic components. In some examples, a controller may also include a non-transitory computer readable media, such as, for example, flash memory (e.g., NAND or NOR) and other forms of volatile or non-volatile computer storage.5.5 AIR CIRCUIT

[0322] An air circuit 4170 in accordance with an aspect of the present technology is a conduit or a tube constructed and arranged to allow, in use, a flow of air to travel between two components such as RPT device 4000 and the patient interface 3000 or 3800.

[0323] In particular, the air circuit 4170 may be in fluid connection with the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases there may be separate limbs of the circuit for inhalation and exhalation. In other cases a single limb is used.

[0324] In some forms, the air circuit 4170 may comprise one or more heating elements configured to heat air in the air circuit, for example to maintain or raise the temperature of the air. The heating element may be in a form of a heated wire circuit, and may comprise one or more transducers, such as temperature sensors. In one form, the heated wire circuit may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller (e.g., a controller of the RPT device 4000). One example of an air circuit 4170 comprising a heated wire circuit is described in United States Patent 8,733,349, which is incorporated herewithin in its entirety by reference.5.6 HUMIDIFIER5.6.1 Humidifier overview

[0325] In one form of the present technology there is provided a humidifier 5000 (e.g. as shown in Fig. 6A) 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. When used in place of humidifier 5000 or in combination of humidifier 5000, vaporization device 4105 may perform the same function.

[0326] The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air. In some forms, as shown in Fig. 6A and Fig. 6B, an inlet and an outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004 respectively. The humidifier 5000 may further comprise a humidifier base 5006, which may be adapted toreceive the humidifier reservoir 5110 and comprise a heating element 5240. Similarly, vaporization device 4105 may, too, have an inlet and an outlet, as well as a reservoir.

[0327] In one form of the present technology there is provided a humidifier 5000 (e.g. as shown in Figs. 1A and IB) 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. When used in place of humidifier 5000 or in combination of humidifier 5000, cartridge assembly 1120, including vaporization device 1105, may perform the same function.

[0328] The humidifier 5000 may comprise a humidifier reservoir 5110, a humidifier inlet 5002 to receive a flow of air, and a humidifier outlet 5004 to deliver a humidified flow of air. In some forms, as shown in Fig. 6A and Fig. 6B, an inlet and an outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004 respectively. The humidifier 5000 may further comprise a humidifier base 5006, which may be adapted to receive the humidifier reservoir 5110 and comprise a heating element 5240. Similarly, cartridge assembly 5140 may, too, have an inlet and an outlet, as well as a reservoir and may operate in a similar manner, as described further below.

[0329] Cartridge assembly 5140, including vaporization device 5105, may be coupled to a one or more components of humidifier 5000. For example, vaporization device 5105may be disposed within the air flow path from the humidifier. In such a way, a liquid may be vaporized and introduced into the air flow to produce humidified air and delivered to the patient. One or more sensors 5111 may be coupled to one or more portions of humidifier 5000, for example, within the air flow path. Sensor(s) 5111 may be configured to detect data, and data received from sensor(s) 5111 may be used to at least partially affect the operation of cartridge assembly 5140 and / or vaporization device 5105. Vaporization device 5105 may be configured to deliver a vaporized substance (e.g., a liquid, a material, a compound, a medicine, etc.) into the air flowing through RPT device 4000 and to the patient.5.6.2 Humidifier components5.6.2.1 Water reservoir

[0330] According to one arrangement, the humidifier 5000 may comprise a water reservoir 5110 configured to hold, or retain, a volume of liquid (e.g. water) to be evaporated for humidification of the flow of air. Vaporization device 4105 may similarly comprise a water reservoir, but the water reservoir of vaporization device 4105 may be substantiallysmaller compared to that of a conventional humidifier 5000. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water in order to provide adequate humidification for at least the duration of a respiratory therapy session, such as one evening of sleep. Typically, the reservoir 5110 is configured to hold several hundred millilitres of water, e.g. 300 millilitres (ml), 325 ml, 350 ml or 400 ml. In other forms, the humidifier 5000 may be configured to receive a supply of water from an external water source such as a building’s water supply system.

[0331] According to one aspect, the water reservoir 5110 of the humidifier 5000 and / or the water reservoir of the vaporization device 4105 is configured to add humidity to a pressurized flow of air from the RPT device 4000 as the flow of air travels therethrough. In one form, the water reservoir 5110 may be configured to encourage the flow of air to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

[0332] According to one form, the reservoir 5110 may be removable from the humidifier 5000, for example in a lateral direction as shown in Fig. 6A and Fig. 6B. In a further example, the water reservoir of the vaporization device 4105 may be removable.

[0333] The reservoir 5110 of the humidifier and / or the water reservoir of the vaporization device 4105 may also be configured to discourage egress of liquid therefrom, such as when the reservoir 5110 is displaced and / or rotated from its normal, working orientation, such as through any apertures and / or in between its sub-components. As the flow of air to be humidified by the humidifier 5000 is typically pressurised, the reservoir 5110 may also be configured to prevent losses in pneumatic pressure through leak and / or flow impedance.

[0334] According to one arrangement, the humidifier 5000 may comprise a water reservoir 5110 configured to hold, or retain, a volume of liquid (e.g. water) to be evaporated for humidification of the flow of air. Cartridge assembly 5140 may similarly comprise a a housing that forms a reservoir, but the reservoir of cartridge assembly 5140 may be substantially smaller compared to that of a conventional humidifier. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water to provide adequate humidification for at least the duration of a respiratory therapy session, such as one evening of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, e.g. 300 milliliters (ml), 325 ml, 350 ml or 400 ml. In other forms, the humidifier 5000 may be configured to receive a supply of water from an external water source such as a building’s water supply system.

[0335] According to one aspect, the water reservoir 5110 and / or cartridge assembly 5140 is configured to add humidity to a flow of air from the RPT device 4000 as the flow of air travels therethrough. In one form, the water reservoir 5110 may be configured to encourage the flow of air to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

[0336] According to one form, the reservoir 5110 and / or cartridge assembly 5140 may be removable from the humidifier 5000, for example in a lateral direction as shown in Fig. 6A and Fig. 6B.

[0337] The reservoir 5110 and / or cartridge assembly 5140 may also be configured to discourage egress of liquid therefrom, such as when the reservoir 5110 is displaced and / or rotated from its normal, working orientation, such as through any apertures and / or in between its sub-components. As the flow of air to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent losses in pneumatic pressure through leak and / or flow impedance.5.6.2.2 Conductive portion

[0338] According to one arrangement, the reservoir 5110 comprises a conductive portion 5120 configured to allow efficient transfer of heat from the heating element 5240 to the volume of liquid in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, although other shapes may also be suitable. All or a part of the conductive portion 5120 may be made of a thermally conductive material such as aluminium (e.g. approximately 2 mm thick, such as 1 mm, 1.5 mm, 2.5 mm or 3 mm), another heat conducting metal or some plastics. In some cases, suitable heat conductivity may be achieved with less conductive materials of suitable geometry.5.6.2.3 Humidifier reservoir dock

[0339] In one form, the humidifier 5000 may comprise a humidifier reservoir dock 5130 (as shown in Fig. 6B) configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir dock 5130 may comprise a locking feature such as a locking lever 5135 configured to retain the reservoir 5110 in the humidifier reservoir dock 5130.5.6.2.4 Water level indicator

[0340] The humidifier reservoir 5110 may comprise a water level indicator 5150 as shown in Fig. 6A-6B. In some forms, the water level indicator 5150 may provide one or more indications to a user such as the patient 1000 or a care giver regarding a quantity of the volume of water in the humidifier reservoir 5110. The one or more indications provided bythe water level indicator 5150 may include an indication of a maximum, predetermined volume of water, any portions thereof, such as 25%, 50% or 75% or volumes such as 200 ml, 300 ml or 400ml.5.6.2.5 Humidifier transducer(s)

[0341] The humidifier 5000 may comprise one or more humidifier transducers (sensors) 5210 instead of, or in addition to, transducers 4270 described above. Similarly, vaporization device 4105 may include one or more sensors or may be in direct or indirect communication with one or more sensors. Similarly, cartridge assembly 5140 may include one or more sensors 5111 or may be in direct or indirect communication with one or more sensors 5111. Humidifier transducers 5210 may include one or more of an air pressure sensor 5212, an air flow rate transducer 5214, atemperature sensor 5216, or a humidity sensor 5218 as shown in Fig. 6C. A humidifier transducer 5210 may produce one or more output signals which may be communicated to a controller. The controller may be part of an RPT device as discussed herein and / or the humidifier controller 5250. In some forms, a humidifier transducer may be located externally to the humidifier 5000 (such as in the air circuit 4170) while communicating the output signal to the controller.5.6.2.5.1 Pressure transducer

[0342] One or more pressure transducers 5212 may be provided to the humidifier 5000, cartridge assembly 4130, 5140, and / or vaporization device 4105, 5105 in addition to, or instead of, a pressure sensor 4272 provided in the RPT device 4000.5.6.2.5.2 Flow rate transducer

[0343] One or more flow rate transducers 5214 may be provided to the humidifier 5000, cartridge assembly 4130, 5140, and / or vaporization device 4105, 5105 in addition to, or instead of, a flow rate sensor 4274 provided in the RPT device 4000.5.6.2.5.3 Temperature transducer

[0344] The humidifier 5000, cartridge assembly 4130, 5140, and / or vaporization device 4105, 5105 may comprise one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures such as of the heating element 5240 and / or of the flow of air downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may further comprise a temperature sensor 5216 to detect the temperature of the ambient air.5.6.2.5.4 Humidity transducer

[0345] In one form, the humidifier 5000, cartridge assembly 4130, 5140, and / or vaporization device 4105, 5105 may comprise one or more humidity sensors 5218 to detect ahumidity of a gas, such as the ambient air. The humidity sensor 5218 may be placed towards the humidifier outlet 5004 in some forms to measure a humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.5.6.2.6 Heating element

[0346] A heating element 5240 may be provided to the humidifier 5000 in some cases to provide a heat input to one or more of the volume of water in the humidifier reservoir 5110 and / or to the flow of air. The heating element 5240 may comprise a heat generating component such as an electrically resistive heating track. One suitable example of a heating element 5240 is a layered heating element such as one described in the PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herewith by reference in its entirety.

[0347] In some forms, the heating element 5240 may be provided in the humidifier base 5006 where heat may be provided to the humidifier reservoir 5110 primarily by conduction as shown in Fig. 6B.5.6.2.7 Humidifier controller

[0348] According to an arrangement of the present technology, a humidifier 5000 , cartridge assembly 4130, 5140, and / or vaporization device 4105, 5105 may comprise or use one or more controllers. Such controllers may include a humidifier controller 5250 as shown in Fig. 6C. In one form, the humidifier controller 5250 may be a part of a central controller that is included in RPT device 4000. In another form, the humidifier controller 5250 may be a separate controller, which may be in communication with such a central controller .

[0349] In one form, the humidifier controller 5250 may receive as inputs measures of properties (such as temperature, humidity, pressure and / or flow rate), for example of the flow of air, the water in the reservoir 5110 and / or the humidifier 5000 (or cartridge assembly 4130, 5140). The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0350] As shown in Fig. 6C, the humidifier controller 5250 include or cooperate with a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of a heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of a heating element 5240. Humidifier controller 5250 may similarly control similar elements of vaporization device 4105, 5105, and / or cartridge assembly 4130, 5140.5.6.2.8 Cartridge Assembly

[0351] As will be discussed in further detail below, a cartridge assembly 5140 and vaporization device 5105, may be used in combination with or instead of humidifier 5000, and may be incorporated as part of or relative to any suitable component of the respiratory therapy system. In the example of Figs. 6A and 6B, cartridge assembly 5140 may be coupled to one or more components of humidifier 5000, such as, for example, humidifier base 5006, or one or more sensors 150 may be coupled to reservoir 5110 or to other components of humidifier 5000 or the respiratory therapy system. One or more sensors 5111, cartridge assembly 5140, and / or vaporization device 5105 may be disposed within the air flow path. Data received from sensor(s) 5111 may be configured to at least partially affect the operation of cartridge assembly 5140. The vaporization device 5105 may be operationally engaged with the cartridge assembly 5140. The vaporization device 5105 may be integrated into the cartridge assembly 5140. Vaporization device 5105 may be configured to deliver a liquid (e.g., water) into the air flowing through humidifier 5000 to the patient.5.6.3 Vaporization Device

[0352] As will be discussed in further detail below, a vaporization device 5105 may be used in combination with or instead of humidifier 5000, and may be incorporated as part of or relative to any suitable component of the respiratory therapy system. In the example of FIGS. 5 A and 5B, a vaporization device 5105 may be coupled to one or more components of humidifier 5000, such as, for example, humidifier base 5006. Additionally, one or more sensors 5111 may be coupled to reservoir 5110 or to other components of humidifier 5000 or the respiratory therapy system. One or more sensors 5111 and vaporization device 5105 may be disposed within or exposed to the air flow path. Data received from sensor(s) 5111 may be configured to at least partially affect the operation of vaporization device 5105. Vaporization device 5105 may be configured to vaporize a liquid (e.g., water) into the air flowing through humidifier 5000 to the patient.5.7 BREATHING WAVEFORMS

[0353] Fig. 7 shows a model typical breath waveform of a person while sleeping. The horizontal axis is time, and the vertical axis is respiratory flow rate. While the parameter values may vary, a typical breath may have the following approximate values: tidal volume Vt 0.5L, inhalation time Ti 1.6s, peak inspiratory flow rate Qpeak 0.4 L / s, exhalation time Te 2.4s, peak expiratory flow rate Qpeak -0.5 L / s. The total duration of the breath, Ttot, is about4s. The person typically breathes at a rate of about 15 breaths per minute (BPM), with Ventilation Vent about 7.5 L / min. A typical duty cycle, the ratio of Ti to Ttot, is about 40%.

