Patient interface

Abstract

A patient interface is provided for sealing a delivery airflow to improve sleep breathing disorders. The patient interface includes a seal forming structure for forming a pneumatic seal with a patient airway inlet; a positioning and stabilizing structure for maintaining the seal-forming structure in sealing contact with an area around the airway inlet of the patient; a plenum chamber pressurized in use at a pressure higher than ambient pressure; a connection port for delivering a flow of breathable gas into the patient interface; and a device positioned within the breathing chamber defined at least in part by the seal-forming structure and the plenum chamber, where the device divides the breathing chamber into a posterior chamber and an anterior chamber, and where the device includes a plurality of apertures to allow air to pass through the device and to capture hot and / or moist air by a patient, and exchange at least part of heat and / or moisture with the air inhaled by the patient.

Description

[0001] 1. Cross-references to related applications

[0002] This application claims priority to Australian Provisional Application No. 2023902762, filed on 28 August 2023, and Australian Provisional Application No. 2024900826, filed on 27 March 2024, the contents of which are incorporated herein by reference in their entirety. Technical Field

[0003] 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. Background Technology

[0004] 2.2 Description of related technologies

[0005] 2.2.1 Human Respiratory System and Its Diseases

[0006] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0007] 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 allowing carbon dioxide to move in the opposite direction. The trachea divides into the left and right main bronchi, which eventually branch into the terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branches of the airways lead 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 John B. West's *Respiratory Physiology*, 9th edition, Lippincott Williams & Wilkins, 2012.

[0008] There are a range of respiratory diseases. Some diseases can be characterized by specific events, such as sleep apnea, hypoventilation, and hyperventilation.

[0009] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It is caused by a combination of abnormally small loss of normal upper airway and muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. The condition causes affected individuals to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often causes excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. This syndrome is a common disorder, particularly prevalent in middle-aged overweight men, but those affected may not be aware of the problem, see, for example, U.S. Patent No. 4,944,310 (Sullivan).

[0010] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and reoxygenation of arterial blood. Due to repetitive oxygen deprivation, CSR can be harmful. In some patients, CSR is associated with repetitive micro-arousals from sleep, which cause severe sleep disruption, increased sympathetic activity, and increased afterload, see, for example, U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Obesity-induced hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These include increased air resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular diseases can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive diseases: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive diseases: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during exercise and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0014] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0015] A range of treatments have been used to treat or improve these conditions. Furthermore, other healthy individuals can utilize these treatments to prevent respiratory distress. However, these therapies have many drawbacks.

[0016] 2.2.2 Treatment

[0017] 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 therapy can be voluntary, so patients may choose not to adhere to treatment if they find the device used to provide such therapy to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0018] 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.

[0019] Invasive ventilation (IV) provides ventilatory support to 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.

[0020] 2.2.3 Diagnostic and Treatment Systems

[0021] 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 a condition without treating it.

[0022] 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.

[0023] 2.2.3.1 Patient Interface

[0024] 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 therapy to be administered, the patient interface can, for example, form a seal with an area of ​​the patient's face to facilitate the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of about 10 cmH2O relative to ambient pressure) to achieve the therapy. For other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply to the airway at a positive pressure of about 10 cmH2O. The design of patient interfaces presents several 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 the duration of the breathing therapy.

[0025] Therefore, some masks have disadvantages such as being obtrusive, unsightly, expensive, poorly fitted, difficult to use, and / or uncomfortable, 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 to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics may be acceptable for their original application, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment, especially if the mask is worn during sleep.

[0026] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. Patients may not adhere to therapy 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.

[0027] 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.

[0028] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0029] 2.2.3.1.1 Sealing Formation Structure

[0030] Patient interfaces may include seal-forming structures. Because the seal-forming structures come into direct contact with the patient's face, their shape and configuration can directly affect the effectiveness and comfort of the patient interface.

[0031] 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 upper lip region and the bridge of the nose region 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 puffs, and oronasal masks.

[0032] A sealing structure 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 that covers a patient's forehead may not be suitable for use on a patient's nose.

[0033] 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 adapted to form a seal.

[0034] 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 gasket, or a molded or formed surface of an elastic sealing element made of an elastomer such as 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.

[0035] 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.

[0036] Another type of sealing structure may include friction-fitting elements, such as those for insertion into the nostrils; however, some patients find these uncomfortable.

[0037] Another form of sealing structure can be achieved using adhesives. Some patients may find it inconvenient to frequently apply and remove adhesives from their face.

[0038] A series of patient interface sealing structure technologies are disclosed in the following patent applications: WO 1998 / 004310; WO 2006 / 074513; WO 2010 / 135785.

[0039] One form of nose pillow was found in the Adam Circuit manufactured by Puritan Bennett. Another nose pillow or nasal puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.), assigned to Puritan Bennett.

[0040] ResMed Inc. has manufactured the following products incorporating a nasal pillow: SWIFT™ Nasal Pillow Cover, SWIFT™ II Nasal Pillow Cover, SWIFT™ LT Nasal Pillow Cover, SWIFT™ FX Nasal Pillow Cover, and MIRAGE LIBERTY™ Full Cover. Examples of nasal pillow covers are described in the following patent applications: International Patent Application WO 2004 / 073778 (describes other aspects of the SWIFT™ Nasal Pillow Cover); U.S. Patent Application 2009 / 0044808 (describes other aspects of the SWIFT™ LT Nasal Pillow Cover); International Patent Applications WO 2005 / 063328 and WO 2006 / 130903 (describe other aspects of the MIRAGE LIBERTY™ Full Cover); and International Patent Application WO 2009 / 052560 (describes other aspects of the SWIFT™ FX Nasal Pillow Cover).

[0041] 2.2.3.1.2 Positioning and Stabilizing Structure

[0042] The seal-forming structure of a patient interface used in pneumatic 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: the effectiveness of the technique in maintaining the seal-forming structure in the desired position and sealing it against the face during use of the patient interface; the comfort of the interface for the patient; whether the patient experiences invasiveness and / or claustrophobia while wearing the patient interface; and aesthetic appeal.

[0043] One technique involves using adhesives, see, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of adhesives may be uncomfortable for some people.

[0044] Another technique involves using one or more straps and / or stabilizing shoulder straps. Many of these shoulder straps suffer from one or more problems such as poor fit, bulkiness, discomfort, and inconvenience of use.

[0045] 2.2.3.1.3 Ventilation port technology

[0046] Some forms of patient interface systems may include vents to allow the removal of exhaled carbon dioxide. Vents can allow gas flow from the internal space of the patient interface (e.g., an inflation chamber) to the outside of the patient interface (e.g., the surrounding environment). Vents may include orifices through which gas can flow during mask use. Many such vents are noisy. Other vents may become clogged during use and therefore provide insufficient clearance. Some vents may, for example, disrupt the sleep of the patient's bed partner 1100 through noise or concentrated airflow.

[0047] ResMed Limited has developed numerous improved mask vent technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0048] The noise level of the existing face mask (ISO 17510-2:2007, 10cmH2O pressure 1m)

[0049]

[0050] (*Only one sample, measured using the test method specified in ISO 3744 in CPAP mode at 10 cmH2O) The sound pressure levels for various objects are listed below.

[0051]

[0052] 2.2.3.1.4 Pressurized Air Circuit

[0053] 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.

[0054] 2.2.3.1.5 Pressurized air ducts used for positioning / stabilizing the sealing structure

[0055] 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.

[0056] 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.

[0057] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0058] 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.

[0059] One example of a specific requirement for certain RPT devices is noise.

[0060] Respiratory pressure therapy (RPT) devices can be used alone or as part of a system to deliver one or more of the aforementioned therapies, such as 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-based therapies such as HFT). Therefore, RPT devices can also be used as flow-based therapy devices. Examples of RPT devices include CPAP devices and ventilators. ISO 3744 specifies CPAP mode at 10 cmH2O.

[0061] One known RPT device for treating sleep-disordered breathing is the ResMed S9 Sleep Therapy System. Another example of an RPT device is a ventilator. ResMed Stellar ventilators, such as those for adults and pediatrics, are also mentioned. TM The series can provide invasive and non-invasive non-dependent ventilation support for a range of patients to treat a variety of conditions, such as, but not limited to, NMD, OHS and COPD.

[0062] ResMed Elisée after treatment TM 150 ventilators and ResMed VS III TM Ventilators provide invasive and non-invasive dependent ventilation support for adult or 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 a 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.

[0063] 2.2.3.3 Humidifier

[0064] Delivering airflow without humidification can lead to airway dryness. Humidifiers using an RPT device and patient interface generate humidified gas, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the surrounding facial area is generally more comfortable than cold air. Many artificial humidification devices and systems are known; however, they do not meet the specific requirements of medical humidifiers.

[0065] 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. Room-based systems (e.g., saunas, air conditioners, evaporative coolers, etc.) can also humidify the air inhaled by the patient; however, these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupant. Furthermore, safety constraints on medical humidifiers can be more stringent than those on industrial humidifiers.

[0066] 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.

[0067] 2.2.3.4 Heat and Humidity Exchanger (HME)

[0068] HMEs can be used in RPT therapy as a form of passive humidification. HMEs work by partially recovering heat and moisture from the patient's exhaled air. As the breathable air stream passes through the HME before inhalation, this heat and moisture can be passively retained and recirculated to the patient. Therefore, the use of HMEs can provide most patients with at least some of the required moisture and humidity (generally considered >10 mg / L) during RPT therapy to minimize any harmful effects associated with RPT therapy and undampened ambient air, while avoiding the need for heated humidifier systems. The use of HMEs also reduces the likelihood of blockage caused by condensation in the air delivery tubing. Heat and moisture exchangers are typically made of foam, paper, or alternative materials that can act as condensation and absorption surfaces. Often, the material can carry hygroscopic salts to improve moisture retention. Suitable salts include calcium chloride.

[0069] When selecting a suitable HME, careful consideration must be given to the HME's materials, sweep length (thickness), flow area, internal surface area, and integrated mask airflow or vent design to provide an effective passive humidification system. These factors are crucial for ensuring proper humidification levels are achieved while minimizing the impact on PAP therapy delivered to the patient. Ensuring that the materials used meet stringent biocompatibility requirements (such as cytotoxicity levels) is also important. Careful consideration must also be given to ensure that the materials do not degrade over time or during thermal cycling, as any particles that can be inhaled by the patient could have negative health effects.

[0070] Passive humidification is needed for patients undergoing PAP therapy, while minimizing negative impacts on patient treatment, inadequate CO2 removal, and reducing the overall volume and weight of the patient interface.

[0071] 2.2.3.5 Mandibular repositioning

[0072] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in an forward position during sleep. The MRD is a removable device that the patient inserts into their mouth before falling asleep and removes it after falling asleep. Therefore, the MRD is not designed to be worn all the time. The MRD can be custom-made or manufactured in a standard form and includes an occlusal impression portion designed to allow for a close fit to the patient's teeth. This mechanical protrusion of the jaw widens the space behind the tongue, applies tension to the pharyngeal walls to reduce airway collapse, and reduces hard palate vibration.

[0073] In some examples, the mandibular advancement device may include an upper splint for engaging or fitting with teeth on the maxilla or mandible and a lower splint for engaging or fitting with teeth on the maxilla or mandible. The upper and lower splints are laterally connected together via a pair of links. These links are symmetrically fixed to the upper and lower splints.

[0074] In this design, the length of the link is chosen so that the mandible remains in an anteriorly positioned position when the MRD is placed in the patient's mouth. The length of the link can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will determine the length of the link.

[0075] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (such as ResMed Narval CC) TM The MRD (Mandibular Joint Disorder) is designed to keep the mandible in an forward position. The device also reduces or minimizes side effects on the teeth and temporomandibular joint (TMJ). Therefore, the device is configured to minimize or prevent any movement of one or more teeth.

[0076] 2.2.4 Screening, Diagnosis and Monitoring System

[0077] Polysomnography (PSG) is a routine system used for the diagnosis and prognosis of cardiopulmonary diseases. PSG typically involves placing 15 to 20 contact sensors on a person to record various biosignals, such as electroencephalography (EEG), electrocardiography (ECG), electrooculography (EOG), and electromyography (EMG). However, while they may be suitable for routine use in a clinical setting, such systems are complex and can be expensive, and / or uncomfortable or impractical for patients trying to sleep at home.

[0078] When designing products or systems, designers are given an almost limitless number of options. Design standards often conflict, meaning that some design choices deviate significantly from the norm or are unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to minute, subtle changes in one or more parameters. Utility Model Content

[0079] 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.

[0080] The first aspect of this technology relates to devices for screening, diagnosing, monitoring, improving, treating or preventing respiratory disorders.

[0081] Another aspect of this technology relates to methods for screening, diagnosing, monitoring, improving, treating, or preventing respiratory disorders.

[0082] One aspect of certain forms of this technology is to provide methods and / or devices for improving patient adherence to respiratory therapy.

[0083] Another aspect of this technology relates to a patient interface for providing a pressurized flow of breathable gas to a patient's airway to treat respiratory illness. The patient interface may include a sealing-forming structure to form a pneumatic seal with an inlet to the patient's airway, an inflation chamber, and a device or insert located within the inflation chamber to divide the inflation chamber into an anterior chamber and a posterior chamber, wherein the device or insert includes a plurality of orifices to allow gas to flow between the anterior and posterior chambers, and wherein the plurality of orifices may include a first set of orifices of a first size and a second set of orifices of a second size, the second size being larger than the first size.

[0084] One form of this technology includes a patient interface comprising a device having at least one orifice with a predetermined surface area, the device including at least one orifice having a predetermined size; the device being positioned along a flow path of a breathable gas flow; wherein the predetermined size of the at least one orifice and the predetermined surface area of ​​the device are selected such that when measured at a flow rate of 100 L / min, the pressure drop through the device is less than 5 cmH2O.

[0085] In one example, the flow can be directed away from the mucosal surface. This can be achieved by changing the flow from turbulent to laminar. By directing a predetermined amount of breathable gas through at least one orifice to change the turbulence to laminar flow, the rate of heat and moisture loss from the mucosal surface can be reduced. During RPT treatment, turbulence in the flow of breathable gas delivered to the patient's airway mucosal surface can lead to surface moisture evaporation and ultimately dryness. Mucosal surface dryness affects breathing comfort. This technology aims to provide a patient interface that includes means to prevent dryness of the patient's airway mucosal surface during RPT treatment to promote breathing comfort. The means can alter the flow of breathable gas delivered to the patient, changing it from turbulent to a more stratified or less turbulent flow, resulting in reduced evaporation from the mucosal surface. The means can function by directing air through an orifice sized to allow an appropriate amount of breathable gas to flow through for RPT treatment, thereby causing the desired reduction in turbulence. The orifice size can also be designed to change the flow of breathable gas from turbulent to laminar flow to a sufficient level to reduce the rate of heat and moisture loss from the mucosal surface. The device may also include a sufficiently large surface area to guide enough breathable material through the orifice. It is also desirable to prevent the patient's airway mucosa from drying out to a level sufficient to maintain breathing comfort without requiring an HME or any other additional humidification, such as via a humidifier.

[0086] In another aspect of this technology, the number and size of the orifices can be selected so that the breathable gas flow can be guided through the orifices within a predetermined pressure range set by the RPT device, ensuring that airway obstruction in the patient can be reduced or minimized, although the presence of the device in the flow path will increase flow resistance. In another aspect of this technology, the device may be provided with a first set of orifices with diameters between 0.05 mm and 1 mm, and a second set of orifices with diameters between 1 mm and 5 mm. The size and position of the second set of orifices are configured to increase the CO2 clearance rate within the patient interface, reduce the patient's CO2 rebreathing rate, and / or reduce the flow resistance caused by the device.

