Ventilation adapter for respiratory therapy system

Abstract

A fluid connector between a patient interface and a respiratory pressure treatment device and a ventilation adapter for a respiratory pressure treatment system. The fluid connector includes two components, a first of which includes a sealing portion and a latching portion, and a second of which includes a complementary latching portion configured to engage with the aforementioned latching portion to provide a fluid flow path between the two components. The vent adapter comprises: a vent assembly comprising a vent housing and an annular plate comprising an array of apertures for discharging pressurized gas to the atmosphere; and the deformable membrane is pressed on the annular plate.

Description

[0001] 1 Cross-reference to related applications

[0002] This application is a divisional application of the patent application with application number 202011097402.X and invention name “Ventilation Adapter for User Respiratory Therapy System”, and patent application 202011097402.X is a divisional application of the patent application with application number 201680058868.4 and invention name “Ventilation Adapter for User Respiratory Therapy System”, and patent application 201680058868.4 is the Chinese national phase application of PCT international application PCT / AU2016 / 050893, which claims the benefit of U.S. Provisional Application No. 62 / 222,604 filed on September 23, 2015, the entire contents of which are incorporated herein by reference. 2 Background technology 2.1 Technical Field

[0003] The present technology relates to one or more of the detection, diagnosis, treatment, prevention and improvement of breathing-related disorders. The present technology also relates to medical devices or equipment and their uses.

[0004] 2.2 Description of related technologies

[0005] 2.2.1 Human respiratory system and its disorders

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

[0007] The airway includes a series of branching tubes, which become narrower, shorter and more numerous as the branching tracheae penetrate deeper into the lungs. The main function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and expel carbon dioxide. The trachea is divided into the left main bronchi and the right main bronchi, which are eventually divided into terminal bronchioles. The bronchi constitute the conducting airways, but do not participate in gas exchange. Further branches of the airway lead to the respiratory bronchioles and eventually to the alveoli. The alveolar region of the lungs is the area where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology", 9th edition, published by John B. West, Lippincott Williams & Wilkins in 2012.

[0008] There is a range of breathing disorders. Some disorders can be characterised by specific events such as apnea, hypopnea and hyperpnea.

[0009] Obstructive sleep apnea (OSA) is a form of sleep disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The condition causes affected patients to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Complications are common disorders, especially in middle-aged overweight men, but those affected may not be aware of the problem. See 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 in which there are rhythmic alternating cycles of boom-and-bust ventilation called CSR cycles. CSR is characterized by repeated hypoxia and reoxygenation of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated arousals from sleep, which leads to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0011] Respiratory insufficiency is an umbrella term for breathing disorders in which a patient cannot ventilate enough to balance the CO2 in his or her blood if his or her metabolic activity is elevated to much higher levels than rest. Respiratory insufficiency may encompass some or all of the following disorders.

[0012] Obesity hyperventilation syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headaches, and excessive daytime sleepiness.

[0013] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that have certain common features. These diseases include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: dyspnea on exertion, chronic cough, and sputum production.

[0014] Neuromuscular disease (NMD) is a broad term that covers many diseases and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of walking ability, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents; (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headaches, and difficulty concentrating and mood changes.

[0015] The chest wall is a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the thorax. These disorders are often characterized by restrictive defects and have the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0016] A range of treatments have been used to treat or improve such conditions. In addition, such treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0017] 2.2.2 Treatment

[0018] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that the continuous positive airway pressure acts as a pneumatic splint and can prevent upper airway occlusion, such as by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA treated by CPAP can be voluntary, so if the patient finds the device used to provide such treatment to be any one or more of: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0019] Non-invasive ventilation (NIV) provides ventilation support to patients through the upper airway to help them breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory insufficiency in the form of OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] Non-invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0021] 2.2.3 Treatment system

[0022] These treatments can be provided by a treatment system or device.Such systems and devices can also be used to diagnose a condition without treating it.

[0023] The therapy system may include a respiratory pressure therapy device (RPT device), air circuit, humidifier, patient interface, and data management.

[0024] Another form of treatment system is a mandibular repositioning device.

[0025] 2.2.3.1 Patient interface

[0026] The patient interface can be used to engage the respiratory apparatus to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with, for example, an area of ​​the patient's face to facilitate the delivery of gas at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of approximately 10 cm H2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cm H2O to the airway.

[0027] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain a suitable pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from an external high pressure, rather than maintaining air at a higher pressure than the environment inside.

[0028] Certain masks may be clinically disadvantageous to the present technology, for example where they block airflow through the nose and only allow it through the mouth.

[0029] Certain masks may be uncomfortable or impractical for the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal with their lips.

[0030] Certain masks may not be feasible for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0031] The design of a patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose varies significantly from person to person. Because the head is composed of bone, cartilage, and soft tissue, different areas of the face react differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory therapy session.

[0032] Due to these challenges, some masks face one or more of the following problems: obtrusive, unsightly, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for long periods of time or when the patient is not familiar with the system. For example, masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original applications, but such masks are not as comfortable as ideal for wearing for long periods of time (e.g., several hours). This discomfort may lead to reduced patient compliance with therapy. This is even more true if the mask is worn during sleep.

[0033] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect patient compliance.

[0034] While masks used in other applications (eg, pilots) may not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing may be suitable for other applications.

[0035] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0036] 2.2.3.1.1 Seal forming part

[0037] The patient interface may include a seal forming portion. Since it is in direct contact with the patient's face, the shape and configuration of the seal forming portion may directly affect the effectiveness and comfort of the patient interface.

[0038] The patient interface may be characterized in part according to the design intent of the seal-forming portion to engage with the face when in use. In one form of the patient interface, the seal-forming portion may include two sub-portions to engage with the corresponding left and right nostrils. In one form of the patient interface, the seal-forming portion may include a single element that surrounds both nostrils when in use. Such a single element may be designed, for example, to cover the upper lip area and the bridge of the nose area of ​​the face. In one form of the patient interface, the seal-forming portion may include an element that surrounds the mouth area when in use, for example, by forming a seal on the lower lip area of ​​the face. In one form of the patient interface, the seal-forming portion may include a single element that surrounds both nostrils and the mouth area when in use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0039] A seal-forming portion that may be effective in one area of ​​a patient's face may not be suitable in another area, for example, because the shape, structure, variability, and sensitive areas of the patient's face are different. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on the patient's nose.

[0040] Certain seal forming portions may be designed for mass manufacturing so that one design is suitable, comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal forming portion of a mass manufactured patient interface, one or both must adapt to form a seal.

[0041] One type of seal forming portion extends around the periphery of the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface while the seal forming portion is in facing engagement with the patient's face. The seal forming portion may include an air or fluid filled cushion, or a molded or formed surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal forming portion, if the fit is inadequate, there will be a gap between the seal forming portion and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0042] Another type of seal forming portion incorporates a sheet seal of thin material positioned around the perimeter of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous forms of seal forming portions, if the fit between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal forming portion does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0043] Another type of seal-forming portion may include friction fit elements, for example for insertion into a nostril, however some patients find these uncomfortable.

[0044] Another form of seal forming portion can use adhesive to achieve the seal. Some patients may find it inconvenient to constantly apply and remove adhesive to their face.

[0045] A range of patient interface seal forming part technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0046] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett Corporation.

[0047] ResMed Inc. already manufactures the following products in combination with nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and MIRAGE LIBERTY TM Full face mask. The following patent applications assigned to ResMed Ltd. describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes the ResMed Ltd. SWIFT TM Other aspects of nasal pillows); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe the MIRAGELIBERTY TM Other aspects of full-face masks); International patent application WO 2009 / 052,560 (which describes the SWIFT TM Other aspects of the FX nasal pillows).

[0048] 2.2.3.1.2 Positioning and stabilization

[0049] The seal-forming portion of the patient interface for positive air pressure therapy is subjected to a corresponding force of air pressure that is intended to break the seal. Therefore, various techniques have been used to position the seal-forming portion and maintain it in a sealing relationship with the appropriate portion of the face.

[0050] One technique is to use an adhesive. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0051] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more of poor fit, bulk, discomfort, and awkward use.

[0052] 2.2.3.1.3 Ventilation technology

[0053] Some forms of patient interface systems may include vents to allow flushing of exhaled carbon dioxide. The vents may allow gas to flow from the interior space of the patient interface (e.g., a plenum) to the exterior space of the patient interface, such as to the environment. The vents may include orifices, and gas may flow through the orifices when the mask is used. Many such vents are noisy. Others may become blocked during use, thereby providing insufficient flushing. Some vents may disrupt the sleep of the bed partner 1100 of the patient 1000, for example, by making noise or gathering airflow.

[0054] ResMed Inc. has developed many improved mask ventilation 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; U.S. Patent Application Publication No. US2009 / 0044808.

[0055] Noise table of existing masks (ISO 17510-2:2007, pressure of 10cm H2O at 1m)

[0056]

[0057]

[0058] ( * Just a sample, measured at 10cm H2O using the test method specified in ISO 3744 in CPAP mode) The sound pressure values ​​for various objects are shown below

[0059]

[0060] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0061] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical applications have specific requirements that are not met by more general air pressure generators, such as reliability, size and weight requirements for medical devices. Furthermore, even devices designed for medical use may have disadvantages with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0062] An example of a special requirement for certain RPT devices is noise.

[0063] Table of noise output levels of existing RPT devices (a sample only, measured at 10 cm H2O in CPAP mode using the test method specified in ISO 3744).

[0064] RPT device name A-weighted sound power level dB(A) Year(approx.) <![CDATA[C-Series Tango TM > 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[With H4i TM S8 Escape humidifier TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i Humidifier TM > 28.6 2010

[0065] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Limited. Another example of an RPT device is a ventilator. A ventilator such as the ResMed Stellar TM The range of adult and pediatric ventilators can provide support for invasive and non-invasive independent ventilation for a range of patients for the treatment of a variety of conditions such as, but not limited to, NMD, OHS and COPD.

[0066] ResMed Elisée TM 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volume and pressure ventilation modes with single-limb or double-limb circuits. RPT devices typically include a pressure generator, such as a blower driven by an electric motor or a compressed gas reservoir, and are configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as described above via an air circuit.

[0067] The designer of the device may be presented with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0068] 2.2.3.3 Humidifier

[0069] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface to produce humidified gas minimizes drying of the nasal mucosa and increases patient airway comfort. In addition, in colder climates, warm air is often more comfortable than cold air applied to the facial area in and around the patient interface. A range of artificial humidification devices and systems are known, however they may not meet the specialized requirements of medical humidifiers.

[0070] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to the ambient air when needed, usually where a patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, however these systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. In addition, medical humidifiers may have more stringent safety restrictions than industrial humidifiers.

[0071] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0072] 2.2.3.4 Data Management

[0073] There may be many clinical reasons to obtain data to determine whether a patient being treated with a prescribed respiratory therapy is "compliant," such as if the patient has used their RPT device in accordance with certain "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order for the patient to be considered compliant. To determine the patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate the usage over a predetermined time period and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0074] There are other aspects of patient treatment that may benefit from communication of treatment data to third parties or external systems.

[0075] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone.

[0076] 2.2.3.5 Mandibular reduction

[0077] 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 supplier that holds the mandible (lower jaw) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom made or produced in a standard form and include a bite impression portion designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, exerts tension on the pharyngeal walls to reduce collapse of the airway and reduce vibrations of the palate.

[0078] In some examples, the mandibular advancement device may include an upper splint intended to engage or cooperate with teeth on the upper jaw or maxilla and a lower splint intended to engage or cooperate with teeth on the upper jaw or mandible. The upper splint and the lower splint are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0079] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible remains in an anteriorly displaced position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

[0080] Some MRDs are configured to push the mandible forward relative to the maxilla, while other MADs (such as the ResMed Narval CC TM The MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0081] 2.2.4 Diagnostic and monitoring systems

[0082] Clinical experts can appropriately diagnose or monitor patients based on human observations. However, there are situations where clinical experts may not be available or clinical experts may not be able to afford. In some cases, different clinical experts may disagree on the patient's condition. In addition, a given clinical expert may apply different standards at different times. Due to the busyness of clinical practice, clinicians may find it difficult to keep up with the evolving patient management guidelines.

[0083] Polysomnography (PSG) is a conventional system for diagnosis and prognosis of cardiopulmonary diseases, and usually involves professional clinical personnel for application and / or interpretation. PSG usually involves the placement of 15 to 20 contact sensors on the human body to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. However, although they may be suitable for their common application in clinical settings, such systems are complex and may be expensive, and / or may be uncomfortable or impractical for patients trying to sleep at home. 3. Summary of the invention

[0084] The present technology is directed to providing a medical device for diagnosing, ameliorating, treating or preventing respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0085] A first aspect of the present technology relates to an apparatus for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0086] Another aspect of the present technology relates to methods for diagnosing, ameliorating, treating or preventing breathing disorders.

[0087] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0088] A first form of the present technology includes a connector kit having a compliant face seal between a first end and a second end of the connector kit and a retention mechanism coupling the first end and the second end together.

[0089] A second form of the present technology includes a fluid connector for delivering breathing gas from a respiratory pressure therapy device to a patient, the fluid connector including a first end having a first opening for fluid flow, a sealing portion extending around the periphery of the first opening, and a latch portion; a second end having a second opening for fluid flow, a sealing surface extending around the periphery of the second opening and configured to engage the sealing portion to form a face seal, and a complementary latch portion configured to engage with the latch portion, wherein the face seal allows breathing gas to travel between the first opening and the second opening, and the engagement between the latch portion and the complementary latch portion secures the first end to the second end.

[0090] A third form of the present technology includes a system for providing respiratory therapy to a patient, the system comprising a respiratory pressure therapy device; an air circuit; a patient interface connected to the air circuit and means for preventing the respiratory pressure therapy device from being connected to the air circuit via an industry standard connector.

[0091] A fourth form of the present technology includes a method of providing a fluid connection for delivering breathing gases from a respiratory pressure therapy device to a patient, the method comprising engaging a latch between a first end and a second end of the fluid connection; and engaging a face seal surrounding a first opening in the first end and surrounding a second opening in the second end, wherein one of the first end and the second end corresponds to the respiratory pressure therapy device.

[0092] A fifth form of the present technology includes a first half of a fluid connector system for delivering respiratory gas from a respiratory pressure therapy device to a patient, the first half including a connector portion having a first opening for fluid flow, a sealing portion extending around the periphery of the first opening; and a latch portion, wherein the sealing portion is constructed to seal against a sealing surface extending around the periphery of a second opening to form a face seal with the second half of the fluid connector system, and the latch portion is constructed to latch with another latch portion of the second half of the fluid connector system.

[0093] A sixth form of the present technology includes a first half of a fluid connector system for delivering respiratory gas from a respiratory pressure therapy device to a patient, the first half including a connector portion having a first opening for fluid flow, a sealing surface surrounding the periphery of the first opening; and a latch portion, wherein the sealing surface is configured to receive a sealing portion seal extending around the periphery of a second opening to form a face seal with the second half of the fluid connector system, and the latch portion is configured to latch with another latch portion of the second half of the fluid connector system.

[0094] A seventh form of the present technology includes a fluid connector for delivering respiratory gas from a respiratory pressure therapy device to a patient, the fluid connector including a first end having a first internal portion for fluid flow and a first retaining portion, and a second end having a second internal portion for fluid flow and a complementary retaining portion, the complementary retaining portion being configured to engage with the retaining portion, wherein the first internal portion and the second internal portion have a first shape perpendicular to a flow direction, the retaining portion and the complementary retaining portion have a second shape perpendicular to the flow direction, and the first shape and the second shape are different.

[0095] An eighth form of the present technology includes a system for providing respiratory therapy to a patient, the system comprising a respiratory pressure therapy device; an air circuit; a patient interface connected to the air circuit, the patient interface being particularly suitable for operating with the respiratory pressure therapy device; and means for ensuring that the patient interface being particularly suitable for operating with the respiratory pressure therapy device is connected to the respiratory pressure therapy device.

[0096] In an example of at least one of the first to eighth forms of the present technology, (a) the first end is connected to a respiratory pressure therapy device including a blower, and the second end is connected to a fluid conduit; (b) the respiratory pressure therapy device is configured to provide therapeutic pressure for sleep-related breathing disorders; (c) the sealing surface is flat; (d) the sealing surface is substantially perpendicular to the direction of fluid flow from the first end to the second end; (e) the sealing surface is inclined; (d) the sealing surface extends circumferentially around the second opening; (e) the sealing surface is formed on a flange extending radially from a tube defining the second opening; (f) the flange extends substantially perpendicular to the tube; (g) the tube extends beyond the flange in a direction toward the sealing portion; and (h) when a complementary latch portion engages with the latch portion, The tube extends at least partially through the sealing portion; (i) the sealing portion is compliant in the engagement direction between the first end and the second end; (j) the sealing portion includes a frustoconical portion; (k) the frustoconical portion contacts the sealing surface to form a face seal; (l) the sealing portion includes a partially spherical surface; (m) the partially spherical surface contacts the sealing surface to form a face seal; (n) the sealing portion includes a bellows-shaped or partially bellows-shaped portion; (o) the bellows-shaped or partially bellows-shaped portion contacts the sealing surface to form a face seal; (p) when the first end and the second end are connected, the sealing portion is configured to engage the sealing surface before the latch portion and the complementary latch portion engage; (q) the sealing portion is radially relative to a direction defined by the engagement direction between the first end and the second end. The seal portion is compliant in the direction of the axis; (r) the seal portion is configured to expand and engage the seal surface due to internal pressurization of the first end when a gap exists between the seal portion and the seal surface in an unpressurized state; (s) contact between the seal portion and the seal surface causes the seal portion to be pressed against the seal surface and compressed opposite to the direction of air flow from the first opening to the second opening; (t) compression of the seal portion does not result in a significant compressive force; (u) the force required to compress the seal portion is less than the force required to engage the latch portion with the complementary latch portion; (v) the force required to compress the seal portion is less than half the force required to engage the latch portion with the complementary latch portion; (w) the force required to compress the seal portion is less than the force required to engage the latch portion with the complementary latch portion one-tenth; (x) at least one of the sealing portion and the sealing surface includes a sufficient contact area between the sealing portion and the sealing surface to form a seal when the respective centers of the sealing portion and the sealing surface are not aligned with each other; (y) the second end includes an inner portion and an outer portion, and the inner portion is rotatably coupled to the outer portion; (z) the inner portion includes the sealing surface; (aa) the inner portion is rigidly connected to the fluid conduit; (bb) the outer portion includes a complementary latch portion; (cc) the complementary latch portion includes a cantilever portion having a protrusion, the protrusion being configured to engage the latch portion; (dd) the cantilever portion is configured to be depressed to engage or disengage the complementary latch portion with the latch portion and allow engagement or disengagement between the first end and the second end;(ee) the first end includes a travel limiter that constrains the second end to prevent it from moving in the engagement direction between the first end and the second end; (ff) the travel limiter is a flange around the first opening, and the second end includes a stop surface configured to contact the flange; (gg) the latch portion constrains the second end to prevent it from moving in a direction opposite to the engagement direction, and when the first end and the second end are engaged, the travel limiter and the latch portion together limit the movement distance of the second end; (hh) the sealing portion is configured to seal against the sealing surface over the entire movement distance, which is a non-zero distance; (ii) the sealing portion is configured to form a seal with the sealing surface under worst-case manufacturing tolerances and after a predetermined amount of wear and / or creep of the fluid connector; (jj) the fluid connector is configured to form a seal with the sealing surface over the entire patient breathing cycle and between 4cm H2O and 40cm The invention relates to a fluid connector having a first end and a second end having a first end and a second end having a second end; wherein the first end comprises a first port connected to the first opening and the ... first end and a second end having a second end; wherein the first end comprises a first port connected to the first opening and the second end having a first end and a second end having a first end and a second end having a first end and a second end having a first end and a second end having a first end and a ) the fluid connector further comprises an industry standard fluid connector, wherein the industry standard fluid connector is in fluid communication with the first opening and on an end opposite the sealing surface; (rr) the first shape is circular and the second shape comprises attributes of a circle and a square; and / or (ss) one of the first inner portion and the second inner portion comprises a first convex portion and the other of the first inner portion and the second inner portion comprises a first concave portion, the first convex portion and the first concave portion comprise a first shape, and one of the retaining portion and the complementary retaining portion comprises a second convex portion and the other of the retaining portion and the complementary retaining portion comprises a second concave portion, the second convex portion and the second concave portion comprise a second shape.;

[0097] One aspect of one form of the present technology is a portable RPT device that can be carried by an individual (eg, around the individual's home) that includes a fluid connector.

[0098] Another aspect of the present technology relates to a ventilation assembly for a respiratory pressure therapy (RPT) system. The ventilation assembly includes: a ventilation housing defining a central orifice for allowing a flow of pressurized gas from a delivery conduit through the ventilation assembly to a patient interface, the ventilation housing having an annular surface surrounding the central orifice, and the annular surface having a plurality of holes for exhausting the pressurized gas to the atmosphere; and a membrane positioned adjacent to the annular surface, wherein the membrane is movable so that when the pressure of the pressurized gas within the ventilation assembly increases, the membrane is urged against the annular surface of the ventilation housing.

[0099] Another aspect of the present technology relates to an RPT system comprising: a ventilation assembly as described in the preceding paragraph; an RPT device configured to produce a pressurized gas flow in the range of 4-20 cm H2O; a patient interface configured to deliver the pressurized gas flow to a patient's airway, the patient interface being a non-ventilation type; and a delivery conduit configured to deliver the pressurized gas flow from the RPT device to the patient interface.

[0100] In the examples of the ventilation assembly and RPT system described in the previous two paragraphs, (a) the multiple holes may include a first group of holes and a second group of holes, the first group of holes being proximal to the central orifice relative to the second group of holes, (b) the shape and size of the membrane may be designed so that the membrane does not cover the first group of holes, (c) the membrane may be constructed to cover more of the second group of holes when the pressure of the pressurized gas in the ventilation assembly increases, (d) the first group of holes may be positioned upstream of the second group of holes relative to the pressurized gas flow, (e) the ventilation assembly may also include a retaining structure to hold the membrane in a position adjacent to the annular surface of the ventilation shell, (f) the membrane may also include an elastic material, (g) the membrane may be annular, (h) the membrane may not be bonded to the ventilation shell, (i) the shape and size of the membrane may be set so that the outer edge of the membrane is adjacent to the inner periphery of the ventilation shell, and / or (j) each of the multiple holes may have a shape that converges from the inner surface of the ventilation shell to the outer surface of the ventilation shell.

[0101] Another aspect of the present technology relates to a ventilation adapter for a respiratory pressure therapy (RPT) system. The ventilation adapter includes: a ventilation housing defining a central orifice for allowing a flow of pressurized gas from a delivery conduit through a ventilation assembly to a patient interface, the ventilation housing having an annular surface surrounding the central orifice, and the annular surface having a plurality of holes for exhausting the pressurized gas to the atmosphere; a membrane positioned adjacent to the annular surface; and a diffusion member.

[0102] Another aspect of the present technology relates to an RPT system. The RPT system includes: a ventilation adapter as described in the previous paragraph; an RPT device configured to generate a pressurized gas flow in the range of 4-20 cm H2O; a patient interface configured to deliver the pressurized gas flow to the patient's airway, the patient interface being a non-ventilation type; and a delivery conduit configured to deliver the pressurized gas flow from the RPT device to the patient interface.

[0103] In the examples of the vent adapter and RPT system described in the previous two paragraphs, (a) the membrane may be movable so that when the pressure of the pressurized gas within the vent assembly increases, the membrane is urged against the annular surface of the vent housing, (b) the plurality of holes may include a first set of holes and a second set of holes, the first set of holes being proximal to the central orifice relative to the second set of holes, (c) the shape and size of the membrane may be designed so that the membrane does not cover the first set of holes, (d) the membrane may be constructed to cover more of the second set of holes when the pressure of the pressurized gas within the vent assembly increases, (e) the first set of holes may be positioned upstream of the second set of holes relative to the flow of pressurized gas, (f) the vent adapter may also include a retaining structure to hold the membrane in a position adjacent to the annular surface of the vent housing, (g) the membrane may also include an elastic material, (h) the membrane may be annular, (i) the membrane may not be bonded to the vent housing, and (j) the shape and size of the membrane may be set so that an outer edge of the membrane is adjacent to the vent housing. the inner periphery of the body, (k) each of the plurality of holes may have a shape converging from the inner surface of the ventilation shell to the outer surface of the ventilation shell, (l) the ventilation adapter may include a heat and moisture exchanger (HME) which may be positioned downstream of the plurality of holes relative to the pressurized gas flow, (m) the diffusion member may be positioned outside the ventilation shell to at least partially cover the plurality of holes, (n) the ventilation adapter may also include a barrier member having an air-impermeable material, the barrier member preventing gas exiting from the plurality of holes from flowing through the diffusion member to the atmosphere along a straight path, (o) the diffusion member and the barrier member may be configured to direct gas exiting from the plurality of holes outwardly from the diffusion member in an orientation different from that of the plurality of holes, (p) the diffusion member may provide a flow path parallel to a surface of the barrier member that contacts the diffusion member, (q) the diffusion member may be a porous material, (r) the diffusion member may be an open-cell foam, and / or (s) the diffusion member may be a fibrous material.

[0104] One aspect of the present technology relates to a ventilation system for use with a patient interface during respiratory therapy of a patient using a therapeutic flow of pressurized gas above ambient pressure, the ventilation system providing a flow of ventilation gas to exhaust gas exhaled by the patient from a pressurized volume, the ventilation flow being continuous during the respiratory therapy. The ventilation system includes a ventilation housing, the ventilation housing including a base having an inlet extending through the base for the flow of therapeutic gas and at least one first orifice extending through the base to allow gas to be discharged from the pressurized volume to atmosphere; at least one second orifice to allow gas to be discharged from the pressurized volume to atmosphere; and a membrane positioned adjacent the base.

