Respiratory pressure treatment system with evaporative humidifier

Abstract

A respiratory pressure therapy (RPT) system may be configured to direct a flow of air to a therapy pressure above atmospheric pressure to reach a patient interface worn by a patient to treat a respiratory disorder. The RPT system may include a component at least partially forming a passage for a flow of air at a treatment pressure, the component being one of a patient interface, a flow generator including a blower, an air circuit, or a humidifier; and an evaporation device, the evaporation device comprising: an evaporation module comprising an evaporator and a heating element; and a reservoir attached to the vaporizing module and configured for storing water and providing water to the vaporizer for vaporizing during use wherein at least a portion of the vaporizer is exposed to a channel for the flow of air at the treatment pressure.

Description

[0001] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights.

[0002] 1. Cross-references to related applications This application claims the benefits of International Application No. PCT / AU2024 / 050696, filed June 28, 2024, and U.S. Provisional Application No. 63 / 517,004, filed August 1, 2023, the entire contents of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field This technology relates to one or more of the screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0004] 2.2 Description of related technologies 2.2.1 Human Respiratory System and Its Diseases The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0005] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from inhaled air into the venous blood and carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchi, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, by John B. West, Lippincott Williams & Wilkins, 2012.

[0006] There are a range of respiratory diseases. Some diseases can be characterized by specific events, such as sleep apnea, hypoventilation, and hyperventilation.

[0007] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0008] 2.2.2 Treatment Various respiratory therapies, such as continuous positive airway pressure (CPAP), noninvasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), have been used to treat one or more of the above-mentioned respiratory disorders.

[0009] 2.2.2.1 Respiratory pressure therapy Respiratory pressure therapy is the application of supplying air to the airway inlet at a controlled target pressure that is nominally positive relative to the atmosphere throughout the patient’s respiratory cycle (as opposed to negative pressure therapy such as canister ventilators or thoracic brachial tubes).

[0010] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0011] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to assist breathing and / or maintain adequate oxygen levels by performing some or all of the work of breathing. Ventilation support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure forms such as OHS, COPD, NMD, and chest wall diseases. In some forms, it can improve the comfort and effectiveness of these treatments.

[0012] Noninvasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube or endotracheal tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0013] 2.2.3 Respiratory Therapy System These respiratory therapies can be provided by respiratory therapy systems or devices. Such systems and devices can also be used to screen, diagnose, or monitor conditions without treating them.

[0014] A respiratory therapy system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management.

[0015] 2.2.3.1 Patient Interface Patient interfaces can be used to attach breathing equipment to their wearer, for example, by providing an airflow into the airway inlet. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cmH2O to the airway. For flow-based treatments such as nasal HFT, the patient interface is configured to blow air into the nostrils, but specifically avoids a complete seal. An example of such a patient interface is a nasal cannula.

[0016] Some mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain proper pressure. Mask systems for underwater swimming or diving may be configured to prevent the ingress of water from higher external pressures, but not to maintain internal air at a pressure higher than ambient pressure.

[0017] Certain masks may be clinically disadvantageous for this technique, for example, if they block airflow through the nose and only allow it through the mouth.

[0018] If patients need to insert part of the mask structure into their mouths to create and maintain a seal through their lips, some masks may be uncomfortable or impractical for this technique.

[0019] Some face masks may be impractical to use while sleeping, such as when lying on your side in bed with your head on a pillow.

[0020] Some masks may cause some patients to experience claustrophobia, discomfort, and / or may feel excessively unpleasant.

[0021] The design of the patient interface presents numerous challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary considerably between individuals. Because the head comprises bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jawbone or mandible can move relative to other bones of the skull. The entire head can move during respiratory therapy.

[0022] Therefore, some masks have disadvantages such as protrusion, aesthetic undesirability, high cost, poor fit, difficulty in use, and / or discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. An incorrectly sized mask can lead to reduced adherence, decreased comfort, and poorer patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks used for the administration of anesthetics may be tolerable for their original application; however, such masks can still be undesirably uncomfortable when worn for extended periods (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, particularly if the mask is worn during sleep.

[0023] CPAP therapy is highly effective for treating certain respiratory conditions, provided the patient adheres to the treatment. Patients may not adhere to treatment if the mask is uncomfortable or difficult to use. Because patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not be able to clean it, and this can affect patient adherence.

[0024] While masks designed for other applications (such as navigators) may not be suitable for treating sleep-disordered breathing, masks designed for treating sleep-disordered breathing may be suitable for other applications.

[0025] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0026] 2.2.3.1.1 Sealing Formation Structure The patient interface may include a seal-forming structure. Since the seal-forming structure comes into direct contact with the patient's face, its shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0027] Patient interfaces can be characterized in part by their design intent to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part forming a seal around the left nostril and a second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element that surrounds both nostrils during use. This single element may be designed, for example, to cover the supralipal and midnasal regions of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both the nostril and mouth regions during use. These different types of patient interfaces may be known by their manufacturers under various names, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0028] A seal that works in one area of ​​a patient's face may be unsuitable in another, for example, due to the different shapes, structures, variability, and sensitive areas of the patient's face. For instance, a seal on swimming goggles covering a patient's forehead may not be suitable for use on a patient's nose.

[0029] Certain seal-forming structures can be designed for mass production, allowing a design to fit comfortably and effectively for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the patient's facial shape and the seal-forming structure of the mass-produced patient interface, one or both must be modified to form a seal.

[0030] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface during face-to-face engagement. This seal-forming structure may include an air- or fluid-filled pad, or a molded or formed surface of an elastic sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0031] Another type of seal-forming structure incorporates a valve seal made of a thin material located around the periphery of the mask to provide a self-sealing effect on the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, 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 the patient's shape, it may wrinkle or buckle during use, causing leakage.

[0032] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0033] Another form of seal formation can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0034] A series of patient interface sealing 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 circuitry manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0036] ResMed Inc. manufactures the following products that combine nose pillows: SWIFT TM Nose pillow cover, SWIFT TM II Nose pillow cover, SWIFT TM LT nose pillow cover, SWIFT TM FX nose pillow and MIRAGE LIBERTY TM Full-face mask. The following patent application describes an example of a nose pillow mask: International Patent Application WO 2004 / 073778 (describes SWIFT). TM Other aspects of the nose pillow cover), U.S. Patent Application 2009 / 0044808 (describes SWIFT) TM Other aspects of the LT nasal pillow cover); International patent applications WO 2005 / 063328 and WO2006 / 130903 (describe MIRAGE LIBERTY) TM Other aspects of full-face masks); International patent application WO 2009 / 052560 (describes SWIFT) TM Other aspects of the FX nose pillow cover.

[0037] 2.2.3.1.2 Positioning and Stabilizing Structure The seal-forming structure of a patient interface used in positive pressure therapy is subject to the corresponding force of pneumatic pressure that can disrupt the seal. Therefore, various techniques have been used to position the seal-forming structure and maintain it in a sealed relationship with the appropriate portion of the face. Several factors can be considered when comparing different positioning and stabilization techniques. These include: how effective the technique is at holding the seal-forming structure in the desired position and sealing it against the face during patient interface use; how comfortable the interface is for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0038] One technique involves using adhesives, see, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0039] Another technique involves using one or more straps and / or stabilizing shoulder straps. Many such shoulder straps suffer from one or more problems of being unsuitable, bulky, uncomfortable, and inconvenient to use.

[0040] 2.2.3.1.3 Pressurized air duct In one type of treatment system, pressurized airflow is supplied to the patient interface via a conduit in an air circuit. When the patient interface is positioned over the patient's face during use, the air circuit is fluidly connected to the patient interface at a location in front of the patient's face. The conduit can extend forward from the patient interface away from the patient's face.

[0041] 2.2.3.1.4 Pressurized air ducts used for positioning / stabilizing the sealing structure Another type of treatment system includes a patient interface in which the tubing that delivers pressurized air to the patient's airway also serves as part of a headgear to position and stabilize a sealing portion of the patient interface in the appropriate part of the patient's face. This type of patient interface may be referred to as having a "catheter headgear" or "headgear tubing." Such a patient interface allows a catheter in the air circuit providing a flow of pressurized air from a respiratory pressure therapy (RPT) device to be connected to the patient interface at a location other than in front of the patient's face. An example of such a treatment system is disclosed in U.S. Patent Publication No. 2007 / 0246043, the contents of which are incorporated herein by reference, wherein the catheter is connected to the tubing in the patient interface via a port positioned on the top of the patient's head during use.

[0042] Ideally, when the patient is asleep, the patient interface with a head cannula should be comfortable for the patient to wear for an extended period of time, forming an airtight and stable seal with the patient's face, while also being adaptable to a range of patient head shapes and sizes.

[0043] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned treatments, for example, by operating the device to generate an airflow for delivery to an airway interface. The airflow can be pressure-controlled (for respiratory pressure therapy) or flow-controlled (for flow therapy such as HFT). Therefore, RPT devices can also be used as flow therapy devices. Examples of RPT devices include CPAP devices and ventilators.

[0044] Pneumatic generators are known in a variety of applications, such as industrial-scale ventilation systems. However, pneumatic generators for medical applications have specific requirements that more general pneumatic generators cannot meet, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical treatment may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0045] One example of a specific requirement for certain RPT devices is noise.

[0046] A table showing the noise output levels of an existing RPT device (only one sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744).

[0047]

[0048] One known RPT device 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 pediatric ventilators, can provide invasive and non-invasive non-dependent ventilatory support for a range of patients to treat various conditions, including but not limited to NMD, OHS, and COPD.

[0049] Therapeutic ResMed Elisée™ 150 and Therapeutic ResMed VS III™ ventilators provide invasive and non-invasive dependent ventilation support for adults and pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure ventilation modes with single-limb or dual-limb circuits. RPT devices typically include a pressure generator, such as a motor-driven blower or compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, the airflow can be supplied to the patient's airway at positive pressure. The RPT device outlet is connected via an air circuit to a patient interface such as those described above.

[0050] 2.2.3.3 Air Circuit An air circuit is a conduit or tube constructed and arranged to allow airflow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, there may be separate branches of the air circuit for inspiratory and expiratory breathing. In other cases, a single branch air circuit is used for both inspiratory and expiratory breathing.

[0051] 2.2.3.4 Humidifier Delivering airflow without humidification can lead to airway dryness. The use of humidifiers with an RPT device and patient interface produces humidified gas that minimizes dryness of the nasal mucosa and increases patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0052] Many artificial humidification devices and systems are known, however, they do not meet the specific requirements of medical humidifiers.

[0053] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air, typically in areas where patients sleep or rest (e.g., in hospitals). Medical humidifiers intended for bedside placement can be small. They can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort for the occupant. Furthermore, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0054] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0055] 2.2.3.5 Ventilation technology Some forms of therapeutic systems may include vents to allow for the flushing of exhaled carbon dioxide. Vents can allow gas to flow from the internal space of the patient interface, such as an inflation chamber, to the outside of the patient interface, such as the surrounding environment.

[0056] The vent may include an opening through which gas can flow during the use of the mask. Many such vents are noisy. Others may become clogged during use and therefore provide insufficient flushing. Some vents may, for example, disrupt the sleep of the patient's bed partner by causing noise or concentrated airflow.

[0057] ResMed Inc. has developed numerous improved mask ventilation technologies, see, for example, International Patent Application Publication No. WO 1998 / 034665; International Patent Application Publication No. WO 2000 / 078381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0058] The noise level of the existing face mask (ISO 17510-2:2007, 10 cmH2O pressure 1m)

[0059] ( (Single sample, measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744) 3. Summary of the Invention This technology aims to provide medical devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0060] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0061] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0062] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0063] One form of this technology includes a positioning and stabilizing structure configured to provide forces that hold the seal-forming structure in a therapeutically effective position on the patient's head. The positioning and stabilizing structure includes at least one band.

[0064] One form of this technology includes a patient interface comprising an inflation chamber, a sealing formation structure, and a positioning and stabilizing structure.

[0065] One form of this technology includes a patient interface comprising an inflatable chamber pressurizable to a treatment pressure at least 4 cmH2O above ambient air pressure. The inflatable chamber includes at least one inflatable chamber inlet port, the inlet port being sized and configured to receive an airflow at the treatment pressure for patient breathing. The patient interface also includes a sealing structure configured and arranged to form a seal with a region of the patient's face surrounding the patient's airway inlet. The sealing structure has an opening therein, such that an airflow at the treatment pressure is delivered to at least an inlet of the patient's nostril. The sealing structure is configured and arranged to maintain the treatment pressure in the inflatable chamber throughout the patient's respiratory cycle in use. The patient interface also includes a positioning and stabilizing structure that provides force to hold the sealing structure in a therapeutically effective position on the patient's head.

[0066] Another aspect of this technology is a series of modular elements that can be interconnected to form different types of patient interfaces.

[0067] In one form, each modular element has at least two versions or types. These versions or types can be used interchangeably to form different modular components.

[0068] One aspect of this technology relates to a patient interface comprising: an inflatable chamber pressurizable to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for patient breathing; a sealing formation structure configured and arranged to seal an inlet area of ​​the patient's face surrounding the patient's airway, the sealing formation structure having an opening therein such that an airflow at the therapeutic pressure is delivered to at least an inlet of the patient's nostril, and the sealing formation structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the entire patient's respiratory cycle in use; a positioning and stabilizing structure providing force to hold the sealing formation structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap configured and arranged such that in use at least a portion covers an area of ​​the patient's head above an ear point; and a connection port. The device is configured to connect to an air circuit to receive and direct an airflow at the treatment pressure to the inflatable chamber for the patient to breathe; an evaporator configured to contain water and include a heating element configured to evaporate the water contained in the evaporator; and a ventilation structure including one or more vents configured to allow exhaled air from the patient to flow continuously from the interior of the inflatable chamber to the surrounding environment, the size and shape of the one or more vents being determined to maintain the treatment pressure in the inflatable chamber during use; wherein the patient interface is configured such that the patient's mouth is not covered, or if the sealing structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the surrounding environment without pressurized airflow through the inflatable chamber inlet port.

[0069] One aspect of this technology relates to a patient interface comprising: an inflation chamber; a sealing formation structure; a positioning stabilization structure; a connection port; an evaporator and a heating element configured to evaporate water contained in the evaporator; and a ventilation structure.

[0070] In examples of the aspects of these two preceding paragraphs: (a) at least a portion of the evaporator may be positioned within the inflation chamber to evaporate water into the airflow at the therapeutic pressure within the inflation chamber; (b) at least a portion of the evaporator may be positioned within the connection port to evaporate water into the airflow at the therapeutic pressure within the inflation chamber; (c) a first sensor may be positioned on the inflation chamber and exposed to the interior of the inflation chamber to detect any one of the pressure, temperature, humidity, or flow rate of the airflow at the therapeutic pressure within the inflation 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 the pressure, temperature, humidity, or flow rate of the airflow at the therapeutic pressure within the connection port; and (e) the positioning and stabilization structure may include a pair of tubes, each of which is fluidly connected at its distal end to the connection port and at its proximal end to the inflation chamber to direct the airflow at the therapeutic pressure into the inflation chamber for respiration by the patient; and a third sensor may be positioned on at least one of these tubes and exposed to the interior of the corresponding tube to detect the airflow at the therapeutic pressure within the corresponding tube. (f) The reservoir may be configured to store water and is in fluid communication with the evaporator to provide water for evaporation during use; (g) the reservoir may be permanently attached to the evaporator or the reservoir may be removably attached to the evaporator; (h) the wicking material may be configured to transport water from the reservoir to the evaporator; (i) the reservoir may be made of rubber or polymer and may be configured to collapse when empty or filled to less than its maximum volume; (j) the evaporator may include a first porous material configured to contain water and thermally connected to the evaporator. A heating element is provided to heat water in the porous material, thereby causing water to evaporate. (k) The first porous material may be any one of ceramic, metal, sintered metal, quartz, polymer, or fibrous material. (l) The first porous material may be configured to transport water by capillary force. (m) The evaporator may include 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 is any one of ceramic, metal, sintered metal, quartz, polymer, or fibrous material.(o) The second porous material may be configured to transport water by capillary force; (p) The heating element may be a resistance heater; (q) A power source may be configured to supply power to the heating element; (r) The power source may be a battery; (s) The heating element may be configured to be electrically connected to an RPT device, which includes a blower to pressurize the airflow to the treatment 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 in the air chamber or the connection along a flow path from the sealing structure to the venting structure. The HMX is located at the port and between the sealing structure and the ventilation structure, exposing it to an airflow at the treatment pressure to absorb heat and moisture from the patient's exhaled air during use. (u) The HMX can be fluidly connected to the vaporizer to deliver water absorbed from the patient's exhaled air to the vaporizer. (v) The vaporizer can be permanently attached to the inflation chamber or removably attached to the inflation chamber. And / or (w) The vaporizer can be permanently attached to the connection port or removably attached to the connection port.

[0071] One aspect of this technology relates to an evaporation device for use with a respiratory pressure therapy (RPT) device, the evaporation device including a blower for pressurizing an airflow to a therapeutic pressure above atmospheric pressure to treat respiratory disorders. An evaporation device comprising: an evaporation module including an evaporator configured to contain water and a heating element configured to heat the evaporator to evaporate the water contained therein; a reservoir attached to the evaporation module in an operational orientation above the evaporation module and configured to store water in fluid contact with the evaporator for supplying water to the evaporator by gravity for evaporation during use; an evaporation channel configured to guide an airflow at the treatment pressure through the evaporation device, and the evaporator being exposed to the airflow at the treatment pressure within the evaporation channel; an inlet pipe configured to receive the airflow at the treatment pressure pressurized by the blower and guide the airflow at the treatment pressure into the evaporation channel; and an outlet pipe configured to receive the humidified airflow at the treatment pressure from the evaporation channel and guide the humidified airflow at the treatment pressure to a patient interface.

[0072] One aspect of this technology relates to an evaporation device for use with a respiratory pressure therapy (RPT) device, the evaporation device including a blower for pressurizing an airflow to a therapeutic pressure above atmospheric pressure to treat respiratory disorders. The evaporation device includes: an evaporation module including an evaporator and a heating element; a reservoir attached to the evaporation module, the reservoir being configured to store water; and an evaporation channel configured to guide the airflow at the therapeutic pressure through the evaporation device.

[0073] In the examples of these two preceding paragraphs: (a) the evaporation module may be positioned above the evaporation channel in the operating direction, such that water evaporated from the evaporator travels downward into the airflow under therapeutic pressure within the evaporation channel; (b) the reservoir and the evaporation module may be permanently or removably attached; (c) the evaporation channel and the evaporation module may be permanently or removably attached; (d) the evaporation module may not include a wicking material; (e) the reservoir may be constructed of rubber or polymer and may be configured to collapse when empty or filled to less than the maximum volume; (f) the evaporator may include a first porous material configured to contain water and thermally connected to a heating element to be heated by the heating element to evaporate the water in the porous material; (g) the first porous material may be ceramic, metal, sintered metal, (h) The first porous material is configured to transport water via capillary force, any of the following: (i) the evaporator may include 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 is any of the following: ceramic, metal, sintered metal, quartz, polymer, or fibrous material; (k) the second porous material may be configured to transport water via capillary force; (l) the heating element may be a resistance heater; (m) a power source may be configured to supply power to the heating element; (n) the power source may be a battery; and / or (o) the heating element may be configured to be electrically connected to the RPT device to supply power to the heating element.

[0074] One aspect of this technology relates to a respiratory pressure therapy (RPT) system configured to direct an airflow to a therapeutic pressure above atmospheric pressure to a patient-worn interface to treat a respiratory disorder. The RPT system includes: a component that at least partially forms a channel for the airflow at the therapeutic pressure, said component being one of: the patient interface configured to direct the airflow at the therapeutic pressure to the patient; a flow generator including a blower to pressurize the airflow to the therapeutic pressure; and an air circuit configured to direct the airflow at the therapeutic pressure from the patient. A flow generator is directed 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 an airflow at a therapeutic pressure; and an evaporation device comprising: an evaporation module including an evaporator configured to contain water and a heating element configured to heat the evaporator to evaporate the water contained therein; and a reservoir attached to the evaporation module and configured to store water and supply water to the evaporator for evaporation during use, wherein at least a portion of the evaporator is exposed to a passage for an airflow at the therapeutic pressure.

[0075] One aspect of this technology relates to a respiratory pressure therapy (RPT) system, comprising: a component that at least partially forms a channel, the component being one of: a patient interface, a flow generator, an air circuit, or a humidifier; and an evaporation device comprising: an evaporation module including an evaporator and a heating element; and a reservoir attached to the evaporation module.

[0076] In the examples of these two preceding paragraphs: (a) the component is one of the following: the patient interface configured to direct an airflow at the treatment pressure to the patient; the flow generator including a blower to pressurize the airflow to the treatment pressure; or the air circuit configured to direct an airflow at the treatment pressure from the flow generator to the patient interface, and the RPT system may also include other parts that are not the component: the patient interface configured to direct an airflow at the treatment pressure to the patient; the flow generator including a blower to pressurize the airflow to the treatment pressure;(a) The air circuit is configured to direct an airflow under the treatment pressure from the flow generator to the patient interface; (b) A humidifier may include and include the water reservoir and the heater plate, the heater plate being configured to heat water stored in the water reservoir to humidify the airflow under the treatment pressure; (c) A first sensor may be positioned along a channel for the airflow under the treatment pressure on a component upstream of the evaporator, the first sensor being exposed to the airflow under the treatment pressure to detect any one of the pressure, temperature, humidity, or flow rate of the airflow under the treatment pressure within the channel, and the first sensor is configured to transmit the detected airflow under the treatment pressure within the channel. (d) The pressure, temperature, humidity, or flow rate of the airflow is transmitted to the evaporator or a controller outside the evaporator; (e) a second sensor may be positioned along a channel for the airflow at therapeutic pressure on a component downstream of the evaporator, the second sensor being exposed to the airflow at therapeutic pressure to detect any one of the pressure, temperature, humidity, or flow rate of the airflow at therapeutic pressure within the channel, and the second sensor is configured to transmit the detected airflow at therapeutic pressure within the channel to the evaporator or a controller outside the evaporator for the pressure, temperature, humidity, or flow rate; and (m) a heat and humidity exchanger (HMX) may be exposed to the airflow at therapeutic pressure to the gas exhaled by the patient in use. (f) The HMX is positioned upstream of the evaporator along the channel of the airflow under the treatment pressure to decompose water into the airflow under the treatment pressure before it reaches the evaporator; (g) the first sensor is positioned between the HMX and the evaporator along the channel of the airflow under the treatment pressure; (h) the third sensor is positioned upstream of the component along the channel of the airflow under the treatment pressure relative to the HMX, the third sensor being exposed to the airflow under the treatment pressure to detect any one of the pressure, temperature, humidity, or flow rate of the airflow under the treatment pressure within the channel. The third sensor is configured to transmit the pressure, temperature, humidity, or flow rate of the detected airflow under the treatment pressure within the channel to the evaporation device or a controller outside the evaporation device. (i) The vent can be positioned upstream of the component relative to the HMX along the channel for the airflow under the treatment pressure, and the vent is configured to allow air to travel from the component to the atmosphere. (j) The vent can be configured to open and / or close in response to airflow through the component; open and / or close in response to the characteristics of airflow through the component; open when the user exhales and / or when the heating element is de-energized, and close when the patient inhales and / or when the heating element is energized.And it opens or closes based on the humidity of the air flowing through the component; (k) the vent may include one or more holes that remain open to the atmosphere throughout the patient’s respiratory cycle; (l) the evaporation device may also include a radiator thermally connected to the evaporator to absorb heat from the evaporator and release the heat into the airflow at therapeutic pressure in the channel; (m) the radiator may be positioned in the channel for the airflow at therapeutic pressure; (n) the entire evaporation device may be positioned in the channel for the airflow at therapeutic pressure; (o) the evaporator may include a first surface and a second surface spaced apart from the first surface, through which water evaporates into the airflow at therapeutic pressure, and the radiator may be positioned on the second surface; (p) the radiator may be made of metal; (q) the radiator may include a plurality of heat sinks. (r) The evaporation device may include a bridge thermally connecting the evaporator and the radiator to transfer heat from the evaporator to the radiator; (s) the bridge may be made of metal; (t) the bridge may be positioned upstream relative to the HMX along a channel for airflow under treatment pressure; (u) a first sensor may be positioned upstream relative to the HMX along the channel for airflow under treatment pressure; (v) the first sensor may be positioned near the radiator; (w) a recirculation channel may be included from the patient interface to the HMX, the recirculation channel being separate from the air circuit and configured to direct airflow under treatment pressure to the HMX; and / or (x) the recirculation path may not include a vent.

[0077] One aspect of this technology relates to a patient interface comprising: an inflatable chamber pressurizable to at least 6 ppm higher than ambient air pressure. The treatment pressure of cmH2O, the inflation chamber includes an inflation chamber inlet port, the size and structure of which are determined to receive an airflow at the treatment pressure for patient breathing; a sealing formation structure configured and arranged to seal an area of ​​the patient's face surrounding an inlet of the patient's airway, the sealing formation structure having an opening therein such that an airflow at the treatment pressure is delivered to at least an inlet of the patient's nostril, and the sealing formation structure is configured and arranged to maintain the treatment pressure in the inflation chamber throughout the entire patient breathing cycle in use; a positioning and stabilizing structure providing force to hold the sealing formation structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap configured and arranged such that in use at least a portion covers an area of ​​the patient's head above the supra-auricular point; a connection port configured to connect to an air circuit to receive and direct the airflow at the treatment pressure to the inflation chamber for patient breathing; evaporation; The device is configured to contain water and includes a heating element configured to evaporate the water contained in the evaporator; a cartridge assembly coupled to the inflation chamber or the connection port and including: a reservoir configured to contain liquid; and an evaporator in fluid communication with the reservoir to receive liquid from the reservoir, the evaporator being configured to contain the liquid and including a heating element configured to evaporate the water contained in the evaporator; and a ventilation structure including one or more vents configured to allow exhaled air from the patient to flow continuously from the interior of the inflation chamber to the surrounding environment, the size and shape of the one or more vents being determined to maintain therapeutic pressure in the inflation chamber during use; wherein the patient interface is configured such that the patient's mouth is not covered, or if the sealing formation is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the surrounding environment without pressurized air flowing through the inflation chamber inlet port.

