Ventilation adapter for a respiratory therapy system

Abstract

A vent assembly for a respiratory pressure therapy (RPT) system. The vent assembly can include a vent housing having a first orifice configured to receive a flow of pressurized gas from an RPT device, and the vent housing having a plurality of holes to discharge the pressurized gas to atmosphere; a vent housing connector having a second orifice configured to direct the flow of pressurized gas to a patient interface; and a heat and moisture exchanger (HME) comprising a HME housing and a HME material within the HME housing, wherein the vent housing and the vent housing connector are configured to at least partially connect to form a cavity, and wherein the HME is positioned in the cavity when the vent assembly is assembled.

Description

[0001] This application is a divisional application of patent application No. 201780087688.3, ​​filed on December 22, 2017, entitled "Ventilation Adapter for a Respiratory Therapy System". Application No. 201780087688.3 is a PCT international application PCT / AU2017 / 051456 that entered the Chinese national phase.

[0002] 1. Cross-references to related applications

[0003] This application claims priority to U.S. Provisional Application No. 62 / 443,305, filed January 6, 2017, the entire contents of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field

[0006] This technology relates to one or more of the detection, diagnosis, treatment, prevention, and improvement of respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0007] 2.2 Description of relevant technologies

[0008] 2.2.1 The Human Respiratory System and Its Disorders

[0009] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0010] The airways consist of a series of branching tubes, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from the air and carbon dioxide to be expelled. The trachea divides into the left and right main bronchioles, which eventually further divide into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Further branching of the airways leads to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0011] There are a range of breathing disorders. Some disorders can be characterized by specific events, such as respiratory arrest, insufficiency, and hyperventilation.

[0012] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. This condition causes affected patients to stop breathing, typically for periods ranging from 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain damage. Concomitant symptoms are common, 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).

[0013] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a dysregulation of the patient's respiratory controller, characterized by rhythmic alternations of waxing and waning ventilation known as CSR cycles. CSR is characterized by repetitive hypoxia and reoxygenation of arterial blood. Due to the repetitive oxygen deprivation, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, leading to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0014] Respiratory insufficiency is a broad term encompassing respiratory disorders in which a patient is unable to adequately ventilate to balance their blood CO2 levels when their metabolic activity is elevated to a level significantly higher than at rest. Respiratory insufficiency may include some or all of the following disorders.

[0015] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0016] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0017] Neuromuscular disease (NMD) is a broad term encompassing many conditions and ailments that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage that worsens over years and only slightly shortens life expectancy (e.g., limb-girdle type, facioscapulohumeral type, and ankylosing spondylitis). Symptoms of respiratory failure in NMD include: progressive general weakness, dysphagia, shortness of breath during and at rest, fatigue, somnolence, morning headache, difficulty concentrating, and mood swings.

[0018] The chest wall is a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and have the potential to cause chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0019] A range of treatments have been used to treat or improve these symptoms. Furthermore, other healthy individuals may utilize these treatments to prevent respiratory distress. However, these treatments have many drawbacks.

[0020] 2.2.2 Treatment

[0021] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and can prevent upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to adhere to treatment if they find the device used to provide such treatment to be uncomfortable, difficult to use, expensive, or unsightly, among other things.

[0022] Noninvasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a noninvasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory insufficiency in forms such as orthostatic hypoxia (OHS), chronic respiratory dysplasia (COPD), non-invasive respiratory disease (NMD), and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0023] Non-invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0024] 2.2.3 Treatment System

[0025] These treatments can be provided by treatment systems or devices. Such systems and devices can also be used to diagnose symptoms without treating them.

[0026] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0027] Another form of treatment system is the mandibular repositioning device.

[0028] 2.2.3.1 Patient Interface

[0029] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cm H2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of a gas supply at a positive pressure of approximately 10 cm H2O to the airway.

[0030] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain adequate pressure. Mask systems for underwater swimming or diving may be configured to prevent water from flowing in from external high pressure, rather than maintaining air at a pressure higher than the environment inside.

[0031] Some masks may be clinically disadvantageous for this technology, for example, in cases where they block airflow through the nose and only allow it through the mouth.

[0032] If certain masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, they may be uncomfortable or not feasible for this technology.

[0033] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on the pillow.

[0034] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the duration of a breathing therapy session.

[0035] Due to these challenges, some face shields suffer from one or more of the following problems: obtrusive, unattractive, expensive, incongruous, difficult to use, and uncomfortable, especially when worn for extended periods or when the patient is unfamiliar with the system. For example, face shields designed solely for pilots, face shields designed to be part of personal protective equipment (such as filtering face shields), SCUBA face shields, or face shields designed to administer anesthetics are acceptable for their original applications, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient adherence to treatment. This is especially true if the face shield is worn during sleep.

[0036] Assuming patient adherence, CPAP therapy is highly effective in treating certain breathing difficulties. However, if the mask is uncomfortable or difficult to use, patient adherence may be compromised. Since patients are often advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), patients may not clean it, which could affect adherence.

[0037] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0038] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0039] 2.2.3.1.1 Sealing Formation Part

[0040] The patient interface may include a seal-forming portion. Because it comes into direct contact with the patient's face, the shape and construction of the seal-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0041] The patient interface can be partially characterized based on the design intent of the sealing portion to engage with the face during use. In one form of patient interface, the sealing portion may include two sub-parts to engage with corresponding left and right nostrils. In another form of patient interface, the sealing portion may include a single element surrounding both nostrils during use. This single element may be designed, for example, to cover the upper lip and bridge of the nose area of ​​the face. In another form of patient interface, the sealing portion may include an element surrounding the mouth area during use, for example, by forming a seal on the lower lip area of ​​the face. In yet another form of patient interface, the sealing portion may include a single element surrounding both nostrils and the mouth area during use. These different types of patient interfaces can be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0042] A seal that works effectively in one area of ​​a patient's face may not be suitable for another, for example, because the shape, structure, variability, and sensitivity of a patient's face differ. For instance, a seal on swimming goggles covering a patient's forehead may not be suitable for use on a patient's nose.

[0043] Certain seal-forming components can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming components of the mass-produced patient interface, one or both must be adapted to form a seal.

[0044] One type of seal-forming portion extends around the periphery of a patient interface and is designed to seal against the patient's face when force is applied to the patient interface and the seal-forming portion engages face-to-face with the patient's face. The seal-forming portion may include an air or fluid-filled pad, or a molded or shaped surface of a resilient sealing element made of an elastomer such as rubber. With this type of seal-forming portion, if the fit is insufficient, a gap will exist 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.

[0045] Another type of seal-forming portion incorporates a sheet-like seal of thin material positioned around the periphery 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 type of seal-forming portion, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming portion does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0046] Another type of sealing component may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0047] Another form of sealant can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0048] A series of patient interface sealing technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0049] One form of nasal pillow was 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.

[0050] ResMed Ltd. has manufactured the following products that combine a nose pillow: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TM Full-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO 2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow); U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of the full-face mask); International Patent Application WO 2009 / 052,560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0051] 2.2.3.1.2 Positioning and Stability

[0052] The sealing portion of the patient interface used in positive pressure therapy is subjected to a force corresponding to the air pressure that would disrupt the seal. Therefore, various techniques have been used to position the sealing portion and maintain it in a sealed relationship with the appropriate part of the face.

[0053] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US 2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0054] Another technique is to use one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following: ill-fitting, bulky, uncomfortable, and awkward to use.

[0055] 2.2.3.1.3 Ventilation port technology

[0056] Some forms of patient interface systems may include vents to allow flushing of exhaled carbon dioxide. Vents allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment. Vents may include orifices through which gas can flow when a mask is used. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents may, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0057] ResMed has developed numerous 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. US 2009 / 0050156; and U.S. Patent Application Publication No. US 2009 / 0044808.

[0058] The noise level of the existing face mask (ISO 17510-2:2007, pressure of 10cm H2O at 1m)

[0059]

[0060] ( * (Based on a single sample, measured in CPAP mode using the test method specified in ISO 3744 at 10 cm H2O) The sound pressure levels for various objects are shown below.

[0061]

[0062] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0063] 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 the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0064] One example of a specific requirement for certain RPT devices is noise.

[0065] Noise output level table for existing RPT devices (only one sample, measured in CPAP mode using the test method specified in ISO 3744 at 10cm H2O).

[0066] RPT device name A-weighted sound power level dB(A) Approximately 1 year <![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

[0067] 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 CPAP machine. CPAP machines include ResMed Stellar... TM The range of adult and pediatric ventilators can support a range of patients with invasive and non-invasive non-dependent ventilation for the treatment of a variety of conditions, such as, but not limited to, NMD, OHS and COPD.

[0068] Elisée TM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients to treat a variety of conditions. These ventilators offer volumetric and pressure ventilation modes with single- or dual-branch circuits. RPT devices typically include a pressure generator, such as an electric motor-driven blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow to the patient's airway can be supplied under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0069] The designer of a device may be presented with an almost infinite number of options. Design standards often conflict, meaning that some design choices are far from unconventional or unavoidable. Furthermore, certain aspects of comfort and efficiency may be highly sensitive to small and subtle changes in one or more parameters.

[0070] 2.2.3.3 Humidifier

[0071] Delivering unhumidified airflow can lead to airway dryness. Humidifiers using an RPT device and patient interface generate humidified gas, minimizing nasal mucosal dryness and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the surrounding facial area is generally more comfortable than cold air. A range of artificial humidification devices and systems are known; however, they may not meet the specific requirements of medical humidifiers.

[0072] When needed, typically in areas where patients may sleep or rest (e.g., in hospitals), medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air. Medical humidifiers intended for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0073] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers may provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0074] 2.2.3.4 Data Management

[0075] There are many clinical reasons to obtain data to determine whether a patient is “adhering” to a prescription respiratory therapy, such as if the patient has been using their RPT device according to certain “adherence rules.” One example of an adherence rule for CPAP therapy is to require the patient to use their RPT device for at least four hours each night for at least 21 or 30 consecutive days to be considered adherent. To determine patient adherence, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s use of the RPT device, calculate usage over the predetermined time period, and compare it to the adherence rules. Once the healthcare provider has determined that the patient has been using their RPT device according to the adherence rules, the healthcare provider can inform the patient of the third part of adherence.

[0076] Patient treatment can benefit from other aspects of communication between treatment data and third-party or external systems.

[0077] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0078] 2.2.3.5 Mandibular repositioning

[0079] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes it after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and reduces vibration of the hard palate.

[0080] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

[0081] In this design, the length of the connecting rod is chosen so that the mandible remains in an advanced position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will then determine the length of the connecting rod.

[0082] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (such as the ResMed Narval CC™ MRD) are designed to hold the mandible in an anterior 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.

[0083] 2.2.4 Diagnostic and Monitoring System

[0084] Clinical experts are capable of appropriately diagnosing or monitoring patients based on human observation. However, there are situations where clinical experts may be unavailable or unaffordable. In some cases, different clinical experts may disagree on a patient's condition. Furthermore, a given clinical expert may apply different criteria at different times. Due to the demanding nature of clinical practice, clinicians may struggle to keep up with evolving patient management guidelines.

[0085] Polysomnography (PSG) is a routine system used for the diagnosis and prognosis of cardiopulmonary diseases and typically involves specialized clinical personnel for application and / or interpretation. PSG usually involves placing 15 to 20 contact sensors on the body to record various bodily signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyography (EMG), etc. However, while they may be suitable for their usual application in a clinical setting, such systems are complex and can be expensive, and / or may be uncomfortable or impractical for patients trying to sleep at home. 3. Summary of the Invention

[0087] This technology aims to provide medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0088] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0089] Another aspect of this technology relates to methods for diagnosing, improving, treating, or preventing respiratory disorders.

[0090] One aspect of certain forms of this technology is for providing methods and / or devices to improve patient adherence to respiratory therapy.

[0091] A first form of the technology includes a connector kit having a compliant face seal between a first end and a second end of the connector kit and a retaining mechanism for joining the first end and the second end together.

[0092] A second form of the 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 opening for fluid flow, a sealing portion extending around the periphery of the first opening, and a latching 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 latching portion configured to engage with the latching portion, wherein the face seal allows respiratory gas to travel between the first opening and the second opening, and the engagement between the latching portion and the complementary latching portion secures the first end and the second end.

[0093] A third form of the 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.

[0094] A fourth form of the technology includes a method of providing a fluid connection for delivering respiratory gas from a respiratory pressure therapy device to a patient, the method comprising latching a first end and a second end of the fluid connection; and 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.

[0095] A fifth embodiment of the invention 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 latching portion wherein the sealing portion is configured to seal against a sealing surface extending around the periphery of a second opening to form a surface seal with the second half of the fluid connector system, and the latching portion is configured to latch with another latching portion of the second half of the fluid connector system.

[0096] A sixth form of the invention 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 latching portion wherein the sealing surface is configured to receive a sealing portion extending around the periphery of a second opening to form a face seal with the second half of the fluid connector system, and the latching portion is configured to latch with another latching portion of the second half of the fluid connector system.

[0097] 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 and a first retaining portion for fluid flow, and a second end having a second internal portion and a complementary retaining portion for fluid flow, 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 the 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.

[0098] An eighth aspect of the invention 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 adapted to operate with the respiratory pressure therapy device; and means for ensuring that the patient interface, particularly adapted to operate with the respiratory pressure therapy device, is connected to the respiratory pressure therapy device.