[0105] One aspect of the present technology relates to a ventilation system for use with a patient interface during respiratory therapy of a patient using a therapeutic flow of pressurized gas at a pressure above ambient pressure, the ventilation system providing a flow of ventilation gas to exhaust gas exhaled by the patient from a pressurized volume, the ventilation flow being continuous during the respiratory therapy. The ventilation system includes a ventilation housing, the ventilation housing including a base having at least one first orifice extending through the base to allow gas to be discharged from the pressurized volume to the atmosphere; at least one second orifice to allow gas to be discharged from the pressurized volume to the atmosphere; and a membrane positioned adjacent to the base, wherein the pressurized volume is in fluid communication with the atmosphere through at least the first orifice and at least the second orifice throughout a range of therapeutic pressures, and wherein the membrane is elastically deformable due to pressure within the pressurized volume to distribute the ventilation flow between the at least first orifice and the at least second orifice throughout the range of therapeutic pressures.

[0106] In examples, (a) the ventilation housing may include an outer wall and an inner wall, the inner wall defining an inlet for a therapeutic gas flow, and the base may be positioned between the outer wall and the inner wall, (b) the base may include an inner base and an outer base, (c) the outer base may be adjacent to the outer wall, the inner base may be adjacent to the outer base, and the inner base may be adjacent to the inner wall, (d) the at least one first orifice may include a plurality of inner orifices, and the at least one second orifice may include a plurality of outer orifices, (e) the plurality of outer orifices may pass through the outer base, and the plurality of inner orifices may pass between the outer base and the inner base, (f) the ventilation system may include a plurality of bases connected to the ventilation housing, The invention relates to a method for manufacturing a vent housing and a vent housing having a plurality of membrane spacers, wherein the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the outer ... outer base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the outer base, the vent housing comprises a plurality of membrane spacers extending from the outer base, the vent housing comprises a plurality of membrane spacers extending from the inner base, the vent housing comprises a plurality of membrane spacers extending from the outer base, the vent housing comprises a plurality of membrane spacers extending from the outer base, the vent housing comprises a plurality of membrane The invention relates to a method of manufacturing a ventilation housing according to the present invention, wherein the ventilation housing comprises a plurality of membrane spacers, the plurality of membrane spacers having an inner surface, and an inner base membrane channel for flushing flow can be defined between the atmosphere side surface of the membrane and the inner base of the ventilation housing, (l) the inner wall membrane channel for flushing flow can be defined between the inner surface of the membrane and the inner wall of the ventilation housing, (m) the inner base can include a plurality of inner base slots between adjacent membrane spacers in a plurality of membrane spacers, (n) the outer base can include a plurality of lateral membrane supports, the plurality of lateral membrane supports being configured to prevent the membrane from covering a plurality of external orifices, (o) the ventilation housing can include a plurality of recesses opposite to the outer base, and at least one of the plurality of external orifices can open into a recess in the plurality of recesses. In one, (p) the inner wall may extend above the inner base and the outer base, (q) the inner wall may extend below the inner base and the outer base, (r) the membrane may include an elastically deformable material, (s) the elastically deformable material may include silicone, (t) the vent housing may be formed from a single uniform piece of relatively rigid material, (u) the relatively rigid material may be polycarbonate, (v) the outer wall, inner wall, inner base, outer base and membrane may be circular, (w) the outer wall, inner wall, inner base, outer base and membrane may be concentric, and / or (x) the membrane may not be attached to the vent housing so that the membrane can move freely toward and away from the base.

[0107] Another aspect of the present technology is directed to a patient interface comprising: a seal-forming structure; an inflatable chamber coupled to the seal-forming structure; a positioning and stabilizing structure to secure the patient interface to the patient during use; and a ventilation system according to any aspect and / or example disclosed in the preceding two paragraphs. The patient interface may include a ventilation connection tube or a decoupling structure to fluidly connect the ventilation system to the inflatable chamber.

[0108] Another aspect of the present technology relates to a ventilation system for use with a patient interface during respiratory therapy of a patient using a therapeutic flow of pressurized gas above ambient pressure, the ventilation system providing a flow of ventilation gas to expel gas exhaled by the patient from a pressurized volume, the ventilation flow being continuous during the respiratory therapy. The ventilation system includes a ventilation housing, the ventilation housing including a base having at least one first orifice extending through the base to allow gas to be discharged from the pressurized volume to the atmosphere; at least one second orifice to allow gas to be discharged from the pressurized volume to the atmosphere; and a membrane positioned adjacent the base, wherein the pressurized volume is in fluid communication with the atmosphere through at least the first orifice and at least the second orifice over a range of therapeutic pressures, wherein the membrane is configured such that an increase in pressure within the pressurized volume causes the membrane to restrict a first ventilation flow through at least the first orifice over the range of therapeutic pressures, and wherein the restriction of the first ventilation flow through at least the first orifice causes an increase in the second ventilation flow through at least the second orifice, such that the ventilation flow through at least the first orifice and at least the second orifice is approximately constant over the range of therapeutic pressures.

[0109] In an example, (a) the ventilation housing may include an outer wall and an inner wall, the inner wall defining an inlet for a flow of therapeutic gas, and the base may be positioned between the outer wall and the inner wall, (b) the flushing flow may be greater than or equal to the sum of a first ventilation flow and a second ventilation flow, (c) the membrane may be elastically deformable toward the base during use, such that the first ventilation flow is restricted when the membrane is deflected toward the base, (d) the membrane may be configured to deflect closer to the base when a treatment pressure increases above a threshold treatment pressure value, (e) the membrane may be configured to reduce the first ventilation flow, such that the second ventilation flow increases when the membrane is deflected closer to the base due to increasing the treatment pressure above the threshold treatment pressure value, (f) the at least one first orifice may include a plurality of inner orifices, and the at least one second orifice may include a plurality of outer orifices, (g) the base may include an inner base and an outer base, (h) the ventilation system may include a plurality of membrane spacers extending from the inner base, (i) ) the membrane may be supported over a plurality of internal orifices on the outer base and the membrane spacer such that increasing the treatment pressure above a threshold treatment pressure value causes the membrane to deflect toward the inner base, (j) the membrane may be constructed such that when the treatment pressure increases above the threshold treatment pressure value, a membrane-inner base gap defined between the membrane and the inner base decreases, (k) the membrane may be constructed such that when the membrane-inner base gap decreases, a first ventilation flow rate decreases and a second ventilation flow rate increases, (l) the membrane may include an elastically deformable material, (m) the elastically deformable material may include silicone, (n) the ventilation shell may be formed from a single uniform piece of relatively rigid material, (o) the relatively rigid material may be polycarbonate, (p) the outer wall, inner wall, inner base, outer base and membrane may be circular, (q) the outer wall, inner wall, inner base, outer base and membrane may be concentric, and / or (r) the membrane may not be attached to the ventilation shell such that the membrane may move freely toward and away from the base.

[0110] Another aspect of the present technology is directed to a patient interface comprising: a seal-forming structure; an inflatable chamber coupled to the seal-forming structure; a positioning and stabilizing structure to secure the patient interface to the patient during use; and a ventilation system according to any aspect and / or example disclosed in the preceding two paragraphs. The patient interface may include a ventilation connection tube or a decoupling structure to fluidly connect the ventilation system to the inflatable chamber.

[0111] Another aspect of the present technology relates to a patient interface that may include: an inflatable chamber that can be pressurized to at least 6 cm above ambient air pressure. The invention relates to a ventilation system for use with a patient interface during respiratory therapy using a therapeutic flow of pressurized gas above ambient pressure, wherein the airflow at the therapeutic pressure is delivered to at least the entrance of the patient's nostrils, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the plenum throughout the patient's breathing cycle; a positioning and stabilizing structure to provide a resilient force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure comprising a strap, the strap being constructed and arranged so that at least a portion covers an area of ​​the patient's head above the supra-auricular base of the patient's head during use, and a portion of the strap being sized and structured to engage a portion of the patient's head in the parietal region during use, wherein the positioning and stabilizing structure has a non-rigid decoupling portion; and a ventilation system for use with a patient interface during respiratory therapy using a therapeutic flow of pressurized gas above ambient pressure, the ventilation system comprising a tether being constructed and arranged so that at least a portion covers an area of ​​the patient's head above the supra-auricular base of the patient's head during use, and a portion of the strap being sized and structured to engage a portion of the patient's head in the parietal region during use. A system provides a flow of ventilation gas to vent gas exhaled by a patient from a pressurized volume, the flow of ventilation gas being continuous during respiratory therapy, the ventilation system comprising: a ventilation housing including a base having at least one first orifice extending through the base to allow gas to vent from the pressurized volume to the atmosphere; at least one second orifice to allow gas to vent from the pressurized volume to the atmosphere; and a membrane positioned adjacent the base, wherein the pressurized volume is in fluid communication with the atmosphere through at least the first orifice and at least the second orifice over a range of therapeutic pressures, wherein the membrane is configured such that the pressurized volume The increase in pressure within the membrane causes the membrane to restrict a first ventilation flow through at least the first orifice over the entire treatment pressure range, and wherein the restriction of the first ventilation flow through at least the first orifice causes an increase in the second ventilation flow through at least the second orifice, so that the ventilation flow through at least the first orifice and at least the second orifice is approximately constant over the entire treatment pressure range, and the patient interface is constructed to allow the patient to breathe from the environment through his or her mouth in the absence of a flow of pressurized gas through the inlet port of the inflation chamber, or the patient interface is constructed so that the patient's mouth is uncovered.

[0112] In an example, (a) the ventilation housing may include an outer wall and an inner wall, the inner wall defining an inlet for a therapeutic gas flow, and the base may be positioned between the outer wall and the inner wall, (b) the flushing flow may be greater than or equal to the sum of a first ventilation flow and a second ventilation flow, (c) the membrane may be elastically deformable toward the base during use, such that the first ventilation flow is restricted when the membrane is deflected toward the base, (d) the membrane may be configured to deflect closer to the base when a therapeutic pressure increases above a threshold therapeutic pressure value, (e) the membrane may be configured to reduce the first ventilation flow, such that the second ventilation flow increases when the membrane is deflected closer to the base due to increasing the therapeutic pressure above the threshold therapeutic pressure value, (f) the base may include an inner base and an outer base, (g) the at least one first orifice may include a plurality of inner orifices, and the at least one second orifice may include a plurality of outer orifices, (h) the ventilation system may include a plurality of membrane spacers extending from the inner base, (i) the membrane may support above multiple internal orifices on the outer base and the membrane spacer, (j) the ventilation shell may include a base spacer between the inner base and the outer base, and the membrane may be supported above multiple internal orifices on the base spacer and the membrane spacer, (k) the outer base may include multiple lateral membrane supports, which are constructed to prevent the membrane from covering the multiple external orifices, (l) the membrane may include an elastically deformable material, (m) the elastically deformable material may include silicone, (n) the ventilation shell may be formed from a single uniform piece of relatively rigid material, (o) the relatively rigid material may be polycarbonate, (p) the outer wall, inner wall, inner base, outer base and membrane may be circular, (q) the outer wall, inner wall, inner base, outer base and membrane may be concentric, (r) the membrane may not be attached to the ventilation shell so that the membrane can move freely toward and away from the base, and / or (s) the patient interface may include a ventilation connection tube or a decoupling junction to connect the ventilation system fluid to the inflation chamber.

[0113] Another aspect of the present technology relates to a patient interface, which may include: an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cm H2O above ambient air pressure, the inflatable chamber including an inlet port of the inlet port, the size and structure of which is designed to receive a flow of air at a therapeutic pressure for patient breathing; a seal-forming structure that is constructed and arranged to form a seal with a patient's facial area around an entrance to the patient's airway so that the flow of air at the therapeutic pressure is delivered at least to the entrance of the patient's nares, the seal-forming structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure to provide a resilient force to maintain the seal-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap that is constructed and arranged so that in use at least a portion covers an area of ​​the patient's head above the supra-auricular base of the patient's head, and a portion of the strap is sized and structured to engage a portion of the patient's head in the parietal region during use, wherein the positioning and stabilizing structure has a non-rigid decoupled portion; and a ventilation system to provide ventilation air a ventilation system comprising: a ventilation housing comprising a base having at least one first orifice extending through the base for the first ventilation flow; at least one second orifice for the second ventilation flow; and a membrane positioned adjacent the base, wherein the pressurized volume is in fluid communication with the atmosphere through at least the first orifice and at least the second orifice over an entire treatment pressure range, wherein the membrane is configured to elastically deform in response to a pressure within the pressurized volume such that an increase in deformation due to an increase in pressure reduces a first ventilation flow through the first ventilation orifice and increases a second ventilation flow through at least the second ventilation orifice to maintain a substantially constant ventilation flow over an entire treatment pressure range, and wherein a patient interface is configured to allow the patient to breathe from the environment through his or her mouth in the absence of a flow of pressurized gas through an inlet port of the plenum chamber, or the patient interface is configured such that the patient's mouth is uncovered.

[0114] In an example, (a) the ventilation housing may include an outer wall and an inner wall, the inner wall defining an inlet for a therapeutic gas flow, and the base may be positioned between the outer wall and the inner wall, (b) the flushing flow may be greater than or equal to the sum of a first ventilation flow and a second ventilation flow, (c) the membrane may be elastically deformable toward the base during use, such that the first ventilation flow is restricted when the membrane is deflected toward the base, (d) the membrane may be configured to deflect closer to the base when a therapeutic pressure increases above a threshold therapeutic pressure value, (e) the membrane may be configured to reduce the first ventilation flow, such that the second ventilation flow increases when the membrane is deflected closer to the base due to increasing the therapeutic pressure above the threshold therapeutic pressure value, (f) the base may include an inner base and an outer base, (g) the at least one first orifice may include a plurality of inner orifices, and the at least one second orifice may include a plurality of outer orifices, (h) the ventilation system may include a plurality of membrane spacers extending from the inner base, (i) the membrane may support above multiple internal orifices on the outer base and the membrane spacer, (j) the ventilation shell may include a base spacer between the inner base and the outer base, and the membrane may be supported above multiple internal orifices on the base spacer and the membrane spacer, (k) the outer base may include multiple lateral membrane supports, which are constructed to prevent the membrane from covering the multiple external orifices, (l) the membrane may include an elastically deformable material, (m) the elastically deformable material may include silicone, (n) the ventilation shell may be formed from a single uniform piece of relatively rigid material, (o) the relatively rigid material may be polycarbonate, (p) the outer wall, inner wall, inner base, outer base and membrane may be circular, (q) the outer wall, inner wall, inner base, outer base and membrane may be concentric, (r) the membrane may not be attached to the ventilation shell so that the membrane can move freely toward and away from the base, and / or (s) the patient interface may include a ventilation connection tube or a decoupling junction to connect the ventilation system fluid to the inflation chamber.

[0115] Of course, a part of these aspects may form a sub-aspect of the present technology. Each aspect and / or each of the aspects may be combined in various ways and also constitute other aspects or sub-aspects of the present technology.

[0116] Other features of the present technology will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. 4. Description of the drawings

[0117] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to like elements, including:

[0118] 4.1 Treatment system

[0119] Figure 1AA system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of nasal pillows receiving a supply of air at a positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown.

[0120] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0121] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0122] 4.2 Respiratory system and facial anatomy

[0123] Figure 2A A schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm is shown.

[0124] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea is shown.

[0125] Figure 2C is a front view of the face with several surface anatomical features labeled, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial fold, and corner of mouth. The superior, inferior, radially inward, and radially outward directions are also labeled.

[0126] Figure 2D It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, subnasal septum point, upper lip, lower lip, supramental point, nasal ridge, nasal apex, supra-auricular base point, and subauricular base point. The superior-inferior and anterior-posterior directions are also labeled.

[0127] Figure 2E This is another lateral view of the head. The approximate location of the Frankfort horizontal plane and the nasolabial angle are indicated. The coronal plane is also indicated.

[0128] Figure 2FA bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, nasal process point, long axis of the nostrils, and the sagittal plane.

[0129] Figure 2G A side view of the nasal surface features is shown.

[0130] 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.

[0131] Fig.2I The medial anatomy of the nose is shown approximately a few millimeters from the sagittal plane, showing, among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0132] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also labeled, as are the maxilla and mandible.

[0133] Figure 2K A side view of the skull is shown with the outline of the head surface and several muscles. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also labeled. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0134] Figure 2L An anterolateral view of the nose is shown.

[0135] 4.3 Patient Interface

[0136] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0137] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Figure 3C The curvature magnitude shown is relatively large in comparison.

[0138] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and is Figure 3B The curvature magnitude shown is relatively small in comparison.

[0139] Figure 3D A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0140] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3F The curvature magnitude shown is relatively small in comparison.

[0141] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and is Figure 3E The curvature magnitude shown is relatively large in comparison.

[0142] Figure 3G A cushion for a mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome area and the saddle area are indicated.

[0143] Figure 3H A cushion for a face mask is shown. The outer surface of the cushion is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle regions and one dome region are indicated.

[0144] 4.4RPT device

[0145] Figure 4A One form of RPT device according to the present technology is shown.

[0146] Figure 4B Schematic diagram of the pneumatic path of an RPT device according to one form of the present technology. The upstream and downstream directions are indicated.

[0147] Figure 4C is a schematic diagram of the electrical components of an RPT device according to one form of the present technology.

[0148] Figure 4D is a schematic diagram of an algorithm implemented in a RPT device according to one form of the present technology.

[0149] Figure 4E is a diagram showing a form of Figure 4D Flowchart of the method performed by the treatment engine module.

[0150] 4.5 Humidifier

[0151] Figure 5A is an isometric view of a humidifier according to one form of the present technology.

[0152] Figure 5BAn isometric view of a humidifier in accordance with one form of the present technology is shown showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0153] Figure 5C A schematic diagram of a humidifier according to one form of the present technology is shown.

[0154] 4.6 Ventilation adapter

[0155] Fig. 6A A side view of a fluid connector having first and second ends mating with each other is shown.

[0156] Figure 6B A side cross-sectional view of a fluid connector having first and second ends decoupled from one another is shown.

[0157] Figure 6C A side cross-sectional view of a fluid connector having first and second ends mating with each other is shown.

[0158] Fig.6D A perspective view of a fluid connector having first and second ends separated from one another is shown, with the interior of the first end visible.

[0159] Fig. 6E A cross-sectional view of a fluid connector with additional fluid ports is shown.

[0160] Fig. 6F A fluid connector is shown with a first end and a second end connected together and the first end integrated into an RTP device.

[0161] Figure 6G A fluid connector is shown with the first and second ends disconnected and the first end integrated into the RTP device

[0162] Figure 6H A perspective view of a fluid connector having first and second ends separated from one another is shown, with a sealing surface of the second end visible.

[0163] Fig. 7A A perspective view of a ventilation adapter according to an example of the present technology is shown.

[0164] Figure 7B A side view of a ventilation adapter according to an example of the present technology is shown.

[0165] Figure 7C A top view of a ventilation adapter according to an example of the present technology is shown.

[0166] Fig.7D A ventilation adapter according to an example of the present technology is shown. Figure 7CA cross-sectional view taken along line 7D-7D.

[0167] Fig. 7E An exploded view of a ventilation adapter according to an example of the present technology is shown.

[0168] Figure 7F Another exploded view of a ventilation adapter according to an example of the present technology is shown.

[0169] Fig. 8A A perspective view of a breather housing according to an example of the present technology is shown.

[0170] Figure 8B Another perspective view of a breather housing according to an example of the present technology is shown.

[0171] Figure 8C A side view of a breather housing according to an example of the present technology is shown.

[0172] Fig.8D Another side view of a breather housing according to an example of the present technology is shown.

[0173] Fig. 8E Shown is a top view of a vent housing according to an example of the present technology.

[0174] Fig.8F A vent housing according to an example of the present technology is shown. Fig. 8E A cross-sectional view taken along line 8F-8F.

[0175] Fig. 9A A perspective view of a breather housing connector is shown in accordance with one example of the present technology.

[0176] Fig. 9B Another perspective view of a breather housing connector is shown in accordance with an example of the present technology.

[0177] Fig. 9C A side view of a breather housing connector is shown in accordance with an example of the present technology.

[0178] Fig.9D Another side view of a breather housing connector is shown in accordance with an example of the present technology.

[0179] Fig.9E A top view of a breather housing connector is shown in accordance with an example of the present technology.

[0180] Fig. 10A A perspective view of a bellows seal according to an example of the present technology is shown.

[0181] Fig. 10BAnother perspective view of a bellows seal according to an example of the present technology is shown.

[0182] Fig. 10C A side view of a bellows seal according to an example of the present technology is shown.

[0183] Fig. 10D Another side view of a bellows seal according to an example of the present technology is shown.

[0184] Fig. 10E A bottom view of a bellows seal according to an example of the present technology is shown.

[0185] Fig.11A A perspective view of a ventilation adapter connector according to an example of the present technology is shown.

[0186] Fig. 11B Another perspective view of a ventilation adapter connector according to an example of the present technology is shown.

[0187] Fig. 11C A side view of a ventilation adapter connector according to an example of the present technology is shown.

[0188] Fig.11D Another side view of a ventilation adapter connector according to an example of the present technology is shown.

[0189] Fig.11E A bottom view of a ventilation adapter connector according to an example of the present technology is shown.

[0190] Fig. 12A A perspective view of a heat and moisture exchanger (HME) clip is shown according to an example of the present technology.

[0191] Fig. 12B A side view of a heat and moisture exchanger (HME) clip is shown according to an example of the present technology.

[0192] Fig. 12C Another side view of a heat and moisture exchanger (HME) clip is shown according to an example of the present technology.

[0193] Fig.12D Another side view of a heat and moisture exchanger (HME) clip is shown according to an example of the present technology.

[0194] Fig.13A A perspective view of a heat and moisture exchanger (HME) housing is shown according to an example of the present technology.

[0195] Fig. 13B A side view of a heat and moisture exchanger (HME) housing is shown according to an example of the present technology.

[0196] Fig. 13C Another side view of a heat and moisture exchanger (HME) housing is shown according to an example of the present technology.

[0197] Fig.13D Shown is a top view of a heat and moisture exchanger (HME) housing according to an example of the present technology.

[0198] Fig.14A A perspective view of a catheter connector according to an example of the present technology is shown.

[0199] Fig. 14B A top view of a catheter connector according to an example of the present technology is shown.

[0200] Fig. 14C A side view of a catheter connector according to an example of the present technology is shown.

[0201] Fig.14D A front view of a catheter connector according to an example of the present technology is shown.

[0202] Fig.15A A perspective view of a ventilation adapter according to an example of the present technology is shown.

[0203] Fig. 15B Another perspective view of a ventilation adapter according to an example of the present technology is shown.

[0204] Fig. 15C An exploded view of a ventilation adapter according to an example of the present technology is shown.

[0205] Fig.15D An exploded view of a ventilation adapter according to an example of the present technology is shown.

[0206] Fig.15E A side view of a ventilation adapter according to an example of the present technology is shown.

[0207] Fig.15F A ventilation adapter according to an example of the present technology is shown. Fig. 15B A cross-sectional view taken along line 15F-15F.

[0208] Fig.16 A graph showing ventilation flow from a full face mask according to the present technology compared to ventilation flow from a constant flow ventilator (CFV) over a therapeutic pressure range is shown.

[0209] Fig.17 A diagram of a patient receiving treatment according to an example of the present technology is shown.

[0210] Fig.18A graph showing ventilation flow from a full face mask according to the present technology compared to ventilation flow from a constant flow ventilator (CFV) over a therapeutic pressure range is shown.

[0211] Fig.19 Graphs of ventilation flow from a constant flow vent (CFV) only, from a passive vent only, and both in accordance with the present technology over a therapeutic pressure range are shown.

[0212] Fig. 20 An example of a constant flow vent (CFV) membrane according to one example of the present technology is shown.

[0213] Fig.21A A cross-sectional view of a ventilation adapter according to an example of the present technology is shown.

[0214] Fig.21B An exploded view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0215] Fig. 21C A rear view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0216] Fig.21D A perspective view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0217] Fig.21E Another perspective view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0218] Fig.21F A cross-sectional view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0219] Fig. 22 An exploded view of a ventilation adapter according to an example of the present technology is shown.

[0220] Fig.23 A diagram illustrating an exemplary patient interface in accordance with the present technology.

[0221] Fig.24A A cross-sectional view of a ventilation adapter according to an example of the present technology is shown.

[0222] Fig. 24B A perspective view of a ventilation adapter according to an example of the present technology is shown.

[0223] Fig.25A Shown is a cross-sectional view of an HME 7000 comprising a single layer 7001 in accordance with one aspect of the present technology.

[0224] Fig.25B An example of a single corrugated crossbar 7030 of an HME 7000 is shown in accordance with one aspect of the present technology.

[0225] Fig.25C is a schematic diagram showing an HME 7000 comprising a plurality of layers 7001 stacked along a vertical axis and a horizontal axis.

[0226] Fig.25D is a diagram showing a HME under preload to compress the corrugations in a fixed volume such that the number of layers 7001 increases within the fixed volume.

[0227] Fig.25E A corrugated structure 7002 is shown comprising a plurality of corrugations 7030 , wherein the corrugated structure is rolled to form the HME 7000 .

[0228] Fig.26 An orifice, a diffuser member, and a barrier member forming part of a gas flushing vent are depicted.

[0229] Fig. 27 An orifice forming part of a gas flushing vent, a diffuser member and a barrier member are depicted, wherein the barrier member has holes disposed therein.

[0230] Fig.28 An exploded view of an orifice, a diffuser member, and a barrier member forming a portion of a gas flushing vent formed circularly around a central hole is depicted.

[0231] Fig.29 Depicted is a simplified view of an orifice, a diffuser member, and a barrier member forming a portion of a gas flushing vent formed circularly around a central hole.

[0232] Fig.30 Depicted through Fig.29 A cross-sectional view taken along line 30-30.

[0233] Fig.31A Depicted is a partial view of an elbow with a gas flush vent having an annular outlet.

[0234] Fig.31B Depicted Fig.31B Axial view of the orifice in the gas flush vent.