[0354] The typical breathing waveform may be used, for example, to provide parameters for turning on or off the vaporization devices discussed above. For example, as the person inhales, the vaporization device (e.g., vaporization device 1105, 3105, 4105, 5105) may be turned on or powered to heat up such that a liquid is vaporized and delivered into the air flow that is delivered to the patient to humidify the air flow. The vaporization device may be configured such that the vaporization device reaches temperatures necessary to vaporize the substance within milliseconds, e.g., tens or hundreds of milliseconds, allowing the vaporization device to heat up quickly and humidify the air during inhalation and then be turned off, powered down, or turned down (i.e., power reduced but not eliminated) to reduce the temperature of the vaporization device during exhalation, as described further below. The material(s) of the vaporization device may be selected such that the vaporization device has low thermal mass or heat capacity. Once the vaporization device vaporizes the liquid contained therein during one heating cycle (e.g., corresponding to one inhalation phase), the heat energy lost by the vaporization device to vaporize the liquid, including latent heat of vaporization, reduces the temperature of the vaporization device such that it does not continue vaporizing liquid after the heating power is removed or reduced. Also because of the relatively low thermal mass or heat capacity of the material(s) of the vaporization device the vaporization device does not retain sufficient heat energy once lost due to vaporization to continue vaporization in the absence of sufficient heating power applied by a heating element.

[0355] The typical breathing waveform may be used, for example, to provide parameters for turning on or off the cartridge assembly discussed above. For example, as the person inhales, cartridge assembly 1120 may be configured to heat liquid within vaporization device 1105 to vaporize the liquid into the air flow that is delivered to the patient. In some examples, the air may be humidified when the liquid is delivered into the air flow path. Additionally or alternatively, the air flow may be dosed with a substance such as a medication. The cartridge assembly 1120 may be configured such that the vaporization device 1105 reaches temperatures necessary to heat the substance within milliseconds, allowing the cartridge to deliver the liquid into the air during inhalation and turn off or turn down the temperature of the vaporization device 1105 during exhalation, as described further below. Since humidification is only needed during inhalation when a user is breathing in the air flow, the cartridge assembly 1120 may be timed to turned on to humidify air only during inhalation.Using the cartridge assembly 1120 in such a manner may decrease the amount of water used by the vaporization device 1105 since it is not constantly running, as well as the amount of power used. This may in turn allow for use of a smaller reservoir in the cartridge assembly 1120, as well as a reduction in power use. Accordingly, the cartridge assembly 1120 may be smaller than a conventional humidifier 5000 by using less water than humidifier 5000, as well as using less power.

[0356] The exemplary data presented in Figs. 7B and 7C may be utilized by cartridge assembly 1120, for example, to tailor or customize a patient’s experience. For example, reference to Figs. 7B and 7C, cartridge assembly 1120 may be configured to turn on or off in response to any number of thresholds set manually or through learning algorithms. For example, cartridge assembly 1120 may be configured such that the liquid is released from vaporization device 1105, into the air flow when SpO2, Flow, Thoracic Movement, and / or Abdominal movement is abnormal, or crosses a set threshold. Similarly, cartridge assembly 1120 may be configured such that the liquid is released from vaporization device 1105 when any number of measurements, not limited to those discussed herein, is / are below or above a threshold. Abnormal readings may indicate the patient is in distress, having difficulty breathing, or experiencing any other symptoms indicative of a medical condition. Vaporizing the substance from vaporization device 1105 into the air flow may assist in minimizing or alleviating the patient’s symptoms and / or to prevent harm to the patient.

[0357] Since humidification may only be needed during inhalation when a user is breathing in the air flow, the vaporization device may be timed to turned on to humidify air only during inhalation. Using the vaporization device in such a manner may decrease the amount of water used by the vaporization device since it is not constantly running, as well as the amount of power used. This may in turn allow for use of a smaller reservoir in the vaporization device, as well as a reduction in power use. Accordingly, the vaporization device to be smaller than a conventional humidifier 5000 by using less water than humidifier 5000, as well as using less power.

[0358] Further, such a short ramp-up time on the order of tens or hundreds of milliseconds may mean that humidification can be provided to the air flow very quickly, which may improve the user experience. Another benefit is that water to be vaporized and added to the air flow may not need to be pre-heated for long, which may further save power.5.8 PATIENT INTERFACE AND VAPORIZATION DEVICE

[0359] As illustrated in Fig. 8A, the patient may wear the cushion 3050-1 in a tube-up configuration with the tubes 3350 and the four-point positioning and stabilizing structure3300. This assembly may form a tube-up, nose-and-mouth patient interface 3000-1. Patient interface 3000-1 may include vaporizer 3105, a cartridge assembly 3120, and / or one or more sensors 3110.

[0360] In some forms, a conduit sleeve may be used with the tubes 3350 in order to enable a patient to experience the “tube up” air delivery style with the mouth and nose cushion 3050-1. As is described below, the conduit sleeve provides additional connection locations for connecting the positioning and stabilizing structure 3300. However, other forms of connectors aside from or in addition to the conduit sleeve may be used.

[0361] In the illustrated example, the conduit sleeves may be connected to the tubes 3350 of the positioning and stabilizing structure 3300. The tubes 3350 (via the conduit connection structure 3500), may be used to connect the tubes 3350 to the cushion 3050-1. The conduit sleeves provide the magnets in order to connect to the magnets of the four-point positioning and stabilizing structure 3300. Alternatively, a different connection form may be used.

[0362] For example, the inferior straps 3304-1 (e.g., via the magnetic members 3306-1) may removably connect to the magnets of the conduit sleeves. In use, each inferior strap 3304-1 may contact the patient’s cheek (e.g., overlaying the masseter muscle). The inferior straps 3304-1 may also extend below the patient’s ears.

[0363] As illustrated in Fig. 8B, the patient may wear the cushion 3050-1 in a tube-down configuration with the rigidiser arms 3340 and the four-point positioning and stabilizing structure 3300. This assembly may form a tube-down, nose-and-mouth patient interface 3000-2.

[0364] In some forms, a conduit sleeve may be used with the rigidiser arms 3340 in order to enable a patient to experience the “tube-down” air delivery style with the mouth and nose cushion 3050-1. As is described below, the conduit sleeve provides additional connection locations for connecting the four-point positioning and stabilizing structure 3300. However, other forms of connectors aside from or in addition to the conduit sleeve may be used.

[0365] As illustrated in Fig. 8C, the patient may wear the cushion 3050-2 in a tube-up configuration with the tubes 3350 and the two-point positioning and stabilizing structure 3300. This assembly may form a tube-up, nose-only patient interface 3000-3.

[0366] A conduit sleeve may be used with the tubes 3350 and may provide additional comfort to the patient. The sleeve may not add additional connection points to connect the positioning and stabilizing structure 3300 on the cushion 3050-2. In the illustrated example, the tubes 3350 of the positioning and stabilizing structure 3300 may be connected directly to the cushion 3050-2.

[0367] As illustrated in Fig. 8C, the two-point positioning and stabilizing structure 3300 may connect to the tabs 3320 on the tubes 3350 in order to provide a tensile force that maintains the cushion 3050-2 in a sealing position on the patient’s head.

[0368] As illustrated in Fig. 8D, the patient may wear the cushion 3050-2 in a tube-up configuration with the rigidiser arms 3340 and the two-point positioning and stabilizing structure 3300. This assembly may form a tube-down, nose-only patient interface 3000-4.

[0369] A conduit sleeve may be used with the rigidiser arms 3340 and may provide additional comfort to the patient. The sleeve may not add additional connection points to connect the positioning and stabilizing structure 3300 on the cushion 3050-2. In the illustrated example, the rigidiser arms 3340 of the positioning and stabilizing structure 3300 may be connected directly to the cushion 3050-2.

[0370] As illustrated in Fig. 8D, the two-point positioning and stabilizing structure 3300 may connect to the tabs 3320 on the sleeve in order to provide a tensile force that maintains the cushion 3050-2 in a sealing position on the patient’s head.

[0371] The elements described above with respect to Fig. 8A-8D may be used in combination with one another, for example, to form different patient interfaces. One or more of the components may be reused for different styles of patient interfaces. This may allow for easier manufacturing and assembly, because a large number of the same components may be produced and used in a variety of styles.

[0372] Furthermore, as illustrated in Figs. 8A-8D, vaporizer 3105, a cartridge assembly 3120, and / or sensor(s) 3110 may each be included in or on or coupled to various aspects of the different patient interfaces. For example, vaporizer 3105 may be disposed between two components of the patient interface. Sensor(s) 3110 may be coupled to the patient interfaces, elsewhere along the air flow path. In any of the configurations described above, vaporizer 3105 is configured such that vaporizer 3105 is at least partially exposed to the air flowing through the patient interface. Additionally, sensor(s) 3110 is / are configured such that sensors(s) 3110 are at least partially exposed to the air flowing through the patient interface. Sensor(s) 3110 may be configured to detect and transmit (e.g., wirelessly or via at least one wire) information that may be used to at least partially affect the operation of vaporizer 3105. The information may pertain to the air flow or any other aspect of the therapy being delivered.5.9 VAPORIZATION DEVICE AND SENSORS

[0373] Devices, systems, and methods to humidify the flow of air supplied to a patient using a vaporization device are described below. Adding a vaporization device to arespiratory therapy system, e.g., with the patient interface or the respiratory pressure therapy device, such as the ones described above, may assist in one or more of decreasing the size, or footprint, of the breathing devices and / or systems, increasing patient comfort during use, decreasing the water necessary to humidify the air flowing through the system, decreasing energy required to power the respiratory therapy system, as compared to conventional systems, among other benefits. In some examples, the vaporization device may be well suited for travel, for example, due to the reduced size of the device and portability of the smaller device. Additionally, the vaporization device may be configured to operably couple to or on or in a respiratory therapy device, and / or between two respiratory therapy devices. In some examples, the vaporization device may be operably coupled to any standard tube connector or air circuit. In such a way, the vaporization device may be used on or with a variety of respiratory therapy devices and / or systems.

[0374] As will be described in further detail below, one or more sensors may be used in combination with the vaporization device. For example, the one or more sensors may be configured to detect a physical phenomenon (e.g., pressure, temperature, force, etc.) and output a signal to thereby provide information to the vaporization device, a controller, or another component in the respiratory therapy system. The information that is received from the sensors may be used to at least partially affect, or control, the operation of the vaporization device, the controller, or other component in the respiratory therapy system.

[0375] A vaporization device may be used to vaporize a substance (e.g., a liquid, such as water, or a material) for inhalation. For example, the vaporization device may be rapidly heated such that vapor is released into the airflow path from the substance held therein for delivery to the patient’s airways. The vapor, e.g., vaporized water, may increase humidity of the air flowing through the respiratory therapy system. In some examples, the vaporization device may be configured to vaporize a liquid (e.g., water, medicine, etc.) or a material (e.g., a medicine, a compound, etc.). In some examples, the substance may be a therapeutic substance to alleviate symptoms of and / or treat breathing disorders, such as those discussed above. Additionally or alternatively, the liquid or solid substance may provide a flavor, an aroma, and / or alter the taste or scent of the air flowing through the respiratory therapy system. In such a way, humid air and / or air dosed with the substance may be delivered to the patient. Delivering humid air and / or delivering air that has been dosed with one or more substances may increase patient comfort and, thus, increase compliance. The vaporization device may be used alone or in combination with a humidifier, such as, for example, humidifier 5000, discussed above.

[0376] The position of the vaporization device and the sensor(s) may vary. For example, the vaporization device may be positioned anywhere along the air flow path. In some examples, the vaporization device may be positioned proximal to a motor control of the RPT device, a pressure sensor, an ambient humidity, and / or ambient temperature sensor, among other components of the respiratory therapy system. In such examples, the vaporization device may be adjacent to or integrated with the respiratory pressure therapy device.