[0099] In an example of at least one of the first to eighth forms of the present technology, (a) a first end is connected to a respiratory pressure therapy device including a blower, and a 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 a 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; (h) when the 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 truncated conical portion; (k) the truncated conical portion contacts a sealing surface to form a face seal; (l) the sealing portion includes a partially spherical surface; (m) the partially spherical surface contacts a 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 a sealing surface to form a face seal; (p) when the first end and the second end are joined, 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 defined in the engagement direction between the first end and the second end. (r) The sealing portion is compliant in the direction of the axis; (r) the sealing portion is configured to expand and engage the sealing surface due to internal pressure at the first end when there is a gap between the sealing portion and the sealing surface in the unpressurized state; (s) the contact between the sealing portion and the sealing surface causes the sealing portion to abut against the seal and compress against the direction of airflow from the first opening to the second opening; (t) the compression of the sealing portion does not result in a significant compressive force; (u) the force required to compress the sealing portion is less than the force required to engage the latch portion and the complementary latch portion; (v) the force required to compress the sealing portion is less than half the force required to engage the latch portion and the complementary latch portion; (w) the force required to compress the sealing portion is less than the force required to engage the latch portion and 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 misaligned 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 configured to engage the latch portion; (dd) the cantilever portion is configured to be pressed down to engage or disengage the complementary latch portion from the latch portion, and to 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 movement therein in the engagement direction between the first and second ends; (ff) the travel limiter is a flange surrounding the first opening, and the second end includes a stop surface configured to contact the flange; (gg) a latching portion constrains the second end to prevent movement therein in the direction opposite to the engagement direction, and the travel limiter and latching portion together define the travel distance of the second end when the first and second ends are engaged; (hh) a sealing portion is configured to seal against a sealing surface over the entire travel 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 predetermined wear and / or creep of the fluid connector; (jj) the fluid connector is configured to seal against the sealing surface throughout the patient's respiratory cycle and from 4 cm H2O to 40 cm H2O. The pressure of H2O provides a negligible pressure drop when air flows through the fluid connector; (kk) the first end is a concave connection and the second end is a convex connection; (11) the concave and convex connections have non-circular profiles; (mm) the first end includes a port that is in fluid communication with the interior of the sealing portion and separate from the first and second openings; (nn) the first and second openings are the interior portions of the tube; (oo) the first end is connected to a respiratory pressure therapy device including a blower, and the second end is connected to an adapter for the fluid conduit connector; (pp) the fluid connector also includes an industry-standard fluid connector, wherein the industry-standard fluid connector is in fluid communication with the first opening and at the end opposite the sealing portion; (qq) The fluid connector also includes an industry-standard fluid connector, wherein the industry-standard fluid connector is in fluid communication with the first opening and at an end opposite to the sealing surface; (rr) the first shape is circular and the second shape includes properties of both circles and squares; and / or (ss) one of the first inner portion and the second inner portion includes a first convex portion, and the other of the first inner portion and the second inner portion includes a first concave portion, the first convex portion and the first concave portion including the first shape, and one of the retaining portion and the complementary retaining portion includes a second convex portion, and the other of the retaining portion and the complementary retaining portion includes a second concave portion, the second convex portion and the second concave portion including the second shape.

[0100] One aspect of this technology is a portable RPT device that can be carried by an individual (e.g., around a personal home) and includes a fluid connector.

[0101] Another aspect of this 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 having a plurality of holes for venting the pressurized gas to the atmosphere; and a membrane positioned adjacent to the annular surface, wherein the membrane is movable such that when the pressure of the pressurized gas within the ventilation assembly increases, the membrane is pushed against the annular surface of the ventilation housing.

[0102] Another aspect of this technology relates to an RPT system comprising: a ventilation assembly described in the preceding 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 a patient airway, the patient interface being non-ventilated; and a delivery catheter configured to deliver the pressurized gas flow from the RPT device to the patient interface.

[0103] In the examples of the ventilation assembly and RPT system described in the first two paragraphs, (a) the plurality of orifices may include a first set of orifices and a second set of orifices, the first set of orifices being proximal to the central orifice relative to the second set of orifices; (b) the shape and size of the membrane may be designed such that the membrane does not cover the first set of orifices; (c) the membrane may be configured to cover more of the second set of orifices as the pressurized gas pressure within the ventilation assembly increases; (d) the first set of orifices may be positioned upstream of the second set of orifices 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 housing; (f) the membrane may also comprise an elastic material; (g) the membrane may be annular; (h) the membrane may not be bonded to the ventilation housing; (i) the shape and size of the membrane may be set such that the outer edge of the membrane is adjacent to the inner periphery of the ventilation housing; and / or (j) each of the plurality of orifices may have a shape that converges from the inner surface of the ventilation housing to the outer surface of the ventilation housing.

[0104] Another aspect of this 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 having a plurality of holes for venting the pressurized gas to the atmosphere; a membrane positioned adjacent to the annular surface; and a diffusion member.

[0105] Another aspect of this technology relates to an RPT system. The RPT system includes: a ventilation adapter as described in the preceding paragraphs; 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 a patient's airway, the patient interface being non-ventilated; and a delivery catheter configured to deliver the pressurized gas flow from the RPT device to the patient interface.

[0106] In the examples of the ventilation adapter and RPT system described in the first two paragraphs, (a) the membrane may be movable such that when the pressure of the pressurized gas within the ventilation assembly increases, the membrane is pushed against the annular surface of the ventilation housing; (b) the plurality of orifices may include a first set of orifices and a second set of orifices, the first set of orifices being proximal to the central orifice relative to the second set of orifices; (c) the shape and size of the membrane may be designed such that the membrane does not cover the first set of orifices; (d) the membrane may be configured to cover more of the second set of orifices when the pressure of the pressurized gas within the ventilation assembly increases; (e) the first set of orifices may be positioned upstream of the second set of orifices relative to the pressurized gas flow; (f) the ventilation adapter may also include a retaining structure to hold the membrane in position adjacent to the annular surface of the ventilation housing; (g) the membrane may also comprise an elastic material; (h) the membrane may be annular; (i) the membrane may not be bonded to the ventilation housing; and (j) the shape and size of the membrane may be set such that the outer edge of the membrane is adjacent to the ventilation housing. The inner periphery of the body, (k) each of the plurality of holes may have a shape that converges from the inner surface of the vent housing to the outer surface of the vent housing, (l) the vent 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) a diffuser may be positioned outside the vent housing to at least partially cover the plurality of holes, (n) the vent adapter may also include a barrier member having an impermeable material that prevents gas exiting the plurality of holes from flowing through the diffuser in a straight path to the atmosphere, (o) the diffuser and the barrier member may be configured to guide gas exiting the plurality of holes outward from the diffuser in an orientation different from that of the plurality of holes, (p) the diffuser may provide a flow path parallel to the surface of the barrier member that contacts the diffuser, (q) the diffuser may be a porous material, (r) the diffuser may be an open-cell foam, and / or (s) the diffuser may be a fibrous material.

[0107] One aspect of the present invention relates to a ventilation system used with a patient interface during patient respiratory therapy using a therapeutic flow of pressurized gas at above ambient pressure. The ventilation system provides a flow of ventilation gas to expel exhaled gas from a pressurized volume, and the flow of ventilation gas is continuous during respiratory therapy. The ventilation system includes a ventilation housing comprising a base having an inlet extending through the base for the therapeutic gas flow and 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.

[0108] One aspect of the present invention relates to a ventilation system used with a patient interface during patient respiratory therapy using a therapeutic flow of pressurized gas at a pressure above ambient, the ventilation system providing a ventilation gas flow to expel exhaled gas from a pressurized volume, the ventilation flow being continuous during respiratory therapy. The ventilation system includes a ventilation housing comprising 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 the therapeutic pressure range, and wherein the membrane is elastically deformable due to pressure within the pressurized volume to distribute the ventilation flow between at least the first orifice and at least the second orifice throughout the therapeutic pressure.

[0109] In the 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 a 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) at least one first orifice may include a plurality of inner orifices, and 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 base connections. The connector combines an inner base and an outer base and separates multiple inner orifices; (g) the ventilation system may include multiple membrane spacers extending from the inner base; (h) the membrane may be supported over multiple inner orifices on the outer base and the membrane spacers; (i) the ventilation housing may include a base partition between the inner base and the outer base, and the membrane may be supported on the base partition and over multiple inner orifices of the membrane spacers; (j) the multiple membrane spacers may define multiple membrane spacer gaps between adjacent membrane spacers; (k) the membrane may include an atmospheric side surface adjacent to the inner base and the outer base of the ventilation housing and defining a membrane opening. The inner surface, and the inner base membrane channel for the flushing flow can be defined between the atmospheric side surface of the membrane and the inner base of the vent housing, (l) the inner wall membrane channel for the flushing flow can be defined between the inner surface of the membrane and the inner wall of the vent 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 configured to prevent the membrane from covering a plurality of external orifices, (o) the vent housing can include a plurality of recesses opposite to the outer base, and at least one of the plurality of external orifices can open to the opposite of the plurality of recesses. (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 comprise an elastically deformable material; (s) The elastically deformable material may include silicone resin; (t) The vent housing may be formed from a single uniform piece of a 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, allowing the membrane to move freely toward and away from the base.

[0110] Another aspect of this technology relates to a patient interface comprising: a sealing-forming structure; an inflation chamber coupled to the sealing-forming structure; a positioning and stabilizing structure for securing the patient interface to a patient in 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 decoupling structure for fluidly connecting the ventilation system to the inflation chamber.

[0111] Another aspect of the invention relates to a ventilation system used with a patient interface during patient respiratory therapy using a therapeutic flow of pressurized gas at a pressure above ambient. The ventilation system provides a flow of ventilation gas to expel exhaled gas from a pressurized volume, the flow being continuous during respiratory therapy. The ventilation system includes a ventilation housing comprising 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 the at least first orifice and the at least second orifice throughout the therapeutic pressure range, wherein the membrane is configured such that an increase in pressure within the pressurized volume causes the membrane to restrict a first ventilation flow rate through the at least first orifice throughout the therapeutic pressure range, and wherein the restriction of the first ventilation flow rate through the at least first orifice causes an increase in a second ventilation flow rate through the at least second orifice, such that the ventilation flow rates through the at least first orifice and the at least second orifice are approximately constant throughout the therapeutic pressure range.

[0112] In the example, (a) the ventilation housing may include an outer wall and an inner wall, the inner wall defining an inlet for the therapeutic gas flow, and a base may be positioned between the outer wall and the inner wall; (b) the flushing flow rate may be greater than or equal to the sum of the first ventilation flow rate and the second ventilation flow rate; (c) the membrane may elastically deform toward the base during use, such that the first ventilation flow rate is restricted when the membrane deflects toward the base; (d) the membrane may be configured to deflect closer to the base when the therapeutic pressure increases above a threshold therapeutic pressure value; (e) the membrane may be configured to reduce the first ventilation flow rate, such that the second ventilation flow rate increases when the membrane deflects closer to the base due to increasing the therapeutic pressure above the threshold therapeutic pressure value; (f) at least one first orifice may include a plurality of inner orifices, and 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) (j) The membrane may be supported above a plurality of internal orifices on the outer base and membrane spacer, such that increasing the treatment pressure above a critical treatment pressure value causes the membrane to deflect toward the inner base; (j) The membrane may be configured such that when the treatment pressure increases above a threshold treatment pressure value, the membrane-inner base gap defined between the membrane and the inner base decreases; (k) The membrane may be configured 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 comprise an elastically deformable material; (m) The elastically deformable material may include silicone resin; (n) The ventilation housing may be formed from a single uniform element of a 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 housing, such that the membrane may move freely toward and away from the base.

[0113] Another aspect of this technology relates to a patient interface comprising: a sealing-forming structure; an inflation chamber coupled to the sealing-forming structure; a positioning and stabilizing structure for securing the patient interface to a patient in 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 decoupling structure for fluidly connecting the ventilation system to the inflation chamber.

[0114] Another aspect of this technology relates to a patient interface that may include: an inflatable chamber pressurizable to at least 6 cm above ambient air pressure. The treatment pressure of H2O, the inflation chamber including an inflation chamber inlet port sized and configured to receive an airflow at the treatment pressure for patient breathing; a sealing structure configured and arranged to form a seal with a patient facial region around an inlet in the patient's airway, such that an airflow at the treatment pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the treatment pressure in the inflation chamber throughout the patient's respiratory cycle during use; a positioning and stabilizing structure to provide a resilient force to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether configured and arranged such that at least a portion of the patient's head covers a region of the patient's head above an auricular base point, and a portion of the tether is sized and configured to engage a portion of the patient's head in a parietal region during use, wherein the positioning and stabilizing structure has a non-rigidly decoupled portion; and a ventilation system used with a patient interface during patient breathing therapy using a treatment flow of pressurized gas at a pressure higher than ambient pressure. The system provides a ventilation gas flow to expel exhaled gas from a pressurized volume, the ventilation flow being continuous during respiratory therapy. The ventilation system includes: a ventilation housing comprising 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 and at least the second orifices throughout the therapeutic pressure range, wherein the membrane is configured such that the pressurized volume... An increase in internal pressure causes the membrane to restrict a first ventilation flow through at least a first orifice throughout the treatment pressure range, and wherein the restriction of the first ventilation flow through at least a first orifice causes an increase in a second ventilation flow through at least a second orifice, such that the ventilation flow through at least the first orifice and at least the second orifice is approximately constant throughout the treatment pressure range, and the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a pressurized gas flow through the inlet port of the inflation chamber, or the patient interface is configured such that the patient's mouth is uncovered.

[0115] In the example, (a) the ventilation housing may include an outer wall and an inner wall, the inner wall defining an inlet for the therapeutic gas flow, and a base may be positioned between the outer and inner walls; (b) the flushing flow rate may be greater than or equal to the sum of the first ventilation flow rate and the second ventilation flow rate; (c) the membrane may elastically deform toward the base during use, such that the first ventilation flow rate is restricted when the membrane deflects toward the base; (d) the membrane may be configured to deflect closer to the base when the therapeutic pressure increases above a threshold therapeutic pressure value; (e) the membrane may be configured to reduce the first ventilation flow rate, such that the second ventilation flow rate increases when the membrane deflects 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) at least one first orifice may include a plurality of inner orifices, and 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; and (i) the membrane may be supported. Above a plurality of internal orifices on the outer base and membrane spacer, (j) the ventilation housing may include a base spacer between the inner base and the outer base, and the membrane may be supported above a plurality of internal orifices on the base spacer and membrane spacer, (k) the outer base may include a plurality of lateral membrane supports configured to prevent the membrane from covering the plurality of external orifices, (l) the membrane may comprise an elastically deformable material, (m) the elastically deformable material may include silicone, (n) the ventilation housing may be formed from a single uniform piece of a 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 housing such that the membrane is free to move toward and away from the base, and / or (s) the patient interface may include a ventilation connection tube or decoupling junction to fluidly connect the ventilation system to the inflation chamber.