[0235] Fig.31C Depicts a cross-sectional view taken through the plane of FIG. 31 , which is equivalent to Fig.31B The plane marked as 31C-31C in.

[0236] Fig.32AAn elbow with a ball joint and a gas flushing vent is depicted.

[0237] Fig.32B yes Fig.32A Exploded view of the elbow.

[0238] Fig.32C It is a side view of the elbow.

[0239] Fig.32D Depicted through Fig.32C A cross-sectional view taken along line 32D-32D.

[0240] Fig.33A Depicted is a perspective view of a ventilation adapter according to an example of the present technology.

[0241] Fig.33B Depicted is another perspective view of a ventilation adapter according to an example of the present technology.

[0242] Fig.33C Depicted is a superior side view of a ventilation adapter according to an example of the present technology.

[0243] Fig.33D Depicted is an underside view of a ventilation adapter according to an example of the present technology.

[0244] Fig.33E Depicted is a side view of a ventilation adapter according to an example of the present technology.

[0245] Fig.33F An example ventilation adapter according to the present technology is shown. Fig.33C A cross-sectional view taken along line 33F-33F.

[0246] Figure 33G Depicted is an exploded view of a ventilation adapter according to one example of the present technology.

[0247] Fig.34A Depicted is a perspective view of a ventilation assembly for use with a ventilation adapter according to one example of the present technology.

[0248] Fig.34B Depicted is another perspective view of a ventilation assembly for use with a ventilation adapter according to an example of the present technology.

[0249] Fig.34C Depicted is a rear view of a ventilation assembly for use with a ventilation adapter according to one example of the present technology.

[0250] Fig.34D Depicted is a front view of a ventilation assembly for use with a ventilation adapter according to one example of the present technology.

[0251] Fig.34EDepicted is a side view of a ventilation assembly for use with a ventilation adapter according to one example of the present technology.

[0252] Fig.34F A ventilation assembly for a ventilation adapter according to an example of the present technology is shown. Fig.34C A cross-sectional view taken along line 34F-34F.

[0253] Figure 34G Depicted is an exploded view of a ventilation assembly for use with a ventilation adapter according to one example of the present technology.

[0254] Fig.35 Depicted is a perspective view of a ventilation adapter with a patient interface according to an example of the present technology.

[0255] Fig.36A Depicted is a perspective view of an air circuit according to one example of the present technology.

[0256] Fig.36B Depicted is another perspective view of an air circuit according to an example of the present technology.

[0257] Fig.36C Depicted is an exploded view of an air circuit according to one example of the present technology.

[0258] Fig.37A Depicted is a perspective view of a ventilation adapter according to an example of the present technology.

[0259] Fig.37B Depicted is another perspective view of a ventilation adapter according to an example of the present technology.

[0260] Fig.37C Depicted is a side view of a ventilation adapter according to an example of the present technology.

[0261] Fig.37D Depicted is an example of a ventilation adapter according to the present technology. Fig.37B A cross-sectional view taken at 37D-37D.

[0262] Fig.37E Depicted is an exploded view of a ventilation adapter according to one example of the present technology.

[0263] Fig.38A Depicted is a perspective view of a heat and moisture exchanger (HME) housing according to an example of the present technology.

[0264] Fig.38B Depicted is another perspective view of an HME housing according to an example of the present technology.

[0265] Fig.38C Depicted is an exploded view of an HME housing according to one example of the present technology.

[0266] Fig.39A Depicted is a perspective view of a heat and moisture exchanger (HME) housing according to an example of the present technology.

[0267] Fig.39B Depicted is another perspective view of an HME housing according to an example of the present technology.

[0268] Fig.39C Depicted is an exploded view of an HME housing according to one example of the present technology.

[0269] Fig.40 Depicted is a perspective view of a ventilation adapter with a patient interface according to an example of the present technology.

[0270] Fig.41 Depicted is a perspective view of a ventilation adapter with a patient interface according to an example of the present technology.

[0271] Fig.42A Shown is a top perspective view of a breather housing according to one example of the present technology.

[0272] Fig.42B A top view of a vent housing according to another example of the present technology is shown.

[0273] Fig.42C A bottom view of a vent housing according to another example of the present technology is shown.

[0274] Fig.42D A bottom perspective view of a breather housing according to another example of the present technology is shown.

[0275] Fig.42E A side view of a breather housing according to another example of the present technology is shown.

[0276] Fig.42F A vent housing according to another example of the present technology is shown. Fig.42B A cross-sectional view taken along line 42F-42F.

[0277] Figure 42G A vent housing according to another example of the present technology is shown. Fig.42B A cross-sectional view taken along line 42G-42G.

[0278] Fig.43A Shown is a top perspective view of a vent system in accordance with an example of the present technology.

[0279] Fig.43B Shown is a top view of a vent system according to another example of the present technology.

[0280] Fig.43C Shown is a top view of a vent system according to another example of the present technology.

[0281] Fig.43D Shown is a bottom perspective view of a vent system according to another example of the present technology.

[0282] Fig.43E A side view of a vent system according to another example of the present technology is shown.

[0283] Fig.43F A vent system according to another example of the present technology is shown. Fig.43B A cross-sectional view taken along line 43F-43F.

[0284] Figure 43G A vent system according to an example of the present technology is shown. Fig.43B A cross-sectional view taken along line 43G-43G. 5. Specific implementation methods

[0285] Before describing the present technology in further detail, it should be understood that the present technology is not limited to the specific examples described herein, which may be varied. It should also be understood that the terminology used in the present disclosure is only for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0286] The following description is provided in relation to various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features may constitute another example.

[0287] 5.1 Treatment

[0288] In one form, the present technology includes a method for treating a breathing disorder, the method comprising the step of applying positive pressure to an airway entrance of a patient 1000 .

[0289] In certain examples of the present technology, a supply of air under positive pressure is provided to the patient's nasal passages via one or both nostrils.

[0290] In certain examples of the present technology, mouth breathing is limited, restricted or prevented.

[0291] 5.2 Treatment system

[0292] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device 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 .

[0293] 5.3 Patient Interface

[0294] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. When in use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of air under positive pressure to the airway.

[0295] 5.3.1 Sealing structure

[0296] In one form of the present technology, the seal-forming structure 3100 provides a seal-forming surface and may additionally provide a cushioning function.

[0297] A seal-forming structure 3100 in accordance with the present technology may be constructed from a soft, flexible and resilient material such as silicone.

[0298] In one form, the seal forming structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member having a thickness of less than about 1 mm, such as about 0.25 mm to about 0.45 mm, which extends around the periphery of the plenum 3200. The support flange can be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the plenum 3200 and extends around at least a portion of the path of the perimeter. The support flange is or includes a spring-like element and acts to support the sealing flange to prevent it from bending when in use. When in use, the sealing flange can easily respond to the system pressure in the plenum 3200 that acts on its bottom surface, so that it forms a tight sealing engagement with the face.

[0299] In one form, the seal-forming portion of the non-invasive patient interface 3000 comprises a pair of nasal puffs or pillows, each of which is constructed and arranged to form a seal with a corresponding nostril of the patient's nose.

[0300] A nasal pillow according to one aspect of the present technology includes: a frustoconical body, at least a portion of which forms a seal on the bottom surface of the patient's nose; a stem; and a flexible region on the bottom surface of the frustoconical body and connecting the frustoconical body to the stem. In addition, the structure to which the nasal pillows of the present technology are connected includes a flexible region adjacent to the bottom of the stem. The flexible region can work together to facilitate a universal engagement structure that can accommodate relative movement of both displacement and angle between the frustoconical body and the structure to which the nasal pillows are connected. For example, the position of the frustoconical body can be moved axially toward the structure to which the stem is connected.

[0301] In one form, the non-invasive patient interface 3000 includes a seal forming portion that forms a seal on the upper lip region (ie, upper lip) of the patient's face when in use.

[0302] In one form, the non-invasive patient interface 3000 includes a seal forming portion that forms a seal over the chin region of the patient's face when in use.

[0303] 5.3.2 Inflatable chamber

[0304] In the area where the seal is formed in use, the plenum 3200 has a perimeter shaped to complement the surface contour of an average human face. In use, the boundary edge of the plenum 3200 is positioned in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend along the entire perimeter of the plenum 3200 in use.

[0305] 5.3.3 Positioning and stabilizing the structure

[0306] The seal-forming structure 3100 of the patient interface 3000 of the present technology may be maintained in a sealed state during use by the positioning and stabilizing structure 3300 .

[0307] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one example, the positioning and stabilizing structure 3300 includes at least one strap that is rectangular in cross-section. In one example, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0308] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer comprises a loop material for engaging with a hook material portion.

[0309] In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to be in a tensioned state when in use and to direct a force to seal the cushion against a portion of the patient's face. In one example, the strap can be configured as a tie.

[0310] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is flexible and, for example, non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0311] 5.3.4 Ventilation

[0312] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0313] One form of a 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.

[0314] The vent 3400 may be located in the plenum chamber 3200. Alternatively, the vent 3400 is located in a decoupling structure such as a swivel.

[0315] 5.3.5 Decoupling structure

[0316] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0317] 5.3.6 Connection Port

[0318] The connection port 3600 allows connection to the air circuit 4170 .

[0319] 5.3.7 Forehead support

[0320] In one form, the patient interface 3000 includes a forehead support 3700 .

[0321] 5.3.8 Anti-asphyxia valve

[0322] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0323] 5.3.9 Ports

[0324] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to supply supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0325] 5.4 Ventilation adapter

[0326] 5.4.1 Constant flow vent

[0327] Fig.16 A comparison of the vent flow rates between a conventional vent (FFM nominal flow) and a constant flow vent (CFV) is shown. A conventional vent is a standard molded vent, such as one formed in Figure 3A 3400 on the patient interface 3000 in FIG. As can be seen in the figure, the ventilation flow is compared over a mask pressure range between 4-20 cm H2O, which is a standard pressure range for SDB and OSA respiratory pressure therapy. It can be seen that the ventilation flow increases logarithmically with increasing pressure. In contrast, CFV shows a flatter curve, where the ventilation flow appears to be more constant and lower over the same pressure range.

[0328] The ventilation flow rate should be at least 16 L / min to flush enough CO2 out of the system so that CO2 rebreathing by the patient is minimized. It has been shown that ventilation flows between 20-27 L / min provide both breathing comfort (no increased arousal of the patient due to CO2 rebreathing) and safety (avoidance of apnea due to excessive CO2 rebreathing). One aspect of the present technology includes providing a minimum (or minimum range) of ventilation flow to ensure that adequate CO2 is flushed out. Any ventilation flow above the minimum can be considered wasteful. For example, when looking at Fig.16 When looking at the graphs shown, the area between the CFV ventilation flow and the FFM nominal flow can be considered as wasted flow. The CFV can achieve the required minimum ventilation flow of 16 L / min across the therapeutic pressure range and maintain this ventilation flow between 16-27 L / min across the pressure range of 4-20 cm H2O. In contrast, the FFM nominal flow is in the range of 22-55 L / min. Therefore, there may be greater unnecessary flow losses when using an FFM nominal flow ventilator.

[0329] In order to compensate for the unnecessary flow loss, an airflow generator or RPT device may be required to increase its flow rate to achieve the same pressure compared to a CFV. Therefore, more power is required and a more complex airflow generator is required to allow a larger flow swing (e.g., between 16-55 L / min of ventilation flow) to compensate for the vent. However, a CFV can adjust the ventilation flow rate according to pressure changes to reduce the ventilation flow rate as pressure increases. Therefore, a CFV can achieve greater power savings through an airflow generator and increase simplicity by avoiding the need for complex pressure / flow control.

[0330] According to the present technology, a constant flow vent (CFV) may be a ventilation flow regulating valve (movable membrane) 9140 that responds to mask pressure to regulate ventilation flow. Figures 21A-21F . The valve 9140 can be adjusted so that the flow rate remains relatively constant within a predetermined pressure range. That is, when the pressure in the mask / system increases, the valve flap 9140 covers more of the internal vent holes 9126 to reduce the ventilation flow (ventilation flow increases at higher pressures); when the pressure in the mask / system is lower, the valve flap 9140 covers less ventilation holes and achieves more ventilation flow (compensating for low ventilation flow at lower pressures). This adjustment can achieve a substantially constant ventilation flow within the pressure range. Fig.18 The graph in shows the change in flow rate under pressure changes in the presence and absence of a CFV. Fig.18 The performance of an exemplary CFV graphed in FIG. 5 has a flow rate up to 24 L / min as pressure increases from 0-40 cm H2O.

[0331] According to one example of the present technology, the CFV may include a movable valve flap or membrane CFV 9140, and may be made of an elastic material, such as silicone or other TPE (thermoplastic elastomer). The valve flap 9140 can be configured so that an increase in pressure in the mask causes the valve flap to cover more of the internal vent 9126 and gradually reduce the flow. The valve flap 9140 can be positioned perpendicular to the flow of pressurized gas flowing to the patient. The ventilation channel of the internal vent 9126 can also be perpendicular to the flow and travel away from the patient to exhaust to the atmosphere. The valve flap 9140 is positioned so that the pressure accumulated in the mask can cause the valve flap to move toward the internal vent 9126.

[0332] Fig.21F An exemplary CFV configuration is shown in cross section. The CFV units may be placed in a row (i.e., within an air delivery conduit loop). Fig.21F As shown, if pressure builds up in the mask, the position of the valve flap 9140 is such that the valve flap 9140 can move toward the internal vent 9126. Pressurized gas that reaches the internal vent 9126 that is not blocked by the valve flap 9140 can then be exhausted to the atmosphere via the external vent 9125.

[0333] The CFV is characterized in that it can achieve simplification of the RPT system. Having a substantially constant ventilation flow within a pressure range means that the complexity of the airflow generator or RPT device can be reduced because a large amount of pressure control is no longer required to compensate for the changing pressure losses caused by ventilation. In addition, since power is no longer required to compensate for flow changes at different pressures, the CFV can achieve reduced power consumption. That is, the CFV passively (pressure-driven) regulates pressure and is able to regulate pressure due to ventilation flow changes, otherwise these ventilation flow changes will be actively compensated by changes in pressure / flow delivery from the RPT device. This simplification allows a simpler RPT device to deliver therapy, for example, the device may have fewer components, may be smaller, may not require powered humidification, and / or may require less overall power to deliver therapy (this is due to the fact that it does not need to compensate for ventilation flow changes). The CFV can also allow passive humidification via a heat and moisture exchanger (HME), as described below.

[0334] One problem with the known CFV concept is that there may be associated noise when regulating ventilation flow. There may be some interaction between the valve flap 9140 and the internal vent holes 9126 that disturbs the ventilation flow and causes noise. For example, assume that when moving under pressure, the movable valve flap 9140 does not completely cover some of the internal vent holes 9126. When gas flows between the valve flap 9140 and the internal vent holes 9126, this interaction may cause turbulence and associated noise.

[0335] One way to reduce turbulence and therefore reduce noise may be to reduce the number of holes 9126 that interact with the flap 9140. However, a minimum ventilation flow is required to prevent rebreathing of CO2 in the mask and reducing the number of vent holes 9126 that interact with the flap 9140 may not allow for adequate ventilation. Therefore, a solution according to the present technology may involve having some of the vent holes 9126 regulated by the radial disc flap 9140, while other vent holes 9126 do not engage the flap 9140 and remain open at all times. Having some of the vent holes 9126 always open, i.e., static vents, means that the ventilation flow will increase as the pressure in the system increases according to the Bernoulli equation.

[0336] In order to compensate for this increased ventilation flow so that the total ventilation flow is substantially constant within the treatment pressure range, the ventilation flow of the remaining vents, i.e., the adjustable vents, can be reduced as the pressure increases. These vents 9126 can be adjusted by a movable valve flap 9140, wherein the vents 9126 are gradually covered as the pressure increases, thereby reducing the ventilation flow. The overall flow of the static vent can then be averaged with the flow of the adjustable vent to achieve a generally constant flow within the treatment pressure range. The lower noise level of ventilation can also be attributed to molded vent technology, which produces low levels of noise when pressure and ventilation flow increase (e.g., by molding small vents with a converging shape). This technology combined with an adjustable vent can achieve a low overall noise alternative to a constant flow vent.

[0337] The ventilation adapter 9100 or fluid connector may include a constant flow vent (CFV) unit. The CFV unit may include: a CFV ring 9150; a flat annular valve 9140; and a ventilation housing 9120. The CFV ring 9150 may hold the valve 9140 in place against the vent 9126. The ventilation housing 9120 may include an annular surface with a plurality of vents 9126. The annular surface may include a central orifice for allowing pressurized gas to flow into the mask chamber (inlet flow). The annular surface may include a plurality of vents 9126 to allow ventilation flow. The valve 9140 may be adjacent to the vent 9126 and may be freely retained, i.e., sandwiched between the CFV ring 9150 and the annular surface of the ventilation housing 9120, i.e., the valve flap 9140 is not fixed to the CFV ring 9150 or the ventilation housing 9120. As mask pressure increases, this increases pressure toward the vent, wherein valve 9140 is pushed toward vent 9126 and covers more of vent 9126. Conversely, as mask pressure decreases, less pressure is applied to valve 9140, so valve 9140 moves away from vent 9126 and covers less of vent 9126.

[0338] Reducing the ventilation noise of the constant flow vent design can be achieved by changing the ventilation flow characteristics using a flow regulating valve or membrane 9140. However, compared to traditional molded or static vents, that is, the vent does not change form or shape during pressure changes, the membrane 9140 can increase the ventilation noise. This noise can be attributed to many factors, including: 1) when the vent 9126 is opened or closed by the membrane 9140, the flow rate changes through the adjustable vent and / or 2) The flow disturbance caused by the membrane 9140, which produces noise, that is, turbulence. For example, changing the direction of the ventilation flow may cause turbulence, which may cause noise from multiple factors. This may be caused by the gas colliding with the surface of the vent (vent wall or CFV membrane) 9140 or the air passing through the surface of the vent (vent wall and / or membrane) 9140. Therefore, partially closing the vent 9126 can produce more noise due to the above factors 1) and / or 2).

[0339] As mentioned above, one aspect of the present technology includes a vent having a substantially constant flow rate within a therapeutic pressure range (i.e., 4-20 cm H2O or 2-40 cm H2O). In order to meet the desired ventilation flow curve under pressure changes, the flow curve of the vent 9126 can be dynamically changed within the therapeutic pressure range. This can be accomplished by changing the size, number and / or shape of the vent. Changing such characteristics may cause changes in the gas flow characteristics through the vent, which may result in increased ventilation noise. Using molded vent technology including converging vent shapes, when the gas is discharged from the vent to the atmosphere, that is, when the inner vent 9126 converges to the outer vent 9125, the noise of the ventilation flow can be adjusted to a minimum. However, it should be understood that the molded vent will not change size, shape or number under pressure changes. Therefore, a deformable membrane or valve flap 9140 that moves under pressure to close or open the vent can be used to change the flow through the vent 9126. However, the deformable membrane or flap 9140 may generate undesirable noise levels due to changes in flow rate through the regulated vent when the vent 9126 is opened or closed by the membrane 9140 and / or due to partially closed vent 9126.

[0340] This noise can be reduced by including a membrane flap 9140 that gradually closes the vent 9126 as pressure increases, wherein the flap 9140 is fixed at one end so that the flap 9140 deflects in response to pressure changes. The problem with this technology is that the membrane 9140 may only partially close a given vent 9126, which may result in flow passing between the vent 9126 and the membrane 9140 at high speeds. This in turn generates noise as the air passes along or impinges upon the surfaces of the vent 9126 and the membrane 9140.

[0341] It is possible to overcome this problem by reducing the number of adjustable vents while maintaining a generally constant ventilation flow rate within the treatment pressure range to reduce ventilation noise. Using molded vents (i.e., static vents) can maintain the desired noise level. However, these vents may not achieve the desired flow curve (i.e., a substantially constant flow rate within the treatment pressure range between 4-20 cm H2O). This can be achieved by combining some adjustable vents with static vents so that the overall ventilation flow rate is substantially constant within the treatment pressure range. Increasing the number of static vents that are not regulated by the membrane may result in a reduction in overall ventilation noise.

[0342] However, the introduction of molded vents may introduce new problems whereby it may be difficult to ensure a substantially constant ventilation flow rate over a therapeutic pressure range using a combination of static vents and regulated vents. Fig.16 As shown, the ventilation flow characteristic of the known molded static vent is a logarithmic curve, in which the ventilation flow increases with increasing pressure. In order to compensate for the flow of the static vent, the regulating vent should provide an inverse flow curve, in which the ventilation flow decreases with increasing pressure. Therefore, the membrane 9140 of the regulating vent 9126 can be adjusted to provide such a ventilation flow.

[0343] There are many ways to adjust the membrane 9140 to provide a ventilation flow rate that is opposite to the logarithmic flow curve of a static molded vent. For example, the shape / structure of the membrane 9140 can be changed to adjust the flow curve of the regulated vent, and the material of the membrane 9140 can be changed to adjust the flow curve of the regulated vent.

[0344] As in Fig. 20 As shown in , the annular disc membrane 9140 structure of the CFV membrane can allow the membrane 9140 to be adjusted in a variety of ways so that it changes the regulated vent flow. The regulated vent flow can be changed by covering / opening the vent holes 9126 at a fixed pressure. The membrane 9140 that covers more vents at a fixed pressure has a lower ventilation flow than the membrane that covers less vents. The annular disc structure 9140 can allow the membrane 9140 to be easily adjusted to cover a variable amount of vents at a fixed pressure. One possible implementation is by changing the diameter of the central orifice or changing the width of the vent engagement surface.

[0345] The overall size of the membrane 9140 is limited by the size of the CFV unit housing 9120, however, it is desirable to reduce the size of the CFV as much as possible. Therefore, the width of the vent engagement surface can be adjusted by adjusting the size of the central orifice. The increase in the size of the central orifice causes the width of the vent engagement surface to also decrease. This reduction in width in turn causes the surface area of ​​the membrane 9140 to decrease. The reduction in surface area means less resistance to deformation under a fixed pressure, thereby covering more vents under a fixed pressure compared to a wider membrane 9140 (i.e., more surface area). This principle is established within a predetermined surface area range. That is, if the surface area is so small that there is not enough surface (i.e., the width of the vent engagement surface is too small), a greater force is required to deform the membrane 9140 (i.e., the surface area is extremely small).

[0346] The thickness of the membrane 9140 can also be varied so that it deforms more easily at a fixed pressure. For example, a thinner membrane 9140 deforms more easily at a 15 cm H2O mask pressure when compared to a thicker membrane 9140 having the same shape at the same pressure.

[0347] The membrane 9140 may also be constructed so that it moves freely to cover the vent hole 9126 under a fixed pressure. For example, in the related art, the membrane 9140 may be fixed at a point such as on the vent housing 9120 so that it is hinged relative to the fixed point, and the membrane 9140 will deflect around the fixed point due to pressure changes.

[0348] The design of the CFV membrane 9140 according to an example of the present technology allows it to move freely between the retaining structure and the vent surface. When compared with a valve flap design, i.e., the membrane is fixed at one end and moves relative to the fixed end, this configuration can allow the membrane 9140 to be more easily adjusted to regulate ventilation flow.

[0349] A more flexible / compliant membrane 9140 can deform more easily at a fixed pressure / load, thereby covering more vents 9126 than a stiffer membrane. Thus, changing the material of the membrane 9140 to a more flexible material (while otherwise having the same size and structure) will allow the membrane 9140 to deform more easily at the same pressure to cover more vents 9126 and reduce ventilation flow. Thus, this can allow the membrane 9140 to be adjusted to provide a desired ventilation flow curve within the therapeutic pressure range.

[0350] As described above, a variety of approaches may be used to provide a membrane 9140 that responds to pressures within a target therapeutic range to provide a predetermined ventilation flow curve, i.e., to provide an overall substantially constant ventilation flow between pressures of 4-30 cm H2O. It may also be desirable to provide such a constant ventilation flow while minimizing ventilation noise, and one solution may be to maximize the number of static non-membrane regulated vents and have a minimum number of membrane regulated vents that provide a substantially constant average total ventilation flow. This flow curve is determined by Fig.19 The thicker solid line named "active vent only" in the figure is shown. In this example, the dotted line represents the static non-membrane regulated vent, while the thinner solid line named "CFV and passive vent" represents the combined vent flow. It is worth noting that as the pressure increases, the vent flow of the static vent gradually increases, while the CFV membrane regulated vent gradually decreases to the threshold.

[0351] Another cause of noise can be attributed to the ventilation flow disturbance caused by the CFV membrane 9140, which can also affect the air flow through the static vent. In the related art, the static vent is positioned on the proximal side of the CFV membrane regulated vent, that is, the vent is positioned on the same surface of the CFV housing 9120. This move produces noise even for non-regulated static vents because the membrane has an effect on the flow characteristics of the static ventilation flow. Therefore, it may be desirable to position the static vent away from the CFV membrane regulated vent so that the membrane 9140 does not affect the static ventilation flow passing therethrough. In one example of the present technology, the static vent is positioned on the distal surface of the CFV regulated vent. For example, the static vent can be positioned on a component different from the CFV housing 9120. The positioning of the static vent may be limited because they may also not be able to flush CO2. When the static vent is positioned closer to the patient, the ability to flush CO2 increases. However, the static vent may also be located on the opposite side of the HME relative to the patient to prevent moisture loss during exhalation, as explained below.

[0352] 5.4.1.1 Ventilated housing

[0353] Figures 42A to 42G An example of a ventilation system 13400 according to an example of the present technology is depicted. The ventilation system 13400 includes a ventilation housing 13401, which can include an outer wall 13402, and the outer wall 13402 can define the outer perimeter of the ventilation housing 13401. The ventilation housing 13401 can also include an inner wall 13410, which can define an inlet for a flow of gas generated by the RPT device 4000 and directed to the plenum chamber 3200 and to the patient for treatment. As can be seen, in this example, the outer wall 13402 and the inner wall 13410 are formed as concentric circles.