[0377] Placing the vaporization device and / or the sensor(s) along the air flow path may provide for additional time for air temperature regulation through the subsequent portions of the air flow path. In some examples, the sensors may be located proximal to the vaporization device, for example, in order to provide additional time to sense and / or analyze data related to the air conditions of the air flow path and / or ambient air. In some examples, the additional time may be used to carry out adjustment of the settings or control of the vaporization device, for example, in response to the air conditions of the air flow path and / or ambient air. In such an example, the sensor(s) may be placed upstream of the vaporization device and proximal to the RPT device relative to the air flow path, and the vaporization device may be placed downstream from the sensor(s) and the RPT device relative to the air flow path. In examples, the sensor(s) and vaporization device may be separated by approximately 0. 1 cm up to over approximately 3 meters. One or more of the arrangements described above may enable humidity sensing within the control system of the vaporization device to enable targeted activation of the humidification system. Inlet can also be integrated with inlet filtration systems that are commonly replaced by the user.5.9.1 Vaporization Device and Sensors Configurations

[0378] Fig. 9A illustrates a partially exploded top view of an exemplary configuration of a vaporization device 100. Fig. 9B illustrates a side view of vaporization device 100. Vaporization device 100 may include a reservoir 120 and a vaporization module 105 containing a vaporizer 110. In this configuration, the vaporization device 100 may be fixedly or removably disposed between a first portion 170A and a second portion 170B of an air circuit 170 such that vaporization module 105 is in fluid communication with first portion 170A and second portion 170B. For example, a proximal end 101 of vaporization module 105 may be coupled to a distal end 171 of first portion 170A, and a distal end 102 of vaporization module 105 may be coupled to a proximal end 173 of second portion 170B of air circuit 170. A distal end 175 of second portion 170B may be in fluid communication with a patient interface, such as those shown and described above. A proximal end 177 of first portion170A may be in fluid communication with an RPT device, such as the RPT devices described above.

[0379] In some examples, the vaporizer 110 may be a capillary force vaporizer constructed from one or more layers of porous material through which a liquid can be transported by capillary effect from a side in contact, or at least in fluid communication with (e.g., via a wick), with the liquid in the reservoir 120 to an opposite side where the vaporized liquid is discharged into the pressurized flow of air. The porous material may be ceramic, metal formed with pores, a sintered material (e.g., metal), quartz, a polymer, or a fibrous material. The porous material may have a relatively low heat capacity such that when heated it does not retain a significant amount of heat after the loss of heat to vaporize the liquid, e.g., due to the latent heat of vaporization. The vaporizer 110 may include a heating element to heat the liquid in the porous material. The heating element may be an electric resistance heater. The heating element may include a conductive filament that generates when a current passes through it. The vaporizer 110 may be sealed around its exterior by a non-porous material so that vaporized liquid is forced to exit through one or more orifices.

[0380] In some examples, the vaporization device 100 may be disposed between first portion 170 A and second portion 170B of air circuit 170 such that air may flow continuously from first portion 170A (e.g., via a central lumen 172 of first portion 170A), through a vaporization passage 106 of the vaporization module 105 (e.g., via a lumen 174 of vaporization module 105), and into second portion 170B of air circuit 170 (e.g., via a central lumen 176 of second portion 170B). Vaporization device 100 may be coupled to first portion 170A and second portion 170B by a screw -fit, a press-fit, adhesive, welding, or any other means commonly used in the art to permanently or temporarily couple two components. Air circuit 170 may or may not be a ‘smart’ tube.

[0381] The vaporizer 110 may be disposed or positioned within a portion of vaporization module 105. For example, the vaporizer 110 may be disposed or positioned within vaporization module 105 such that a first side 110A of the vaporizer 110 is exposed to the air flowing through vaporization module 105, and such that a second side 110B is exposed to container 122 of reservoir 120. In such a way, the vaporizer 110 is configured such that a material or liquid contained within container 122 of reservoir 120 may be vaporized by the vaporizer 110 and delivered into the air path. Reservoir 120 may be out of the air path, which may reduce the number of components that may need to be reprocessed. In some examples, the reservoir 120 is positioned above the vaporizer 110 in an operational orientation such that the material or liquid contained within container 122 of reservoir 120 may be gravity-fed ontothe vaporizer 110. For example, the material or liquid contained within container 122 of reservoir 120 may seep into the vaporizer 110. In such examples, a wick may be included to ensure a constant supply of liquid or material to the vaporizer 110 during, or the gravity-fed arrangement may be sufficient to ensure a constant supply of liquid or material to the vaporizer 110 such that there is no wicking element, and the liquid or material in the container 122 of the reservoir 120 is directly exposed to the vaporizer 110.

[0382] In some examples, reservoir 120 may be pre-filled or refillable. For example, reservoir 120 may be replaced prior to or after each use to provide a new supply of liquid for the vaporizer 110 to vaporize. In other aspects, reservoir 120 may be refilled prior to or following use. In either case, the reservoir 120 may be removable for replacement with a new pre-filled reservoir 120, or the refilled reservoir may be returned after refilling. In a further alternative of the refillable reservoir 120, the reservoir 120 may be permanently attached to the vaporization module 105, and in a still further the vaporization device 100 may be removable from other components of the RPT system, e.g., the air circuit 170, for refilling of the reservoir 120. Also, the whole vaporization device 100 may be replaceable on a periodic basis.

[0383] In some examples, the vaporizer 110 may be built into the reservoir 120, and the vaporizer 110 may also be disposable or reusable. For example, the reservoir 120 may be a container with a lid on or in which the vaporizer 110 is incorporated. In some examples, the reservoir 120 may be made of a polymer, such as polyethylene terephthalate, polycarbonate, or other suitable material. The reservoir 120 may be expandable or made with a pliable material. In such a way, the reservoir 120 may be folded, compressed, or bent, for example, during travel or storage. The reservoir 120 may also be collapsible as the volume of the substance contained therein decreases during therapy. Accordingly, a volume of reservoir 120 may be minimized when the reservoir 120 is not in use and maximized during use. In still further examples, a water purification system may be incorporated into the reservoir 120. The reservoir 120 may be constructed from a relatively flexible material, e.g., more flexible than the remainder of the vaporization module 105, to allow it to collapse when empty or filled to less than its maximum volume. The relatively flexible material may be a rubber or a polymer. For example, a distiller or reverse osmosis mechanism may be incorporated to clean the liquid, e.g., water, prior to vaporization to improve the consistency of water quality.

[0384] In some examples, the vaporizer 110 is configured to vaporize the substance based, at least in part, on ambient room conditions. For example, the vaporizer 110 may be configured to vaporize the substance or vaporize more of the substance if the humidity in theroom is below a desired threshold. Alternatively, the vaporizer 110 may be configured to vaporize less or none of the substance if the humidity in the room is at or above a desired threshold. For example, if ambient conditions are sufficiently humid, the vaporizer 110 may be configured to turn off and stop vaporizing the liquid. One or more sensors incorporated as part of the respiratory therapy system may be configured to detect ambient humidity levels and may transmit detected information to the vaporizer 110 or a controller operably coupled to the vaporizer 110. If ambient humidity is below a certain threshold, then the vaporizer 110 may be turned on, e.g., by the controller. If ambient humidity is below a certain threshold, then the vaporizer 110 may be turned off, e.g., by the controller. One or more sensors may be configured to detect ambient conditions at regular or irregular time intervals (e.g., each time an RPT system is powered on, each time a blower is started, every hour, etc.) so that if ambient conditions change, operation of the vaporizer 110 may be adjusted appropriately.

[0385] In some examples, the vaporizer 110 may be configured to vaporize the substance based on an algorithm. The algorithm may be provided in the form of a firmware, software, and / or hardware. For example, the controller (which comprises one or more hardware processors) may execute a software program that acquires or otherwise processes (e.g., from sensors or the like) and stores (e.g., to a non-transitory storage medium) data regarding the user, the user’s humidification profile (e.g., humidification preferences), ambient humidity of the room in which the vaporizer 110 is located, and / or other aspects. The algorithm may then process information regarding the user, the user’s humidification profile (e.g., humidification preferences), ambient humidity of the room in which the vaporizer 110 is located, etc., to control or influence the performance of the vaporizer 110, thereby tailoring the delivery of the substance to the user.

[0386] As an illustrative example, heating of the vaporization module 105 may be timed (e.g., based on processing performed by the algorithm) such that the vaporizer 110 vaporizes the substance when the user is inhaling or just before the user inhales. For example, a software application may generate (or cause to generate) a control signal that is communicated to the vaporizer. The control signal may be to activate (e.g., such that when the vaporizer 110 received the signal, it activates), or may be provided to activate at a given timing. In such a way, an amount of the substance that reaches the user may be controlled based on the processing that is performed by the algorithm. The amount of substance that is lost due to ventilation when the user exhales may also be decreased because the vaporized substance is distributed to the pressurized air flow when inhalation is predicted and only in the quantity necessary for a single phase of inhalation. In some examples, the energy neededto power the vaporization module 105 and / or the vaporizer 110 may be reduced because the vaporizer 110 is only on (or otherwise activated to perform vaporization of a substance) when the patient inhales. As a non-limiting illustrative example, over the course of 8 hours, vaporizer 110 may activate in correspondence with or based on inhalation (e.g. whether predicated or detected inhalation). At other time periods (e.g., when the patient is exhaling during sleep), the vaporizer may not be activated. In certain examples, the vaporizer 110 may be “on” during the entire period (e.g., of treatment) and may dynamically switch between two (or more) operating modes. A first mode may correspond to a patient inhaling, a second mode to a patient exhaling (or not inhaling). In the second mode, the vaporizer may consume less power and / or decrease an amount of vaporization of the substance.

[0387] In other examples, default humidity thresholds may be set in the controller to determine when the controller turns on or turns off (e.g., it is or is not powered) the vaporizer 110. In still further examples, these default thresholds may be adjusted by a user or adjusted automatically based on one or more of the user’s preferred humidification profile (e.g., drier or more humid), geographic location (e.g., a typical humidity level for a given area or geographical location), seasons (e.g., winter or summer), etc.

[0388] In some examples, an algorithm stored and operated by the controller may be programmed to leam a user’s personal humidification profile overtime and may adjust the functional performance of the vaporizer 110 to deliver more or less humidity to the air flow. In some examples, a user may be able to temporarily adjust his or her personal humidification preferences (e.g., to a higher or lower humidity) when the user has a cold or following a nose bleed.

[0389] In some examples, an air inlet filtration device (e.g., a filter) may be positioned upstream of the vaporization module 105 and the vaporizer 110. The air inlet filtration device may be configured to permit airflow through or to one or more components of the respiratory therapy system, such as, for example, the vaporization module 105. The air inlet filtration device may be configured to filter out any particulates, debris, or other foreign matter from the air flowing through the respiratory therapy system. In some examples, the air inlet filtration device may filter the air prior to the air reaching the vaporization module 105. Filtering the air before the air reaches the vaporization module 105 may aid in limiting buildup of particulates or debris on the vaporization module 105 and / or the vaporizer 110.

[0390] In other examples, the air inlet and / or the air inlet filtration device may be integrated with the vaporization module 105, for example, upstream of the vaporizer 110. In such examples, the air inlet filtration device may be proximal to the vaporizer 110, forexample, on a proximal portion of the vaporization module 105. The air inlet may be configured to permit airflow through or into the vaporization module 105 and / or to the vaporizer 110. The air inlet filtration device may filter the air after the air reaches the vaporization module 105, but prior to the air reaching the vaporizer 110. Filtering the air before the air reaches the vaporizer 110 may also aid in limiting buildup of particulates or debris on the vaporizer 110.

[0391] The air inlet and / or air inlet filtration device may be removable (e.g., for cleaning) and / or be replaceable.

[0392] Figs. 9A and 9B illustrate an exemplary position of the vaporization module 105 in line with air circuit 170. Fig. 9B is an elevation view that depicts the operational orientation of the vaporizer device 100 of this example, and the reservoir 120 is above the vaporization module 105, which is above the vaporization passage 106. However, the vaporizer 110 may be disposed along any portion of the air path such that the vaporizer 110 is exposed to the air flowing through any portion of the respiratory therapy system. In some examples, the vaporizer 110 may be disposed on / in or integrated with a surface of one or more components, and in other examples, the vaporizer 110 may be coupled to, between, or in line with one or more components. For example, the vaporizer 110 may be incorporated in, on, between, or adjacent to one or more of a patient interface, air circuit, blower, RPT device, or any other suitable component. In some examples, vaporizer 110 may be incorporated as part of a separate dongle or adapter that may permanently or removably connected with one or more of the components described herein. For example, Figs. 1A, IB, 4A-4C, 5A, 6A-6C, and 8A-8D depict exemplary components and locations on components where one or more of the vaporizer and / or the sensor(s) may be incorporated in a respiratory therapy system. Further, in regards to the location of the vaporizer on an individual component, the location may be optimized depending on the type of component used. For example, the location of a vaporization device on a patient interface or the characteristics of the vaporization device may depend, at least in part, on the type of patient interface (e.g., a nasal cannula versus a full face mask versus nasal cushions, etc.).

[0393] FIG. 10 illustrates a schematic of a vaporization device 200 temporarily or permanently disposed on a surface 250 of a component 251 of an exemplary respiratory therapy system. Component 251 may be a patient interface, an air circuit, a blower, an RPT device, or any component described above that is included in a respiratory therapy system. In some examples, the component 251 may be a separate dongle or adapter that may permanently or removably connected with one or more of the other components describedherein. Accordingly, the surface 250 may be a surface of any such component. The pressurized air flow 290 passes through the component 251.

[0394] Vaporization device 200 includes a vaporization unit 205 containing a vaporizer 210. Vaporization device 200 further includes a reservoir 220. Vaporization device 200 may be used similarly to vaporization device 100, described above. For example, the vaporization device 200 may be configured to deliver water vapor to air flowing through a respiratory therapy system. Additionally or alternatively, the vaporization device 200 may be configured to deliver a substance (e.g., a liquid substance such as medicine or water) into the air flowing through the respiratory therapy system. Reservoir 220 may be configured such that the liquid substance contained within the reservoir 220 wicks into the vaporizer 210, e.g., via capillary action, as indicated at 292. Once the substance wicks into the vaporizer 210, the substance may then be heated and vaporized by the vaporizer 210 and delivered into the air flow path, as indicated at 291. In some examples, the vaporizer 210 may include an absorbent wicking layer to assist in wicking liquid substance into the vaporizer 210. The wicking layer may also be configured to absorb the liquid substance such that the liquid substance is evenly distributed over the vaporizer 210. In such a way, the wicking layer may also inhibit clogs or blockages.