[0087] In one aspect of this technology, the patient interface further includes a bend in fluid communication with the connection port, wherein the device is located within the bend. In another aspect of this technology, the connection port may be fluidly connected to an air delivery conduit for delivering a breathable gas flow, wherein the device may be located within the air delivery conduit in the flow path of the breathable gas flow. This technology aims to provide a device that can be positioned anywhere in the flow path of the breathable gas flow during RPT treatment to reduce turbulence in the breathable gas flow toward the patient's airway mucosal surface.

[0088] In another aspect of this technology, the patient interface further includes a connection port, and the device is positioned relative to the connection port in a spaced-out relationship. In another aspect of this technology, the device may be located between 1 mm and 10 mm from the connection port.

[0089] In another aspect of this technology, a predetermined surface area of ​​the device is selected to guide all breathable gas flow through the orifice. This technology aims to physically disrupt and guide the laminar flow of breathable gas on the mucosal surface of the patient's airway to prevent surface evaporation and ultimately prevent dryness.

[0090] In another aspect of this technology, the device material, size, and construction can be selected to maintain the moisture concentration of the air inhaled by the patient at a level of 10 mg / L or higher. For example, in one example, the device 6000 can be configured to maintain the moisture concentration in the inhaled air at 15 mg / L or higher, or in some examples, at 18 mg / L or higher.

[0091] Another aspect of this technology provides a heat and moisture exchange device comprising a material coated, bonded, or impregnated with a humidifying agent configured to promote condensation formation on the surface of the material. In some aspects of this technology, the humidifying agent is polyethylene glycol or calcium chloride. In some aspects, the material may include approximately 2% to 20% of the humidifying agent.

[0092] Another aspect of this technology provides a heat and moisture exchange device comprising an open-cell hygroscopic or hydrophilic foam, such as polyurethane foam.

[0093] In some examples, the device can be configured to have foam with a density of approximately 30 to 150 holes per inch (PPI), such as approximately 40 to 80 PPI, such as approximately 60 PPI.

[0094] Another aspect of this technology is a system for treating respiratory diseases, comprising a patient interface, an air circuit, and a heat and moisture exchange device, wherein, in use, the air circuit delivers a breathable gas stream to the patient's airway to treat the respiratory disease, and the patient interface is configured to maintain the treatment pressure within a range of approximately 4 cmH2O to approximately 30 cmH2O above the ambient pressure.

[0095] In the example, the heat and moisture exchange device can be located in or attached to the connection port on the patient interface.

[0096] In other examples, the heat and humidity exchange device may be located in or attached to the air circuit.

[0097] In the example, the system may include one or more head sleeves, and a heat and moisture exchange device may be disposed in one or more head sleeves.

[0098] In the example, the system may include one or more head tubes, and the head tubes include an inlet configured to receive a breathable gas flow in use, wherein a heat and moisture exchange device may be disposed in or attached to the inlet.

[0099] In other examples, the patient interface may include one or more air chamber inlet ports, wherein a heat and moisture exchange device may be disposed in or attached to the air chamber inlet port.

[0100] Another aspect of this technology is a patient interface that includes a vent for clearing exhaled air from the patient interface. In use, the device can be located in the flow path of the breathable gas flow between the vent and the patient's airway inlet. Preferably, the device can be positioned near the patient's airway to maximize its effect of physically interfering with the breathable gas flow.

[0101] In another aspect of one form of this technology, the patient interface also includes an inflatable chamber divided by the device into a first anterior chamber and a second posterior chamber, the inflatable chamber being configured to be in fluid communication with the inlet of the patient's airway. The device can be located within the inflatable chamber such that it spans the entire cross-sectional area of ​​the inflatable chamber. The device can be located within the inflatable chamber to minimize its resistance to the flow of breathable gas because the inflatable chamber can have a larger volume to accommodate the device compared to a connection port, tubing, or bend.

[0102] Another aspect of this technology relates to a device that physically interferes with the exhaled gas flow to increase the humidity in the second rear chamber to a predetermined absolute humidity. The predetermined absolute humidity may be greater than 10 mg / L. It is desirable to provide a device that physically interferes with the exhaled gas flow to retain moisture in the second rear chamber of the patient interface, such that the moisture is very close to the entrance of the patient's airway for re-delivery. It is also desirable to provide a humidity level equivalent to the predetermined absolute humidity, which is sufficient to prevent drying of the patient's airway mucosal surface, thereby preventing respiratory discomfort.

[0103] It should be understood that the device's reduced humidity loss from the second rear chamber compared to a patient interface without the device may result in an increase in absolute humidity. The absolute humidity in the second rear chamber increases as the patient exhales gas humidified by the patient's airway mucosa; this moisture loss may be caused by the expulsion of humidified gas from the inflation chamber.

[0104] Another aspect of this technology is a device comprising at least one orifice of a predetermined size, wherein the predetermined size of the at least one orifice is selected such that a predetermined amount of breathable gas flows through the orifice to deliver a breathable gas flow at a predetermined pressure level. The predetermined pressure level can be between 2 cm H2O and 40 cm H2O. The predetermined size of the orifice can be selected to increase the permeability of the device to the breathable gas flow. Permeability can be increased by increasing the forward flow area of ​​the orifice. The forward flow area is the surface area of ​​the device on the front side of the device away from the patient airway inlet. The permeability of the device can also be increased by increasing the number of orifices. It is desirable to provide a device that does not significantly impede the flow of breathable gas to maintain a predetermined pressure level. Pressure levels in RPT therapy, particularly PAP therapy in the treatment of OSA and other SDB diseases, require a set of therapeutic pressure levels delivered to the inlet airway. Therefore, it is also desirable to provide a device including orifices to prevent significant pressure loss when a pressurized breathable gas flow is delivered to the patient interface, thereby maintaining the therapeutic pressure level and delivering it to the inlet of the patient airway.

[0105] Another aspect of this technology relates to a device including an orifice of a predetermined size, the predetermined size being selected to allow an exhaled gas flow through the orifice for CO2 removal at a predetermined level via a ventilation port. The orifice may include an inner surface profile configured to direct the exhaled gas flow towards the ventilation port for CO2 removal. The predetermined size of the orifice can be selected to increase the permeability of the device to the exhaled gas flow for CO2 removal. Permeability can be increased by increasing the backflow area of ​​the orifice. The backflow area of ​​the orifice can be increased by increasing the size of the orifice on the rear side of the device. The permeability of the device can also be increased by increasing the number of orifices. It is desirable to provide a device that does not obstruct the exhaled gas flow to adequately remove CO2. Blocking the exhaled gas flow towards the ventilation port for CO2 removal leads to an increase in the CO2 concentration in the patient interface and will effectively result in CO2 rebreathing. Therefore, it is also desirable to provide a device including an orifice through which exhaled gas flows, wherein the device has increased permeability to the exhaled gas flow to adequately remove CO2.

[0106] Another aspect of this technology is the device, which is a flexible diaphragm. Optionally, the device is a fabric formed of textile fibers, wherein the fibers form multiple pores between adjacent fibers. The device can also be a mesh structure. The device can be a thin, flexible structure that does not occupy a significant volume along the flow path of RPT treatment, such as in an inflatable chamber located at the patient interface. This thin structure allows for reduced flow resistance during RPT treatment and also allows for easier positioning of the device within a fixed volume of space along the flow path. Furthermore, the flexibility of the device allows for easy manipulation to conform to the internal volume of the patient interface.

[0107] Another aspect of this technology is a device having a reduced thickness to reduce the flow resistance of the flowing breathable gas. The thickness can range from about 0.5 cm to 1 cm. Optionally, the thickness can range from 1 mm to 0.5 cm. The thickness can be less than 1 mm. A thinner device can occupy a smaller volume in the inflation chamber of the patient interface, thereby reducing its impact on flow resistance and its impact on the volume required to accommodate a portion of the patient's face. Therefore, it is desirable to provide a device with a reduced thickness to reduce the impact on the flow resistance of both the breathable and exhaled gas flows and to effectively reduce the volume occupied by the device in the inflation chamber. It is also desirable to provide a device that effectively reduces the drying of the patient's airway mucosal surface while having lower flow resistance and occupying a smaller volume in the patient interface compared to an HME. HMEs absorb heat and moisture, thus requiring a certain volume of absorbent substrate to capture desired levels of humidity. In contrast, this technology also desires to prevent the drying of the patient's airway mucosal surface and to prevent the re-transfer of moisture from exhaled gas to the patient without requiring materials that absorb heat and moisture.

[0108] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to an inlet of a patient's airway, the inlet of which includes at least an inlet to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle when in use while the patient is asleep, in order to improve sleep-disordered breathing. The patient interface may include: a sealing-forming structure for forming a pneumatic seal with the inlet of the patient's airway; a positioning and stabilizing structure for maintaining a sealing contact between the sealing-forming structure and the area surrounding the inlet of the patient's airway while maintaining a treatment pressure at the inlet of the patient's airway; an inflation chamber pressurized during use at a pressure higher than ambient pressure; a connection port for delivering a flow of breathable gas to the patient interface; and a device having a predetermined surface area, the device including at least one orifice of a predetermined size; the device being positioned along the flow path of the breathable gas to physically interfere with the flow; wherein the predetermined size of the at least one orifice and the predetermined surface area of ​​the device are selected such that a predetermined amount of breathable gas flows through the at least one orifice; and wherein the device does not absorb heat or moisture, and the device reduces the rate of heat and moisture loss from the mucosal surface by guiding the predetermined amount of breathable gas through the at least one orifice, thereby changing the flow of breathable gas toward the mucosal surface of the patient's airway from turbulent to laminar flow.

[0109] In the example, (a) the patient interface may further include a bend in fluid communication with the connection port, wherein the device is located within the bend; (b) the patient interface may further include an air delivery conduit for delivering a breathable gas flow to the patient interface, the air delivery conduit being in fluid communication with the connection port, wherein the device is located within the conduit; (c) the patient interface may further include a gas purging vent configured to allow exhaled CO2 to flow to the outside of the patient interface to minimize rebreathing of exhaled CO2; and (d) in use, the device may be located in the flow path of the breathable gas flow between the vent and the patient's airway inlet. (e) The device may be located within an inflation chamber, such that the inflation chamber is divided into a first anterior chamber and a second posterior chamber, the second posterior chamber being closer to the patient's airway inlet than the first anterior chamber; (f) The device may physically interfere with the exhaled gas flow to increase the humidity in the second posterior chamber to a predetermined absolute humidity; (g) The device may physically interfere with the exhaled gas flow by slowing the exhaled gas flow toward the first anterior chamber to redirect it back to the patient's airway inlet; (h) The predetermined absolute humidity may be greater than 10 mg / L; (i) A predetermined size may be selected for each of at least one orifice to substantially maintain a predetermined pressure level as the breathable gas flow passes through the orifice; (j) The predetermined pressure level may be from 2 cm H2O to 40 cm H2O. Between H2O, (k) a predetermined size of at least one orifice can be selected to maintain a predetermined pressure level by increasing the permeability of the device to a breathable gas flow; (l) permeability can be increased by increasing the front flow area of ​​the orifice; (m) the front flow area of ​​the orifice can be increased by increasing the size of the orifice on the front side of the device; (n) at least one orifice can be multiple orifices, and the permeability of the device can be increased by increasing the number of orifices; (o) a predetermined size of the orifice can be selected to allow exhaled gas flow through the orifice for CO2 removal at a predetermined level through the vent; (p) the orifice may include an inner surface profile configured to direct the exhaled gas flow to the vent for CO2 removal; (q) a predetermined size of the orifice can be selected to increase the permeability of the device to the exhaled gas flow for CO2 removal, allowing for... (r) Permeability can be increased by increasing the backflow area of ​​the pores; (s) at least one pore may include multiple pores, and the permeability of the device can be increased by increasing the number of pores; (t) the device may be a flexible membrane; (u) the device may be a fabric formed of woven fibers, and the fibers may form multiple pores between adjacent fibers; (v) the device may be a mesh structure; (w) the device may include any material from the group consisting of synthetic materials, thermoplastic elastomers, or hydrophobic polymers; (x) the device may have a predetermined thickness, selected to reduce the flow resistance of the breathable gas flow; (y) the predetermined thickness of the device may be in the range of about 0.5 cm to 1 cm; (z) the predetermined thickness of the device may be in the range of about 1 mm to 0.Within a 5cm range, (aa) the predetermined thickness of the device can be less than 1mm, and / or (bb) the predetermined size of the device can be selected for fitting into the inflatable chamber of the patient interface.

[0110] Another aspect of this technology relates to a patient interface for sealingly delivering an airflow at a continuous positive pressure relative to ambient air pressure to an inlet of a patient's airway, the inlet of which includes at least an inlet to the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's respiratory cycle when in use while the patient is asleep, in order to improve sleep-disordered breathing. The patient interface may include: a sealing-forming structure for forming a pneumatic seal with the inlet of the patient's airway; a positioning and stabilizing structure for maintaining the sealing-forming structure in sealed contact with an area surrounding the patient's airway inlet while maintaining a treatment pressure at the patient's airway inlet; an inflation chamber pressurized during use at a pressure higher than ambient pressure; a connection port for delivering a breathable gas flow to the patient interface; and a device positioned within the breathing chamber, wherein the breathing chamber is at least partially defined by the sealing-forming structure and the inflation chamber when the sealing-forming structure is in sealed contact with the area surrounding the patient's airway inlet, wherein the device divides the breathing chamber into a rear chamber and an anterior chamber, and wherein the device includes a plurality of orifices such that air turbulence in the rear chamber is less than air turbulence in the anterior chamber.

[0111] In the example, (a) the device can be positioned, shaped, and sized such that air in a breathing chamber moving between the posterior and anterior chambers passes only through the plurality of orifices; (b) the device can be shaped and sized such that at least a portion of the peripheral edge region of the device substantially conforms to the inner surface of at least one of the sealing structure and the inflation chamber; (c) the peripheral edge region can form a pneumatic seal against the inner surface of at least one of the sealing structure and the inflation chamber; (d) the entire peripheral edge region of the device can substantially conform to the inner surface of at least one of the sealing structure and the inflation chamber; (e) the patient interface can further include at least one gap located between the peripheral edge region of the device and the inner surface of at least one of the sealing structure and the inflation chamber; (f) at least a portion of the peripheral edge region of the device can be fixedly attached to the inner surface of at least one of the sealing structure and the inflation chamber; (g) at least a portion of the peripheral edge region of the device can be removably attached to the inner surface of at least one of the sealing structure and the inflation chamber; (h) at least one of the size, shape, and density of the plurality of orifices throughout the device can be uniform; (i) the plurality of orifices throughout the device... (j) At least one of the dimensions, shape, and density of the device may be non-uniform; (k) Each of the plurality of orifices may have a rear region adjacent to the rear chamber and a front region adjacent to the front chamber; (l) The rear region of each of the plurality of orifices may be greater than, less than, or equal to the front region of each of the plurality of orifices; (m) The flow path through each of the plurality of orifices may be linear or non-linear; (n) The device may include a material resistant to moisture absorption and / or heat; and (n) The material may be composed of nylon, polycarbonate, silicone, polyurethane, thermoplastic elastomers, hydrophobic polymers, and other synthetic materials. Any of the following groups: (o) the device may include a single, continuous, and uniform sheet of material; (p) the device may have a mesh, foam, or woven structure; (q) the device may be positioned within a breathing chamber such that the volume of the rear chamber is greater than, less than, or equal to the volume of the anterior chamber; (r) the patient interface may further include a vent for purging gas from the patient interface; (s) the vent may be positioned on a bend in the inflation chamber or the patient interface such that gas from the anterior chamber is purged through the vent; and / or (t) the vent and connection port may be positioned opposite the patient airway inlet relative to the device.