[0078] One aspect of this technology relates to a patient interface comprising: an inflation chamber; a sealing formation structure; a positioning stabilization structure; a connection port; a box assembly including: a reservoir; and an evaporator including a heating element configured to evaporate water contained therein; and a ventilation structure.

[0079] In examples of these two preceding paragraphs: (a) the cartridge assembly can be removably coupled to the inflation chamber such that at least a portion of the evaporator is positioned within the inflation chamber to evaporate water into the airflow under therapeutic pressure within the inflation chamber; (b) the cartridge assembly can be removably coupled to the connection port such that at least a portion of the evaporator is positioned within the connection port to evaporate water into the airflow under therapeutic pressure within the inflation chamber; (c) a first sensor can be positioned on the inflation chamber and exposed to the interior of the inflation chamber to detect the pressure of the airflow under therapeutic pressure within the inflation chamber. (d) A second sensor may be positioned on and exposed inside the connection port to detect any one of the pressure, temperature, humidity, or flow rate of the airflow under therapeutic pressure within the connection port; (e) The positioning and stabilization structure may include a pair of tubes, each of which is fluidly connected at its distal end to the connection port and at its proximal end to an inflation chamber to direct the airflow under therapeutic pressure into the inflation chamber for the patient to breathe; and a third sensor may be positioned on at least one tube and exposed inside the corresponding tube to detect the therapeutic pressure within the corresponding tube. (f) The pressure, temperature, humidity, or flow rate of the airflow under force; (g) at least one of a porous wicking material, aerogel, or hydrogel can be positioned within the reservoir to store liquid; (h) the reservoir can be permanently attached to the evaporator, or the reservoir can be removably attached to the evaporator; (i) the reservoir can be constructed of rubber or polymer and configured to collapse when empty or filled to less than its maximum volume; (j) the cartridge assembly can be configured to be removably coupled to the inflation chamber or connection port by snap-fit ​​or friction fit; and (e) the evaporator can include a first porous material configured to contain water and thermally bonded. The evaporator is connected to the heating element to be heated by the heating element, thereby causing water in the first porous material to evaporate; (k) the first porous material may be any one of ceramic, metal, sintered metal, quartz, polymer, or fibrous material; (l) the first porous material may be configured to transport water by capillary force; (m) the evaporator may include 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 is any one of ceramic, metal, sintered metal, quartz, polymer, or fibrous material.(o) The second porous material may be configured to transport water by capillary force; (p) The heating element may be a resistance heater; (q) A power source may be configured to supply power to the heating element; (r) The power source may be a battery; (s) The heating element may be configured to be electrically connected to an RPT device, which includes a blower to pressurize the airflow to the treatment pressure, and the heating element is configured to be powered by the RPT device; (t) A heat and moisture exchanger (HMX) may be positioned along a flow path from the sealing structure to the ventilation structure on the inflation chamber or the connection port and between the sealing structure and the ventilation structure, such that the HMX is exposed to the airflow at the treatment pressure to absorb heat and moisture from the patient's exhaled air during use; (u) The HMX MX can be fluidly connected to the vaporizer to deliver water absorbed from the patient's exhaled gas to the vaporizer; (v) the inflation chamber or the connection port may include an opening, and the cartridge assembly is configured to be removably coupled to the inflation chamber or the connection port at the opening; and at least one seal is configured to seal between the cartridge assembly and the inflation chamber or the connection port; (w) the at least one seal may be positioned on the cartridge assembly, or a first seal may be positioned on the cartridge assembly and a second seal may be positioned on the inflation chamber or the connection port; (x) the cartridge assembly is removably coupled to the inflation chamber or the connection port, or the cartridge assembly may be permanently coupled to the inflation chamber or the connection port.

[0080] One aspect of this technology relates to a respiratory pressure therapy (RPT) system configured to direct an airflow to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder. The RPT system includes: a component that at least partially forms a channel for the airflow at the therapeutic pressure, said component being one of: the patient interface configured to direct the airflow at the therapeutic pressure to the patient; a flow generator including a blower to pressurize the airflow to the therapeutic pressure; an air circuit configured to direct the airflow at the therapeutic pressure from the flow generator to the patient interface; or a humidifier including a water reservoir and A heater plate configured to heat water stored in the water reservoir to humidify an airflow under therapeutic pressure; and a first housing assembly coupled to the component and comprising: a first reservoir configured to contain a first liquid; and a first evaporator in fluid communication with the first reservoir to receive the first liquid from the first reservoir, the first evaporator being configured to contain the first liquid and including a first heating element configured to heat the first evaporator to evaporate the first liquid contained therein; wherein at least a portion of the first evaporator is exposed to a channel for the airflow under the therapeutic pressure.

[0081] One aspect of this technology relates to a respiratory pressure therapy (RPT) system, comprising: a component that at least partially forms a channel for airflow; and a first housing assembly coupled to the component and including: a first reservoir; and a first evaporator including a first heating element configured to heat the first evaporator to cause the first liquid contained in the first evaporator to evaporate.

[0082] In the examples of these two preceding paragraphs: (a) the component is one of: the patient interface configured to direct an airflow at the treatment pressure to the patient; the flow generator including a blower to pressurize the airflow to the treatment pressure; or the air circuit configured to direct an airflow at the treatment pressure from the flow generator to the patient interface, and wherein the RPT system may include other parts that are not the component: the patient interface configured to direct an airflow at the treatment pressure to the patient; the flow generator including a blower to pressurize the airflow to the treatment pressure;(a) The air circuit is configured to direct an airflow under the treatment pressure from the flow generator to the patient interface; (b) the humidifier may include a water reservoir and the heater plate, the heater plate being configured to heat water stored in the water reservoir to humidify the airflow under the treatment pressure; (c) a first sensor may be positioned upstream of the component relative to the first housing assembly along a channel for the airflow under the treatment pressure, the first sensor being exposed to the airflow under the treatment pressure to detect any one of the pressure, temperature, humidity, or flow rate of the airflow under the treatment pressure within the channel, and the first sensor is configured to transmit the detected airflow within the channel. (d) A second sensor may be positioned downstream of the first box assembly relative to the component along a channel for the airflow under treatment pressure, the second sensor being exposed to the airflow under treatment pressure to detect any one of the pressure, temperature, humidity, or flow rate of the airflow under treatment pressure within the channel, and the second sensor is configured to transmit the detected pressure, temperature, humidity, or flow rate of the airflow under treatment pressure within the channel to the first box assembly or a controller outside the first box assembly; (e) the first box assembly may be capable of transmitting the pressure, temperature, humidity, or flow rate of the airflow under treatment pressure within the channel to the first box assembly or a controller outside the first box assembly. (f) At least one of a porous wicking material, aerogel, or hydrogel can be positioned within the first reservoir to store the first liquid; (g) The surface of the first evaporator exposed to airflow within the channel is substantially flush with the surface of the component adjacent to the first evaporator; (h) The surface of the first evaporator exposed to airflow within the channel extends over the surface of the component adjacent to the first evaporator and into the channel; (i) The first wicking assembly can be removably attached to the component, or the first wicking assembly can be permanently attached to the component; (j) The reservoir can be attached to the component. The reservoir is configured to capture excess first liquid that is not absorbed into the airflow under the treatment pressure. (h) A second cartridge assembly can be coupled to this assembly and may include: a second reservoir configured to contain a second liquid; and a second evaporator in fluid communication with the second reservoir to receive the second liquid from the second reservoir, the second evaporator being configured to contain the second liquid and including a second heating element configured to heat the second evaporator to evaporate the second liquid contained therein; wherein at least a portion of the second evaporator is exposed to the channel for the airflow under the treatment pressure.

[0083] One aspect of this technology relates to a cartridge assembly for a respiratory pressure therapy (RPT) system configured to direct an airflow to a therapeutic pressure above atmospheric pressure to a patient interface worn by a patient to treat a respiratory disorder. The cartridge assembly includes: a reservoir configured to contain liquid; and an evaporator fluidly connected to the reservoir to receive liquid from the reservoir. The evaporator is configured to contain the liquid and includes a heating element configured to evaporate water contained within the evaporator.

[0084] In the examples of aspects mentioned in the preceding paragraphs: (a) at least one of a porous wicking material, aerogel, or hydrogel may be positioned inside the reservoir to store the liquid; (b) the reservoir may be constructed of rubber or polymer and configured to collapse when empty or filled to less than its maximum volume; (c) the cartridge assembly may be configured to be removably coupled to the inflation chamber or connection port of the patient interface of the RPT system via a snap-fit ​​or friction fit; (d) the inflation chamber or connection port may include an opening, and the cartridge assembly may be configured to be removably coupled to the inflation chamber or connection port at the opening; (e) at least one seal may be configured to seal between the cartridge assembly and the inflation chamber or connection port; (f) the at least one seal may be positioned on the cartridge assembly; and (g) the evaporator may include a first porous material. The first porous material is configured to contain water and is thermally connected to the heating element to be heated by the heating element, thereby causing the water in the first porous material to evaporate; (h) the first porous material may be any one of ceramic, metal, sintered metal, quartz, polymer or fibrous material; (i) the first porous material may be configured to transport water by capillary force; (j) the evaporator may include a second porous material, the second porous material being 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, polymer or fibrous material; (l) the second porous material may be configured to transport water by capillary force; (m) the heating element may be a resistance heater.

[0085] Another aspect of this technology is a patient interface that is molded or otherwise constructed to have a peripheral shape that complements the peripheral shape of the intended wearer.

[0086] One aspect of this technology is a method for manufacturing equipment.

[0087] Another aspect of this technology is a method for assembling a modular system, including selecting positioning and stabilizing structures and connecting the positioning and stabilizing structures to a first liner or a second liner.

[0088] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by a person without medical training, by a person with limited dexterity, vision, or by a person with limited experience in using this type of medical device.

[0089] One aspect of this technology is a portable RPT device that can be carried by a person (e.g., in a person's home).

[0090] One aspect of this technology is a patient interface that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment. Another aspect of this technology is a humidifier canister that can be used in a patient's home, for example, by washing it in soapy water without the need for specialized cleaning equipment.

[0091] The described methods, systems, apparatus, and devices can be implemented to improve the functionality of processors, such as dedicated computers, respiratory monitors, and / or respiratory therapy devices. Furthermore, the described methods, systems, apparatus, and devices can provide improvements in the technical field of automated management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep-disordered breathing.

[0092] Of course, some of these aspects can form sub-aspects of this technology. Furthermore, sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0093] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions The technology is illustrated in the accompanying drawings by way of example and not limitation, and the same reference numerals in the drawings denote similar elements, including: 4.1 Respiratory Therapy System Figure 1A and 1B Various configurations of respiratory therapy systems in use are shown.

[0095] 4.2 Respiratory System and Facial Anatomy Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0096] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, supralabial and sublabial folds, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0097] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper vermilion, lower vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial groove, and corners of the mouth. It also indicates the directions of up, down, radially inward, and radially outward.

[0098] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, supralipal, sublipal, supramental, nasal ridge, nasal alar apex, supraauricular, and subauricular points. It also indicates the vertical and horizontal directions.

[0099] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfurt plane and the nasolabial angle. The coronal plane is also indicated.

[0100] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, sublipus, upper vermilion border, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0101] Figure 2G A side view showing the surface features of the nose is shown.

[0102] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0103] Figure 2I The diagram shows the medial anatomy of the nose a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0104] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0105] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0106] Figure 2L The frontal lateral view of the nose is shown.

[0107] 4.3 Patient Interface Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0108] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0109] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0110] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0111] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0112] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0113] Figure 3G The padding for a face mask comprising two pillows is shown. The outer surface of the padding is indicated. The edges of the surface are indicated. The dome and saddle-shaped areas are indicated.

[0114] Figure 3H The padding used for the face mask is shown. The outer surface of the padding is indicated. The edge of the surface is indicated. The path on the surface between points A and B is indicated. The straight-line distance between A and B is indicated. Two saddle-shaped areas and a dome-shaped area are indicated.

[0115] Figure 3I The diagram shows a surface with a structure having a one-dimensional hole. The planar curves shown form the boundary of the one-dimensional hole.

[0116] Figure 3J It shows crossing Figure 3I The cross-section of the structure. The surface shown is in Figure 3I The structure defines a two-dimensional hole.

[0117] Figure 3K It shows Figure 3IA perspective view of the structure, including two-dimensional and one-dimensional holes. Also shown is... Figure 3I The surface of the two-dimensional hole is defined in the structure.

[0118] Figure 3L A face mask with an inflatable airbag as padding is shown.

[0119] Figure 3M It shows crossing Figure 3L The image shows a cross-section of the mask, and the inner surface of the airbag is also shown. The inner surface defines a two-dimensional aperture in the mask.

[0120] Figure 3N Showing through Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0121] Figure 3O The left-hand rule is shown.

[0122] Figure 3P The right-hand rule is shown.

[0123] Figure 3Q The left ear is shown, including the left ear spiral.

[0124] Figure 3R The right ear is shown, including the right ear spiral.

[0125] Figure 3S A right-handed spiral is shown.

[0126] Figure 3T A view of the face mask is shown, including symbols representing the twisting of spatial curves defined by the edges of the sealing membrane in different areas of the face mask.

[0127] Figure 4A A patient interface in the form of a nasal mask according to the present technology is shown.

[0128] Figure 4B A patient interface in the form of a nasal cannula according to the present technology is shown.

[0129] Figure 4C A patient interface with a catheter tip cap, according to this technology, is shown.

[0130] 4.4 RPT device Figure 5A An RPT device of one form according to the present technology is shown.

[0131] Figure 5BThis is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated by reference to a blower and a patient interface. The blower is defined as upstream of the patient interface and the patient interface as downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0132] 4.5 Humidifier Figure 6A An isometric view of one form of humidifier according to the present technology is shown.

[0133] Figure 6B An isometric view of a humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0134] Figure 6C A schematic diagram of one type of humidifier according to the present technology is shown.

[0135] 4.6 Respiratory waveform Figure 7A The diagram shows a typical breathing waveform of a person during sleep.

[0136] Figure 7B The selected polysomnography channels (pulse oximetry, flow, chest movement, and abdominal movement) of a patient during a non-REM sleep apnea period of approximately ninety seconds under normal conditions are shown.

[0137] Figure 7C The patient's polysomnography was displayed before treatment.

[0138] 4.7 Examples of patient interfaces and evaporation devices Figure 8A This is a front view of a patient wearing a head-up configuration with a patient interface.

[0139] Figure 8B This is a front view of a patient wearing a tube with the patient interface positioned downwards.

[0140] Figure 8C This is a front view of a patient with the tube wearing the patient interface positioned upwards.

[0141] Figure 8D This is a front view of a patient wearing a replaceable tube with the patient interface positioned downwards.

[0142] Figure 9A This is a top-down view of an exemplary configuration of an evaporation apparatus.

[0143] Figure 9B yes Figure 9A The evaporation apparatus shown is a side view.

[0144] Figure 10 This is an exemplary schematic diagram of an alternative evaporation device.

[0145] Figure 11 This is another exemplary schematic diagram of an alternative evaporation device.

[0146] Figure 12 This is another exemplary schematic diagram of an alternative evaporation device.

[0147] Figure 13 This is an exemplary schematic diagram of another alternative evaporation device.

[0148] Figure 14 This is an exemplary schematic diagram of another alternative evaporation device.

[0149] Figure 15 This is a schematic diagram of an exemplary configuration of the box module.

[0150] Figure 16 This is a schematic diagram of an alternative exemplary configuration of the box module.

[0151] Figure 17 This is a schematic diagram of an exemplary configuration of the replaceable box module. 5. Detailed Implementation Before describing this technology in further detail, it should be understood that this technology is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0153] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any example may be combined with one or more features of another example or other examples. In addition, in any example, any single feature or combination of features may constitute another example.

[0154] 5.1 Treatment In one form, the technology includes a method for treating respiratory disorders, the method comprising applying positive pressure to the airway inlet of a patient 1000.

[0155] In some examples of this technique, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0156] In some examples of this technique, mouth breathing is limited, restricted, or prevented.

[0157] 5.2 Respiratory Therapy System In one form, the technology includes a respiratory therapy system for treating respiratory disorders. The respiratory therapy system may include an RPT device 4000 for supplying an airflow to a patient 1000 via an air circuit 4170 and a patient interface 3000 or 3800.

[0158] Figure 1A A respiratory therapy system is shown, comprising a patient 1000 wearing a patient interface 3000 via a nasal mask receiving a positive-pressure air supply from an RPT device 4000. In some examples, the air from the RPT device 4000 is humidified in a conventional humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient sleeps in a supine position. Alternatives to the humidifier 5000 may be used in some examples, as will be discussed in further detail below.

[0159] For example, as will be discussed in further detail below, a respiratory therapy system may include an evaporator 1105 in place of a conventional humidifier 5000 for humidifying or pressurizing the airflow, or in addition to a conventional humidifier 5000 for humidifying or pressurizing the airflow. The evaporator 1105 may be coupled to one or more components of the respiratory therapy system such that it is exposed to the pressurized airflow to increase the humidity in the pressurized airflow. The evaporator 1105 may include a capillary evaporator or a heating element to evaporate liquids, such as water and / or other substances, such as medications, stored in the evaporator 1105 or elsewhere in the respiratory therapy system. The evaporator 1105 may be configured to evaporate liquids, such as water and / or other substances, such as medications, to introduce the evaporated liquids and / or other substances into the pressurized airflow. The evaporator 1105 may also include a reservoir for storing liquids (e.g., water and / or other substances such as medications) to be evaporated during treatment. Alternatively or additionally, the respiratory therapy system may include a reservoir for liquid, which is separate from and fluidly connected to the evaporator 1105. Compared to a conventional humidifier 5000, the evaporator 1105 is capable of evaporating liquid more efficiently, and therefore, can work with a smaller reservoir compared to a conventional humidifier 5000. That is, the amount of liquid required to adequately humidify pressurized air throughout the entire duration of nighttime sleep or other treatments is less than that required by a conventional humidifier 5000, because the evaporator 1105 is capable of more precisely and effectively evaporating the amount of liquid relevant to the clinician and / or patient's needs. Therefore, whether integrated with or separate from the reservoir of a conventional humidifier 5000, the evaporator 1105 can be significantly smaller in volume, internally, and / or externally.

[0160] Traditional positive airway pressure (PAP) systems utilize a pass-through humidification system, which typically includes a water reservoir. Water in the reservoir is heated to a warm, but not boiling, temperature, and the increased warmth from the heating accelerates evaporation beyond what would occur under ambient conditions, humidifying the pressurized air as it passes through the reservoir and over the heated water. Traditional pass-through humidifiers function by maintaining a constant temperature in the water reservoir, which requires a large amount of water because it is constantly lost through evaporation (e.g., regardless of the patient's respiratory phase, as humidification of pressurized air may not be necessary during the exhalation phase when the patient is not exposed to increased humidity, and also because in many treatment types, pressurized air is continuously released into the atmosphere, preventing the accumulation of exhaled carbon dioxide within the system). Furthermore, constant heating of the water throughout the treatment (e.g., 8 hours of sleep) requires a constant power supply to the heating element, and there is a long start-up time (i.e., the time it takes for the temperature to be reached within the humidifier before evaporation occurs at the desired rate) when the humidifier is turned on due to the large heat mass. Maintaining a larger reservoir also increases the likelihood of overflow compared to a smaller one. Furthermore, a larger volume of water is more likely to damage components of the respiratory therapy system upon overflow compared to a smaller volume. Therefore, conventional humidifiers are designed to exceed the volume of water intended to be carried, including structures to prevent or at least limit the amount of water that could leak from the reservoir if it is moved out of its intended operating position, for example, by being accidentally knocked off a bedside table. In contrast, due to the efficiency of the evaporator 1105, it may require a significantly smaller reservoir, and the much higher temperatures achievable by the evaporator 1105 compared to conventional humidifiers may also require a much smaller volume of water to provide sufficient humidity throughout the treatment.

[0161] Evaporator 1105 converts liquid into vapor or gas form, which is then distributed into a pressurized airflow within the respiratory therapy system for inhalation by the patient. Compared to conventional pass-through humidifiers, evaporator 1105 is more efficient at increasing humidity levels because the evaporator disperses moisture more quickly, thus increasing humidity levels more rapidly. Evaporator 1105 is designed to increase or maximize the surface area to volume ratio between its heating element and water. Therefore, humidification can occur at a much faster rate when evaporator 1105 is used. Furthermore, the smaller footprint of evaporator 1105 compared to conventional humidifiers allows for a much faster start-up time (e.g., on the order of tens or hundreds of milliseconds). As a result, evaporator 1105 can be turned on and off rapidly, allowing its use to be synchronized with the patient's breathing. In other words, evaporator 1105 can be turned on solely to evaporate the liquid when the system detects inhalation or predicts that inhalation will occur, as will be discussed in more detail below. This reduces the amount of water required to supply the evaporation unit 1105 compared to a conventional humidifier, thereby allowing the use of a smaller storage tank compared to a conventional humidifier, and reducing the energy required for the evaporation unit 1105 to evaporate the liquid compared to a conventional humidifier.

[0162] The evaporation device 1105 of this technology differs from nebulizers that convert liquids into a mist or aerosol. Nebulizers typically use an ultrasonic transducer, compressed air, or oxygen to break down a liquid into droplets, which are then inhaled by the patient. In contrast, the evaporation device 1105 of this technology uses heat to convert the liquid into its gaseous state. Therefore, the evaporation device 1105 of this technology operates by changing the phase of the liquid to a gas, rather than changing it into a fine mist of droplets as in a nebulizer.

[0163] Compared to sprayers or conventional pass-through humidifiers, the evaporator 1105 reduces the risk of bacterial growth. The heating element in the evaporator 1105 can kill or inhibit the growth of microorganisms and promote the generation of relatively clean steam, thus reducing cleaning and maintenance, for example, due to the higher temperature generated by the evaporator 1105 during operation.

[0164] The smaller vaporization device 1105 can be integrated into, or near, various components of the respiratory therapy system, such as the patient interface, RPT device 4000, air circuit 4170, or one or more other components. For example, as... Figure 1AAs shown, the evaporator 1105 may be included in, on, or coupled to a portion of the air circuit 4170. In other examples, the evaporator 1105 may be located between components of the respiratory therapy system, for example, between the RPT device 4000 and the air circuit 4170, or between the air circuit 4170 and the 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 the evaporator 1105 may or may not be affected by data detected by one or more sensors 1110. If combined, one or more sensors 1110 may be combined on the same or different components, or in the case of multiple sensors 1110, they may be combined on the same or different components, such as the evaporator 1105. Figure 1A As shown, one or more sensors 1110 may be arranged on the patient interface 3000 and / or the air circuit 4170. Information from one or more sensors 1110 can be used to at least partially influence the operation of the evaporation device 1105, as discussed further below.

[0165] Figure 1B Another alternative configuration of the respiratory therapy system is shown, which includes a patient 1000 wearing a full-face mask-like patient interface 3000 receiving a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient sleeps in a side-lying position. Alternatives to the humidifier 5000 may be used in some examples, as will be discussed in further detail below.

[0166] Furthermore, as will be discussed in more detail below, Figure 1B The respiratory therapy system shown may include an evaporator 1105. For example, the evaporator 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 shown, one or more sensors 1110 may be positioned on the air circuit 4170, for example, near and / or away from the evaporator 1105. One or more sensors 1110 may be used to at least partially influence the operation of the evaporator 1105.

[0167] As will be discussed in more detail below, box assembly 1120 can be with Figure 1A and 1B The respiratory therapy system shown is used in conjunction with this. The cassette assembly 1120 may be configured to receive or contain the evaporation device 1105. The evaporation device 1105 may be a capillary evaporator configured to evaporate a liquid, such as water or other substance, in order to introduce the evaporated liquid and / or substance into an airflow.

[0168] The cartridge assembly 1120 may include a housing forming a reservoir fluidly coupled to an evaporator 1105 to supply water or other substances to the evaporator 1105 for evaporation. The evaporator 1105 may be configured to operate with a smaller reservoir compared to a conventional humidifier 5000 that heats water stored in the reservoir. The cartridge assembly 1120 may be used in place of a conventional humidifier 5000, or, in addition to a conventional humidifier 5000, may be coupled to one or more components of a respiratory therapy system. The cartridge assembly 1120 and the evaporator 1105 will be described in more detail below, and both may be significantly smaller than a conventional humidifier 5000. The smaller cartridge assembly 1120 may be incorporated into, on, or near various components of a respiratory therapy system, such as the patient interface, RPT device 4000, air circuit 4170, or one or more other components. Furthermore, the cartridge assembly 1120 and / or one or more components of the cartridge assembly 1120 (e.g., the vaporizer 1105 and / or associated reservoir or filter) may be removably coupled to one or more components within the respiratory therapy system. In other examples, the cartridge assembly 1120 and / or the vaporizer 1105 may be removably coupled between components of the respiratory therapy system, for example, between the RPT device 4000 and the air circuit 4170, or between the air circuit 4170 and the patient interface. The removability of the cartridge assembly 1120 and / or its components facilitates the replacement, cleaning, refilling, etc., of the cartridge assembly 1120.