[0395] In other aspects, one or more wicks may be included in a vaporization device within an associated reservoir or in place of a reservoir. When the respiratory therapy system is not being used, e.g., during the day, a user may connect the vaporization device having one or more rechargeable wicks to a dock with a water chamber or may otherwise submerge in or provide water that may be absorbed by the one or more rechargeable wicks, e.g., saturating the rechargeable wicks. Prior to use, the vaporization device may be reattached to the respiratory therapy system. By recharging the wicks when the vaporization device is not in use, even with a smaller reservoir, the vaporization device may have sufficient water to provide humidified air during use. This may provide for a smaller respiratory therapy system.

[0396] In yet other aspects, a device may be disposed on or around component 251. The device may be exposed to the surrounding atmosphere. The device may include a material configured to absorb moisture from the surrounding atmosphere. The material may be a nonwoven material. In some examples, the material may be a shroud or a cylindrical covering that is disposed around a component of the respiratory therapy system, e.g., disposed around a tube, such as air circuit 4170, described above. The material and absorbed moisture may be stored in a wicking chamber. The vaporizer 210 may be configured to absorb the moisturecontained within the wicking chamber. Such a configuration may be used in addition to or instead of a reservoir for use with the vaporizer 210.

[0397] The vaporizer 210 may have any one or more of the characteristics of the vaporizer 110, described above with respect to Figs. 9A and 9B.

[0398] One or more sensors may be utilized in conjunction with the vaporizer 210. For example, one or more sensors may be disposed on or within the air pathway of the component 251 and may directly or indirectly (e.g., via a controller or other component) provide feedback (e.g., in the form of a signal that is generated by the sensor based on the sensed physical quantity) to the vaporizer 210 and / or additional devices of the respiratory therapy system (e.g., a controller or a computer).

[0399] The one or more sensors may provide data regarding the air flowing through the device or system. For example, the one or more sensors may provide information regarding the temperature of the air flowing through the device / system and / or the humidity of the air flowing through the device / system. Additionally or alternatively, the one or more sensors may be configured to sense physical phenomena regarding a direction, a volume, and / or a velocity of the air flowing through the respiratory therapy device and / or system. For example, an increase in air velocity may indicate the patient is inhaling, and a decrease in air velocity may indicate the patient is exhaling. Such information may be transmitted or relayed to the vaporizer, and the vaporizer may be operated (e.g., based on processing performed with the algorithm) to respond accordingly.

[0400] As illustrated in Fig. 10, a first sensor 240 may be disposed along the air pathway, for example, proximal to the vaporizer 210. First sensor 240 may be configured to detect a physical quantity of the air and to transmit information regarding the air upstream of the vaporizer 210. First sensor 240 may transmit (e.g., to a controller of the vaporizer 210 or to the vaporizer 210) a signal wirelessly or via a wired connection (e.g., via first cable 241) that may extend between the first sensor 240, a controller, and / or the vaporizer 210.

[0401] The vaporizer 210 may be configured to receive the data from the first sensor 240 and execute actions according to the data received (e.g., based on processing performed in connection with one or more algorithms as described herein). For example, in response to receiving data from first sensor 240, the vaporizer may be configured to do nothing or to alter its function. For example, the vaporizer 210 may be configured to turn on in response to an increase in air velocity, turn off in response to a decrease in air velocity, turn on to vaporize a liquid to increase the humidity of the air flowing through the device, turn off in response to stop vaporizing a liquid when sufficient humidity is detected upstream of the vaporizer 210and / or external to the respiratory therapy system, vaporize a liquid substance (e.g. a medicine, mixture, reagent, etc.) to release the liquid substance into the air flowing through the device, increase the temperature of the air flowing through the device, or any other action for which the vaporizer 210 may be configured to execute. In other aspects, the first sensor 240 may be configured to transmit data to a controller, which may then send instructions to the vaporizer 210 to function as previously described.

[0402] Additionally or alternatively, a second sensor 242 may be placed downstream of the vaporizer 210, for example, along a distal portion of the air pathway. Accordingly, the second sensor 242 may provide a signal regarding the air flow after the air flow passes the vaporizer 210. Second sensor 242 may be configured to transmit data regarding the airflow to the vaporizer 210. The transmission may be carried out via a wireless connection or via a second cable 243 extending between second sensor 242 and the vaporizer 210. In such a way, the second sensor 242 may provide feedback to the vaporizer 210. For example, the vaporizer 210 may be configured to receive the information from the second sensor 242 and adjust one or more aspects of the delivery of the vapor to the air flow (e.g., an amount, a type of material, a temperature, etc.). In other aspects, the second sensor 242 may be configured to transmit data to a controller, which may then send instructions to the vaporizer 210 to function as previously described.

[0403] Fig. 11 illustrates an alternative configuration of a vaporizer 310, which includes a vaporizer and an associated reservoir, coupled to a surface 350 of a component 351. In such a way, vaporizer 310 is configured such that a surface 312 of the vaporizer 310 is exposed to air flowing within component 351. In this configuration, a humidifying filter 370, e.g., a heat and moisture exchanger (HMX), may be included in the respiratory therapy system in conjunction with the vaporizer 310. The humidifying filter 370 may be constructed of a fibrous or non-fibrous and porous material that absorbs heat and moisture from exhaled gas from the patient and desorbs the heat and moisture into the incoming pressurized flow of air. The humidifying filter 370 may be treated with a salt to increase its absorbency.

[0404] In the example shown in FIG. 11, humidifying filter 370 may be located proximal to or upstream of vaporizer 310, for example, within a proximal portion of the pressurized air flow 390. In such a way, air may first flow through humidifying filter 370 and then past vaporizer 310. In this configuration, vaporizer 310 may be configured to provide additional humidity to the air flowing through humidifying filter 370, as indicated at 391. Humidifying filter 370 may be formed of a material configured to absorb moisture in the air flow. For example, humidifying filter 370 may be configured to absorb water vapor from a user’sexhaled air. The absorbed water vapor on or in humidifying filter 370 may then be evaporated into and reintroduced into the air flow during inspiration. Inclusion of fdter 370 may thus also promote humidification of the air flow. By incorporating the humidifying filter 370 in addition to the vaporizer 310, a reservoir of vaporizer 310 may not need to hold as much water, since the humidifying filter 370 may also capture and reintroduce water vapor into the inhaled air flow. Additionally or alternatively, a smaller vaporizer 310 and / or a smaller humidifying filter 370 may be used. Accordingly, inclusion of the humidifying filter 370 may allow the vaporizer 310 to be smaller.

[0405] One or more sensors may be disposed along the air flow path. For example, a first sensor 340 may be located upstream, e.g., proximal to, humidifying filter 370. A second sensor 342 may be located downstream, e.g., distal to, humidifying filter 370 and proximal, e.g., upstream, of the vaporizer 310. A third sensor 344 may be located downstream, e.g., distal to, both humidifying filter 370 and vaporizer 310. Each of the first sensor 340, the second sensor 342, and / or the third sensor 344 may be configured to transmit data related to the air flowing within component 351 to one or more of the vaporizer 310, the RPT device 4000, or one or more controllers operably coupled to the vaporizer 310. For example, in some aspects, the first sensor 340, the second sensor 342, and / or the third sensor 344 may be operably coupled to the RPT device 4000 wirelessly or via a wire extending between the RPT device 4000 and each respective sensor. In such a way, the first sensor 340, the second sensor 342, and / or the third sensor 344 may be configured to transmit information about the air flow to the RPT device 4000. Additionally or alternatively, the first sensor 340, the second sensor 342, and / or the third sensor 344 may be operably coupled to the vaporizer 310 or an associated controller wirelessly or via a wire extending between the vaporizer 310 and one or more of the first sensor 340, the second sensor 342, and / or the third sensor 344.

[0406] RPT device 4000 or a controller may be configured to store the information transmitted by each of the first sensor 340, the second sensor 342, and / or the third sensor 344. RPT device 4000 or a controller may also be operably coupled to the vaporizer 310. In such a way, the RPT device 4000 or an associated controller may be configured to transmit a signal to the vaporizer 310, for example, in response to the information received by one or more of the first sensor 340, the second sensor 342, and / or the third sensor 344. For example, the RPT device 4000 or an associated controller may be configured to turn on the vaporizer 310, increase the temperature of the vaporizer 310, or turn off the vaporizer 310, among other actions.

[0407] The vaporizer 310 may be powered by a power supply 380. Power supply 380 may be a batery or an external device, such as the RPT device 4000, configured to provide power to the vaporizer 310. Power supply 380 may be integrally formed with the vaporizer 310 or may be external to the vaporizer 310.

[0408] Component 351 may include a vent 352. In some examples, the operation of vent 352 may be powered by the power supply 380 or other power sources of the respiratory treatment device. Vent 352 may be configured for active or passive ventilation. For example, the vent 352 may include a fan or a motor (e.g., powered by the power supply 380) to aid the air flowing in or out of the component 351. In some examples, the vent 352 may be configured to open and / or close in response to the air flowing through the component 351 and / or in response to characteristics of the air flowing through the component 351. For example, the vent 352 may be configured to open when the user exhales and / or when the vaporizer 310 is off and close when the patient inhales and / or when the vaporizer 310 is on. By closing vent 352 when the user inhales and / or when the vaporizer 310 is vaporizing the liquid or substance, the loss of the liquid or substance vaporized into the air flow by the vaporizer 310 may be reduced. Vent 352 may be configured to release excess humidity within component 351. Vent 352 may be configured to open or close based on the humidity of the air flowing through component 351. For example, if the humidity within component 351 is above a threshold, vent 352 may open, thereby decreasing the humidity of the air. When the humidity within component 351 is at or below a threshold, vent 352 may close. In such a way, vent 352 may provide active ventilation. Additionally or alternatively, vent 352 may be configured as a valve. In such an example, vent 352 may be configured to operate within a pressurized system. For example, vent 352 may be configured to open and close at different pressure thresholds. In some examples, vent 352 may open when the user is exhaling and close when the patient is inhaling. The use of vent 352 may assist in improving the efficiency of vaporizer 310 and / or other aspects of the respiratory therapy system. In a still further example, the vent 352 may include or more holes that remains open to atmosphere continuously throughout the patient’s breathing cycle.

[0409] Although the power supply 380 is shown with respect to this configuration, any of the vaporization devices discussed herein may be batery powered or powered via an alternative power source. A batery-powered vaporization device may enable use of the vaporization devices discussed herein during travel and / or where remote power is difficult to source. Additionally or alternatively, the vaporization devices discussed herein may draw power from, e.g., RPT device 4000, or other components of the respiratory therapy system inor on which, or adjacent to which, the vaporizer 310 is incorporated. In further examples, the vaporizer discussed herein may draw power from alternative power sources. For example, in some configurations, the vaporizer 310 may be electrically coupled to a heating coil extending circumferentially around the air circuit 4170. The heating coil may be configured to heat the air flowing through the air circuit 4170 in addition to supplying power to the vaporizer. Alternatively, the vaporizer may be configured to plug into a separate controller or a separate module that is configured to provide power to the vaporizer.

[0410] Any of the vaporizers and vaporization devices discussed herein may also be removable or interchangeable. For example, the vaporizers discussed herein may be removable from the vaporization devices discussed herein. In such a way, the vaporizer may be easily changed or cleaned by removing the vaporizer from the vaporization device. In other aspects, the vaporization device and / or a reservoir or vaporizer in the vaporization device may be removable to be cleaned or refilled, for example.

[0411] Fig. 12 illustrates a vaporization device 400, including a vaporizer 410 and a heat sink 413. In this configuration, the vaporization device 400 may be disposed entirely within a component 451, for example, within the air flow path of the component 451. Component 451 may be any component of the respiratory therapy system described above. Except as described below, the vaporizer 410 may have any or all of the characteristics of the vaporizer 110 of Figs. 9A and 9B, the vaporizer 210 of Fig. 10, and / or the vaporizer 310 of Fig. 11. For example, the vaporizer 410 is configured to vaporize a liquid and / or a substance, as indicated at 491. In such a way, the humidity of the air flowing through the component 451 may be increased and / or the air flowing through the component 451 may be dosed with the substance.

[0412] In this configuration, the vaporizer 410 is operably coupled to the heat sink 413.For example, a first surface 412 of the vaporizer 410 may be exposed to the air flowing through the component 451. The vaporized liquid and / or substance may into the air flow path via the first surface 412.

[0413] Heat sink 413 may be operably coupled to a second surface 414 of the vaporizer 410. Heat sink 413 may be configured to absorb excess heat coming from the vaporizer 410. As the heat sink 413 absorbs the heat from the vaporizer 410, the air flowing through the component 451 may be heated by the heat sink 413. Providing warm air to the patient may increase patient comfort. Furthermore, removing excess heat from the vaporizer 310 may increase the longevity of the vaporizer 310. As illustrated, the heat sink 413 may include a plurality of fins, thereby providing more surface area during a heat transfer.