[0112] 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.

[0113] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. Attached Figure Description

[0114] 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:

[0115] 4.1 Breathing Therapy System

[0116] Figure 1A A system including a patient 1000 wearing a patient interface 3000 in the form of a nose pillow, receiving a positive pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed partner 1100 is also shown. The patient is sleeping in a supine position.

[0117] Figure 1B A system including a patient 1000 wearing a patient interface 3000 in the form of a nasal mask is shown, 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.

[0118] Figure 1C A system including a patient 1000 wearing a full-face mask-like patient interface 3000 receives 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 is sleeping in a side-lying position.

[0119] 4.2 Respiratory System and Facial Anatomy

[0120] 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.

[0121] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0122] Figure 2C It is a frontal view of a face with many recognizable surface anatomical features, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the lips. It also indicates the directions of up, down, radially inward, and radially outward.

[0123] Figure 2DIt is a side view of the head with many recognizable surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal point, upper lip, lower lip, supramental point, nasal ridge, alar ridge, supraauricular base, and subauricular base. The vertical and horizontal directions are also indicated.

[0124] Figure 2E This is another side view of the head. It indicates the approximate location of the Frankfort horizontal plane and the nasolabial angle. The coronal plane is also indicated.

[0125] Figure 2F A bottom view of the nose with many recognizable features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, subnasal point, columella, nasal protuberance, long axis of the nostrils, and midsagittal plane.

[0126] Figure 2G A side view showing the surface features of the nose.

[0127] 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.

[0128] Figure 2I An anatomical view of the medial part of the nose is shown, approximately a few millimeters from the midsagittal plane, with particular emphasis on the medial crus of the septal cartilage and the greater alar cartilage.

[0129] Figure 2J A frontal view of the skull, including the frontal bone, nasal bone, and zygomatic bone, is shown. The nasal conchae, as well as the maxilla and mandible, are also indicated.

[0130] Figure 2K This diagram shows a side view of the skull, including the surface contours of the head and several muscles. 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 indicated. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0131] Figure 2L The frontal lateral view of the nose is shown.

[0132] 4.3 Patient Interface

[0133] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0134] Figure 3B A patient interface with a catheter tip cap, according to this technology, is shown.

[0135] 4.4RPT device

[0136] Figure 4A An RPT device of one form according to the present technology is shown.

[0137] Figure 4B This 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 the blower and patient interface. The blower is positioned upstream of the patient interface, and the patient interface is positioned 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 downstream of the blower and upstream of the patient interface.

[0138] Figure 4C This is a schematic diagram of the electrical components of one form of RPT device according to the present technology.

[0139] Figure 4D This is another schematic diagram of the electrical components of an RPT device according to one form of the present technology.

[0140] 4.5 Humidifier

[0141] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0142] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0143] Figure 5C A schematic diagram of one form of humidifier according to the present technology is shown.

[0144] 4.6 Respiratory waveform

[0145] Figure 6 A typical breathing waveform model of a person sleeping is shown.

[0146] 4.7 Other Examples of This Technology

[0147] Figure 7A A side view of a patient receiving a pressurized breathable gas flow from a patient interface, according to an example of this technology, is shown.

[0148] Figure 7B A side view of a patient receiving a pressurized breathable gas flow from a patient interface using a device according to an example of the present technology is shown.

[0149] Figure 8A A side view of a patient with a patient interface is shown, which includes a device according to an example of the present technology.

[0150] Figure 8BA side view of a patient with a patient interface is shown, which includes a device according to an example of the present technology.

[0151] Figure 8C A side view of a patient with a patient interface is shown, which includes a device according to an example of the present technology.

[0152] Figure 9A A perspective view of an example of an apparatus according to the present technology is shown.

[0153] Figure 9B A perspective view of an example of an apparatus according to the present technology is shown.

[0154] Figure 9C A perspective view of another example of an apparatus according to this technology is shown.

[0155] Figure 10A A rear view of a patient with a patient interface, according to an example of this technology, is shown.

[0156] Figure 10B A rear view of a patient with a patient interface is shown, which includes an apparatus according to an example of the present technology.

[0157] Figure 11 A graph showing the average absolute humidity on the back side of the device in a patient interface based on different device materials, according to an example of this technology, is presented.

[0158] Figure 12A A front perspective view of a model of a sealing structure and an inflation chamber of a device having an air vent, a connection port, and an example of a device according to the present technology is shown.

[0159] Figure 12B A front perspective view of a model of a sealed formation structure and an inflation chamber for a patient interface having an air vent, a connection port, and a device, according to an example of the present technology, is shown.

[0160] Figure 13A This shows the flow rate from the computational fluid dynamics program when the flow rate generated by the patient is zero. Figure 12A and Figure 12B Flow velocity modeling within the model (where the device does not exist).

[0161] Figure 13B This shows the flow rate from the computational fluid dynamics program when the flow rate generated by the patient is zero. Figure 12A and Figure 12B Flow velocity modeling within the model (where the device exists).

[0162] Figure 14AThis shows the flow rate from the computational fluid dynamics program when the patient-generated flow rate is 10 L / min. Figure 12A and Figure 12B Flow velocity modeling within the model (where the device does not exist).

[0163] Figure 14B This shows the flow rate from the computational fluid dynamics program when the patient-generated flow rate is 10 L / min. Figure 12A and Figure 12B Flow velocity modeling within the model (where the device exists).

[0164] Figure 15A This shows the flow rate from the computational fluid dynamics program when the patient-generated flow is zero. Figure 12A and Figure 12B The velocity streamlines simulated within the model (the device does not exist).

[0165] Figure 15B This shows the flow rate from the computational fluid dynamics program when the patient-generated flow is zero. Figure 12A and Figure 12B The simulated velocity streamlines within the model (where the device exists).

[0166] Figure 16A This shows the flow rate generated by the patient at 10 L / min, as shown in the computational fluid dynamics program. Figure 12A and 12B The velocity streamlines simulated within the model (the device does not exist).

[0167] Figure 16B This shows the flow rate generated by the patient at 10 L / min, as shown in the computational fluid dynamics program. Figure 12A and 12B The simulated velocity streamlines within the model (where the device exists).

[0168] 4.8 Modularity

[0169] Figure 17A-1 A perspective view of a pad for a patient interface is shown, which is configured to be worn by the patient and deliver pressurized air to the patient's nose and mouth.

[0170] Figure 17A-2 It shows Figure 17A-1 A perspective view of the liner, wherein the device is located in at least one inlet port of the inflation chamber.

[0171] Figure 17A-3 It shows Figure 17A-1 A perspective view of the mat, wherein the device is located in at least one ventilation opening or connection port.

[0172] Figure 17B-1A perspective view of a pad for a patient interface is shown, which is configured to be worn by a patient and deliver pressurized air to the patient's nose.

[0173] Figure 17B-2 It shows Figure 17B-1 A perspective view of the liner, wherein the device is located in at least one inlet port of the inflation chamber.

[0174] Figure 17B-3 It shows Figure 17B-1 A perspective view of the liner, wherein the device is located in at least one vent opening or connection port.

[0175] Figure 17C It shows that it can be used with Figures 17A-1 to 17B-3 A perspective view of the tube used with the liner.

[0176] Figure 17D It shows that it can be used with Figures 17A-1 to 17B-3 A perspective view of the hardener arm used with the padding.

[0177] Figure 17E It shows that it can be used with Figure 17A-1 A perspective view of the headband strip used with the padding.

[0178] Figure 17F It shows that it can be used with Figure 17B-1 A perspective view of the headband strip used with the padding.

[0179] Figure 17G It shows removable assembly to Figure 17C pipe or Figure 17D Front view of a pair of sleeves on the hardener arm.

[0180] Figure 17H It shows removable assembly to Figure 17D Front view of the complete sleeve of the hardener arm.

[0181] Figure 17I It shows removable assembly to Figure 17D A front perspective view of another alternative form of the complete sleeve of the hardener arm.

[0182] Figure 17J-1 Is wearing Figures 17A-1 to 17A-3 A front view of the patient with any of the pads, which are connected to Figure 17C pipe, Figure 17E headgear and Figure 17G The sleeve.

[0183] Figure 17J-2 Is wearing Figures 17A-1 to 17A-3 A front view of the patient with any of the pads, which are connected to Figure 17C pipe, Figure 17E headgear and Figure 17GThe sleeve and the device in the inlet.

[0184] Figure 17K Is wearing Figure 17A-1 or Figure 17A-3 A front view of the patient with the liner attached to Figure 17D hardener arm, Figure 17E headgear and Figure 17H The sleeve.

[0185] Figure 17L Is wearing Figures 17B-1 to 17B-3 A front view of the patient with any of the pads, which are connected to Figure 17C catheter head cover and Figure 17F The headgear.

[0186] Figure 17M Is wearing Figure 17B-1 or Figure 17B-3 A front view of the patient with the liner attached to Figure 17D hardener arm, Figure 17F headgear and Figure 17I The sleeve.

[0187] Figure 17N yes Figure 17L An independent perspective view of the vent.

[0188] Figure 17O yes Figure 17M A separate perspective view of a portion of the air circuit.

[0189] Figure 17P This is a schematic diagram illustrating possible combinations of patient interfaces. Detailed Implementation

[0190] Before describing the technology in further detail, it should be understood that the technology is not limited to the specific examples described herein, and the specific examples described herein may vary. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples discussed herein and is not intended to be limiting.

[0191] The following descriptions are provided for various examples that may share one or more common characteristics and / or features. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. Furthermore, in any example, any single feature or combination of features may constitute another example.

[0192] 5.1 Therapy

[0193] In one form, the technology includes a method for treating respiratory distress, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0194] In some examples of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0195] In some examples of this technology, mouth breathing is restricted, constrained, or prevented.

[0196] 5.2 Treatment System

[0197] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000.

[0198] 5.3 Patient Interface

[0199] According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, and a connection port 3600 of one form for connection to an air circuit 4170. 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 is arranged around the inlet of the patient's airway to facilitate the supply of positive pressure air to the airway.

[0200] 5.3.1 Sealing Formation Structure

[0201] In one form of this technology, the sealing forming structure 3100 provides a sealing forming surface and may additionally provide a cushioning function.

[0202] The sealing structure 3100 according to this technology can be made of a soft, flexible, elastic material, such as silicone resin.

[0203] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the periphery. The support flange is a spring-like element or includes a spring-like element and functions to support the sealing flange 3110 in use and prevent it from buckling. In use, the sealing flange 3110 is readily responsive to system pressure acting on its bottom surface by the inflation chamber 3200, thereby forming a tight seal with the surface.

[0204] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal flaps or nasal pillows, each flap or pillow being constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0205] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region located on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle connection structure.

[0206] In one embodiment, the non-invasive patient interface 3000 includes a sealing formation structure 3100 that forms a seal in use on the upper lip region (e.g., above the lip) of the patient's face.

[0207] In one embodiment, the non-invasive patient interface 3000 includes a sealing forming portion that forms a seal in the chin area of ​​the patient's face during use.

[0208] 5.3.2 Inflation Chamber

[0209] In the area formed during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a normal person's 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 can extend along the entire periphery of the air chamber 3200 during use.

[0210] 5.3.2.1 Multiple openings

[0211] like Figures 17A-1 to 17B-3 As shown, different air chambers 3200-1, 3200-2 can be formed as part of multi-opening liners 3050-1, 3050-2. In the example shown, liners 3050-1, 3050-2 each include three openings, although alternative liners may be formed with more or fewer openings.

[0212] In some forms, different openings can serve different purposes. For example, some openings may be solely entrance openings, while others may be solely exit openings.

[0213] In other forms, at least one opening can provide two different functions. For example, during the same respiratory cycle, one opening can serve as both an inlet and an outlet.

[0214] These multiple openings allow for various configurations of air delivery to the inflation chambers 3200-1 and 3200-2. For example, depending on the patient's needs and / or comfort, the patient can use a given liner 3050-1 or 3050-2 in a "tube-up" configuration (e.g., using a catheter head described below) or a "tube-down" configuration (e.g., using a single catheter in front of the patient's face).

[0215] 5.3.2.2 Nose mask

[0216] like Figures 17A-1 to 17A-3 As shown, the inflation chamber 3200-1 includes a pair of inflation chamber inlet ports 3254-1, which can be used to deliver gas into and / or discharge gas from the inflation chamber 3200-1. The inflation chamber inlet ports 3254-1 may be arranged on opposite sides of the inflation chamber 3200-1 (e.g., left and right sides).

[0217] In some forms, the inflation chamber 3200-1 may also include at least one ventilation opening 3402-1 (see, for example, see...). Figure 17A-1 Ventilation opening 3402-1 is located in the center of inflation chamber 3200-1. For example, ventilation opening 3402-1 can be located between inlet ports 3254-1 of the inflation chamber.

[0218] It should be understood that, in cases such as Figure 17K In the illustrated tube-down patient interface 3000, the vent 3402-1 can be a connection port 3600, which is configured to connect to the air circuit 4170 in use. Similarly, the inflation chamber inlet port 3254-1 can be configured to connect to one or more bands of the positioning and stabilizing structure 3300.

[0219] In some forms, the inflation chamber 3200-1 may include a pair of recesses 3266-1. Each recess 3266-1 may be located near one of the inflation chamber inlet ports 3254-1. Each recess 3266-1 may form a partially recessed surface.

[0220] 5.3.2.3 Nose mask only

[0221] Only the air chamber 3200-2 of the nasal liner 3050-2 can be similar to the air chamber 3200-1 of the mouth and nose liner 3050-1. The following describes only some similarities and differences between the air chambers 3200-1 and 3200-2.

[0222] like Figures 17B-1 to 17B-3As shown, the inflation chamber 3200-2 includes a pair of inflation chamber inlet ports 3254-2, which can be used to deliver gas into and / or discharge gas from the inflation chamber 3200-2. The inflation chamber inlet ports 3254-2 may be arranged on opposite sides of the inflation chamber 3200-2 (e.g., left and right sides).

[0223] In some forms, the inflation chamber 3200-2 may also include at least one vent opening 3402-2 or connection port 3600 (see, for example, see...). Figure 17B-1 Ventilation opening 3402-2 can be arranged in the center of inflation chamber 3200-2. For example, ventilation opening 3402-2 can be arranged between inflation chamber inlet ports 3254-2.

[0224] In some forms, the inflation chamber 3200-2 may include a pair of recesses 3266-2. Each recess 3266-2 may be located near one of the inflation chamber inlet ports 3254-2. Each recess 3266-2 may form a partially recessed surface.

[0225] 5.3.3 Positioning and Stabilization Structure

[0226] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed position during use by positioning and stabilizing structure 3300.

[0227] In one form of this technology, a positioning and stabilization structure 3300 is provided, configured in a manner consistent with a patient wearing it 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.

[0228] 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.

[0229] 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.

[0230] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt that is flexible and, for example, non-rigid. The advantage of this is that the belt makes it more comfortable for the patient to lie on while sleeping.

[0231] 5.3.3.1 Catheter head cover

[0232] 5.3.3.1.1 Catheter head sheath

[0233] 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 forming structure 3100. Figure 17J-1 and Figure 17J-2 In the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350 that deliver air from an air circuit 4170 connected to an inlet 3332-1 to an inflation chamber 3200. The tubes 3350 are configured to, in use, position and stabilize the sealing formation 3100 of the patient interface 3000 at an appropriate portion of the patient's face (e.g., the nose and / or mouth). This allows a conduit providing a 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.

[0234] exist Figure 17J-1 and Figure 17J-2 In the illustrated form of this technology, the positioning and stabilizing structure 3300 includes two tubes 3350, each located 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 region to a curved tube 3610 at the top of the patient's head. This form of the 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.