[0116] Another aspect of this technology relates to a patient interface that may include: an inflatable chamber pressurizable to a therapeutic pressure at least 6 cm H2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow at the therapeutic pressure for patient breathing; a sealing structure configured and arranged to form a seal with a patient facial region around an inlet in the patient's airway, such that an airflow at the therapeutic pressure is delivered at least to the inlet of the patient's nostrils, the sealing structure being configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use; a positioning and stabilizing structure to provide a resilient force to hold the sealing structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a tether configured and arranged such that at least a portion of the patient's head covers an area of ​​the patient's head above an auricular base point, and a portion of the tether is sized and configured to engage a portion of the patient's head in a parietal region during use, wherein the positioning and stabilizing structure has a non-rigidly decoupled portion; and a ventilation system to provide ventilation air. The ventilation system includes a ventilation housing that expels exhaled gas from a pressurized volume, the ventilation flow being continuous during respiratory therapy, the ventilation flow including a first ventilation flow and a second ventilation flow, the ventilation system comprising: a ventilation housing including 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 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 the therapeutic pressure range, wherein the membrane is configured to elastically deform according to pressure within the pressurized volume, such that increased deformation due to increased pressure reduces the first ventilation flow through the first ventilation orifice and increases the second ventilation flow through the at least second ventilation orifice to maintain a substantially constant ventilation flow throughout the therapeutic pressure range, and wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of pressurized gas flow through the inlet port of the inflation chamber, or the patient interface is configured such that the patient's mouth is uncovered.

[0117] In the example, (a) the ventilation housing may include an outer wall and an inner wall, the inner wall defining an inlet for the therapeutic gas flow, and a base may be positioned between the outer and inner walls; (b) the flushing flow rate may be greater than or equal to the sum of the first ventilation flow rate and the second ventilation flow rate; (c) the membrane may elastically deform toward the base during use, such that the first ventilation flow rate is restricted when the membrane deflects toward the base; (d) the membrane may be configured to deflect closer to the base when the therapeutic pressure increases above a threshold therapeutic pressure value; (e) the membrane may be configured to reduce the first ventilation flow rate, such that the second ventilation flow rate increases when the membrane deflects 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) at least one first orifice may include a plurality of inner orifices, and 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; and (i) the membrane may be supported. Above a plurality of internal orifices on the outer base and membrane spacer, (j) the ventilation housing may include a base spacer between the inner base and the outer base, and the membrane may be supported above a plurality of internal orifices on the base spacer and membrane spacer, (k) the outer base may include a plurality of lateral membrane supports configured to prevent the membrane from covering the plurality of external orifices, (l) the membrane may comprise an elastically deformable material, (m) the elastically deformable material may include silicone, (n) the ventilation housing may be formed from a single uniform piece of a 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 housing such that the membrane is free to move toward and away from the base, and / or (s) the patient interface may include a ventilation connection tube or decoupling junction to fluidly connect the ventilation system to the inflation chamber.

[0118] Another aspect of this technology relates to a ventilation assembly for a respiratory pressure therapy (RPT) system, for providing a pressurized gas flow from an RPT device to a patient interface at a therapeutic pressure at least 6 cmH2O higher than ambient air pressure to treat respiratory symptoms. The ventilation assembly includes: a ventilation housing having a first orifice configured to receive the pressurized gas flow from the RPT device and having a plurality of orifices to discharge the pressurized gas to the atmosphere; a ventilation housing connector having a second orifice; a tube connected at the second orifice to the ventilation housing connector, the tube being configured to connect to a patient interface to direct the pressurized gas flow to the patient interface; and a heat and moisture exchanger (HME) including an HME housing and HME material within the HME housing, wherein the ventilation housing and the ventilation housing connector are configured to be at least partially connected to form a cavity, and wherein the HME is positioned within the cavity when the ventilation assembly is assembled.

[0119] Another aspect of this technology relates to an RPT system. The RPT system includes: a ventilation assembly; an RPT device configured to generate a pressurized gas flow; a patient interface configured to deliver the pressurized gas flow to a patient's airway, the patient interface being non-ventilated; and a delivery conduit configured to deliver the pressurized gas flow from the RPT device to the ventilation assembly.

[0120] In the examples of the ventilation assembly and RPT system described in the above two paragraphs, (a) the ventilation assembly may further include an annular lip extending from the inner periphery of the ventilation housing and at least one retaining protrusion extending from the annular lip; (b) the ventilation assembly may further include an annular recess extending around the outer periphery of the HME housing, and the at least one retaining protrusion and the annular recess are configured to removably attach the HME housing to the ventilation housing; (c) the HME housing is removably attached to the ventilation housing via a snap-fit ​​engagement; (d) the HME housing may include a patient-side HME housing portion and an atmospheric-side HME housing portion, and the ventilation assembly may be configured such that the patient-side HME housing portion is positioned closer to the patient in use than the atmospheric-side HME housing portion; (e) the annular recess may be disposed on the atmospheric-side HME housing portion; (f) the ventilation housing may further include an annular surface surrounding a first orifice and a plurality of holes passing through the annular surface, and the ventilation assembly may include positioning adjacent to the annular surface. The membrane may be movable such that when the pressure of the pressurized gas within the ventilation assembly increases, the membrane is pushed against the annular surface of the ventilation housing; (g) the plurality of orifices may include a first set of orifices and a second set of orifices, the first set of orifices being proximal to the first orifice relative to the second set of orifices; (h) the shape and size of the membrane may be designed such that the membrane does not cover the first set of orifices; (i) the membrane may be configured to cover more of the second set of orifices when the pressure of the pressurized gas within the ventilation assembly increases; (j) the first set of orifices is positioned upstream of the second set of orifices relative to the pressurized gas flow; (k) the ventilation assembly may also include a retaining structure to hold the membrane in a position adjacent to the annular surface of the ventilation housing; (l) the membrane may also comprise an elastic material; (m) each of the plurality of orifices may have a shape converging from the inner surface of the ventilation housing to the outer surface of the ventilation housing; (n) the HME comprising the HME housing and HME material is removable from the cavity; and / or (o) the respiratory therapy system does not include a humidifier.

[0121] Another aspect of this technology relates to a ventilation system used with a patient interface during patient respiratory therapy using a therapeutic flow of pressurized gas at a pressure above ambient, the ventilation system providing a ventilation gas flow to expel the patient's exhaled gas from the pressurized volume, the ventilation gas flow being continuous during the respiratory therapy. The ventilation system includes: a 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; a ventilation housing connector having a second orifice configured to direct the therapeutic gas flow to a patient interface; and a heat and moisture exchanger (HME) including an HME housing and HME material within the HME housing, and a membrane positioned adjacent to the base, wherein the ventilation housing and the ventilation housing connector are configured to be at least partially connected to form a cavity, and wherein, when the ventilation assembly is assembled, the HME is positioned in the cavity, wherein the pressurized volume is in fluid communication with the atmosphere through at least one first orifice and at least one second orifice throughout the therapeutic pressure range, and wherein the membrane is capable of elastically deforming due to pressure within the pressurized volume to distribute the ventilation gas flow between the at least one first orifice and the at least one second orifice throughout the therapeutic pressure range.

[0122] Another aspect of this technology relates to a patient interface. The patient interface includes: a sealing structure; an inflatable chamber coupled to the sealing structure; a positioning and stabilizing structure for securing the patient interface to the patient during use; and a ventilation system.

[0123] In the examples of the ventilation system and patient interface described in the above two paragraphs, (a) the ventilation system may further include an annular lip extending from the inner periphery of the ventilation housing and at least one retaining protrusion extending from the annular lip; (b) the ventilation system may further include an annular recess extending around the outer periphery of the HME housing, and the at least one retaining protrusion and the annular recess may be configured to removably attach the HME housing to the ventilation housing; (c) the HME housing may be removably attached to the ventilation housing via a snap-fit ​​engagement; and (d) the HME housing may include a patient-side HME housing portion. (e) The ventilation assembly may include an atmospheric-side HME housing portion and an atmospheric-side HME housing portion, and the patient-side HME housing portion may be configured such that the patient-side HME housing portion is positioned closer to the patient than the atmospheric-side HME housing portion during use; (f) the annular recess may be provided in the atmospheric-side HME housing portion; (g) the ventilation housing may include an outer wall and an inner wall, the inner wall defining an inlet for the therapeutic gas flow, and the base is positioned between the outer wall, the inner wall, and the base; (h) the base may further include an inner base and an outer base; (h) 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. (i) the at least one first orifice may further include a plurality of inner orifices, and the at least one second orifice may further include a plurality of outer orifices; (j) 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; (k) the membrane may comprise an elastically deformable material; (l) the elastically deformable material may include silicone resin; (m) the venting housing may be formed from a single uniform piece of a relatively rigid material; (n) the relatively rigid material may be polycarbonate; (o) the outer wall, the inner wall, the inner base, the outer base, and the membrane may be circular; (p) the outer wall, the inner wall, the inner base, the outer base, and the membrane may be concentric; (q) the membrane may not be attached to the venting housing, such that the membrane can move freely toward and away from the base; (r) the venting system may further include a venting connection pipe or decoupling structure to fluidly connect the venting system to the inflation chamber, and / or the HME comprising the HME housing and the HME material may be removed from the cavity.

[0124] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0125] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions

[0127] This technology is illustrated by way of example and not limitation in the figures, and similar reference numerals in the figures refer to similar elements, including:

[0128] 4.1 Treatment System

[0129] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown.

[0130] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0131] Figure 1C A system is shown in which a patient 1000 wearing a patient interface 3000 in a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0132] 4.2 Respiratory System and Facial Anatomy

[0133] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0134] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0135] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0136] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, subnasal septum, upper lip, lower lip, supramental point, nasal ridge, nasal alar apex, supraauricular base, and subauricular base. The vertical and anteroposterior directions are also marked.

[0137] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0138] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and sagittal plane.

[0139] Figure 2G A side view showing the surface features of the nose.

[0140] 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.

[0141] Figure 2I An anatomical view of the nose is shown, approximately a few millimeters from the sagittal plane, including, among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0142] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0143] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0144] Figure 2L The frontal lateral view of the nose is shown.

[0145] 4.3 Patient Interface

[0146] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0147] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0148] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0149] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a zero value.

[0150] Figure 3E A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0151] Figure 3F A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0152] Figure 3G A cushion for a face mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0153] Figure 3H The pad used for the face mask is shown. The outer surface of the pad 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-shaped areas and one dome-shaped area are indicated.

[0154] 4.4 RPT device

[0155] Figure 4A An RPT device of one form according to the present technology is shown.

[0156] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to this technology. The upstream and downstream directions are indicated.

[0157] Figure 4C This is a schematic diagram of the electrical components of one form of RPT device according to the present technology.

[0158] Figure 4D This is a schematic diagram of an algorithm implemented in one form of RPT device according to the present technology.

[0159] Figure 4E This is an illustration of one form according to the present technology. Figure 4D A flowchart of the methods performed by the treatment engine module.

[0160] 4.5 Humidifier

[0161] Figure 5AThis is an isometric view of one form of humidifier according to this technology.

[0162] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, which shows the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0163] Figure 5C A schematic diagram of one form of humidifier according to the present technology is shown.

[0164] 4.6 Ventilation adapter

[0165] Figure 6A A side view of a fluid connector with a first end and a second end that mate with each other is shown.

[0166] Figure 6B A side cross-sectional view of a fluid connector having a first end and a second end that are detached from each other is shown.

[0167] Figure 6C A side cross-sectional view of a fluid connector having a first end and a second end that mate with each other is shown.

[0168] Figure 6D A perspective view of a fluid connector having a first end and a second end that are separate from each other is shown, with the interior of the first end visible.

[0169] Figure 6E A cross-sectional view of a fluid connector with an additional fluid port is shown.

[0170] Figure 6F A fluid connector is shown, wherein a first end and a second end are connected together and the first end is integrated into an RTP device.

[0171] Figure 6G A fluid connector is shown, wherein the first end and the second end are disconnected and the first end is integrated into the RTP device.

[0172] Figure 6H A perspective view of a fluid connector with a first end and a second end that are separated from each other is shown, with the sealing surface of the second end visible.

[0173] Figure 7A A perspective view of a ventilation adapter according to an example of the present technology is shown.

[0174] Figure 7B A side view of a ventilation adapter according to an example of the present technology is shown.

[0175] Figure 7C A top view of a ventilation adapter according to an example of this technology is shown.

[0176] Figure 7D An example of a ventilation adapter according to the present technology is shown. Figure 7C A cross-sectional view taken from line 7D-7D.

[0177] Figure 7E An exploded view of a ventilation adapter according to an example of the present technology is shown.

[0178] Figure 7F Another exploded view of a ventilation adapter according to an example of the present technology is shown.

[0179] Figure 8A A perspective view of a ventilated housing according to an example of the present technology is shown.

[0180] Figure 8B Another perspective view of a ventilated housing according to an example of the present technology is shown.

[0181] Figure 8C A side view of a ventilated housing according to an example of the present technology is shown.

[0182] Figure 8D Another side view of a vent housing according to an example of the present technology is shown.

[0183] Figure 8E A top view of a ventilated housing according to an example of the present technology is shown.

[0184] Figure 8F An example of a ventilated housing according to the present technology is shown. Figure 8E A cross-sectional view taken from line 8F-8F.

[0185] Figure 9A A perspective view of a vent housing connector according to an example of the present technology is shown.

[0186] Figure 9B Another perspective view of a vent housing connector according to an example of the present technology is shown.

[0187] Figure 9C A side view of a vent housing connector according to an example of the present technology is shown.

[0188] Figure 9D Another side view of a vent housing connector according to an example of the present technology is shown.

[0189] Figure 9E A top view of a vent housing connector according to an example of this technology is shown.

[0190] Figure 10A A perspective view of a bellows seal according to an example of the present technology is shown.

[0191] Figure 10B Another perspective view of a bellows seal according to an example of the present technology is shown.

[0192] Figure 10C A side view of a bellows seal according to an example of the present technology is shown.