[0414] One or more sensors may be utilized in the configuration shown in Fig. 12. For example, a first sensor 440 may be disposed within the air flow path, upstream, e.g., proximal of, the vaporization device 400. Additionally or alternatively, a second sensor 442 may be disposed downstream, e.g., distal to, vaporization device 400. First sensor 440 and / or the second sensor 442 may have any or all of the characteristics of the sensors described above with respect to Figs. 10 and 11. For example, the first sensor 440 and / or the second sensor 442 may detect a physical quantity of the air, generate a signal, and then transmit data regarding the air flowing through the component 451 to one or more of the vaporizer 410, a controller, and / or to other components of the respiratory therapy system. For example, the first sensor 440 and / or the second sensor 442 may transmit a signal to a controller that causes the controller to adjust one or more parameters of the delivery of the liquid or substance into the air from the vaporizer 410.

[0415] Fig. 13 illustrates an alternative vaporization device 500. In this configuration, the vaporization device 500 may be disposed along an external surface 550 of the component 551. Vaporization device 500 includes a vaporizer 510 and a heat sink 513 coupled by a bridge 515. The heat sink 513 and the bridge 515 may each be constructed from a heat- conductive material, such as metal. In this configuration, the vaporizer 510 may be downstream, e.g., distal to, a humidifying filter 570, which may be an HMX. The humidifying filter 570 may be constructed of a fibrous or non-fibrous and porous material that absorbs heat and moisture from exhaled gas from the patient and desorbs the heat and moisture into the incoming pressurized flow of air. The humidifying filter 570 may be treated with a salt to increase its absorbency. Humidifying filter 570 may have one or more of the characteristics described above with respect to humidifying filter 370 of Fig. 11. For example, humidifying filter 570 may absorb water vapor from exhaled air and provide some humidity to the air flowing through component 551 , as indicated by 591. In such a way, the vaporizer 510 may be configured to provide additional humidity to the air flowing through the component 551 and / or to dose the air flowing through the component 551 with a substance.

[0416] Heat sink 513 may be upstream, e.g., proximal to, the 510 and humidifying filter 570 along the air flow path 590. Heat sink 513 may be fixed to an external surface of component 551. Bridge 515 extends between the vaporizer 510 and the heat sink 513. Bridge 515 may be coupled to a surface 514 of the vaporizer 510. Bridge 515 may extend parallel to the component 551. In such a way, as the vaporizer 510 heats up, the bridge 515 may absorb the heat generated by the vaporizer 510. The heat may be absorbed through the bridge 515and into a plurality of fins forming the heat sink 513. The plurality of fins of heat sink 513 may abut or touch the external surface 550 of the component 551, thereby heating the external surface 550. Heating the external surface 550 may increase the temperature of the air flowing through component 551.

[0417] One or more sensors may be disposed within the air flow path. For example, a first sensor 540 may be disposed within the air flow path, proximal to the vaporizer 510 and / or humidifying filter 570. A second sensor 542 may be disposed distal to the vaporizer 510. First sensor 540 and / or second sensor 542 may have one or more of the characteristics described above with respect to the sensors described in Figs. 10 and 11. For example, the first sensor 540 and / or the second sensor 542 may transmit data regarding the air flowing through component 551 to the vaporizer 510, a controller operably coupled to the vaporizer 510, and / or to other devices of the respiratory therapy system. For example, the first sensor 540 and / or the second sensor 542 may transmit a signal that then causes a processor to adjust one or more parameters of the delivery of the liquid or substance into the air 592 from the vaporizer 510, which occurs at 593.

[0418] In some examples, the plurality of fins of the heat sink 513 may extend partially into or completely through the component 551. Thus, the air flowing through the component 551 may flow around each fin of the plurality of fins. In such a way, the air may be heated and heated air may be delivered to the user.

[0419] Fig. 14 depicts a further example that utilizes an HMX 670, e.g., as described above with respect to Figs. 11 and 13, to absorb heat and moisture from air exhaled by the patient along a recirculation path 602 and desorb the heat and moisture into the incoming flow of pressurized air along an air circuit 601 before reaching the patient interface 3000 worn by the patient. A vaporization device 600 may also include a vaporizer 610 similar to those described above. The vaporization may optionally include a wick 690 to draw moisture from a reservoir 620 and / or the HMX 670 and direct it to the vaporizer 610 for vaporization into the pressurized flow of air. A surface 680 of the vaporization device 600 may be sealed so that moisture only passes into the pressurized flow of air after being vaporized by the vaporizer 610. Also, the system may include a vent 3400 to allow for the washout of exhaled gas and prevent the build up of carbon dioxide, but it should be noted that the vent 3400 is positioned outside of the recirculation path 602 so that warm, moist exhaled air is not lost to atmosphere before the heat and moisture can be absorbed by the HMX 670.

[0420] Each example discussed herein may enable humidification of inhaled air or delivery a substance to the air flowing through a respiratory therapy device. Each example may help to increase patient use and / or patient comfort, among other benefits.

[0421] The use of one or more sensors in conjunction with a vaporization device may provide more precise humidification sensing within the air flow of the respiratory therapy system. Control of humidification may be linked to known (e.g., detected using one or more sensors) conditions within one or more components of the respiratory therapy system, which may allow for closed-loop control of humidification within the respiratory therapy system. Further, as described above, humidification within the respiratory therapy system may also be linked to patient preference and / or environmental (e.g., ambient) conditions. In other aspects, sensed conditions within the patient interface may also be used to control operation of the vaporization device. Use of sensors and / or patient preference may allow for closed-loop control of the vaporization device, and thus humidification system of respiratory therapy system. This may allow for real-time, automatic, and / or dynamic adjustment of the humidification within the respiratory therapy system.

[0422] In some aspects, multiple vaporization devices may be incorporated into a single components of a respiratory therapy system, or multiple vaporization devices may be incorporated into different components of the respiratory therapy system. For example, each vaporization device may be smaller than a conventional humidifier 5000 and thus may hold less water in an associated reservoir as compared to a conventional humidifier 5000. By including multiple vaporization devices in a respiratory therapy system, when one vaporization device is emptied of water or other liquid, the next vaporization device may be activated. In other aspects, there may be benefits to ‘stacking’ multiple vaporization devices in a component. For example, operation of one or more vaporization devices may be alternated or switched, e.g., to control heat buildup or to achieve vaporization efficiency.

[0423] In other aspects, including multiple vaporization devices incorporated into different components of a respiratory therapy system may allow vapor to be added to in series at different points of the air pathway to facilitate humidification of the air flow. Accordingly, vaporization may be staged.5.9.2 CARTRIDGES

[0424] Devices, systems, and methods to humidify the flow of air supplied to a patient and / or deliver a vaporized liquid into the air supplied to a patient using one or more removable cartridges are described herein. Using at least one removable cartridge containinga reservoir that contains liquid and in some examples also contains a vaporization device, e.g., in the form of a capillary force vaporizer, in combination with a respiratory device and / or a respiratory therapy system, such as the ones described above, may assist in one or more decreasing the size, or footprint, of the breathing devices and / or systems, increasing patient comfort during use, decreasing the water necessary to humidify the air flowing through the devices or system, decreasing energy required to power the respiratory system, allow a user to customize or personalize the therapy received, and / or increase the usability of the respiratory therapy system, among other benefits.

[0425] In some examples, the cartridge may be configured for travel, for example, due to the size of the device and / or the portability of the device. Travel cartridges may be reusable and refillable or disposable and replaceable. In some aspects, a disposable cartridge may be beneficial, particularly during travel, because the cartridge may be pre-filled with sterile water. Accordingly, the user may not need to find sufficiently clean water when on the go or worry about setup and / or mess. Further, the user may not need to worry about cleaning a vaporization device and / or reservoir or refilling a reservoir. Such disposable cartridges may function similar to a coffee filter pod and may be used similarly to the razor / razorblade model, wherein the components of the respiratory therapy system are reusable, but the humidification cartridge assemblies are disposable. In other aspects, cartridges as described herein may be used in everyday respiratory therapy systems, not just travel systems. In still further aspects, removable cartridge assemblies as described herein may be useful in a hospital setting, in which clinicians can easily and quickly remove the vaporization device and / or entire cartridge assembly and replace it with a new one while disposing of or cleaning the removed vaporization device or cartridge.

[0426] As will be described in further detail below, one or more sensors may be used in combination with the cartridge(s). For example, the one or more sensors may be configured to detect and transmit information to a cartridge assembly, a vaporization device, a controller, or another component in the respiratory therapy system. The information received from the sensors may be used to at least partially affect the operation of the cartridge assembly and, thus, the delivery of the vaporized liquid into the air flow.

[0427] The cartridge may be configured to deliver a vaporized liquid into the air flow path for inhalation by the user. In some examples, the liquid may be water, a medicine, a compound, or other therapeutic liquid, or a combination of more than one of water, a medicine, a compound, or other therapeutic liquid that may be used, for example, to alleviate symptoms of and / or treat breathing disorders or other medical disorders, such as thosediscussed above. Additionally or alternatively, the liquid may provide a flavor, an aroma, and / or otherwise alter the taste or scent of the air flowing through the respiratory therapy system. In such a way, humid air and / or air dosed with the liquid may be delivered to the patient. Delivering humid air and / or delivering air that has been dosed with one or more liquids may increase patient comfort and, thus, increase compliance. The cartridge may be used alone or in combination with a humidifier, such as, for example, humidifier 5000, discussed above.5.9.2.1 Cartridge Configurations

[0428] Fig. 15 illustrates a schematic of a cartridge assembly 1200 containing a vaporization device 1210. In this configuration, cartridge assembly 1200 may be disposed on or within a surface 1220 of a component 1221. Component 1221 may be any component of the respiratory therapy systems described above. For example, component 1221 may be a patient interface, an air circuit, an RPT device, a humidifier, a blower, or any other component that is exposed to air flowing through the system and to the patient.

[0429] Cartridge assembly 1200 may be permanently or removably coupled to component 1221, e.g., to a surface 1220. Vaporization device 1210 may be removably or permanently disposed within cartridge assembly 1200. Vaporization device 1210 may be configured to contain a liquid (e.g., water, a medicine, etc.). As alluded to above, having a cartridge assembly that is removable may facilitate replacement, refilling, or cleaning of a reservoir, replacement or cleaning of vaporization device 1210, and / or the replacement or cleaning of any other components (e.g., filters, etc.) within cartridge assembly 1200. Removability of cartridge assembly 1200 may also facilitate cleaning of components to which cartridge assembly 1200 is coupled or incorporated as part of. In some aspects, as will be described in more detail, the removability of cartridge assembly 1200 may also allow a user to select one or more liquids that will be delivered into the air path of the respiratory therapy system during use. The cartridge assembly 1200 may be removably connected with a snap fit or a friction fit. The cartridge assembly 1200 and / or the component 1221 it is coupled to may include a seal to prevent leakage of liquid from the cartridge assembly 1200 and / or leakage of the pressurized flow of air. For example, some cartridges may contain water for humidification purposes, while others may contain a medication, flavoring, scent (e.g., aromatherapy), or combinations thereof.

[0430] In some aspects, multiple cartridge assemblies 1200 may be used in a respiratory therapy system, e.g., for introducing multiple medications into the air flowing therethroughand / or for humidifying the air flowing therethrough. In this way, a user of respiratory therapy system may personalize the system for his or her preferred use or as prescribed by a clinician. In some aspects, if multiple cartridge assemblies are incorporated into a respiratory therapy system, they may be removably coupled to the same general components of the respiratory therapy system or to different components of the respiratory therapy system. If multiple cartridges are configured for use in a single respiratory therapy system, the cartridges may be color-coded or may have other indicia configured to communicate to the user the contents of the cartridge assembly 1200. In other aspects, portions of the respiratory therapy system configured to accept multiple cartridge assemblies 1200 may have coloring or other indicia (e.g., text, shapes, and / or patterns) indicating where different cartridge assemblies 1200 may be received. For example, a cartridge assembly of one color may be coupled to the respiratory therapy system in a location that has a matching color. Other types of indicia, such as text, shapes, and / or patterns, on the respiratory therapy system and cartridge assembly 1200 may also be matched so as to indicate to a user where in the system the cartridge assembly 1200 should be inserted.

[0431] In other aspects, a single cartridge assembly 1200 may include a plurality of vaporization devices 1210, each fluidly connected to its own fluid source. The fluid sources may contain the same type of fluid or may contain different types of fluid. Further, it is contemplated that one or more vaporization devices 1210 may be permanently fixed within cartridge assembly 1200 or may themselves be removably coupled to cartridge assembly 1200, e.g., to facilitate cleaning or replacement of the vaporization device.