[0235] 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 the band forms part of the positioning and stabilizing structure 3300 and is positioned on the other side of the patient's head during use (e.g., across another area) to help 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 maintain the sealing structure 3100 in a sealed position.

[0236] 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.

[0237] exist Figure 17J-1 and Figure 17J-2 In the illustrated embodiment, the two tubes 3350 are fluidly connected to each other at their upper ends and fluidly connected to the connection port 3600. In some examples, the device 6000 may be disposed in the connection port 3600 or otherwise connected to the connection port 3600.

[0238] In some examples, the two tubes 3350 are formed integrally, while in other examples, the tubes 3350 are formed separately but can be connected and disconnected during use, for example, for cleaning or storage. When using separate tubes, they can be indirectly connected together, for example, each can be connected to a T-connector. The T-connector can have two arms / branches, each of which can be fluidly connected to a corresponding tube 3350.

[0239] 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.

[0240] In some examples, the one or more tubes 3350 are compression-resistant to prevent blockage if compressed during use, such as if compressed between a patient's head and a pillow, especially if there is only one tube 3350. The tube 3350 may be formed with sufficient structural stiffness to resist crushing, or may be as described in U.S. Patent No. 6,044,844, the contents of which are incorporated herein by reference.

[0241] Each tube 3350 can be configured to receive an airflow from a connection port 3600 or inlet 3332 on the top of the patient's head and deliver that airflow to a sealing structure 3100 at the patient's airway inlet. Figure 17J-1 and Figure 17J-2 In the example shown, each tube 3350 is located in use on a path extending from the inflation chamber 3200 through the patient's cheek region and above the patient's ear to the curved tube 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 curved tube 3610 may be located in use on the patient's parietal bone, frontal bone, and / or at the junction between them (e.g., the coronal suture).

[0242] In some forms of this technology, the patient interface 3000 is configured such that the connection port 3600 or inlet 3332 can be positioned within a range spanning the top of the patient's head, thereby allowing the patient interface 3000 to be positioned to suit 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).

[0243] 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.

[0244] 5.3.3.1.2 Extendable and Non-extendable Tube Sections

[0245] In some examples of this technology, one or both of the tubes 3350 are not extendable in length. However, in some forms, the tubes 3350 may include one or more extendable segments, for example formed by an extendable accordion-like structure 3362. In some forms, the patient interface 3000 may include a positioning and stabilizing structure 3300 comprising at least one gas delivery tube having a tube wall having an extendable accordion-like structure. Figure 17C The patient interface 3000 shown includes a tube 3350, the upper part of which includes extendable tube segments, each in the form of an extendable accordion structure 3362.

[0246] In some forms, the extendable accordion-like structure 3362 can be formed as a series of ridges and grooves on the surface of the tube 3350. The accordion-like structure 3362 can be biased toward a retracted position and can be moved to an extended position when the patient is prone, positioning, and stabilizing the structure 3300. Because portions of the tube 3350 can be substantially non-extendable (e.g., a non-extendable tube segment 3363), the accordion-like structure 3362 allows the positioning and stabilizing structure 3300 to be stretched to fit 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 3362, the positioning and stabilizing structure 3300 can be “one-size-fits-all.” Alternatively, the tube 3350 can be manufactured in multiple sizes (e.g., small, medium, large). The patient can choose a length that most closely matches their head, and the accordion-like structure 3362 can be slightly adjusted to fit an individual patient.

[0247] In some configurations, inlet 3332 may be located in the middle of the conduit. For example, conduit 3350 may be symmetrical about inlet 3332 via at least one axis.

[0248] 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.

[0249] In some examples of this technology, a non-extendable tube segment 3363 connects to the inflation chamber 3200 at a low angle. The headgear tube 3350 may extend downwards to the side of the patient's head and then bend forward and inwards to connect to the inflation chamber 3200 in front of the patient's face. Before connecting to the inflation chamber 3200, the tube 3350 extends to a position at the same vertical position as (or, in some examples, below) the connection to the inflation chamber 3200. That is, the tube 3350 may protrude at least partially upwards before connecting to the inflation chamber 3200. 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 may be more comfortable than contacting the patient's cheekbone and may avoid excessively obscuring the patient's peripheral vision.

[0250] 5.3.3.1.3 Catheter head connection port

[0251] In some forms of this technology, the patient interface 3000 may include a connection port 3600 located near the upper, outer, or rear portion of the patient's head. For example, in Figure 3B In the illustrated form of the present technology, the connection port 3600 is located at the top of the patient's head (e.g., above the supraauricular base point of 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 for 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 a tube 3350 via a ball-and-socket connector. The connection port 3600 may be located in the sagittal plane of the patient's head during use.

[0252] In some examples of this technology, a device 6000 configured to exchange heat and / or moisture between the patient's exhaled air and the patient's inhaled air may be located in or configured to be attached to a connection port 3600. For example, in use, the device 6000 may be located in or configured to be attached to a bend 3610.

[0253] A patient interface with a connection port 3600 that is not located in front of the patient's face may be advantageous because some patients may find catheters connected to a patient interface 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. The form of this technology, including a patient interface with a connection port positioned above the patient's head during use, allows the patient to lie or sleep more easily or comfortably 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 movement or catheter movement, resulting in displacement away from the face. Tube resistance is likely to be a less problematic issue when the forces applied at the position above the patient's head are greater than those applied in front of the patient's face, near the sealing structure (where tube resistance may be more likely to disrupt the seal).

[0254] 5.3.3.1.4 Fluid Connection of Head Sleeve

[0255] Two tubes 3350 are fluidly connected at their lower ends to an inflation chamber 3200. 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 onto 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 to connect to a concave mating feature on the inflation chamber 3200. In other examples, each tube 3350 may include a convex or concave connector formed of a flexible material (e.g., silicone or TPE), for example, the tubes 3350 may be formed of the same material.

[0256] 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 to hermetically seal the tube 3350 in the port. 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-activated seal, such as a peripheral sealing flange. When pressurized gas is supplied through the tube 3350, the sealing flange may be pressed against the engagement between the tube and the circumferential surface around the port or connector of the inflation chamber 3200 to form or reinforce the seal between the tube 3350 and the inflation chamber 3200.

[0257] 5.3.3.2 Headgear

[0258] like Figure 17F As shown, some forms of the headgear 3302-2 can 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) can be wider than the surrounding portion of the headgear 3302-2. The middle portion 3308-2 of the back band 3307-2 may include a slit 3309-2. Thus, due to the slit 3309-2, the upper section of the back band 3307-2 can move 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).

[0259] 5.3.4 Vent

[0260] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow the clearance of exhaled gases (e.g., carbon dioxide).

[0261] 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.

[0262] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in the dissociation structure 3500 (e.g., the swivel shaft 3510).

[0263] 5.3.5 Dissociated Structure

[0264] In one form, the patient interface 3000 includes at least one dissociative structure 3500, such as a spindle 3510 or a sphere and a socket.

[0265] 5.3.6 Connection Port

[0266] Connection port 3600 allows connection to air circuit 4170.

[0267] 5.3.7 Forehead Support

[0268] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0269] 5.3.8 Anti-suffocation valve

[0270] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0271] Port 5.3.9

[0272] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to a volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In another embodiment, this allows direct measurement of properties of the gas within the inflation chamber 3200, such as pressure.

[0273] 5.3.10 The patient interface 3000 includes device 6000.

[0274] In related technologies, a gas supply generated by an RPT device 4000 can be provided to a patient 1000, as described elsewhere herein. The patient interface 3000 of these related technologies may include a ventilation port 3400 to allow the clearance or expulsion of exhaled gas from the patient 1000, thereby removing CO2 from the patient's airway 1004 and preventing the patient 1000 from inhaling gas with an undesirable high concentration of CO2. When the patient 1000 inhales the gas supply generated by the RPT device during respiration, the mucosal surfaces of the patient's airway 1004 provide moisture to the air as air is inhaled, and this moisture is retained in the air once the air is exhaled. However, the clearance of exhaled gas with a higher concentration of CO2, or the airflow 7004, will expel the moisture added to the air by the patient's mucosal surfaces along with the CO2. During treatment, such as when the patient is sleeping, this can lead to dryness of the mucosal surfaces, causing discomfort to the patient.

[0275] The relevant technology has addressed this problem by providing a humidifier 5000, which will be described in more detail elsewhere in this document, to add moisture (i.e., humidify) to the airflow 7000 provided to the patient interface 3000 for therapy. In other words, the humidifier 5000 can be understood as replenishing the moisture lost through the airflow 7004 by providing moisture in the airflow 7000 supplied to the patient. While the humidifier 5000 can effectively reduce dryness of the patient's airway 1004 during therapy, it may require a moisture source, power supply, and control system to coordinate the operation of the humidifier 5000 with the RPT device 4000 to deliver the desired level of humidity and therapy to the patient. Therefore, it may be desirable to provide an alternative solution to the problem of moisture loss during therapy without requiring the humidifier 5000.

[0276] According to one aspect of the present technology, the non-invasive patient interface 3000 includes a device 6000. The device 6000 may be non-heat-absorbing or heat-resistant, and / or the device 6000 may be non-moisture-absorbing or heat-resistant.

[0277] According to one example of the present technology, the device 6000 may be located within the inflation chamber 3200 of the patient interface 3000. The device 6000 may also be located within a breathing chamber at least partially defined by the sealing formation 3100 and the inflation chamber 3200. Optionally, the device 6000 may be located within the dissociation structure 3500 or a bend in the patient interface 3000. Optionally, the device 6000 may be located within the air circuit 4170. The device 6000 may be configured to direct a breathable gas flow 7000 through at least one orifice 6002 to reduce turbulence of the airflow 7000 flowing toward the mucosal surface of the patient airway 1004, thereby reducing dryness of the mucosal surface.

[0278] The device may include a plurality of pores 6002. These pores may be formed, for example, during a foaming process. For example, in the production of foam, two or more components typically react together to produce gas, which forms a series of pores as it expands and escapes from the mixture.

[0279] For example, in the case of polyurethane foam, isocyanates and polyols are sometimes mixed in the presence of a catalyst or ultraviolet light. During the reaction, water may be added to form carbon dioxide gas, the escape of which creates one or more pores. These pores can be expressed as an average pore size, or more commonly as pores per inch (PPI).

[0280] In various aspects of this technology, it may be desirable to have devices with apertures 6002 ranging from approximately 30 PPI to 150 PPI, such as between approximately 40 PPI and 80 PPI, such as approximately 60 PPI. These ranges can advantageously provide devices with low impedance characteristics while allowing sufficient moisture retention.

[0281] The device 6000 may be located between the connection port 3600 and the inlet 1006 of the patient airway 1004, such that it guides part or all of the breathable gas flow 7000 through the orifice 6002. The device 6000 may include a predetermined surface area to physically interfere with and guide all the flow 7000 through the orifice 6002. Furthermore, the exhaled airflow 7002 from the patient airway 1004 may be discharged from the inflation chamber 3200 by passing through the orifice 6002 in the opposite direction and exiting the ventilation port 3400 as a purge or ventilation airflow 7004.

[0282] In one embodiment, the device 6000 divides the inflation chamber 3200 into a first pre-chamber 6004 and a second rear chamber 6006. The second rear chamber 6006 is positioned such that it is adjacent to the inlet 1006 of the patient's airway 1004. The device 6000 can physically interfere with the flow of exhaled air 7002 to increase the humidity in the second rear chamber 6006 to a predetermined absolute humidity for re-delivery humidification to the mucosal surface of the patient's airway 1004. The humidified flow of the patient's exhaled air 7002 can be slowed down to prevent it from flowing into the first pre-chamber 6004, thereby increasing the humidity within the second rear chamber 6006 for re-delivery to the inlet of the patient's airway 1004. Thus, by reducing the velocity of the exhaled airflow 7002 within the inflation chamber 3200, and by forcing the exhaled airflow 7002 from the second rear chamber 6006 through the orifice 6002 to the first pre-chamber 6004, turbulence in the second rear chamber 6006 can be reduced. It should be understood that device 6000 can reduce the velocity or kinetic energy of fluid 7000 by preventing fluid 7000 from flowing into the second rear chamber 6006, which in turn reduces turbulence in the fluid. This reduction in turbulence in the second rear chamber 6006 further reduces the mixing between the exhaled airflow 7002 and the breathable gas flow 7000 from the RPT device 4000, which may be less humid. Therefore, moisture loss from the exhaled airflow 7002 can be reduced, most of which can ultimately be retained in the second rear chamber 6006 and used to humidify the air inhaled by the patient 1000, preventing the patient's airway 1004 from drying out. Furthermore, by retaining more moisture in the second rear chamber 6006, less moisture is transferred to the first anterior chamber 6004, which may ultimately be lost from the inflation chamber 3200 via, for example, the ventilation airflow 7004. The absolute humidity within the second rear chamber 6006 can reach greater than 10 mg / L.

[0283] In one embodiment, the sealing structure 3100 of the patient interface 3000 can be configured to seal a portion of the patient's face 1000 to provide a breathable gas flow 7000 at the therapeutic pressure level of RPT, thereby treating conditions such as sleep apnea. The breathable gas flow 7000 flows from the connection port 3600 into the inflation chamber 3200 and passes through the orifice 6002 of the device 6000 before reaching the inlet of the patient airway 1004. The permeability of the device 6000 to the breathable gas flow 7000 can be increased to maintain a predetermined pressure level as the breathable gas flow 7000 flows through the orifice 6002, thereby avoiding significant loss of therapeutic pressure before reaching the inlet of the patient airway 1004. The predetermined pressure level can be between 2 cm H2O and 40 cm H2O. Permeability can be increased by increasing the forward flow area of ​​the orifice 6002. The front flow area of ​​orifice 6002 is the area occupied by the orifice on the front side of device 6000 to allow breathable gas 7000 to flow through it. The front flow area can be selected by choosing orifices 6002 with predetermined dimensions. Alternatively, the permeability of device 6000 to the breathable gas flow 7000 can be increased by increasing the number of orifices 6002. Therefore, the area and number of orifices 6002 on the front side of device 6000 are two factors that determine the front flow area of ​​device 6000.

[0284] In one configuration, device 6000 may be positioned between ventilation port 3400 and patient 1000 such that an exhaled gas flow 7002 flows as a ventilation flow 7004 through orifice 6002 of device 6000 before exiting ventilation port 3400 for CO2 clearance. The permeability of device 6000 to the exhaled gas flow 7002 can be increased to allow the exhaled gas flow 7002 to pass through orifice 6002 for a predetermined level of CO2 clearance. The permeability of the exhaled gas flow 7002 can be increased by increasing the backflow area of ​​orifice 6002. The desired backflow area of ​​device 6000 can be selected by choosing orifices 6002 with a predetermined size. Furthermore, permeability can be increased by increasing the number of orifices 6002. Therefore, the area of ​​orifices 6002 on the rear side of device 6000 and the number of orifices 6002 are two factors determining the backflow area of ​​device 6000.

[0285] In another form, each of the orifices 6002 may include an inner surface profile configured to direct a flow of exhaled gas 7002 toward the ventilation port 3400 for a predetermined level of CO2 clearance. The predetermined level of CO2 clearance or ventilation 7004 may be sufficient to prevent significant CO2 rebreathing, which could lead to harmful effects such as sudden awakening during RPT in SDB treatment.

[0286] In one form, the device 6000 can be a flexible diaphragm, such as... Figure 8AAs shown. Optionally, the device 6000 can be a fabric formed of woven fibers, wherein the fibers form a plurality of holes 6002 between adjacent fibers, as shown. Figure 8B As shown. In another form, the device 6000 can be a mesh structure, such as... Figure 8C As shown.