[0193] Figure 10D Another side view of a bellows seal according to an example of the present technology is shown.

[0194] Figure 10E A bottom view of a bellows seal according to an example of the present technology is shown.

[0195] Figure 11A A perspective view of a ventilation adapter connector according to an example of the present technology is shown.

[0196] Figure 11B Another perspective view of a ventilation adapter connector according to an example of the present technology is shown.

[0197] Figure 11C A side view of a ventilation adapter connector according to an example of the present technology is shown.

[0198] Figure 11D Another side view of a ventilation adapter connector according to an example of this technology is shown.

[0199] Figure 11E A bottom view of a ventilation adapter connector according to an example of this technology is shown.

[0200] Figure 12A A perspective view of a heat and moisture exchanger (HME) clip according to an example of the present technology is shown.

[0201] Figure 12B A side view of a heat and moisture exchanger (HME) clip according to an example of the present technology is shown.

[0202] Figure 12C Another side view of a heat and moisture exchanger (HME) clip according to an example of the present technology is shown.

[0203] Figure 12D Another side view of a heat and moisture exchanger (HME) clip according to an example of the present technology is shown.

[0204] Figure 13A A perspective view of the housing of a heat and moisture exchanger (HME) according to an example of the present technology is shown.

[0205] Figure 13BA side view of the housing of a heat and moisture exchanger (HME) according to an example of the present technology is shown.

[0206] Figure 13C Another side view of the heat and moisture exchanger (HME) housing according to an example of the present technology is shown.

[0207] Figure 13D A top view of the housing of a heat and moisture exchanger (HME) according to an example of the present technology is shown.

[0208] Figure 14A A perspective view of a catheter connector according to an example of the present technology is shown.

[0209] Figure 14B A top view of a catheter connector according to an example of this technology is shown.

[0210] Figure 14C A side view of a catheter connector according to an example of the present technology is shown.

[0211] Figure 14D A front view of a catheter connector according to an example of this technology is shown.

[0212] Figure 15A A perspective view of a ventilation adapter according to an example of the present technology is shown.

[0213] Figure 15B Another perspective view of a ventilation adapter according to an example of the present technology is shown.

[0214] Figure 15C An exploded view of a ventilation adapter according to an example of the present technology is shown.

[0215] Figure 15D An exploded view of a ventilation adapter according to an example of the present technology is shown.

[0216] Figure 15E A side view of a ventilation adapter according to an example of the present technology is shown.

[0217] Figure 15F An example of a ventilation adapter according to the present technology is shown. Figure 15B A cross-sectional view taken from line 15F-15F.

[0218] Figure 16 The graph shows the airflow from the full-face mask according to this technology within the therapeutic pressure range, compared to the airflow from the constant flow ventilation port (CFV).

[0219] Figure 17 A diagram of a patient receiving treatment according to an example of this technology is shown.

[0220] Figure 18 The graph shows the airflow from the full-face mask according to this technology within the therapeutic pressure range, compared to the airflow from the constant flow ventilation port (CFV).

[0221] Figure 19 The graphs show the airflow rates from constant flow ventilation (CFV) only, passive ventilation only, and both, according to this technique within the therapeutic pressure range.

[0222] Figure 20 An example of a constant flow vent (CFV) membrane according to an example of the present technology is shown.

[0223] Figure 21A A cross-sectional view of a ventilation adapter according to an example of the present technology is shown.

[0224] Figure 21B An exploded view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0225] Figure 21C A rear view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0226] Figure 21D A perspective view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0227] Figure 21E Another perspective view of a constant flow vent (CFV) of a ventilation adapter according to an example of the present technology is shown.

[0228] Figure 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.

[0229] Figure 22 An exploded view of a ventilation adapter according to an example of the present technology is shown.

[0230] Figure 23 A diagram illustrating an exemplary patient interface according to this technology is shown.

[0231] Figure 24A A cross-sectional view of a ventilation adapter according to an example of the present technology is shown.

[0232] Figure 24B A perspective view of a ventilation adapter according to an example of the present technology is shown.

[0233] Figure 25AA cross-sectional view of an HME 7000 comprising a single layer 7001 is shown according to one aspect of the present technology.

[0234] Figure 25B An example of a single-corrugated horizontal 7030 of the HME 7000 according to one aspect of the present technology is shown.

[0235] Figure 25C This is a schematic diagram showing an HME 7000 comprising multiple layers 7001 stacked along the vertical and horizontal axes.

[0236] Figure 25D The diagram shows an HME under preload to compress corrugations in a fixed volume, thereby increasing the number of layers 7001 within the fixed volume.

[0237] Figure 25E A corrugated structure 7002 is shown, which includes multiple corrugations 7030, wherein the corrugated structure is rolled to form HME 7000.

[0238] Figure 26 The orifice, diffuser, and barrier are depicted as part of the gas flushing vent.

[0239] Figure 27 An orifice, a diffuser, and a barrier are depicted as part of a gas flushing vent, wherein the barrier has an orifice.

[0240] Figure 28 An exploded view depicts the orifice, diffuser, and barrier components that form part of a gas flushing vent that is circularly formed around a central hole.

[0241] Figure 29 A simplified view depicts the orifice, diffuser, and barrier that form part of a gas flushing vent that is circularly formed around a central hole.

[0242] Figure 30 Depicting through Figure 29 A cross-sectional view taken from line 30-30.

[0243] Figure 31A A partial view of a bend with a gas flushing vent having an annular outlet is depicted.

[0244] Figure 31B Depicting Figure 31B Axial view of the orifice in the gas flushing vent.

[0245] Figure 31C Depicting through Figure 31A The figure is a cross-sectional view taken from a plane, which is equivalent to... Figure 31BThe plane marked as 31C-31C.

[0246] Figure 32A A bend with a ball joint and a gas flushing vent is depicted.

[0247] Figure 32B yes Figure 32A An exploded view of the bent pipe.

[0248] Figure 32C This is a side view of the bent pipe.

[0249] Figure 32D Depicting through Figure 32C A cross-sectional view taken from line 32D-32D.

[0250] Figure 33A A perspective view of a ventilation adapter according to an example of the present technology is depicted.

[0251] Figure 33B Another perspective view depicting a ventilation adapter according to an example of the present technology is shown.

[0252] Figure 33C A top view of a ventilation adapter according to an example of the present technology is depicted.

[0253] Figure 33D A lower view of a ventilation adapter according to an example of the present technology is depicted.

[0254] Figure 33E A side view of a ventilation adapter according to an example of the present technology is depicted.

[0255] Figure 33F An example of a ventilation adapter according to the present technology is shown. Figure 33C A cross-sectional view taken from line 33F-33F.

[0256] Figure 33G A cross-sectional view of a ventilation adapter with a heat and humidity exchanger (HME) housing according to an example of the present technology is depicted, the cross-section being along... Figure 33C The line was cut off at 33F-33F.

[0257] Figure 33H A cross-sectional view of a ventilation adapter with a heat and humidity exchanger (HME) housing according to an example of the present technology is depicted, the cross-section being along... Figure 33C The line was cut off at 33F-33F.

[0258] Figure 33I An exploded view of a ventilation adapter according to an example of the present technology is depicted.

[0259] Figure 34AA perspective view is depicted of a ventilation component for a ventilation adapter according to an example of the present technology.

[0260] Figure 34B Another perspective view depicts a ventilation component for a ventilation adapter according to an example of the present technology.

[0261] Figure 34C A rear view of the ventilation assembly for a ventilation adapter according to an example of the present technology is depicted.

[0262] Figure 34D A front view of a ventilation component for a ventilation adapter according to an example of the present technology is depicted.

[0263] Figure 34E A side view of a ventilation component for a ventilation adapter according to an example of the present technology is depicted.

[0264] Figure 34F A ventilation assembly for a ventilation adapter according to an example of the present technology is shown. Figure 34C A cross-sectional view taken from line 34F-34F.

[0265] Figure 34G An exploded view of the ventilation assembly for a ventilation adapter according to an example of the present technology is depicted.

[0266] Figure 35 A perspective view of a ventilation adapter with a patient interface according to an example of the present technology is depicted.

[0267] Figure 36A A perspective view of an air circuit according to an example of this technology is depicted.

[0268] Figure 36B Another perspective view depicting an air circuit according to an example of this technology is shown.

[0269] Figure 36C An exploded view of an air circuit according to an example of this technology is depicted.

[0270] Figure 37A A perspective view of a ventilation adapter according to an example of the present technology is depicted.

[0271] Figure 37B Another perspective view depicting a ventilation adapter according to an example of the present technology is shown.

[0272] Figure 37C A side view of a ventilation adapter according to an example of the present technology is depicted.

[0273] Figure 37D An example of a ventilation adapter according to this technology is depicted. Figure 37BA cross-sectional view taken from 37D-37D.

[0274] Figure 37E An exploded view of a ventilation adapter according to an example of the present technology is depicted.

[0275] Figure 38A A perspective view of a heat and moisture exchanger (HME) housing according to an example of the present technology is depicted.

[0276] Figure 38B Another perspective view of an HME housing according to an example of this technology is depicted.

[0277] Figure 38C An exploded view of an HME housing according to an example of the present technology is depicted.

[0278] Figure 39A A perspective view of a heat and moisture exchanger (HME) housing according to an example of the present technology is depicted.

[0279] Figure 39B Another perspective view of an HME housing according to an example of this technology is depicted.

[0280] Figure 39C An exploded view of an HME housing according to an example of the present technology is depicted.

[0281] Figure 40 A perspective view of a ventilation adapter with a patient interface according to an example of the present technology is depicted.

[0282] Figure 41 A perspective view of a ventilation adapter with a patient interface according to an example of the present technology is depicted.

[0283] Figure 42A A top perspective view of a ventilated housing according to an example of the present technology is shown.

[0284] Figure 42B A top view of a vent housing according to another example of this technology is shown.

[0285] Figure 42C A bottom view of a vent housing according to another example of the present technology is shown.

[0286] Figure 42D A bottom perspective view of a vent housing according to another example of the present technology is shown.

[0287] Figure 42E A side view of a vent housing according to another example of the present technology is shown.

[0288] Figure 42F The ventilation housing shown is another example of the present technology. Figure 42B A cross-sectional view taken from line 42F-42F.

[0289] Figure 42G The ventilation housing shown is another example of the present technology. Figure 42B A cross-sectional view taken from line 42G-42G.

[0290] Figure 43A A top perspective view of a vent system according to an example of the present technology is shown.

[0291] Figure 43B A top view of a vent system according to another example of this technology is shown.

[0292] Figure 43C A top view of a vent system according to another example of this technology is shown.

[0293] Figure 43D A bottom perspective view of a vent system according to another example of the present technology is shown.

[0294] Figure 43E A side view of a vent system according to another example of the present technology is shown.

[0295] Figure 43F A vent system according to another example of the present technology is shown. Figure 43B A cross-sectional view taken from line 43F-43F.

[0296] Figure 43G A vent system according to an example of the present technology is shown. Figure 43B A cross-sectional view taken from line 43G-43G. 5. Detailed Implementation

[0298] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific instances described herein, and the specific instances described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific instances described herein only and is not intended to be limiting.

[0299] The following description is provided in relation to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. In addition, in any instance, any single feature or combination of features may constitute another instance.

[0300] 5.1 Treatment

[0301] In one form, the technology includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the airway inlet of a patient 1000.

[0302] In some instances of this technique, positive pressure air is supplied to the patient's nasal passages through one or both nostrils.

[0303] In some instances of this technology, mouth breathing is limited, restricted, or prevented.

[0304] 5.2 Treatment System

[0305] In one form, the technology includes a device or apparatus for treating respiratory disorders. The device or apparatus may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000.

[0306] 5.3 Patient Interface

[0307] According to one aspect of the present technology, the noninvasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an air vent 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around the inlet of the patient's airway to facilitate the supply of positively pressurized air to the airway.

[0308] 5.3.1 Sealing Formation Structure

[0309] In one form of this technology, the sealing forming structure 3100 provides a sealing forming surface and may additionally provide a cushioning function.

[0310] The sealing structure 3100 according to this technology can be constructed from a soft, flexible and resilient material such as silicone.

[0311] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the circumference. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use. In use, the sealing flange is readily responsive to system pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight sealing engagement with the surface.

[0312] In one embodiment, the sealing portion of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0313] A nasal pillow according to one aspect of the present technology includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow connection structure of the present technology includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate a universal connection structure that can adapt to relative movement of both the truncated cone and the nasal pillow connection structure in terms of displacement and angle. For example, the position of the truncated cone can be axially moved toward the handle connection structure.

[0314] In one embodiment, the non-invasive patient interface 3000 includes a sealing forming portion that, in use, forms a seal on the upper lip region (i.e., the upper lip) of the patient's face.

[0315] In one embodiment, the non-invasive patient interface 3000 includes a sealing portion that forms a seal on the chin region of the patient's face during use.

[0316] 5.3.2 Inflation Chamber

[0317] In the area formed during use, the air chamber 3200 has a periphery shaped to complement the surface contours of a normal person's face. During use, the boundary edges of the air chamber 3200 are positioned very close to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 can extend along the entire periphery of the air chamber 3200 during use.

[0318] 5.3.3 Positioning and Stabilizing Structure

[0319] The sealing structure 3100 of the patient interface 3000 of this technology can be kept in a sealed state during use by positioning and stabilizing structure 3300.

[0320] In one form of this technology, a positioning and stabilization structure 3300 is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one example, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one example, the positioning and stabilization structure 3300 includes at least one strap with a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0321] In one form of this technology, the positioning and stabilizing structure 3300 includes a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0322] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For example, the strap may be configured to be taut during use and to guide forces to create a sealed contact between the pad and a portion of the patient's face. In one instance, the strap may be configured as a tie.

[0323] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible and, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on it while sleeping.

[0324] 5.3.4 Vent

[0325] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0326] One form of the vent 3400 according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0327] The vent 3400 may be located in the inflation chamber 3200. Alternatively, the vent 3400 may be located in a decoupling structure, such as a rotating shaft.

[0328] 5.3.5 Decoupling Structure

[0329] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball head and a ball socket.

[0330] 5.3.6 Connection Port

[0331] Connection port 3600 allows connection to air circuit 4170.