[0432] When cartridge assembly 1200 is coupled to component 1221 of a respiratory therapy system, surface 1211 of vaporization device 1210 may be exposed to the air flow path. For example, air flowing through component 1221, indicated at 1290, may flow past surface 1211. As air flows past surface 1211, one or more liquids within cartridge assembly 1200 may be heated and vaporized by vaporization device 1210 and then may be released into the air flow path, indicated at 1291. In such a way, the air may be humidified and / or the air may be dosed with the vaporized liquid before being delivered to the patient. For example, cartridge assembly 1200 may include a reservoir and / or one or more materials housed inside of the cartridge assembly 1200 to absorb the liquid, such as a porous wicking material, an aerogel, a hydrogel, or a combination of two or more thereof. The one or more materials designed to absorb liquid may be used in place of or in combination with a reservoir and may be fluidly coupled to vaporization device 1210. The porous wicking material, the aerogel, the hydrogel, or the combination of two or more thereof that may be in contact with thevaporization device 1210 to fluidly transfer liquid thereto for vaporization. The porous wicking material, the aerogel, the hydrogel, or the combination of two or more thereof may also allow the vaporization device 1210 to receive liquid in any orientation so that it can vaporize the liquid in any orientation as contrasted with an open reservoir that has a limited range of orientations that can direct a sufficient quantity of liquid to the vaporization device 1210 with gravity. Once vaporization device 1210 vaporizes the liquid(s), they may be released into the air.

[0433] One or more sensors 1250 may be disposed along or in the air flow path. Sensor(s) 1250 may be configured to measure properties of the air flowing through component 1221, through other portions of the respiratory therapy system, or ambient conditions. For example, the one or more sensors 1250 may provide information regarding the temperature of the air flowing through the component / system and / or the amount of humidity of the air flowing through the component / system and / or the temperature and / or humidity of the ambient air. Additionally or alternatively, sensor(s) 1250 may be configured to detect information regarding a direction, a volume, and / or a velocity of the air flowing through component 1221. For example, an increase in air velocity may indicate the patient is inhaling, and a decrease in air velocity may indicate the patient is exhaling. Such information may be transmitted or relayed to the cartridge assembly 1200 and / or vaporization device 1210 and / or a controller operably coupled to cartridge assembly 1200 and / or vaporization device 1210. The function of cartridge assembly 1200 and / or vaporization device 1210 may be altered or otherwise controlled based at least in part on the information detected by sensor(s) 1250.

[0434] For example, a first sensor 1250A may be upstream, e.g., proximal of, cartridge assembly 1200 and / or vaporization device 1210. First sensor 1250A may measure one or more properties of the air flowing through component 1221 and transmit that information to cartridge assembly 1200 and / or a controller operably coupled to cartridge assembly 1200. Upon receiving information from first sensor 1250A, cartridge assembly 1200 may be instructed to not alter its function, to turn on vaporization device 1210 to vaporize liquid, to increase the temperature of vaporization device 1210 to vaporize more liquid, to turn off vaporization device 1210 to stop vaporizing liquid, to reduce a temperature of vaporization device 1210 to vaporize less liquid, and / or any other action for which cartridge assembly 1200 is configured to execute.

[0435] Additionally or alternatively, a second sensor 1250B may be placed downstream of, e.g., distally to, cartridge assembly 1200 and / or vaporization device 1210, for example,along a distal portion of the air pathway. Accordingly, second sensor 1250B may provide information regarding the air after the air passes by vaporization device 1210. Second sensor 125 OB may be configured to detect and to transmit information regarding the airflow to cartridge assembly 1200 or a controller configured to control cartridge assembly 1200 wirelessly or via a cable extending between second sensor 1250B, cartridge assembly 1200, and / or a controller. In such a way, second sensor 1250B may provide feedback to cartridge assembly 1200 or a controller of cartridge assembly 1200. For example, cartridge assembly 1200 or a controller may be configured to receive the information from second sensor 1250B and adjust one or more aspects (e.g., an amount, a type of liquid, a temperature, etc.) of the delivery of the vaporized liquid from vaporization device 1210.

[0436] Cartridge assembly 1200 may be pre-filled and / or refillable. For example, a prefilled cartridge assembly 1200 may come with a liquid already contained within the cartridge. In such an example, the quality and / or amount of the liquid within the cartridge may be controlled. After use of the respiratory therapy system, a pre-filled cartridge assembly 1200 may be disposed of and replaced with a new one. Alternatively, cartridge assembly 1200 may be fillable or refillable. For example, a patient may refill the cartridge following or prior to use or when the liquid is below a threshold level. If refillable cartridges are used, the user may be instructed to refill the cartridge with water of a sufficient quality. For example, distilled water, or water with a known total dissolved solids (TDS) may be used. Further, in refillable and / or re-usable examples, vaporization device 1210 and / or an associated reservoir within cartridge assembly 1200 may need to be cleaned. In the case of a cartridge assembly 1200 that is not reusable, it may include a puncturable seal that is punctured when inserted into the component 1221, which allows the release of the liquid during use.

[0437] In some examples, cartridge assembly 1200 may contain a cleaning reagent. For example, once a procedure is complete and / or if the patient initiates a cleaning cycle, the cleaning reagent may be released into the air flow pathway. The cleaning reagent may assist in reducing a buildup of bacteria or particulate matter, among other benefits. In some aspects, following or prior to use of the respiratory therapy device, a user may remove a cartridge assembly 1200 that had been used to deliver vaporized liquid during therapy and may insert a cartridge assembly 1200 for cleaning the respiratory therapy system. Then, once the cleaning is completed, the user may remove the cleaning cartridge assembly 1200 and replace it with a new cartridge assembly 1200 for delivering therapy. As mentioned above, cleaning cartridge assembly 1200 may include color coding or other indicia indicating to a user that it is for use when cleaning the respiratory therapy system.

[0438] Fig. 16 illustrates an alternative example of a cartridge assembly 1300 positioned adjacent to surface 1320 of component 1321. As discussed above, component 1321 may be any component of the respiratory therapy system. In this example, cartridge assembly 1300 may be configured to receive (either permanently or removably) a vaporization device 1310. For example, vaporization device 1310 may be inserted into or removed from cartridge assembly 1300, e.g., similar to how a cassette is inserted or removed from a cassette player. Cartridge assembly 1300 and vaporization device 1310 may have any or all of the characteristics of cartridge assembly 1200 and vaporization device 1210, described above with respect to Fig. 15. For example, cartridge assembly 1300 is configured to contain or hold vaporization device 1310 and one or more liquid(s) for delivery into the air flow path of component 1321. For example, vaporization device 1310 may be configured to engage with cartridge assembly 1300. In such a way, cartridge assembly 1300 may be configured so as to operationally engage with vaporization device 1310, e.g., when cartridge assembly 1300 and vaporization device 1310 are placed in operational engagement with the respiratory therapy system.

[0439] In this configuration, vaporization device 1310 may be configured to extend at least partially into the air flow path 1390 of component 1321. As air flows over surface 1311 or through a portion of vaporization device 1310 (e.g., the portion of vaporization device 1310 that extends into the air flow path), one or more liquids within cartridge assembly 1300 may be heated and vaporized by vaporization device 1310 and then may be released into the air flow path at 1391. In such a way, the air may be humidified and / or the air may be dosed with the vaporized liquid. For example, cartridge assembly 1300 may include a reservoir and / or one or more wicking materials, such as a porous wicking material, an aerogel, a hydrogel, or a combination of two or more thereof, designed to absorb the liquid. The one or more wicking materials designed to absorb liquid may be used in place of or in combination with a reservoir and may be fluidly coupled to vaporization device 1310. The use of one or more wicking materials inside cartridge assembly 1300 may reduce the chance of the liquid spilling out of the reservoir and / or cartridge assembly 1300, since the wicking material may absorb and retain the liquid. Once vaporization device 1310 vaporizes the liquid(s), they may be released into the air.

[0440] Similar to the configuration discussed above with respect to Fig. 15, one or more sensors 1350 may be disposed on or within the air flow path. The sensor(s) may be configured to measure properties of the air flowing through component 1321 and / or other portions of the respiratory therapy system. That information may be transmitted to cartridgeassembly 1300 and / or a controller of cartridge assembly 1300. Operation of cartridge assembly 1300 may be affected, at least in part, based on the information detected by sensor(s) 1350.

[0441] As shown in Fig. 16, cartridge assembly 1300 may be removed and / or inserted relative to component 1321 in the directions indicated by the double-sided arrow. Removal of cartridge assembly 1300 may be achieved by moving cartridge assembly 1300 in a first direction, while insertion of cartridge assembly 1300 may be achieved by moving cartridge assembly 1300 in a second, opposite direction.

[0442] Fig. 17 illustrates an alternative configuration of a cartridge assembly 1400 containing a series of cartridges 1410 and a reservoir 1430 in line with the air flow path. For example, cartridge assembly 1400 may be disposed within or between two portions of a component 1420. Series of cartridges 1410 may include a first cartridge 1410A, a second cartridge 1410B, and / or a third cartridge 1410C. Although a series of cartridges is shown, cartridge assembly 1400 may contain a singular cartridge in some examples. In other examples, two cartridges may be included within cartridge assembly 1400, or four or more cartridges may be included. Each cartridge of the series of cartridges 1410 may be configured to deliver a liquid or material into the air flow path. In some examples, each cartridge of the series of cartridges 1410 may contain the same liquid or a different liquid. For example, first cartridge 1410A, second cartridge 1410B, and third cartridge 1410C may contain the same kind of liquid or liquids. In other examples, at least one of first cartridge 1410A, second cartridge 1410B, and / or third cartridge 1410C may contain a different liquid. In some examples, each cartridge of the series of cartridges 1410 may be color-coded or include other indicia (e.g., writing or patterns) based on the liquid or material each cartridge contains.

[0443] Each cartridge of the series of cartridges 1410 may be configured to deliver each liquid into the air flow path at a same rate or a different rate or at a same or a different time. For example, first cartridge 1410A may be configured to deliver a first liquid at a first rate and / or a first time, second cartridge 1410B may be configured to deliver a second liquid at a second rate or a second time, and third cartridge 1410C may be configured to deliver a third liquid at a third rate or a third time. One or more of the first rate, second rate, and third rate, or first time, second time, and third time, may be the same or different. In some examples, each cartridge of the series of cartridges 1410 may be color-coded or include other indicia (e.g., text, shapes, and / or patterns) based on the different delivery rates.

[0444] In a further example, the surface of each cartridge of the series of series of cartridges 1410 may be configured similar to an inkjet printer cartridge. For example, firstcartridge 1410A, second cartridge 1410B, and / or third cartridge 410B may include one or more nozzles through which liquid is delivered onto a respective vaporization device or heated surface within each cartridge for fast vaporization. In other aspects, an inkjet printertype cartridge may be used in place of a vaporization device as a stand-alone humidification device. An inkjet printer-type humidification device may be integrated within a cartridge or may be separately incorporated into a respiratory therapy system. Thus, the cartridges 1410 may be separate from the vaporization device, and when installed, the cartridges 1410 engage the vaporization device to provide the corresponding liquid thereto. In other words, the cartridges 1410 themselves may, in a further example, not include and be separate from the vaporization device.

[0445] Additionally or alternatively, each cartridge of the series of cartridges 1410 may be configured to deliver a liquid or material in response to an input from RPT device 4000 (not shown in Fig. 17) and / or a controller, and the input may be based at least in part on data detected by one or more sensors 1450. For example, first cartridge 1410A may be configured to deliver water, for example, to humidify the air flowing through the air flow path of a component 1420 of the respiratory therapy system. First cartridge 1410A may start, increase, decrease, or stop the delivery of vaporized water into the air flow path in response to signals being transmitted to cartridge assembly 1400 by a controller based on information received from sensor(s) 1450. Second cartridge 1410B may also be configured to deliver a different liquid in response to input from RPT device 4000 and / or a controller, and the input may be based at least in part on data detected by one or more sensor(s) 1450.

[0446] For example, as described above, one or more cartridges may contain a medication or a combination of water and medication. In some aspects, the medication may be delivered to a patient throughout the delivery of therapy using the respiratory therapy system or until the medication is used up. In other aspects, however, one or more medications within one or more cartridges may be delivered to the user only when needed. For example, one or more sensors in or coupled to the respiratory therapy system may measure one or more parameters of the user, e.g., heart rate, breathing patterns, physical movements, posture, electromyography signals, blood oxygen or blood carbon dioxide levels, etc. Exemplary patient parameters to measure are discussed, e.g., in reference to Figs. 5A-5C. When a patient parameter indicative of a condition requiring medication is detected, then the respiratory therapy system may automatically trigger the delivery of one or more medications from one or more cartridges. For example, in reference to cartridge assembly 1400, a second liquid medication may be delivered by second cartridge 1410B if the patient’s heart rate isabnormal. Second cartridge 1410B may increase, decrease, or stop delivery of the second liquid or material when, for example, the patient’s heart rate normalizes. In some aspects, one or more medications for breathing (e.g., asthma medications or obstructive sleep apnea (OSA) medications), migraine medications, heart medications, or any suitable medications may be delivered through one or more cartridge assemblies via the respiratory therapy system.

[0447] One potential benefit, e.g., in regards to the delivery of OSA medications via the respiratory therapy system, is that the OSA medication may be used in lower dosages while also lowering the therapy pressure of the CPAP device. For example, the combination of CPAP therapy and medication may allow for a lower therapy pressure to be used.Additionally or alternatively, the combination of CPAP therapy with medication may allow for the dosages of the medication to be reduced. The combination of CPAP therapy and medication may allow the CPAP therapy to be provided at a lower therapy pressure and medication dosages can be minimal.