[0169] As will be discussed in further detail below, the cartridge assembly 1120 may be configured to receive the evaporator 1105. The evaporator 1105 is configured to convert liquid into vapor or gas form, which can be incorporated into the airflow of a respiratory therapy system for inhalation by a patient. The evaporator 1105 is more efficient at increasing humidity levels than conventional pass-through humidifiers because, for example, a capillary evaporator can disperse moisture more quickly and increase humidity levels more rapidly. The evaporator 1105 is designed to increase or maximize the surface area to volume ratio between the heating element and the water in the evaporator 1105. Therefore, humidification can occur at a much faster rate when the evaporator 1105 is used. Furthermore, the smaller footprint of the evaporator 1105 and / or the cartridge assembly 1120 allows for a faster start-up time for the evaporator (e.g., on the order of tens or hundreds of milliseconds). As a result, the evaporator 1105 can be turned on and off rapidly, allowing its use to be synchronized with the patient's breathing. In other words, the evaporator 1105 can be turned on only when the patient inhales, which will be discussed in more detail below. This reduces the amount of water required to supply the evaporator 1105, thereby allowing the use of a smaller storage tank and reducing the amount of power required to supply the evaporator 1105.

[0170] For example, such as Figure 1A As shown, the cartridge assembly 1120 may be included in or on a portion of the air circuit 4170, 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 the cartridge assembly 1120 may or may not be affected by data detected by one or more sensors 1110. If combined, one or more sensors 1110 may be combined on the same or different components, or in the case of multiple sensors 1110, they may be combined on the same or different components. For example, multiple sensors 1110 may be combined on or in a component in which the cartridge assembly 1120 is incorporated, and / or multiple sensors 1110 may be combined on or in the same component in which the cartridge assembly 1120 is incorporated. Figure 1A As shown, one or more sensors 1110 may be arranged on the patient interface 3000 and / or the air circuit 4170. Information from one or more sensors 1110 may be used to at least partially influence the operation of the cartridge assembly 1120, as discussed further below.

[0171] In some examples, the evaporator 1105 may be configured to humidify the air flowing through the respiratory therapy system. Additionally or alternatively, the evaporator 1105 may be configured to deliver a substance into the air flowing through the respiratory therapy system. This substance may be a liquid, gel, gas, vapor, or any combination thereof. In this manner, at least a portion of the cartridge assembly 1120 and / or the evaporator 1105 may be exposed to the airflow path, such that the air flowing through the illustrated respiratory therapy system also flows through, within, or above the evaporator 1105.

[0172] As an example, in Figure 1A and 1B In the illustration, the cartridge assembly 1120 is depicted arranged along the air circuit 4170 between the patient interface 3000 and the RPT device 4000. However, the positioning of the cartridge assembly 1120 and the evaporator 1105 is merely exemplary. For example, the cartridge assembly 1120 and the evaporator 1105 could be arranged anywhere along the airflow path, such as on or within the RPT device 4000, on or within the air circuit 4170, and / or on or within the patient interface 3000. In some examples, the cartridge assembly 1120 could be arranged between components of the respiratory therapy system, such as between the RPT device 4000 and the air circuit 4170, or between the air circuit 4170 and the patient interface.

[0173] One or more sensors 1110 can be additionally connected with Figure 1A and 1BThe respiratory therapy system shown is used together. One or more sensors 1110 may be exposed to air flowing through the respiratory therapy system. In this way, the one or more sensors 1110 may be arranged on or among any of the components constituting the respiratory therapy system. For example, see reference... Figure 1B The first sensor 1110 may be positioned proximal to the patient along the air circuit 4170 relative to the housing assembly 1120. (See reference...) Figure 1B The first sensor 1110 may be positioned proximally to the patient relative to the housing assembly 1120. The second sensor 1110 may be positioned distally to the patient relative to the housing assembly 1120 along the airflow path. Additional sensors (e.g., a third sensor, a fourth sensor, etc.) may be positioned along the airflow path at other locations near or far from the patient relative to the housing assembly 1120. Each of the one or more sensors 1110 may be a temperature sensor, humidity sensor, pressure sensor, flow rate sensor, etc. The one or more sensors 1110 may be configured to transmit information to the RPT device 4000 and / or the housing assembly 1120 and / or a controller operatively coupled to the housing assembly 1120.

[0174] The relative size, shape, and / or location of the housing assembly 1120 and / or one or more sensors 1110 described herein are merely exemplary. For example, the housing assembly 1120 may be larger, and / or one or more sensors may be positioned elsewhere along the airflow path of the respiratory therapy system. Furthermore, multiple housing assemblies 1120 may be combined within the respiratory therapy system, either in different locations within the system or adjacent to each other within the respiratory therapy system.

[0175] 5.3 Patient Interface According to one aspect of this technology, such as Figure 3A The illustrated noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connecting to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to maintain positive pressure at the inlet of the patient's airway. Therefore, the sealed patient interface 3000 is suitable for delivering positive pressure therapy.

[0176] As will be discussed in further detail below, the evaporator 3105 may be included in, on, or coupled to the connection port 3600 or decoupling structure 3500, for example, between the connection port 3600 and the air circuit 4170. In this way, air can flow from the air circuit 4170, through, and / or through the evaporator 3105, and flow to the patient through the connection port 3600. In some examples, one or more sensors 3110 may be coupled to the inflation chamber 3200 and / or the sealing forming structure 3100 and the breathing chamber exposed therein. One or more sensors 3110 may be arranged within the airflow path and configured to transmit information to the controller in the evaporator 3105 or the RPT device 4000. The evaporator 3105 is configured to evaporate water into the air flowing through the patient interface 3000, thereby providing humidification to the airflow.

[0177] exist Figure 4B An example of an unsealed patient interface 3800 in the form of a nasal cannula is shown, which can be used with the high-flow therapy discussed above and below. The patient interface 3800 includes nasal inserts 3810a and 3810b, which deliver air to the individual nostrils of a patient 1000 via corresponding orifices in their tips. These nasal inserts typically do not form a seal with the inner or outer skin surface of the nostril. This type of interface results in one or more gaps that are intentionally present by design during use, but are generally not fixed, allowing them to change unpredictably during use due to movement. Unlike other types of mask-based respiratory therapy systems, this allows for complex pneumatic variables in the respiratory therapy system when pneumatic control and / or evaluation are implemented. Air can be delivered to the nasal inserts via one or more air supply lumens 3820a and 3820b coupled to the nasal cannula-type unsealed patient interface 3800. Lumens 3820a and 3820b extend from the nasal cannula-type unsealed patient interface 3800 to the respiratory therapy device via an air circuit. The unsealed patient interface 3800 is particularly suitable for delivering flow therapy, where the RPT device generates an airflow at a controlled flow rate rather than a controlled pressure. The "vent" or gap at the unsealed patient interface 3800 is a passage between the ends of pins 3810a and 3810b of the nasal cannula-type unsealed patient interface 3800, through which excess airflow escapes into the surrounding environment via the patient's nostrils.

[0178] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0179] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply at a positive pressure higher than that of the ambient environment, for example, at least 2, 4, 6, 10 or 20 cmH2O relative to the ambient environment.

[0180] exist Figure 4B In the illustrated configuration, an vaporizer 3105 may be included in, on, or coupled to the patient interface 3800. In this manner, air can flow in from one or more air supply ducts 3820a, 3820b, pass through and / or through the vaporizer 3105, and through pins 3810a and 3810b of the unsealed nasal cannula-type 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 arranged within the airflow path, and data received from the sensors 3110 can be used to at least partially influence the operation of the vaporizer 3105. The vaporizer 3105 evaporates liquid into the air flowing through the patient interface 3800. In some aspects, two vaporizers 3105 may be combined on the patient interface 3800, for example, one on each pin 3810a and 3810b. In such an example, different doses of the evaporated substance, such as water vapor, may be delivered to each nostril. Dosage differences can depend at least in part on the nasal cycle and / or the openness of one or both nostrils.

[0181] like Figure 4C As shown, a non-invasive patient interface 3000 according to another aspect of the present technology includes the following functional aspects: a sealing forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, and a connection for connecting to an air circuit (e.g., Figure 1A and 1B The air circuit 4170 shown is a connection port 3600 in one form. The air chamber 3200 can be formed by one or more modular components (e.g., pad module 3150 together with sealing forming structure 3100), in which sense it or they can be replaced by different components, such as components of different sizes.

[0182] As will be discussed in further detail below, the vaporizer 3105 may be included in, on, or coupled to the connection port 3600, for example, between the connection port 3600 and the bend connector 3610. In this way, air can flow through the connection port 3600, enter, pass through, and / or through the vaporizer 3105, and reach the patient through the bend connector 3610. The bend connector 3610 may include an air vent 3615. One or more sensors 3110 may be coupled to the inflation chamber 3200 and / or the sealing formation 3100, and exposed to the breathing chamber therein. One or more sensors 3110 may be arranged within the airflow path, and data received from the sensors 3110 may be used to at least partially influence the operation of the vaporizer 3105. The vaporizer 3105 may be configured to evaporate a liquid (e.g., water) into the air flowing through the patient interface 3000. In some examples, the evaporator 3105 may be integrally formed with or otherwise coupled to the elbow joint 3610. Integration of the evaporator 3105 with the elbow joint 3610 may be suitable, for example, due to the location and / or design of the vent 3615 on the elbow joint 3610, and for other reasons.

[0183] As will be discussed in further detail below, the cartridge assembly 1120 may be included in, on, or coupled to the connection port 3600, for example, between the connection portion 3600 and the bend connector 3610. The cartridge assembly 1120 may include an evaporation device 1105. In this way, air can enter through the connection port 3600, pass through the cartridge assembly 1120, and flow to the patient through the bend connector 3610. One or more sensors 1110 may be coupled to the inflation chamber 3200. One or more sensors 1110 may be arranged within the airflow path and configured to transmit information to the cartridge assembly 1120 and / or be operatively coupled to a controller of the cartridge assembly 1120. The evaporation device 1105 may be configured to deliver water and / or substances (e.g., liquids, materials, compounds, drugs, etc.) into the air flowing through the patient interface 3000, thereby providing humidification to the airflow and / or metering the supply of substances to the airflow. Although the housing assembly 1120 is depicted in one location and the sensor 1110 is depicted on the inflation chamber 3200, one or more sensors or housing assemblies 1120 may be incorporated into any suitable location on the patient interface 3000. Furthermore, the location of one or more sensors 1110 and / or housing assemblies 1120 may depend at least in part on the type of patient interface (e.g., full face mask, nasal cannula, etc.) to which the sensor 1110 and / or housing assembly 1120 is coupled or adjacent to the patient interface.

[0184] exist Figure 4BIn the illustrated configuration, the cartridge assembly 1120, including the evaporator 1105, may be included in or on the patient interface 3800, or coupled to the patient interface 3800. In this manner, air can flow from one or more air supply lumens 3820a, 3820b, through or across the cartridge assembly 1120 and / or the evaporator 1105, and through pins 3810a and 3810b of the unsealed nasal cannula type 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 arranged within the airflow path, and data received from the sensors 1110 can be used to at least partially influence the operation of the cartridge assembly 1120 and / or the evaporator 1105. The evaporator 1105 may be configured to deliver liquid into the air flowing through the patient interface 3800.

[0185] As will be discussed in further detail below, the cartridge assembly 1120, including the evaporator 1105, can be coupled to a connection port 3600, for example, between the connection portion 3600 and the bend connector 3610. In this way, air can enter through the connection port 3600, pass through the cartridge assembly 1120, and flow to the patient through the bend connector 3610. One or more sensors 1110 can be coupled to the inflation chamber 3200. One or more sensors 1110 can be arranged within the airflow path, and data received from the sensors 1110 can be used to at least partially influence the operation of the cartridge assembly 1120 and / or the evaporator 1105. The evaporator 1105 can be configured to deliver water or a substance (e.g., a liquid, material, compound, drug, etc.) into the air flowing through the patient interface 3000.

[0186] In addition, such as Figures 8A-8D As shown, each of the cartridge assembly 1120, the evaporator 1105, and / or the sensor 1110 may be included in or on different aspects of different patient interfaces, or coupled to different aspects of different patient interfaces. For example, the cartridge assembly 1120 and / or the evaporator 1105 may be arranged between two components of the patient interface. The sensor 1110 may be coupled to the patient interface elsewhere along the fluid flow path. In any of the above configurations, the cartridge assembly 1120 and / or the evaporator 1105 may be configured such that the cartridge assembly 1120 and / or the evaporator 1105 are at least partially exposed to air flowing through the patient interface. Additionally, the sensor 1110 may be configured such that the sensor 1110 is at least partially exposed to air flowing through the patient interface. The sensor 1110 may be configured to detect and transmit (e.g., wirelessly or via at least one wire) information that may at least partially affect the operation of the cartridge assembly 1120 and / or the evaporator 1105. This information may relate to airflow or any other aspect of the treatment being performed.

[0187] 5.3.1 Sealing Formation Structure In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—can vary from day to day and from patient to patient within a given treatment course, depending on a range of factors, including, for example, the placement of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0188] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0189] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material such as silicone rubber.

[0190] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material, such as silicon.

[0191] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure 3100 being configured to correspond to a different range of sizes and / or shapes. For example, the system may include one type of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, while another type is suitable for small-sized heads but not for large-sized heads.

[0192] 5.3.2 Inflation Chamber In the area forming a seal during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a typical human face. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single sheet of homogeneous material.

[0193] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment adherence.

[0194] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. Using a transparent material reduces the prominence of the patient interface and helps improve treatment adherence. The transparent material also helps clinicians observe how the patient interface is positioned and functions.

[0195] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve treatment adherence.

[0196] In some forms, the air chamber 3200 is made of a rigid material such as polycarbonate. The rigid material can provide support for the seal-forming structure.

[0197] In some forms, the air chamber 3200 is made of a flexible material (e.g., a soft, flexible, elastic material such as silicone, fabric, foam, etc.). For example, in one example, it may be formed of a material with a Young's modulus of 0.4 GPa or lower, such as foam. In some forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.1 GPa or lower, such as rubber. In other forms of this technology, the air chamber 3200 may be made of a material with a Young's modulus of 0.7 MPa or less, such as a material between 0.7 MPa and 0.3 MPa. An example of such a material is silicone.

[0198] 5.3.3 Positioning and Stabilization Structure The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by the positioning and stabilizing structure 3300. Since the positioning and stabilizing structure 3300 engages with the patient's head to hold the patient interface 3000 in a sealed position, the positioning and stabilizing structure 3300 may include and serve as a "headgear". Figure 3A and 3A An example of a positioning and stabilizing structure is shown in -1.

[0199] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the positive pressure in the inflation chamber 3200 to lift the face (i.e., F). 充气 ).

[0200] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the gravitational effects on the patient interface 3000.

[0201] Positioning and stabilizing structure 3300 provides force F PSS The force F PSS This helps maintain the air chamber 3200 in a sealed position on the patient's face. Positioning and stabilizing force F PSSIt can be the resultant force of various forces from different components of the positioning and stabilizing structure 3300. For example, the headgear strap can provide a strap force F on its own. 带 This is to hold the sealing structure 3100 on the patient's face. The force band F can also be at least partially pointed upwards to overcome gravity F. g Gravity F g Specific details can be shown for the sealing structure 3100 and the inflation chamber 3200, but gravity will act on the entire patient interface 3000 (i.e., in relation to the gravity F shown). g (in the same direction).

[0202] Gravity F g It can be related to frictional force F f Conversely, frictional force F f It can act on gravity F g In the opposite direction. When gravity pulls the sealing structure 3100 and the air chamber 3200 downwards, the frictional force F... f The force will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F on their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 3100). f This is to resist movement in the downward direction (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 g Conversely, the component of total friction (not shown) will also be associated with gravity F of any other part of the positioning and stabilizing structure 3300 and the patient interface 3000. g Conversely, friction can act at any point along the patient interface 3000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair). In some forms, gravity F g It can also be counteracted by the vertical component of the reaction force from the patient's face acting on the sealing structure 3100, for example, in the bridge of the nose and chin area of ​​the patient's face.

[0203] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g and blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g and blowing force F 充气 (and any frictional force F) fAnd maintain the proper positioning of the sealing structure 3100. Despite the positioning and stabilizing force F PSS Possibly exceeding gravity F g and blowing force F 充气 The sum of (any additional positioning and stabilizing forces F) PSS The reaction force from the patient's head acting on the portion of the patient interface 3000 is balanced, and the sealing structure 3100 is still held in the proper sealing position, but this may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some examples, the positioning and stabilizing structure 3300 can be adjustable, such that when assembled, the positioning and stabilizing force F... PSS Greater than the precise balancing force F g and blowing force F 充气 The required force is sufficient to hold the patient interface 3000 tightly against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) will not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 determine the positioning and stabilizing force F required to achieve balance. PSS .

[0204] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of destructive forces on the patient interface 3000, such as from tube drag or accidental interference with the patient interface.

[0205] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strip having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strip.

[0206] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying down in a supine sleeping position, wherein the back area of ​​the patient's head rests on a pillow.

[0207] In one form of this technology, a positioning and stabilizing structure 3300 is provided, which is configured to be neither too large nor too bulky to prevent the patient from lying on the pillow in a side-sleeping position with the side of the patient's head on the pillow.

[0208] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. This decoupling portion does not resist compression and may be, for example, a flexible band or soft band. The decoupling portion is constructed and arranged such that when the patient lies their head on the pillow, its presence prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0209] In one form of this technology, the positioning and stabilizing structure 3300 includes a strip constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strip. In one form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0210] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be tensioned during use and to guide a force to pull the sealing structure into a sealing contact with a portion of the patient's face. In one example, the strap may be configured as a tie.

[0211] In one form of the present technology, the positioning and stabilizing structure includes a first frenulum, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first frenulum passes over the supraauricular point of the patient's head and covers a portion of the parietal bone but not the occipital bone.

[0212] In one form of the technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a second strap that is configured and arranged such that, in use, at least a portion of the upper edge of the second strap passes below the subauricular point of the patient's head and covers or is located below the occipital bone of the patient's head.

[0213] In one form of this technology applicable to nasal masks or full-face masks, the positioning and stabilizing structure includes a third strap constructed and arranged to interconnect the first and second straps to reduce the tendency of the first and second straps to separate from each other.

[0214] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt that is flexible and, for example, non-rigid. An advantage of this is that the belt makes it more comfortable for the patient to lie on while sleeping.

[0215] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture to be transported through the belt.

[0216] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide holding force to correspond to different size and / or shape ranges. For example, the system may include one form of positioning and stabilizing structure 3300 suitable for large-sized heads but not for small-sized heads, while another form of positioning and stabilizing structure is suitable for small-sized heads but not for large-sized heads.

[0217] 5.3.3.1 Catheter head cover 5.3.3.1.1 Catheter head sheath In some forms of this technology, the positioning and stabilizing structure 3300 includes one or more head tubes 3350 that deliver pressurized air received from a conduit forming part of the air circuit 4170 from the RPT device to the patient's airway, for example, through the inflation chamber 3200 and the sealing formation 3100. The positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from the air circuit 4170 to the inflation chamber 3200. The tubes 3350 are configured to position and stabilize the sealing formation 3100 of the patient interface 3000 in appropriate portions of the patient's face (e.g., nose and / or mouth) during use. This allows the conduit providing the pressurized airflow from the air circuit 4170 to connect to a connection port 3600 of the patient interface, located at a position other than the front of the patient's face, such as at the top of the patient's head.

[0218] The positioning and stabilizing structure 3300 includes two tubes 3350, each positioned on a different side of the patient's head during use, and extending above the corresponding ear (above the supraacus point on the patient's head) through the corresponding cheek area to a curved tube 3610 at the top of the patient's head. This form of technology may be advantageous because if the patient is sleeping with their head on their 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 pressurized gas to the patient. In other examples of this technology, the patient interface 3000 may include a different number of tubes, such as one tube, or two or more tubes.

[0219] In one example where the patient interface has a tube 3350, the single tube 3350 is positioned on one side of the patient's head during use (e.g., across a cheek area), and a band forming part of the positioning and stabilizing structure 3300 is positioned on the other side of the patient's head during use (e.g., across another area) to help secure the patient interface 3000 to the patient's head. For example, the tube 3350 and the band may each be under tension during use to help hold the sealing structure 3100 in a sealed position.

[0220] In one embodiment, the tube 3350 may be at least partially extendable, such that the tube 3350 and the band can be adjusted to substantially equal lengths when worn by a patient. This allows for substantially symmetrical adjustment between the tube 3350 and the band, such that the sealing structure remains substantially centered.

[0221] Two tubes 3350 are fluidly connected to each other at their upper ends and to a connection port 3600. In some examples, the two tubes 3350 are formed integrally, while in other examples, the tubes 3350 are formed separately but are connected in use and can be disconnected, for example, for cleaning or storage. When using separate tubes, they can be indirectly connected together, for example, each tube can be connected to a T-connector. The T-connector may have two arms / branches, each of which is fluidly connected to a corresponding one of the tubes 3350. Additionally, the T-connector may have a third arm or opening that provides a connection port 3600 for fluid connection with the air circuit 4170 in use. This opening may be an inlet 3332 for receiving a pressurized airflow (see, for example, 7C).

[0222] In some forms, the third arm of a T-connector can be substantially perpendicular to each of the first two arms.

[0223] In some forms, the third arm of a T-connector can be formed at an angle relative to each of the first two arms.

[0224] In some configurations, a Y-shaped connector can be used instead of a T-shaped connector. The first two arms can be tilted relative to each other, and the third arm can be tilted relative to the first two arms. The angled formation of the first two arms can resemble the shape of the patient's head to conform to that shape.

[0225] In some forms, at least one arm of the T-connector (or Y-connector) can be flexible. This allows the connector to bend based on the shape of the patient's head and / or the forces in the positioning and stabilizing structure 3300.

[0226] In some forms, at least one arm of a T-connector (or Y-connector) may be at least partially rigid. This helps maintain the shape of the connector so that bending of the connector does not close the airflow path.

[0227] Tube 3350 may be formed of a flexible material, such as an elastomer, like silicone or TPE, and / or of one or more fabrics and / or foam materials. Tube 3350 may have a pre-shaped form and be able to bend or move into another shape when a force is applied, but return to the original pre-shaped form when the force is not applied. Tube 3350 may typically be arched or curved, its shape approximating the head contour between the top of the patient's head and the nasal or oral region.

[0228] In some examples, the one or more tubes 3350 are compression-resistant to prevent blockage during use if they are flattened, for example, if squeezed between a patient's head and a pillow, especially if there is only one tube 3350. The tube 3350 may be formed to have sufficient structural rigidity to resist flattening, or may be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0229] Each tube 3350 can be configured to receive an airflow from a connection port 3600 on the top of the patient's head and deliver that airflow to a sealing structure 3100 at the patient's airway inlet. In use, each tube 3350 is located on a path extending from the inflation chamber 3200 through the patient's cheek region and above the patient's ear to the bend 3610. For example, the portion of each tube 3350 near the inflation chamber 3200 may cover the maxillary region of the patient's head in use. Another portion of each tube 3350 may cover the area of ​​the patient's head above the supraauricular point. Each tube 3350 may also be located on one or both of the patient's sphenoid and / or temporal bones and the patient's frontal and parietal bones. The bend 3610, in use, may be located on the patient's parietal bone, frontal bone, and / or at the junction between them (e.g., the coronal suture).

[0230] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3600 can be positioned within a range spanning the top of the patient's head, thus allowing the patient interface 3000 to be positioned for the comfort or fit of an individual patient. In some examples, the headgear 3350 is configured to allow movement of the upper portion of the patient interface 3000 (e.g., the connection port 3600) relative to the lower portion of the patient interface 3000 (e.g., the inflation chamber 3200). That is, the connection port 3600 can be at least partially separated from the inflation chamber 3200. Thus, the sealing structure 3100 can form an effective seal with the patient's face, regardless of the position of the connection port 3600 on the patient's head (at least within a predetermined range of positions).

[0231] As described above, in some examples of this technology, the patient interface 3000 includes a sealing-forming structure 3100 in the form of a pad, which is generally located below the nose and seals to the lower periphery of the nose (e.g., a subnasal pad). A positioning and stabilizing structure 3300 (including a tube 3350) can be configured and arranged to pull the sealing-forming structure 3100 under the patient's nose using sealing forces in a posterior and superior direction (e.g., a posterosuperior direction). The posterosuperior sealing force allows the sealing-forming structure 3100 to form a good seal against the lower periphery of the patient's nose and the forward-facing surfaces of the patient's face, for example, on either side of the patient's nose and lips.

[0232] The catheter, such as a headband, which forms part of the positioning and stabilizing structure 3300, can provide positioning and stabilizing force F. PSS Contributing force. Positioning and stabilizing force F PSS It can be the resultant force of various forces from different components of the positioning and stabilizing structure 3300. For example, each conduit can provide a force F pointing in the rearward direction and the corresponding lateral direction. 导管 This is to hold the sealing structure 3100 on the patient's face (entering the upper lip and sealing below the nose) and to resist the positive pressure (i.e., F) in the inflation chamber 3200. 充气 The force F acts to lift the face away. 导管 It can also be guided, at least partially, in the upward direction to overcome gravity F. g .

[0233] In some forms, when the catheter is filled with pressurized air, it can provide a force directed towards the patient's head. This force can help grip the patient's head. This force can be caused by the expansion of the catheter during normal use. In some forms, this force can provide cushioning for the patient's head. The catheter can be designed to limit expansion to prevent excessive clamping of the patient's head.