[0354] Positioned between the outer wall 13402 and the inner wall 13410 is a base. The base may further include an outer base 13403 and an inner base 13406. The outer base 13403 may extend from the inner periphery of the outer wall 13402, and the inner base 13406 may extend from the outer periphery of the inner wall 13410. As can be seen, in this example, the outer base 13403 and the inner base 13406 are also formed as concentric circles.

[0355] The outer base 13403 may include one or more outer orifices 13404 radially distributed around the outer base 13403. These outer orifices 13404 can completely pass through the outer base 13403 to provide a flow path from the interior of the ventilation system 13400 to the atmosphere. The outer orifices 13404 can be straight, that is, perpendicular to the outer base 13403, or the outer orifices 13404 can pass through the outer base 13403 in a curved path or an inclined path. The diameter of the outer orifice 13404 can be constant along its length, or the diameter can vary. The outer orifices 13404 can be all the same or some outer orifices can be different from other outer orifices. The edges of the outer orifices 13404 can have chamfers or fillets. The outer base 13403 can at least partially support the membrane 13430 to prevent the membrane 13430 from completely blocking the inner orifice 13407. Thus, the outer base 13403 can extend upwardly higher than the inner base 13406, as can be seen in FIG. Figures 42A to 42G As seen in.

[0356] The ventilation housing 13401 can also include lateral membrane supports 13405 distributed around the inner periphery of the outer base 13403 and the outer wall 13402. The lateral membrane supports 13405 can abut the membrane 13430 and prevent the membrane 13430 from moving laterally during use, thereby covering the outer orifice 13404. As will be explained below, it may be desirable to not block the outer orifice 13404 so that the ventilation system 13400 will be able to maintain a substantially constant ventilation flow over most of the typical treatment pressure range. Therefore, the lateral membrane supports 13405 can protrude radially inward beyond the edge of the outer orifice 13404. The lateral membrane supports 13405 can be semicircular, such as Figures 42A to 42G In Figures 42A to 42G In the depicted example, the outer orifices 13404 are evenly distributed in groups of three between adjacent lateral membrane supports 13405 around the circumference of the outer base 13403.

[0357] The vent housing 13401 may also have a circular shape. However, the vent housing 13401 may also be oval, or the vent housing 13401 may have a polygonal shape, such as a triangle, square, rectangle, pentagon, hexagon, etc. In any of these configurations, the membrane 13430 may be shaped to correspond to the shape of the vent housing 13401.

[0358] The inner base 13406 can be positioned radially inward of the outer base 13403, and the inner base 13406 and the outer base 13403 can be joined by a base connector 13408 radially distributed therebetween. One or more inner orifices 13407 are present between adjacent base connectors 13408 and between the inner base 13406 and the outer base 13403. In these examples, the inner orifices 13407 are formed as slots having an arcuate cross-section. However, it is contemplated that, similar to the outer orifices 13404, the inner orifices 13407 can be circular holes. The inner orifices 13407 extend completely through the vent housing 13401, between the inner base 13406 and the outer base 13403. As will be explained below, it may be desirable to allow the inner orifice 3407 to be at least partially blocked by the membrane 13430 to allow the ventilation system 13400 to maintain a substantially constant ventilation flow over a large portion of the typical therapeutic pressure range. The edges of the inner orifice 13407 may have chamfers or rounded corners.

[0359] The inner base 13406 of the vent housing 13401 may also include a plurality of membrane spacers 13409. The membrane spacers 13409 may be evenly distributed radially around the inner base 13406. Figures 42A to 42G As shown, the membrane spacer 13409 can be located on the edge of the inner base 13406 so as to fade into the inner wall 13410. The membrane spacer 13409 is configured to at least partially support the membrane 13430, as will be described in more detail below. The membrane spacer 13409 can extend from the inner base 13406 in a semi-cylindrical shape or a rectangular shape, such as Figures 42A to 42G The edges of the membrane spacer 13409 may have chamfers or rounded corners.

[0360] The vent housing 13401 may also include one or more recesses 13415 spaced around opposite sides of the outer base, as can be seen in Figures 42A to 42G. The recesses 13415 may be separated by recess dividers 13414. The outer apertures 13404 may extend through the outer base 13403 and open into corresponding recesses 13415, and multiple outer apertures 13404 may open into a single recess 13415.

[0361] In an alternative example, the ventilation housing 13401 may include only one set of orifices similar to the inner orifices 13407 described above, since the ventilation flow therethrough may be limited by the position of the membrane 13430. Thus, another set of orifices may also be provided elsewhere on the patient interface 3000, which is similar to the outer orifices 13404 described above, since the ventilation flow therethrough is not limited by the membrane 13430, regardless of the position of the membrane 13430. The latter set of orifices not limited by the membrane 13430 may be located on any of the plenum chamber 3200, the seal-forming structure 3100, the decoupling structure 3500, the vent connection tube 4180, or other components that are closer to the patient than the ventilation housing 13401. It is contemplated that the operating principles of the ventilation system 13400 described above will apply to this alternative arrangement, but the ability to position the orifices that are not limited by the membrane 13430 closer to the patient may improve the discharge of exhaled CO2.

[0362] The vent housing 13401 can be made of a single uniform piece of material. The material of the vent housing 13401 can be relatively rigid. The material of the vent housing 13401 can be polycarbonate.

[0363] 5.4.1.2 Membrane

[0364] Figures 43A to 43G Also depicted is a view of an exemplary membrane 13430 having a vent system 13400 and positioned adjacent to a vent housing 13401. The exemplary membrane 13430 can be used with any of the various vent housing 13401 configurations disclosed above. The membrane 13430 can be in the shape of a flat disc. In other words, the membrane 13430 (see Fig.43F and 43G ) can be relatively small in thickness relative to its outer diameter. The thickness of the membrane 13430 can be uniform throughout, such as Fig.43F and 43G Alternatively, the thickness of the membrane 13430 may vary in the radial direction.

[0365] The membrane 13430 includes a membrane opening 13431 so that when assembled to the ventilation housing 13401, the air flow through the inlet 13411 also passes through the membrane opening 13431 and all the way to the patient. The membrane 13430 also includes a patient-side surface 13432 facing the patient in use and an atmosphere-side surface 13433 facing the atmosphere in use, opposite to the patient-side surface 13432. In addition, the atmosphere-side surface 13433 faces the ventilation housing 13401 when assembled. The membrane 13430 also includes an inner surface 13434 defining the membrane opening 13431 and an outer surface 13435 opposite to the inner surface 13434.

[0366] The inner radius, i.e., the radius of the inner surface 13434, and the outer radius, i.e., the radius of the outer surface 13435, can be selected so that the membrane 13430 can be located on the inner orifice 13407 in use without covering the outer orifice 13404. In addition, the inner radius and the outer radius can be selected so that the membrane 13430 covers a relatively large portion of the inner base 13406 while being supported on the membrane spacer 13409 proximal to the inner surface 13434 and on the outer base 13403.

[0367] The membrane 13430 can be made of a single uniform piece of material. The material can be elastically deformable so that the membrane 13430 can be deflected by pressure from air flow when in use. The material can be silicone. The membrane 13430 can be "tuned" to deform in a desired manner by changing one or more of its thickness, length, material, shape, inner radius and / or outer radius.

[0368] 5.4.1.3 Constant flow ventilation system

[0369] Figures 43A to 43G Several views of an exemplary vent system 13400 are depicted in which a membrane 13430 is assembled with a vent housing 13401. Figures 43A to 43G In the instance where the inner wall 13410 extends upward from the inner base 13406, the inner wall 13410 can provide a baffle function that separates the gas flow traveling into the ventilation system 13400 via the inlet 13411 from the ventilation flow leaving the ventilation system 13400, which in turn can reduce the flow entering from the inlet 13411 and then directly out of the ventilation system 13400.

[0370] exist Figures 43A to 43G In the example of FIG. 134, the portion of the membrane 13430 proximal to the outer surface 13435 can be seen supported on the inner portion of the outer base 13403. In addition, the portion of the membrane 13430 proximal to the inner surface 3434 can be seen supported just above the membrane spacer 13409. However, even though there may not be any gas pressure causing deformation, the membrane 13430 can deform toward the membrane spacer 13409 by its own weight, so that the membrane 13430 is also supported on the membrane spacer 13409.

[0371] Figures 43A to 43GAlso shown is the position of the membrane 13430 constrained by the lateral membrane supports 13405. As described above, the membrane 13430 is shaped and sized to cover only the inner orifice 13407 and not the outer orifice 13404. However, the membrane 13430 may not cover the vent housing 13401 directly attached and may therefore be free to move. Therefore, a sufficient number of lateral membrane supports 13405 may prevent lateral movement of the membrane 13430 so that the membrane 13430 cannot cover one or more outer orifices 13404 during use.

[0372] The reversal of these examples is also contemplated, wherein the outer orifice 13404 may be blocked by the membrane 13430 while the inner orifice 13407 is not blocked by the membrane 13430. Thus, lateral membrane supports 13405 may be provided to prevent the membrane 13430 from covering the inner orifice 13407.

[0373] As described above, the exemplary vent system 13400 may include a membrane 13430 positioned above the inner orifice 13407 to at least partially restrict gas flow through the inner orifice 13407 , while the vent flow through the outer orifice 13404 is not restricted by the membrane 13430 .

[0374] It should also be understood that the features of the ventilation system 13400 described in Sections 5.4.1.1 through 5.4.1.3 may be incorporated into any of the ventilation adapters 9100 disclosed in Section 5.4.5.

[0375] 5.4.2 Ventilation Diffuser

[0376] The vent adapter 9100 may also include a portion for accommodating a diffuser 9146. The diffuser 9146 may be removable for replacement. The diffuser 9146 may have an annular disk shape that is complementary to the shape of the annular surface of the vent housing 9120 on the side facing the atmosphere (i.e., outside the inlet flow). The diffuser 9146 may cover the vent holes 9125 and may diffuse the vent flow after the vent flow leaves the plurality of vent holes 9125. That is, the vent flow flowing through the molded vent holes 9125 may flow through the diffuser 9146 before reaching the atmosphere.

[0377] The diffuser 9146 may also act as a sound absorbing material to reduce some of the noise generated by the CFV membrane 9140 adjustable vent and static vent.

[0378] Fig.26A cross section through some of the orifices 3402 is shown. The orifices 3402 are shown as holes through the wall 3404 of the plenum 3200. However, the orifices 3402 may be located at a location other than the wall 3404. For example, the orifices 3402 may be located between the decoupling structure 3500 and the connection port 3600 or in a portion of the air circuit 4170, preferably near the connection port 3600 or in the ventilation adapter 9100. The diameter of the hole is shown to be smaller than the axial length of the hole. The length and / or diameter can be selected so that an appropriate flow rate is generated when the plenum 3200 is pressurized to a treatment pressure. At treatment pressures (e.g., at pressures of 4 cm H2O or higher), the flow through the orifices 3402 may be choked (e.g., a Mach number of 1), or the flow may produce a pressure drop that is not sufficient to be choked. Choking can result in substantially all of the pressure drop in the vent 3400 caused by the orifices 3402. The arrows conceptually illustrate the direction of flow when the plenum 3200 is pressurized above ambient pressure.

[0379] The orifices 3402 are formed by the material thickness of the wall 3404. Each orifice 3402 defines an axis, for example, along the center of the orifice. The axis forms an acute angle with the normal to the surface of the wall 3404. The angle may be between 15 and 75 degrees or between 30 and 60 degrees, including any integer within the range. For example, the angle may be about 45 degrees.

[0380] The orifice 3402 is covered by a diffusion member 3406 so that the flow leaving the orifice 3402 impinges on the diffusion member 3406 and flows at least partially into the diffusion member 3406. The diffusion member 3406 can be formed of a material, such as a porous material, that allows the gas to flow through the material but diffuses any jet or other flow formation leaving the orifice 3402. Some suitable examples of diffusion materials include non-woven fiber materials; woven fiber materials; or open-cell foam materials. The diffusion material can be similar or identical to the filter medium. The diffusion member 3406 can reduce the perceptible noise generated by the vent 3400 in use (e.g., when the therapeutic pressure is applied).

[0381] Diffusion member 3406 is shown as a barrier member covered by 3408, which prevents gas from flowing out of orifice 3402 and directly passing through diffusion member 3406. Barrier member 3408 can be constructed at least in part by an airtight material. Airtight material can be any suitable flexible or rigid material. For example, airtight material can be rigid plastic (e.g., molded polycarbonate) or flexible plastic (e.g., commercially available sheet form plastic). Barrier member 3408 can be formed integrally with diffusion member 3406, formed separately but permanently attached to diffusion member 3406, formed separately and removably contacted with diffusion member 3406, or a combination thereof. Barrier member 3408 is shown as relative to the thickness of diffusion member 3406 and outlet orifice 3402.

[0382] The blocking member may cause the flow to change direction (relative to the direction through the orifice 3402) before leaving the diffusion member 3406. The blocking member 3408 and / or the diffusion member 3406 may be configured so that the flow out of the orifice 3402 must flow through the diffusion member 3406 for at least a predetermined distance before being discharged to the ambient atmosphere. The blocking member 3408 may also be configured to provide a specific direction and / or orientation to the flow leaving the vent 3400 to minimize any interference caused by the flow to the wearer and / or bed partner. For example, the blocking member 3408 may cause the gas to flow through the diffusion member 3406 and be generally parallel to the surface of the blocking member 3408 closest to the diffusion member 3406.

[0383] exist Fig.26 8, the orifices 3402 and the diffusion member 3406 are oriented relative to each other such that the central axis of each orifice is not perpendicular to the nearest surface of the diffusion member 3406, but a perpendicular arrangement may also be provided as shown in FIG.

[0384] Channel 3410 may also be provided on the outer surface of wall 3404. Channel 3410 is shown as having a V-shaped cross-section, but may be formed to have any suitable cross-section, such as a U-shape. Channel 3410 may be configured to allow liquid to exit from one or more outlets of orifice 3402. Orifice 3402 may be formed as a leg of a V-shape or a U-shape.

[0385] Fig. 27 An alternative configuration of blocking member 3408 is shown. Fig. 27 3408. In the embodiment of the present invention, the blocking member 3408 includes a hole 3412. The hole 3412 can direct the flow to flow out of the diffusion member 3406 on the opposite side of the orifice 3402 but in a different direction. Therefore, the flow path is not straight through the orifice 3402 and the diffusion member 3406. Although the arrows associated with the hole 3412 are shown as parallel, this is only for ease of illustration. The hole 3412 can be configured to redirect the flow in multiple directions.

[0386] The holes 3412 each define an axis that is neither aligned with nor parallel to the axis defined by each orifice 3402. Fig. 27 When viewed in a cross section of , any axis defined by hole 3412 and any axis defined by orifice 3402 form an angle. The angle can be between 15 and 75 degrees or between 30 and 60 degrees, including any integer within the range. For example, the angle can be about 45 degrees.

[0387] Figure 28-30 An alternative configuration of vent 3400 is shown. Fig.28 A partial exploded view is shown, Fig.29 A simplified assembly diagram is shown, and Fig.30 Shown along Fig.29 30-30 of . In these figures, the orifices 3402 are shown as a circular array around a central hole 3414. The circular array is shown as including three rows of circular holes, wherein the two innermost circular rows are closer together than the outermost circular rows, but any number of circular rows may be provided and the spacing between the rows may be equal. The central hole 3414 allows fluid communication between the plenum 3200 and the connection port 3600 and therefore the air circuit 4170. The diffusion member 3406 and the blocking member 3408 are also shown as being arranged around the central hole 3414. With this construction, the blocking member 3408 can be removably attached (e.g., a removable snap fit or threaded engagement) or fixedly attached (e.g., a permanent adhesive or a snap fit that must be broken to remove), and the diffusion member 3406 can be fixed to the blocking member 3408 or not fixed to the blocking member 3408, but is retained by the blocking member 3408. As shown in Fig.29 As best seen in FIG. 34 , radial openings 3416 are provided to allow gas to escape diffuser member 3406 radially outward from central aperture 3414 .

[0388] Figures 31A to 31C Another alternative configuration of vent 3400 is shown. Fig.31A A partial view of a flow passage in the form of an elbow 3418 is shown, which may be disposed between the decoupling structure 3500 and the connection port 3600 and includes the vent 3400. This configuration largely hides the features of the vent 3400, so the remaining description is relative to Fig.31B and 9C of.

[0389] Fig.31BAn axial view is shown, in which the cap 3422 and the diffusion member 3406 are omitted. This provides a clear view of the outlet orifice 3402. Two annular rows are shown, each row including forty outlet orifices 3402. The orifices are offset so that the outlet orifices 3402 in the inner and outer rows are not radially aligned. This configuration can allow the annular rows to have closer radial spacing. Although two rows are shown, any number of rows can be provided, such as one row or three or more rows. Although forty outlet orifices 3402 are shown in each annular row, more or less orifices can be provided as needed to maintain an appropriate level of gas flushing. For example, each annular row can be provided with one, five, ten, fifteen, twenty, twenty-five, thirty, thirty-five, forty, forty-five, fifty or more outlet orifices 3402, or any number therebetween.

[0390] exist Fig.31C 34, an annular array of orifices 3402 is visible in a cross section through wall 3420. Wall 3420 is similar to wall 3404, except that wall 3420 is shown remote from plenum 3200; however, wall 3420 may be part of plenum 3200.

[0391] The diffusion member 3406 is shown as an annular shape having a rectangular cross-section. The barrier member 3408 is shown as a relatively thin sheet-like ring on the side of the diffusion member 3406 opposite the orifice 3402. The barrier member 3408 can be attached to the diffusion member 3406 by any suitable means, such as by an adhesive.

[0392] Cap 3422 is shown covering diffusion member 3406 and barrier member 3408. Cap 3422 may contact barrier member 3408 such that diffusion member 3406 is pressed against wall 3420. Alternatively, diffusion member 3406 may not be pressed against wall 3420. Cap 3422 may act as barrier member 3408, in which case the cap 3422 may be omitted. Fig.31C An annular blocking member 3408 is shown in FIG.

[0393] The cap 3422 can include an angled annular flange 3424 that can be spaced apart from the wall 3420 to form an annular gap 3426. The annular flange 3424 can also be considered to be skirt-shaped or frustoconical. The annular gap 3426 can provide a flow path to the ambient atmosphere so that the gas flow flushing is not overly restricted. Alternatively, one or more openings (such as radial openings 3416) can be provided in the annular flange 3424 to provide a flow path to the ambient atmosphere, which can also allow the annular gap 3426 to be eliminated in whole or in part.

[0394] The cap 3422 is shown as having an annular groove 3428 that cooperates with the annular protrusion 3430 to hold the cap 3422 in place. The annular protrusion can be continuous to form a snap fit, or can be a plurality of annularly spaced annular protrusions to provide a configuration that allows for minimal or no interference during axial insertion and then twisting to provide axial interference and hold the cap 3422 in place. Fig.31C , the annular protrusion 3430 is shown as three annularly spaced annular protrusions. The lip 3432 of the annular groove 3428 can be omitted in three corresponding positions and sizes to reduce interference with the cap 3422 or not interfere with the cap 3422 during axial insertion. Other forms of attachment are possible. For example, a threaded fastening device can be provided and the cap 3422 can be held in place with an adhesive or welding. A releasable fastening such as the illustrated configuration or threaded connection can allow replacement of the diffusion member 3406 in the event that, for example, the diffusion member is damaged, blocked or dirty.

[0395] Although the vent 3400 is shown on one side of the bend of the elbow 3418 (eg, upstream with respect to the direction of exhalation), the vent 3400 may be upstream or downstream of the bend.

[0396] FIG. 32A to FIG. 32C Another alternative configuration of the vent 3400 is shown. Similar reference numerals are similar to those described above, so further description is omitted except as noted below. The vent 3400 in these figures is formed around an example of a decoupling structure 3500 that includes a ball head 3434 and a socket 3436 as part of an elbow 3418. In the form shown here, the ball head 3434 and the socket 3436 allow three degrees of rotational freedom. However, there may be fewer degrees of rotational freedom, such as one or two degrees of rotational freedom.

[0397] As in Fig.32D As best seen in FIG. 34 , the cap 3422 is connected by means of a snap-fit ​​connection 3438, wherein the first half 3440 is located on the cap 3422 and the second half 3442 is located on the mating component. Each of the first half 3440 and the second half 3442 is disposed between six radial openings 3416, three of which are located in the Fig.32A However, more or less may be provided as required to allow for adequate retention and / or flow.

[0398] As in Fig.32CAs best seen in FIG. 44, 44 orifices 3402 are shown, which are equally spaced in a single annular row. However, the number and spacing of the orifices 3402 can take other configurations. For example, if, for example, a lower flow rate is required, fewer orifices 3402 can be provided, or if, for example, a larger flow rate is required, more orifices 3402 can be provided. And as described above, more rows can be provided. In addition, the orifices need not be in an annular array. For example, if the orifices are located at positions other than those shown, the orifices can be arranged in a grid based on Cartesian coordinates. Alternatively, the orifices 3402 need not be in any type of row and can be located in random or pseudo-random positions.

[0399] 5.4.3 Heat and Moisture Exchanger (HME)

[0400] Heat and moisture exchangers (HMEs) can include materials with water-retaining properties. Respiratory pressure therapy (RPT) can cause the airways to dry out, causing respiratory discomfort to the patient. To prevent this, a humidifier can be used in conjunction with the respiratory pressure device to deliver humidified air to the patient. This added humidifier may increase the size and power requirements of the RPT device.

[0401] It is known that the patient generates a level of humidified air when exhaling, which originates from the mucous membranes of the respiratory tract. HMEs can be used to recirculate the exhaled moisture by capturing moisture from the humidified air when exhaling and then re-delivering it to the patient. A challenge in using HMEs is their efficacy (i.e., the efficacy of being able to capture enough heat and moisture) and their impact on treatment (i.e., HMEs can be placed in a flow circuit and thus cause flow impedance).

[0402] In order to improve efficacy, on the one hand, it is to reduce any loss of heat and moisture captured by the HME. The problem of using HME in RPT may be that the heat and moisture exhaled by the patient are lost due to ventilation before reaching the HME. In order to minimize this loss, the HME can be placed on the near side of the patient's airway (i.e., humidity source), and the vent can be placed on the opposite side of the HME, i.e. away from the patient. This configuration can ensure that the exhaled humidified gas flows through the HME so that moisture is captured by the HME before leaving through the vent. The ventilation adapter can be configured so that the HME is located between the patient's airway and the constant flow vent.

[0403] The ventilation adapter may also include an HME unit, which is removable. That is, the ventilation adapter may or may not be used with an HME. The HME unit may include a housing that holds the HME in place. The housing may be opened (the housing may include a front component and a rear component) to remove the HME.

[0404] The HME can be designed to maximize the surface area per unit volume for heat and moisture exchange. In addition, the HME can also be designed to reduce its impact on flow impedance. The design can include multiple corrugations to allow flow to pass through the corrugations. The HME can be formed as a coiled layer of HME material including corrugations.

[0405] As described above, CFV can reduce flow waste by regulating the ventilation flow to a level higher than but close to the minimum required ventilation flow. Due to the reduction in flow waste, the level of humidity loss in the treatment system can also be reduced. It is known in the art that patients exhale humidified air, which may in turn cause mucosal dryness. Applying RPT treatment to SDB may exacerbate this dryness. Therefore, reducing the flow required to achieve the treatment pressure and simultaneously reducing the level of humidified air loss from the system can result in a reduction in mucosal dryness.

[0406] One way to increase the level of humidified air delivered to the patient is to use powered humidification. Another way to humidify the air delivered to the patient is to use heat and moisture exchangers (HMEs), which capture water vapor from the air so that it can be delivered back to the patient. HMEs can be used to capture moisture from the patient's exhaled breath and then deliver this moisture back to the patient. Fig.17 As shown, the HME should be positioned so that it captures sufficient moisture from the exhaled gas stream, but allows this moisture to be re-delivered through the therapeutic stream. To ensure maximum moisture captured from the exhaled gas stream, the HME should be placed between the patient and the vent. If the vent is placed between the patient and the HME, this will cause moisture in the exhaled gas stream to be discharged before reaching the HME for capture and re-delivery. However, Fig.17 The configuration shown also allows moisture to be lost to ventilation via therapy flow through the HME and then directly out of the vent (before patient delivery). Fig.17 HME ventilation flow becomes more problematic as therapy flow increases. Fig.18 As shown in the curve graph in , as the mask pressure increases, the flow rate may increase. The flow rate can be increased to compensate for the ventilation flow loss. When the flow rate increases, the speed of the treatment flow increases, which may cause the treatment flow to penetrate the HME more deeply. However, some of this infiltration flow is delivered to the patient, and a portion of the flow can also be directed to the vent before the patient is delivered (as shown in the HME ventilation flow). Therefore, the HME ventilation flow may also cause moisture loss by drying the HME.

[0407] As in Fig.18As shown in the graph of , CFV can reduce ventilation flow over the same pressure range compared to a standard FFM nominal flow vent. This reduction in flow can reduce HME ventilation flow, thereby reducing moisture loss. In other words, when compared to a standard ventilation system, less flow occurs at the same pressure in a CFV system, thereby reducing HME ventilation flow. This reduction in HME ventilation flow enhances the ability of the HME to capture and re-deliver moisture from the exhaled gas flow, thereby synergistically enhancing the HME effect to reduce mucosal drying.

[0408] Another way to reduce HME ventilation flow may be to redirect the flow direction so that less flow passes through the vent and is redirected back into the system. Redirection may be achieved by a structure (e.g., a baffle) positioned in the flow path between the HME and the vent so that less flow is directed from the vent to the atmosphere.

[0409] The technology of the present invention is able to achieve near powered humidification levels without using powered humidification. Since powered humidification is no longer required, the airflow generator can be further simplified because it no longer requires a water reservoir and a heating mechanism to deliver powered humidification to the treatment flow. Therefore, both CFV and HME can allow airflow generators associated with the present technology to be effective in providing RPT therapy for OSA and other SDBs without the need for complex pressure / flow control and powered humidification, which can ultimately benefit patients by providing a smaller airflow generator with fewer controls.