[0448] Also, the device may be capable of detecting when apneas are occurring, which may correspond to an increase in therapy pressure in response to detected apneas. In this instance, it may temporarily increase the pressure to relieve the apnea, but also deliver the medication. When the medication effect has been detected or a presumed amount of time for its effect to take hold has elapsed, the CPAP therapy pressure can be reduced again. Alternatively, the system may periodically release the medication to avoid ever having to increase the therapy pressure because the patient is receiving medication at regular intervals throughout therapy.

[0449] Also, the medication may not be vaporized. The medication may be injected into the airpath as an aerosol, similar to a nebulizer. By delivering small amounts periodically or when needed, there is no 'spike' in the meds in the patient’s body, which may occur when a patient receives one large dose for a therapy period.

[0450] The respiratory therapy system and / or cartridge assembly 1400 may be configured to detect (e.g., via sensors 1450) when a patient is experiencing or is about to experience apnea. In response to detecting when a patient is undergoing apnea, cartridge assembly 1400 may be configured to deliver medication from one or more cartridges of the series of cartridges 1410. The medication may be delivered in a single delivery dose or may be continuously or periodically delivered into the air flow, for example, until the medication takes effect. In some aspects, the medication may be continuously or periodically delivered into the air flow until the patient’s breathing normalizes. The medication may be delivered incombination with an increase in therapy pressure, and, in some aspects, the pressure may be reduced to a more typical level once the medication has taken effect and breathing normalizes.

[0451] In yet other aspects, CPAP medication may be delivered in small amounts periodically, whether or not an apnea is detected, in order to prevent apneas from occurring or to prevent a sudden spike in the amount of medication in the patient’s body. By delivering small amounts of medication to the patient periodically or when needed, the patient may not experience a rapid and / or significant increase in the amount of medicine in the patient’s body. For example, rapid and / or significant increases of medicine concentrations in the patient’s body may be associated with adverse effects and / or complications. In some instances, higher concentrations of medicine in a patient’s body may increase the likelihood and / or severity of side effects. Additionally, in some instances, prolonged exposure to high concentrations of the medicine may lead to a patient’s body developing a tolerance of the medicine.

[0452] Although the delivery of medication is described in reference to cartridge assembly 1400, the delivery of medication may function similarly in regard to any of the cartridge assemblies described herein. Further, the medications being delivered may not be vaporized and may instead be delivered as an aerosol or delivered into the air path in any suitable manner.

[0453] In respect to the cartridge assembly 1400, some examples, first cartridge 1410A, second cartridge 1410B, and / or third cartridge 1410C may include an actuator (e.g., a button, a knob, a lever, etc.). Similar actuators may be included in combination with any of the cartridge assemblies described herein. The actuator may be configured such that a patient or operator may manually turn on / off delivery of a liquid from the respective cartridge. For example, if a patient is suffering from a dry nose, the patient may use the actuator to release or adjust the amount of liquid being delivered. In such a way, the patient or operator may tailor the delivery of liquids (e.g., water, scents, flavors, etc.) into the air flow path. Or, if the patient believes that a medication may need to be delivered or that sufficient medication has been received, the patient may use the actuator to start, stop, or adjust the amount of medication being delivered.

[0454] In some examples, cartridge assembly 1400 may include a common reservoir 1430 or a plurality of separate reservoirs 1430. Reservoir 1430 may be configured to contain or capture excess liquids from each of first cartridge 1410A, second cartridge 1410B, and / or third cartridge 1410C. In some examples, reservoir 1430 may include a material designed to absorb and slowly release the excess liquids or substances. For example, the excess liquidsmay evaporate from reservoir 1430 as air flows over reservoir 1430. Additionally, reservoir 1430 may be configured to heat up, for example, to increase the evaporation rate of the liquids and / or vaporize the liquids caught by reservoir 1430.

[0455] In some examples, one or more cartridges of the series of cartridges 1410 may be used in conjunction with cartridge assembly 1200 and / or cartridge assembly 1300. For example, one or more cartridges of the series of cartridges 1410 may be used in place of vaporization device 1210 of Fig. 15. For example, in some examples, one or more cartridges of the series of cartridges 1410 may be removably or permanently disposed within cartridge assembly 1200 (e.g., in place of vaporization device 1210).

[0456] In other examples, one or more cartridges of the series of cartridges 1410 may be configured to operably engage with cartridge assembly 1300. For example, cartridge assembly 1300 may be configured to receive (either permanently or removably) one or more cartridges of the series of cartridges 1410.5.9.3 Vaporization Device Cleaning

[0457] The quality of the liquid (e.g., water) used with the vaporization devices in these examples may have a significant effect on the performance and efficiency of the vaporization device during an individual therapy session and over the course of multiple therapy sessions. The quality of the liquid may refer to the presence of dissolved solids in the liquid. For example, water may contain various concentrations of dissolved solids depending on the source. Tap water from one geographic region may contain more dissolved solids per unit volume than another geographic region, while distilled water may contain zero to a negligible quantity of dissolved solids. Dissolved solids in the liquid to be vaporized by the vaporization device may be problematic because when the liquid is vaporized, the dissolved solids are not and may accumulate on the vaporization device (e.g., in the form of scaling).

[0458] As described above, the vaporization device may include a porous material that the liquid flows through and because the capillary effect may be relied on for liquid transport, the passages of the porous material are relatively small and therefore are susceptible to blockage by the accumulation of dissolved solids. As dissolved solids accumulate on the porous material of the vaporization device, the dissolved solids may inhibit the transport of liquid through the porous material and / or insulate the liquid from heat that vaporizes the liquid. These effects can reduce the performance and / or efficiency of the vaporization device. The accumulation of dissolved solids may also encourage the growth of bacteria and / or may inhibit inherent properties of the porous material to resist bacterial growth. During a sessionof therapy, a certain quantum of humidification may be desired, for example, and the accumulation of dissolved solids over the course of one or multiple therapy sessions may necessitate increasing the heating power of the vaporization device to achieve the same level of vaporization of water as if there were less accumulation of dissolved solids. Also, dissolved solids accumulated on the vaporization device may be dislodged inadvertently from the vaporization device during therapy, and then the dissolved solids could reach the flow of pressurized air and ultimately the patient’s airways.

[0459] As discussed above, one way to avoid the problem of accumulation of dissolved solids on the vaporization device altogether is by using liquid (e.g., water) that is very pure in that it has little to no dissolved solids, and this may be accomplished by providing the very pure liquid in a prefilled cartridge. In other scenarios, it may be desirable for the vaporization device to be designed to accept liquid (e.g., water) provided by the patient. The patient, however, may not have access to sufficiently pure liquid (e.g., water) to avoid the problem of accumulation of dissolved solids on the vaporization device during therapy, for example, because the patient only has access to tap water with a high concentration of dissolved solids. In such cases, it may be beneficial to detect when the accumulation of dissolved solids has reached a level that diminishes the performance and / or efficiency of the vaporization to the point that cleaning is warranted and then perform such cleaning.

[0460] Fig. 20 depicts how the accumulation of solids on a vaporization device can reduce its performance and / or efficiency. The solid line 7001 depicts the change in temperature over time of a vaporization device with zero or a negligible quantity of accumulated solids as a given quantity of power is applied to it. The dashed line 7002 depicts the change in temperature over time of the same vaporization device applied with the same quantity of power, but in this instance the vaporization device has accumulated a moderate amount of solids. The dotted line 7003 depicts the change in temperature overtime of the same vaporization device applied with the same quantity of power, but in this instance the vaporization device has accumulated an even greater amount of solids. The differences in temperature that the vaporization device can achieve under the same amount of power as the amount of accumulated solids increases indicates the effect that the solids have on the heating, and therefore vaporization, performance and / or efficiency of the vaporization device. Thus, as more and more solids accumulate on the vaporization device, the vaporization device’s ability to rapidly heat to a target temperature is reduced such that it may be less able to provide the intended amount vaporized liquid to the patient during therapy. A threshold temperature is indicated at 7000, and if the vaporization device cannot reach this temperatureat a given power level over an extended period of time, then the controller may determine that cleaning is necessary and subsequently actions described below may be implemented.5.9.3.1 Cleaning and Apparatuses Methods

[0461] The various ways in which a cleaning function may be initiated and performed are explained below.

[0462] The cleaning function may be initiated based on detection of blockage in the vaporization such that the cleaning function is only initiated when needed. Alternatively or additionally, the cleaning function may be performed prior to therapy starting and / or after therapy has completed. The cleaning function may be performed automatically by the RPT system or it may be performed in response to a patient’s action. If the cleaning function is performed in response to a patient’s action, the RPT system may notify the patient that the cleaning function should be initiated.

[0463] The cleaning function itself may be performed internally by the RPT system. That is, the RPT system may use the heating element of the vaporization device to heat and break down and vaporize whatever material (e.g., dissolved solids) has accumulated on the vaporization device. The vaporization device may in some examples include an ultrasonic transducer that vibrates the vaporization device at a sufficiently high frequency to dislodge whatever material (e.g., dissolved solids) has accumulated on the vaporization device. In other examples, the vaporization device may be removed from the RPT system for manual cleaning with a solvent or in an ultrasonic bath.

[0464] Figs. 18 and 19 show examples of systems that may include components related to a cleaning function.

[0465] Fig. 18 is based on the example depicted in Fig. 15, and in addition to the cleaning-related features described below, the example of Fig. 18 may include any of the features described in conjunction with Fig. 15.

[0466] Fig. 18 shows an example of a cartridge assembly 2100 containing a vaporization device 2110. The cartridge assembly 2100 may be disposed on or within a surface 2120 of a component 2121. When cartridge assembly 2100 is coupled to component 2121 of a respiratory therapy system, surface 2111 of vaporization device 2110 may be exposed to the air flow path. For example, air flowing through component 2121, indicated at 2190, may flow past surface 2111. As air flows past surface 2111, one or more liquids within cartridge assembly 2100 may be heated and vaporized by vaporization device 2110 and then may be released into the air flow path, indicated at 2191.

[0467] One or more sensors 2150 may be disposed along or in the air flow path. Sensor(s) 2150 may be configured to measure properties of the air flowing through component 2121, through other portions of the respiratory therapy system, or ambient conditions. For example, a first sensor 2150A may be upstream, e.g., proximal of, cartridge assembly 2100 and / or vaporization device 2110. First sensor 2150A may measure one or more properties of the air flowing through component 2121 and transmit that information to cartridge assembly 2100 and / or a controller operably coupled to cartridge assembly 2100. Additionally or alternatively, a second sensor 2150B may be placed downstream of, e.g., distally to, cartridge assembly 2100 and / or vaporization device 2110, for example, along a distal portion of the air pathway. Accordingly, second sensor 2150B may provide information regarding the air after the air passes by vaporization device 2110. Second sensor 2150B may be configured to detect and to transmit information regarding the airflow to cartridge assembly 2100 or a controller configured to control cartridge assembly 2100 wirelessly or via a cable extending between second sensor 2150B, cartridge assembly 2100, and / or a controller.

[0468] In the example of Fig. 18, the cartridge assembly 2100 may include a vaporization device sensor 2170 on the vaporization device 2110 of the cartridge assembly 2100 to measure a parameter at the vaporization device 2110 such as temperature or moisture. The vaporization device sensor 2170 may, in other examples, be included in the cartridge assembly 2100, and it may not be directly in contact with the vaporization device 2110 but positioned in the cartridge assembly 2100 sufficiently close to measure a parameter such as temperature or moisture. The measured parameter may be applied to the cleaning function as will be discussed below.

[0469] In the example of Fig. 18, the cartridge assembly 2100 may include an ultrasonic transducer 2180 or the ultrasonic transducer 2180 may be in physical contact, directly or indirectly, with the ultrasonic transducer 2180. An electric current may be applied to the ultrasonic transducer 2180 causing it to vibrate at an ultrasonic frequency when a cleaning function is initiated, and the vibration from the ultrasonic transducer 2180 may vibrate the vaporization device 2110 to dislodge matter that has accumulated on the vaporization device 2110. It should be noted that the ultrasonic transducer 2180 is optional, and if the ultrasonic transducer 2180 is not included, the cleaning function may be performed by other components.

[0470] Fig. 19 is based on the example depicted in Fig. 10, and in addition to the cleaning-related features described below, the example of Fig. 19 may include any of the features described in conjunction with Fig. 10.

[0471] Fig. 19 shows an example of a vaporization device 2200 having a vaporization unit 2205, a vaporizer 2210, and a reservoir 2220. The vaporization device 2200 may be disposed on or within a surface 2250 of a component 2251. Component 2251 may be a patient interface, an air circuit, a blower, an RPT device, or any component described above that is included in a respiratory therapy system. In some examples, the component 2251 may be a separate dongle or adapter that may permanently or removably connected with one or more of the other components described herein. Accordingly, the surface 2250 may be a surface of any such component. The pressurized air flow 2290 passes through the component 2251. Additionally or alternatively, the vaporization device 2200 may be configured to deliver a substance (e.g., a liquid substance such as medicine or water) into the air flowing through the respiratory therapy system. Reservoir 2220 may be configured such that the liquid substance contained within the reservoir 2220 wicks into the vaporizer 2210, e.g., via capillary action, as indicated at 2292. Once the substance wicks into the vaporizer 2210, the substance may then be heated and vaporized by the vaporizer 2210 and delivered into the air flow path, as indicated at 2291.