[0234] The position of the patient's head can also change the clamping force of the catheter. For example, if the patient is lying on their side, the weight of the patient's head can compress one catheter, while another catheter (e.g., on the side not between the patient's head and the sleeping surface, such as a pillow) can expand further in order to maintain substantially the same pressurized airflow rate.

[0235] Gravity F g It can be related to frictional force F f Conversely, frictional force F f It can act on gravity F g In the opposite direction. When gravity pulls the sealing structure 3100 and the air chamber 3200 downwards, the frictional force F... fThe force will act in an upward direction (e.g., against the patient's face). For example, the patient may experience frictional force F on their lips (and / or other surfaces of the patient's face that are in contact with the sealing structure 3100). f This is to resist movement in the downward direction (which helps stabilize the pad in place). Despite the frictional force F... f Specifically shown as the gravity F of the sealing structure 3100 and the inflation chamber 3200 g Conversely, the component of total friction (not shown) will also be associated with gravity F of any other part of the positioning and stabilizing structure 3300 and the patient interface 3000. g Conversely, friction can act at any point along the patient interface 3000 that contacts the patient's skin (or hair). Friction force F f Along gravity F g It extends in the opposite direction and along the patient's skin (or hair).

[0236] In some forms, the sum of all forces can equal zero, so that the patient interface 3000 is in equilibrium (e.g., it does not move along the patient's face during use). Specifically, gravity F g and blowing force F 充气 The tendency is to move the seal-forming structure 3100 away from the desired sealing position. A positioning and stabilizing force F is applied. PSS In order to counteract gravity F g and blowing force F 充气 (and any frictional force F) f And maintain the proper positioning of the sealing structure 3100. Despite the positioning and stabilizing force F PSS Possibly exceeding gravity F g and blowing force F 充气 The sum of (any additional positioning and stabilizing forces F) PSS The reaction force from the patient's head acting on the portion of the patient interface 3000 is balanced, and the sealing structure 3100 is still held in the proper sealing position, but this may sacrifice patient comfort. When the net force on the patient interface 3000 is zero and the positioning and stabilizing force F... PSS When the force is just strong enough to achieve this, maximum patient comfort can be achieved. In some examples, the positioning and stabilizing structure 3300 can be adjustable, such that when assembled, the positioning and stabilizing force F... PSS Greater than the precise balancing force F g and blowing force F 充气The required force is sufficient to hold the patient interface 3000 tightly against the patient's head so that destructive forces that may occur during use (such as tube resistance or lateral shunting of the inflation chamber 3200 during lateral recumbency) will not break the seal. As described below, various positions of the patient's head when using the patient interface 3000 determine the positioning and stabilizing force F required to achieve balance. PSS .

[0237] 5.3.3.1.2 Extendable and non-extendable pipe sections In some examples of this technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tube 3350 may include one or more extendable segments, such as segments formed by an extendable accordion-like structure. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 including at least one gas delivery tube comprising a tube wall having an extendable accordion-like structure. The patient interface 3000 includes the tube 3350, the upper portion of which includes extendable segments, each segment in the form of an extendable accordion-like structure 3362.

[0238] In some forms, the extendable accordion-like structure 3328 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion-like structure 3328 can be biased toward a retracted position and can be moved to an extended position when the patient is prone and the positioning and stabilizing structure 3300 is in place. Because portions of the tube 3350 can be substantially non-extendable (e.g., a non-extendable tube segment 3363), the accordion-like structure 3328 allows the positioning and stabilizing structure 3300 to extend to accommodate different head sizes. This allows a single-size tube 3350 to be used with multiple head sizes. For example, as a result of the accordion-like structure 3328, the positioning and stabilizing structure 3300 can be “single-size fit”. Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can select a length that most closely matches their head, and the accordion-like structure 3328 can be slightly adjusted to fit an individual patient.

[0239] In some configurations, inlet 3332 may be located in the middle of conduit 6320. For example, conduit 3350 may be symmetrical about inlet 3332 via at least one axis.

[0240] The cross-sectional shape of the non-extendable segment 3363 of tube 3350 can be circular, elliptical, oval, D-shaped, or rounded rectangular, as described, for example, in U.S. Patent No. 6,044,844. A cross-sectional shape that presents a flat surface on the side of the tube facing and contacting other parts of the patient's face or head can be more comfortable to wear than a tube with, for example, a circular cross-section.

[0241] In some examples of this technology, the non-extendable tube segment 3363 connects to the inflation chamber 3200 at a low angle. The headgear tube 3350 may extend downward to the side of the patient's head and then bend forward and inward to connect to the inflation chamber 3200 in front of the patient's face. Before connecting to the inflation chamber 3200, the tube 3350 may extend to a position at the same vertical position as the connection to the inflation chamber 3200 (or, in some examples, below it). That is, before connecting to the inflation chamber 3200, the tube 3350 may protrude in at least a partially upward direction. A portion of the tube 3350 may be located below the inflation chamber 3200 and / or the sealing forming structure 3100. The tube 3350 may contact the patient's face below the cheekbone, which is more comfortable than contacting the patient's cheekbone and avoids excessively obscuring the patient's peripheral vision.

[0242] 5.3.3.1.3 Catheter head connection port In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the upper, side, or rear portion of the patient's head. For example, the connection port 3600 is located at the top of the patient's head (e.g., in a position relative to the patient's head). In this example, the patient interface 3000 includes a bend 3610 forming the connection port 3600. The bend 3610 may be configured to be in fluid connection with a conduit of the air circuit 4170. The bend 3610 may be configured to rotate relative to the positioning and stabilizing structure 3300 to at least partially disengage the conduit from the positioning and stabilizing structure 3300. In some examples, the bend 3610 may be configured to rotate by rotating about a substantially vertical axis, and in some specific examples, by rotating about two or more axes. In some examples, the bend may include a tube 3350 or be connected to the tube 3350 via a ball-and-socket joint. The connection portion 3600 may be located in the sagittal plane of the patient's head during use.

[0243] Patient interfaces with a connection port not located in front of the patient's face may be advantageous, as some patients may find catheters connected to patient interfaces in front of the patient's face unsightly and / or not prominent. For example, a catheter connected to a patient interface in front of the patient's face may easily disturb bedding or sheets, especially if the catheter extends downward from the patient interface during use. Forms of this technology that include patient interfaces with a connection port positioned above the patient's head during use can make it easier or more comfortable for the patient to lie or sleep in one or more of the following positions: a side-lying position, a supine position (e.g., on their back, generally up), or a prone position (e.g., on their front, generally down). Furthermore, connecting the catheter to the front of the patient interface exacerbates a problem known as tube resistance, where the catheter exerts undesirable forces on the patient interface during head or catheter movement, resulting in displacement away from the face. Tube resistance may be less of a problem when the force is received at the upper part of the patient's head than at the front of the patient's face, closer to the sealing structure (where tube drag forces are more likely to disrupt the seal).

[0244] 5.3.3.1.4 Fluid Connection of Head Sleeve Two tubes 3350 are fluidly connected to an inflation chamber 3200 at their lower ends. In some forms of this technology, the connection between the tubes 3350 and the inflation chamber 3200 is achieved through the connection of two rigid connectors. The tubes 3350 and the inflation chamber 3200 can be configured to allow the patient to easily and reliably connect the two components together. The tubes 3350 and the inflation chamber 3200 can be configured to provide tactile and / or auditory feedback in the form of a “re-secure click” or similar sound, allowing the patient to easily know that each tube 3350 has been correctly connected to the inflation chamber 3200. In one form, the tubes 3350 are formed of silicone or textile material, and the lower end of each silicone tube 3350 is overmolded to a rigid connector made of, for example, polypropylene, polycarbonate, nylon, etc. The rigid connector on each tube 3350 may include a concave mating feature configured to engage with a convex mating feature on the inflation chamber 3200. Alternatively, the rigid connector on each tube 3350 may include a convex mating feature configured for connection to a concave mating feature on the inflation chamber 3200. In other examples, each tube 3350 may each include a convex or concave connector formed of a flexible material (e.g., silicone or TPE), such as the same material formed of the tube 3350.

[0245] In other examples, compression seals are used to connect each tube 3350 to the inflation chamber 3200. For example, a resilient, flexible (e.g., silicone) tube 3350 without a rigid connector can be configured to be compressed to reduce its diameter, allowing it to be compressed into a port in the inflation chamber 3200, and the inherent elasticity of the silicone pushes the tube 3350 outward, thereby sealing the tube 3350 in the port in an airtight manner. Alternatively, in a hard-on-hard engagement between the tube 3350 and the inflation chamber 3200, each tube 3350 and / or inflation chamber 3200 may include a pressure-actuated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange can be pressed against the engagement between the tube and the circumferential surface of the port or connector surrounding the inflation chamber 3200 to form or reinforce a seal between the tube 3350 and the inflation chamber 3200.

[0246] 5.3.3.2 Headgear In some forms, the positioning and stabilizing structure 3300 may include a headgear 3302 having at least one strap that can be worn by a patient to help the sealing-forming structure 3100 be properly oriented against the patient's face (e.g., to limit or prevent leakage).

[0247] As described above, some forms of the headgear 3302 can be made of fabric material that can comfortably conform to the patient's skin. The fabric can be flexible to conform to various facial contours. Although the fabric may include a hardener along a selected length, it can limit the bending, flexing, and / or stretching of the headgear 3302.

[0248] In some forms, the hood 3302 may be at least partially stretchable. For example, the hood 3302 may comprise an elastic or similar stretchable material. For example, the entire hood 3302 may be stretchable, or selected portions may be stretchable (or more stretchable than the surrounding portions). This allows the hood 3302 to stretch under tension, which may help provide a sealing force for the seal-forming structure 3100.

[0249] The two types of hoods, the four-point hood 3302-1 and the two-point hood 3302-2, are discussed in more detail below as illustrative examples.

[0250] 5.3.3.2.1 Four-point connection Some forms of the headgear 3302-1 can be a four-point connection headgear. This means that the headgear 3302-1 can be attached to four separate locations on the inflation chamber 3200, to the frame of the inflation chamber 3200, and / or to the arm of the inflation chamber 3200. The headgear 3302-1 may include four different straps that provide tension to help hold the sealing formation 3100 in the sealed position. Figure 8AThe positioning and stabilizing structure of the 3300 can also be considered as a four-point connection headgear.

[0251] In some forms, the headgear 3302-1 may include a lower band 3304-1, which may be attached to the lower part of the padding 3050-1. The lower band 3304-1 may extend along the patient's cheek toward the back of the patient's head. For example, the lower band 3304-1 may cover the masseter muscle on either side of the patient's face. Therefore, the lower band 3304-1 may contact the patient's head below the ear. The lower band 3304-1 may meet at the back of the patient's head and may cover the occipital bone and / or trapezius muscle.

[0252] The headgear 3302-1 may also include an upper band 3305-1 that may cover the temporal bone, parietal bone, and / or occipital bone. The upper band 3305-1 may also be connected to the tube 3350 (e.g., by engaging with the flap 3320).

[0253] The posterior strap 3307-1 can extend between the upper strap 3305-1 and the lower strap 3304-1. The lower strap 3304-1 and upper strap 3305-1 on a given side (e.g., left or right) can also be connected adjacent to each other to the posterior strap 3307-1. Therefore, the height of the posterior strap 3307-1 can be approximated as the combined height of the lower strap 3304-1 and the upper strap 3305-1. In use, the posterior strap 3307-1 can cover the occipital and / or parietal bones. This allows the posterior strap 3307-1 to help anchor the headgear 3302-1 to the patient's head.

[0254] In the example shown, the headband 3302-1 can be formed into a generally X shape. The lower band 3304-1 and the upper band 3305-1 can be attached to the rear band 3307-1 by stitching, ultrasonic welding or any similar process.

[0255] In some configurations, the lower band 3304-1 is connected to the magnetic member 3306-1. For example, each lower band 3304-1 may pass through the magnetic member 3306-1, thereby allowing adjustment of the length of each lower band 3304-1. The magnetic member 3306-1 may be removably connected to the magnet 3370-1 (described below), such that the lower band 3304-1 can be disconnected from the inflation chamber 3200, but the length of the lower band 3304-1 may remain unaffected.

[0256] In some configurations, the top band 3305-1 can be directly connected to the tab 3320 of the tube 3350. The top band 3305-1 can pass through the tab 3320 to adjust the length and control the tension of each top band 3305-1.

[0257] In some forms, the headgear 3302-1 can be used only with the nose and mouth pads 3050-1 (e.g., because the nose pad 3050-1 alone does not have four connection points). However, the headgear 3302-1 can be used interchangeably with the tube 3350 and the hardener arm 3340.

[0258] 5.3.3.2.2 Two-point connection like Figure 8C As shown, some forms of the headgear 3302-2 can be two-point connected headgear. This means that the headgear 3302-2 can be connected to two separate locations.

[0259] In some forms, the headgear 3302-2 may be formed from a continuous sheet of material. In other words, the headgear 3302-2 may not be formed from multiple straps connected (e.g., sewn) together. This may be comfortable for the patient, as they will not come into contact with any seams or joints connecting the different straps. In other forms, the headgear-2 may be formed from multiple straps (e.g., two upper straps, a back strap, etc.) connected together (e.g., by sewing, ultrasonic welding, etc.).

[0260] In some forms of this technology, the positioning and stabilizing structure 3300 includes at least one headband that, in addition to the tube 3350, is used to position and stabilize the sealing forming structure 3100 at the patient's airway inlet. The patient interface 3000 may include a band 3307-2 forming part of the positioning and stabilizing structure 3300. For example, the band 3307-2 may be referred to as a back strap or a posterior headband. The posterior band 3307-2 may cover the temporal bone, parietal bone, and / or occipital bone. In other examples of this technology, one or more additional bands may be provided. For example, a patient interface 3000 with a nose and mouth pad according to an example of this technology may have a second lower band configured to abut against the patient's head near the patient's neck and / or against the posterior surface of the patient's neck.

[0261] The positioning and stabilizing structure 3300 has a strap 3310 connected between two tubes 3350 located on each side of the patient's head and passing around the back of the patient's head, for example, covering or lying beneath the occipital bone of the patient's head during use. The strap 3310 is connected to each tube above the patient's ear. The positioning and stabilizing structure 3300 includes a pair of tabs 3320. During use, the strap 3310 can be connected between the tabs 3320. The strap 3310 can be flexible enough to wrap around the back of the patient's head and rest comfortably against the patient's head, even under tension during use.

[0262] Some forms of the headgear 3302-2 may be at least partially bifurcated. For example, the back band 3307-2 of the headgear 3302-2 (e.g., configured to contact the back of the patient's head) may be wider than the surrounding portion of the headgear 3302-2. The middle section 3308-2 of the back band 3307-2 may include a slit 3309-2. Thus, due to the slit 3309, the upper section of the back band 3307-2 may be movable relative to the lower section. This can allow for greater band coverage over the back area of ​​the patient's head, which can help to better anchor the headgear 3302-2 to the patient's head, since there is no lower band (e.g., 3304-1).

[0263] In some configurations, the headgear 3302-2 can be used only with the nose pad 3050-2 (e.g., because the nose and mouth pads 3050-1 do not have four connection points). However, the headgear 3302-2 can be used interchangeably with the tube 3350 and the hardener arm 3340.

[0264] 5.3.3.3 Hardener Arm like Figure 8D As shown, the hardening arm 3340 may be an elongated, rigid member that helps hold the pad (e.g., nose and mouth pad 3050-1 or nose pad 3050-2) in the operating position. The hardening arm 3340 may contact one side of the patient's head and provide force to limit the sliding of the seal-forming structure 3100 from the patient's nose and / or mouth.

[0265] In some forms, the hardening arm 3340 is made of a rigid material (e.g., plastic). A rigid material may not allow the hardening arm 3340 to stretch. Additionally, the hardening arm 3340 may be inflexible and may be non-flexible. The hardening arm 3340 may be pre-molded into a desired shape to fit the patient's head. For example, the hardening arm 3340 may be molded into a curved shape to substantially correspond to the shape of the side of the patient's head (e.g., covering the masseter muscle and / or temporal bone).

[0266] In some forms, the hardener arm 3340 can be molded to fit a specific patient's head (e.g., a custom hardener arm 3340).

[0267] In some forms, the hardening arm 3340 may be flexible in at least one direction. For example, the hardening arm 3340 may be flexible in its width but inflexible in its length. In other words, the hardening arm 3340 may bend about an axis along its width, but not about an axis perpendicular to its length. This allows individual patients to adjust the hardening arm 3340 to better fit their individual head.

[0268] In some forms, the hardening arm 3340 can remain in its new position after bending. This allows patients to adjust the shape of the hardening arm 3340 to suit their specific head shape, and then the hardening arm 3340 will maintain the desired shape during use to improve patient comfort.

[0269] In some forms, the first end 3342 of the hardening arm 3340 may be a free end, while the second end 3344 of the hardening arm 3340 (e.g., opposite the first end 3342) may be fixed. The first end 3342 may be curved to minimize sharp edges that could cause patient discomfort. In use, the first end 3342 may also cover the patient's head adjacent to the temporal bone. The second end 3344 may be fixed to the arm connection structure 3504.

[0270] In some forms, the arm connection structure 3504 may resemble the conduit connection structure 3500. For example, the arm connection structure 3504 and the conduit connection structure 3500 may have substantially the same shape. This allows the conduit connection structure 3500 or the arm connection structure 3504 to fit into a recess (e.g., 3266-1 or 3266-2) and connect to the inflation chamber inlet port 3254. The arm connection structure 3504 may connect to the nose and mouth pad 3050-1 or the nose pad 3050-2 in substantially the same manner as the conduit connection structure 3500 (e.g., via snap-fit, press-fit, friction fit, etc.).

[0271] In some forms, the arm connection structure 3504 can be used as a plug for the inflation chamber inlet port 3254 (e.g., 3254-1 and / or 3254-2). Unlike the tube 3350, the hardener arm 3340 does not deliver pressurized air to the inflation chamber 3200. The hardener arm 3340 can be used in a "tube-down" configuration, where the hose is connected to and delivers air to the inflation chamber 3200 through the vent opening 3402 (e.g., 3402-1 and / or 3402-2). In this example, air does not need to travel into or out of the inflation chamber inlet opening 3254. Therefore, the arm connection structure 3504 can form a seal with the inflation chamber inlet opening 3254 to restrict airflow into or out of the inflation chamber 3200.

[0272] 5.3.4 Vent In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0273] In some configurations, the airway 3400 is configured to allow continuous ventilation flow from the interior of the inflation chamber 3200 to the surrounding environment, while the pressure within the inflation chamber is positive relative to the surrounding environment. The airway 3400 is configured such that the ventilation flow rate is sufficient to reduce the patient's rebreathing of exhaled CO2, while maintaining the therapeutic pressure within the inflation chamber during use.

[0274] One form of the vent 3400 according to the present technology includes 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.

[0275] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure (e.g., a rotation).

[0276] 5.3.5 Decoupling Structure In one form, the patient interface 3000 includes at least one decoupling structure, such as a spindle or a ball and a socket.

[0277] 5.3.6 Connection Port Connection port 3600 allows connection to air circuit 4170.

[0278] 5.3.7 Forehead Stent In one configuration, the patient interface 3000 includes a forehead support 3700.

[0279] 5.3.8 Anti-asphyxiation valve In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0280] Port 5.3.9 In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0281] 5.4 RPT device refer to Figure 5A and 5B According to one aspect of the present technology, the RPT device 4000 includes mechanical, pneumatic and / or electrical components and is configured to perform one or more algorithms 4300, such as any of the methods described herein in whole or in part. The RPT device 4000 may be configured to generate an airflow for delivery to a patient's airway, for example for treating one or more respiratory conditions described elsewhere in this document.

[0282] In one embodiment, the RPT device 4000 is constructed and arranged to deliver an airflow in the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 4 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0283] The RPT device may have an outer housing 4010, which is formed in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a base frame 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0284] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0285] One or more air path items may be located within a removable integral structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be located within an outer housing 4010. In one form, pneumatic block 4020 is supported by or formed as part of a base frame 4016.

[0286] As will be discussed in further detail below, the evaporation device 4105 may be included in or on the blower 4142 or coupled to the blower 4142. One or more sensors 4111 may be coupled to the blower 4142 or other components of the RPT device 4000. One or more sensors 4111 and the evaporation device 4105 may be arranged within or exposed to the airflow path. The sensors 4111 may be configured to detect data, and the data received from the sensors 4111 may be transmitted to the controller of the RPT device 4000 and used to at least partially influence the operation of the evaporation device 4105. The evaporation device 4105 may be configured to evaporate liquid into the air flowing through the RPT device 4000 to the patient.

[0287] As will be discussed in further detail below, the cartridge assembly 4130, including the evaporator 4105, may be included in or on the blower 4142, or coupled to the blower 4142. One or more sensors 4111 may be coupled to the blower 4142 or other components of the RPT device 4000. One or more sensors 4111 and the cartridge assembly 4130 may be arranged within the airflow path. The sensors 4111 may be configured to detect data, and the data received from the sensors 4111 may be used to at least partially influence the operation of the cartridge assembly 4130. The evaporator 4105 may be configured to deliver liquid into the air flowing through the RPT device 4000 to the patient.

[0288] 5.4.1 Mechanical & Pneumatic Components of RPT Unit An RPT device may include one or more of the following components in a single unit. Alternatively, one or more of the following components may be positioned as respective independent units.

[0289] 5.4.1.1 Air Filter One form of RPT device according to the present technology may include one air filter 4110 or multiple air filters 4110.

[0290] exist Figure 5B In one embodiment shown, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0291] exist Figure 5B In one embodiment shown, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0292] 5.4.1.2 Muffler One form of RPT device according to the present technology may include one or more mufflers 4120.

[0293] In one form of this technology (for example, see...) Figure 5B The inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140.

[0294] In one embodiment of this technology, the outlet silencer 4124 is located in the pneumatic path between the pressure generator 4140 and the patient interface 3000 or 3800.

[0295] 5.4.1.3 Pressure Generator In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers. The impellers may be located in a volute. The blower is capable of delivering an air supply, for example, at a rate up to about 120 liters / minute, at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O when delivering respiratory pressure therapy. The blower may be as described in any 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.

[0296] The pressure generator 4140 can be controlled by the treatment device controller 4240.

[0297] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0298] 5.4.1.4 Converter The transducer can be located inside or outside the RPT device. An external transducer can be situated on, for example, an air circuit (e.g., a patient interface) or form part of an air circuit. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits data or transfers it to the RPT device.

[0299] In one form of this technology (for example, see...) Figure 5B One or more converters 4270 are located upstream and / or downstream of pressure generator 4140. The one or more converters 4270 may be configured and arranged to generate signals representing characteristics of the airflow at that point in the pneumatic path, such as flow rate, pressure, or temperature.

[0300] In one form of this technology, one or more converters 4270 may be located near the patient interface 3000 or 3800.

[0301] In one configuration, the signal from converter 4270 can be filtered, such as by low-pass, high-pass, or band-pass filtering.

[0302] 5.4.1.5 Anti-overflow valve like Figure 5BAs shown, in one form of this technology, an anti-backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0303] 5.4.2 Electrical components of RPT device 5.4.2.1 Power Supply The power supply 4210 can be located inside or outside the housing 4010 of the RPT device 4000.

[0304] In one embodiment of this technology, power source 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power source 4210 supplies power to RPT device 4000 and evaporation device 4105 and / or box assembly 4130.

[0305] 5.4.2.2 Input Device In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow human interaction with the device. The buttons, switches, or dials can be physical or software devices accessible via a touchscreen. The buttons, switches, or dials can be physically connected to the housing 4010 in one form, or wirelessly communicate with a receiver electrically connected to the central controller 4230 in another form.

[0306] In one form, the input device 4220 may be constructed and arranged to allow a person to select values ​​and / or menu options.

[0307] 5.4.2.3 Controller In one form of this technology, the RPT device 4000 includes a controller. Any or all of the controllers discussed herein may include one or more hardware processors. Illustrative hardware processors may include x86 Intel processors, processors based on ARM® Cortex®-M processors from ARM Holdings, such as the STM32 series microcontrollers from ST Microelectronics. In some alternative forms of this technology, a 32-bit RISC CPU (e.g., the STR9 series microcontrollers from ST Microelectronics) or a 16-bit RISC CPU (e.g., a processor from the MSP430 series microcontrollers manufactured by Texas Instruments) may also be used. In some examples, the controller may be application-specific electronic circuitry. In some examples, the controller may be an application-specific integrated circuit (ASIC). In some examples, the controller includes discrete electronic components. In some examples, the controller may also include non-transitory computer-readable media, such as fast flash memory (e.g., NAND or NOR) and other forms of volatile or non-volatile computer storage devices.

[0308] 5.5 Air Circuit According to one aspect of the art, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow to travel between two components, such as the RPT device 4000 and the patient interface 3000 or 3800.

[0309] Specifically, the air circuit 4170 can be fluidly connected to the outlet and patient interface of the pneumatic block 4020. The air circuit may be referred to as an air delivery tube. In some cases, it may have separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0310] In some forms, the air circuit 4170 may include 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 the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around an axis of the air circuit 4170. The heating element may communicate with a controller (e.g., the controller of the RPT device 4000). An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0311] 5.6 Humidifier 5.6.1 Overview of Humidifiers In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 6AAs shown), it changes the absolute humidity of the air or gas intended to be delivered to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway. When used in place of or in combination with the humidifier 5000, the evaporator 4105 performs the same function.

[0312] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering the humidified airflow. In some forms, such as Figure 6A and Figure 6B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006 adapted to receive the humidifier reservoir 5110 and includes a heating element 5240. Similarly, the evaporation device 4105 may also have an inlet and an outlet, as well as a reservoir.