[0410] FIG. 25A to FIG. 25D An example of an HME according to the present technology is shown. Fig.25AA cross section of an HME 7000 is shown that includes a corrugated structure 7002 that includes a plurality of corrugations 7030 between a substantially flat substrate top structure 7010 and a substantially flat substrate base structure 7020 to form a bellows layer 7001. The layer 7001 includes a plurality of upper channels 7012 formed between the upper surface of the corrugated structure 7002 and the top structure 7010. In addition, the layer 7001 includes a plurality of lower channels 7022 between the lower surface of the corrugated structure 7002 and the base structure 7020. The HME 7000 allows the flow of breathable gas and exhaled gas to flow through the plurality of upper channels 7012 and the lower channels 7022 along the surface of the corrugated structure to exchange heat and moisture. Moisture is absorbed from the exhaled gas exhaled by the patient and retained in the material of the corrugated structure 7002. The material of corrugations 7030, top structure 7010 and / or base structure 7020 may include paper or a paper-based material capable of absorbing water and / or heat. The material of corrugations 7030, top structure 7010 and / or base structure 7020 may be porous, water-permeable and / or breathable. The retained moisture may then be re-delivered to the patient by humidifying the flow of breathable gas delivered to the patient's airway. In other words, the flow of breathable gas delivered to the patient's airway may absorb moisture from HME 7000. Fig.25B Various sizes of HMEs according to these examples are depicted.

[0411] The plurality of corrugations 7030 increase the surface area of ​​the corrugated structure 7002, thereby increasing the active surface area for heat and moisture exchange between the corrugated structure 7002 and the surrounding volume provided by the plurality of upper channels 7012 and the plurality of lower channels 7022. The top structure 7010 and the base structure 7020 may also be formed of the same heat and moisture exchange material as the corrugated structure 7022. Alternatively, the top structure 7010 and / or the base structure 7020 may be formed of a rigid or semi-rigid material that does not absorb moisture to support the corrugated structure 7002.

[0412] The humidification performance of the HME 7000 depends on the effective surface area of ​​the HME 7000 provided in a fixed volume of space. The effective surface area is the surface area of ​​the HME 7000 that is exposed to the flow of breathable gas flowing along the surface of the HME, in which heat and moisture exchange occurs. The surface area per unit volume of the HME 7000 can be adjusted by providing corrugations 7030 within the heat and moisture exchange portion of the HME 7000. In addition, the surface area per unit volume can also be adjusted by modifying any of the fin thickness, the pitch or height of the corrugations or flutes that have an impact on the surface area per unit volume of the HME 7000.

[0413] like Fig.25CAs shown, HME 7000 can include multiple layers 7001 stacked along the vertical axis of HME 7000. Layers 7001 can be stacked vertically so that the base structure 7020 is stacked on top of the corrugated structure 7002 of the adjacent layer 7001 below. There can also be multiple layers 7001 of HME stacked in the horizontal direction. Having multiple layers 7001 including corrugated structures 7002 stacked along the vertical axis of HME 7000 further increases the surface area per unit volume of the HME. This increased surface area within a predetermined volume increases the efficiency of heat and moisture exchange of HME 7000. In addition, as Fig.25D As depicted, layer 7001 can be compressed under preload to increase the number of layers within a fixed volume, thereby increasing the surface area per unit volume. The preload is calculated by the following formula: where P is the preload, and h 起始 is the corrugation or flute height before compression, and where h 最终 is the height of the corrugation after compression.

[0414] Alternatively, the final three-dimensional shape of the HME 7000 may be formed by combining layers 7001 of different sizes and shapes to produce an irregularly shaped HME 7000 adapted to fit within the plenum 3200 of the patient interface 3000. The layers 7001 may be laser cut to form the desired shape and size.

[0415] As shown in the alternative example Fig.25E As shown in FIG, HME 7000 can be rolled up from a single strip layer 7001 that includes a corrugated structure 7002 extending from the surface of a base structure 7020 to form a plurality of corrugations 7030. The single strip layer 7001 can be rolled up so that the upper folded portions 7031 of the corrugations 7030 engage the lower surface of the base structure 7020. This configuration ensures that the plurality of channels 7012 are maintained between each roll of the single strip layer 7001.

[0416] As mentioned above, CFV can reduce ventilation flow in the same pressure range compared to standard FFM nominal flow vents. This reduction in flow can reduce HME ventilation flow, thereby reducing moisture loss. In other words, when compared to standard ventilation systems, less flow occurs at the same pressure in CFV systems, thus reducing HME ventilation flow. This reduction in HME ventilation flow can enhance the ability of HME to capture and re-deliver moisture from the exhaled gas flow, thereby synergistically enhancing the HME effect to reduce mucosal drying.

[0417] The CFV membrane can allow the ventilation flow to remain at or above the minimum required level within the therapeutic pressure range, and can also regulate the ventilation flow to be lower than the ventilation flow that occurs under the standard static vent. Therefore, CO2 flushing will always remain at a sufficient level. The ventilation flow can be adjusted so that it achieves the minimum level required for CO2 cleaning. This will lead to minimization of ventilation flow, thereby minimizing moisture loss from the HME.

[0418] Another way to reduce HME ventilation flow is to redirect the flow direction so that less flow passes through the vent and is redirected back into the air delivery circuit. That is, the flow can be redirected so that it minimizes HME ventilation flow, where the flow penetrates the HME and then flows directly out of the vent. The redirection of the flow can be achieved by a structure (e.g., a baffle) positioned in the flow path between the HMX and the vent so that less flow is directed from the vent to the atmosphere.

[0419] FIG. 38A to FIG. 38C Describe an example of an HME housing 9400 according to an example of the present technology.HME housing 9400 can have a two-part structure including a patient-side HME housing portion 9402 and an atmosphere-side HME housing portion 9404.Patient-side HME housing portion 9402 and atmosphere-side HME housing portion 9404 can be assembled together to retain HME material therein.Patient-side HME housing portion 9402 can include a patient-side HME housing portion crossbar 9406 to maintain HME material in an axial direction toward the patient in use, and atmosphere-side HME housing portion 9404 can include an atmosphere-side HME housing portion crossbar 9408 to maintain HME material in an axial direction toward the atmosphere in use.Atmosphere-side HME housing portion 9404 can also include one or more openings 9410, which are connected to the corresponding tabs 9412 of the patient-side HME housing portion 9402 to engage the two parts together. The connection between the opening 9410 and the tab 9412 may include a snap fit and may be releasable to allow disassembly of the HME housing 9400 so that the HME material may be removed for cleaning or replacement.

[0420] FIG. 39A to FIG. 39CDescribe another example of HME housing 9400 according to an example of the present technology.HME housing 9400 can have a two-part structure including a patient-side HME housing portion 9402 and an atmosphere-side HME housing portion 9404.Patient-side HME housing portion 9402 and atmosphere-side HME housing portion 9404 can be assembled together to retain HME material therein.Patient-side HME housing portion 9402 can include a patient-side HME housing portion crossbar 9406 to maintain HME material in an axial direction toward the patient in use, and atmosphere-side HME housing portion 9404 can include an atmosphere-side HME housing portion crossbar 9408 to maintain HME material in an axial direction toward the atmosphere in use.Atmosphere-side HME housing portion 9404 can also include one or more openings 9410, which are connected to the corresponding tabs 9412 of the patient-side HME housing portion 9402 to engage the two parts together. The connection between the opening 9410 and the tab 9412 may include a snap fit and may be releasable to allow disassembly of the HME housing 9400 so that the HME material may be removed for cleaning or replacement. The atmosphere-side HME housing portion 9404 may also include an atmosphere-side HME housing portion ring 9414 and extending from the atmosphere-side HME housing portion ring 9414 is an HME inner housing 9416 that may contain the HME material. The HME inner housing 9416, together with the patient-side HME housing portion 9402 and the atmosphere-side HME housing portion 9404, may form an HME bypass channel 9418 to allow a portion of the flow traveling through the HME housing 9400 to bypass the HME material.

[0421] 5.4.4 Custom Connection

[0422] 6a shows a side view of a fluid connector 9000 having a first end 9002 and a second end 9004 that mate with each other. A portion of a fluid conduit 9006, which may be part of the air circuit 4170, is connected to the second end 9004. Instead of the fluid conduit 9006, an adapter or connector to the fluid conduit may be provided. The outlet of the RPT device 4000 may include the second end 9004 in some forms of the present technology.

[0423] The fluid connector 9000 can be configured as a removable sealed connection to allow air flow, such as from the RPT device 4000, to pass therethrough to the patient interface 3000. The fluid connector 9000 can include a plurality of components, such as a first end 9002 and a second end 9004 that can be releasably connected to each other to form and / or break the sealed connection.

[0424] The first end 9002 and the second end 9004 can form a pneumatic path therebetween via complementary sealing portions and be retained by complementary retaining portions, which can be separate portions relative to the complementary sealing portions. Thus, each of the first end 9002 and the second end 9004 can include separate sealing portions and retaining portions, as described in further detail elsewhere in this document.

[0425] When the sealing function and the retaining function are performed by separate complementary parts, each of the sealing function and / or the retaining function can be more easily optimized to address one or more of the competing design requirements. For example, where a pair of complementary parts are used to seal and retain two components, the formation of a tight seal may result in high friction forces, thereby reducing the ease with which the components can be connected and / or disconnected.

[0426] Additionally, in situations where the usability of connection / disconnection is enhanced, the seal may not be as robust, such as in situations where the two components may be subjected to and / or torques in different directions and magnitudes. In the case of fluid connectors such as those described in this document, a patient wearing the patient interface 3000 may move around while sleeping or preparing to go to sleep, causing the fluid connector to be pulled and / or twisted in various directions.

[0427] Thus, one aspect of the present technology is directed to a fluid connector 9000 wherein a first end 9002 and a second end 9004 are connected to one another via complementary sealing portions and complementary retaining portions.

[0428] In one form, the first end 9002 and the second end 9004 may include complementary sealing portions to form an air seal when connected. The air seal may be configured to form and maintain a sealing joint to allow air flow to pass therethrough. The sealing joint may be sufficient to allow a pressurized air flow, such as at a pressure between 4 cm H2O and 40 cm H2O, to pass therethrough to provide respiratory therapy.

[0429] In some forms, the first end 9002 and the second end 9004 may include complementary portions to retain the first end 9002 and the second end 9004. The retaining portion may retain the first end 9002 and the second end 9004 in sealing engagement with each other, such as by preventing accidental disengagement. The retaining portion may include a latching mechanism, as will be further detailed in this document.

[0430] Fig. 6b shows a cross-sectional view of a fluid connector 9000 that is not connected to each other at the first end 9002 and the second end 9004. In this view, a sealing portion 9008 is visible. The sealing portion 9008 can be formed by any material (e.g., silicone) suitable for forming a seal in the air path of the device providing breathing gas to the patient. The sealing portion 9008 extends around the first opening 9010, which is shown as the inside of the first tube 9022. A latch portion 9012 that can be in the form of a recessed portion is arranged at the first end 9002. The latch portion 9012 can be arranged on the opposite side as shown in Fig. 6b, the single side of the first end 9002 or around the periphery. As shown, the latch portion 9012 is an undercut portion substantially perpendicular to the central axis of the first end 9002. According to the required holding force, other angles are possible.

[0431] The second end 9004 includes a sealing surface 9016. The sealing surface 9016 can be formed circumferentially around the second opening 9018, which is shown as the interior of the second tube 9020. The sealing surface 9016 is shown as a generally annular surface that extends radially and vertically (i.e., at 90°) away from the second tube 9020. This can cause the sealing surface 9016 to be substantially perpendicular to the direction of fluid flow from the first end 9002 to the second end 9004. However, the sealing surface 9016 can also extend outward at a certain angle so that the sealing surface 9016 is inclined. For example, the sealing surface can be at an angle of 85°, 80°, 75°, 70°, 65°, 60°, 55°, 50°, or 45°, positive or negative, or any value therebetween. As can be seen in FIG. 6b, the second tube 9020 can include an overhang 9034 that extends beyond the sealing surface 9016 toward the sealing portion 9008. This can result in the overhang portion 9034 of the second tube 9020 extending through the sealing portion 9008, as shown in Figure 6c. It should be understood that in some examples of the present technology, the second tube 9020 need not include an overhang portion.

[0432] The overhang portion can be configured to align the first end 9002 with the second end 9004 in one or more directions. The overhang portion 9034 can be configured to be inserted into the guide portion 9038 on the first end 9002 to act as an introduction end and align the second end 9004 with the first end 9002 in a radial (or transverse) direction. Therefore, the first end 9002 and the second end 9004 can have a convex / concave relationship. In addition, a stopper 9030 can be provided to limit the stroke of the second tube 9020, for example, by abutting the overhang portion 9034 at the stroke limit. Although the overhang portion 9034 is shown as a tube, the overhang portion may not extend continuously around the periphery of the second end 9004 because it will be internal relative to the seal formed by the complementary sealing portion (sealing portion 9008 and sealing surface 9016). The overhang portion may only partially extend through the sealing portion 9008, such as in a castellated extension, a tab, a rib, etc.

[0433] 6c, the internal flow path of the fluid connector 9000 defined by the first tube 9022, the second tube 9020, and the stopper 9030 can have very little flow restriction because the internal flow path is substantially identical to the interior of the fluid conduit 9006, e.g., as assessed in terms of cross-sectional shape and size. Thus, the fluid connector 9000 can have a negligible pressure drop as air flows through the fluid connector 9000 throughout the patient's breathing cycle and therapeutic pressure (e.g., at a pressure between 4 cmH2O and 40 cmH2O).

[0434] Sealing portion 9008 may include a portion that contacts sealing surface 9016 in any form suitable for forming a face seal, such as by tangential contact therebetween. As shown, sealing portion 9008 contacts sealing surface 9016 in a substantially truncated conical shape similar to a bellows shape or a partial bellows shape. Alternatively, a partial spherical or partial annular surface may be provided on sealing portion 9008. In the case of any of these shapes, sealing portion 9008 may contact sealing surface 9016 before latch portion 9012 and complementary latch portion 9014 are fully or even partially engaged. Alternatively, sealing portion 9008 and sealing surface 9016 may also be separated by a gap even after latch portion 9012 and complementary latch portion 9014 are fully engaged. In this case, internal pressurization may cause sealing portion 9008 to move into contact with sealing surface 9016 and form a seal.

[0435] The sealing portion 9008 may include an elastic and compliant material so that it can be deformed under a load and maintain its original configuration when the load is removed therefrom. The sealing portion 9008 may be constructed to be easily deformed under a load to form and / or maintain a seal with the sealing surface 9016. In some forms, the sealing portion 9008 may include a film composed of silicone. The silicone film sealing portion 9008 may have sufficient compliance so that it will deform and move into contact with the sealing surface 9016 due to the pressure caused by the airflow. In addition or alternatively, the silicone film sealing portion 9008 may be sufficiently compliant so that even when compressed from its undeformed configuration, it will maintain a sealing engagement with the sealing surface 9016.

[0436] The proposed construction of the sealing portion 9008 can provide a seal that is compliant relative to the mating direction between the first end 9002 and the second end 9004 (e.g., to the left in FIG. 6b ) and / or compliant in a direction radial to an axis defined by the engagement direction between the first end 9002 and the second end 9004 (e.g., upward and downward in FIG. 6b ).

[0437] The force required to compress the sealing portion 9008 (e.g., when compression is required to form and / or maintain a seal) can be sufficiently low so that there is no significant compression force. For example, the force required to compress the sealing portion 9008 can be less than the force required to engage the latch portion 9012 with the complementary latch portion 9014, for example to overcome any friction forces connecting the second end 9004 and the first end 9002. Alternatively, the force required to compress the sealing portion 9008 can be less than half the force required to engage the latch portion 9012 with the complementary latch portion 9014. Alternatively, the force required to compress the sealing portion 9008 can be less than one-tenth the force required to engage the latch portion 9012 with the complementary latch portion 9014. Therefore, in a configuration where the sealing portion 9008 contacts the sealing surface 9016 before the latch portion 9012 and the complementary latch portion 9014 are fully engaged, the user may not encounter a significant force that could be mistaken for full engagement. In some forms, any force used to connect the second end 9004 and the first end 9002 caused by the compression of the sealing portion 9008 can be small enough to be substantially imperceptible to the user. That is, in a configuration where the sealing portion 9008 is removed from the first end 9002, the force felt by the user can be substantially the same as in a configuration where the sealing portion 9008 must be compressed in order to connect.

[0438] The shape of the sealing portion 9008 according to the present technology can provide a seal that is compliant on the opposite side of the mating direction between the first end 9002 and the second end 9004 (e.g., to the right in FIG. 6 b). This can achieve a sealing portion 9008 that can seal with the sealing surface 9016 even if there is a gap between the sealing portion 9008 and the sealing surface 9016 when the fluid connector 9000 is not pressurized. When pressure is provided to the interior of the fluid connector 9000 (e.g., to the first tube 9022), the sealing portion 9008 can expand toward the sealing surface 9016 and contact the sealing surface 9016 to form a seal. With this configuration, the user should not encounter any additional force beyond the force required to engage the latch portion 9012 and the complementary latch portion 9014 when connecting the first end 9002 to the second end 9004.

[0439] Although the specific configuration of the sealing portion 9008 is described above, other configurations are possible. For example, some forms of the sealing portion 9008 may include an o-ring or gasket material.

[0440] The sealing portion 9008 or the sealing surface 9016, or both, may be configured such that misalignment between the sealing portion 9008 and the sealing surface 9016 still results in a seal between the sealing portion 9008 and the sealing surface 9016. For example, the sealing portion 9008 and / or the sealing surface 9016 may be configured to form a seal therebetween while allowing for a certain range of misalignment in the radial (or lateral) and / or axial directions.

[0441] For example, the sealing surface 9016 may include an annular shape (eg, Figure 6H ), the annular shape is configured to form a face seal with the surface of the sealing portion 9008 at multiple radial positions. That is, although the axis of the first tube 9022 and the axis of the second tube 9020 may be misaligned, for example, by 0.5 mm, 1 mm, 1.5 mm, 2 mm, 3 mm, or 4 mm, the sealing portion 9008 and the sealing surface 9016 can form a seal therebetween. In one form, the sealing surface 9016 may include a sufficiently wide annular portion so that the sealing portion 9008 may be able to form a seal therewith.

[0442] The second end 9004 also includes a complementary latch portion 9014. The complementary latch portion 9014 is shown as a cantilever hook, which includes a protrusion that cooperates or engages with the latch portion 9012. Like the latch portion 9012, the complementary latch portion 9014 can be arranged on multiple (e.g., opposite) sides as shown in Figure 6b or on a single side. As shown in Figure 6d, the complementary latch portion 9014 can be in the form of a U-shaped or C-shaped cutout. The complementary latch portion 9014 can be pressed down to engage or disengage the complementary latch portion 9014 with the latch portion 9012 and allow engagement or disengagement between the first end 9002 and the second end 9004. Although it is possible to provide more than two complementary latch portions 9014, doing so may make it unnecessarily difficult to disengage the second end 9004 from the first end 9002.

[0443] In combination, the stopper 9030 and the latch portion 9012 can define a predetermined distance (stroke) that the second end 9004 can move relative to the first end 9002 while the two ends are connected. For example, if the first axial distance between the stopper 9030 and the latch portion 9012 is greater than the second axial distance between the end of the second tube 9020 and the protrusion on the complementary latch portion 9014, the difference between the first axial distance and the second axial distance will define a non-zero predetermined stroke amount. If the first axial distance and the second axial distance are equal, there can be no stroke. However, there may be benefits related to non-zero stroke at least in terms of ease of manufacture, because non-zero stroke will allow manufacturing tolerances, which can reduce costs. Therefore, it is also beneficial for the sealing portion 9008 to be constructed to form a seal with the sealing surface 9016 under the worst-case manufacturing tolerance and after a predetermined wear and / or creep amount in the fluid connector 9000. The shape of the sealing portion 9008 discussed above can allow the sealing portion 9008 to consider this worst-case scenario.

[0444] As best seen in FIG. 6 b, the second end 9004 can include an inner portion 9024 and an outer portion 9026 rotatably coupled to each other at an interface 9028. The inner portion 9024 can include a sealing portion 9008 and the outer portion 9026 can include a complementary latch portion 9014. As shown, the inner portion 9024 is rigidly or fixedly connected to the fluid conduit 9006 so that the inner portion 9024 and the fluid conduit 9006 can rotate together relative to the outer portion 9026. At least a portion of the fluid conduit 9006 can be overmolded onto the inner portion 9024 to form a rigid connection therebetween. In other forms, the fluid conduit 9006 can be friction fit or interference fit into the inner portion 9024 to form a rigid connection.

[0445] As best seen in FIG. 6d , the outer portion 9026 may have an outer profile having four sides but also having a circular shape, which may be uniquely identifiable compared to a typical circular profile. The first end 9002 may include a recessed portion of a complementary shape. Thus, the first end 9002 includes a concave portion and the second end 9004 includes a convex portion. Convex and concave portions of the form described above, or any other non-standard shape or configuration may provide benefits. First, a fluid connector 9000 including a non-standard shape and / or configuration may not comply with industry standards (e.g., ISO 5356-1), which include the use of a circular socket including an introduction taper, over which a sleeve (e.g., rubber) is inserted. While non-compliance with industry standards may seem counterintuitive, there may be benefits. For example, the fluid connector 9000 can be used to connect an RPT device and a patient interface that are designed to operate optimally together. For example, if an RPT device provides a lower flow rate that can only be utilized by a patient interface designed to operate at the lower flow rate, having a fluid connector 9000 that does not match an industry standard will ensure that only the correct RPT device is used with the patient interface. Second, particularly for the profile shown, the first and second ends 9004 can only mate with each other in a predetermined number of relative orientations (e.g., four). The quadrilateral shape of the present invention can also provide well-defined sides that are easy to identify and grasp in order to actuate the complementary latch portion 9014. Third, non-standard shapes such as those described herein or others can allow a user to easily identify which end of the patient conduit 4170 may be a connector that is complementary to another connector, such as the outlet of an RPT device.

[0446] FIG. 6e shows another example of the present technology, wherein a port 9032 is included in the first end 9002. The port 9032 can be used to sense the pressure downstream of the blower and outside the blower housing, such as by sensing the pressure downstream of the RPT device. The port 9032 can be fluidly connected to the second end 9004 to determine the pressure of the air in the second opening 9018.

[0447] In one form, port 9032 can be in fluid communication with the interior of second opening 9018, such as by forming a fluid connection with an opening in the interior of sealing portion 9008. The opening in the interior of sealing portion 9008 can, in turn, be in fluid communication with pressure tap 9036 to second opening 9018. Thus, first end 9002 and second end 9004 can form two fluid connections between them when connected to one another. Port 9032 can provide the advantage of being able to measure pressure closer to the patient than would be the case if pressure were measured in an RPT device. Due to the inherent pressure losses in internal fluid flow and possible leaks in the entire air path from the blower to the patient, measuring pressure closer to the patient can provide a more accurate measurement than pressure measurements taken away from the patient.

[0448] In addition, the arrangement of the present invention allows the second end 9004 to rotate relative to the first end 9002 while still maintaining two fluid connections (i.e., one conveying air flow and the other measuring pressure). This may be advantageous for allowing the fluid conduit 9006 to rotate relative to the outer portion 9026, thereby reducing the torque applied to the fluid conduit and / or the outer portion 9026. In addition, this configuration may also allow a user to connect the first end 9002 and the second end 9004 to each other in one of a plurality of rotational orientations while maintaining the two fluid connections.

[0449] Figure 6f shows the first end 9002 integrated into an RPT device, wherein the second end 9004 is disconnected. Figure 6f shows the first end 9002 integrated into an RPT device, wherein the second end 9004 is connected.

[0450] Although the foregoing description generally describes the two halves of the connector system together, eg, the first end 9002 and the second end 9004, it should be understood that the description of either half may be considered separately.

[0451] It can also be advantageous to ensure that the appropriate mask is used with the membrane CFV regulated vent. The mask according to an example of the present technology can be a non-ventilated mask specifically designed to be compatible with the above-mentioned CFV membrane regulated ventilation. The system can be designed so that the airflow generator is also compatible with the ventilation adapter, which means that the airflow generator will be programmed to work with the mask system with a constant ventilation flow rate. That is, each mask type (nasal pillow mask and full face mask) can be connected to the same ventilation adapter, and therefore, the ventilation adapter should allow sufficient CO2 flushing for each mask type. The lowest CO2 flushing volume is usually seen in full face masks because the volume of the mask dead space increases. Therefore, the ventilation adapter must allow sufficient CO2 flushing for the full face mask (i.e., the worst case). Because the system of the present technology (including the airflow generator, the ventilation adapter and each mask type) can be specifically designed to work together, it may be advantageous to prevent incompatible masks from being connected to the CFV connector.

[0452] In this way, the connection mechanism can be configured so that a seal is formed between two detachably connected components by the connection mechanism. As previously described, a nasal pillow mask can be connected to a short tube connector and then to a ventilation adapter. In contrast, a full face mask can be directly connected to the ventilation adapter 9100. In another example, the HME may include a separate detachable housing that can be removed from the ventilation adapter. However, in order to reduce the overall size, the HME can be incorporated into the ventilation adapter together with the CFV unit, wherein the HME slides into the same housing as the CFV. Such a design means that when the HME is removed, there may be unused empty space in the CFV housing of the ventilation adapter 9100.

[0453] In the full face type mask according to the present technology, the short tube connector end can be formed as the inlet of the full face mask. That is, the same bellows engagement surface is designed as a part of the mask shell, which can form a part of the mask inflation chamber.

[0454] The bellows seal membrane may be configured to move under pressure so that the membrane moves toward a sealing surface on an opposing connector. A pressure-backed seal may mean that the seal between the CFV unit and the connector remains stable under high pressure.