[0287] Figure 9A and Figure 9B Two perspective views of a device 6000 according to the present technology are shown. It can be seen that the device 6000 has a plurality of holes 6002. The size and shape of the holes 6002 can be substantially uniform throughout the device 6000; for example, each hole may be formed to have approximately the same size using a piercing or drilling process, or the device 6000 may be characterized by a general range of holes per inch, such as approximately 60 PPI, as described herein. Optionally, the size of the holes 6002 may vary in different areas of the device 6000, the shape of the holes 6002 may vary in different areas of the device 6000, and / or the density of the holes 6002 (i.e., the number of holes 6002 per unit area (PPI) of the surface of the device 6000) may vary in different areas of the device 6000.

[0288] In some examples of this technology, pores 6002 can be formed during the manufacturing process. For example, during foam formation, pores can be formed by selecting a suitable foaming agent, foam material / composition, or controlling operating parameters such as temperature, pressure, and time. In some examples of this technology, such as Figure 9C As shown, it may be advantageous for the device 6000 to include a plurality of orifices 6002A configured to retain moisture and one or more orifices 6002B configured to reduce the flow resistance of the device 6000. For example, the device 6000 may be provided to include a first set of orifices 6002A having a first aperture size or diameter and a second set of orifices 6002B having a second aperture size or diameter, the second size or diameter being larger than the first size.

[0289] For example, the first set of orifices 6002A, which can be configured to exchange moisture, can be configured with a diameter between approximately 0.05 mm and approximately 1 mm, such as approximately 0.1 mm to approximately 0.5 mm. In some examples, the first set of orifices 6002A may include a plurality of different orifices between 0.05 mm and 1 mm. In some examples, the first set of orifices may be characterized by a pore density between approximately 30 PPI and 150 PPI, such as between approximately 40 PPI and 80 PPI, such as approximately 60 PPI.

[0290] In some examples, when measured at a flow rate of 100 L / min, the size or dimension of the second set of orifices 6002B, which can be configured to reduce flow resistance, can be set to provide a total pressure drop of less than 5 cmH2O through the device 6000. For example, when measured at a flow rate of 100 L / min, it may be advantageous for the device 6000 to be configured to provide a pressure drop of less than 3 cmH2O or less than 1 cmH2O. For example, the dimensions of the second set of orifices 6002B can be between approximately 1 mm and approximately 5 mm, such as between approximately 1.5 mm and approximately 3 mm, such as between 2 mm and 2.5 mm. In some examples, the second set of orifices is characterized by a pore density of less than 20 PPI.

[0291] The second set of holes 6002B can be formed during the production of material in the production apparatus 6000, for example, by expanding foam around one or more pillars whose dimensions match the desired size of the holes 6002B. Alternatively, the holes 6002B can be formed after the material has been produced, such as by stamping, drilling, or cutting processes.

[0292] The orifices 6002B can be evenly distributed around the device, such as in a grid or geometric pattern, or have a fixed spacing with adjacent orifices 6002B. In other examples, the orifices 6002B can be positioned to provide controlled airflow within the patient interface 3000. For example, the orifices 6002B can be positioned in areas of the device 6000 to aid in CO2 removal, such as areas within the inflation chamber with the lowest total airflow rate.

[0293] Therefore, in one example of this technology, device 6000 may include a first set of orifices 6002A configured for exchanging heat and / or moisture between the patient's exhaled and inhaled gases, and a second set of orifices larger than the first set to reduce flow resistance of the device. In some examples, the second set of orifices may be positioned to facilitate or increase airflow in certain areas of the patient interface, such as below the patient's mouth, the bridge of the nose area, one or more cheek areas, one or more sides of the nose area, and one or more corners of the patient interface.

[0294] Furthermore, the device 6000 can be shaped such that its periphery substantially conforms to the inner surface of the inflation chamber 3200 to provide a secure fit within the patient interface 3000. The device 6000 can be secured to the interior of the inflation chamber 3200 by friction fit, press fit, snap fit, adhesive, molding and / or clips or other attachment structures. Optionally, the device 6000 can be integrally formed with the inflation chamber 3200, such that both the device 6000 and the inflation chamber 3200 comprise a single piece made of a homogeneous and continuous material.

[0295] According to a further example, device 6000 may be formed of a material that does not absorb heat or resists heat absorption, and / or device 6000 may be non-hygroscopic or resist moisture absorption. The material of device 6000 may be any of the group consisting of nylon, polycarbonate, silicone, polyurethane, thermoplastic elastomers, hydrophobic polymers, and other synthetic materials. Optionally, device 6000 may include a material forming a heat and moisture exchanger, such as paper. However, in this case, device 6000 may be too thin to effectively exchange heat and moisture to provide a predetermined level of humidification. Therefore, device 6000 may rely primarily on its ability to guide the flow of breathable gas 7000 to reduce turbulence in the flow toward the mucosal surface of the patient's airway 1004, thereby reducing dryness of the mucosal surface.

[0296] According to one example of the present technology, in one form, the device 6000 may be less than 1 cm thick. According to another example of the present technology, the device 6000 may be less than 0.5 cm thick. According to yet another example of the present technology, the device 6000 may be less than 1 mm thick. The device 6000 may occupy a small volume within the inflation chamber 3200 to reduce its impact on the breathable gas flow 7000, the exhaled gas flow 7002 from the patient, and / or the ventilation flow 7004. The device 6000 may reduce dryness of the mucosal surface of the patient's airway 1004 to avoid respiratory discomfort, achieving the same effect as powered humidification or the use of an HME. However, the device 6000 will not require any external power source, and when compared to an HME that can provide a similar level of respiratory comfort through heat and moisture exchange, the device 6000 can occupy a significantly smaller size and volume. Occupying a smaller volume may have the effect of reducing the flow resistance of the breathable gas 7000, which results in pressure loss during RPT for the treatment of SDB. The smaller device 6000 also has reduced resistance to the exhaled airflow 7002 and / or the CO2-clearing airflow 7004 flowing towards the ventilation port 3400. Furthermore, compared to using an in-mask HME, the smaller device 6000 allows for additional space to accommodate a portion of the patient's face within the patient interface 3000.

[0297] In one embodiment, the material of device 6000 may include a humectant. For example, the humectant may be coated, bonded, or impregnated, and is configured to promote condensation formation on the material surface. For instance, the humectant may be a biocompatible hydrophilic material, such as calcium chloride or polyethylene glycol. In some examples of this technology, the humectant may constitute 2% to 20% of the device material.

[0298] In one form, the device 6000 may be made of molded foam material. For example, the foam may be a hygroscopic and / or hydrophilic foam. In an example, the foam may be an open-cell foam. For example, the device may include an open-cell absorbent and / or hydrophilic polyurethane foam.

[0299] In one embodiment, the device 6000 can be configured to maintain a moisture concentration in the air inhaled by the patient at 10 mg / L or higher. For example, in one example, the device 6000 can be configured to maintain a moisture concentration in the inhaled air at 15 mg / L or higher, or in some examples, at 18 mg / L or higher. In some examples of this technology, a moisture concentration greater than one of the aforementioned levels may be advantageous to minimize potential dryness of the patient's airway during use.

[0300] In practice, exhaled air from a patient's airway may have a moisture concentration between approximately 40 mg / L and 50 mg / L, and in this example of the technique, maintaining this moisture concentration as high as possible may be advantageous to prevent or reduce airway dryness, potentially increasing patient comfort and compliance.

[0301] In one configuration, the device 6000 can be configured to provide a pressure drop of less than 5 cmH2O when measured at an airflow rate of 100 L / min. For example, it may be advantageous for the device 6000 to be configured to provide a pressure drop of less than 3 cmH2O or less than 1 cmH2O when measured at an airflow rate of 100 L / min. Reducing or minimizing the pressure drop caused by the device 6000 can advantageously improve patient comfort and compliance and reduce the effort required to breathe through the device 6000.

[0302] In examples of techniques where device 6000 is provided within a patient interface, the size and thickness of device 6000 can be adjusted to achieve any or more of the aforementioned moisturizing and flow resistance parameters described herein. For example, when positioned within a patient interface, the size of device 6000 can match the inner bore of connection port 3600. In other examples, device 6000 can be spaced relative to connection port 3600, such as an air gap between connection port 3600 and device 6000 of approximately 1 mm and approximately 10 mm, such as 5 mm. In larger masks, such as full-face masks, the air gap between connection port 3600 and device 6000 can be between 5 mm and 10 mm, while in nasal interfaces, the air gap between connection port 3600 and device 6000 can be between 1 mm and 5 mm.

[0303] In an example of a technology that provides multiple connection ports 3600, a device 6000 may be configured to be located in an airflow path between each connection port 3600 and the patient's airway, or alternatively, multiple devices 6000 may be provided, such as one for each connection port 3600.

[0304] The device 6000 is located in a full enclosure near, inside, or otherwise in contact with the connection port 3600. The device can be configured with a width between approximately 20 mm and 50 mm, a height between 20 mm and 50 mm, and a thickness between 2 mm and 10 mm. For example, the dimensions of the device 6000 can be designed to engage with and / or attach to the connection port 3600.

[0305] The device 6000 is positioned in a full-face mask in an inflatable chamber in an arrangement spaced apart from the connection port 3600. The device 6000 can be configured to have a width between 20 mm and 70 mm, a height between 20 mm and 100 mm, and a thickness between 2 mm and 5 mm.

[0306] In which device 6000 is positioned near, inside, or otherwise in contact with connection port 3600 in a nasal mask, the device may be configured to have a width between approximately 10 mm and 25 mm, a height between 10 mm and 25 mm, and a thickness between 3 mm and 15 mm. For example, the dimensions of device 6000 may be designed to engage with and / or attach to connection port 3600.

[0307] The device 6000 is positioned in the nasal mask of the inflation chamber in an arrangement spaced apart from the connection port 3600. The device 6000 can be configured to have a width between 20 mm and 50 mm, a height between 20 mm and 50 mm, and a thickness between 2 mm and 10 mm.

[0308] The device 6000 can have any suitable shape, including square, rectangular, circular, or any other suitable geometry. For example, the device 6000 can be provided with an outer periphery that is complementary to the inner surface of the patient interface, such that the device engages with and is supported by the inner surface of the patient interface.

[0309] In one example of this technology, the device 6000 may have one or more of the following: a humectant concentration between about 7% and about 12%, a humectant rate of 13 to 20 mg / L, and a resistance that results in a pressure drop of less than 1 cmH2O at 100 L / min (e.g., between 0.3 cmH2O and 0.7 cmH2O).

[0310] In one example of this technology, the device 6000 may have a substantially circular or rectangular heat and moisture exchange material with a diameter, width, and / or height between approximately 24 mm and 28 mm. In the example, the thickness of the heat and moisture exchange material may be between 8 mm and 12 mm, such as substantially 10 mm.

[0311] In one example of this technology, the device 6000 may have a substantially circular or rectangular heat and moisture exchange material with a diameter, width, and / or height between approximately 8 mm and 15 mm. In the example, the thickness of the heat and moisture exchange material may be between 8 mm and 12 mm, such as substantially 10 mm.

[0312] Figure 11 The increase in mean absolute humidity is shown when measured in the rear chamber 6006 of the patient interface 3000 including the device 6000 during use. As shown, absolute humidity was measured in the patient interface 3000 near the inlet of the patient airway 1004, wherein: 1) a patient interface 3000 without the device 6000, 2) a patient interface 3000 including the device 6000 (which includes HME material), and 3) a patient interface 3000 including the device 6000 (which is in the form of a non-heat-absorbing or non-moisture-absorbing woven material). Results show a significant increase in absolute humidity, with optimal results observed when the patient interface includes the device 6000 in the form of a non-heat-absorbing or moisture-absorbing woven material that does not absorb heat or resists the absorption of heat and moisture.

[0313] Figure 12A and Figure 12B A test apparatus or model 3900 is shown for measuring the turbulence of a breathable gas flow 7000 in a simulated patient interface system with and without device 6000. The test apparatus 3900 includes a simulated inlet 1002 for a patient airway, a simulated ventilation port 3400, and a simulated connection port 3600. The volume of the test apparatus 3900 can also be understood as being at least partially defined by a simulated form of a sealing structure 3100 and an inflation chamber 3200. In other words, the test apparatus 3900 can be understood as simulating a breathing chamber at least partially defined by the sealing structure 3100 and the inflation chamber 3200 when placed against a patient's face.

[0314] Figures 13A to 16B Results of measuring turbulence or flow in test apparatus 3900 using computational fluid dynamics programs are shown. The results demonstrate that, in test apparatus 3900 including device 6000, device 6000 can significantly reduce gas turbulence compared to test apparatus 3900 without device 6000. Although Figure 12A and Figure 12B The test apparatus 3900 with device 6000 is shown, but it should be understood that... Figure 13A , Figure 14A , Figure 15A and Figure 16A Flow modeling was depicted in test apparatus 3900 excluding device 6000, while Figure 13B , Figure 14B , Figure 15B and Figure 16B Flow modeling in a test apparatus 3900 with device 6000 is shown.

[0315] Figure 13A and Figure 13B The airflow velocities in the test device 3900 with and without device 6000 are shown respectively. In this simulation, the patient's exhaled airflow 7002 through the simulation inlet 1002 is zero, and there is a breathable gas flow 7000 entering the test device 3900 through the connection port 3600. Figure 13B As shown, when the test apparatus 3900 includes the apparatus 6000, the turbulence in the rear chamber 6006 is reduced relative to the front chamber 6004.

[0316] Figure 14A and Figure 14B The airflow velocities in the test device 3900 with and without device 6000 are shown respectively. In this simulation, the patient's exhaled airflow 7002 through the simulation inlet 1002 is positive, that is, the patient is exhaling, and there is a breathable gas flow 7000 entering the test device 3900 through the connection port 3600. Figure 13B As shown, when the test apparatus 3900 includes the apparatus 6000, the turbulence in the rear chamber 6006 is reduced relative to the front chamber 6004.

[0317] Figure 15A and Figure 15B The airflow streamlines in the test device 3900 with and without device 6000 are shown respectively. In this simulation, the patient's exhaled airflow 7002 through the simulation inlet 1002 is zero, and there is a breathable gas flow 7000 entering the test device 3900 through the connection port 3600. Figure 15B As shown, when the test apparatus 3900 includes the apparatus 6000, the turbulence in the rear chamber 6006 is reduced relative to the front chamber 6004.

[0318] Figure 16A and Figure 16B The airflow streamlines in the test device 3900 with and without device 6000 are shown respectively. In this simulation, the patient's exhaled airflow 7002 through the simulation inlet 1002 is positive, that is, the patient is exhaling, and there is a breathable gas flow 7000 entering the test device 3900 through the connection port 3600. Figure 16B As shown, when the test apparatus 3900 includes the apparatus 6000, the turbulence in the rear chamber 6006 is reduced relative to the front chamber 6004.

[0319] 5.3.11 Modularization

[0320] As mentioned above, the pads, hoods, and sleeves can be of different types, which can correspond to different uses (e.g., mouth breathing, nose breathing, etc.). Patients or clinicians can choose certain combinations of pads, hoods, and sleeves to optimize the effectiveness of the therapy and / or the comfort of the individual patient. An example of such a modular design is described in PCT / SG2022 / 050777, filed on 28 October 2022, the entire contents of which are incorporated herein by reference.

[0321] In some forms, different types of pads, caps, and sleeves can be used interchangeably to create different combinations of patient interfaces. This can be advantageous from a manufacturing perspective, as it allows for the creation of a greater variety of patient interfaces using fewer parts. Additionally or optionally, various combinations can allow patients to change the type of patient interface without altering each component.