[0313] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 1A and 1B As shown), to change the absolute humidity of the air or gas intended to be delivered to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway. When used in place of or in combination with the humidifier 5000, the cartridge assembly 1120 (including the evaporator 1105) performs the same function.

[0314] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an airflow, and a humidifier outlet 5004 for delivering the humidified airflow. In some forms, such as Figure 6A and Figure 6B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006 adapted to receive the humidifier reservoir 5110 and includes a heating element 5240. Similarly, the cartridge assembly 5140 may also have an inlet and an outlet, as well as a reservoir, and can operate in a similar manner as further described below.

[0315] The cartridge assembly 5140, including an evaporator 5105, can be coupled to one or more components of the humidifier 5000. For example, the evaporator 5105 may be arranged within an airflow path from the humidifier. In this way, liquid can be evaporated and introduced into the airflow to produce humidified air, which is then delivered to the patient. One or more sensors 5111 may be coupled to one or more parts of the humidifier 5000, for example, within the airflow path. The sensors 5111 may be configured to detect data, and the data received from the sensors 5111 can be used to at least partially influence the operation of the cartridge assembly 5140 and / or the evaporator 5105. The evaporator 5105 may be configured to deliver evaporated substances (e.g., liquids, materials, compounds, drugs, etc.) into the air flowing through the RPT device 4000 and to the patient.

[0316] 5.6.2 Humidifier Components 5.6.2.1 Water Storage Tank According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) capacity for evaporation to humidify the airflow. The evaporation unit 4105 may similarly include a water reservoir, but the water reservoir of the evaporation unit 4105 may be significantly smaller than that of a conventional humidifier 5000. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory therapy, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0317] According to one aspect, the water reservoir 5110 of the humidifier 5000 and / or the water reservoir of the evaporator 4105 are configured to add humidity to the pressurized airflow from the RPT device 4000 as it passes through the RPT device 4000. In one form, the water reservoir 5110 may be configured to facilitate the airflow traveling in a curved path through the reservoir 5110 while in contact with the water volume therein.

[0318] According to one form, the storage 5110 can, for example, be along such a path. Figure 6A and Figure 6B The lateral direction shown is removed from the humidifier 5000. In another example, the water reservoir of the evaporator 4105 may be removable.

[0319] The humidifier's reservoir 5110 and / or the water reservoir of the evaporator 4105 can also be configured to prevent liquid from flowing out therefrom, for example, when the reservoir 5110 is displaced and / or rotated from its normal operating orientation, such as through any orifice and / or between its sub-components. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 can also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.

[0320] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) capacity to be evaporated for humidifying the airflow. The cartridge assembly 5140 may similarly include a housing forming the reservoir, but the reservoir of the cartridge assembly 5140 may be significantly smaller than that of a conventional humidifier. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0321] According to one aspect, the water reservoir 5110 and / or the box assembly 5140 are configured to increase the humidity of an airflow from the RPT device 4000 as airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow traveling in a curved path through the reservoir 5110 while in contact with the water volume therein.

[0322] According to one configuration, the storage unit 5110 / or the housing assembly 5140 may, for example, be along such a path. Figure 6A and Figure 6B The lateral direction shown is removed from the humidifier 5000.

[0323] The reservoir 5110 / or box assembly 5140 may also be configured to prevent liquid from flowing out of it, such as through any orifice and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.

[0324] 5.6.2.2 Conductive Component According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.

[0325] 5.6.2.3 Humidifier storage base In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 6B As shown, it is configured to receive a humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include locking features, such as a locking lever 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0326] 5.6.2.4 Water level indicator The humidifier storage unit 5110 may include, for example: Figures 6A-6B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as a patient 1000 or a caregiver) with one or more indications regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0327] 5.6.2.5 Humidifier Converter Humidifier 5000 may include one or more humidifier converters (sensors) 5210, alternative to or in addition to the converter 4270 described above. Similarly, evaporation 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. Figure 6CAs shown, the humidifier converter 5210 may include one or more of an air pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier converter 5210 may generate one or more output signals that can be transmitted to a controller. The controller may be part of an RPT device and / or a humidifier controller 5250 as discussed herein. In some forms, the humidifier converter may be located external to the humidifier 5000 (e.g., in the air circuit 4170) when communicating output signals to the controller.

[0328] 5.6.2.5.1 Pressure Transmitter In addition to, or in place of, the pressure sensor 4272 provided in the RPT device 4000, one or more pressure transducers 5212 may be provided to the humidifier 5000, the cartridge assemblies 4130, 5140 and / or the evaporators 4105, 5105.

[0329] 5.6.2.5.2 Air Flow Converter In addition to, or in place of, the flow rate sensor 4274 provided in the RPT device 4000, one or more flow rate converters 5214 may be provided to the humidifier 5000, the cartridge assemblies 4130, 5140 and / or the evaporation units 4105, 5105.

[0330] 5.6.2.5.3 Temperature Converter The humidifier 5000, cartridge assemblies 4130, 5140, and / or evaporation units 4105, 5105 may include one or more temperature transducers 5216. These one or more temperature transducers 5216 may be configured to measure, for example, one or more temperatures of the airflow downstream of the heating element 5240 and / or the humidifier outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 to detect the temperature of the ambient air.

[0331] 5.6.2.5.4 Humidity Converter In one embodiment, the humidifier 5000, cartridge assemblies 4130, 5140, and / or evaporation units 4105, 5105 may include one or more humidity sensors 5218 to detect the humidity of a gas (e.g., ambient air). The humidity sensor 5218 may be positioned toward the humidifier outlet 5004 in some manner to measure the humidity of the gas supplied from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0332] 5.6.2.6 Heating element In some cases, a heating element 5240 may be provided to the humidifier 5000 to provide heat input to one or more volumes of water and / or airflow in the humidifier reservoir 5110. The heating element 5240 may include a heating component, such as a resistance-heated rail. A suitable example of the heating element 5240 is a layered heating element, such as that described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0333] In some configurations, the heating element 5240 may be housed in the humidifier base 5006, where heat can be supplied primarily to the humidifier reservoir 5110 via conduction, such as... Figure 6B As shown.

[0334] 5.6.2.7 Humidifier Controller According to one arrangement of the present technology, the humidifier 5000, the cartridge assemblies 4130, 5140, and / or the evaporation devices 4105, 5105 may include or use one or more controllers. Such controllers may include, for example, Figure 6C The humidifier controller 5250 is shown. In one form, the humidifier controller 5250 may be part of a central controller included in the RPT device 4000. In another form, the humidifier controller 5250 may be a separate controller that can communicate with such a central controller.

[0335] In one embodiment, the humidifier controller 5250 may receive measurements of characteristics such as temperature, humidity, pressure, and / or flow rate as input, such as the flow of air, water in the reservoir 5110, and / or the flow of the humidifier 5000 (or cartridge assemblies 4130, 5140). The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0336] like Figure 6C As shown, the humidifier controller 5250 includes a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240, or in cooperation with thereto. The humidifier controller 5250 may similarly control similar elements of the evaporation units 4105, 5105 and / or the cartridge assemblies 4130, 5140.

[0337] 5.6.2.8 Box Components As will be discussed in further detail below, the box assembly 5140 and the evaporation device 5105 can be used in combination with or in place of the humidifier 5000, and can be incorporated as part of or relative to any suitable component of the respiratory therapy system. Figure 6A and 6B In the example, cartridge assembly 5140 may be coupled to one or more components of humidifier 5000, such as humidifier base 5006, or one or more sensors 150 may be coupled to reservoir 5110, or to other components of humidifier 5000 or respiratory therapy system. One or more sensors 5111, cartridge assembly 5140, and / or evaporator 5105 may be arranged within an airflow path. Data received from sensor 5111 may be configured to at least partially influence the operation of cartridge assembly 5140. Evaporator 5105 may be operatively engaged with cartridge assembly 5140. Evaporator 5105 may be integrated into cartridge assembly 5140. Evaporator 5105 may be configured to deliver liquid (e.g., water) into the air flowing through humidifier 5000, thereby reaching the patient.

[0338] 5.6.3 Evaporation Unit As will be discussed in further detail below, the evaporation device 5105 can be used in combination with or in place of the humidifier 5000, and can be part of or incorporated into any suitable component of the respiratory therapy system relative to any suitable component of the respiratory therapy system. Figure 5A and 5B In the example, the evaporator 5105 may be coupled to one or more components of the humidifier 5000, such as the humidifier base 5006. Additionally, one or more sensors 5111 may be coupled to the reservoir 5110 or to other components of the humidifier 5000 or the respiratory therapy system. One or more sensors 5111 and the evaporator 5105 may be arranged within or exposed to the airflow path. Data received from the sensors 5111 may be configured to at least partially influence the operation of the evaporator 5105. The evaporator 5105 may be configured to evaporate a liquid (e.g., water) into the air flowing through the humidifier 5000 to the patient.

[0339] 5.7 Respiratory waveform Figure 7 shows a typical respiratory waveform of a sleeping human. The horizontal axis represents time, and the vertical axis represents respiratory flow. Parameter values ​​can vary, and a typical breath may have the following approximate values: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 s, peak inspiratory flow Qpeak 0.4 L / s, expiratory time Te 2.4 s, and peak expiratory flow Qpeak -0.5 L / s. The total duration of respiration, Ttot, is approximately 4 s. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM) with a ventilation rate of approximately 7.5 L / min. The typical duty cycle is the ratio of Ti to Ttot, which is approximately 40%.

[0340] Typical respiratory waveforms can be used, for example, to provide parameters for turning the aforementioned evaporation device on or off. For example, when a person inhales, the evaporation device (e.g., evaporation devices 1105, 3105, 4105, 5105) can be turned on or powered to heat, causing the liquid to evaporate and be delivered into the airflow, which is then delivered to the patient to humidify the airflow. The evaporation device can be configured such that it reaches the temperature required for evaporating the substance within milliseconds (e.g., tens or hundreds of milliseconds), allowing the evaporation device to rapidly heat and humidify the air during inhalation, and then be turned off, de-energized, or shut off (i.e., power reduced but not eliminated) to lower the temperature of the evaporation device during exhalation, as further described below. The material of the evaporation device can be selected such that it has a low thermal mass or heat capacity. Once the evaporation device evaporates the liquid contained therein during a heating cycle (e.g., corresponding to an inhalation phase), the heat energy lost by the evaporation device in evaporating the liquid (including latent heat of vaporization) lowers the temperature of the evaporation device, such that the evaporation device does not continue to evaporate the liquid after the heating power is removed or reduced. Similarly, due to the relatively low thermal mass or heat capacity of the materials used in the evaporator, once lost due to evaporation, the evaporator cannot retain enough thermal energy to continue evaporation without sufficient heating power applied by the heating elements.

[0341] For example, a typical breathing waveform can be used to provide parameters for turning the aforementioned cartridge assembly on or off. For instance, when a person inhales, cartridge assembly 1120 can be configured to heat the liquid within evaporator 1105 to evaporate the liquid into the airflow delivered to the patient. In some examples, the air can be humidified as the liquid is delivered into the airflow path. Alternatively or additionally, the airflow can be dosed with a substance such as a drug. Cartridge assembly 1120 can be configured such that evaporator 1105 reaches the temperature required to heat the substance within milliseconds, thereby allowing the cartridge to deliver the liquid into the air during inhalation and to close or reduce the temperature of evaporator 1105 during exhalation, as further described below. Since humidification is only required during inhalation when the user breathes into the airflow, cartridge assembly 1120 can be timed to humidify the air only during inhalation. Using cartridge assembly 1120 in this way reduces the amount of water used by evaporator 1105, as it is not frequently operated, and also reduces the amount of power used. This, in turn, allows for the use of a smaller reservoir in cartridge assembly 1120 and reduces power consumption. Therefore, by using less water and less power than the humidifier 5000, the box assembly 1120 can be smaller than the conventional humidifier 5000.

[0342] exist Figure 7B and 7C The exemplary data presented can be utilized by the box component 1120, for example, to customize or tailor the patient's experience. See, for example, [link to relevant documentation]. Figure 7B and 7C The cartridge assembly 1120 can be configured to open or close in response to any number of thresholds set manually or through a learning algorithm. For example, the cartridge assembly 1120 can be configured to release liquid from the evaporator 1105 into the gas stream when SpO2, flow rate, chest movement, and / or abdominal movement are abnormal or exceed set thresholds. Similarly, the cartridge assembly 1120 can be configured to release liquid from the evaporator 1105 when any number of measurements (not limited to those discussed herein) are below or above a threshold. Abnormal readings may indicate that a patient is in pain, experiencing difficulty breathing, or experiencing any other symptoms indicative of a medical condition. Evaporating the substance from the evaporator 1105 into the gas stream can help minimize or alleviate the patient's symptoms and / or prevent harm to the patient.

[0343] Since humidification is only needed during inhalation when the user breathes in the airflow, the evaporator can be turned on periodically to humidify the air only during inhalation. Using the evaporator in this way reduces the amount of water used (because it doesn't run frequently) and the amount of power used. This, in turn, allows for the use of a smaller reservoir in the evaporator, as well as reduced power consumption. Therefore, by using less water and less power than a conventional humidifier 5000, the evaporator will be smaller than a conventional humidifier 5000.

[0344] Furthermore, this short rise time of approximately tens or hundreds of milliseconds likely means that humidification can be delivered to the airflow very quickly, which can improve the user experience. Another benefit is that the water to be evaporated and added to the airflow may not require a long preheating period, which can further save power.

[0345] 5.8 Patient Interface and Evaporation Device like Figure 8A As shown, a patient can wear a pad 3050-1 in a tube-up configuration having a tube 3350 and a four-point positioning and stabilization structure 3300. This assembly can form a tube-up nose-to-mouth patient interface 3000-1. The patient interface 3000-1 may include an vaporizer 3105 / cassette assembly 3120 and / or one or more sensors 3110.

[0346] In some configurations, the catheter sleeve can be used with the tube 3350 to allow the patient to experience a "tube-up" air delivery type with a mouth and nose pad 3050-1. As described below, the catheter sleeve provides additional connection points for connecting the positioning and stabilizing structure 3300. However, other types of connectors besides the catheter sleeve may be used.

[0347] In the example shown, the conduit sleeve can be connected to the tube 3350 of the positioning and stabilizing structure 3300. The tube 3350 (via the conduit connection structure 3500) can be used to connect the tube 3350 to the gasket 3050-1. The conduit sleeve provides a magnet for connection to the magnet of the four-point positioning and stabilizing structure 3300. Alternatively, different connection methods can be used.

[0348] For example, the lower band 3304-1 (e.g., via magnetic member 3306-1) can be removably attached to a magnet on the catheter sleeve. In use, each lower band 3304-1 can contact the patient's cheek (e.g., covering the masseter muscle). The lower band 3304-1 can also extend below the patient's ear.

[0349] like Figure 8BAs shown, the patient can wear a pad 3050-1 in a downward tube structure having a hardening arm 3340 and a four-point positioning and stabilization structure 3300. This assembly forms a downward tube-to-nose mouthpiece patient interface 3000-2.

[0350] In some configurations, the catheter sleeve can be used in conjunction with the sclerotherapy arm 3340 to allow the patient to experience a “tube-down” air delivery mode with a mouth and nasal pad 3050-1. As described below, the catheter sleeve provides additional connection points for connecting the four-point positioning and stabilization structure 3300. However, other types of connectors besides the catheter sleeve may be used.

[0351] like Figure 8C As shown, the patient can wear the pad 3050-2 in a tube-up configuration with a tube 3350 and a two-point positioning and stabilizing structure 3300. This assembly forms a tube-up nasal-only patient interface 3000-3. The catheter sleeve can be used with the tube 3350 and can provide additional comfort to the patient. The sleeve can be used to connect the positioning and stabilizing structure 3300 to the liner 3050-2 without adding an additional connection point. In the example shown, the tube 3350 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0352] like Figure 8C As shown, the two-point positioning and stabilizing structure 3300 can be connected to the tab 3320 on the tube 3350 to provide tension in a sealed position that holds the liner 3050-2 on the patient's head.

[0353] like Figure 8D As shown, the patient can wear the pad 3050-2 in a tube-up configuration with a hardening arm 3340 and a two-point positioning and stabilization structure 3300. This assembly can form a tube-down nasal-only patient interface 3000-4.

[0354] The catheter sleeve can be used with the scleroder arm 3340 and can provide additional patient comfort. The sleeve can be used to attach the positioning and stabilizing structure 3300 to the liner 3050-2 without adding additional connection points. In the example shown, the scleroder arm 3340 of the positioning and stabilizing structure 3300 can be directly attached to the liner 3050-2.

[0355] like Figure 8D As shown, the two-point positioning and stabilizing structure 3300 can be attached to the tab 3320 on the sleeve to provide tension in a sealed position that holds the pad 3050-2 on the patient's head.

[0356] The above is about Figures 8A-8DThe described components can be combined with each other, for example, to form different patient interfaces. One or more of these components can be reused for different types of patient interfaces. This allows for easier manufacturing and assembly because a large number of the same components can be produced and used in multiple types.

[0357] In addition, such as Figures 8A-8D As shown, each of the evaporator 3105, the housing assembly 3120, and / or the sensor 3110 can be included in or on various aspects of different patient interfaces, or coupled to various aspects of different patient interfaces. For example, the evaporator 3105 may be arranged between two components of the patient interface. The sensor 3110 may be coupled to the patient interface elsewhere along the airflow path. In any of the above configurations, the evaporator 3105 is configured such that the evaporator 3105 is at least partially exposed to the air flowing through the patient interface. Additionally, the sensor 3110 is configured such that the sensor 3110 is at least partially exposed to the air flowing through the patient interface. One or more sensors 3110 may be configured to detect and transmit (e.g., wirelessly or via at least one wire) information that can at least partially affect the operation of the evaporator 3105. This information may relate to airflow or any other aspect of the treatment being performed.

[0358] 5.9 Evaporation Unit and Sensors The following describes apparatus, systems, and methods for humidifying the airflow supplied to a patient using an evaporator. Adding an evaporator to a respiratory therapy system (e.g., a system with a patient interface or a respiratory pressure therapy device, as described above) can contribute to one or more of the following compared to conventional systems: reducing the size or footprint of the respiratory device and / or system; increasing patient comfort during use; reducing the amount of water required to humidify the air flowing through the system; reducing the energy required to power the respiratory therapy system; and other benefits. In some examples, the evaporator is well-suited for mobility, for example, due to its smaller size and portability. Additionally, the evaporator can be configured to be operatively coupled to or to a respiratory therapy device, or to a respiratory therapy device and / or between two respiratory therapy devices. In some examples, the evaporator can be operatively connected to any standard tubing connector or air circuit. In this way, the evaporator can be used on or with a variety of respiratory therapy devices and / or systems.

[0359] As will be described in further detail below, one or more sensors may be used in conjunction with the evaporation device. For example, the one or more sensors may be configured to detect physical phenomena (e.g., pressure, temperature, force, etc.) and output signals to thereby provide information to the evaporation device, controller, or other component in the respiratory therapy system. The information received from the sensors may be used to at least partially influence or control the operation of the evaporation device, controller, or other component in the respiratory therapy system.

[0360] An evaporation device can be used to evaporate substances (e.g., liquids, such as water, or materials) intended for inhalation. For example, the evaporation device can be rapidly heated so that vapor is released from the substance contained therein into an airflow path for delivery to the patient's airway. The vapor (e.g., evaporated water) can increase the humidity of the air flowing through the respiratory therapy system. In some examples, the evaporation device can be configured to evaporate liquids (e.g., water, medications, etc.) or materials (e.g., medications, compounds, etc.). In some examples, the substance can be a therapeutic substance that relieves symptoms of respiratory distress and / or treats respiratory distress, such as those discussed above. Additionally or optionally, the liquid or solid substance can provide a fragrance, aroma, and / or alter the taste or odor of the air flowing through the respiratory therapy system. In this way, humidified air and / or air with added substances can be delivered to the patient. Delivering humidified air and / or air that has been given one or more substances can increase patient comfort and thus increase compliance. The evaporation device can be used alone or in combination with a humidifier, such as the humidifier 5000 discussed above.

[0361] The location of the evaporation device and sensors can vary. For example, the evaporation device can be located anywhere along the airflow path. In some examples, the evaporation device can be positioned close to the motor controller, pressure sensor, ambient humidity and / or ambient temperature sensor of the RPT device, in addition to other components of the respiratory pressure therapy system. In such examples, the evaporation device can be adjacent to or integrated with the respiratory pressure therapy device.

[0362] Placing the evaporator and / or sensor along the airflow path can provide additional time for air temperature regulation of subsequent sections of the airflow path. In some examples, the sensor may be located near the evaporator, for example, to provide additional time to sense and / or analyze data related to the air conditions of the airflow path and / or the surrounding air. In some examples, the additional time can be used, for example, to adjust the settings or control of the evaporator in response to air conditions of the airflow path and / or the surrounding air. In such examples, the sensor may be positioned upstream of the evaporator and close to the RPT device relative to the airflow path, and the evaporator may be positioned downstream of the sensor and the RPT device relative to the airflow path. In examples, the sensor and the evaporator may be separated by approximately 0.1 cm to more than approximately 3 meters. One or more of the above arrangements can enable humidity sensing within the control system of the evaporator to achieve targeted activation of the humidification system. The inlet can also be integrated with an inlet filter system that is typically replaced by the user.

[0363] 5.9.1 Evaporation Unit and Sensor Configuration Figure 9A A partially exploded top view of an exemplary configuration of the evaporation apparatus 100 is shown. Figure 9B A side view of the evaporation device 100 is shown. The evaporation device 100 may include a reservoir 120 and an evaporation module 105 containing an evaporator 110. In this configuration, the evaporation device 100 may be fixedly or removably arranged between a first portion 170A and a second portion 170B of an air circuit 170, such that the evaporation module 105 is in fluid communication with the first portion 170A and the second portion 170B. For example, the proximal end 101 of the evaporation module 105 may be coupled to the distal end 171 of the first portion 170A, and the distal end 102 of the evaporation module 105 may be coupled to the proximal end 173 of the second portion 170B of the air circuit 170. The distal end 175 of the second portion 170B may be in fluid communication with a patient interface, such as those shown and described above. The proximal end 177 of the first portion 170A may be in fluid communication with an RPT device, such as the RPT device described above.

[0364] In some examples, evaporator 110 may be a capillary evaporator composed of one or more layers of porous material, through which liquid can be transported via capillary effect from one side in contact with or at least in fluid communication (e.g., via a wick) with the liquid in reservoir 120 to the opposite side, where the evaporated liquid is discharged into a pressurized airflow. The porous material may be ceramic, a porous metal, a sintered material (e.g., a metal), quartz, a polymer, or a fibrous material. The porous material may have a relatively low heat capacity, such that when heated, after losing heat, for example due to latent heat of vaporization, to cause the liquid to evaporate, the porous material does not retain a significant amount of heat. Evaporator 110 may include a heating element to heat the liquid in the porous material. The heating element may be a resistance heater. The heating element may include a conductive filament generated when an electric current passes through it. Evaporator 110 may be sealed around its exterior by a non-porous material, thereby forcing the evaporated liquid to drain through one or more orifices.

[0365] In some examples, the evaporator 100 may be arranged between a first portion 170A and a second portion 170B of the air circuit 170, such that air can continuously flow from the first portion 170A (e.g., via the central cavity 172 of the first portion 170A), through the evaporation channel 106 of the evaporation module 105 (e.g., via the cavity 174 of the evaporation module 105), and into the second portion 170B of the air circuit 170 (e.g., via the central cavity 176 of the second portion 170B). The evaporator 100 may be connected to the first portion 170A and the second portion 170B by threaded connection, press fit, adhesive, welding, or any other means commonly used in the art to permanently or temporarily connect the two components. The air circuit 170 may or may not be a “smart” conduit.

[0366] Evaporator 110 may be arranged or positioned within a portion of evaporation module 105. For example, evaporator 110 may be arranged or positioned within evaporation module 105 such that a first side 110A of evaporator 110 is exposed to air flowing through evaporation module 105, and a second side 110B is exposed to container 122 of reservoir 120. In this way, evaporator 110 is configured such that material or liquid contained in container 122 of reservoir 120 can be evaporated by evaporator 110 and conveyed into the air path. Reservoir 120 may be outside the air path, which can reduce the number of components that may require reprocessing. In some examples, reservoir 120 is positioned above evaporator 110 in an operational orientation such that material or liquid contained in container 122 of reservoir 120 may be supplied to evaporator 110 by gravity. For example, material or liquid contained in container 122 of reservoir 120 may permeate into evaporator 110. In such an example, a wick may be included to ensure a constant supply of liquid or material to the evaporator 110 during the process, or a gravity supply arrangement may be sufficient to ensure a constant supply of liquid or material to the evaporator 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 evaporator 110.

[0367] In some examples, the reservoir 120 may be pre-filled or refillable. For example, the reservoir 120 may be replaced before or after each use to provide a fresh liquid supply to the evaporator 110 for evaporation. In other aspects, the reservoir 120 may be refilled before or after use. In either case, the reservoir 120 may be removable so that it can be replaced with a new pre-filled reservoir 120, or a refilled reservoir may be returned after refilling. In another alternative to the refillable reservoir 120, the reservoir 120 may be permanently attached to the evaporation module 105, and in yet another alternative, the evaporator 100 may be removed from other components of the RPT system (e.g., the air circuit 170) for refilling the reservoir 120. Moreover, the entire evaporator 100 may be replaced on a periodic basis.