[0455] The bellows seal may allow a seal to be formed between the CFV unit and the connector with minimal friction between the two components, which allows for a swivel connection. For example, a seal using an interference fit, lip seal, gasket configuration, or other form of compression seal between components may not allow for easy enough movement between the components so that the components can rotate while maintaining a secure seal.

[0456] 5.4.5 Exemplary Ventilation Adapters

[0457] An example of a ventilation adapter 9100 and its components is shown in Figures 7A-14D The ventilation adapter 9100 according to this example of the present technology may include a catheter connector 9110, a ventilation housing 9120, a ventilation diffuser cover 9130, a septum 9140, a CFV ring 9150, a ventilation housing connector 9160, a heat and moisture exchanger (HME) clip 9170, an HME housing 9180, a bellows seal 9190, and a ventilation adapter connector 9200.

[0458] The ventilation housing 9120 may include an end 9121 having a protrusion 9122 to connect the ventilation housing 9120 to the catheter connector 9110 at the ventilation adapter end 9112. The end 9121 may define a central orifice of the ventilation housing 9120 through which a pressurized gas flow is provided to the patient. The ventilation housing 9120 may include an external vent 9125 and an internal vent 9126 that define a passage for discharging pressurized gas from the RPT system, i.e., gas can be discharged from the internal vent 9126 through the passage to the external vent 9125 and exhausted to the atmosphere. The ventilation housing 9120 may also include a tab 9123 engaged to the lip 9124 via a support 9128 to releasably attach the ventilation housing 9120 to the ventilation housing connector 9160 and the ventilation adapter connector 9200. The patient can actuate the tab 9123 to depress the support 9128 to disengage the lip 9124 from the ventilation housing connector 9160 and the ventilation adapter connector 9200. When attached, the lip 9124 allows the ventilation housing 9120 to rotate relative to the ventilation adapter connector 9200 while remaining connected. The ventilation housing 9120 can also be a shoulder 9127 to fit into a corresponding recess 9164 of the ventilation housing connector 9160. The ventilation housing 9120 can also include a recess 9129 to accommodate a corresponding bellows seal connector 9191, which attaches the bellows seal 9190 to the ventilation housing 9120 to seal the interior of the ventilation adapter 9100 against the ventilation adapter connector 9200 when assembled.

[0459] The vent housing connector 9160 may include a first stem 9161 and a second stem 9162 forming a receptacle 9163 that receives a corresponding lip 9124 of the vent housing 9120 to attach the vent housing connector 9160 to the vent housing 9120. As described above, 9164 also receives a shoulder 9127 of the vent housing 9120. The vent housing connector 9160 may also include a curved outer surface 9165.

[0460] The bellows seal 9190 may be similar to that described above with respect to Figures 6A-6H The bellows seal 9190 may have a shoulder surface 9194 with a bellows seal connector 9191 to attach the bellows seal 9190 to the recess 9129 of the vent housing 9120. The bellows seal 9190 may also have an inner surface 9193 that contacts the pressurized gas and pushes outward when assembled so that the outer surface 9192 forms a seal against the vent adapter connector 9200.

[0461] The ventilation adapter connector 9200 may have an orifice 9201 through which pressurized gas passes from the ventilation adapter 9100 to the patient during treatment. In addition, exhaled gas may be discharged into the ventilation adapter 9100 via the orifice 9201. The ventilation adapter connector 9200 may be connected to a patient interface via another tube (not shown) at the orifice 9201. The ventilation adapter connector 9200 may also have an edge 9202 to connect to a lip 9124 of the ventilation housing 9120 to allow the ventilation housing 9120 to be connected to the ventilation adapter connector 9200 and rotate relative to the ventilation adapter connector 9200. It should be understood that in another form of the present technology, the ventilation adapter connector 9200 may be directly connected to the patient interface, or it may be integrally formed with the patient interface, such as a mask shell.

[0462] As described above, the ventilation adapter 9100 may also include an HME clip 9170 and an HME shell 9180 to hold the HME material in a position within the ventilation adapter 9100, between the internal vent 9126 and the patient. The HME material (not shown) may be a spiral or cylindrical structure that is inserted into the HME shell 9180 and held therein by the HME clip 9170. The HME clip 9170 may have a pair of arms 9171 extending from a central axis 9172. The central axis 9172 may extend through the center of the HME material to secure the shaft end 9173 to a receiver 9183 suspended from a cross member 9182 of the HME shell 9180 to secure the HME material inside the HME shell 9180. The HME housing 9180 may also include a pair of slots 9181 in the outer wall 9184 that correspond to the arms 9171 and receive the arm ends 9174 so that when assembled the HME clip 9170 does not rotate relative to the HME housing 9180. Thus, the HME material will be secured between the arms 9171 and the cross member 9182. The outer wall 9184 may include a plurality of cutouts 9185.

[0463] The catheter connector 9110 may include a ventilation adapter end 9112 and a catheter end 9111. As described above, the ventilation adapter end 9112 may be connected to the ventilation housing 9120 and the catheter end may be connected to a catheter (not shown) whose other end is connected to the RPT device to receive the pressurized gas flow. The catheter connector 9110 may also include an anti-asphyxia valve (AAV) opening 9113.

[0464] Another example of a ventilation adapter 9100 and its components is shown in Figures 15A-15F This example includes the Figures 7A-14D9120. In this example, the ventilation adapter connector 9200 includes an edge 9203 that is connected to a tab 9123 of a ventilation housing 9120 to connect the ventilation adapter connector 9200 to the ventilation housing 9120. In addition, this example shows an anti-asphyxia valve (AAV) 9135 that can be installed in a catheter connector 9110. The catheter connector 9110 can also have a ring 9115 to connect to a catheter (not shown). In addition, in this example, a bellows seal 9190 can be seen attached to the ventilation housing connector 9160. The ventilation housing connector 9160 also has a ridge to allow attachment to the ventilation housing 9120 by tabs 9123. In addition, examples of HME material 9145 and diffuser 9146 are shown.

[0465] Another example of a ventilation adapter 9100 and its components is shown in Figures 21A-21F This example includes the above Figures 7A-14D and Figures 15A-15F 9100. In this example, the HME housing 9180 is not completely contained within the interior of the ventilation adapter 9100. Instead, it is partially exposed so that it forms part of the structure that connects the ventilation housing 9120 to the ventilation adapter connector 9200.

[0466] Another example of a ventilation adapter 9100 and its components is shown in Fig. 22 This example includes the above Figures 7A-14D and Figures 15A-15F Similar possibilities characterize the examples shown in . Fig. 22 Also included is a flap retaining structure 9141 which may be attached to the HME clip 9170 on one side and abut the flap 9140 on the other side to retain the flap 9140 in an operational position relative to the vent housing 9120 .

[0467] Another example of a ventilation adapter 9100 and its components is shown in Figures 24A-24B This example includes the above Figures 7A-14D and Figures 15A-15F Similar possibilities characterize the examples shown in .

[0468] Fig.23A diagram depicting methods in which a ventilation adapter 9100 may be attached to different patient interfaces. In the case of a nasal cushion patient interface 3000A or a nasal pillow patient interface 3000B, the ventilation adapter 9100 may be coupled to either patient interface via a short tube 9210. One end of the short tube 9210 may be coupled to the patient interface 3000A, 3000B, and the other end may be coupled to the ventilation adapter connector 9200 described above. Alternatively, in the case of a full face patient interface 3000C, the ventilation adapter 9100 does not include a ventilation adapter connector 9200, and the ventilation adapter 9100 is directly connected to the full face patient interface 3000C, such that the short tube 9210 is not provided.

[0469] Figures 33A to 33G Another example of a ventilation adapter 9100 according to an example of the present technology is depicted. Fig.35 As shown, the ventilation adapter 9100 can be connected to the patient interface 3000 to, for example, provide the functionality of its components.

[0470] The ventilation adapter includes an elbow assembly 9220 to provide a fluid connection with the patient interface 3000, for example, via a connection port 3600 on the plenum chamber 3200. This example of the elbow assembly 9220 includes an elbow frame 9222 and an elbow overmolding 9224. The elbow assembly 9220 can provide a releasable connection with the plenum chamber 3200 at the connection port. The elbow frame 9222 can include a tab that can be elastically deformed for releasable connection, and the elbow overmolding 9224 can provide a fluid-tight seal around the opening in the elbow frame 9222 and add elasticity to the elbow frame 9222. The elbow assembly 9220 can also rotate relative to the plenum chamber 3200 to reduce the effects of tube resistance from the ventilation adapter 9100 and other components of the air circuit 4170. The elbow assembly 9220 can also be removably connected to the patient interface 3000 and can be able to rotate relative to the patient interface 3000.

[0471] The ventilation adapter 9100 may also include a short tube assembly 9210. The short tube assembly 9210 may decouple the other components of the ventilation adapter 9110, such as the ventilation housing 9320 and the ventilation core structure 9300, from the elbow assembly 9220 connected to the plenum chamber 3200. By decoupling the other components of the ventilation adapter 9110 in this manner, the weight that must be carried directly on the patient's head via the patient interface 3000 may be reduced, which in turn provides a lighter and more comfortable experience for the patient. The short tube assembly 9210 may include a tube 9212, which may be composed of one or more spiral coils. The short tube assembly 9210 may include a tube-elbow connector 9216 to provide a connection to the elbow assembly 9220. The connection between the tube-elbow connector 9216 and the elbow assembly 9220 may include a snap fit. The connection between the tube-elbow connector 9216 and the elbow assembly 9220 may be permanent - in other words, the connection may be separable only if the components are damaged. The short tube assembly 9210 may include a tube-housing connector 9214 to provide a connection to the exhaust housing connector 9160. The connection between the tube-housing connector 9214 and the vent housing connector 9160 may include a snap fit. The connection between the tube-housing connector 9214 and the vent housing connector 9160 may be permanent - in other words, the connection may be separable only by damage to the components.

[0472] The ventilation adapter 9100 may include a ventilation housing connector 9160 to couple the short tube assembly 9210 to the ventilation housing 9320. As described above, the ventilation housing connector 9160 may be coupled to the short tube assembly 9210 via a tube-housing connector 9214, which may be snap-on and may be permanent. The ventilation housing connector 9160 may also include a bayonet connector 9166 to facilitate a releasable bayonet connection to the ventilation housing 9320 or a heat and moisture exchanger (HME) housing 9400, such as Figures 38A to 39C Thus, the HME associated with HME housing 9400 may be optional and thus not shown in FIG. Figures 33A to 33G The bayonet connector 9166 may be convex or concave. Additionally, having the vent housing 9320 removably connected to the exhaust vent housing connector 9160 allows the vent components to be removed and disassembled for cleaning.

[0473] Figures 34A to 34G An example of a vent housing 9320, a valve flap or membrane 9140, a vent core structure 9300, a diffuser member 9146, a diffuser retaining ring 9148, and a vent diffuser cover 9330 is shown. These components can be assembled into subassemblies, such as Figures 34A to 34G as shown in , and coupled to the ventilation housing connector 9160 for use. Figures 34A to 34GThe components of the subassembly depicted in the embodiment may be inseparable via a permanent snap fit, or the components may be separated by the user. In the case of being inseparable, the snap fit may be permanent, so that the components can only be separated if they are damaged.

[0474] The vent housing 9320 may also include a bayonet connector 9322 to correspondingly connect with the bayonet connector 9166 of the vent housing connector 9160 to removably connect the vent housing 9320 to the vent housing connector 9160. The vent 9320 housing may also include a membrane retainer 9324 to hold the membrane 9140 against the vent core structure 9300 when assembled. The membrane retainer 9324 may include an open, radial, and cage-like structure to allow ventilation flow to travel through the membrane retainer 9324 to exit through the vent core structure 9300. The membrane retainer 9324 may also be open at its center to allow therapeutic flow to pass from the RPT device 4000 all the way to the patient.

[0475] The flap or membrane 9140 may be positioned between the membrane holder 9324 and the vent core structure 9300. The membrane 9140 may be held in position between these two structures, but may also be otherwise free to deform by pressure within the vent adapter 9100. The membrane 9140 may function similarly to the other examples of membranes 9140 disclosed above.

[0476] The ventilation core structure 9300 may include an inlet 9301 to allow the flow of gas generated by the RPT device 4000 to pass through the ventilation adapter 9100 and all the way to the patient for treatment. The ventilation core structure 9306 may include a ventilation core extension 9306 by which the inlet 9301 may be defined. The ventilation core extension 9306 may extend axially and may include an air circuit connector 9302 to connect the ventilation core 9300 to the air circuit 4170. As can be seen, the shape and size of the ventilation core extension 9306 are designed to extend through the diffuser retaining ring 9148, the diffuser 9146, and the ventilation diffuser cover 9330 to align these components when the ventilation adapter 9100 is assembled. The ventilation core structure 9300 may also include clips on the alignment structure 9312, which are connected to the connection surface 9334 of the ventilation diffuser cover 9330. The clip 9304 may be connected to the connection surface 9334 by a snap fit to allow the vent diffuser cover 9330 to be disassembled and removed to allow cleaning and / or replacement of the vent adapter component 9100, such as the diffuser 9146. The alignment structure 9312 may also facilitate axial alignment of the vent core structure 9300 with the diffuser 9146 and the vent diffuser cover 9330 by means of corresponding shapes.

[0477] The vent core structure 9300 may also include a plurality of outer orifices 9308 and a plurality of inner orifices 9310. The plurality of inner orifices 9310 may be configured such that ventilation flow through the inner orifices 9310 to the atmosphere may be obstructed or restricted by the membrane 9140 in use. The plurality of outer orifices 9308 may be configured such that ventilation flow through the outer orifices 9308 to the atmosphere may not be obstructed or restricted by the membrane 9140 in use. However, the membrane 9140 may also be configured such that it does not completely block the inner orifices 9310 at any pressure at least within a typical therapeutic pressure range (e.g., between about 6 cm H2O and about 20 cm H2O). In other words, the ventilation flow can be discharged through both the inner orifice 9310 and the outer orifice 9308 at any pressure within the typical therapeutic pressure range, while the pressure within the ventilation adapter 9110 causes the membrane 9140 to deform to change the ventilation flow rate passing through the outer orifice 9308 and the inner orifice 9310 to maintain a constant ventilation flow rate, as described above.

[0478] The diffuser 9146 may include a diffuser opening 9147 through which the core extension 9306 may pass. The diffuser 9146 may include similar features as the diffusers described above.

[0479] The diffuser 9146 can be held in a downstream position relative to the vent flow at the inner orifice 9310 and the outer orifice 9308 by a diffuser retaining ring 9148 and a vent diffuser cover 9330. The diffuser retaining ring 9148 can be fixed to the vent diffuser cover 9330, such as by a snap fit to hold the diffuser 9146. The diffuser retaining ring 9148 can include a radial diffuser retainer 9149 to hold the diffuser 9146 against the vent diffuser cover 9330. The diffuser retaining ring 9148 and the radial diffuser retainer 9149 can define a rear vent outlet 9342 around the vent housing 9320. The vent flow leaving the vent core structure 9300 can pass through the diffuser 9148 and out through the rear vent outlet 9340. The vent diffuser cover 9332 can include a series of cover spacers 9332 radially spaced around the vent diffuser cover 9330 to define a front vent outlet 9342. The ventilation flow leaving the ventilation core structure 9300 can pass through the diffuser 9148 and out through the front ventilation outlet 9342.

[0480] The above is publicly available and Figures 33A to 34G The exemplary ventilation adapter 9100 is shown connected to Fig.35The patient interface 3000 in FIG. 1 is shown in FIG. 1 . The elbow assembly 9220 is excluded in this example because the plenum chamber 3200 includes a connection port 3600 that is angled to point in a downward direction relative to the patient during use, thereby directing the ventilation adapter 9100 away from the patient's head. Alternatively, the short tube assembly 9210 may be permanently connected to the plenum chamber 3200 at the connection port 3600.

[0481] Figures 37A to 37E Another example of a ventilation adapter 9100 according to the present technology is depicted. The ventilation adapter 9100 may include a plenum connector 9700 to connect the ventilation adapter 9100 directly to the connection port 3600 of the plenum 3200 and / or its shield 3305 (see Fig.41 ) to provide a fluid connection between the pressurized gas flow from the ventilation adapter 9100 and the inflation chamber 3200.

[0482] The vent adapter 9100 may also include a baffle 9600. The baffle 9600 may separate the pressurized gas flow entering from the RPT device 4000 from the outgoing vent flow exiting through the outer orifice 9308 and the inner orifice 9310 of the vent housing 9120. The baffle 9600 may be positioned inside the plenum connector 9700. The baffle 9600 and the plenum connector 9700 may be aligned when connected to form concentric circles.

[0483] The ventilation adapter 9100 may also include a lip seal 9500 that fits around the outer periphery of the plenum chamber connector 9700. The lip seal 9500 may seal with the connection port 3600 of the plenum chamber 3200 and / or the inner periphery of its shield 3305 to provide a pneumatic seal while allowing the ventilation adapter 9100 to rotate relative to the patient interface 3000.

[0484] According to the above-mentioned embodiments, for example Figures 33A to 34G In the example shown in FIG. 9 , the ventilation adapter 9140 may also include a valve flap or membrane 9140 to regulate the ventilation flow of the inner orifice 9310 and the outer orifice 9308 of the ventilation housing 9120 .

[0485] The vent housing 9120 may include an inner aperture 9310 and an outer aperture 9308, and these apertures may allow ventilation flow to exit from the vent adapter 9100 to the atmosphere, as in the above example, such as in Figures 33A to 34G As described in the examples.

[0486] The ventilation housing 9120 may also include a tab 9123 and a lip 9124 to provide a releasable and rotatable connection with the connection port 3600 of the plenum chamber 3200 and / or its shield 3305. The tab 9123 may be manually depressed to release the lip 9123 from a corresponding annular protrusion (not shown) of the connection port 3600 of the plenum chamber 3200 and / or its shield 3305. When connected, the lip 9124 allows the ventilation adapter 9100 to remain connected to the connection port 3600 of the plenum chamber 3200 and / or its shield 3305 while being rotatable to reduce the effects of tube resistance.

[0487] The vent housing 9120 can be connected to a conduit connector 9110, which in turn can connect the vent adapter 9100 to the air circuit. The conduit connector 9110 can be in the form of an elbow. The conduit connector 9110 can have a conduit end 9111 connected to the air circuit 4170 and a vent adapter end 9112 connected to the vent housing 9120. The connection between the vent adapter end 9112 of the conduit connector 9110 and the vent housing 9120 can include a snap fit, can be permanent so that the connection can only be separated if at least one component is damaged, and / or can be non-rotatable to prevent the conduit connector 9110 from contacting the tab 9123. The conduit connector 9110 can also include one or more anti-asphyxia valve (AAV) openings 9113 for the AAV 9135.

[0488] The ventilation adapter 9100 may also include an air circuit connector 9116, which may be attached to the catheter end 9111 of the catheter connector 9110. The air circuit connector 9116 may include a bayonet connector 9117 to connect to the corresponding Figures 36A to 36C 9116 and 9175 of an exemplary air circuit 4170. The connection between the air circuit connector 9116 and the air circuit 4170 may be releasable.

[0489] Figures 37A to 37E The ventilation adapter depicted in the figure may not include a heat and moisture exchanger (HME) material 9145. The absence of a heat and moisture exchanger material 9145 positioned within the ventilation flow path may minimize ventilation flow impedance, thereby minimizing CO2 accumulation within the plenum 3200. The ventilation adapter depicted 9100 may be suitable, for example, for use with a Fig.41 The depicted full-face patient interface is used in conjunction with the

[0490] Figures 37A to 37E The ventilation adapter 9100 depicted in FIG. 1 may form an elbow assembly that may be removably connected to a patient interface 3000, such as Fig.41 as shown, and may be capable of rotating relative to the patient interface.

[0491] Fig.40 and 41 A further example of a ventilation adapter 9100 coupled to a patient interface 3000 is shown.

[0492] Fig.40 A patient interface 3000 is depicted having a seal-forming structure 3100 that forms a seal only around the patient's nose (i.e., a nasal mask) in use. The ventilation adapter 9100 is shown coupled to a shield 3305 that covers a portion of the plenum chamber 3200. In this example, the ventilation adapter 9100 features an elbow that is directly and rotatably attached to the shield 3305 to provide a fluid connection with the plenum chamber 3200. However, it should be understood that Figures 33A to 33G The ventilation adapter can be attached to the shield 3305 to form a fluid connection with the inflation chamber 3200 via the elbow assembly 9220. The shield 3305 has a rigid arm 3301 joined to the shield 3305 at a hinge 3307. The side arm 3301 can include an upper attachment point 3302 and a lower attachment point 3304 to attach a strap that positions and stabilizes the structure 3300. The upper attachment point 3302 can form a loop through which the upper strap can be passed, and the lower connection point 3304 can receive a clip 3306, which in turn receives the lower strap.

[0493] Fig.40 An exemplary patient interface 3000 is depicted, which may include a seal-forming structure 3100 to form a seal over the patient's nose and mouth in use. A ventilation adapter 9100, such as the examples depicted in 37A to 37E, may be connected to a shroud 3305 to provide a fluid connection with the plenum chamber 3200. The shroud 3305 may be coupled to a rigid arm 3301, which may have an upper attachment point 3302 to attach a strap of the positioning and stabilizing structure 3300. The shroud 3305 may be connected to a lower strap connector 3303 separate from the rigid arm 3301 to attach the strap of the positioning and stabilizing structure 3300 at a lower connection point 3304. The upper attachment point 3302 may form a loop through which the upper strap may be passed, and the lower connection point 3304 may receive a clip 3306, which in turn receives the lower strap.

[0494] 5.5RPT device

[0495] The RPT device 4000 according to one aspect of the present technology includes mechanical and pneumatic components 4100, electrical components 4200, and is configured to execute one or more algorithms 4300. The RPT device can have an outer housing 4010 that is constructed in two parts: an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can 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 can include a handle 4018.

[0496] The pneumatic path of the RPT device 4000 may include one or more air path items and silencers 4120, 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 a positive pressure, an outlet silencer 4124, and one or more converters 4270, such as a pressure sensor and a flow sensor.

[0497] One or more air path items may be disposed within a removable separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0498] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0499] 5.5.1 Mechanical and pneumatic components of RPT device

[0500] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be provided as separate units.

[0501] 5.5.1.1 Air filter

[0502] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0503] In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140. Figure 4B .

[0504] In one form, an outlet air filter 4114, such as an antimicrobial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000. Figure 4B .

[0505] 5.5.1.2 Silencer

[0506] In one form of the present technology, the inlet muffler 4122 is positioned in the pneumatic path upstream of the pressure generator 4140. Figure 4B .

[0507] In one form of the present technology, the outlet muffler 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000. Figure 4B .

[0508] 5.5.1.3 Pressure generator

[0509] In one form of the present technology, the pressure generator 4140 for generating an air flow or air supply under positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers housed in a volute. The blower may deliver the air supply, for example, at a rate of up to about 120 liters per minute and at a positive pressure in the range of about 4 cm H2O to about 20 cm H2O or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, 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 No. WO 2013 / 020167.

[0510] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0511] In other words, the pressure generator 4140 may be a piston driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0512] 5.5.1.4 Converter

[0513] The transducer may be internal to the RPT device, or external to the RPT device. An external transducer may be located, for example, on or form part of an air circuit such as a patient interface. An external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0514] In one form of the present technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and arranged to measure a characteristic such as flow, pressure or temperature at that point in the pneumatic path.

[0515] In one form of the present technology, one or more transducers 4270 may be positioned proximal to the patient interface 3000 .

[0516] In one form, the signal from converter 4270 may be filtered, such as by low pass filtering, high pass filtering, or band pass filtering.

[0517] 5.5.1.4.1 Flow sensor

[0518] A flow sensor according to the present technology may be based on a differential pressure transducer, such as the SDP600 series differential pressure transducer from SENSIRION.

[0519] In one form, a signal representing a flow rate, such as a total flow rate Qt, is received from a flow sensor by the central controller 4230 .

[0520] 5.5.1.4.2 Pressure sensor

[0521] A pressure sensor according to the present technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure transducer is a sensor from the ASDX series of HONEYWELL. An alternative suitable pressure transducer is a sensor from the NPA series of GENERALELECTRIC.

[0522] In one form, signals from the pressure sensors may be received by the central controller 4230 .

[0523] 5.5.1.4.3 Motor speed converter

[0524] In one form of the present technology, a motor speed converter is used to determine the rotational speed of the motor 4144 and / or blower 4142. A motor speed signal from the motor speed converter may be provided to the treatment device controller 4240. The motor speed converter may be, for example, a speed sensor such as a Hall effect sensor.

[0525] 5.5.1.5 Anti-overflow valve

[0526] In one form of the present technology, an anti-spillback valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve 4160 is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to the motor 4144, for example.

[0527] 5.5.1.6 Air circuit

[0528] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that, when in use, is constructed and arranged to allow air flow to travel between two components, such as the pneumatic block 4020 and the patient interface 3000 .

[0529] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block and the patient interface. The air circuit can be referred to as an air delivery tube. In some cases, there can be separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0530] 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 increase the temperature of the air. In other words, the air circuit 4170 may be a heated air circuit 4171. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be spirally wound around the axis of the air circuit 4170. The heating element may be in communication with a controller such as a central controller 4230. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent Application No. US / 2011 / 0023874, which is incorporated herein by reference in its entirety.

[0531] FIG. 36A to FIG. 36C An example of an air circuit 4170 according to an example of the present technology is depicted. The air circuit 4170 may include a tube 4172 that is composed of one or more spiral coils. The air circuit 4173 may include an RPT device connector 4173 at one end that is configured to connect to the RPT device 4000 to receive a pressurized gas flow. At the other end, the air circuit 4170 may include a ventilation adapter connector 4174 that may be connected to a ventilation adapter 9100, such as in Figures 33A to 34G 9302. The ventilation adapter connector 4174 may include a connector 4175 to engage with the corresponding air circuit connector 9302 of the ventilation adapter 9300. The connector 4175 may be in the form of a female bayonet connector corresponding to the air circuit connector 9302. The ventilation adapter connector 4174 may also include a gripping recess 4176 to allow the patient to grip the ventilation adapter connector 4174 to rotate the air circuit 4170 to connect to or disconnect from the ventilation adapter 9100. The ventilation adapter connector 4174 may also include a seal 4177 to form a pneumatic seal between the ventilation adapter connector 4174 and a tube connector 4178 that connects the ventilation adapter connector 4174 to the tube 4172.