[0322] Air can be delivered to the patient in one of two main ways. In one example, the patient can be delivered through a head cannula 3350 (e.g., see...). Figure 3B This receives a pressurized airflow. This can be referred to as a "tube-up" configuration, and the connection port can be positioned at the top of the patient's head. In other examples, the patient can be connected via a catheter to the inflation chamber 3200 (e.g., via connection port 3600 (e.g., see...)). Figure 3B This receives a pressurized airflow. This can be called a "tube-down" configuration, where the airflow duct is located in front of the patient's face. Different patients are more comfortable with one type of air delivery than another (e.g., due to the patient's sleep type). Therefore, it may be beneficial to allow the use of a single type of patient interface in either a "tube-up" or "tube-down" configuration.

[0323] The patient interface can be part of a modular component with various interchangeable parts, which patients and / or clinicians can swap out for one or more components of different types. The following describes the various combinations that can be produced by assembling the different parts together.

[0324] 5.3.11.1 Sleeve

[0325] In some configurations, to allow for modularity, the sleeve can be used with the tube 3350 and / or the hardener arm 3340. The sleeve may at least partially surround the tube 3350 and / or the hardener arm 3340. For example... Figures 17G to 17I As shown, sleeves of different shapes can be used, corresponding to different types of positioning and stabilization structures 3300. In some forms, the sleeve can be customized to fit a specific user's face. For example, the sleeve can be positioned in a relatively posterior area of ​​the patient's head.

[0326] In some forms, the sleeve can be made of comfort materials. For example, the sleeve can be made of textile materials, foam materials, or a combination of both. Comfort materials can come into contact with the patient during use and feel soft against the patient's skin, thereby improving patient compliance.

[0327] The material can also be flexible to facilitate the donning or removal of the sleeve from the tube 3350 or the hardener arm 3340. For example, the material may allow the sleeve to bend to conform to the shape of the tube or catheter head cap 3350 or the hardener arm 3340, which can be adapted to the shape of an individual patient's head.

[0328] In some forms, the sleeve may also be at least partially elastic (e.g., the material may allow the sleeve to stretch). The elastic material can help the sleeve stretch to fit around the tube 3350 or hardener arm 3340. The elastic material can then return to its initial position, which is in close contact with the tube 3350 or hardener arm 3340, to limit sleeve slippage during use.

[0329] As described in more detail below, some forms of the sleeve can be specifically designed for hardening elements (e.g., tube 3350 and / or hardener arm 3340). However, the sleeve can facilitate interchangeable connection of the hardening element with versions or types of pads (e.g., mouth and nose pad 3050-1, nose pad only 3050-2, etc.).

[0330] 5.3.11.1.1 Catheter sleeve

[0331] like Figure 17G As shown, one example of a sleeve is a catheter sleeve 3351, which can be used with the tube 3350 described above.

[0332] like Figure 17G As shown, the catheter sleeve 3351 may include similar components. Figure 17C The tube 3350 shown is in a curved shape. The flexible material used to construct the catheter sleeve 3351 allows the catheter sleeve 3351 to be further bent to correspond to the shape of the tube 3350 (e.g., when worn by a patient).

[0333] In some forms, the catheter sleeve 3351 may include a first or upper opening 3352. The upper opening 3352 may be disposed at one end of the catheter sleeve 3351. The upper opening 3352 may be an opening of a channel extending along at least a portion of the catheter sleeve 3351.

[0334] like Figure 17GAs shown, some forms of the catheter sleeve 3351 may also include a lower extension 3354. The lower extension 3354 may be positioned on the end of the catheter sleeve 3351 opposite to the upper opening 3352. The catheter sleeve 3351 may be customized to fit a particular user's face. For example, the lower extension 3354 of the catheter sleeve 3351 may be configured in a relatively posterior or relatively anterior region of the patient's head.

[0335] Some forms of the lower extension 3354 may include a rigid or semi-rigid member (e.g., within the sleeve 3351). The rigid or semi-rigid member may be made of a plastic material or a similar material. Alternatively, the lower extension 3354 may be hardened using manufacturing processes (e.g., stitching hardened threads, plain knitting, using a thicker material).

[0336] like Figure 17G As shown, some forms of the lower extension 3354 may include a connecting member 3356. In the illustrated example, the connecting member 3356 may be a magnet, although in other examples, the connecting member 3356 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3356 may also be positioned at one end of the lower extension 3354, although the connecting member 3356 may also be positioned anywhere along the lower extension 3354.

[0337] In some forms, the connecting member 3356 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the conduit sleeve 3351 is connected to the tube 3350 (e.g., see...). Figure 17J-1 When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3356 to provide tension.

[0338] 5.3.11.1.2 Four-point arm sleeve

[0339] like Figure 17H As shown, another example of the sleeve is the four-point arm sleeve 3380, which can be used with the hardener arm 3340 described above.

[0340] like Figure 17H As shown, the four-point arm sleeve 3380 may include similar components. Figure 17D The curvature arm 3340 shown is curved in shape. The flexible material used to construct the four-point arm sleeve 3380 allows the four-point arm sleeve 3380 to be further bent to correspond to the shape of the curvature arm 3340 (e.g., when worn by a patient and / or bent by a patient).

[0341] like Figure 17HAs shown, some forms of the four-point arm sleeve 3380 may include a lower extension 3384. The lower extension 3384 may be located at one end of the four-point arm sleeve 3380.

[0342] In the example shown, the shape and / or structure of the lower extension 3384 is substantially the same as that of the lower extension 3354. For example, the lower extension 3384 may be more rigid than the rest of the four-point arm sleeve 3380 (e.g., due to rigidification of the thread or rigid material).

[0343] like Figure 17H As shown, some forms of the lower extension 3384 may include a connecting member 3386. In the illustrated example, the connecting member 3386 may be a magnet, although in other examples, the connecting member 3386 may be different types of connectors (e.g., mechanical fasteners, adhesives, hook and ring materials, etc.). The connecting member 3386 may also be positioned at one end of the lower extension 3384, although the connecting member 3386 may also be positioned anywhere along the lower extension 3384.

[0344] In some forms, the connecting member 3386 (e.g., a magnet) can be removably connected to the magnet 3370-1 of the headgear 3302-1. For example, when the four-point arm sleeve 3380 is connected to the hardener arm 3340 (e.g., see...), Figure 17K When connected to the lower band 3304-1, the magnet 3370-1 can be removably connected to the connecting member 3386 to provide tension.

[0345] like Figure 17H As shown, the four-point arm sleeve 3380 may include a pair of tabs 3394, which may be similar to the tabs 3320 on the tube 3350. When a patient wears the four-point arm sleeve 3380, the tabs 3394 may be positioned on the patient's head at a position substantially the same as the position of the tabs 3320 when the patient wears the tube 3350.

[0346] 5.3.11.1.3 Two-point arm sleeve

[0347] like Figure 17I As shown, another example of a sleeve is the two-point arm sleeve 3380-1, which can be used with the hardener arm 3340 described above.

[0348] In some forms, the two-point arm sleeve 3380-1 can be similar to the four-point arm sleeve 3380 described above. Only some similarities and differences are described below.

[0349] like Figure 17IAs shown, the two-point arm sleeve 3380-1 may include a lower opening 3388-1 located at one end of the two-point arm sleeve 3380-1. The lower opening 3388-1 may form an opening for a channel passing through the two-point arm sleeve 3380-1. In the example shown, the lower opening 3388-1 may lead to the surface of the conduit sleeve 3380-1.

[0350] like Figure 17I As shown, the two-point arm sleeve 3380-1 may include a pair of tabs 3394-1, which may resemble the tabs 3320 on the tube 3350. When a patient wears the two-point arm sleeve 3380-1, the tabs 3394-1 may be positioned on the patient's head at a position substantially the same as the position of the tabs 3320 when the patient wears the tube 3350.

[0351] 5.3.11.2 Assembled Patient Interface

[0352] like Figures 17J-1 to 17M As shown, the various components described above can be combined to form four different patient interfaces. Different patient interfaces allow patients to use different types based on their individual comfort levels. The modularity of the different components (e.g., the ability to use multiple types of patient interfaces) simplifies manufacturing and / or allows patients to switch more easily between different types of patient interfaces.

[0353] 5.3.11.2.1 Nasal mask tube upward structure

[0354] like Figure 17J-1 and Figure 17J-2 As shown, the patient can wear a pad 3050-1 with a tube 3350 and a four-point head covering 3302-1 constructed with the tube facing upwards. This assembly forms a tube-up nose and mouth patient interface 3000-1.

[0355] In some configurations, the catheter sleeve can be used with tube 3350 to allow the patient to experience a "tube-up" air delivery type with mouth and nose pads 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, other types of connectors besides the catheter sleeve may be used.

[0356] 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 3370-1 of the four-point sleeve 3302-1 (see, for example, [link to example]). Figure 17E Alternatively, different connection methods can be used.

[0357] As shown in Figure 17J, the four-point headgear 3302-1 can be connected at four separate locations to provide tension for holding the pad 3050-1 in a sealed position on the patient's head.

[0358] 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.

[0359] In some examples, a device 6000 configured to exchange heat and / or moisture between the patient's exhaled air and the patient's inhaled air may be located in one or more head sleeves 3350, for example, a first device 6000 located in a first head sleeve 3350 extending on a first side of the patient's face during use, and a second device 6000 located in a second head sleeve 3350 located on a second side of the patient's face during use.

[0360] In another example, the device 6000 may be located in or near one or more inflation chamber inlet ports 3254-1. For example, see reference... Figure 17A-2 The first device 6000 may be attached to the first chamber entrance port 3254-1, and the second device 6000 may be attached to the second chamber entrance port 3254-1. In some examples, the device 6000 may be releasably attached as described herein.

[0361] In another example, the device 6000 may be located at or near the inlet 3332, for example, the device 6000 may be configured to be releasably attached to the inlet 3332. By providing the device 6000 attached to or otherwise located in the inlet 3332, this technology can be provided with a single device 6000, without the need to provide a device in each inflation chamber inlet port 3254-1 or each head sleeve 3350.

[0362] In another example, such as Figure 17A-3 As shown, and as Figure 17K As part of the system, device 6000 may be located in or near ventilation opening 3402-1 or connection port 3600.

[0363] Alternatively, as described herein, the device 6000 may be positioned in the inflation chamber 3200 or otherwise attached to the inflation chamber 3200.

[0364] 5.3.11.2.2 Nasal mask tube downward construction

[0365] like Figure 17KAs shown, the patient can wear a pad 3050-1 with a tube-down construction, featuring a hardener arm 3340 and a four-point headgear 3302-1. This assembly forms a tube-down nose and mouth patient interface 3000-2.

[0366] In some configurations, the catheter sleeve can be used with the sclerotherapy arm 3340 to allow patients to experience a “tube-down” air delivery type with the mouth and nose pad 3050-1. As described below, the catheter sleeve provides additional connection points for attaching the four-point headgear 3302-1. However, other types of connectors besides the catheter sleeve may be used.

[0367] In the example shown, the conduit sleeve can be connected to the hardener arm 3340 of the positioning and stabilizing structure 3300. The hardener arm 3340 (via conduit connection structure 3504) can be used to connect the hardener arm 3340 to the liner 3050-1. The conduit sleeve provides a magnet for connection to the magnet 3370-1 of the four-point head sleeve 3302-1 (see, for example, [link to example]). Figure 17E Alternatively, different connection methods can be used.

[0368] like Figure 17K As shown, the four-point headgear 3302-1 can be connected in four separate positions to provide tension for holding the pad 3050-1 in a sealed position on the patient's head.

[0369] 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.

[0370] In the patient-facing interface, for example Figure 3A , Figure 3B and Figure 17K The devices 6000 shown, configured to exchange heat and / or moisture between the patient's exhaled air and the patient's inhaled air, may be located in or otherwise attached to the connection port 3600, such as... Figure 17A-3 As shown in the diagram. For example, the device 6000 can be configured to be releasably attached to the connection port 3600 or the vent opening 3402-1.

[0371] In other examples, device 6000 may be disposed in or otherwise attached to air circuit 4170. Alternatively, as described herein, device 6000 may be located in or otherwise attached to inflation chamber 3200.

[0372] 5.3.11.2.3 Nasal mask tube upward structure

[0373] like Figure 17L As shown, the patient can wear a pad 3050-2 with a tube 3350 and a two-point head covering 3302-2 constructed with the tube facing upwards. This assembly can form a tube-up, nasal-only patient interface 3000-3.

[0374] The catheter sleeve can be used with the tube 3350 and can provide additional comfort to the patient. The sleeve can be connected to the positioning and stabilizing structure 3300 on 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.

[0375] like Figure 17L As shown, the two-point headgear 3302-2 can be connected to the tab 3320 on the tube 3350 to provide tension for holding the pad 3050-2 in a sealed position on the patient's head.

[0376] As discussed with respect to the patient interface 3000 with an upward-facing nose and mouth tube configuration, the device 6000 may be positioned or otherwise attached to any one or more of the following: head tube 3350, inflation chamber inlet port 3254-1, or inlet 3332; see, for example, [link to relevant documentation]. Figure 17B-2 and Figure 17B-3 .

[0377] Alternatively, as described herein, the device 6000 may be located in the inflation chamber 3200 or otherwise attached to the inflation chamber 3200.

[0378] 5.3.11.2.4 Nasal mask tube downward construction

[0379] like Figure 17M As shown, the patient can wear a pad 3050-2 with a tube-up configuration, featuring a hardener arm 3340 and a two-point headgear 3302-2. This assembly can form a tube-down, nasal-only patient interface 3000-4.

[0380] The catheter sleeve can be used with the sclerosing arm 3340 and can provide additional patient comfort. The sleeve can be connected to the positioning and stabilizing structure 3300 on the liner 3050-2 without adding an additional connection point. In the example shown, the sclerosing arm 3340 of the positioning and stabilizing structure 3300 can be directly connected to the liner 3050-2.

[0381] like Figure 17M As shown, the two-point headgear 3302-2 can be connected 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.

[0382] In the patient-to-tub interface, such as Figure 17M The devices 6000 shown, configured to exchange heat and / or moisture between the patient's exhaled air and the patient's inhaled air, can be positioned in or otherwise attached to the connection port 3600, such as... Figure 17B-3 As shown. For example, device 6000 can be configured to be releasably attached to connection port 3600.

[0383] In other examples, device 6000 may be disposed in or otherwise attached to air circuit 4170. Alternatively, as described herein, device 6000 may be located in or otherwise attached to inflation chamber 3200.

[0384] 5.3.11.2.5 Component Modularization

[0385] Figure 17P This illustrates how different components can be combined to form the four different patient interfaces described above. As shown, different parts can be reused for different types of patient interfaces. This allows for easier manufacturing and assembly because a large number of the same parts can be produced and used in multiple types. The only part not used in multiple types could be a sleeve. However, sleeves are easier to manufacture. Figure 17O A portion of the air circuit 4170 that can interface with a patient is shown, while Figure 17N This demonstrates interchangeable replacements based on the type of patient interface. Figure 17O The air vent 3404 of the air circuit shown.

[0386] 5.4RPT device

[0387] According to one aspect of the present technology, an RPT device 4000 includes mechanical and pneumatic components 4100, electrical components 4200, and is programmed to execute one or more algorithms 4300. The RPT device may have an outer housing 4010 formed by 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 chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0388] The pneumatic path of the RPT device 4000 may include one or more air path objects, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet silencer 4124, and one or more transducers 4270, such as a pressure sensor 4272 and a flow sensor 4274.

[0389] One or more of the air path objects 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 chassis 4016.

[0390] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller 4230, a therapy device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. Alternatively, the RPT device 4000 may include more than one PCBA 4202.