[0332] 5.3.7 Forehead Stent

[0333] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0334] 5.3.8 Anti-asphyxiation valve

[0335] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0336] Port 5.3.9

[0337] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to supply supplemental oxygen. In one embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0338] 5.4 Ventilation adapter

[0339] 5.4.1 Constant flow vent

[0340] Figure 16 This illustrates a comparison of ventilation flow rates between a standard vent (FFM nominal flow rate) and a constant flow vent (CFV). A standard vent is a standard molded vent, for example, formed on... Figure 3A The patient interface 3000 is connected to the ventilation port 3400. As can be seen in the figure, the ventilation flow rate is compared within the mask pressure range of 4-20 cm H2O, which is the standard pressure range for SDB and OSA respiratory pressure therapy. It can be seen that the ventilation flow rate increases logarithmically with increasing pressure. In contrast, CFV shows a flatter curve, where the ventilation flow rate appears to be more constant and lower within the same pressure range.

[0341] The ventilation flow rate should be at least 16 L / min to flush sufficient CO2 from the system, minimizing CO2 rebreathing by the patient. It has been shown that ventilation flow rates between 20 and 27 L / min provide respiratory comfort (no increased patient arousal due to CO2 rebreathing) and safety (avoidance of asphyxiation due to excessive CO2 rebreathing). One aspect of this technique involves providing a minimum (or minimum range) ventilation flow rate to ensure sufficient CO2 is flushed out. Any ventilation flow rate exceeding the minimum can be considered wasteful. For example, when viewing… Figure 16As shown in the graph, the area between the CFV ventilation flow rate and the FFM nominal flow rate can be considered wasted flow. The CFV achieves the required minimum ventilation flow rate of 16 L / min within the treatment pressure range and maintains this flow rate between 16-27 L / min within a pressure range of 4-20 cm H2O. In contrast, the FFM nominal flow rate ranges from 22-55 L / min. Therefore, using the FFM nominal flow rate may result in greater unnecessary flow loss.

[0342] To compensate for unnecessary flow loss, an airflow generator or RPT device might be needed to increase its flow rate to achieve the same pressure as a CFV. Therefore, more power and a more complex airflow generator are required to allow for a larger flow rate swing (e.g., between 16-55 L / min) to compensate for the vent. However, a CFV can adjust the ventilation flow rate according to pressure changes, decreasing the flow rate as pressure increases. Therefore, a CFV can achieve greater power savings with an airflow generator and is simpler due to the avoidance of the need for complex pressure / flow control.

[0343] According to this technology, a constant flow vent (CFV) can be a flow rate regulating valve (movable diaphragm) 9140 that responds to mask pressure to regulate the flow rate. An exemplary CFV is... Figure 21A-21F As depicted, valve 9140 can be adjusted to maintain a relatively constant flow rate within a predetermined pressure range. That is, when the pressure in the mask / system increases, valve 9140 covers more of the internal vent 9126 to reduce the ventilation flow rate (the ventilation flow rate increases at higher pressures); when the pressure in the mask / system is lower, valve 9140 covers fewer vents and achieves a greater ventilation flow rate (compensating for lower ventilation flow rates at lower pressures). This adjustment allows for a substantially constant ventilation flow rate within a pressure range. Figure 18 The graph in the figure shows the change in flow rate under pressure variation with and without CFV. Figure 18 The performance of the exemplary CFV, represented by the graph, has a flow rate of up to 24 L / min as the pressure increases from 0-40 cm H2O.

[0344] According to one embodiment of the present technology, the CFV may include a movable valve flap or diaphragm CFV 9140 and may be made of an elastic material, such as silicone or other TPEs (thermoplastic elastomers). The valve flap 9140 may be configured such that an increase in pressure within the mask causes the valve flap to cover more of the internal vent hole 9126 and gradually reduce the flow rate. The valve flap 9140 may be positioned perpendicular to the flow of pressurized gas toward the patient. The ventilation passage of the internal vent hole 9126 may also be perpendicular to the flow and travel away from the patient to exhaust to the atmosphere. The valve flap 9140 is positioned such that pressure accumulated within the mask causes the valve flap to move toward the internal vent hole 9126.

[0345] Figure 21F An exemplary CFV configuration in cross-section is shown. CFV units can be arranged in a row (i.e., within the air delivery duct loop). Figure 21F As shown, if pressure accumulates in the mask, the position of valve 9140 allows it to move toward the internal vent 9126. Pressurized gas reaching the internal vent 9126, which is not blocked by valve 9140, can then be released to the atmosphere through the external vent 9125.

[0346] The CFV is characterized by its ability to simplify the RPT system. The essentially constant ventilation flow rate within the pressure range means that the complexity of the airflow generator or RPT device can be reduced, as extensive pressure control is no longer required to compensate for pressure losses due to variations in ventilation. Furthermore, the CFV reduces power consumption because it eliminates the need for power to compensate for flow rate variations at different pressures. That is, the CFV passively (pressure-driven) regulates pressure and is able to adjust pressure in response to changes in ventilation flow rate that would otherwise be actively compensated for by changes in pressure / flow rate delivery from the RPT device. This simplification allows for simpler RPT devices 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 (due to the fact that it does not need to compensate for changes in ventilation flow rate). The CFV can also allow for passive humidification via a heat and moisture exchanger (HME), as described below.

[0347] One problem with the known CFV concept is the potential for associated noise when regulating the ventilation flow rate. There may be some interaction between the valve disc 9140 and the internal vent 9126, which can interfere with the ventilation flow rate and cause noise. For example, suppose that when moving under pressure, the movable valve disc 9140 does not completely cover some of the internal vent 9126. This interaction can lead to turbulence and associated noise as gas flows between the valve disc 9140 and the internal vent 9126.

[0348] One way to reduce turbulence and thus noise is to reduce the number of orifices 9126 interacting with the valve disc 9140. However, a minimum ventilation flow rate is required to prevent CO2 rebreathing from the mask, and reducing the number of vents 9126 interacting with the valve disc 9140 may not allow sufficient ventilation. Therefore, a solution according to this technology could involve having some vents 9126 regulated by the radial disc valve disc 9140, while other vents 9126 do not engage with the valve disc 9140 and remain open at all times. Having some vents 9126 always open, i.e., static vents, means, according to Bernoulli's equation, that the ventilation flow rate will increase with increasing pressure in the system.

[0349] To compensate for this increased ventilation flow rate and keep the total ventilation flow rate substantially constant within the treatment pressure range, the remaining vents, i.e., the adjustable vents, can have their ventilation flow rate reduced as pressure increases. These vents 9126 can be adjusted via a movable valve 9140, in which the vents 9126 are gradually covered as pressure increases, thereby reducing the ventilation flow rate. The overall flow rate of the static vents can then be averaged with the flow rate of the adjustable vents to achieve a substantially constant overall flow rate within the treatment pressure range. The lower noise level of ventilation can also be attributed to the molded vent technology, which generates low levels of noise as pressure and ventilation flow rate increase (e.g., by molding small vents with a converging shape). This technology, combined with adjustable vents, provides a low-overall-noise alternative to constant-flow vents.

[0350] The vent 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 vent housing 9120. The CFV ring 9150 may hold the valve 9140 in place against a vent hole 9126. The vent housing 9120 may include an annular surface having a plurality of vent holes 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 vent holes 9126 to allow airflow. The valve 9140 may be adjacent to the vent hole 9126 and may be freely held, i.e., sandwiched between the CFV ring 9150 and the annular surface of the vent housing 9120, i.e., the valve disc 9140 is not fixed to the CFV ring 9150 or the vent housing 9120. When the mask pressure increases, this increases the pressure toward the vent, where valve 9140 is pushed toward vent 9126 and covers more of vent 9126. Conversely, when the mask pressure decreases, a smaller pressure is applied to valve 9140, so valve 9140 moves away from vent 9126 and covers less of vent 9126.

[0351] Reducing ventilation noise in a constant flow vent design can be achieved by altering the ventilation flow characteristics using a flow regulating valve or membrane 9140. However, compared to conventional molded or static vents, where the vent does not change form or shape during pressure variations, membrane 9140 can increase ventilation noise. This noise can be attributed to several factors, including: 1) changes in flow rate through the regulating vent when the vent 9126 opens or closes through membrane 9140, and / or 2) flow disturbances caused by membrane 9140, which generate noise, i.e., turbulence. For example, changing the direction of the ventilation flow may cause turbulence, which can lead to noise from multiple factors. This could be due to gas impacting the surface of the vent (vent wall or CFV membrane) 9140 or air passing through the surface of the vent (vent wall and / or membrane) 9140. Therefore, partially closing the vent 9126 can generate more noise due to factors 1) and / or 2) above.

[0352] As mentioned above, one aspect of this technology includes a vent with a substantially constant flow rate within a treatment pressure range (i.e., 4-20 cm H2O or 2-40 cm H2O). To meet the desired ventilation flow rate profile under pressure variations, the flow rate profile of the vent 9126 can be dynamically varied within the treatment pressure range. This can be accomplished by changing the size, number, and / or shape of the vents. Changing such characteristics may result in alterations to the gas flow characteristics through the vents, which can lead to increased ventilation noise. Using a molded vent technology that includes a converging vent shape, the noise of the ventilation flow can be minimized when gas is discharged from the vent to the atmosphere, i.e., when it converges from the inner vent 9126 to the outer vent 9125. However, it should be understood that the size, shape, or number of molded vents does not change under pressure variations. Therefore, a deformable diaphragm or valve 9140 that moves under pressure to close or open the vent can be used to alter the flow through the vent 9126. However, the deformable membrane or valve disc 9140 may generate undesirable noise levels due to the opening or closing of the vent 9126 through the membrane 9140 and / or due to the flow rate variation of the partially closed vent 9126 through the regulating vent.

[0353] This noise can be reduced by including a diaphragm valve 9140 that gradually closes the vent 9126 as pressure increases, wherein the valve 9140 is fixed at one end so that it deflects according to pressure changes. The problem with this technique is that the diaphragm 9140 may only partially close a given vent 9126, which could result in a high-speed flow between the vent 9126 and the diaphragm 9140. This generates noise as air passes over or collides with the surfaces of the vent 9126 and the diaphragm 9140.

[0354] This problem may be overcome by reducing the number of adjustable ventilators while maintaining a substantially constant overall ventilation flow rate across the treatment pressure range to reduce ventilation noise. Using molded ventilators (i.e., static ventilators) can maintain the desired noise level. However, these ventilators may not achieve the desired flow rate profile (i.e., a substantially constant flow rate across the treatment pressure range of 4–20 cm H₂O). This can be achieved by combining some adjustable ventilators with static ventilators to maintain a substantially constant overall ventilation flow rate across the treatment pressure range. Increasing the number of non-membrane-regulated static ventilators may result in a reduction in overall ventilation noise.

[0355] However, this introduction of molded vents may introduce new problems, making it difficult to ensure a substantially constant ventilation flow rate within the treatment pressure range using a combination of static and adjustable vents. Figure 16 As shown, the known ventilation flow characteristics of a molded static vent are logarithmic curves, where the ventilation flow rate increases with increasing pressure. To compensate for the flow rate of the static vent, the regulating vent should provide a reverse flow rate curve, where the ventilation flow rate decreases with increasing pressure. Therefore, the membrane 9140 of the regulating vent 9126 can be adjusted to provide this ventilation flow rate.

[0356] There are many methods to adjust the membrane 9140 to provide a venting flow rate that is the opposite of the logarithmic flow rate profile of the statically molded vent. For example, the shape / structure of the membrane 9140 can be changed to adjust the flow rate profile of the regulating vent, and the material of the membrane 9140 can be changed to adjust the flow rate profile of the regulating vent.

[0357] As in Figure 20 As shown, the annular disc structure of the CFV membrane 9140 allows the membrane 9140 to be adjusted in multiple ways to change the flow rate of the regulating vent. The flow rate of the regulating vent can be changed by the amount of vent 9126 covered / opened at a fixed pressure. A membrane 9140 covering more vents at a fixed pressure has a lower vent flow rate compared to a membrane covering fewer vents. The annular disc structure 9140 allows the membrane 9140 to be easily adjusted to cover varying amounts of vents at a fixed pressure. One possible implementation is by changing the diameter of the central orifice or by changing the width of the vent mating surface.

[0358] The overall dimensions of membrane 9140 are limited by the dimensions of the CFV unit housing 9120; however, it is desirable to minimize the size of the CFV. Therefore, the width of the vent engagement surface can be adjusted by regulating the size of the central orifice. Increasing the size of the central orifice results in a decrease in the width of the vent engagement surface. This decrease in width, in turn, reduces the surface area of ​​membrane 9140. A smaller surface area means less resistance to deformation under constant pressure, thus covering more vents under constant pressure compared to a wider membrane 9140 (i.e., more surface area). This principle holds true within a predetermined surface area range. That is, if the surface area is too small to provide sufficient surface area (i.e., the width of the vent engagement surface is too small), a greater force is required to deform membrane 9140 (i.e., the surface area is extremely small).

[0359] The thickness of membrane 9140 can also be varied to make it more easily deformable under a fixed pressure. For example, compared to a thicker membrane 9140 with the same shape under the same pressure, the thinner membrane 9140 is more easily deformable under a 15 cm H2O mask pressure.

[0360] The membrane 9140 can also be configured to move freely to cover the vent 9126 under a fixed pressure. For example, in related art, the membrane 9140 can be fixed at a point on, for example, the vent housing 9120 such that it is hinged relative to the fixed point, and the membrane 9140 will deflect about the fixed point due to pressure changes.

[0361] The design of the CFV membrane 9140, according to one example of this technology, allows it to move freely between the retaining structure and the vent surface. This configuration allows the membrane 9140 to be more easily adjusted to regulate the ventilation flow rate compared to a valve design, where the membrane is fixed at one end and moves relative to that fixed end.

[0362] A more flexible / compliant membrane 9140 can deform more easily under a fixed pressure / load, thus covering more vents 9126 compared to a stiffer membrane. Therefore, changing the material of membrane 9140 to a more flexible material (while maintaining the same dimensions and structure in other respects) would allow membrane 9140 to deform more easily under the same pressure to cover more vents 9126 and reduce ventilation flow. This, in turn, allows membrane 9140 to be tuned to provide the desired ventilation flow profile within the therapeutic pressure range.