[0532] 5.5.1.7 Oxygen delivery

[0533] In one form of the present technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic pathway, such as upstream of the pneumatic block 4020 , the air circuit 4170 , and / or the patient interface 3000 .

[0534] 5.5.2 RPT device electrical components

[0535] 5.5.2.1 Power supply

[0536] The power source 4210 may be positioned inside or outside of the outer housing 4010 of the RPT device 4000 .

[0537] In one form of the present technology, power supply 4210 provides power only to RPT device 4000. In another form of the present technology, power supply 4210 provides power to both RPT device 4000 and humidifier 5000.

[0538] 5.5.2.2 Input device

[0539] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessed via a touch screen. In one form, the buttons, switches, or dials may be physically connected to the external housing 4010, or in another form, may be in wireless communication with a receiver that is electrically connected to a central controller 4230.

[0540] In one form, input device 4220 may be constructed or arranged to allow a person to select values ​​and / or menu options.

[0541] 5.5.2.3 Central Controller

[0542] In one form of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0543] Suitable processors may include x86 Intel processors, A processor of a processor such as the STM32 series microcontroller from ST MICROELECTRONIC. In some alternative forms of the present technology, a 32-bit RISC CPU such as the STR9 series microcontroller from ST MICROELECTRONICS, or a 16-bit RISC CPU such as the MSP430 series microcontroller from TEXAS INSTRUMENTS may also be suitable.

[0544] In one form of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0545] In one form, the central controller 4230 is an application specific integrated circuit. In another form, the central controller 4230 includes discrete electronic components.

[0546] The central controller 4230 may be configured to receive input signals from one or more converters 4270 , one or more input devices 4220 , and the humidifier 5000 .

[0547] The central controller 4230 may be configured to provide output signals to one or more output devices 4290 , the treatment device controller 4240 , the data communication interface 4280 , and the humidifier 5000 .

[0548] In some forms of the present technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 represented as computer programs stored in a non-transitory computer readable storage medium such as memory 4260. In some forms of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of the present technology, some of the methods may be performed by a remotely located device. For example, the remotely located device may determine a control set point for the ventilator or detect a breathing-related event by analyzing stored data such as from any of the sensors described herein.

[0549] 5.5.2.4 Clock

[0550] The RPT device 4000 may include a clock connected to the central controller 4230 .

[0551] 5.5.2.5 Treatment device controller

[0552] In one form of the present technology, the treatment device 4350 may include a treatment device controller 4240 which is a treatment control module 4330 that forms part of an algorithm 4300 executed by a central controller 4230 .

[0553] In one form of the present technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one form, the MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0554] 5.5.2.6 Protection circuit

[0555] One or more protection circuits 4250 in accordance with the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0556] 5.5.2.7 Memory

[0557] According to one form of the present technology, the RPT device 4000 includes memory 4260, such as non-volatile memory. In some forms, the memory 4260 may include battery-powered static RAM. In some forms, the memory 4260 may include volatile RAM.

[0558] Memory 4260 may be located on PCBA 4202. Memory 4260 may be in the form of EEPROM or NAND flash memory.

[0559] Additionally or alternatively, the RPT device 4000 includes memory 4260 in a removable form, such as a memory card made in accordance with the Secure Digital (SD) standard.

[0560] In one form of the present technology, the memory 4260 serves as a non-transitory computer-readable storage medium on which are stored computer program instructions representing one or more of the methods described herein, such as one or more algorithms 4300 .

[0561] 5.5.2.8 Data Communication System

[0562] In one form of the present technology, a data communication interface 4280 is provided and connected to the central controller 4230. The data communication interface 4280 can be connected to a remote external communication network and / or a local external communication network. The remote external communication network can be connected to a remote external device. The local external communication network can be connected to a local external device.

[0563] In one form, the data communications interface 4280 is part of the central controller 4230. In another form, the data communications interface 4280 is separate from the central controller 4230 and may include an integrated circuit or processor.

[0564] In one form, the remote external communication network is the Internet. The data communication interface 4280 may be connected to the Internet using wired communication (eg, via Ethernet or optical fiber) or wireless protocols (eg, CDMA, GSM, LTE).

[0565] In one form, the local external communications network utilizes one or more communications standards, such as Bluetooth or consumer infrared protocols.

[0566] In one form, the remote external device can be one or more computers, such as a cluster of network computers. In one form, the remote external device can be a virtual computer rather than a physical computer. In either case, this remote external device can be accessed by a properly authorized person (such as a clinician).

[0567] The local external device may be a personal computer, a mobile phone, a tablet or a remote control device.

[0568] 5.5.2.9 Output devices including optional displays and alarms

[0569] Output devices 4290 according to the present technology may take the form of one or more of visual, audio, and tactile units.The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0570] 5.5.2.9.1 Display Driver

[0571] The display driver receives as input characters, symbols or images for display on the display and converts them into commands that cause the display to display those characters, symbols or images.

[0572] 5.5.2.9.2 Display

[0573] The display is configured to visually display characters, symbols or images in response to commands received from a display driver. For example, the display may be an eight-segment display, in which case the display driver converts each character or symbol (such as the number "0") into eight logic signals indicating whether the eight corresponding segments are to be activated to display a particular character or symbol.

[0574] 5.5.3RPT device algorithm

[0575] 5.5.3.1 Preprocessing module

[0576] A pre-processing module 4310 according to one form of the present technology receives as input a signal from a transducer 4270 (e.g., a flow sensor or a pressure sensor) and performs one or more processing steps to calculate one or more output values ​​to be used as input to another module (e.g., a treatment engine module 4320).

[0577] In one form of the present technology, the output values ​​include interface or mask pressure Pm, respiratory flow Qr, and leak flow rate Ql.

[0578] In various forms of the present technology, the pre-processing module 4310 includes one or more of the following algorithms: pressure compensation 4312 , ventilation flow estimation 4314 , leak flow estimation 4316 , and respiratory flow estimation 4318 .

[0579] 5.5.3.1.1 Pressure compensation

[0580] In one form of the present technology, the pressure compensation algorithm 4312 receives as input a signal indicative of the pressure in the pneumatic path proximal to the pneumatic block outlet. The pressure compensation algorithm 4312 estimates the pressure drop through the air circuit 4170 and provides as output an estimated pressure Pm in the patient interface 3000.

[0581] 5.5.3.1.2 Ventilation Flow Estimation

[0582] In one form of the present technology, the ventilation flow estimation algorithm 4314 receives as input an estimated pressure Pm in the patient interface 3000 and estimates a ventilation flow Qv of air from the vent 3400 in the patient interface 3000 .

[0583] 5.5.3.1.3 Leakage flow estimation

[0584] In one form of the present technology, the leakage flow estimation algorithm 4316 receives the total flow Qt and the exhaust flow Qv as inputs and provides an estimate of the leakage flow Ql as output. In one form, the leakage flow estimation algorithm estimates the leakage flow Ql by averaging the difference between the total flow Qt and the ventilation flow Qv over a period of time long enough to include several respiratory cycles (e.g., about 10 seconds).

[0585] In one form, the leak flow estimation algorithm 4316 receives as input the total flow rate Qt, the ventilation flow Qv, and the estimated pressure Pm in the patient interface 3000, and provides as output a leak flow Ql by calculating a leak conductivity and determining the leak flow Ql as a function of the leak conductivity and the pressure Pm. The leak conductivity is calculated as the quotient of the low-pass filtered non-ventilation flow equal to the difference between the total flow Qt and the ventilation flow Qv and the low-pass filtered square root of the pressure Pm, where the low-pass filter time constant has a value long enough to include several respiratory cycles (e.g., about 10 seconds). The leak flow Ql can be estimated as the product of the leak conductivity and the pressure Pm function.

[0586] 5.5.3.1.4 Respiratory flow estimation

[0587] In one form of the present technology, a respiratory flow estimation algorithm 4318 receives as input a total flow Qt, a ventilation flow Qv, and a leak flow rate Ql, and estimates an air respiratory flow Qr to the patient by subtracting the ventilation flow Qv and the leak flow Ql from the total flow Qt.

[0588] 5.5.3.2 Treatment Engine Module

[0589] In one form of the present technology, therapy engine module 4320 receives as input one or more of pressure Pm in patient interface 3000 and air respiratory flow Qr to the patient, and provides as output one or more therapy parameters.

[0590] In one form of the present technology, the treatment parameter is treatment pressure Pt.

[0591] In one form of the present technology, the therapy parameter is one or more of a pressure support level, a basal pressure, and a target ventilation.

[0592] In various forms, the therapy engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / hypopnea determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328 and therapy parameter determination 4329.

[0593] 5.5.3.2.1 Phase determination

[0594] In one form of the present technology, the RPT device 4000 is phase indeterminate.

[0595] In one form of the present technology, the phase determination algorithm 4321 receives as input a signal indicative of respiratory flow Qr and provides as output the phase Φ of the current respiratory cycle of the patient 1000.

[0596] In some forms, referred to as discrete phase determination, the phase output Φ is a discrete variable. One embodiment of discrete phase determination provides a two-value phase output Φ having an inspiratory or expiratory value upon detection of the onset of spontaneous inspiration and expiration, respectively, e.g., values ​​represented as 0 and 0.5 turns, respectively. An RPT device 4000 that "triggers" and "cycles" effectively performs discrete phase determination because the trigger and cycle points are the moments of phase change from exhalation to inspiration and from inspiration to exhalation, respectively. In one embodiment of two-value phase determination, when the respiratory flow rate Qr has a value exceeding a positive threshold, the phase output Φ is determined to have a discrete value of 0 (thereby "triggering" the RPT device 4000), and when the respiratory flow rate Qr has a value more negative than a negative threshold, the phase output Φ is determined to have a discrete value of 0 (thereby "cycling" the RPT device 4000).

[0597] Another embodiment of discrete phase determination provides a three-valued phase output Φ having a value of one of inspiration, mid-inspiratory pause, and expiration.

[0598] In other forms referred to as continuous phase determination, the phase output Φ is a continuous value, for example varying from 0 to 1 turn or 0 to 2π radians. The RPT device 4000 performing continuous phase determination can trigger and loop when the continuous phase reaches 0 and 0.5 turns, respectively. In one embodiment of continuous phase determination, a fuzzy logic analysis of the respiratory flow Qr is used to determine the continuous values ​​of the phase Φ. The continuous values ​​of the phase determined in this embodiment are generally referred to as "fuzzy phase". In one embodiment of the fuzzy phase determination algorithm 4321, the following rules are applied to the respiratory flow Qr:

[0599] 1. If the respiratory flow is zero and increases rapidly, the phase is 0 turns.

[0600] 2. If the respiratory flow is largely positive and stable, the phase is 0.25 turns.

[0601] 3. If the respiratory flow is zero and decreases rapidly, the phase is 0.5 turns.

[0602] 4. If the respiratory flow is largely negative and stable, the phase is 0.75 turns.

[0603] 5. If the respiratory flow is zero and stable and the 5-second low-pass filtered absolute value of the respiratory flow is large, the phase is 0.9 turns.

[0604] 6. If the respiratory flow is positive and it is the exhalation phase, the phase is 0 revolutions.

[0605] 7. If the respiratory flow is negative and it is the inspiratory phase, the phase is 0.5 turns.

[0606] 8. If the absolute value of a 5 second low pass filter of the respiratory flow is large and the phase increases at a steady rate equal to the patient's respiratory rate, then the low pass filter has a time constant of 20 seconds.

[0607] The output of each rule can be represented as a vector whose phase is the result of the rule and whose magnitude is the ambiguity of the rule being true. The ambiguity of respiratory flow "large", "stable", etc. is determined using appropriate membership functions. The results of the rules, represented as vectors, are then combined by some function, such as taking the centroid. In such a combination, the rules can be weighted equally, or differently.

[0608] In another embodiment of continuous phase determination, the inspiratory time Ti and the expiratory time Te are first estimated from the respiratory flow Qr. The phase Φ is then determined as half of the proportion of the inspiratory time Ti that has passed since the previous triggering moment, or 0.5 turns plus half of the proportion of the expiratory time Te that has passed since the previous cycle moment (whichever is newer).

[0609] 5.5.3.2.2 Waveform determination

[0610] In one form of the present technology, the therapy parameter determination algorithm 4329 provides an approximately constant therapy pressure throughout the patient's breathing cycle.

[0611] In other forms of the present technology, the therapy parameter determination algorithm 4329 controls the pressure generator 4140 to provide a therapy pressure Pt that varies throughout the patient's breathing cycle according to a waveform template.

[0612] In one form of the present technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ) with a value in the range of [0,1] over the domain of the phase value Φ provided by the phase determination algorithm 4321 for use by the treatment parameter determination algorithm 4329.

[0613] In one form applicable to discrete or continuous valued phases, the waveform template Π(Φ) is a square wave template having a value of 1 for phase values ​​up to and including 0.5 turns, and having a value of 0 for phase values ​​above 0.5 turns. In one form applicable to continuous valued phases, the waveform template Π(Φ) includes two smoothly curved portions, namely a smoothly curved (e.g., raised cosine) rise from 0 to 1 for phase values ​​up to 0.5 turns, and a smoothly curved (e.g., exponential) decay from 1 to 0 for phase values ​​above 0.5 turns. In one form applicable to continuous valued phases, the waveform template Π(Φ) is based on a square wave, but has a smooth rise from 0 to 1 for phase values ​​up to a "rise time" significantly less than 0.5 turns, and smoothly decays from 1 to 0 for phase values ​​within a "fall time" after 0.5 turns.

[0614] In some forms of the present technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates based on the set value of the RPT device. Each waveform template Π(Φ) in the library can be provided as a lookup table of values ​​Π relative to phase values ​​Φ. In other forms, the waveform determination algorithm 4322 calculates a "real-time" waveform template Π(Φ) using a predetermined functional form that may be parameterized by one or more parameters (e.g., a time constant of an exponential curve portion). The parameters of the functional form may be predetermined or depend on the current state of the patient 1000.

[0615] In some forms of the present technology applicable to discrete two-valued phases for inspiration (Φ=0 turns) or exhalation (Φ=0.5 turns), the waveform determination algorithm 4322 calculates a "real-time" waveform template Π as a function of both the discrete phase Φ and the time t measured since the most recent trigger moment. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ, t) in both parts (inspiration and exhalation) as follows:

[0616]

[0617] where Πi (t) and Π e (t) is the inspiratory and expiratory portions of the waveform template Π(Φ,t). In one such form, the inspiratory portion Π i (t) is a smooth rise from 0 to 1 parameterized by a rise time, and the expiratory portion Π e (t) is a smooth fall from 1 to 0 parameterized by a fall time.

[0618] 5.5.3.2.3 Tidal volume determination

[0619] In one form of the present technique, the tidal volume determination algorithm 4323 receives the respiratory flow Qr as an input and determines a measurement indicative of the current patient tidal volume Vent.

[0620] In some embodiments, the tidal volume determination algorithm 4323 determines a measurement of the tidal volume Vent, which is an estimate of the actual patient tidal volume. One such embodiment is to optionally filter half of the absolute value of the respiratory flow Qr by a low-pass filter (such as a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).

[0621] In other embodiments, the tidal volume determination algorithm 4323 determines a measurement of the tidal volume Vent, which is approximately proportional to the actual patient tidal volume. One such embodiment estimates the peak respiratory flow Qpeak during the inspiratory portion of the cycle. This and many other procedures involving sampling the respiratory flow Qr produce measurements that are approximately proportional to the tidal volume, provided that the flow waveform shape does not vary greatly (here, the shapes of two breaths are considered similar when the flow waveforms of normal breaths in terms of time and amplitude are similar). Some simple examples include the median of the respiratory flow when it is positive, the median of the absolute value of the respiratory flow, and the standard deviation of the flow. Any linear combination of any order statistics of the absolute value of the respiratory flow using positive coefficients, and even some that use both positive and negative coefficients simultaneously, is approximately proportional to the tidal volume. Another example is the average of the respiratory flow for the middle K proportion (by time) of the inspiratory portion, where 0 < K < 1. If the flow shape remains constant, there can be any number of measurements that are exactly proportional to the tidal volume.

[0622] 5.5.3.2.4 Inspiratory flow limit determination

[0623] In one form of the present technique, the central controller 4230 executes an inspiratory flow limit determination algorithm 4324 for determining the degree of inspiratory flow limit.

[0624] In one form, the inspiratory flow limit determination algorithm 4324 receives the respiratory flow signal Qr as an input and provides as an output a measure of the degree to which the inspiratory portion of the breath exhibits an inspiratory flow limit.

[0625] In one form of the present technology, the inspiratory portion of each breath is identified by a zero crossing detector. A number of evenly spaced points (e.g., sixty-five) representing the time points are interpolated along the inspiratory flow-time curve for each breath by an interpolator. The curve described by the points is then scaled by a scaler to have unit length (duration / cycle) and unit area to remove the effects of changing breathing rate and depth. The scaled breath is then compared in a comparator to a graph representing a flow rate similar to Fig. 6A . As determined by the test element, breaths from this template that deviate from a specified threshold (usually 1 scaling unit) at any time during inspiration due to coughing, sighing, swallowing, and hiccups are rejected. For data that are not rejected, the moving average of the first such scaling point is calculated by the central controller 4230 for several preceding inspiratory events. This is repeated for the second such point on the same inspiratory event, and so on. Thus, for example, sixty-five scaling data points are generated by the central controller 4230, and these data points represent the moving average of several preceding inspiratory events, such as three events. The moving average of the continuously updated values ​​of (e.g., sixty-five) points is hereinafter referred to as "scaled flow", named Qs(t). Alternatively, a single inspiratory event can be used instead of a moving average.

[0626] From the scaled flow, two shape factors relevant to determining partial blockage can be calculated.

[0627] Shape Factor 1 is the ratio of the average of the middle (e.g., thirty-two) scaled flow points to the average overall (e.g., sixty-five) scaled flow points. If this ratio exceeds 1, the breath will be considered normal. If the ratio is 1 or less, the breath will be considered obstructed. A ratio of about 1.17 is considered the threshold between partially obstructed and unobstructed breaths and is equivalent to a degree of obstruction that will allow adequate oxygenation to be maintained in a typical patient.

[0628] Shape Factor 2 is calculated as the RMS deviation from unit scaled flow taken at an intermediate (e.g., thirty-two) point. An RMS deviation of about 0.2 units is considered normal. A zero RMS deviation is considered a completely flow-restricted breath. The closer the RMS deviation is to zero, the more flow-restricted the breath will be considered.

[0629] Form factors 1 and 2 may be used as alternatives or in combination. In other forms of the present technology, the number of sampling points, the number of breaths, and the number of intermediate points may be different from those described above. Furthermore, the thresholds may be different from those described.

[0630] 5.5.3.2.5 Determination of respiratory arrest and hypopnea

[0631] In one form of the present technology, the central controller 4230 executes an apnea / hypopnea determination algorithm 4325 to determine the presence of apnea and / or hypopnea.

[0632] The apnea / hypopnea determination algorithm 4325 receives as input the respiratory flow signal Qr and provides as output a flag indicating that an apnea or hypopnea has been detected.

[0633] In one form, when the function of respiratory flow Qr falls below a flow threshold for a predetermined period of time, apnea may be considered detected. The function may determine a peak flow, a relatively short-term average flow, or an intermediate flow of a relatively short-term average flow and a peak flow (e.g., RMS flow). The flow threshold may be a measure of a relatively long-term flow.

[0634] In one form, when the function of respiratory flow Qr falls below a second flow threshold within a predetermined time period, hypopnea may be detected. The function may determine a peak flow, a relatively short-term average flow, or an intermediate flow of a relatively short-term average flow and a peak flow (e.g., RMS flow). The second flow threshold may be a measurement of a relatively long-term flow. The second flow threshold is greater than a flow threshold for detecting apnea.

[0635] 5.5.3.2.6 Snoring Determination

[0636] In one form of the present technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the level of snoring.

[0637] In one form, the snoring determination algorithm 4326 receives as input a signal of respiratory flow Qr and provides as output a measure of the degree to which snoring is present.

[0638] The snore determination algorithm 4326 may include a step of determining the flow signal strength within the range of 30-300 Hz. In addition, the snore determination algorithm 4326 may include a step of filtering the signal of the respiratory flow Qr to reduce background noise (e.g., the sound of air flow from a blower in the system).

[0639] 5.5.3.2.7 Determination of airway patency

[0640] In one form of the present technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 for determining airway patency.

[0641] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines the power of the signal within a frequency range of about 0.75 Hz and about 3 Hz. The presence of a peak in this frequency range is considered to indicate an open airway. The absence of a peak is considered to be an indication of a closed airway.

[0642] In one form, the frequency range in which the peak is sought is the frequency of a small forced oscillation in the process pressure Pt. In one embodiment, the forced oscillation frequency is 2 Hz and the amplitude is about 1 cm H2O.

[0643] In one form, the airway patency determination algorithm 4327 receives as input the respiratory flow signal Qr and determines the presence or absence of a cardiogenic signal. The absence of a cardiogenic signal is considered indicative of airway closure.

[0644] 5.5.3.2.8 Determination of target ventilation

[0645] In one form of the present technology, the central controller 4230 takes as input a measured value of the current ventilation Vent and executes one or more target ventilation determination algorithms 4328 to determine a target value Vtgt for the measured ventilation.

[0646] In some forms of the present technology, there is no target ventilation determination algorithm 4328 and the target value Vtgt is predetermined, for example by hard coding during configuration of the RPT device 4000 or by manual entry via the input device 4220.

[0647] In other forms of the present technology, such as adaptive servo-ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp indicative of the patient's typical recent ventilation.

[0648] In some forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated as a high proportion of the typical recent ventilation Vtyp but less than Vtyp. The high proportion in such forms may be in the range of (80%, 100%), or (85%, 95%), or (87%, 92%).

[0649] In other forms of adaptive servo-ventilation, the target ventilation Vtgt is calculated to be slightly greater than a multiple of the typical recent ventilation Vtyp.

[0650] The typical recent ventilation Vtyp is the value around which the distribution of the current ventilation Vent measurements at multiple moments within some predetermined time scale tends to cluster, that is, a measure of the central tendency of the current ventilation measurements in the recent history. In one embodiment of the target ventilation determination algorithm 4328, the recent history is on the order of a few minutes, but in any case should be longer than the time scale of the tidal increase and decrease cycle. The target ventilation determination algorithm 4328 can use a variety of known central tendency measures to determine the typical recent ventilation Vtyp from the current ventilation Vent measurements. One such measurement is the output of a low pass filter on the current ventilation Vent measurements, with a time constant equal to 100 seconds.

[0651] 5.5.3.2.9 Treatment parameter determination

[0652] In some forms of the present technology, the central controller 4230 executes one or more treatment parameter determination algorithms 4329 to determine one or more treatment parameters using values ​​returned by one or more other algorithms in the treatment engine module 4320.

[0653] In one form of the present technology, the treatment parameter is the instantaneous treatment pressure Pt. In one embodiment of this form, the treatment parameter determination algorithm 4329 determines the treatment pressure Pt using the following equation:

[0654] Pt=AΠ(Φ,t)+P0 (1)

[0655] in:

[0656] A is the amplitude,

[0657] Π(Φ, t) is the waveform template value (in the range of 0 to 1) at the current value of phase Φ and time t, and

[0658] P0 is the base pressure.

[0659] If the waveform determination algorithm 4322 provides the waveform template Π(Φ, t) as a numerical lookup table indexed by phase, the treatment parameter determination algorithm 4329 applies equation (1) by locating the nearest lookup table entry to the phase current value Φ returned by the phase determination algorithm 4321, or by interpolating between two entries spanning the phase current value Φ.

[0660] Depending on the selected respiratory pressure therapy mode, the values ​​of amplitude A and basal pressure P0 may be set by therapy parameter determination algorithm 4329 in the following manner.

[0661] 5.5.3.3 Treatment Control Module

[0662] The therapy control module 4330 according to one aspect of the present technology receives therapy parameters as input from the therapy parameter determination algorithm 4329 of the therapy engine module 4320 and controls the pressure generator 4140 to deliver air flow in accordance with the therapy parameters.

[0663] In one form of the present technology, the therapy parameter is a therapy pressure Pt, and the therapy control module 4330 controls the pressure generator 4140 to deliver an air flow with a mask pressure Pm at the patient interface 3000 equal to the therapy pressure Pt.

[0664] 5.5.3.4 Fault Condition Detection

[0665] In one form of the present technology, the central controller 4230 executes one or more methods 4340 for detecting a fault condition. The fault condition detected by the one or more methods may include at least one of the following:

[0666] Power failure (no power, or insufficient power)

[0667] Converter fault detection

[0668] Unable to detect the presence of parts

[0669] Operating parameters outside the recommended range (e.g. pressure, flow, temperature, PaO2)

[0670] The test alarm fails to produce a detectable alarm signal.

[0671] Upon detecting a fault condition, the corresponding algorithm signals the presence of a fault by one or more of the following:

[0672] Activate audible, visual and / or dynamic (e.g. vibration) alarms

[0673] Send messages to external devices

[0674] Recording events

[0675] 5.6 Humidifier

[0676] 5.6.1 Overview of Humidifier

[0677] In one form of the present technology, a humidifier 5000 (e.g., Figure 5A ) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0678] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. 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 can also include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0679] 5.6.2 Mechanical components of the humidifier

[0680] 5.6.2.1 Water storage tank

[0681] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a liquid (e.g., water) volume to be evaporated for humidifying the air flow. The water reservoir 5110 may be configured to hold a predetermined maximum water volume so as to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (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.