[0368] In some examples, the evaporator 110 may be incorporated into the reservoir 120, and the evaporator 110 may also be disposable or reusable. For example, the reservoir 120 may be a container with a lid, on which the evaporator 110 is attached or within. In some examples, the reservoir 120 may be made of a polymer, such as polyethylene terephthalate, polycarbonate, or other suitable materials. The reservoir 120 may be expandable or made of a flexible material. In this way, the reservoir 120 may be folded, compressed, or bent, for example, during transport or storage. The reservoir 120 may also be collapsible, as the volume of the substance contained therein decreases during treatment. Thus, the volume of the reservoir 120 can be minimized when the reservoir 120 is not in use, and maximized during use. In a further example, a water purification system may be incorporated into the water reservoir 120. The reservoir 120 may be made of a relatively flexible material, for example, more flexible than the rest of the evaporation module 105, to allow it to collapse when emptied or filled to less than its maximum volume. The relatively flexible material may be rubber or a polymer. For example, a distiller or reverse osmosis mechanism may be incorporated to clean the liquid, such as water, prior to evaporation to improve water quality consistency.

[0369] In some examples, evaporator 110 is configured to evaporate the substance at least in part based on ambient room conditions. For example, if the humidity in the room is below a desired threshold, evaporator 110 may be configured to evaporate the substance or evaporate more of the substance. Alternatively, if the humidity in the room is at or above a desired threshold, evaporator 110 may be configured to evaporate less of the substance or not evaporate any substance. For example, if the ambient conditions are sufficiently humid, evaporator 110 may be configured to shut off and stop evaporating the liquid. One or more sensors incorporated as part of a respiratory therapy system may be configured to detect the ambient humidity level and may transmit the detected information to or operatively coupled to a controller on evaporator 110. If the ambient humidity is below a certain threshold, evaporator 110 may be turned on, for example, by the controller. If the ambient humidity is below a certain threshold, evaporator 110 may be turned off, for example, by the controller. One or more sensors can be configured to detect environmental conditions at regular or irregular time intervals (e.g., every time the RPT system is powered on, every time the blower is started, every hour, etc.) so that the operation of the evaporator 110 can be appropriately adjusted if the environmental conditions change.

[0370] In some examples, evaporator 110 can be configured to evaporate the substance based on an algorithm. This algorithm can be provided in the form of firmware, software, and / or hardware. For example, a controller (which includes one or more hardware processors) can execute a software program that acquires or otherwise processes (e.g., from sensors, etc.) and stores (e.g., to a non-transient storage medium) data about the user, the user's humidification profile (e.g., humidification preferences), the ambient humidity of the room where evaporator 110 is located, and / or other aspects. The algorithm can then process the information about the user, the user's humidification profile (e.g., humidification preferences), the ambient humidity of the room where evaporator 110 is located, etc., to control or influence the performance of evaporator 110, thereby customizing the delivery of the substance to the user.

[0371] As an illustrative example, the heating of the evaporation module 105 can be timed (e.g., based on processing executed by an algorithm) so that the evaporator 110 evaporates the substance while the user is inhaling or just before the user inhales. For example, a software application can generate (or cause to generate) a control signal that is transmitted to the evaporator. This control signal can be active (e.g., causing the evaporator 110 to activate when it receives the signal) or can be provided for activation at a given timing. In this way, the amount of substance reaching the user can be controlled based on processing executed by an algorithm. The amount of substance lost due to ventilation when the user exhales can also be reduced because the substance to be evaporated when predicted to inhale is allocated to the pressurized airflow and is only the amount required for a single-phase inhalation. In some examples, the energy required to power the evaporation module 105 and / or the evaporator 110 can be reduced because the evaporator 110 is only turned on (or otherwise activated to perform the evaporation of the substance) when the patient inhales. As a non-limiting illustrative example, during an 8-hour period, the vaporizer 110 may be activated in response to inhalation or based on inhalation (e.g., whether it is a predicted or detected inhalation). At other times (e.g., when the patient exhales during sleep), the vaporizer may not be activated. In some examples, the vaporizer 110 may be "on" throughout the entire time period (e.g., the duration of treatment) and may dynamically switch between two (or more) operating modes. A first mode may correspond to the patient's inhalation, and a second mode may correspond to the patient's exhalation (or no inhalation). In the second mode, the vaporizer may consume less power and / or reduce the amount of substance evaporated.

[0372] In other examples, a default humidity threshold can be set in the controller to determine when the controller turns the evaporator 110 on or off (e.g., when it is powered or not). In yet another example, these default thresholds can be adjusted by the user or automatically based on one or more of the user's preferred humidification profile (e.g., drier or more humid), geographic location (e.g., typical humidity levels in a given area or geographic location), season (e.g., winter or summer), etc.

[0373] In some examples, the algorithms stored and operated by the controller can be programmed to learn a user's personal humidification profile over time and can adjust the functional performance of the evaporator 110 to deliver more or less humidity to the airflow. In some examples, when a user is cold or after a nosebleed, the user can temporarily adjust his or her personal humidification preferences (e.g., adjust to higher or lower humidity).

[0374] In some examples, an air inlet filter (e.g., a filter) may be located upstream of the evaporation module 105 and the evaporator 110. This air inlet filter may be configured to allow airflow through or to one or more components of the respiratory therapy system, such as the evaporation module 105. The air inlet filter may be configured to filter out any particles, debris, or other foreign matter from the air flowing through the respiratory therapy system. In some examples, the air inlet filter may filter the air before it reaches the evaporation module 105. Filtering the air before it reaches the evaporation module 105 can help limit the accumulation of particles or debris on the evaporation module 105 and / or the evaporator 110.

[0375] In other examples, the air inlet and / or air inlet filter can be integrated with the evaporation module 105, for example, upstream of the evaporator 110. In such examples, the air inlet filter can be located close to the evaporator 110, for example, on the proximal portion of the evaporation module 105. The air inlet can be configured to allow airflow through or into the evaporation module 105 and / or to reach the evaporator 110. The air inlet filter can filter the air after it reaches the evaporation module 105 but before it reaches the evaporator 110. Filtering the air before it reaches the evaporator 110 can also help limit the accumulation of particles or debris on the evaporator 110.

[0376] The air inlet and / or air inlet filter may be removable (e.g., for cleaning) and / or replaceable.

[0377] Figure 9A and 9B An exemplary location of the evaporation module 105, which is aligned with the air circuit 170, is shown. Figure 9BThis is a front view showing the operational orientation of the evaporator device 100 of this example, with the reservoir 120 above the evaporation module 105, which is above the evaporation channel 106. However, the evaporator 110 can be arranged along any part of the air path, such that the evaporator 110 is exposed to air flowing through any part of the respiratory therapy system. In some examples, the evaporator 110 can be arranged on or integrated with the surface of one or more components, and in other examples, the evaporator 110 can be coupled to one or more components, coupled between one or more components, or aligned with one or more components. For example, the evaporator 110 can be incorporated into, 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, the evaporator 110 can be incorporated as part of a separate dongle or adapter, which can be permanently or removably connected to one or more of the components described herein. For example, Figure 1A , 1B Examples 4A-4C, 5A, 6A-6C, and 8A-8D depict exemplary components and their locations, wherein one or more of the vaporizer and / or sensor may be integrated into a respiratory therapy system. Furthermore, the location of the vaporizer on a single component can be optimized based on the type of component used. For example, the location of the vaporizer on the patient interface or the characteristics of the vaporizer may depend at least in part on the type of patient interface (e.g., nasal cannula versus full-face mask versus nasal pad, etc.).

[0378] Figure 10 A schematic diagram is shown of an evaporation 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, air circuit, blower, RPT device, or any of the aforementioned components included in the respiratory therapy system. In some examples, component 251 may be a separate dongle or adapter that may be permanently or removably connected to one or more other components described herein. Therefore, surface 250 may be the surface of any such component. A pressurized airflow 290 passes through component 251.

[0379] Evaporation device 200 includes an evaporation unit 205 containing an evaporator 210. Evaporation device 200 also includes a reservoir 220. Evaporation device 200 can be used similarly to the evaporation device 100 described above. For example, evaporation device 200 can be configured to deliver water vapor to air flowing through a respiratory therapy system. Additionally or alternatively, evaporation device 200 can be configured to deliver a substance (e.g., a liquid substance such as a drug or water) to air flowing through a respiratory therapy system. Reservoir 220 can be configured such that liquid substance contained within reservoir 220 is drawn into evaporator 210, for example, via capillary wicking, as shown at 292. Once the substance is wicked into evaporator 210, it can be heated and evaporated by evaporator 210 and delivered into an airflow path, as shown at 291. In some examples, evaporator 210 may include an absorbent wicking layer to aid in wicking liquid substance into evaporator 210. The wicking layer can also be configured to absorb the liquid substance, thus ensuring that the liquid substance is evenly distributed on the evaporator 210. In this way, the wicking layer can also suppress blockage or clogging.

[0380] In other respects, one or more cores may be included in or replace the evaporator within an associated reservoir. When the respiratory therapy system is not in use, such as during the day, the user can connect the evaporator with one or more rechargeable cores to a base with a water chamber, or immerse it in one or more rechargeable cores or provide water that can be absorbed by one or more rechargeable cores, for example, to saturate the rechargeable cores. Before use, the evaporator can be reattached to the respiratory therapy system. By refilling the cores when the evaporator is not in use, even with a small reservoir, the evaporator can have sufficient water to provide humidified air during use. This allows for a smaller respiratory therapy system.

[0381] In other respects, the device may be arranged on or around component 251. The device may be exposed to the ambient atmosphere. The device may include a material configured to absorb moisture from the ambient atmosphere. The material may be a non-woven material. In some examples, the material may be a shield or cylindrical cover arranged around components of the respiratory therapy system, for example, around a tube, such as the air circuit 4170 described above. The material and the absorbed moisture may be stored in a wicking chamber. Evaporator 210 may be configured to absorb moisture contained within the wicking chamber. Such a configuration may be attached to or used in place of a reservoir used with evaporator 210.

[0382] Evaporator 210 may have the above-mentioned features Figure 9A and 9B Any one or more of the features of the described evaporator 110.

[0383] One or more sensors may be used in conjunction with the vaporizer 210. For example, one or more sensors may be arranged on or within the air path of component 251 and may provide feedback (e.g., in the form of signals generated by the sensors based on sensed physical quantities) directly or indirectly (e.g., via a controller or other component) to the vaporizer 210 and / or other devices of the respiratory therapy system (e.g., a controller or computer).

[0384] The one or more sensors can provide data about the air flowing through the device or system. For example, the one or more sensors can provide information about the temperature and / or humidity of the air flowing through the device / system. Additionally or alternatively, the one or more sensors can be configured to sense physical phenomena regarding the direction, volume, and / or velocity of the air flowing through the respiratory therapy device and / or system. For example, an increase in air velocity can indicate that the patient is inhaling, while a decrease in air velocity can indicate that the patient is exhaling. Such information can be transmitted or relayed to the vaporizer, and the vaporizer can be operated (e.g., based on processing performed using the algorithm) to respond accordingly.

[0385] like Figure 10 As shown, the first sensor 240 can be arranged along the air path, for example, near the evaporator 210. The first sensor 240 can be configured to detect physical quantities of air and to transmit information about the air upstream of the evaporator 210. The first sensor 240 can transmit signals wirelessly or via a wired connection (e.g., via the first cable 241) that can extend between the first sensor 240, the controller, and / or the evaporator 210 (e.g., via the first cable 241) to transmit signals (e.g., to the controller of the evaporator 210 or to the evaporator 210).

[0386] Evaporator 210 can be configured to receive data from first sensor 240 and perform actions based on the received data (e.g., based on processing performed in conjunction with one or more algorithms as described herein). For example, in response to receiving data from first sensor 240, evaporator can be configured to do nothing or change its function. For example, evaporator 210 can be configured to open in response to an increase in air velocity, close in response to a decrease in air velocity, open to increase the humidity of the air flowing through the device by evaporating liquid, close in response to stopping liquid evaporation when sufficient humidity is detected upstream of evaporator 210 and / or outside the respiratory therapy system, release liquid substances (e.g., drugs, mixtures, reagents, etc.) into the air flowing through the device by evaporating liquid substances, increase the temperature of the air flowing through the device, or any other action that evaporator 210 can be configured to perform. In other aspects, first sensor 240 can be configured to transmit data to a controller, which can then send instructions to evaporator 210 to function as previously described.

[0387] Alternatively or concurrently, the second sensor 242 may be placed downstream of the evaporator 210, for example, at the distal end of the air path. Thus, the second sensor 242 can provide a signal about the airflow after it has passed through the evaporator 210. The second sensor 242 can be configured to transmit data about the airflow to the evaporator 210. This transmission can be performed wirelessly or via a second cable 243 extending between the second sensor 242 and the evaporator 210. In this way, the second sensor 242 can provide feedback to the evaporator 210. For example, the evaporator 210 can be configured to receive information from the second sensor 242 and adjust one or more aspects of the delivery of vapor to the airflow (e.g., the amount, type, temperature, etc. of the material). In other respects, the second sensor 242 can be configured to transmit data to a controller, which can then send instructions to the evaporator 210 to function as previously described.

[0388] Figure 11An alternative configuration of evaporator 310 is shown, comprising an evaporator and an associated reservoir coupled to a surface 350 of a component 351. In this manner, evaporator 310 is configured such that surface 312 of evaporator 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 with evaporator 310 in the respiratory therapy system. Humidifying filter 370 may be constructed of a fibrous or non-fibrous porous material that absorbs heat and moisture from the patient's exhaled air and releases the heat and moisture into the incoming pressurized airflow. Humidifying filter 370 may be treated with salt to increase its absorbency.

[0389] exist Figure 11 In the example shown, the humidifying filter 370 can be located near or upstream of the evaporator 310, for example, within the near-side portion of the pressurized airflow 390. In this way, air can flow first through the humidifying filter 370 and then through the evaporator 310. In this configuration, the evaporator 310 can be configured to provide additional humidity to the airflow passing through the humidifying filter 370, as shown in 391. The humidifying filter 370 can be formed of a material configured to absorb moisture from the airflow. For example, the humidifying filter 370 can be configured to absorb water vapor from the user's exhaled air. The water vapor absorbed on or in the humidifying filter 370 can then evaporate into the airflow during inhalation and be reintroduced into the airflow. Therefore, including the filter 370 also promotes the humidification of the airflow. By incorporating the humidifying filter 370 outside the evaporator 310, the reservoir of the evaporator 310 does not need to hold as much water, because the humidifying filter 370 can also capture water vapor and reintroduce it into the intake airflow. Alternatively or alternatively, a smaller evaporator 310 and / or a smaller humidifying filter 370 can be used. Therefore, including the humidifying filter 370 allows for a smaller evaporator 310.

[0390] One or more sensors may be arranged along the airflow path. For example, a first sensor 340 may be located upstream of the humidifier filter 370, such as near the humidifier filter 370. A second sensor 342 may be located downstream (e.g., distal) of the humidifier filter 370 and near (e.g., upstream) of the evaporator 310. A third sensor 344 may be located downstream of both the humidifier filter 370 and the evaporator 310, such as distal. Each of the first sensor 340, the second sensor 342, and / or the third sensor 344 may be configured to transmit data relating to the air flowing within component 351 to the evaporator 310, the RPT device 4000, or operatively coupled to one or more controllers of the evaporator 310. For example, in some aspects, the first sensor 340, the second sensor 342, and / or the third sensor 344 may be operatively coupled wirelessly or via a wire extending between the RPT device 4000 and each corresponding sensor. In this way, the first sensor 340, the second sensor 342, and / or the third sensor 344 can be configured to transmit information about airflow to the RPT device 4000. Alternatively or additionally, the first sensor 340, the second sensor 342, and / or the third sensor 344 can be wirelessly or operatively connected to the evaporator 310 or an associated controller via wires extending between the evaporator 310 and one or more of the first sensor 340, the second sensor 342, and / or the third sensor 344.

[0391] The RPT device 4000 or controller can be configured to store information transmitted by each of the first sensor 340, the second sensor 342, and / or the third sensor 344. The RPT device 4000 or controller can also be operatively coupled to the evaporator 310. In this way, the RPT device 4000 or associated controller can be configured to transmit signals to the evaporator 310, for example, in response to 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 associated controller can be configured to turn on the evaporator 310, increase the temperature of the evaporator 310, or turn off the evaporator 310, and other actions.

[0392] The evaporator 310 can be powered by a power supply 380. The power supply 380 can be a battery or an external device, such as an RPT device 4000, which is configured to provide power to the evaporator 310. The power supply 380 can be integrated with the evaporator 310 or can be external to the evaporator 310.

[0393] Component 351 may include an air vent 352. In some examples, operation of the air vent 352 may be powered by a power source 380 of the respiratory therapy device or other power sources. The air vent 352 may be configured for active or passive ventilation. For example, the air vent 352 may include a fan or motor (e.g., powered by the power source 380) to facilitate airflow into or out of component 351. In some examples, the air vent 352 may be configured to open and / or close in response to the airflow through component 351 and / or in response to the characteristics of the airflow through component 351. For example, the air vent 352 may be configured to open when the user exhales and / or when the vaporizer 310 is closed, and close when the patient inhales and / or when the vaporizer 310 is open. By closing the air vent 352 when the user inhales and / or when the vaporizer 310 is evaporating liquid or substance, the loss of liquid or substance evaporated into the airflow by the vaporizer 310 can be reduced. Vent 352 can be configured to release excess humidity within component 351. Vent 352 can 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 can open, thereby reducing the humidity of the air. When the humidity within component 351 is equal to or below the threshold, vent 352 can close. In this way, vent 352 can provide active ventilation. Additionally or alternatively, vent 352 can be configured as a valve. In such an example, vent 352 can be configured to operate within a pressurized system. For example, vent 352 can be configured to open and close at different pressure thresholds. In some examples, vent 352 can open when the user exhales and close when the patient inhales. The use of vent 352 can help improve the efficiency of vaporizer 310 and / or other aspects of the respiratory therapy system. In yet another example, the vent 352 may include one or more orifices that remain continuously open to the atmosphere throughout the patient’s respiratory cycle.

[0394] Although a power source 380 is shown relative to this configuration, any evaporator discussed herein can be powered by a battery or by an alternative power source. A battery-powered evaporator allows for use during travel and / or in situations where remote power is difficult to obtain. Alternatively or additionally, the evaporator discussed herein may draw power from, for example, the RPT device 4000, or other components of the respiratory therapy system in which the evaporator 310 is integrated, or on, or adjacent to such other components. In another example, the evaporator discussed herein may draw power from an alternative power source. For example, in some configurations, the evaporator 310 may be electrically connected to a heating coil that extends circumferentially around an air circuit 4170. This heating coil may be configured to heat the air flowing through the air circuit 4170 in addition to supplying power to the evaporator. Alternatively, the evaporator may be configured to be inserted into a separate controller or module configured to supply power to the evaporator.

[0395] Any evaporator and evaporation unit discussed herein may also be removable or interchangeable. For example, the evaporator discussed herein may be removed from the evaporation unit discussed herein. In this way, the evaporator can be easily replaced or cleaned by removing it from the evaporation unit. In other respects, for example, the evaporation unit and / or the reservoir or evaporator in the evaporation unit may be removable for cleaning or refilling.

[0396] Figure 12 An evaporation device 400 is shown, which includes an evaporator 410 and a radiator 413. In this configuration, the evaporation device 400 can be entirely arranged within a component 451, for example, within the airflow path of the component 451. The component 451 can be any component of the aforementioned respiratory therapy system. In addition to the following description, the evaporator 410 may have… Figure 9A and 9B Evaporator 110 Figure 10 Evaporator 210 and / or Figure 11 Any or all features of the evaporator 310. For example, the evaporator 410 is configured for evaporating liquids and / or substances, as shown at 491. In this way, the humidity of the air flowing through component 451 can be increased, and / or the air flowing through component 451 can be metered with substances.

[0397] In this configuration, the evaporator 410 is operatively coupled to the radiator 413. For example, the first surface 412 of the evaporator 410 may be exposed to air flowing through the component 451. Evaporated liquid and / or substances may enter the airflow path via the first surface 412.

[0398] A radiator 413 may be operatively coupled to a second surface 414 of an evaporator 410. The radiator 413 may be configured to absorb excess heat from the evaporator 410. When the radiator 413 absorbs heat from the evaporator 410, air flowing through component 451 may be heated by the radiator 413. Providing warm air to the patient increases patient comfort. Furthermore, removing excess heat from the evaporator 310 increases the lifespan of the evaporator 310. As shown, the radiator 413 may include multiple fins, thereby providing a larger surface area during heat transfer.

[0399] exist Figure 12 One or more sensors can be used in the configuration shown. For example, a first sensor 440 can be arranged within the airflow path, upstream of the evaporator 400, such as its proximal end. Alternatively, a second sensor 442 can be arranged downstream of the evaporator 400, such as its distal end. The first sensor 440 and / or the second sensor 442 can have the features described above. Figure 10 and 11 The sensor described may possess any or all of the following characteristics. For example, the first sensor 440 and / or the second sensor 442 may detect a physical quantity of air, generate a signal, and then transmit data regarding the air flowing through component 451 to one or more of the following: the evaporator 410, a controller, and / or other components of the respiratory therapy system. For example, the first sensor 440 and / or the second sensor 442 may transmit a signal to the controller, which causes the controller to adjust one or more parameters of the delivery of the liquid or substance from the evaporator 410 into the air.

[0400] Figure 13 An alternative evaporator 500 is shown. In this configuration, the evaporator 500 can be arranged along the outer surface 550 of component 551. The evaporator 500 includes an evaporator 510 and a radiator 513 connected by a bridge 515. Both the radiator 513 and the bridge 515 can be made of a thermally conductive material (e.g., metal). In this configuration, the evaporator 510 can be downstream (e.g., distal) of a humidifying filter 570, which can be an HMX. The humidifying filter 570 can be made of a fibrous or non-fibrous porous material that absorbs heat and moisture from the patient's exhaled air and releases the heat and moisture into the incoming pressurized airflow. The humidifying filter 570 can be treated with salt to increase its absorbency. The humidifying filter 570 can have the above-mentioned... Figure 11The humidifier filter 570 may contain one or more of the features described herein. For example, the humidifier filter 570 may absorb water vapor from exhaled air and provide a certain level of humidity to the air flowing through the component 551, as shown in 591. In this way, the evaporator 510 may be configured to provide additional humidity to the air flowing through the component 551 and / or to measure the air flowing through the component 551 with a substance.

[0401] Radiator 513 may be upstream of, for example, near, evaporator 510 and humidifier filter 570 along airflow path 590. Radiator 513 may be fixed to the outer surface of component 551. Bridge 515 extends between evaporator 510 and radiator 513. Bridge 515 may be coupled to surface 514 of evaporator 510. Bridge 515 may extend parallel to component 551. In this way, when evaporator 510 is heated, bridge 515 may absorb the heat generated by evaporator 510. Heat can be absorbed through bridge 515 and enter into the plurality of heat sinks forming radiator 513. The plurality of heat sinks of radiator 513 may abut or contact the outer surface 550 of component 551, thereby heating the outer surface 550. Heating the outer surface 550 may increase the temperature of the air flowing through component 551.

[0402] One or more sensors may be arranged within the airflow path. For example, a first sensor 540 may be arranged within the airflow path, adjacent to the evaporator 510 and / or the humidifier filter 570. A second sensor 542 may be arranged distal to the evaporator 510. The first sensor 540 and / or the second sensor 542 may have the above-mentioned features. Figure 10 and 11 One or more of the characteristics described by the sensors described herein. For example, the first sensor 540 and / or the second sensor 542 can transmit data about the air flowing through component 551 to evaporator 510, a controller operatively coupled to evaporator 510, and / or other devices of the respiratory therapy system. For example, the first sensor 540 and / or the second sensor 542 can transmit a signal that then causes a processor to adjust one or more parameters of the liquid or substance delivered from evaporator 510 to air 592, which occurs at 593.

[0403] In some examples, the multiple fins of the radiator 513 may extend partially into or completely through component 551. Therefore, air flowing through component 551 can circulate around each of the multiple fins. In this way, the air can be heated, and the heated air can be delivered to the user.

[0404] Figure 14 Another example is described, which utilizes the HMX 670 (e.g., as mentioned above regarding...). Figure 11 and13 The system (described) absorbs heat and moisture from the air exhaled by the patient along the recirculation path 602 and decomposes the heat and moisture into the incoming pressurized airflow along the air circuit 601 before reaching the patient interface 3000 worn by the patient. The evaporator 600 may also include an evaporator 610 similar to those described above. The evaporator may optionally include a core 690 to draw moisture from the reservoir 620 and / or HMX 670 and direct it to the evaporator 610 for evaporation into the pressurized airflow. The surface 680 of the evaporator 600 may be sealed so that moisture enters only the pressurized airflow after being evaporated by the evaporator 610. Furthermore, the system may include a vent 3400 to allow for the cleaning of exhaled air and prevent the accumulation of carbon dioxide; however, it should be noted that the vent 3400 is located outside the recirculation path 602 so that warm, humid exhaled air does not escape into the atmosphere before the heat and moisture can be absorbed by the HMX 670.

[0405] Each example discussed herein enables the humidification of inhaled air or the delivery of substances to air flowing through the respiratory therapy device. Among other benefits, each example can help increase patient usability and / or patient comfort.

[0406] The use of one or more sensors in conjunction with the evaporation device can provide more precise humidification sensing within the airflow of the respiratory therapy system. Control of humidification can be correlated with known conditions (e.g., detected using one or more sensors) within one or more components of the respiratory therapy system, allowing for closed-loop control of humidification within the system. Furthermore, as mentioned above, humidification within the respiratory therapy system can also be correlated with patient preferences and / or environmental (e.g., ambient) conditions. In other aspects, sensed conditions within the patient interface can also be used to control the operation of the evaporation device. The use of sensors and / or patient preferences allows for closed-loop control of the evaporation device, and thus, closed-loop control of the humidification system within the respiratory therapy system. This allows for real-time, automatic, and / or dynamic adjustment of humidification within the respiratory therapy system.