[0363] As described above, various methods can be used to provide a membrane 9140 that responds to pressure within the target therapeutic range to provide a predetermined ventilation-flow profile, i.e., providing a substantially constant ventilation flow rate across a pressure range of 4–30 cm H2O. It may also be desirable to provide this constant ventilation flow rate while minimizing ventilation noise; one solution could be to maximize the number of static non-membrane-regulated ventilators and have a minimum number of membrane-regulated ventilators providing a substantially constant average total ventilation flow rate. This flow profile is determined by… Figure 19 The thicker solid line labeled "Passive Vent Only" is shown in the diagram. In this example, the dashed line represents a static, non-membrane-regulated vent, while the thinner solid line labeled "CFV and Passive Vent" represents the combined vent flow rate. Notably, as pressure increases, the vent flow rate of the static vent gradually increases, while the CFV membrane-regulated vent gradually decreases to a threshold value.

[0364] Another cause of noise can be attributed to ventilation flow interference caused by the CFV membrane 9140, which can also affect the airflow through the static ventilation port. In related technologies, the static ventilation port is positioned proximal to the CFV membrane-adjustable ventilation port, i.e., the ventilation orifice is located on the same surface of the CFV housing 9120. This also generates noise even for non-adjustable static ventilation ports because the membrane affects the flow characteristics of the static ventilation airflow. Therefore, it may be desirable to position the static ventilation port away from the CFV membrane-adjustable ventilation port so that the membrane 9140 does not affect the static ventilation airflow through it. In one example of this technology, the static ventilation orifice is positioned on the distal surface of the CFV-adjustable ventilation port. For example, the static ventilation orifice may be positioned on a different component than the CFV housing 9120. The positioning of static ventilation ports may be limited because they may also not be able to flush CO2. When the static ventilation port is positioned closer to the patient, the ability to flush CO2 increases. However, static ventilation ports can also be positioned on the opposite side of the HMX relative to the patient to prevent moisture loss during exhalation, as explained below.

[0365] 5.4.1.1 Ventilation housing

[0366] Figures 42A to 42G An example of a ventilation system 13400 according to an embodiment of the present technology is depicted. The ventilation system 13400 includes a ventilation housing 13401, which may include an outer wall 13402 and may define an outer periphery of the ventilation housing 13401. The ventilation housing 13401 may also include an inner wall 13410, which may define an inlet for an inlet for a gas flow generated by the RPT device 4000 and directed to the inflation chamber 3200 and directed 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.

[0367] 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.

[0368] The outer base 13403 may include one or more external orifices 13404 radially distributed around the outer base 13403. These external orifices 13404 may pass entirely through the outer base 13403 to provide a flow path from the interior of the ventilation system 13400 to the atmosphere. The external orifices 13404 may be straight, i.e., perpendicular to the outer base 13403, or the external orifices 13404 may pass through the outer base 13403 in a curved or inclined path. The diameter of the external orifices 13404 may be constant along its length, or the diameter may vary. All external orifices 13404 may be identical, or some external orifices may differ from the others. The edges of the external orifices 13404 may have chamfered or rounded corners. The outer base 13403 may at least partially support the membrane 13430 to prevent the membrane 13430 from completely blocking the internal orifice 13407. Therefore, the outer base 13403 can extend upwards higher than the inner base 13406, for example, it can... Figures 42A to 42G As seen in the image.

[0369] The ventilation housing 13401 may further 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 may abut the membrane 13430 and prevent lateral movement of the membrane 13430 during use, thereby covering the outer orifice 13404. As will be explained below, it may be desirable not to block the outer orifice 13404, so that the ventilation system 13400 will be able to maintain a substantially constant ventilation flow rate over most of the typical therapeutic pressure range. Therefore, the lateral membrane supports 13405 may project radially inward beyond the edge of the outer orifice 13404. The lateral membrane supports 13405 may be semi-circular, such as... Figures 42A to 42G Like that. In Figures 42A to 42G In the depicted example, the external aperture 13404 is evenly distributed in three groups among adjacent lateral membrane supports 13405 around the circumference of the outer base 13403.

[0370] The vent housing 13401 can also be circular. However, the vent housing 13401 can also be elliptical, or it can be polygonal, such as triangular, square, rectangular, pentagonal, hexagonal, etc. In any of these configurations, the membrane 13430 can be shaped to correspond to the shape of the vent housing 13401.

[0371] The inner base 13406 can be positioned radially inside the outer base 13403, and the inner base 13406 and the outer base 13403 can be engaged by base connectors 13408 radially distributed between them. One or more inner orifices 13407 exist between adjacent base connectors 13408 and between the inner base 13406 and the outer base 13403. In these examples, the inner orifice 13407 is formed as a slot with an arcuate cross-section. However, it is contemplated that, similar to the outer orifice 13404, the inner orifice 13407 can be a circular hole. The inner orifice 13407 extends entirely 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 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 rate over most of the typical therapeutic pressure range. The edges of the orifice 13407 may be chamfered or rounded.

[0372] The inner base 13406 of the vent housing 13401 may further include a plurality of membrane spacers 13409. The membrane spacers 13409 may be radially and uniformly distributed around the inner base 13406. For example... Figures 42A to 42G As shown, the membrane spacer 13409 may be located on the edge of the inner base 13406 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 may extend from the inner base 13406 in a semi-cylindrical or rectangular shape, as shown below. Figures 42A to 42G As in the middle. The edges of the membrane spacer 13409 may have chamfers or rounded corners.

[0373] The vent housing 13401 may also include one or more recesses 13415 spaced apart around opposite sides of the outer base, as can be seen in Figures 42A to 42G. The recesses 13415 may be separated by recess spacers 13414. External openings 13404 may extend through the outer base 13403 and into corresponding recesses 13415, and multiple external openings 13404 may lead to individual recesses 13415.

[0374] In an alternative embodiment, the ventilation housing 13401 may include only a set of orifices similar to the inner orifice 13407 described above, since the ventilation flow through it may be limited by the position of the membrane 13430. Therefore, another set of orifices, similar to the outer orifice 13404 described above, may also be provided elsewhere on the patient interface 3000, since the ventilation flow through it is not limited by the membrane 13430 and is independent of the position of the membrane 13430. This latter set of orifices, not limited by the membrane 13430, may be located on any of the following: the inflation chamber 3200, the sealing structure 3100, the decoupling structure 3500, the vent connection tube 4180, or other components closer to the patient than the ventilation housing 13401. It is conceivable that the operating principles of the ventilation system 13400 described above would apply to this alternative arrangement, but the ability to position the orifices not limited by the membrane 13430 closer to the patient could improve the emission of exhaled CO2.

[0375] The vent housing 13401 can be made from a single, homogeneous material. The material of the vent housing 13401 can be relatively rigid. The material of the vent housing 13401 can be polycarbonate.

[0376] 5.4.1.2 Membrane

[0377] Figures 43A to 43G A view of an exemplary membrane 13430 having a ventilation system 13400 and positioned adjacent to a ventilation housing 13401 is also depicted. The exemplary membrane 13430 can be used with any of the various ventilation housing 13401 configurations disclosed above. The membrane 13430 can be in the shape of a flattened disk. In other words, the membrane 13430 (see...) Figure 43F and 43G The thickness of the membrane can be relatively small compared to its outer diameter. The thickness of the 13430 membrane can be uniform throughout, such as... Figure 43F and 43G As shown. Alternatively, the thickness of membrane 13430 can be varied in the radial direction.

[0378] The membrane 13430 includes a membrane opening 13431 such that, when assembled onto the ventilation housing 13401, airflow through the inlet 13411 also passes through the membrane opening 13431 and extends to the patient. The membrane 13430 also includes a patient-side surface 13432 facing the patient during use and an atmospheric-side surface 13433 facing the atmosphere and opposite to the patient-side surface 13432. Additionally, the atmospheric-side surface 13433 faces the ventilation housing 13401 during assembly. 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.

[0379] 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 such that the membrane 13430 can be positioned on the inner orifice 13407 during use without covering the outer orifice 13404. Alternatively, the inner and outer radii can be selected such that the membrane 13430 covers a relatively large portion of the inner base 13406 while being supported on the membrane spacer 13409 and the outer base 13403 proximal to the inner surface 13434.

[0380] Membrane 13430 can be made from a single, homogeneous material. The material can be elastically deformable, allowing membrane 13430 to be deflected by pressure from an airflow during use. The material can be silicone. Membrane 13430 can be "adjusted" to deform in a desired manner by changing one or more of its thickness, length, material, shape, inner radius, and / or outer radius.

[0381] 5.4.1.3 Constant Flow Ventilation System

[0382] Figures 43A to 43G Several views of an exemplary ventilation system 13400 are depicted, in which a membrane 13430 is assembled with a ventilation housing 13401. Figures 43A to 43G In the example where the inner wall 13410 does not extend above the inner base 13406, in the example 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 through the inlet 13411 into the ventilation system 13400 from the ventilation flow leaving the ventilation system 13400, which can reduce the flow rate that enters from the inlet 13411 and then exits directly from the ventilation system 13400.

[0383] exist Figures 43A to 43G In this example, the portion of membrane 13430 near its outer surface 13435 can be seen supported on the inner portion of the outer base 13403. Additionally, the portion of membrane 13430 near its inner surface 3434 can be seen supported directly above the membrane spacer 13409. However, even without any gas pressure that could cause deformation, membrane 13430 can deform towards the membrane spacer 13409 by its own weight, causing membrane 13430 to also be supported on the membrane spacer 13409.

[0384] Figures 43A to 43GThe position of the membrane 13430, constrained by the lateral membrane support 13405, is also shown. As described above, the shape and size of the membrane 13430 are configured to cover only the inner orifice 13407 without covering the outer orifice 13404. However, the membrane 13430 can be directly attached to the vent housing 13401 without covering it, and therefore can move freely. Thus, a sufficient number of lateral membrane supports 13405 prevent lateral movement of the membrane 13430, ensuring that the membrane 13430 does not cover one or more outer orifices 13404 during use.

[0385] It is also conceivable that these examples are reversed, where the outer orifice 13404 can be blocked by the membrane 13430 while the inner orifice 13407 is not blocked by the membrane 13430. Therefore, a lateral membrane support 13405 can be provided to prevent the membrane 13430 from covering the inner orifice 13407.

[0386] As described above, the exemplary ventilation system 13400 may include a membrane 13430 positioned above an inner orifice 13407 to at least partially restrict the gas flow through the inner orifice 13407, while the ventilation flow through the outer orifice 13404 is not restricted by the membrane 13430.

[0387] It should also be understood that the features of the ventilation system 13400 described in sections 5.4.1.1 to 5.4.1.3 can be incorporated into any of the ventilation adapters 9100 disclosed in section 5.4.5.

[0388] 5.4.2 Ventilation Diffuser

[0389] The vent adapter 9100 may also include a portion for housing a diffuser 9146. The diffuser 9146 may be removable for replacement. The diffuser 9146 may have an annular disc shape that complements the shape of the annular surface of the vent housing 9120 on the atmospheric side (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 has exited the plurality of vent holes 9125. That is, the vent flow passing through the molded vent holes 9125 may pass through the diffuser 9146 before reaching the atmosphere.

[0390] The diffuser 9146 can also act as a sound-absorbing material to reduce some of the noise generated by the CFV membrane 9140 adjustable vent and static vent.

[0391] Figure 26A cross-section through some orifices 3402 is shown. Orifices 3402 are shown as holes through the wall 3404 of the inflation chamber 3200. However, orifices 3402 may be located elsewhere than the wall 3404. For example, 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 vent adapter 9100. The diameter of the orifice is shown as less than the axial length of the orifice. The length and / or diameter can be selected such that an appropriate flow is generated when the inflation chamber 3200 is pressurized to the treatment pressure. At the treatment pressure (e.g., at 4 cm H2O or higher), the flow through orifices 3402 may be choked (e.g., at a Mach number of 1), or the flow may produce a pressure drop insufficient to be choked. Choking can cause substantially all of the pressure drop in the vent 3400 caused by orifices 3402. The arrows conceptually indicate the flow direction when the inflation chamber 3200 is pressurized above ambient pressure.

[0392] 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. This axis forms an acute angle with the normal to the surface of the wall 3404. This 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 approximately 45 degrees.

[0393] Orifice 3402 is covered by diffuser 3406, such that flow exiting orifice 3402 impinges on diffuser 3406 and flows at least partially into diffuser 3406. Diffusion member 3406 may be formed of a material, such as a porous material, which allows gas to flow through the material but diffuses any jets or other flows exiting orifice 3402. Some suitable examples of diffusion materials include nonwoven fiber materials; woven fiber materials; or open-cell foam materials. The diffusion material may be similar to or the same as the filter medium. Diffusion member 3406 can reduce perceptible noise generated by vent 3400 in use (e.g., when therapeutic pressure is applied).

[0394] The diffuser 3406 is shown as a barrier member covered by 3408, which prevents gas from flowing out of the orifice 3402 and directly through the diffuser 3406. The barrier member 3408 may be constructed at least partially of an impermeable material. The impermeable material may be any suitable flexible or rigid material. For example, the impermeable material may be a rigid plastic (e.g., molded polycarbonate) or a flexible plastic (e.g., commercially available sheet plastic). The barrier member 3408 may be integrally formed with the diffuser 3406, separately formed but permanently attached to the diffuser 3406, separately formed and removably contacted with the diffuser 3406, or a combination thereof. The barrier member 3408 is shown with its thickness relative to the diffuser 3406 opposite to the outlet orifice 3402.

[0395] The blocking member can cause the flow to change direction (relative to the direction of passage through orifice 3402) before leaving diffuser 3406. Blocking member 3408 and / or diffuser 3406 can be configured such that the flow exiting orifice 3402 must travel at least a predetermined distance through diffuser 3406 before being discharged into the ambient atmosphere. Blocking member 3408 can also be configured to provide a specific direction and / or orientation to the flow exiting vent 3400 to minimize any disturbance to the wearer and / or bed partner caused by the flow. For example, blocking member 3408 can allow gas to flow through diffuser 3406 and substantially parallel to the surface of blocking member 3408 closest to diffuser 3406.