[0391] 5.4.1 Mechanical and pneumatic components of the RPT device

[0392] The RPT device may include one or more of the following components in an overall unit. In an alternative form, one or more of the following components may be positioned as respective individual units.

[0393] 5.4.1.1 Air Filter

[0394] One form of RPT device according to the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0395] exist Figure 4B In one configuration shown, the inlet air filter 4112 is located at the beginning of the pneumatic path upstream of the pressure generator 4140. See figure.

[0396] exist Figure 4B In one embodiment shown, an outlet air filter 4114 (e.g., an antibacterial filter) is located between the outlet of the pneumatic block 4020 and the patient interface 3000 or 3800.

[0397] 5.4.1.2 Muffler

[0398] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0399] In one form of this technology (for example, see...) Figure 4B The inlet silencer 4122 is located in the pneumatic path upstream of the pressure generator 4140. See figure.

[0400] 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.

[0401] 5.4.1.3 Pressure Generator

[0402] 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. These 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 per 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.

[0403] The pressure generator 4140 can be controlled by the therapy device controller 4240.

[0404] 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.

[0405] 5.4.1.4 Transducer

[0406] 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. The external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to or from the RPT device.

[0407] In one form of this technology (see example) Figure 4B One or more transducers 4270 are located upstream and / or downstream of pressure generator 4140. One or more transducers 4270 may be configured and arranged to generate signals representing characteristics of airflow, such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0408] In one form of this technology, one or more converters 4270 may be located near the patient interface 3000 or 3800.

[0409] In one embodiment, the signal from transducer 4270 may be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0410] 5.4.1.4.1 Flow Sensor

[0411] The flow sensor 4274 according to this technology can be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION.

[0412] In one configuration, a signal generated by flow sensor 4274 and representing flow velocity, such as the total flow velocity Qt from flow velocity sensor 4274, is received by central controller 4230.

[0413] 5.4.1.4.2 Pressure Sensor

[0414] The pressure sensor 4272 according to this technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure sensor is the converter from the HONEYWELL ASDX series. Another suitable pressure sensor is the converter from the GENERALELECTRIC NPA series.

[0415] In one configuration, the signal generated by pressure sensor 4272 and representing pressure is received by central controller 4230.

[0416] 5.4.1.4.3 Motor speed transducer

[0417] In one embodiment of this technology, a motor speed transducer 4276 is used to determine the rotational speed of a motor 4144 and / or a blower 4142. The motor speed signal from the motor speed transducer 4276 can be provided to a therapy device controller 4240. The motor speed transducer 4276 can be, for example, a speed sensor, such as a Hall effect sensor.

[0418] 5.4.1.5 Anti-overflow valve

[0419] like Figure 4B As shown, in one form of this technology, an anti-backflow valve 4160 is located 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 (e.g., to the motor 4144).

[0420] 5.4.1.6 Air Circuit

[0421] According to one aspect of the technology, 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 pneumatic block 4020 and the patient interface 3000.

[0422] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block and the patient interface. This air circuit can be referred to as an air delivery tube. In some cases, separate branches of the circuit may exist for inhalation and exhalation. In other cases, a single branch is used.

[0423] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit, for example, to maintain or raise the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as temperature sensors. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may communicate with a controller such as a central controller 4230 or a humidifier controller 5250. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0424] 5.4.1.7 Oxygen Delivery

[0425] In one form of this technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path (such as upstream of pneumatic block 4020), to air circuit 4170, and / or to patient interface 3000.

[0426] 5.4.2 Electrical components of the RPT device

[0427] 5.4.2.1 Power Supply

[0428] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0429] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of this technology, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0430] 5.4.2.2 Input Device

[0431] 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 an external housing 4010 in one form, or wirelessly communicate with a receiver electrically connected to a central controller 4230 in another form.

[0432] In one form, the input device 4220 may be constructed and arranged to allow a person to select values ​​and / or menu options.

[0433] 5.4.2.3 Central Controller

[0434] In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.

[0435] Suitable processors may include x86 Intel processors, based on those from ARM Holdings. -M processors, such as the STM32 series microcontrollers from STMicroelectronics. In some alternative forms of this technology, 32-bit RISC CPUs (such as the STR9 series microcontrollers from STMicroelectronics) or 16-bit RISC CPUs (such as processors from the MSP430 series microcontrollers manufactured by Texas Instruments) may also be used.

[0436] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0437] In one form, the central controller 4230 is an application-specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0438] The central controller 4230 can be configured to receive input signals from one or more transducers 4270 and one or more input devices 4220.

[0439] The central controller 4230 can be configured to provide output signals to one or more of the output device 4290, pressure generator 4140, therapy device controller 4240, data communication interface 4280 and / or humidifier controller 5250.

[0440] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 that can be implemented using processor control instructions, which are represented as a computer program stored in a non-transient computer-readable storage medium (such as memory 4260). In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remotely located device. For example, a remotely located device may determine the control settings of the ventilator or detect respiratory-related events by analyzing stored data (e.g., from any sensors described herein).

[0441] 5.4.2.4 Clock

[0442] RPT device 4000 may include a clock 4232 connected to central controller 4230.

[0443] 5.4.2.5 Therapeutic Device Controller

[0444] In one form of this technology, the therapeutic device controller 4240 is a control module 4330 that forms part of an algorithm 4300 executed by a central controller 4230.

[0445] In one form of this technology, the therapy device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0446] 5.4.2.6 Protection Circuit

[0447] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0448] 5.4.2.7 Memory

[0449] According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0450] The memory 4260 can be located on PCBA 4202. The memory 4260 can be in the form of EEPROM or NAND flash memory.

[0451] Additionally or optionally, the RPT device 4000 includes a removable memory 4260, such as a memory card manufactured according to the Secure Digital (SD) standard.

[0452] In one form of the present technology, memory 4260 acts as a non-transitory computer-readable storage medium storing computer program instructions, such as one or more algorithms 4300, representing one or more methods described herein.

[0453] 5.4.2.8 Data Communication System

[0454] In one form of this technology, a data communication interface 4280 is provided, which is connected to a central controller 4230 (see, for example, [link to relevant documentation]). Figure 4BThe data communication interface 4280 can be connected to a remote external communication network 4282 and / or a local external communication network 4284. The remote external communication network 4282 can be connected to a remote external device 4286. The local external communication network 4284 can be connected to a local external device 4288.

[0455] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0456] In one form, the remote external communication network 4282 is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0457] In one form, the local external communication network 4284 utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0458] In one form, the remote external device 4286 is one or more computers, such as a cluster of networked computers. In another form, the remote external device 4286 may be a virtual computer rather than a physical computer. In either case, such a remote external device 4286 may be accessed by an appropriately authorized person, such as a clinician.

[0459] The local external device 4288 can be a personal computer, mobile phone, tablet or remote control device.

[0460] 5.4.2.9 Includes optional display and alarm output devices.

[0461] The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0462] 5.4.2.9.1 Display Driver

[0463] Display driver 4292 receives characters, symbols, or images to be displayed on monitor 4294 as input and converts them into commands that cause monitor 4294 to display those characters, symbols, or images.

[0464] 5.4.2.9.2 Monitor

[0465] The display 4294 is configured to visually display characters, symbols, or images in response to commands received from the display driver 4292. For example, the display 4294 may be an eight-segment display, in which case the display driver 4292 converts each character or symbol (e.g., figure “0”) into eight logic signals that indicate whether to activate eight corresponding segments to display a specific character or symbol.

[0466] 5.5 Humidifier

[0467] 5.5.1 Overview of Humidifiers

[0468] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas 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 the airflow is delivered to the patient's airway.

[0469] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some forms, such as Figure 5A and Figure 5B 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, which is adapted to house the humidifier reservoir 5110 and includes a heating element 5240.

[0470] 5.5.2 Humidifier Components

[0471] 5.5.2.1 Water Storage Tank

[0472] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to contain or retain a volume of liquid to be evaporated (e.g., water) to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum volume of water to provide adequate humidification at least for the duration of a respiratory therapy session, such as an overnight 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.

[0473] According to one aspect, the water reservoir 5110 is 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's travel in a curved path through the reservoir 5110 while in contact with the water contained therein.

[0474] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.

[0475] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any orifice and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating 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.

[0476] 5.5.2.2 Conductivity Component

[0477] 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 plastic. In some cases, suitable thermal conductivity can be achieved using materials with appropriate geometries and lower thermal conductivity.

[0478] 5.5.2.3 Humidifier reservoir base

[0479] In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B As shown, the humidifier reservoir base 5130 is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include locking features, such as a locking lever 5135 configured to retain the reservoir 5110 in the humidifier reservoir base 5130.

[0480] 5.5.2.4 Water level indicator

[0481] The humidifier reservoir 5110 may include, for example: Figures 5A to 5BThe water level indicator 5150 is shown. In some forms, the water level indicator 5150 can provide a user (such as a patient 1000 or a caregiver) with one or more indications of the amount of water in the humidifier reservoir 5110. One or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof (such as 25%, 50%, 75%), or a volume such as 200 ml, 300 ml, or 400 ml.

[0482] 5.5.3 Humidifier electrical and thermal components

[0483] The humidifier 5000 may include a number of electrical and / or thermal components, such as those listed below.

[0484] 5.5.3.1 Humidifier Transducer

[0485] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210, replacing or additional to the transducer 4270 described above. The humidifier transducer 5210 may include, for example... Figure 5C One or more of the following are shown: air pressure sensor 5212, air flow sensor 5214, temperature sensor 5216, or humidity sensor 5218. The humidifier transducer 5210 can generate one or more output signals that can be transmitted to a controller (such as a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier transducer can be externally located to the humidifier 5000 (such as in the air circuit 4170) when communicating output signals to the controller.

[0486] 5.5.3.1.1 Pressure Transducer

[0487] As an addition to or replacement of the pressure sensor 4272 provided in the RPT device 4000, one or more pressure transducers 5212 may be provided to the humidifier 5000.

[0488] 5.5.3.1.2 Flow Transducer

[0489] As an addition to or replacement of the flow sensor 4274 provided in the RPT device 4000, one or more flow transducers 5214 may be provided to the humidifier 5000.

[0490] 5.5.3.1.3 Temperature Transducer

[0491] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the temperature of the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may also include a temperature sensor 5216 for detecting the ambient air temperature.

[0492] 5.5.3.1.4 Humidity Transducer

[0493] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 to detect the humidity of a gas, such as ambient air. In some forms, the humidity sensor 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensor may be an absolute humidity sensor or a relative humidity sensor.

[0494] 5.5.3.2 Heating element

[0495] 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 in the humidifier reservoir 5110 and / or to an airflow. 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 the layered heating element described in PCT patent application publication number WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0496] In some configurations, the heating element 5240 may be disposed within the humidifier base 5006, wherein heat can be supplied primarily to the humidifier reservoir 5110 via conduction, such as... Figure 5B As shown.

[0497] 5.5.3.3 Humidifier Controller

[0498] According to one arrangement of the present technology, the humidifier 5000 may include, for example: Figure 5C The humidifier controller 5250 is shown. In one form, the humidifier controller 5250 may be part of a central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that can communicate with the central controller 4230.

[0499] In one embodiment, the humidifier controller 5250 may receive measurements of characteristics (such as temperature, humidity, pressure, and / or flow rate) of water in, for example, airflow, reservoir 5110, and / or humidifier 5000 as input. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0500] like Figure 5C As shown, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heating air circuit controller 5254 configured to control the temperature of the heating air circuit 4171, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.

[0501] 5.6 Respiratory waveform

[0502] Figure 6 The diagram shows a typical respiratory waveform of a sleeping person. The horizontal axis represents time, and the vertical axis represents respiratory flow. Although parameter values ​​can vary, typical breathing can be approximated by the following: tidal volume Vt 0.5 L, inspiratory time Ti 1.6 seconds, peak inspiratory flow rate Qpeak 0.4 L / s, expiratory time Te 2.4 seconds, and peak expiratory flow rate Qpeak -0.5 L / s. The total duration of breathing, Ttot, is approximately 4 seconds. A person typically breathes at a rate of approximately 15 breaths per minute (BPM), with a tidal volume (Vent) of approximately 7.5 L / min. The typical duty cycle (the ratio of Ti to Ttot) is approximately 40%.

[0503] 5.7 Glossary

[0504] 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.

[0505] 5.7.1 General

[0506] 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.

[0507] Environment: In some forms of this technology, the term environment will be considered to mean (i) the exterior of the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0508] For example, relative to the environment of the humidifier humidity This could 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.

[0509] In another example, environment pressure It can be pressure directly around the body or pressure outside the body.

[0510] In some forms, the environment (e.g., acoustics) noiseThis can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0511] Continuous positive airway pressure (CPAP) therapy: CPAP therapy involves supplying air to the airway inlet at a continuous positive pressure relative to atmosphere. The pressure can remain approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during exhalation and slightly lower during inhalation. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing when such an indication is absent.

[0512] Patient: A person, whether or not they have a respiratory illness.

[0513] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure can be automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0514] 5.7.2 Aspects of the respiratory cycle

[0515] Apnea: According to some definitions, apnea is considered to occur when airflow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to have occurred when, despite the patient's efforts, some form of airway obstruction prevents airflow. Central apnea is considered to have occurred when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to have occurred when reduced or absent respiratory effort is accompanied by airway obstruction.

[0516] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0517] Duty cycle: The ratio of inhalation time Ti to total breathing time Ttot.

[0518] Effort (breathing): Breathing effort is the work that a person who breathes voluntarily tries to do.

[0519] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0520] Flow restriction: Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. If flow restriction occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow restriction. If flow restriction occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow restriction.

[0521] Types of flow-limited inhalation waveforms:

[0522] (i) Flattening: has an upward section, followed by a relatively flat section, followed by a downward section.

[0523] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0524] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0525] (Iv) Inverted chair shape: has a relatively flat portion, followed by a single local peak at the trailing edge.

[0526] Insufficient breathing: Preferably, insufficient breathing will be considered as a reduction in flow rate, rather than a cessation of flow. In one form, insufficient breathing can be considered to have occurred when the flow rate decreases below a threshold rate for a sustained period of time. Central insufficient breathing is considered to have occurred 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:

[0527] (i) The patient's breathing decreases by 30% for at least 10 seconds, plus an associated 4% desaturation; or

[0528] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% of associated desaturation or arousal.

[0529] Hyperventilation: The flow rate increases to a level higher than normal.

[0530] The inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow rate to the start of expiratory flow rate is considered the inspiratory portion of the respiratory cycle.

[0531] Patentity (airway): The degree to which the airway is open or the extent to which the airway is open. A patent airway is open. Airway patentness can be quantified, for example, a value (1) for patent and a value of zero (0) for closed (obstructed).

[0532] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0533] Peak flow (Qpeak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0534] Respiratory flow, airflow, patient airflow, respiratory airflow (Qr): These synonymous terms can be understood as the RPT device's estimate of respiratory airflow, as opposed to "true respiratory flow" or "true respiratory airflow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0535] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort.

[0536] (Inhalation) Time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0537] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0538] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0539] Typical recent ventilation: The recent ventilation values ​​tend to cluster around their respective values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0540] 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 may even decrease as the pressure differential across the upper airway increases (Starling resistance behavior).

[0541] Ventilation: A measurement of the total amount of gas exchanged by a patient's respiratory system. A measurement of ventilation can include one or both inspiratory flow rate and expiratory flow rate (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.