[0407] In some respects, multiple evaporation devices can be integrated into a single component of a respiratory therapy system, or multiple evaporation devices can be integrated into different components of the respiratory therapy system. For example, each evaporation device can be smaller than a conventional humidifier 5000, and therefore can hold less water in the associated water reservoir compared to a conventional humidifier 5000. By including multiple evaporation devices in the respiratory therapy system, when one evaporation device is emptied of water or other liquid, the next evaporation device can be activated. In other respects, it may be advantageous to “stack” multiple evaporation devices in a component. For example, the operation of one or more evaporation devices can be alternating or switched, for example, to control heat accumulation or achieve evaporation efficiency.

[0408] In other respects, multiple evaporation devices integrated into different components of a respiratory therapy system can allow vapor to be added in series at different points in the air path to humidify the airflow. Therefore, evaporation can be performed in stages.

[0409] 5.9.2 boxes This document describes apparatus, systems, and methods for using one or more removable cartridges to humidify the airflow supplied to a patient and / or to deliver evaporated liquid into the air supplied to the patient. The use of at least one removable cartridge in conjunction with a respiratory apparatus and / or respiratory therapy system (such as those described above), which includes a reservoir containing liquid and, in some examples, an evaporation device (e.g., in the form of a capillary evaporator), can contribute to one or more of the following: reducing the size or footprint of the respiratory apparatus and / or respiratory therapy system; increasing patient comfort during use; reducing the amount of water required to humidify the air flowing through these apparatuses or systems; reducing the energy required to power the respiratory system; allowing the user to customize or personalize the received treatment; and / or increasing the availability of the respiratory therapy system, among other benefits.

[0410] In some examples, such as due to the size and / or portability of the device, the cartridge can be configured for use on the go. The travel cartridge can be reusable and refillable or disposable and replaceable. In some respects, a disposable cartridge may be advantageous, particularly during travel, as the cartridge can be pre-filled with sterile water. Therefore, the user may not need to find sufficiently clean water while traveling, or worry about setup and / or mess. Furthermore, the user may not need to worry about cleaning the evaporator and / or reservoir or refilling the reservoir. Such a disposable cartridge can function similarly to a coffee filter cartridge and can be used similarly to a razor / shaver model, where the components of the respiratory therapy system are reusable, but the humidifier cartridge assembly is disposable. In other respects, the cartridge described herein can be used in routine respiratory therapy systems, not just travel systems. In yet another respect, the removable cartridge assembly described herein can be used in hospital settings where clinicians can easily and quickly remove the evaporator and / or the entire cartridge assembly and replace it with a new cartridge assembly, while simultaneously disposing of or cleaning the removed evaporator or cartridge.

[0411] As will be described in further detail below, one or more sensors may be used in combination with one or more cartridges. For example, the one or more sensors may be configured to detect and transmit information to a cartridge assembly, evaporation device, controller, or another component in a respiratory therapy system. The information received from the sensors may be used to at least partially influence the operation of the cartridge assembly, and thus affect the delivery of the evaporated liquid into the airflow.

[0412] The cartridge can be configured to deliver evaporated liquid into the airflow path for inhalation by the user. In some examples, the liquid may be water, a drug, a compound, or other therapeutic liquid, or a combination of more than one of these, which may be used to, for example, alleviate symptoms of respiratory disorders or other medical disorders (such as those discussed above) and / or treat respiratory disorders or other medical disorders. Additionally or alternatively, the liquid may provide flavor, aroma, and / or otherwise alter the taste or odor of the air flowing through the respiratory therapy system. In this way, humidified air and / or metered air supplied with liquid can be delivered to the patient. Delivering humidified air and / or air metered with one or more liquids can increase patient comfort and thus increase compliance. The cartridge can be used alone or in combination with a humidifier, such as the humidifier 5000 discussed above.

[0413] 5.9.2.1 Box Configuration Figure 15 A schematic diagram of a cartridge assembly 1200 including an evaporation device 1210 is shown. In this configuration, the cartridge assembly 1200 may be arranged on or within the surface 1220 of the component 1221. The component 1221 may be any component of the aforementioned respiratory therapy system. For example, the component 1221 may be a patient interface, an air circuit, an RPT device, a humidifier, a blower, or any other component exposed to air flowing through the system and toward the patient.

[0414] The cartridge assembly 1200 may be permanently or removably attached to the component 1221, for example, to the surface 1220. The evaporation device 1210 may be removably or permanently disposed within the cartridge assembly 1200. The evaporation device 1210 may be configured to contain a liquid (e.g., water, medication, etc.). As described above, having a removable cartridge assembly facilitates replacement, refilling, or cleaning of the reservoir, replacement or cleaning of the evaporation device 1210, and / or replacement or cleaning of any other components within the cartridge assembly 1200 (e.g., filters, etc.). The removability of the cartridge assembly 1200 also facilitates cleaning of components attached to or incorporated into the cartridge assembly 1200. In some aspects, as will be described in more detail, the removability of the cartridge assembly 1200 may also allow the 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 attached by snap-fit ​​or friction fit. The cartridge assembly 1200 and / or the component 1221 connected thereto may include seals to prevent leakage of liquid from the cartridge assembly 1200 and / or leakage of pressurized air. For example, some cartridges may contain water for humidification purposes, while others may contain medicines, flavorings, fragrances (e.g., aromatherapy), or combinations thereof.

[0415] In some aspects, multiple box components 1200 can be used in a respiratory therapy system, for example, for introducing multiple medications into the air flowing through it and / or for humidifying the air flowing through it. In this way, a user of the respiratory therapy system can personalize the system for his or her preferred use or as prescribed by a clinician. In some aspects, if multiple box components are incorporated into a respiratory therapy system, they can be removably coupled to the same common parts of the respiratory therapy system or different parts of the respiratory therapy system. If multiple boxes are configured for use in a single respiratory therapy system, these boxes can be color-coded or can have other markings configured to communicate the contents of the box component 1200 to the user. In other aspects, multiple parts of a respiratory therapy system configured to receive multiple box components 1200 can have colors or other markings (e.g., text, shapes, and / or patterns) indicating where different box components 1200 can be received. For example, a box component of one color can be coupled to the respiratory therapy system at a location with a matching color. Other types of markings, such as text, shapes, and / or patterns, on the respiratory therapy system and the box assembly 1200 may also be matched to indicate to the user where the box assembly 1200 should be inserted into the system.

[0416] In other respects, a single box assembly 1200 may include a plurality of evaporation units 1210, each evaporation unit 1210 being fluidly connected to its own fluid source. The fluid source may contain the same type of fluid or may contain different types of fluid. Furthermore, it is conceivable that one or more evaporation units 1210 may be permanently fixed within the box assembly 1200, or may be removably attached to the box assembly 1200, for example, to facilitate cleaning or replacement of the evaporation units.

[0417] When the cartridge assembly 1200 is coupled to a component 1221 of the respiratory therapy system, the surface 1211 of the evaporator 1210 may be exposed to the airflow path. For example, air flowing through component 1221 (denoted as 1290) may flow over surface 1211. As air flows over surface 1211, one or more liquids within the cartridge assembly 1200 may be heated and evaporated by the evaporator 1210 and then released into the airflow path, as shown in 1291. In this way, air can be humidified and / or air can be metered with evaporated liquid before being delivered to the patient. For example, the cartridge assembly 1200 may include a reservoir and / or one or more materials housed within the cartridge assembly 1200 to absorb liquid, such as porous wicking materials, aerogels, hydrogels, or combinations of two or more thereof. One or more materials designed to absorb liquid may replace or be used in conjunction with a reservoir and may be fluidly coupled to the evaporator 1210. A porous wicking material, aerogel, hydrogel, or a combination of two or more thereof may be contacted with the evaporator 1210 to fluidly transfer liquid thereto for evaporation. The porous wicking material, aerogel, hydrogel, or a combination of two or more thereof also allows the evaporator 1210 to receive liquid in any orientation, enabling it to evaporate the liquid in any orientation. This contrasts with open reservoirs, which have a limited range of orientations and can use gravity to guide a sufficient amount of liquid to the evaporator 1210. Once the evaporator 1210 has evaporated the liquid, it can be released into the air.

[0418] One or more sensors 1250 may be arranged along or within the airflow path. Sensors 1250 may be configured to measure the characteristics of air flowing through component 1221, through other parts of the respiratory therapy system, or environmental conditions. For example, one or more sensors 1250 may provide information about the temperature and / or humidity of the air flowing through the component / system and / or the temperature and / or humidity of the surrounding air. Additionally or alternatively, sensors 1250 may be configured to detect information about the direction, volume, and / or velocity of air flowing through component 1221. For example, an increase in air velocity may indicate that the patient is inhaling, while a decrease in air velocity may indicate that the patient is exhaling. Such information may be transmitted or relayed to cartridge assembly 1200 and / or vaporizer 1210 and / or operatively coupled to a controller of cartridge assembly 1200 and / or vaporizer 1210. The function of cartridge assembly 1200 and / or vaporizer 1210 may be altered or otherwise controlled based at least in part on the information detected by sensors 1250.

[0419] For example, the first sensor 1250A may be located upstream of the cartridge assembly 1200 and / or the evaporator 1210, such as near its proximal end. The first sensor 1250A may measure one or more characteristics of the air flowing through the component 1221 and transmit this information to the cartridge assembly 1200 and / or a controller operatively coupled to the cartridge assembly 1200. Upon receiving information from the first sensor 1250A, the cartridge assembly 1200 may be instructed to not change its function, to turn on the evaporator 1210 to evaporate the liquid, to increase the temperature of the evaporator 1210 to evaporate more liquid, to turn off the evaporator 1210 to stop evaporating the liquid, to decrease the temperature of the evaporator 1210 to evaporate less liquid, and / or any other action configured to be performed by the cartridge assembly 1200.

[0420] Additionally or optionally, the second sensor 1250B may be positioned, for example, downstream of the cassette assembly 1200 and / or the evaporator 1210 along the distal portion of the air passage, such as at the distal end of the cassette assembly 1200 and / or the evaporator 1210. Thus, after the air has passed through the evaporator 1210, the second sensor 1250B can provide information about the air. The second sensor 1250B may be configured to detect information about the airflow and transmit it to the cassette assembly 1200 or a controller configured to control the cassette assembly 1200 wirelessly or via a cable extending between the second sensor 1250B, the cassette assembly 1200, and / or the controller. In this way, the second sensor 1250B can provide feedback to the cassette assembly 1200 or its controller. For example, the cassette assembly 1200 or the controller may be configured to receive information from the second sensor 1250B and adjust one or more aspects of the delivery of the evaporating liquid from the evaporator 1210 (e.g., the amount, type, temperature, etc. of the liquid).

[0421] The cartridge assembly 1200 can be pre-filled and / or refillable. For example, a pre-filled cartridge assembly 1200 may contain liquid already contained within the cartridge. In such an example, the quality and / or quantity of liquid within the cartridge can be controlled. After use of the respiratory therapy system, the pre-filled cartridge assembly 1200 can be discarded and replaced with a new cartridge assembly. Alternatively, the cartridge assembly 1200 can be refillable or refillable. For example, the patient can refill the cartridge after use, before use, or when the liquid level is below a threshold. If a refillable cartridge is used, the user can be instructed to refill the cartridge with a sufficient mass of water. For example, distilled water or water with a known total dissolved solids (TDS) can be used. Furthermore, in refillable and / or reusable examples, it may be necessary to clean the evaporation device 1210 and / or the associated reservoir within the cartridge assembly 1200. In the case of a non-reusable cartridge assembly 1200, it may include a puncture-resistant seal that is punctured upon insertion into the component 1221, allowing the release of liquid during use.

[0422] In some examples, the cartridge assembly 1200 may contain a cleaning agent. For example, the cleaning agent may be released into the airflow channels once the procedure is complete and / or if the patient begins a cleaning cycle. Among other benefits, the cleaning agent may help reduce the accumulation of bacteria or particulate matter. In some aspects, after or before using the respiratory therapy device, the user may remove the cartridge assembly 1200 that has been used to deliver evaporative fluid during treatment and may insert the cartridge assembly 1200 for cleaning the respiratory therapy system. Then, once cleaning is complete, the user may remove the cleaned cartridge assembly 1200 and replace it with a new cartridge assembly 1200 for treatment delivery. As described above, the cleaned cartridge assembly 1200 may include color coding or other markings to indicate to the user when using the cleaned cartridge assembly 1200 to clean the respiratory therapy system.

[0423] Figure 16 An alternative example of a cartridge assembly 1300 positioned near surface 1320 of component 1321 is shown. As described above, component 1321 can be any component of a respiratory therapy system. In this example, cartridge assembly 1300 can be configured to receive (permanently or removably) vaporization device 1310. For example, vaporization device 1310 can be inserted into or removed from cartridge assembly 1300, similar to how a magnetic tape is inserted into or removed from a tape player. Cartridge assembly 1300 and vaporization device 1310 can have any or all of the features of cartridge assembly 1200 and vaporization device 1210, as referenced above. Figure 15 For example, the cartridge assembly 1300 is configured to contain or hold the evaporator 1310 and one or more liquids for delivery into the airflow path of the component 1321. For example, the evaporator 1310 may be configured to engage with the cartridge assembly 1300. In this way, the cartridge assembly 1300 may be configured to be operatively engaged with the evaporator 1310, for example, when the cartridge assembly 1300 and the evaporator 1310 are positioned for operative engagement with a respiratory therapy system.

[0424] In this configuration, the evaporator 1310 can be configured to extend at least partially into the airflow path 1390 of component 1321. One or more liquids within the cartridge assembly 1300 can be heated and evaporated by the evaporator 1310 as air flows over surface 1311 or through a portion of the evaporator 1310 (e.g., the portion of the evaporator 1310 extending into the airflow path), and can then be released into the airflow path at 1391. In this way, air can be humidified and / or air can be metered along with the evaporated liquid. For example, the cartridge assembly 1300 may include a reservoir designed to absorb liquid and / or one or more wicking materials, such as porous wicking materials, aerogels, hydrogels, or combinations thereof. One or more wicking materials designed to absorb liquid can be used in place of or in conjunction with a reservoir and can be fluidly coupled to the evaporator 1310. Using one or more wicking materials within the cartridge assembly 1300 reduces the chance of liquid spillage from the reservoir and / or cartridge assembly 1300, as the wicking material absorbs and retains the liquid. Once the evaporator 1310 evaporates the liquid, it can be released into the air.

[0425] Similar to the above about Figure 15 In the discussed configuration, one or more sensors 1350 may be arranged on or within the airflow path. The sensors may be configured to measure the characteristics of air flowing through component 1321 and / or other parts of the respiratory therapy system. This information may be transmitted to cartridge assembly 1300 and / or its controller. The operation of cartridge assembly 1300 may be influenced at least in part based on the information detected by the sensors 1350.

[0426] like Figure 16 As shown, the box assembly 1300 can be removed and / or inserted relative to the component 1321 in the directions indicated by the double arrows. Removal of the box assembly 1300 can be achieved by moving the box assembly 1300 in a first direction, while insertion of the box assembly 1300 can be achieved by moving the box assembly 1300 in the opposite second direction.

[0427] Figure 17Alternative configurations of a cartridge assembly 1400 are shown, which includes a series of cartridges 1410 and a reservoir 1430 aligned with an airflow path. For example, the cartridge assembly 1400 may be arranged within or between two portions of component 1420. The series of cartridges 1410 may include a first cartridge 1410A, a second cartridge 1410B, and / or a third cartridge 1410C. While a series of cartridges is shown, in some examples, the cartridge assembly 1400 may contain a single cartridge. In other examples, two cartridges may be included within the cartridge assembly 1400, or four or more cartridges may be included. Each cartridge in the series of cartridges 1410 may be configured to deliver a liquid or material into the airflow path. In some examples, each cartridge in the series of cartridges 1410 may contain the same liquid or different liquids. For example, the first cartridge 1410A, the second cartridge 1410B, and the third cartridge 1410C may contain one or more liquids of the same kind. In other examples, at least one of the first box 1410A, the second box 1410B, and / or the third box 1410C may contain different liquids. In some examples, each box in the series of boxes 1410 may be color-coded or include other markings (e.g., writing or patterns) based on the liquid or material contained in each box.

[0428] Each box in the series 1410 can be configured to deliver each liquid into the airflow path at the same or different rates or at the same or different times. For example, a first box 1410A can be configured to deliver a first liquid at a first rate and / or a first time, a second box 1410B can be configured to deliver a second liquid at a second rate or a second time, and a third box 1410C can be configured to deliver a third liquid at a third rate or a third time. One or more of the first, second, and third rates, or the first, second, and third times, can be the same or different. In some examples, each box in the series 1410 can be color-coded or include other markings (e.g., text, shapes, and / or patterns) based on different delivery rates.

[0429] In another example, the surface of each cartridge in the series 1410 can be configured similarly to an inkjet printer cartridge. For example, the first cartridge 1410A, the second cartridge 1410B, and / or the third cartridge 410B may include one or more nozzles through which liquid is delivered to a corresponding evaporation device or heated surface within each cartridge for rapid evaporation. Alternatively, an inkjet printer-type cartridge can be used instead of an evaporation device as a standalone humidification unit. The inkjet printer-type humidification unit can be integrated within the cartridge or can be combined separately with a respiratory therapy system. Therefore, cartridge 1410 can be separate from the evaporation device, and when installed, cartridge 1410 engages with the evaporation device to provide it with the corresponding liquid. In other words, in another example, cartridge 1410 itself may not include an evaporation device, or it may be separate from the evaporation device.

[0430] Additionally or alternatively, each of the boxes in the series 1410 can be configured to respond to an input from the RPT device 4000 (in Figure 17 The delivery of liquids or materials is based at least in part on inputs from the RPT device 4000 and / or the controller, and this input may be based at least in part on data detected by one or more sensors 1450. For example, a first cartridge 1410A may be configured to deliver water, for example, to humidify air flowing through the airflow path of component 1420 of the respiratory therapy system. The first cartridge 1410A may start, increase, decrease, or stop the delivery of evaporated water into the airflow path in response to a signal transmitted to the cartridge assembly 1400 by the controller based on information received from the sensors 1450. A second cartridge 1410B may also be configured to deliver a different liquid in response to inputs from the RPT device 4000 and / or the controller, and this input may be based at least in part on data detected by one or more sensors 1450.

[0431] For example, as described above, one or more boxes may contain medication or a combination of water and medication. In some aspects, medication may be delivered to the patient throughout the entire course of treatment using a respiratory therapy system or until the medication is depleted. However, in other aspects, one or more medications within one or more boxes may be delivered to the user only when needed. For example, one or more sensors in or connected to a respiratory therapy system may measure one or more parameters of the user, such as heart rate, breathing pattern, body movement, posture, electromyographic signals, blood oxygen or blood carbon dioxide levels, etc. For example, reference Figure 5A-5C discusses exemplary patient parameters to be measured. When a patient parameter indicating a condition requiring medication is detected, the respiratory therapy system can automatically trigger the delivery of one or more medications from one or more cartridges. For example, referring to cartridge assembly 1400, if the patient's heart rate is abnormal, a second liquid medication can be delivered via a second cartridge 1410B. For example, when the patient's heart rate normalizes, the second cartridge 1410B can increase, decrease, or stop the delivery of a second liquid or substance. In some aspects, one or more medications for breathing (e.g., asthma medications or obstructive sleep apnea (OSA) medications), migraine medications, cardiac medications, or any suitable medications can be delivered via the respiratory therapy system through one or more cartridge assemblies.

[0432] For example, one potential benefit of delivering OSA medications via a respiratory therapy system is that the OSA medications can be used at lower doses, while also reducing the treatment pressure of the CPAP device. For instance, a combination of CPAP therapy and medication can allow for the use of lower treatment pressures. Alternatively or additionally, a combination of CPAP therapy and medication can allow for a reduction in the dosage of the medication. The combination of CPAP therapy and medication can allow for the delivery of CPAP therapy at lower treatment pressures, and the medication dosage can be minimized.

[0433] Furthermore, the device can detect when apnea is occurring, which can correspond to an increase in treatment pressure in response to the detected apnea. In this case, it can temporarily increase the pressure to alleviate the apnea, or it can deliver medication. Once the medication's effect has been detected or the assumed duration for which its effect is maintained has elapsed, the CPAP treatment pressure can be reduced again. Alternatively, the system can periodically release medication to avoid having to increase treatment pressure due to the patient receiving medication at regular intervals throughout the treatment.

[0434] Similarly, medications can also be non-evaporative. Similar to a nebulizer, medications can be injected into the airway as an aerosol. By delivering small amounts periodically or as needed, there is no "spike" in the medication within the patient's body, unlike what might occur when a patient receives a large dose during treatment.

[0435] The respiratory therapy system and / or cartridge assembly 1400 can be configured to detect (e.g., via sensor 1450) when a patient is experiencing or about to experience apnea. In response to detecting when a patient is experiencing apnea, cartridge assembly 1400 can be configured to deliver medication from one or more cartridges in a series of cartridges 1410. The medication can be delivered in a single-dose delivery, or it can be delivered continuously or periodically into the airflow, for example, until the medication takes effect. In some respects, the medication can be delivered continuously or periodically into the airflow until the patient's breathing normalizes. The medication can be delivered in conjunction with an increase in therapeutic pressure, and in some respects, once the medication has taken effect and breathing has normalized, the pressure can be reduced to a more typical level.

[0436] In other respects, CPAP medications can be delivered periodically in small amounts, regardless of whether apnea is detected, to prevent apnea from occurring or to prevent sudden spikes in drug levels in the patient. By delivering small amounts of medication to the patient regularly or as needed, the patient may not experience a rapid and / or significant increase in drug levels in their body. For example, a rapid and / or significant increase in drug concentration in the patient's body may be associated with adverse effects and / or complications. In some cases, higher drug concentrations in the patient's body can increase the likelihood and / or severity of side effects. Additionally, in some cases, prolonged exposure to high drug concentrations can lead to drug tolerance in the patient's body.

[0437] Although reference cassette assembly 1400 describes drug delivery, drug delivery can serve a similar purpose for any cassette assembly described herein. Furthermore, the delivered drug may not be evaporated, but may be delivered as an aerosol or in any suitable manner into an airborne path.

[0438] Regarding cartridge assembly 1400, some examples include a first cartridge 1410A, a second cartridge 1410B, and / or a third cartridge 1410C, which may include actuators (e.g., buttons, knobs, levers, etc.). Similar actuators can be used in conjunction with any cartridge assembly described herein. The actuator can be configured to allow a patient or operator to manually turn on / off the delivery of liquid from the respective cartridge. For example, if a patient has a dry nose, the patient can use the actuator to release or regulate the amount of liquid being delivered. In this way, the patient or operator can customize the delivery of liquid (e.g., water, flavoring, fragrance, etc.) into the airflow path. Alternatively, if the patient deems medication delivery necessary or has received sufficient medication, the patient can use the actuator to initiate, stop, or regulate the amount of medication being delivered.

[0439] In some examples, the cartridge assembly 1400 may include a common reservoir 1430 or multiple separate reservoirs 1430. Reservoirs 1430 may be configured to contain or trap excess liquid from each of the first cartridge 1410A, the second cartridge 1410B, and / or the third cartridge 1410C. In some examples, reservoirs 1430 may include materials designed to absorb and slowly release excess liquid or substance. For example, excess liquid may evaporate from reservoir 1430 when air flows over it. Additionally, reservoirs 1430 may be configured to be heated, for example, to increase the evaporation rate of the liquid and / or to evaporate the liquid trapped by reservoir 1430.

[0440] In some examples, one or more boxes from the series 1410 can be used in conjunction with box assembly 1200 and / or box assembly 1300. For example, one or more boxes from the series 1410 can be used instead of Figure 15 Evaporation device 1210 in the series of boxes 1410. For example, in some examples, one or more boxes in the series of boxes 1410 may be removably or permanently arranged within the box assembly 1200 (e.g., in place of evaporation device 1210).

[0441] In other examples, one or more boxes in the series of boxes 1410 may be configured to be operatively engaged with box assembly 1300. For example, box assembly 1300 may be configured to receive (permanently or removably) one or more boxes in the series of boxes 1410.

[0442] 5.10 High-flow treatment In other forms of respiratory therapy, the pressure of the airflow is not controlled as in respiratory pressure therapy. Instead, a central controller 4230 controls a pressure generator 4140 to deliver airflow, with its device flow rate Qd controlled as a therapeutic or target flow rate Qtgt, which is typically positive throughout the patient's respiratory cycle. These forms are often grouped under the heading of flow therapy. In flow therapy, the therapeutic flow rate Qtgt can be a constant value, either hard-coded or manually entered into the RPT device 4000. If the therapeutic flow rate Qtgt is sufficient to exceed the patient's peak inspiratory flow rate, the therapy is typically referred to as high-flow therapy (HFT). Alternatively, the therapeutic flow rate can be a curve Qtgt(t) that varies with the respiratory cycle.

[0443] 5.11 Glossary To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0444] 5.11.1 Overview Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0445] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0446] For example, the ambient humidity relative to a humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0447] In another example, environmental stress can be stress that is directly around the body or outside the body.

[0448] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or transmitted from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0449] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SDB event.

[0450] Continuous positive airway pressure (CPAP) therapy: respiratory pressure therapy in which the treatment pressure remains substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In some forms, the pressure will vary between the patient's different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of an indication of partial upper airway obstruction.