[0396] exist Figure 26 In this arrangement, the orifice 3402 and the diffuser 3406 are oriented relative to each other such that the central axis of each orifice is not perpendicular to the nearest surface of the diffuser 3406, but a perpendicular arrangement is also possible. Figures 8A-8F Set it as shown.

[0397] 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 can be formed to have any suitable cross-section, such as U-shaped. Channel 3410 may be configured to allow liquid to drain from one or more outlets of orifice 3402. Orifice 3402 may be formed as V-shaped or U-shaped legs.

[0398] Figure 27 An alternative construction of the blocking member 3408 is shown. Figure 27 In this design, the blocking member 3408 includes an orifice 3412. The orifice 3412 can direct flow onto the opposite side of the orifice 3402 but out of the diffuser 3406 in a different direction. Therefore, the flow path is not a straight path through the orifice 3402 and the diffuser 3406. Although the arrows associated with the orifice 3412 are shown as parallel, this is merely for illustrative purposes. The orifice 3412 can be configured to redirect the flow in multiple directions.

[0399] Each of the holes 3412 defines an axis that is neither aligned with nor parallel to the axis defined by each orifice 3402. When in Figure 27 When viewed in cross-section, an angle is formed between any axis defined by aperture 3412 and any axis defined by aperture 3402. This angle can be between 15 and 75 degrees or between 30 and 60 degrees, including any integer within said range. For example, the angle can be approximately 45 degrees.

[0400] Figures 28-30 An alternative construction for vent 3400 is shown. Figure 28 A partial exploded view is shown. Figure 29 A simplified assembly diagram is shown, and Figure 30 It shows along Figure 29 The cross-sectional view is taken from line 30-30. In these views, the orifice 3402 is shown as a circular array surrounding the central orifice 3414. The circular array is shown as comprising three rows of circular orifices, wherein the two innermost rows are closer together than the outermost rows, but any number of rows can be provided, and the spacing between the rows can be equal. The central orifice 3414 allows fluid communication between the inflation chamber 3200 and the connection port 3600 and thus with the air circuit 4170. The diffuser member 3406 and the blocking member 3408 are also shown arranged around the central orifice 3414. With this configuration, the blocking member 3408 can be removably attached (e.g., a removable snap-fit ​​or threaded engagement) or permanently attached (e.g., a permanent adhesive or a snap-fit ​​that must be broken to remove), and the diffuser member 3406 can be fixed to the blocking member 3408 or not fixed to the blocking member 3408, but held by the blocking member 3408. Figure 29 Ideally, a radial opening 3416 is provided to allow gas to escape radially outward from the central hole 3414 from the diffuser member 3406.

[0401] Figures 31A to 31C Another alternative configuration of the vent 3400 is shown. Figure 31A A partial view is shown of a flow channel in the form of a bend 3418, which may be disposed between the decoupling structure 3500 and the connection port 3600 and includes a vent 3400. This configuration largely conceals the features of the vent 3400; therefore, the remaining description is relative to... Figure 31B and 9C of.

[0402] Figure 31BAn axial view is shown, with the cap 3422 and diffuser 3406 omitted. This provides a clear view of the outlet orifices 3402. Two annular rows are shown, each containing forty outlet orifices 3402. The orifices are offset such that the outlet orifices 3402 in the inner and outer rows are not radially aligned. This configuration allows the annular rows to have closer radial spacing. Although two rows are shown, any number of rows, such as one, three, or more, can be provided. Although forty outlet orifices 3402 are shown in each annular row, more or fewer orifices can be provided as needed to maintain an appropriate level of gas flushing. For example, each annular row may have one, five, ten, fifteen, twenty, twenty-five, thirty, thirty-five, forty, forty-five, fifty, or more outlet orifices 3402, or any number in between.

[0403] exist Figure 31C In the diagram, the 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 as being away from inflation chamber 3200; however, wall 3420 may be part of inflation chamber 3200.

[0404] The diffuser member 3406 is shown in an annular shape with a rectangular cross-section. The barrier member 3408 is shown as a relatively thin, sheet-like ring on the side of the diffuser member 3406 opposite to the orifice 3402. The barrier member 3408 can be attached to the diffuser member 3406 by any suitable means, such as by an adhesive.

[0405] Cap 3422 is shown covering the diffuser 3406 and the barrier 3408. Cap 3422 may contact the barrier 3408 such that the diffuser 3406 presses against the wall 3420. Alternatively, the diffuser 3406 may not press against the wall 3420. Cap 3422 may also act as the barrier 3408, in which case it may be omitted. Figure 31C The annular blocking member 3408 is shown in the figure.

[0406] The cap 3422 may include an angled annular flange 3424, which may be spaced apart from the wall 3420 to form an annular gap 3426. The annular flange 3424 may also be considered as skirt-shaped or truncated conical. The annular gap 3426 provides a flow path to the ambient atmosphere, allowing gas flow flushing to be unduly restricted. Alternatively, one or more openings (such as radial openings 3416) may be provided in the annular flange 3424 to provide a flow path to the ambient atmosphere, which may also allow the annular gap 3426 to be completely or partially eliminated.

[0407] The cap 3422 is shown having an annular groove 3428 that mates with the annular protrusion 3430 to hold the cap 3422 in place. The annular protrusion may be continuous to form a snap-fit, or it may be a plurality of annularly spaced protrusions to provide a configuration that achieves minimal or no interference upon axial insertion, followed by twisting to provide axial interference and hold the cap 3422 in place. Figure 31C In the diagram, the annular protrusion 3430 is shown as three annularly spaced protrusions. The lip 3432 of the annular groove 3428 can be omitted in three corresponding positions and dimensions to reduce or eliminate interference with the cap 3422 during axial insertion. Other forms of attachment are possible. For example, threaded fasteners can be provided, and the cap 3422 can be held in place by adhesive or welding. Releasable fasteners, such as those shown or threaded connections, allow for replacement of the diffuser member 3406 in case, for example, damage, blockage, or contamination of the diffuser member.

[0408] Although the ventilation port 3400 is shown on one side of the bend of the bend in the bend of the bend 3418 (e.g., upstream relative to the direction of exhalation), the ventilation port 3400 may be upstream or downstream of the bend.

[0409] Figures 32A to 32C Another alternative configuration of the vent 3400 is shown. Similar reference numerals are used as described above, therefore further description is omitted except as mentioned below. The vent 3400 in these figures is formed around an example of a decoupling structure 3500, which includes a ball head 3434 and a ball socket 3436 as part of a bend 3418. In the form shown here, the ball head 3434 and ball socket 3436 allow three rotational degrees of freedom. However, fewer rotational degrees of freedom may be allowed, such as one or two.

[0410] As in Figure 32D As best viewed, the cap 3422 is connected via 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 part. Each of the first half 3440 and the second half 3442 is positioned between six radial openings 3416, three of which are located in... Figure 32A As can be seen. However, more or less can be provided as needed to ensure sufficient hold and / or flow.

[0411] As in Figure 32CThe diagram best illustrates 44 orifices 3402, equally spaced in a single annular row. However, the number and spacing of the orifices 3402 can be configured differently. For example, fewer orifices 3402 can be provided if, for example, a lower flow rate is required, or more orifices 3402 can be provided if, for example, a higher flow rate is required. And as mentioned above, more rows can be provided. Furthermore, the orifices do not need to be in a annular array. For example, if the orifices are located in positions other than those shown, they can be arranged in a grid based on Cartesian coordinates. Alternatively, the orifices 3402 do not need to be in any type of row and can be located in random or pseudo-random positions.

[0412] 5.4.3 Heat and Humidity Exchanger (HME)

[0413] Heat and moisture exchangers (HMEs) can include materials with water-retaining properties. Respiratory pressure therapy (RPT) can cause airway dryness, leading to breathing discomfort in patients. To prevent this, a humidifier can be used in conjunction with a respiratory pressure device to deliver humidified air to the patient. This addition of a humidifier may increase the size and power requirements of the RPT device.

[0414] It is known that patients generate humidified air during exhalation, which originates from the mucous membranes of the respiratory tract. HMEs can be used to recirculate this exhaled moisture by capturing moisture from the humidified air during exhalation and then re-delivering it to the patient. One challenge in using HMEs is their efficacy (i.e., their ability to capture sufficient heat and moisture) and their impact on therapy (i.e., the possibility that HMEs can be placed in flow loops and thus cause flow resistance).

[0415] To improve efficacy, one aspect is to minimize any loss of heat and moisture captured by the HME. A problem with using an HME in RPT can be the loss of heat and moisture exhaled by the patient due to ventilation before it reaches the HME. To minimize this loss, the HME can be placed proximal to the patient's airway (i.e., the source of humidity), with the airway positioned on the opposite side of the HME, away from the patient. This configuration ensures that exhaled humidified gas flows through the HME, allowing moisture to be captured by the HME before leaving through the airway. The ventilation adapter can be configured such that the HME is positioned between the patient's airway and the constant flow airway.

[0416] In the example where the HME is set in the ventilation adapter, the RPT system may not include a humidifier. Humidification of the incoming pressurized breathable gas can be adequately achieved through the HME, making the humidifier (e.g., using a humidifier such as...) unnecessary. Figure 5A and 5BThe power humidification (as depicted in the diagram) may be unnecessary and can be excluded. Alternatively, if a humidifier is included in the RPT system when an HME is provided, the humidifier can be deactivated or simply not powered. In yet another alternative, the HME and the RPT humidifier can work together to provide the desired total humidity, for example, the HME provides a portion of the desired humidity and the RPT humidifier provides a second portion.

[0417] The ventilation adapter may also include a removable HME unit. 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 front and rear components) to remove the HME.

[0418] HMEs can be designed to maximize the surface area per unit volume available for heat and moisture exchange. Furthermore, HMEs can be designed to reduce their impact on flow resistance. This design can include multiple corrugations to allow flow through them. HMEs can be formed as a wound layer of corrugated HME material.

[0419] As described above, CFV can reduce flow waste by adjusting the ventilation flow rate to a level higher than, but close to, the minimum required ventilation flow rate. Because of the reduced 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 can in turn lead to mucosal dryness. Applying RPT to SDB may exacerbate this dryness. Therefore, reducing the flow rate required to achieve the treatment pressure while simultaneously reducing the level of humidified air loss from the system may result in a reduction in mucosal dryness.

[0420] One way to increase the level of humidified air delivered to a patient is by using powered humidification. Another way to humidify the air delivered to a patient is by using a heat-humidity exchanger (HME), which captures water vapor in the air so that this water vapor can be returned to the patient. HMEs can be used to capture moisture from a patient's exhalation and then return that moisture to the patient. Figure 17 As shown, the HME should be positioned to capture sufficient moisture from the exhaled airflow, but allow this moisture to be re-delivered through the therapeutic airflow. To ensure maximum moisture capture from the exhaled airflow, the HME should be placed between the patient and the airway. If the airway is placed between the patient and the HME, this will cause moisture in the exhaled airflow to be expelled before reaching the HME for capture and re-delivery. However, Figure 17 The configuration shown may also result in moisture loss through ventilation, with the therapeutic flow passing through the HME and then exiting directly from the ventilator (before patient delivery). This flow... Figure 17This is labeled "HME ventilation". HME ventilation becomes more problematic as treatment flow increases. Figure 18 As the graph shows, the flow rate may increase with increasing mask pressure. This flow rate can be increased to compensate for ventilation flow loss. When the flow rate increases, the velocity of the therapeutic flow increases, which may cause the therapeutic flow to penetrate the HME more deeply. However, some of this infiltration flow is delivered to the patient, and a portion of this flow may also be directed to the ventilator before patient delivery (as shown in the HME ventilation flow). Therefore, the HME ventilation flow may also result in moisture loss by drying the HME.

[0421] As in Figure 18 As shown in the graph, CFV reduces ventilation flow rate compared to a standard FFM nominal flow rate ventilator within the same pressure range. This reduction in flow rate decreases HME ventilation flow rate, thereby reducing moisture loss. In other words, less flow occurs in the CFV system at the same pressure compared to a standard ventilation system, thus reducing HME ventilation flow rate. This reduction in HME ventilation flow rate enhances the HME's ability to capture and retransport moisture from the exhaled airflow, thereby synergistically enhancing the HME effect to reduce mucosal dryness.

[0422] Another way to reduce HME airflow is to redirect the flow direction, causing less flow to pass through the vent and be redirected back into the system. Redirection can be achieved using structures (such as baffles) positioned in the flow path between the HME and the vent, directing less flow from the vent into the atmosphere.

[0423] The technology of this invention enables near-powered humidification levels without the need for powered humidification. Since powered humidification is no longer required, the airflow generator can be further simplified, as it eliminates the need for a water reservoir and heating mechanism to deliver powered humidification to the therapeutic flow. Therefore, both CFV and HME allow airflow generators associated with this technology to be effective in providing RPT therapy for OSA and other SDBs without the need for complex pressure / flow control and powered humidification, ultimately benefiting patients by providing smaller airflow generators with less control.

[0424] Figures 25A to 25D An example of an HME according to this technology is shown. Figure 25AA cross-section of an HME 7000 including a corrugated structure 7002 is shown. The corrugated structure 7002 includes a plurality of corrugations 7030 located between a substantially flat base top structure 7010 and a substantially flat base base structure 7020 to form a corrugated layer 7001. Layer 7001 includes a plurality of upper channels 7012 formed between the upper surface of the corrugated structure 7002 and the top structure 7010. Furthermore, 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 and exhaled gases along the surface of the corrugated structure through the plurality of upper channels 7012 and lower channels 7022 to exchange heat and moisture. Moisture is absorbed from the patient's exhaled gases and retained in the material of the corrugated structure 7002. The materials of the corrugations 7030, top structure 7010, and / or base structure 7020 may include paper or paper-based materials capable of absorbing water and / or heat. The materials of the corrugations 7030, top structure 7010, and / or base structure 7020 may be porous, water-permeable, and / or air-permeable. The retained moisture can then be re-delivered to the patient via a humidified stream of breathable gas delivered to the patient's airway. In other words, the breathable gas stream delivered to the patient's airway can absorb moisture from the HME 7000. Figure 25B Various sizes of HME based on these instances are described.