[0472] As illustrated in Fig. 19, a first sensor 2240 may be disposed along the air pathway, for example, proximal to the vaporizer 2210. First sensor 2240 may be configured to detect a physical quantity of the air and to transmit information regarding the air upstream of the vaporizer 2210. First sensor 2240 may transmit (e.g., to a controller of the vaporizer 2210 or to the vaporizer 2210) a signal wirelessly or via a wired connection (e.g., via first cable 2241) that may extend between the first sensor 2240, a controller, and / or the vaporizer 2210. Additionally or alternatively, a second sensor 2242 may be placed downstream of the vaporizer 2210, for example, along a distal portion of the air pathway. Accordingly, the second sensor 2242 may provide a signal regarding the air flow after the air flow passes the vaporizer 2210. Second sensor 2242 may be configured to transmit data regarding the airflow to the vaporizer 2210. The transmission may be carried out via a wireless connection or via a second cable 2243 extending between second sensor 2242 and the vaporizer 2210.

[0473] In the example of Fig. 19, the vaporization device 2200 may include a vaporization device sensor 2270 on the vaporization device 2220 to measure a parameter at the vaporization device 2220 such as temperature or moisture. The vaporization device sensor 2270 may, in other examples, be included in the vaporization device 2200, and it may not bedirectly in contact with the vaporization device 2200 but positioned sufficiently close to measure a parameter such as temperature or moisture. The measured parameter may be applied to the cleaning function as will be discussed below.

[0474] In the example of Fig. 19, the vaporization device 2200 may include an ultrasonic transducer 2280 or the ultrasonic transducer 2280 may be in physical contact, directly or indirectly, with the ultrasonic transducer 2280. An electric current may be applied to the ultrasonic transducer 2280 causing it to vibrate at an ultrasonic frequency when a cleaning function is initiated, and the vibration from the ultrasonic transducer 2280 may vibrate the vaporization device 2220 to dislodge matter that has accumulated on the vaporization device 2220. It should be noted that the ultrasonic transducer 2280 is optional, and if the ultrasonic transducer 2280 is not included, the cleaning function may be performed by other components.

[0475] In some aspects, users may initiate cleaning cycles when their respiratory therapy system is not in use. For example, the user may unplug the RPT device from the power source and disconnect any of its components, e.g., the vaporizer 110 (if removable), vaporization device 100 (if removable), patient interface, and / or air circuits. Any of the components herein may be washed in any appropriate liquid or mixture. For example, the components may be cleaned with a mild liquid detergent, water, and / or mixtures thereof. Any detergents and / or cleaning products that may damage the components and / or leave harmful residue on the components should be avoided. For example, dish detergent may be avoided. After cleaning the components, they may be thoroughly rinsed, e.g., with water. In some examples, the components may be cleaned and / or rinsed with warm, drinking-quality water. The components may then be air-dried. In some examples, the components may be cleaned before and / or after each use, daily, weekly, or bi-weekly.

[0476] In examples in which one or more vaporizers 110 and / or vaporization devices 100 may be incorporated within or attached to a component of the respiratory therapy device, the vaporizer(s) 110 may not need to be removed from the component to be cleaned. For example, if a vaporizer is incorporated as part of an air circuit, the cleaning cycles as discussed herein may be used to clean vaporizer 110 and corresponding air circuit, without removing vaporizer 110 from the air circuit. In other aspects, vaporizer 110 may be removed from the associated component prior to cleaning. In still other aspects, the vaporizer 110 and vaporization device 100 may be a separate attachment configured to couple to or between one or more components, and may be configured to be cleaned as a separate, standalone component.

[0477] Fig. 21 depicts a flowchart of various steps, including optional steps, that may be performed in conjunction with cleaning a vaporization device and associated data acquisition. Any one or more of these steps may be performed by a controller of the RPT system or the vaporization device or may be performed remotely with the acquired data and instructions for cleaning operations being communicated over a network.

[0478] In some examples, the cleaning operation (e.g., heating of the vaporization device for a predetermined period of time and / or vibrating the vaporization device with an ultrasonic transducer) may be performed independently of any monitored parameter before the vaporization device is operated during therapy, as indicated at step 6000. In other words, step 6000 is optional. As will be explained below, one or more parameters may be monitored and the cleaning function may be initiated based on the data acquired, but it is also possible to initiate the cleaning function regardless of whether one or more monitored parameters meets a threshold and do so before therapy begins to ensure that the vaporization device is sufficiently free of debris prior to a therapy session. Step 6000 may be initiated prior to every single therapy session, or it may only be initiated after a certain number of therapy sessions, such as every other therapy session, every fifth therapy session, every tenth therapy session, etc.

[0479] At step 6001, data may be acquired from one or more sensors as described above with respect to Figs. 18 and 19. The data may be one or more of temperature, presence or absence of moisture (e.g., by measuring conductivity or impedance of water on the sensor), weight, light, electrical power, and time (e.g., via a counter or clock). The data acquired may be indicative of the performance and / or efficiency of the vaporization device. For example, Fig. 20 explains how the performance and / or efficiency of the vaporization device, as indicated by its temperature, can be assessed. With reference to Fig. 20, for example, the solid and dashed lines may represent acceptable performance and / or efficiency, but once the measured temperature falls to the level of the dotted line, that threshold may indicate that cleaning is necessary. Thus, if the parameter is determined (step 6002) to be within a desired range or below a desired threshold, the monitoring continues while therapy is ongoing (step 6003).

[0480] If the monitored parameter exceeds a desired threshold or measures outside of the desired range, then one or more additional actions may be triggered. The additional actio...

Claims

6 CLAIMSWe claim:

1. A respiratory pressure therapy (RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the RPT system comprising: a component that at least partly forms a passage for the flow of air at the therapeutic pressure, the component being one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, a flow generator comprising a blower to pressurize the flow of air to the therapeutic pressure, an air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, or a humidifier comprising a water reservoir and a heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure; a first cartridge assembly coupled to the component and comprising: a first reservoir configured to contain a first liquid; and a first vaporizer in fluid communication with the first reservoir to receive the first liquid from the first reservoir, the first vaporizer being configured to contain the first liquid, and the first vaporizer comprising a first heating element configured to heat the first vaporizer to vaporize the first liquid contained in the first vaporizer; a vaporizer sensor positioned on or proximal to the first vaporizer and configured to detect a physical phenomenon and generate a first signal indicative of a first parameter; and a controller configured to receive the first signal from the vaporizer sensor, the controller configured to determine whether the first parameter exceeds a predetermined threshold, wherein at least a portion of the first vaporizer is exposed to the passage for the flow of air at the therapeutic pressure.

2. The RPT system of claim 1, wherein the component is one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, or the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, andwherein the RPT system further comprises the others of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, and the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface that are not the component.

3. The RPT system of claim 1, further comprising the humidifier comprising the water reservoir and the heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure.

4. The RPT system of any one of claims 1 to 3, further comprising a first sensor positioned on the component upstream relative to the first cartridge assembly along the passage for the flow of air at the therapeutic pressure, the first sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the first sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the first cartridge assembly or a controller external of the first cartridge assembly.

5. The RPT system of any one of claims 1 to 4, further comprising a second sensor positioned on the component downstream relative to the first cartridge assembly along the passage for the flow of air at the therapeutic pressure, the second sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the second sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the first cartridge assembly or a controller external of the first cartridge assembly.

6. The RPT system of any one of claims 1 to 5, wherein the first cartridge assembly is removably coupled to the component, or wherein the first cartridge assembly is permanently coupled to the component.

7. The RPT system of any one of claims 1 to 6, wherein the first cartridge assembly is removably coupled to the component, or wherein the first cartridge assembly is permanently coupled to the component.

8. The RPT system of any one of claims 1 to 7, wherein the physical phenomenon includes one or more of temperature, presence or absence of moisture, weight, light, electrical power, and time.

9. The RPT system of any one of claims 1 to 8, wherein the controller is configured to instruct the first heating element to generate heat in response to a determination that the first parameter exceeded the predetermined threshold.

10. The RPT system of any one of claims 1 to 9, wherein the controller is configured to cause a notification to be generated in response to a determination that the first parameter exceeded the predetermined threshold.

11. The RPT system of any one of claims 1 to 9, wherein the vaporizer sensor is configured to repeatedly generate the first signal during therapy.

12. The RPT system of any one of claims 1 to 10, wherein the controller is configured to receive the first signal from the vaporizer sensor and determine whether the first parameter exceeds a predetermined threshold continuously during therapy.

13. The RPT system of any one of claims 1 to 11, further comprising an ultrasonic transducer positioned on or proximal to the first cartridge assembly or the first vaporizer, and the ultrasonic transducer being configured to vibrate in response to an instruction from the controller.

14. The RPT system of claim 13, wherein the controller is configured to trigger the instruction based on determination that the first parameter exceeded the predetermined threshold.

15. A respiratory pressure therapy (RPT) system configured to direct a flow of air to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder, the RPT system comprising: a component that at least partly forms a passage for the flow of air at the therapeutic pressure, the component being one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, a flow generator comprising a blower to pressurize the flow of air to the therapeutic pressure, an air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, or a humidifier comprising a water reservoir and a heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure; a vaporization device comprising: a vaporization module comprising a vaporizer configured to contain water and a heating element configured to heat the vaporizer to vaporize water contained in the vaporizer; and a reservoir attached to the vaporization module, and the reservoir being configured to store water and provide water to the vaporizer for vaporization during use; a vaporizer sensor positioned on or proximal to the vaporizer and configured to measure a physical phenomenon and generate a first signal indicative of a first parameter; and a controller configured to receive the first signal from the vaporizer sensor, the controller being configured to determine whether the first parameter exceeds a predetermined threshold, wherein at least a portion of the vaporizer is exposed to the passage for the flow of air at the therapeutic pressure.

16. The RPT system of claim 15, wherein the component is one of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, or the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface, and wherein the RPT system further comprises the others of the patient interface configured to direct the flow of air at the therapeutic pressure to the patient, the flow generator comprising the blower to pressurize the flow of air to the therapeutic pressure, and the air circuit configured to direct the flow of air at the therapeutic pressure from the flow generator to the patient interface that are not the component.

17. The RPT system of claim 15, further comprising the humidifier comprising the water reservoir and the heater plate configured to heat water stored in the water reservoir to humidify the flow of air at the therapeutic pressure.

18. The RPT system of any one of claims 15 to 17, further comprising a first sensor positioned on the component upstream relative to the vaporization device along the passage for the flow of air at the therapeutic pressure, the first sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the first sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the vaporization device or a controller external of the vaporization device.

19. The RPT system of any one of claims 15 to 18, further comprising a second sensor positioned on the component downstream relative to the vaporization device along the passage for the flow of air at the therapeutic pressure, the second sensor being exposed to the flow of air at the therapeutic pressure to detect any one of pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage, and the second sensor being configured to communicate the detected pressure, temperature, humidity, or flow rate of the flow of air at the therapeutic pressure inside the passage to the vaporization device or a controller external of the vaporization device.

20. The RPT system of any one of claims 15 to 19, wherein the physical phenomenon includes one or more of temperature, presence or absence of moisture, weight, light, electrical power, and time.

21. The RPT system of any one of claims 15 to 20, wherein the controller is configured to instruct the heating element to generate heat in response to a determination that the first parameter exceeded the predetermined threshold.

22. The RPT system of any one of claims 15 to 21, wherein the controller is configured to instruct the RPT system to generate a notification in response to a determination that the first parameter exceeded the predetermined threshold.

23. The RPT system of any one of claims 15 to 22, wherein the vaporizer sensor is configured to measure the physical phenomenon and generate the first signal repeatedly during therapy.

24. The RPT system of any one of claims 15 to 23, wherein the controller is configured to receive the first signal from the vaporizer sensor and determine whether the first parameter exceeds a predetermined threshold repeatedly during therapy.

25. The RPT system of any one of claims 15 to 24, further comprising an ultrasonic transducer positioned on or proximal to the vaporizer, and the ultrasonic transducer being configured to vibrate in response to an instruction from the controller.

26. The RPT system of claim 25, wherein the controller is configured to trigger the instruction based on determination that the first parameter exceeded the predetermined threshold.

27. A method of facilitating cleaning of a respiratory pressure therapy (RPT) system, the method comprising: supplying a flow of air at a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder; vaporizing, using a vaporizer, a liquid into the flow of air; detecting a physical phenomenon using a sensor that is positioned on or proximal to the vaporizer; generating a first signal indicative of a first parameter that is associated with the physical phenomenon; determining, using at least one processor and based on the first signal, whether the first parameter exceeds a predetermined threshold; and in response to determination that the first parameter exceeds a predetermined threshold, triggering a responsive action.

28. The method of claim 27, wherein the physical phenomenon includes one or more of temperature, presence or absence of moisture, weight, light, electrical power, and time.

29. The method of claim 27 or 28, wherein the responsive action includes causing an increase in heat generated by the vaporizer.

30. The method of any one of claims 27 to 29, wherein the responsive action includes generating a notification.

31. The method of any one of claims 27 to 30, further comprising repeatedly generating the first signal and detecting the physical phenomenon.

32. The method of any one of claims 27 to 31, further comprising repeatedly determining whether the first parameter exceeds the predetermined threshold during therapy.

33. The method of any one of claims 27 to 32, wherein the RPT system further comprises an ultrasonic transducer positioned on or proximal to the vaporizer, and wherein the responsive action includes causing the ultrasonic transducer to vibrate.

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