[0451] Flow rate: The volume (or mass) of air transported per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, that is, a quantity that only has a magnitude. In other cases, the reference to flow rate will be a vector quantity, that is, a quantity that has both magnitude and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0452] In the example of patient breathing, the flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle, and therefore negative for the expiratory portion. Device flow rate Qd is the flow rate of air leaving the RPT device. Total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. Ventilation flow rate Qv is the flow rate of air leaving the vent to allow flushing of exhaled gases. Leakage flow rate Ql is the leakage flow rate from the patient interface system or elsewhere. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0453] Flow therapy: Breathing therapy involves delivering a controlled flow of air to the inlet of the airway at a rate known as the therapeutic flow, which is generally positive throughout the patient’s respiratory cycle.

[0454] Humidifier: The term humidifier will be considered to refer to a humidification device that is constructed and arranged or configured with a physical structure that provides a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.

[0455] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one example, a leak could occur due to an incomplete seal between the mask and the patient's face. In another example, a leak could occur in a rotating bend in the conduit leading to the surrounding environment.

[0456] Noise, Conducted (Acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0457] Noise, radiation (acoustics): Radiated noise in this document refers to noise transmitted to the patient through the ambient air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0458] Noise, ventilation (acoustics): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilation opening, such as a ventilation opening for a patient interface.

[0459] Oxygen-enriched air: Air with an oxygen concentration greater than that of atmospheric air (21%), such as at least about 50% oxygen, at least about 60% oxygen, at least about 70% oxygen, at least about 80% oxygen, at least about 90% oxygen, at least about 95% oxygen, at least about 98% oxygen, or at least about 99% oxygen. “Oxygen-enriched air” is sometimes shortened to “oxygen”.

[0460] Medical oxygen: Medical oxygen is defined as oxygen-enriched air with an oxygen concentration of 80% or higher.

[0461] Patient: A person, regardless of whether they have a respiratory illness.

[0462] Pressure: Force per unit area. Pressure can be expressed in units of area, including cmH2O and gf / cm². 2 1000 Pascals. 1 cmH2O equals 1 gf / cm³ 2 And it is approximately 0.98 hPa (1 hPa = 100 Pa = 100 N / m). 2 =1 millibar to 0.001 atmospheres. In this specification, unless otherwise stated, pressure is given in cmH2O.

[0463] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained through the interface pressure Pm at the current moment.

[0464] Respiratory pressure therapy: Applying an air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0465] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0466] 5.11.1.1 Materials and their properties Hardness: refers to the hardness of a hardness tester or indentation hardness, which is a material property measured by indentation through an indenter (e.g., measured according to ASTM D2240).

[0467] • "Soft" materials may include silicone resins or thermoplastic elastomers (TPEs) and can be easily deformed, for example, under finger pressure.

[0468] • "Hard" materials can include polycarbonate and polypropylene, and are not easily deformed, for example, under finger pressure.

[0469] Silicone resin or silicone elastomer: synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0470] Polycarbonate: is a thermoplastic polymer of bisphenol A carbonate.

[0471] 5.11.1.2 Mechanics axis: a. Neutral axis: An axis in the cross-section of a beam or plate that has no longitudinal stress or strain.

[0472] b. Vertical axis: The axis that extends along the length of the shape. This axis usually passes through the center of the shape.

[0473] c. Circumferential axis: An axis oriented perpendicularly to the longitudinal axis. This axis can specifically exist in pipes, tubes, cylinders, or similar shapes with circular and / or elliptical cross-sections.

[0474] Deformation: The process by which the original geometry of a component changes when subjected to a force (e.g., a force in the direction relative to an axis). This method can include stretching or compression, bending, and twisting.

[0475] Elasticity: The ability of a material to return to its original geometry after deformation.

[0476] Flexible structures or components: structures or components that will change shape (e.g., bend) when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0477] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0478] Elastic: Releases virtually all energy upon unloading. Includes, for example, certain silicone resins and thermoplastic elastomers.

[0479] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting up and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway under a pressure of approximately 20 to 30 cmH2O.

[0480] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0481] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. The structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.

[0482] Viscosity: The ability of a material to resist flow.

[0483] Viscoelasticity: The ability of a material to exhibit both elastic and viscous behavior during deformation.

[0484] Yield: The condition where a material, after being deformed, no longer returns to its original geometry.

[0485] 5.11.1.3 Structural Components Compression component: A structural element that resists compressive forces.

[0486] Bend: A bend is an example of a structure that directs the axis of an airflow traveling through it by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The bend can have an approximately circular cross-section. In another form, the bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating component, for example, approximately 360 degrees. In some forms, the bend can be removable from the mating component, for example, via a snap-fit ​​connection. In some forms, the bend can be assembled to the mating component during manufacturing via a single snap-fit, but cannot be removed by the patient.

[0487] Frame: The frame is generally considered to refer to the mask structure that bears tensile loads between two or more connection points to the hood. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0488] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0489] Lacing (noun): A structure used to resist tension.

[0490] Thin structure: a. Beam, i. Compared to the other two dimensions, the beam can be relatively long in one dimension, making the smaller dimension relatively thinner compared to the longer dimension.

[0491] b. Membrane, i. Relatively long in two dimensions and relatively thin in one dimension. Easily deforms in response to bending forces. Resistant to tension (and possibly compression).

[0492] c. Plates and outer casing i. They can be relatively long in two directions and relatively thin in one dimension. They can have bending, tensile, and / or compressive stiffness.

[0493] Thick structure: solid Seal: can refer to the noun form of a structure ("seal") or the verb form of the effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or to achieve 'seal' between them, without the need for a separate 'seal' element itself.

[0494] Shell: Shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a mask can be an outer shell. In some forms, the outer shell can be multifaceted. In some forms, the outer shell can be airtight. In some forms, the outer shell may not be airtight.

[0495] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0496] Support: A support rod is considered a structural component designed to increase the compressive strength of another component in at least one direction.

[0497] Rotary shaft (noun): A sub-assembly of a component configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft can be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft can be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the component preferably comprises a pair of mating cylindrical ducts. During use, there can be little or no airflow leakage from the rotary shaft.

[0498] 5.11.2 Respiratory and Circulatory Systems Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0499] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0500] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0501] Effort (breathing): The work that spontaneous breathers do by trying to breathe.

[0502] The expiratory phase of the respiratory cycle: the time period from the start of expiratory flow rate to the start of inspiratory flow rate.

[0503] Flow restriction: Flow restriction is considered a state of respiratory function in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0504] Types of flow-limiting inhalation waveforms: (i) Flat: It has an upward movement, followed by a relatively flat section, followed by a downward movement.

[0505] (ii) M-shape: has two local crests, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two crests.

[0506] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0507] (iv) Inverted chair shape: has a relatively flat section followed by a single local crest at the trailing edge.

[0508] Insufficient breathing: By some definitions, insufficient breathing is considered a reduction in flow rate, rather than a cessation of flow. In one form, insufficient breathing can be considered to occur when the flow rate drops below a threshold rate for a sustained period of time. Central insufficient breathing is considered to occur when insufficient breathing is detected due to a reduction in respiratory effort. In one form for adults, any of the following can be considered insufficient breathing: (i) The patient’s breathing decreased by 30% for at least 10 seconds plus an associated 4% desaturation; (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0509] Hyperventilation: Increased airflow to above normal levels.

[0510] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow rate to the start of expiratory flow rate is considered the inspiratory portion of the respiratory cycle.

[0511] Airway openness: The degree to which the airway is open or the degree to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, a value (1) for open and a value of zero (0) for closed (obstructed).

[0512] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure present in the lungs at the end of expiration.

[0513] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0514] Respiratory flow, patient air flow, respiratory air flow (Qr): These terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0515] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) equals the expiratory volume Ve (the volume of air exhaled), so a single tidal volume Vt can be defined as equal to any quantity. In practice, tidal volume Vt is estimated as some combination of inspiratory volume Vi and expiratory volume Ve, such as an average.

[0516] Inhalation time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0517] Expiratory time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0518] Total Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.

[0519] Typical recent ventilation: The recent values ​​of ventilation (Vent) tend to cluster around their respective values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0520] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases as the pressure gradient across the upper airway increases (Starling resistance behavior).

[0521] Ventilation: A measurement of the rate at which gases are exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0522] 5.11.3 Anatomy 5.11.3.1 Facial Anatomy Ala: The outer wall or "wing" of each nostril (plural: alar) Nasal wing angle: The angle formed between the nasal wings of each nostril.

[0523] Alar tip: the outermost point on the ala of the nose.

[0524] The nasal wing curve (or nasal wing tip) point: the last point on the curve baseline of each nasal wing, found in the crease formed by the junction of the nasal wing and the cheek.

[0525] Auricle: The entire visible external part of the ear.

[0526] (Nose) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0527] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0528] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0529] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).

[0530] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0531] The glabella (between the eyebrows): Located on the soft tissue, it is the most prominent point in the sagittal plane at the midline of the forehead.

[0532] External nasal cartilage: a cartilaginous plate that is basically triangular in shape. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0533] Lip, lower (midpoint of the lower lip): The lip that extends between the lower point of the nasal septum and the mouth.

[0534] Upper lip (midpoint of the upper lip): The lip that extends between the mouth and the supramental point of the chin.

[0535] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0536] Nostrils (Nares (Nostrils)): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal (naris) (nostril). Nostrils are separated by the nasal septum.

[0537] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0538] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0539] The lowest point on the face where the auricle attaches to the skin.

[0540] The highest point on the face where the auricle attaches to the skin.

[0541] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0542] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0543] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0544] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0545] Sagittal plane: A vertical plane running from front to back. The central sagittal plane is the sagittal plane that divides the body into the right and left halves.

[0546] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0547] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0548] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0549] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the central sagittal plane.

[0550] Supramental point: The point on the midline of the lower lip where the greatest concavity occurs between the midpoint of the lower lip and the premental point of the soft tissue. Skull Anatomy Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0551] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0552] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the orbit. The frontal process of the maxilla projects upward from the side of the nose and forms part of the transverse boundary.

[0553] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0554] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper middle part of the nose.

[0555] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0556] The eye socket is the bony cavity in the skull that houses the eyeball.

[0557] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0558] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0559] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the prominent parts of the cheeks.

[0560] 5.11.3.2 Anatomy of the Respiratory System Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0561] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0562] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0563] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located in the middle of the face above and behind the nose. It is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal turbinates. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0564] Pharynx: The part of the throat located just below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (hyperpharynx), the oropharynx (middlepharynx), and the laryngopharynx (hypopharynx).

[0565] 5.11.4 Patient Interface Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0566] Headgear: A headgear is a form of positioning and stabilizing structure designed to hold a device (such as a mask) on the head.

[0567] Inflation chamber: The mask inflation chamber is considered to refer to a portion of the patient interface having walls that at least partially enclose a volume of space, which, in use, contains air pressurized therein to above atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.

[0568] Seal: can refer to the noun form of a structure ("seal") or the verb form of the effect ("seal"). Two elements can be constructed and / or arranged to 'seal' or to achieve 'seal' between them, without the need for a separate 'seal' element itself.

[0569] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air for clinically effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow rate from about 10 liters per minute to about 100 liters per minute, depending on the mask design and treatment pressure.

[0570] 5.11.5 Shape of the structure Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In another example, a structure may include a first surface and a second surface.

[0571] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure. See also Figures 3B to 3F They show examples of cross-sections at point p on the surface and the resulting planar curves. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at p points away from the surface. In some examples, we describe the surface from the viewpoint of an imaginary little person standing on the surface.

[0572] 5.11.5.1 One-dimensional curvature The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0573] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the imagined figures leave point p, they must walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0574] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .

[0575] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if the figures in the image were to leave point p, they would have to go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0576] 5.11.5.2 Curvature of Two-Dimensional Surfaces A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has, for example, a relatively small amplitude. Figures 3B to 3F A planar curve in a diagram can be an example of multiple cross-sections at a specific point.

[0577] Principal curvature and direction: The direction of the normal plane to which the curvature of a curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, the minimum curvature appears Figure 3F Therefore Figure 3B and Figure 3F It is the cross-section along the principal direction. The principal curvature at point p is the curvature along the principal direction.

[0578] Surface region: A set of connected points on a surface. The points in this region can have similar properties, such as curvature or sign.

[0579] Saddle-shaped region: At each point, the region where the principal curvature has opposite signs, that is, one is positive and the other is negative (depending on the direction the imagined person is turning, they can be walking uphill or downhill).

[0580] Dome region: A region where the principal curvatures at each point have the same sign, such as both being positive ("concave dome") or both being negative ("convex dome").

[0581] Cylindrical region: A region with one principal curvature of 0 (or, for example, 0 within manufacturing tolerances) and another principal curvature of non-0.

[0582] Planar region: A surface region where both principal curvatures are 0 (or, for example, 0 within manufacturing tolerances).

[0583] Surface edge: The boundary or limit of a surface or region.

[0584] Path: In some forms of this technique, "path" will be considered as a path in the mathematical topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, "path" can be described as a route or road, including, for example, a set of points on a surface. (Imagine a person's path is where they walk on the surface, and is similar to a garden path).

[0585] Path length: In some forms of this technique, "path length" refers to the distance along the surface from f(0) to f(1), that is, the distance along a path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length of an imagined person would be the distance they must walk along the path on the surface).

[0586] Straight-line distance: Straight-line distance is the distance between two points on a surface, but it is independent of the surface itself. On a planar region, there will exist paths on the surface with the same path length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same path length as the straight-line distance between the two points. (For the imaginary person, straight-line distance will correspond to a distance that is "in a straight line".) 5.11.5.3 Space Cu...

Claims

1. A patient interface, including An inflatable chamber that can be pressurized to a treatment pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port whose size and structure are determined to receive an airflow at the treatment pressure for the patient to breathe; A sealing structure is configured and arranged to seal with a region of the patient's face surrounding the patient's airway inlet, the sealing structure having an opening therein such that an airflow under the therapeutic pressure is delivered to at least the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflation chamber throughout the patient's respiratory cycle in use. A positioning and stabilizing structure that provides force to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether that is constructed and arranged such that, in use, at least a portion of the tether covers an area of ​​the patient's head above the point above the ear. A connection port is configured to connect to an air circuit to receive an airflow at the treatment pressure and direct the airflow at the treatment pressure to the inflation chamber for the patient to breathe. A box assembly, which is coupled to the inflation chamber or the connection port, includes: A reservoir, configured to contain liquid; and An evaporator, in fluid communication with the reservoir to receive liquid from the reservoir, the evaporator being configured to contain the liquid, and the evaporator including a heating element configured to evaporate water contained in the evaporator; and A ventilation structure includes one or more ventilation holes configured to allow continuous flow of gas exhaled by a patient from the interior of the inflatable chamber to the surrounding environment, the size and shape of the one or more ventilation holes being determined to maintain therapeutic pressure in the inflatable chamber during use; The patient interface is configured such that the patient's mouth is not covered, or if the sealing structure is configured to seal around the patient's nose and mouth, the patient interface is configured to allow the patient to breathe from the surrounding environment without pressurized air flowing through the inlet port of the inflation chamber.

2. The patient interface of claim 1, wherein the cartridge assembly is removably coupled to the inflation chamber such that at least a portion of the evaporator is positioned within the inflation chamber to evaporate water into the airflow under therapeutic pressure within the inflation chamber.

3. The patient interface of claim 1, wherein the cartridge assembly is removably coupled to the connection port such that at least a portion of the evaporator is positioned within the connection port to evaporate water into the airflow under therapeutic pressure in the inflation chamber.

4. The patient interface according to any one of claims 1 to 3, further comprising a first sensor positioned on the inflation chamber and exposed to the interior of the inflation chamber to detect any one of the pressure, temperature, humidity, or flow rate of an airflow under therapeutic pressure within the inflation chamber.

5. The patient interface according to any one of claims 1 to 4, further comprising a second sensor positioned on the connection port and exposed inside the connection port to detect any one of the pressure, temperature, humidity, or flow rate of an airflow under therapeutic pressure within the connection port.

6. The patient interface according to any one of claims 1 to 5, wherein the positioning and stabilizing structure further comprises 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 inflation chamber, so as to direct an airflow under the treatment pressure into the inflation chamber for breathing by the patient, and A third sensor is positioned on at least one of these tubes and exposed to the interior of the corresponding tube in order to detect any one of the pressure, temperature, humidity, or flow rate of the airflow under the treatment pressure within the corresponding tube.

7. The patient interface according to any one of claims 1 to 6 further comprises at least one of a porous wicking material, an aerogel, or a hydrogel, said porous wicking material, aerogel, or hydrogel being positioned inside the reservoir to store the liquid.

8. The patient interface of claim 7, wherein the reservoir is permanently attached to the evaporator, or the reservoir is removably attached to the evaporator.

9. The patient interface according to claim 7 or 8, wherein the reservoir is made of rubber or polymer and is configured to collapse when empty or filled to less than the maximum volume.

10. The patient interface according to any one of claims 1 to 9, wherein the box assembly is configured to be removably coupled to the inflation chamber or the connection port by snap-fit ​​or friction engagement.

11. The patient interface according to any one of claims 1 to 10, wherein the evaporator comprises a first porous material configured to contain water and thermally connected to the heating element for being heated by the heating element to evaporate the water in the first porous material.

12. The patient interface of claim 11, wherein the first porous material is any one of ceramic, metal, sintered metal, quartz, polymer or fiber material.

13. The patient interface according to claim 11 or 12, wherein the first porous material is configured to deliver water via capillary action.

14. The patient interface according to any one of claims 11 to 13, wherein the evaporator includes a second porous material configured to contain water and fluidly connected to the first porous material to deliver water from the second porous material to the first porous material.

15. The patient interface of claim 14, wherein the second porous material is any one of ceramic, metal, sintered metal, quartz, polymer or fiber material.

16. The patient interface according to claim 14 or 15, wherein the second porous material is configured to deliver water via capillary action.

17. The patient interface according to any one of claims 1 to 16, wherein the heating element is a resistance heater.

18. The patient interface according to any one of claims 1 to 17, further comprising a power supply configured to supply power to the heating element.

19. The patient interface of claim 18, wherein the power source is a battery.

20. The patient interface according to any one of claims 1 to 17, wherein the heating element is configured to be electrically connected to an RPT device, the RPT device including a blower to pressurize the airflow to the treatment pressure, and the heating element is configured to be powered by the RPT device.

21. The patient interface according to any one of claims 1 to 20, further comprising a heat and moisture exchanger (HMX) positioned on the inflation chamber or the connection port along a flow path from the sealing structure to the ventilation structure and between the sealing structure and the ventilation structure, such that the HMX is exposed to an airflow at the therapeutic pressure to absorb heat and moisture from the patient's exhaled gases during use.

22. The patient interface of claim 21, wherein the HMX fluid is connected to the vaporizer to deliver water absorbed from the patient's exhaled gas to the vaporizer.

23. The patient interface according to any one of claims 1 to 22, wherein the air chamber or the connection port includes an opening, and the housing assembly is configured for removably coupling to the air chamber or the connection port at the opening, and The at least one of the seals is configured to seal between the box assembly and the inflation chamber or the connection port.

24. The patient interface of claim 23, wherein the at least one seal is positioned on the cartridge assembly. The at least one of the seals is positioned on the inflation chamber or the connection port, or The first seal is positioned on the box assembly and the second seal is positioned on the inflation chamber or the connection port.

25. The patient interface according to any one of claims 1 to 24, wherein the housing assembly is removably coupled to the inflation chamber or the connection port, or The box assembly is permanently attached to the inflation chamber or the connection port.

26. A respiratory pressure therapy (RPT) system configured to direct an airflow to a therapeutic pressure above atmospheric pressure to a patient-worn interface to treat a respiratory disorder, said RPT system comprising: A component, which at least partially forms a channel for an airflow under the treatment pressure, the component being one of the following: the patient interface, which is configured to direct the airflow under the treatment pressure to the patient; A flow generator, comprising a blower to pressurize the airflow to the treatment pressure; An air circuit configured to direct an airflow under the treatment 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 airflow under the treatment pressure; as well as The first component box, which is attached to the component, includes: A first reservoir, configured to contain a first liquid; as well as A first evaporator is in fluid communication with the first reservoir to receive the first liquid from the first reservoir. The first evaporator is configured to contain the first liquid, and the first evaporator includes a first heating element configured to heat the first evaporator to evaporate the first liquid contained in the first evaporator. At least a portion of the first evaporator is exposed to the channel for an airflow under the treatment pressure.

27. The RPT system of claim 26, wherein the component is one of: the patient interface configured to direct an airflow at the treatment pressure to the patient; the flow generator including a blower to pressurize the airflow to the treatment pressure; or the air circuit configured to direct an airflow at the treatment pressure from the flow generator to the patient interface, and The RPT system also includes, but is not the component described above, the patient interface configured to direct an airflow under the treatment pressure to the patient; The flow generator includes a blower to pressurize the airflow to the treatment pressure; And the air circuit, which is configured to direct an airflow under the treatment pressure from the flow generator to the patient interface.

28. The RPT system of claim 26 further includes a humidifier comprising the water reservoir and the heater plate, the heater plate being configured to heat water stored in the water reservoir to humidify the airflow at therapeutic pressure.

29. The RPT system of any one of claims 26 to 28, further comprising a first sensor positioned upstream of the first housing assembly relative to the component along a channel for airflow under treatment pressure, the first sensor being exposed to the airflow under treatment pressure to detect any one of pressure, temperature, humidity, or flow rate of the airflow under treatment pressure within the channel, and the first sensor being configured to transmit the detected pressure, temperature, humidity, or flow rate of the airflow under treatment pressure within the channel to the first housing assembly or a controller outside the first housing assembly.

30. The RPT system of any one of claims 26 to 29 further includes a second sensor positioned downstream of the first housing assembly relative to the component along a channel for airflow under treatment pressure, the second sensor being exposed to the airflow under treatment pressure to detect any one of pressure, temperature, humidity, or flow rate of the airflow under treatment pressure within the channel, and the second sensor being configured to transmit the detected pressure, temperature, humidity, or flow rate of the airflow under treatment pressure within the channel to the first housing assembly or a controller outside the first housing assembly.

31. The RPT system according to any one of claims 26 to 30, wherein the first box assembly is removably coupled to the component, or The first box assembly is permanently attached to the component.

32. The RPT system according to any one of claims 26 to 31 further comprises at least one of a porous wicking material, an aerogel, or a hydrogel, said porous wicking material, aerogel, or hydrogel being positioned within the first reservoir to store the first liquid.

33. The RPT system according to any one of claims 26 to 32, wherein the surface of the first evaporator exposed to the airflow in the channel is substantially flush with the surface of the component adjacent to the first evaporator.

34. The RPT system according to any one of claims 26 to 32, wherein the surface of the first evaporator exposed to the airflow in the channel extends over the surface of the component adjacent to the first evaporator and into the channel.

35. The RPT system according to any one of claims 26 to 34, wherein the first box assembly is removably coupled to the component, or The first box assembly is permanently attached to the component.

36. The patient interface according to any one of claims 26 to 35, further comprising a reservoir attached to the component, and the reservoir being configured to capture excess of the first liquid that was not absorbed into the airflow under the treatment pressure.

37. The patient interface according to any one of claims 26 to 36, further comprising a second housing assembly, the second housing assembly being coupled to the component and comprising: A second reservoir is configured to contain a second liquid; as well as A second evaporator is in fluid communication with the second reservoir to receive the second liquid from the second reservoir. The second evaporator is configured to contain the second liquid, and the second evaporator includes a second heating element configured to heat the second evaporator to evaporate the second liquid contained in the second evaporator. At least a portion of the second evaporator is exposed to the channel for the airflow under the treatment pressure.

38. A cartridge assembly for a respiratory pressure therapy (RPT) system, configured to direct an airflow to a therapeutic pressure above atmospheric pressure to a patient-worn interface to treat a respiratory disorder, the cartridge assembly comprising: A reservoir configured to hold liquid; as well as An evaporator, which is in fluid communication with the reservoir to receive liquid from the reservoir, the evaporator being configured to contain the liquid, and the evaporator including a heating element configured to evaporate the water contained in the evaporator.

39. The cartridge assembly of claim 38, further comprising at least one of a porous wicking material, an aerogel, or a hydrogel, the porous wicking material, aerogel, or hydrogel being positioned inside the reservoir to store the liquid.

40. The cartridge assembly of claim 38 or 39, wherein the reservoir is made of rubber or polymer and is configured to collapse when empty or filled to less than the maximum volume.

41. The box assembly according to any one of claims 38 to 40, wherein the box assembly is configured to be removably coupled to the inflation chamber or connection port of the patient interface of the RPT system by snap-fit ​​or friction engagement.

42. The box assembly of claim 41, wherein the inflation chamber or the connection port includes an opening, and the box assembly is configured for removably coupling to the inflation chamber or the connection port at the opening.

43. The box assembly of claim 42, wherein the at least one seal is configured to seal between the box assembly and the inflation chamber or the connection port.

44. The box assembly of claim 43, wherein the at least one seal is positioned on the box assembly.

45. The box assembly of any one of claims 38 to 44, wherein the evaporator comprises a first porous material configured to contain water and thermally connected to the heating element for being heated by the heating element to evaporate the water in the first porous material.

46. ​​The box assembly of claim 45, wherein the first porous material is any one of ceramic, metal, sintered metal, quartz, polymer or fibrous material.

47. The box assembly of claim 45 or 46, wherein the first porous material is configured to transport water by capillary force.

48. The box assembly of any one of claims 45 to 47, wherein the evaporator includes 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.

49. The box assembly of claim 48, wherein the second porous material is any one of ceramic, metal, sintered metal, quartz, polymer or fibrous material.

50. The box assembly of claim 48 or 49, wherein the second porous material is configured to transport water by capillary force.

51. The box assembly according to any one of claims 38 to 50, wherein the heating element is a resistance heater.

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