[0682] According to one aspect, the water reservoir 5110 is configured to add humidity to the air flow from the RPT device 4000 as the air flow travels therethrough. In one form, the water reservoir 5110 may be configured to encourage the air flow to travel in a tortuous path through the reservoir 5110 while in contact with the volume of water therein.

[0683] According to one form, the reservoir 5110 may be arranged, for example, along a Figure 5A and Figure 5B The lateral orientation is shown removed from the humidifier 5000.

[0684] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any holes and / or between its subcomponents, such as when the reservoir 5110 is displaced and / or rotated from its normal working orientation. Since the air flow to be humidified by the humidifier 5000 is generally pressurized, the reservoir 5110 may also be configured to avoid loss of pneumatic pressure through leakage and / or flow resistance.

[0685] 5.6.2.2 Conductive part

[0686] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 that is configured to allow efficient transfer of heat from the heating element 5240 to the liquid content in the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes may also be equally suitable. All or a portion of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., having a thickness of approximately 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, a material with a suitable geometry having a lower conductivity may be used to achieve appropriate thermal conductivity.

[0687] 5.6.2.3 Humidifier reservoir dock

[0688] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (eg, Figure 5B ), which is configured to receive the humidifier reservoir 5110. In some arrangements, the humidifier reservoir base 5130 may include a locking structure, such as a locking rod 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0689] 5.6.2.4 Water level indicator

[0690] The humidifier reservoir 5110 may include Figure 5A-5B 1000 or a caregiver. The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as the patient 1000 or a caregiver) with one or more indications regarding the amount of water volume in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a 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.

[0691] 5.6.3 Humidifier electrical & thermal components

[0692] Humidifier 5000 may include several electrical and / or thermal components, such as those listed below.

[0693] 5.6.3.1 Humidifier converter

[0694] The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 instead of or in addition to the transducers 4270 described above. Figure 5CAs shown, the humidifier converter 5210 may include one or more of an air pressure sensor 5212, an air flow converter 5214, a temperature sensor 5216, or a humidity sensor 5218. The humidifier converter 5210 may generate one or more output signals that may be communicated to a controller, such as the central controller 4230 and / or the humidifier controller 5250. In some forms, the humidifier converter may be provided externally to the humidifier 5000 (such as in the air circuit 4170) when communicating the output signals to the controller.

[0695] 5.6.3.1.1 Pressure converter

[0696] In lieu of or in addition to the pressure sensor provided in the RPT device 4000 , one or more pressure transducers 5212 may be provided to the humidifier 5000 .

[0697] 5.6.3.1.2 Flow converter

[0698] In lieu of or in addition to the flow sensors provided in the RPT device 4000 , one or more flow transducers 5214 may be provided to the humidifier 5000 .

[0699] 5.6.3.1.3 Temperature converter

[0700] 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 air flow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may further include a temperature sensor 5216 for detecting the ambient air temperature.

[0701] 5.6.3.1.4 Humidity converter

[0702] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 that 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.

[0703] 5.6.3.2 Heating elements

[0704] In some cases, a heating element 5240 can be provided to the humidifier 5000 to provide heat input to one or more of the water volumes in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 can include a heat generating component, such as a resistive electric heating rail. A suitable example of a heating element 5240 is a layered heating element, such as the layered heating element described in PCT Patent Application Publication No. WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0705] In some forms, the heating element 5240 may be disposed in the humidifier base 5006, such as Figure 5B As shown in , heat can be provided to the humidifier reservoir 5110 primarily by conduction.

[0706] 5.6.3.3 Humidifier controller

[0707] According to one arrangement of the present technology, Figure 5C The humidifier 5000 shown in FIG. 5 may include a humidifier controller 5250. In one form, the humidifier controller 5250 may be part of the central controller 4230. In another form, the humidifier controller 5250 may be a separate controller that may communicate with the central controller 4230.

[0708] In one form, the humidifier controller 5250 may receive as input, for example, measurements of characteristics of the air flow, water flow (such as temperature, humidity, pressure and / or flow) in the reservoir 5110 and / or the humidifier 5000. The humidifier controller 5250 may also be configured to execute or implement a humidifier algorithm and / or deliver one or more output signals.

[0709] like Figure 5C As shown in , the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4170, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.

[0710] 5.7 Respiratory Pressure Therapy Mode

[0711] In one form of the present technology, the RPT device 4000 can implement various respiratory pressure therapy modes based on the values ​​of parameters A and P0 in the therapy pressure equation (1) used by the therapy parameter determination algorithm 4329.

[0712] 5.7.1 CPAP therapy

[0713] In some embodiments of this form of the present technology, the amplitude A is uniformly zero, so the treatment pressure Pt is uniformly equal to the base pressure P0 throughout the respiratory cycle. Such embodiments are generally grouped under the heading of CPAP therapy. In such embodiments, the therapy engine module 4320 does not need to determine the phase Φ or waveform template Π(Φ).

[0714] In CPAP therapy mode, the basal pressure P0 can be a constant value that is hard-coded or manually input into the RPT device 4000. This alternative approach is sometimes referred to as constant CPAP therapy. A constant value for the basal pressure P0 can be selected for a given patient via a process known as titration. During titration, the clinician typically adjusts the therapy pressure Pt in response to observations of flow limitation, apnea, hypopnea, openness, and snoring during the titration phase. The titrated basal pressure P0 can then be calculated as a statistical summary of the therapy pressures Pt during the titration phase.

[0715] Alternatively, the therapy parameter determination algorithm 4329 can continuously calculate the basal pressure P0 during CPAP therapy. In this alternative approach, the therapy parameter determination algorithm 4329 continuously calculates the basal pressure P0 as a function of an indicator or measurement of sleep breathing disorders (such as one or more of flow limitation, apnea, hypopnea, openness, and snoring) returned by a corresponding algorithm in the therapy engine module 4320. This alternative approach is sometimes referred to as APAP therapy. Because the continuous calculation of the basal pressure P0 is similar to the clinician manually adjusting the therapy pressure Pt during titration, APAP therapy is sometimes also referred to as auto-titration CPAP.

[0716] 5.7.2 Bi-level treatment

[0717] In other embodiments of this form of the present technology, the value of the amplitude A in equation (1) can be positive. Such embodiments are referred to as bi-level therapy because when the therapy pressure Pt is determined using equation (1) with a positive amplitude A, the therapy parameter determination algorithm 4329 oscillates the therapy pressure Pt between two values ​​or levels that are synchronized with the spontaneous breathing efforts of the patient 1000. That is, based on the typical waveform template Π(Φ, t) described above, the therapy parameter determination algorithm 4329 will increase the therapy pressure Pt to P0+A (referred to as IPAP) at the beginning of therapy or during or during inspiration and reduce the therapy pressure Pt to the base pressure P0 (referred to as EPAP) at the beginning of therapy or during or during inspiration.

[0718] In some forms of bi-level therapy, IPAP is a prescribed therapy pressure that has the same purpose as the therapy pressure in the CPAP therapy mode, and EPAP is IPAP minus amplitude A, which has a "small" value (a few cm H2O), sometimes referred to as expiratory pressure relief (EPR). Such forms are sometimes referred to as CPAP therapy with EPR, which is generally considered to be more comfortable than straight CPAP therapy. In CPAP therapy with EPR, one or both of IPAP and EPAP can be constant values ​​hard-coded or manually entered into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 can continuously calculate IPAP and / or EPAP during CPAP with EPR. In this alternative approach, the therapy parameter determination algorithm 4329 continuously calculates EPAP and / or IPAP as a function of an indicator or measurement of sleep disordered breathing returned by a corresponding algorithm in the therapy engine module 4320, which is similar to the calculation of the basal pressure P0 in the above-mentioned APAP therapy.

[0719] In other forms of bi-level therapy, Amplitude A is large enough that RPT device 4000 does some or all of the work of breathing for patient 1000. In such forms, called pressure support ventilation therapy, Amplitude A is called pressure support or swing. In pressure support ventilation therapy, IPAP is the base pressure P0 plus pressure support A, and EPAP is the base pressure P0.

[0720] In some forms of pressure support ventilation therapy, referred to as fixed pressure support ventilation therapy, pressure support A is fixed at a predetermined value, e.g., 10 cm H 2 O. The predetermined pressure support value is a setting of the RPT device 4000 and may be set, for example, by hard coding during configuration of the RPT device 4000 or by manual entry through the input device 4220.

[0721] In some forms of pressure support ventilation therapy known as servo-ventilation, a therapy parameter determination algorithm 4329 takes as input a current measurement of ventilation Vent and a ventilation target value Vtgt provided by a target ventilation determination algorithm 4328, and continuously adjusts the parameters of equation (1) to adjust the current measurement of ventilation Vent toward the ventilation target value Vtgt. In a form of servo-ventilation known as adaptive servo-ventilation (ASV) that has been used to treat CSR, the target ventilation Vtgt is calculated by the target ventilation determination algorithm 4328 based on the typical recent ventilation Vtyp, as described above.

[0722] In some forms of servo-ventilation, the therapy parameter determination algorithm 4329 applies a control method to continuously calculate the pressure support A so as to adjust the current measurement of ventilation Vent toward the target ventilation Vtgt. One such control method is proportional integral (PI) control. In one embodiment of PI control, applicable to ASV mode in which the target ventilation Vtgt is set slightly less than the typical recent ventilation Vtyp, the pressure support is calculated as:

[0723] A=G∫(Vent-Vtgt)dt (2)

[0724] Where G is the gain value of the PI control. Larger gain G values ​​may result in positive feedback in the treatment engine module 4320. Smaller gain G values ​​may allow some remaining untreated CSR or central sleep apnea. In some implementations, the gain G is fixed at a predetermined value, such as 0.4 cm H2O / (L / min) / s. Alternatively, the gain G may vary between treatment stages, starting with a small value and gradually increasing between stages until a value is reached that almost eliminates the CSR. In such embodiments, conventional means for retrospectively analyzing the parameters of the treatment stage to assess the severity of the CSR during the treatment stage may be employed. In yet other embodiments, the gain G may vary based on the difference between the current measurement of ventilation and the target ventilation Vtgt.

[0725] Other servo-ventilation control methods that may be applied by the therapy parameter determination algorithm 4329 include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0726] The value of the pressure support A calculated by formula (2) can be limited to a range defined as [Amin, Amax]. In this embodiment, the pressure support A is at the minimum pressure support Amin by default until the current ventilation measurement value Vent is lower than the target ventilation value Vtgt, at which time A starts to increase, and only when Vent exceeds Vtgt again, it falls back to Amin.

[0727] The pressure support limits Amin and Amax are set values ​​for the RPT device 4000, such as by hard coding during configuration of the RPT device 4000 or by manual entry through the input device 4220. The minimum pressure support value Amin of 3 cm H2O is approximately 50% of the pressure support required to perform all the work of breathing for a typical patient in a steady state. The maximum pressure support Amax of 12 cm H2O is approximately twice the pressure support required to perform all the work of breathing for a typical patient, and is therefore sufficient to support the patient's breathing if any effort is ceased, but below a value that would be uncomfortable or dangerous.

[0728] In the pressure support ventilation therapy mode, EPAP is the base pressure P0. As with the base pressure P0 in CPAP therapy, EPAP can be a constant value that is specified or determined during titration. This constant EPAP can be set, for example, by hard coding during configuration of the RPT device 4000 or by manual input through the input device 4220. This alternative approach is sometimes referred to as fixed EPAP pressure support ventilation therapy. Titration of EPAP for a given patient can be performed by the clinician with the aid of PSG during the titration phase with the goal of preventing obstructive apnea, thereby maintaining an open airway for pressure support ventilation therapy, in a manner similar to the titration of the base pressure P0 in constant CPAP therapy.

[0729] Alternatively, the therapy parameter determination algorithm 4329 can continuously calculate the basal pressure P0 during the pressure support ventilation therapy. In such an alternative approach, the therapy parameter determination algorithm 4329 continuously calculates EPAP as a function of an indicator or measurement of sleep disordered breathing (such as one or more of flow limitation, apnea, hypopnea, openness, and snoring) returned by a corresponding algorithm in the therapy engine module 4320. Because the continuous calculation of EPAP is similar to the manual adjustment of EPAP by the clinician during EPAP titration, the process is sometimes also referred to as automatic titration of EPAP, and the overall therapy is referred to as automatically titrating EPAP pressure support ventilation therapy, or automatic EPAP pressure support ventilation therapy.

[0730] 5.8 Glossary

[0731] For purposes of this technical disclosure, one or more of the following definitions may apply in certain forms of the technology. In other forms of the technology, alternative definitions may apply.

[0732] 5.8.1 General

[0733] Air: in some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0734] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0735] For example, relative to the humidifier environment humidity This may be the humidity of the air directly surrounding the humidifier, such as the humidity inside the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0736] In another example, the environment pressureThis can be pressure directly around the body or outside the body.

[0737] In some forms, the environment (e.g., acoustic) noise It can be considered as the background noise level in the room the patient is in addition to the noise generated, for example, by the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0738] Respiratory Pressure Therapy (RPT): The application of a supply of air to the airway entrance at a therapeutic pressure that is typically positive relative to atmosphere.

[0739] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the therapy pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0740] Patient: A person, whether or not they have a respiratory illness.

[0741] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, e.g., with each breath, depending on whether there is an indication of an SBD event.

[0742] 5.8.2 Aspects of the respiratory cycle

[0743] Apnea: According to some definitions, an apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway does not allow air to flow despite the patient's efforts. Central apnea is considered to occur when apnea is detected due to a decrease or absence of respiratory effort despite a patent airway. Mixed apnea is considered to occur when a decrease or absence of respiratory effort occurs simultaneously with an obstructed airway.

[0744] Respiratory Rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0745] Duty cycle: the ratio of inspiratory time Ti to total breathing time Ttot.

[0746] Effort (Breathing): Respiratory effort will be described as the work done by a spontaneous breather in an attempt to breathe.

[0747] Expiratory portion of the respiratory cycle: the period from the start of expiratory flow to the start of inspiratory flow.

[0748] Flow Limitation: Flow limitation is to be considered a state in the patient's breathing where an increase in the patient's effort does not result in a corresponding increase in flow. Where flow limitation occurs during the inspiratory portion of the breathing cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the breathing cycle, it may be described as expiratory flow limitation.

[0749] Types of flow-limited inspiratory waveforms:

[0750] (i) Flattened: Having a rise followed by a relatively flat portion and then a fall.

[0751] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks.

[0752] (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat section.

[0753] (iv) Reverse chair shape: has a relatively flat section followed by a single local peak located at the trailing edge.

[0754] Hypopnea: Preferably, hypopnea will be considered a decrease in flow, rather than a cessation of flow. In one form, hypopnea is considered to occur when flow drops below a threshold for a sustained period of time. Central hypopnea is considered to occur when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0755] (i) The patient's respiration decreases by 30% for at least 10 seconds with an associated 4% desaturation; or

[0756] (ii) The patient has a decrease in breathing (but less than 50%) lasting at least 10 seconds with an associated desaturation or arousal of at least 3%.

[0757] Hyperpnea: Increased air flow to above normal levels.

[0758] Inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0759]

[00136] Patency (airway): The degree to which an airway is open or the degree to which an airway is open. An open airway is open. Airway patency can be quantified, for example with a value (1) for open, and a value of zero (0) for closed (obstructed).

[0760] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure that exists in the lungs at the end of exhalation.

[0761] Peak Flow (Q Peak): The maximum value of the flow during the inspiratory portion of the respiratory flow waveform.

[0762] Respiratory flow, air flow, patient air flow, respiratory air flow (Qr): These synonymous terms may be understood to refer to the RPT device's estimate of respiratory air flow, as contrasted with "true respiratory flow" or "true respiratory air flow", which is the actual respiratory flow experienced by the patient, typically expressed in liters per minute.

[0763] Tidal volume (Vt): The volume of air inspired or exhaled during normal breathing when no extra effort is exerted.

[0764] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0765] (Expiratory) Time (Te): Duration of the expiratory portion of the respiratory flow waveform.

[0766] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of one respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0767] Typical Recent Ventilation: The ventilation value around which recent values ​​tend to cluster over some predetermined time scale, ie, a measure of the central tendency of recent values ​​of ventilation.

[0768] Upper airway obstruction (UAO): includes partial and total upper airway obstruction. This may be associated with a state of flow limitation, where the flow level increases only slightly, or even decreases, as the pressure difference across the upper airway increases (Starling impedance behavior).

[0769] Ventilation (Vent): A measurement of the total amount of gas exchanged by a patient's respiratory system. Measurements of ventilation may include one or both of inspiratory and expiratory flow (per unit time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation". Minute ventilation is sometimes given simply as volume, and is understood to be the volume per minute.

[0770] 5.8.3RPT device parameters

[0771] Flow: The instantaneous volume (or mass) of air delivered per unit time. When flow and ventilation have the same volume or mass scale per unit time, flow is measured over a shorter period of time. In some cases, the reference to flow will be a reference to a scalar, i.e., a quantity having only magnitude. In other cases, the reference to flow will be a reference to a vector, i.e., a quantity having both magnitude and direction. In the case where it is referred to as a scalar, flow may be nominally positive for the inspiratory portion of a patient's breathing cycle, and therefore negative for the expiratory portion of a patient's breathing cycle. Flow may be given by the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow'. The total flow Qt is the flow of air leaving the RPT device. The ventilation flow Qv is the flow of air leaving the vent to allow flushing of exhaled gases. The leakage flow Ql is the leakage flow from the patient interface system. The respiratory flow Qr is the flow of air received into the patient's respiratory system.

[0772] Leakage: The word leakage is to be considered as undesired air flow. In one example, leakage may occur due to an incomplete seal between the mask and the patient's face. In another example, leakage may occur in the return elbow to the ambient environment.

[0773] Noise, conducted (acoustic): Conducted noise in this document refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface 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.

[0774] Noise, radiated (acoustic): Radiated noise in this document refers to the noise that is brought to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0775] Noise, ventilatory (acoustic): Ventilatory noise in this document refers to the noise generated by the flow of air through any vent, such as the vent in a patient interface.

[0776] Pressure: Force per unit area. Pressure can be expressed in units including cm H2O, gf / cm 2 , hectopascals). 1cmH2O is equal to 1g-f / cm 2 and is approximately 0.98 hPa. In this specification, unless otherwise specified, pressure is given in cm H2O. The pressure in the patient interface is given in the symbol Pm, while the treatment pressure is given in the symbol Pt, which represents the target value obtained by the mask pressure Pm at the current moment.

[0777] Acoustic power: The energy carried by a sound wave per unit time. Acoustic power is proportional to the square of the sound pressure multiplied by the wavefront area. Acoustic power is usually given in decibels SWL, i.e. decibels relative to a reference power, which is usually taken as 10 -12 watt.

[0778] Sound pressure: The local deviation from the ambient pressure at a given moment in time due to the propagation of sound waves through a medium. Sound pressure is usually given in decibels SPL, i.e. decibels relative to a reference pressure, which is usually taken as 20×10 -6 Pascal (Pa), which is considered the threshold of human hearing.

[0779] 5.8.4 Terminology used for ventilators

[0780] Adaptive servo ventilator (ASV): A servo ventilator with a variable rather than fixed target ventilation. The variable target ventilation may be derived from some characteristics of the patient, such as the patient's breathing characteristics.

[0781] Backup Rate: A parameter of a ventilator that determines the minimum rate of breaths (usually measured in breaths per minute) that the ventilator will deliver to the patient if not triggered by a spontaneous respiratory effort.

[0782] Cyclic: The termination of the inspiratory phase of a ventilator. When a ventilator is delivering a breath to a spontaneously breathing patient, at the end of the inspiratory portion of the respiratory cycle, the ventilator is considered to cycle to stop delivering a breath.

[0783] Expiratory Positive Airway Pressure (EPAP): The base pressure to which the intra-breath varying pressures are added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0784] End-expiratory pressure (EEP): The desired mask pressure that the ventilator attempts to achieve at the end of the expiratory portion. If the pressure waveform template Π(Φ) is zero at the end of exhalation, that is, Π(Φ) = 0, when Φ = 1, then EEP is equal to EPAP.

[0785] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure that the ventilator attempts to achieve during the inspiratory portion of a breath.

[0786] Pressure Support: A number that indicates the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, and usually means the difference in pressure between the maximum during inspiration and the base pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator aims to achieve, rather than the difference that is actually achieved.

[0787] Servomotor: A ventilator that measures patient ventilation, has a target ventilation and adjusts the level of pressure support to bring the patient's ventilation to the target ventilation.

[0788] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the onset of a breath in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0789] Swing: A term equivalent to pressure support.

[0790] Triggered: When the ventilator delivers breathed air to a spontaneously breathing patient, it is considered to be triggered at the beginning of the breath portion of the breathing cycle through the patient's effort.

[0791] Typical recent ventilation: Typical recent ventilation Vtyp is the value around which recent ventilation measurements tend to cluster over some predetermined timescale. For example, a measure of the central tendency of ventilation measurements in recent history may be a suitable value for a typical recent flux value.

[0792] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0793] 5.8.5 Facial anatomy

[0794] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0795] Alar tip: The outermost point on the wing of the nose.

[0796] Alar bend (or alar apex) point: The most posterior point in the base line of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0797] Auricle: The entire external visible part of the ear.

[0798] (Nose) Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0799] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0800] Columella: The strip of skin that separates the nostrils and extends from the nasal prominence to the upper lip.

[0801] Columellar angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (where both lines intersect at the lower point of the nasal septum).

[0802] Frankfurt horizontal plane: A line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0803] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0804] External nasal cartilage: A cartilaginous plate that is essentially triangular in shape. Its upper edge is attached to the nasal bone and the frontal process of the maxilla, and its lower edge is connected to the greater alar cartilage.

[0805] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar.

[0806] Nare: The approximately oval-shaped hole that forms the entrance to the nasal cavity. The singular form of nare is naris (nare). The nostrils are separated by the nasal septum.

[0807] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0808] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0809] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0810] Auricular base: The highest point where the auricle attaches to the facial skin.

[0811] Nasal prominence: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0812] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0813] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0814] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0815] Sagittal Plane: A vertical plane that passes from anterior (front) to posterior (back) and divides the body into right and left halves.

[0816] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0817] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal cavity.

[0818] Posterior superior lateral flap: The point at the inferior edge of the alar base where the alar base joins the skin of the upper (superior) lip.

[0819] Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

[0820] Mandibular alveolar seat point: the point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue

[0821] 5.8.6 Anatomy of the skull

[0822] Frontal Bone: The frontal bone includes a large vertical portion (the squama) which corresponds to the area called the forehead.

[0823] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0824] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0825] Nasal Bones: The nasal bones are two small oval bones that vary in size and form in different individuals; they lie side by side in the middle and upper part of the face and form the "bridge" of the nose at their junction.

[0826] Nasal root: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0827] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains an oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0828] Orbit: The bony cavity in the skull that holds the eyeball.

[0829] Parietal bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0830] Temporal Bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0831] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the prominence of the cheeks.

[0832] 5.8.7 Anatomy of the respiratory system

[0833] Diaphragm: A sheet of muscle that extends across the base of the rib cage. 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.

[0834] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0835] Lung: The respiratory organ of humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0836] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the nasal conchae (singular "concha") or turbinates. The front of the nasal cavity is the nose, while the back joins into the nasopharynx via the internal nostrils.

[0837] Pharynx: The part of the throat located just below (under) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (nasal portion of the pharynx), the oropharynx (mesopharynx) (oral portion of the pharynx), and the hypopharynx (hypopharynx).

[0838] 5.8.8 Materials

[0839] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, 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.

[0840] Polycarbonate: A transparent thermoplastic polymer typically based on bisphenol A carbonate.

[0841] 5.8.9 Aspects of the patient interface

[0842] Anti-Asphyxia Valve (AAV): A component or subcomponent of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0843] Bend: A conduit that directs the axis of the air flow to change direction at an angle. In one form, the angle may be about 90 degrees. In another form, the angle may be less than 90 degrees. The conduit may have a cross-section that is approximately circular. In another form, the conduit may have an elliptical or rectangular cross-section.

[0844] Frame: A frame will be considered to mean the mask structure that carries the tensile load between two or more connection points to the headgear. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0845] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. Preferably, the headgear includes a collection of one or more support bars, straps, and reinforcement bars configured to position and maintain the patient interface in position on the patient's face for delivery of respiratory therapy. Some straps are formed of soft, flexible, resilient materials, such as a laminate composite of foam and fabric.

[0846] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0847] Plenum: A mask plenum will be taken to mean a portion of...

Claims

1. A method of providing a fluid connection for delivering respiratory gas from a respiratory pressure therapy device to a patient, the method comprising: engaging a latch between the first and second ends of the fluid connection; as well as engaging a face seal around a first opening in the first end and around a second opening in the second end, wherein one of the first end and the second end corresponds to the respiratory pressure therapy device; and Wherein the face seal comprises a bellows-shaped or partially bellows-shaped portion.

2. A fluid connector for delivering respiratory gas from a respiratory pressure therapy device to a patient, the fluid connector comprising: a first end having a first interior portion for fluid flow and a first retaining portion, and a second end having a second interior portion for flow of the fluid and a complementary retaining portion configured to engage with the first retaining portion, The first inner portion and the second inner portion have a first shape perpendicular to a flow direction, the first retaining portion and the complementary retaining portion have a second shape perpendicular to the flow direction, and the first shape and the second shape are different.

3. A system for providing respiratory therapy to a patient, the system comprising: Respiratory pressure therapy devices; Air circuit; a patient interface connected to the air circuit, the patient interface being particularly adapted to operate with the respiratory pressure therapy device; as well as Means for ensuring that the patient interface specifically adapted for operation with the respiratory pressure therapy device is connected to the respiratory pressure therapy device.

4. A ventilation adapter for a respiratory pressure therapy (RPT) system, the ventilation adapter comprising: A vent assembly comprising: a vent housing defining a central orifice for flow of pressurized gas from a delivery conduit through the vent assembly to a patient interface, the vent housing having an annular surface surrounding the central orifice and having a plurality of holes for exhausting the pressurized gas to atmosphere; and a membrane positioned adjacent the annular surface; and Diffusion component.

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