[0542] 5.7.3 RPT Device Parameters

[0543] Flow rate: The instantaneous volume (or mass) of air delivered per unit time. While flow rate and ventilation volume have the same volume or mass per unit time, flow rate is measured over a much shorter period of time. In some cases, the reference to flow rate will be a scalar, i.e., a quantity that has only magnitude. In other cases, the reference to flow rate will be a vector, i.e., a quantity that has both magnitude and direction. Flow rate can be nominally positive for the inspiratory portion of a patient's respiratory cycle and therefore negative for the expiratory portion. Flow rate will be given by the symbol Q. "Flow rate" is sometimes abbreviated as "flow". Total flow rate Qt is the flow rate of air leaving the RPT device. Tidal flow rate Qv is the flow rate of air leaving the vent to allow the clearance of exhaled gas. Leakage flow rate Ql is the flow rate leaking from the patient interface system. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0544] Leakage: The term "leakage" will be considered as an unintended flow of air. In one example, a leak might occur due to an incomplete seal between the mask and the patient's face. In another example, a leak might occur in a swivel bend leading to the environment.

[0545] Conducted noise (acoustic): In this document, conducted noise refers to noise transmitted to the patient through pneumatic paths, 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.

[0546] Radiated noise (acoustic): In this document, radiated noise refers to noise transmitted to the patient by 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.

[0547] Ventilation noise (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any ventilator, such as the vent of a patient interface.

[0548] Pressure: The force per unit area. Pressure can be measured in a range of units, including cmH2O, gf / cm². 2 And 1000 pascals. 1 cmH2O equals 1 g-f / cm 2 The pressure is approximately 0.98 hectopascals. In this instruction manual, unless otherwise stated, pressure is given in cmH2O. Pressure at the patient interface is given by the symbol Pm, while treatment pressure is given by the symbol Pt, which represents the target value to be achieved at the current moment through the mask pressure Pm.

[0549] Sound power: The energy carried by a sound wave per unit time. Sound power is proportional to the square of the sound pressure level multiplied by the wavefront area. Sound power is usually given in decibels (SWL), i.e., decibels relative to a reference power, typically taken as 10. -12 watt.

[0550] Sound pressure level (SPL): The local deviation of sound waves from ambient pressure at a given moment due to their propagation in a medium. SPL is typically given in decibels (SPL), i.e., decibels relative to a reference pressure, usually taken as 20 × 10⁻⁶. -6 Pascal (Pa) is considered the threshold of human hearing.

[0551] 5.7.4 Ventilator Terminology

[0552] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable rather than a fixed target ventilation. The variable target ventilation can be determined based on a certain characteristic of the patient (e.g., the patient's breathing characteristics).

[0553] Standby rate: A parameter of the ventilator that sets the minimum respiratory rate (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by spontaneous breathing effort.

[0554] Cycled: The termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a spontaneously breathing patient, the ventilator cycle is considered to have ended at the end of the inspiratory portion of the respiratory cycle.

[0555] EPAP: The base pressure is added to the pressure of changes in breathing to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0556] IPAP: The desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of breathing.

[0557] Pressure support: A number indicating the increase in pressure during inspiration that exceeds the pressure during expiration, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP – EPAP). In some cases, pressure support refers to the difference the ventilator is designed to achieve, rather than the difference it actually achieves.

[0558] Servo ventilator: A ventilator that measures a patient’s ventilation, has a target ventilation, and adjusts the pressure support level to bring the patient’s ventilation close to the target ventilation.

[0559] Spontaneous / Timed (S / T): A mode of operation for a ventilator or other device that attempts to detect the onset of spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0560] Swaying: A term equivalent to pressure support.

[0561] Trigger: When a ventilator delivers a breath of air to a patient who is breathing spontaneously, it is considered to be triggered by the patient's effort at the beginning of the breathing phase of the respiratory cycle.

[0562] Typical recent ventilation: Typical recent ventilation (Vtyp) is the value around which recent ventilation measurements tend to cluster within a predetermined time range. For example, a measure of the central tendency of recent historical ventilation measurements can be a suitable value for typical recent ventilation.

[0563] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0564] 5.7.5 Facial Anatomy

[0565] Alar: The outer wall or "wing" of each nostril (plural: alar).

[0566] Alar tip: the outermost point on the ala of the nose.

[0567] Alar curvature (or alar ridge) point: the last point in the curvature baseline of each alar, found in the crease formed by the connection between the alar and the cheek.

[0568] Auricle: The entire visible external part of the ear.

[0569] (Nasal) Bone framework: The bony framework of the nose includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0570] (Nasal) Cartilaginous Framework: The cartilaginous framework of the nose includes the septal cartilage, lateral cartilage, major cartilage, and minor cartilage.

[0571] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0572] 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 subnasal point).

[0573] Frankfurt plane: A line extending from the lowest point of the orbital rim to the left tragus point. The tragus point is the deepest point in the notch above the tragus of the auricle.

[0574] The glabella is the most prominent point on the soft tissue of the forehead in the sagittal plane.

[0575] Lateral nasal cartilage: a roughly triangular cartilaginous plate. 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.

[0576] Greater alar cartilage: A cartilaginous plate located beneath the lateral 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 small cartilages of the alar.

[0577] Nostrils (Nares / Nostrils): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostrils (nares) is nasal nasal (naris) (nostril). Nostrils are separated from the nasal septum.

[0578] Nasolabial folds or nasolabial grooves: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lips.

[0579] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0580] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0581] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0582] 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.

[0583] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0584] Prechin point: Located on the soft tissue, at the very front midpoint of the chin.

[0585] The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the tip of the nose.

[0586] Arrow plane: A vertical plane that runs from front to back, dividing the body into the right and left halves.

[0587] Nasal bridge point: Located on the soft tissue, it is the most concave point superimposed on the nasal suture area.

[0588] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0589] Lower edge of the nasal ala: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (upper) lip.

[0590] Subnasal point: Located on the soft tissue, at the point where the columella and the upper lip meet in the midline sagittal plane.

[0591] Mandibular alveolar point: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior chin point.

[0592] 5.7.6 Skull Anatomy

[0593] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0594] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0595] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla protrudes upward from one side of the nose and forms part of the lateral border.

[0596] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary among individuals; they are placed side by side in the middle and upper part of the face and form the "bridge" of the nose through their intersection.

[0597] Nasal root: The indentation between the frontal bone and the two nasal bones, located directly between the eyes and above the bridge of the nose.

[0598] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes the foramen magnum (oval foramen), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0599] The eye socket is the bony cavity in the skull that houses the eyeball.

[0600] Parietal bone: The parietal bone is the skeleton that forms the top and sides of the skull when they are joined together.

[0601] 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.

[0602] Cheekbones: The face consists of two cheekbones, located on the upper and outer parts of the face and forming the protruding part of the cheek.

[0603] 5.7.7 Respiratory System Anatomy

[0604] Diaphragm: A muscular sheet 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.

[0605] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0606] 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.

[0607] 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 either side of the nasal cavity are three horizontal branches called nasal conchae (singular "concha") or nasal bones. The anterior part of the nasal cavity is the nasal part, while the posterior part connects to the nasopharynx through the posterior nasal aperture.

[0608] 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 segments: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0609] 5.7.8 Materials

[0610] 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.

[0611] Polycarbonate: is a typical transparent thermoplastic polymer of bisphenol A carbonate.

[0612] 5.7.9 Patient Interface Aspects

[0613] 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.

[0614] A bend: A conduit that guides airflow through an angle that changes direction. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. A bend can have a nearly circular cross-section. In another form, a 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 via a single snap-fit ​​during manufacturing, but cannot be removed by the patient.

[0615] 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.

[0616] Headgear: A headgear is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headgear comprises an assembly of one or more supports, straps, and reinforcements configured to position and hold the patient interface in place on the patient's face for the delivery of respiratory therapy. Some straps are formed from soft, flexible, and resilient materials, such as laminated composites of foam and fabric.

[0617] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0618] Inflation chamber: The mask inflation chamber is considered to refer to the portion of the patient interface having walls that at least partially enclose a volumetric space, which, during use, contains air pressurized therein to above atmospheric pressure. An outer shell may form part of the wall of the mask inflation chamber.

[0619] Sealing: The noun form ("sealing") refers to a structure or barrier that intentionally prevents air from passing through the interface between two surfaces. The verb form ("sealing") is used to mean preventing the flow of air.

[0620] Shell: The shell is considered to refer to a curved, relatively thin structure with bending, tensile, and compressive stiffness. For example, the curved structural wall of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0621] Reinforcement: Reinforcement is considered to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0622] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0623] 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 may be little or no airflow leakage from the rotary shaft.

[0624] Lace-up: Lace-up will be considered as a structural component used to resist tension.

[0625] Ventilation port (noun): A structure that allows airflow from inside the mask or catheter to ambient air for clinically effective clearance of exhaled gases.

[0626] 5.7.10 Terminology related to the patient interface

[0627] (Surface) Curvature: A saddle-shaped region of a surface that bends upwards in one direction and downwards in another is called negative curvature. A dome-shaped surface region that bends in the same way along both principal directions is said to have positive curvature. A flat surface is considered to have zero curvature.

[0628] Softness: One or more properties of a material, structure, or composite material.

[0629] • It easily adapts to finger pressure.

[0630] • It cannot maintain its shape when supporting its own weight.

[0631] • Non-rigid.

[0632] • It can be stretched or bent with ease.

[0633] The property of softness can have a related direction, so a particular material, structure or composite material can be soft along a first direction, but hard or rigid along a second direction (e.g., a second direction orthogonal to the first direction).

[0634] Elasticity: It is able to deform essentially elastically in a relatively short time (e.g., within 1 second) and release essentially all of its energy upon unloading.

[0635] Rigidity: It is not easily deformed under finger pressure and / or tension or load, which are typically encountered when establishing and maintaining a seal between the patient interface and the patient airway inlet.

[0636] Semi-rigid: refers to something that is rigid enough that it will not deform under the mechanical forces typically applied during respiratory pressure therapy.

[0637] 5.8 Other Remarks

[0638] 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.

[0639] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges (which may be independently included within the intermediate range) are also covered within this technique, but are subject to any explicit exclusions within the range. Where the range includes one or two limitations, the range excluding any one or both of those included limitations is also included within this technique.

[0640] Furthermore, where one or more values ​​are stated herein as part of the implementation of the technology, it should be understood that, unless otherwise stated, such values ​​may be approximate and may be used to any suitable significant number to the extent that the actual technical implementation allows or requires them.

[0641] Furthermore, as used herein, “approximately,” “substantially,” “about,” or any similar terms mean + / - 5-10% of the stated value.

[0642] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this technology pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0643] When a particular material is set for use in constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise specified, any and all components described herein should be understood as capable of being manufactured, and therefore can be manufactured together or separately.

[0644] It must be noted that, as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include their plural equivalents, unless the context clearly indicates otherwise.

[0645] All publications mentioned herein are incorporated herein by reference in their entirety to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their disclosure prior to the filing date of this application. This document should not be construed as an admission that the present technology is not entitled to any prior disclosure due to a prior invention. Furthermore, the publication dates provided may differ from the actual publication dates, which may require independent verification.

[0646] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0647] The subject headings included in the detailed description are for the reader's convenience only and should not be used to limit the subject matter found throughout the disclosure or claims. Subject headings should not be used to interpret the claims or limit their scope.

[0648] Although the techniques described herein have been illustrated with reference to specific examples, it should be understood that these examples are merely illustrative of the principles and applications of the techniques. In some cases, terms and symbols may imply specific details that are not required for practicing the techniques described. For example, although the terms “first” and “second” may be used, they are not intended to indicate any order unless otherwise stated, but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0649] Therefore, it should be understood that numerous modifications can be made to the exemplary examples, and that other arrangements can be designed without departing from the spirit and scope of this technology.

[0650] 5.9 List of reference numerals

[0651]

[0652]

[0653]

[0654]

Claims

1. A patient interface for sealingly delivering an airflow to an inlet of a patient airway at a continuous positive pressure relative to ambient air pressure, the patient airway including at least an inlet of the patient's nostrils, wherein the patient interface is configured to maintain a therapeutic pressure within a range of about 4 cmH2O to about 30 cmH2O above ambient air pressure during use throughout the patient's respiratory cycle when the patient is asleep, to improve sleep-disordered breathing, the patient interface comprising: A sealing structure is provided for forming a pneumatic seal with the inlet of the patient's airway; Positioning and stabilizing structures are used to maintain a sealed contact between the sealing structure and the area surrounding the inlet of the patient's airway while maintaining therapeutic pressure at the inlet of the patient's airway; An air chamber, which is pressurized to a pressure higher than ambient pressure during use; A connection port for delivering a breathable gas flow to the patient interface; and Devices positioned along the flow path of breathable gases to physically disrupt the flow. The device is characterized in that it is configured to exchange heat and / or moisture between the air exhaled by the patient and the air inhaled by the patient to maintain the humidity level of the inhaled air at 10 mg / L or higher.

2. The patient interface according to claim 1, characterized in that, The device is located in the connection port or is configured to be attached to the connection port.

3. The patient interface according to claim 1, characterized in that, The patient interface also includes a bend in fluid communication with the connection port, and the device is located within the bend or configured to be attached to the bend.

4. The patient interface according to claim 1, characterized in that, The patient interface also includes an air delivery conduit for delivering the breathable gas flow to the patient interface, the air delivery conduit being in fluid communication with the connection port, and the device being located within the conduit or configured to be attached to the conduit.

5. The patient interface according to claim 1, characterized in that, The patient interface further includes a gas purge vent configured to allow exhaled CO2 from the patient to flow to the outside of the patient interface to minimize rebreathing of the exhaled CO2, and the device is located in the flow path of the breathable gas flow between the vent and the inlet of the patient's airway during use.

6. The patient interface according to claim 1, characterized in that, The device is located in the inflation chamber, such that the inflation chamber is divided into a first anterior chamber and a second posterior chamber, the second posterior chamber being closer to the inlet of the patient's airway than the first anterior chamber.

7. The patient interface according to claim 6, characterized in that, The device physically interferes with the exhaled airflow to increase the humidity in the second rear chamber to 15 mg / L or higher.

8. The patient interface according to claim 7, characterized in that, The device physically interferes with the exhaled airflow by slowing down the airflow flowing toward the first pre-ventricular chamber and redirecting it to the inlet of the patient's airway.

9. The patient interface according to claim 1, characterized in that, The device has a plurality of orifices configured to provide resistance that results in a pressure drop of less than 5 cm H2O when measured at a flow rate of 100 liters / minute.

10. The patient interface according to claim 9, characterized in that, When measured at a flow rate of 100 liters per minute, the impedance results in a pressure drop of less than 2 cm H2O.

11. The patient interface according to claim 9 or 10, characterized in that, The plurality of holes includes a first set of holes having a first size and a second set of holes having a second size, wherein the second size is larger than the second size.

12. The patient interface according to claim 9, characterized in that, At least one of the plurality of holes includes an inner surface configured to direct exhaled airflow to a vent for CO2 removal.

13. The patient interface according to claim 1, characterized in that, The device comprises any one of the following materials: synthetic materials, thermoplastic elastomers, or hydrophobic polymers.

14. The patient interface according to claim 13, characterized in that, The device comprises open-cell polyurethane foam.

15. The patient interface according to claim 1, characterized in that, The device has a mesh structure.

16. The patient interface according to claim 1, characterized in that, The thickness of the device is in the range of approximately 2 mm to 10 mm.

17. The patient interface according to claim 1, characterized in that, The positioning and stabilizing structure includes one or more head sleeves.

18. The patient interface according to claim 17, characterized in that, The device is disposed in one or more head sleeves.

19. The patient interface according to claim 17 or 18, characterized in that, The head sleeve is connected to the inlet, and the device is disposed in the inlet or configured to be attached to the inlet.

20. The patient interface according to claim 1, characterized in that, The patient interface also includes one or more air chamber inlet ports, and the device is disposed in or configured to be attached to the one or more air chamber inlet ports.

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