[0425] Multiple 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 multiple upper channels 7012 and the multiple 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.

[0426] The humidification performance of the HME 7000 depends on the effective surface area provided by the HME 7000 within a fixed volume. The effective surface area is the area of ​​the HME 7000 exposed to the flow of breathable gas along its surface, where 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 section of the HME 7000. Furthermore, the surface area per unit volume can also be adjusted by modifying any of the following: fin thickness, the spacing or height of the corrugations or grooves, which affect the surface area per unit volume of the HME 7000.

[0427] like Figure 25CAs shown, the HME 7000 may include multiple layers 7001 stacked along the vertical axis of the HME 7000. The layers 7001 may be stacked vertically such that a base structure 7020 is stacked on top of the corrugated structure 7002 of the adjacent layer 7001 below. Multiple layers 7001 stacked horizontally may also be present in the HME. Having multiple layers 7001 including corrugated structures 7002 stacked along the vertical axis of the 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 the HME 7000. Furthermore, as... Figure 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 using the following formula: Where P is the preload, and h 起始 It is the height of the corrugations or grooves before compression, and where h is... 最终 It is the height after the corrugations are compressed.

[0428] Alternatively, the final three-dimensional shape of the HME 7000 can be formed by combining layers 7001 of different sizes and shapes to produce an irregularly shaped HME 7000 suitable for fitting within the inflation chamber 3200 of the patient interface 3000. Layers 7001 can be laser-cut to form the desired shape and size.

[0429] For example, in displaying alternative instances Figure 25E As shown, the HME 7000 can be rolled up from a single strip layer 7001, which includes a corrugated structure 7002 extending from the surface of the base structure 7020 to form a plurality of corrugations 7030. The single strip layer 7001 can be rolled up such 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 held between each roll of the single strip layer 7001.

[0430] As mentioned above, CFV reduces ventilation flow rate compared to a standard FFM nominal flow rate ventilator within the same pressure range. This reduction in flow rate decreases HME ventilation flow rate, thereby reducing moisture loss. In other words, less flow occurs in a CFV system at the same pressure compared to a standard ventilation system, thus reducing HME ventilation flow rate. This reduction in HME ventilation flow rate enhances the HME's ability to capture and retransport moisture from the exhaled airflow, thereby synergistically enhancing the HME effect to reduce mucosal dryness.

[0431] The CFV membrane allows ventilation flow to be maintained at or above the minimum required level within the treatment pressure range, and can also be adjusted to a level lower than that occurring under standard static ventilation. Therefore, CO2 flushing will always be maintained at an adequate level. The ventilation flow can be adjusted to the minimum level required to achieve CO2 flushing. This results in minimized ventilation flow, and consequently, minimized moisture loss from the HME.

[0432] Another way to reduce HME venting volume is to redirect the flow direction, causing less flow to pass through the vent and be redirected back into the air delivery loop. In other words, the flow can be redirected to minimize HME venting, where the flow penetrates the HME and then exits directly through the vent. Flow redirection can be achieved using structures (e.g., baffles) positioned in the flow path between the HME and the vent, directing less flow from the vent into the atmosphere.

[0433] Figures 38A to 38C An example of an HME housing 9400 according to an embodiment of the present technology is depicted. The HME housing 9400 may have a two-part configuration including a patient-side HME housing portion 9402 and an atmospheric-side HME housing portion 9404. The patient-side HME housing portion 9402 and the atmospheric-side HME housing portion 9404 may be assembled together to retain HME material therein. The patient-side HME housing portion 9402 may include a patient-side HME housing portion crossbar 9406 to hold the HME material axially toward the patient during use, and the atmospheric-side HME housing portion 9404 may include an atmospheric-side HME housing portion crossbar 9408 to hold the HME material axially toward the atmosphere during use. The atmospheric-side HME housing portion 9404 may also include one or more openings 9410 that connect to corresponding tabs 9412 of the patient-side HME housing portion 9402 to engage the two portions together. The connection between the opening 9410 and the tab 9412 may include a snap-fit ​​engagement and may be releasable to allow disassembly of the HME housing 9400, thereby allowing the removal of the HME material for cleaning or replacement.

[0434] Figures 39A to 39CAnother example of an HME housing 9400 according to an embodiment of the present technology is depicted. The HME housing 9400 may have a two-part configuration including a patient-side HME housing portion 9402 and an atmospheric-side HME housing portion 9404. The patient-side HME housing portion 9402 and the atmospheric-side HME housing portion 9404 may be assembled together to retain HME material therein. The patient-side HME housing portion 9402 may include a patient-side HME housing portion crossbar 9406 to hold the HME material axially toward the patient in use, and the atmospheric-side HME housing portion 9404 may include an atmospheric-side HME housing portion crossbar 9408 to hold the HME material axially toward the atmosphere in use. The atmospheric-side HME housing portion 9404 may also include one or more openings 9410 that connect to corresponding tabs 9412 of the patient-side HME housing portion 9402 to engage the two portions together. The connection between the opening 9410 and the tab 9412 may include a snap-fit ​​engagement and may be releasable to allow disassembly of the HME housing 9400, thereby allowing removal of the HME material for cleaning or replacement. The atmospheric-side HME housing portion 9404 may also include an atmospheric-side HME housing portion ring 9414, and extending from the atmospheric-side HME housing portion ring 9414 is an inner HME housing 9416 that can accommodate the HME material. The inner HME housing 9416, together with the patient-side HME housing portion 9402 and the atmospheric-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.

[0435] 5.4.4 Custom Connection

[0436] Figure 6A A side view of a fluid connector 9000 with a first end 9002 and a second end 9004 mating with each other is shown. A portion of a fluid conduit 9006, which may be part of an air circuit 4170, is connected to the second end 9004. Instead of the fluid conduit 9006, an adapter or connector may be provided to the fluid conduit. The outlet of the RPT device 4000 may include the second end 9004 in some forms of the present technology.

[0437] The fluid connector 9000 can be configured as a removable, sealed connection to allow airflow, such as from the RPT device 4000, to travel through it to the patient interface 3000. The fluid connector 9000 may include multiple components, such as a first end 9002 and a second end 9004, which can be releasably connected to each other to form and / or open a sealed connection.

[0438] The first end 9002 and the second end 9004 may form a pneumatic path therebetween via complementary sealing portions and be held together by complementary retaining portions, which may be separate parts relative to the complementary sealing portions. Thus, each of the first end 9002 and the second end 9004 may include separate sealing and retaining portions, as described in further detail elsewhere in this document.

[0439] When sealing and retaining functions are performed by separate complementary parts, each of the sealing and / or retaining functions can be more easily optimized to address one or more of the competing design requirements. For example, in the case of a pair of complementary parts used to seal and retain two components, the formation of a tight seal may result in high friction, thereby reducing the ease of joining and / or disconnecting the components.

[0440] Furthermore, with enhanced connectivity, the seals may become less robust, such as in cases where the two components may be subjected to torque in different directions and sizes. In the case of fluid connectors such as those described in this document, a patient wearing the Patient Interface 3000 may move around while asleep or preparing to sleep, causing the fluid connector to be pulled and / or twisted in various directions.

[0441] Therefore, one aspect of this technology relates to a fluid connector 9000, wherein a first end 9002 and a second end 9004 are connected to each other by complementary sealing portions and complementary retaining portions.

[0442] In one embodiment, the first end 9002 and the second end 9004 may include complementary sealing portions to form an air seal upon connection. The air seal may be configured to form and maintain a sealing engagement to allow airflow to travel through it. The sealing engagement may be sufficient to allow pressurized airflow, such as at pressures between 4 cm H2O and 40 cm H2O, to travel through it to provide respiratory therapy.

[0443] 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 portions may, for example, seal the first end 9002 and the second end 9004 together to prevent accidental disengagement. The retaining portions may include a latching mechanism, as will be further detailed in this document.

[0444] Figure 6BA cross-sectional view of a fluid connector 9000, where the first end 9002 and the second end 9004 are not connected to each other, is shown. In this view, a sealing portion 9008 is visible. The sealing portion 9008 can be formed of any material (e.g., silicone) suitable for forming a seal in the air path of a device supplying breathing gas to a patient. The sealing portion 9008 extends around a first opening 9010, which is shown as the interior of a first tube 9022. A latching portion 9012, which may be in the form of a recess, is provided at the first end 9002. The latching portion 9012 can be provided as... Figure 6B The opposite side, one side of the first end 9002, or the periphery shown. As shown, the latch portion 9012 is an undercut portion substantially perpendicular to the central axis of the first end 9002. Other angles are possible depending on the required retaining force.

[0445] The second end 9004 includes a sealing surface 9016. The sealing surface 9016 may be formed circumferentially around a 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 extending radially and perpendicularly (i.e., at 90°) away from the second tube 9020. This can result in the sealing surface 9016 being substantially perpendicular to the direction of fluid flow from the first end 9002 to the second end 9004. However, the sealing surface 9016 may also extend outward at an angle, such that the sealing surface 9016 is inclined. For example, the sealing surface may be at an angle of 85°, 80°, 75°, 70°, 65°, 60°, 55°, 50°, or 45°, positive or negative, or any value in between. Figure 6B As seen in the image, the second tube 9020 may include a dangling portion 9034 that extends toward the sealing portion 9008 beyond the sealing surface 9016. This can result in the dangling portion 9034 of the second tube 9020 extending through the sealing portion 9008, as... Figure 6C As shown. It should be understood that in some instances of this technology, the second tube 9020 does not need to include a hanging portion.

[0446] 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 insert into a guide portion 9038 on the first end 9002 to act as an inlet 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. Additionally, a stop 9030 can be provided to limit the travel of the second tube 9020, for example by abutting the overhang portion 9034 at the travel limit. Although the overhang portion 9034 is shown as a tube, it may not extend continuously around the periphery of the second end 9004, as it will be internal relative to the seal formed by the complementary sealing portions (sealing portion 9008 and sealing surface 9016). The overhang portion may extend only partially through the sealing portion 9008, such as in a crenellated extension, tab, rib, etc.

[0447] exist Figure 6C In the configuration shown, the internal flow path of the fluid connector 9000, defined by the first tube 9022, the second tube 9020, and the stop 9030, can have very little flow restriction because the internal flow path is substantially the same as the interior of the fluid conduit 9006, for example, as evaluated in terms of cross-sectional shape and size. Therefore, the fluid connector 9000 can have a negligible pressure drop as air flows through it throughout the patient's respiratory cycle and at therapeutic pressures (e.g., between 4 cm H2O and 40 cm H2O).

[0448] The sealing portion 9008 may include a portion that contacts the sealing surface 9016 in any form suitable for forming a facet seal, such as through tangential contact between the two. As shown, the sealing portion 9008 contacts the sealing surface 9016 in a basic frustoconical shape similar to or partially to a bellows shape. Alternatively, a partially spherical or partially annular surface may be provided on the sealing portion 9008. In either of these shapes, the sealing portion 9008 may contact the sealing surface 9016 before the latching portion 9012 and the complementary latching portion 9014 are fully or even partially engaged. Alternatively, even after the latching portion 9012 and the complementary latching portion 9014 are fully engaged, the sealing portion 9008 and the sealing surface 9016 may be separated by a gap. In this case, internal pressure may cause the sealing portion 9008 to move into contact with the sealing surface 9016 and form a seal.

[0449] The sealing portion 9008 may comprise an elastic and compliant material, allowing it to deform under load and retain its original configuration when the load is removed. The sealing portion 9008 may be configured to readily deform under load to form and / or maintain a seal with the sealing surface 9016. In some forms, the sealing portion 9008 may comprise a membrane made of silicone resin. The silicone membrane sealing portion 9008 may be sufficiently compliant to deform and move into contact with the sealing surface 9016 due to pressure caused by airflow. Alternatively or concurrently, the silicone membrane sealing portion 9008 may be sufficiently compliant to maintain a sealing engagement with the sealing surface 9016 even when compressed from its undeformed configuration.

[0450] The proposed configuration of the sealing portion 9008 can provide a seal that is compliant with the mating direction between the first end 9002 and the second end 9004 (e.g., in...). Figure 6B (from center to left) and / or in the direction radial to the axis defined by the engagement direction between the first end 9002 and the second end 9004, it is compliant (e.g., in...). Figure 6B (Up and down).

[0451] 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 compressive 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 frictional 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 noticeable 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 that the user is essentially unaware of it. That is, in a configuration where the sealing portion 9008 is removed from the first end 9002, the force perceived by the user can be substantially the same as in a configuration where the sealing portion 9008 must be compressed for connection.

[0452] The shape of the sealing portion 9008 according to this 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., in...). Figure 6B(From center to right). This allows the sealing portion 9008 to seal against the sealing surface 9016 even when 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 applied to the interior of the fluid connector 9000 (e.g., to the first tube 9022), the sealing portion 9008 expands toward and contacts the sealing surface 9016 to form a seal. With this configuration, the user should not encounter any additional force beyond that required for the engagement latch portion 9012 and the complementary latch portion 9014 when connecting the first end 9002 to the second end 9004.

[0453] While the specific construction of the seal 9008 is as described above, other constructions are possible. For example, some forms of the seal 9008 may include O-rings or gasket materials.

[0454] 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 a certain degree of misalignment in the radial (or lateral) and / or axial directions.

[0455] For example, the sealing surface 9016 may include an annular shape (such as...) Figure 6H As shown in the diagram, the annular shape is configured to form a surface seal with the surface of the sealing portion 9008 at multiple radial locations. That is, although the axes of the first tube 9022 and the second tube 9020 may be misaligned, for example, by a deviation of 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 between them. In one embodiment, the sealing surface 9016 may include a sufficiently wide annular portion such that the sealing portion 9008 can form a seal therewith.

[0456] 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 mates with or engages with the latch portion 9012. Like the latch portion 9012, the complementary latch portion 9014 can be positioned as follows: Figure 6B As shown, on multiple (e.g., opposite) sides or on one side. Figure 6DAs shown, 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 from the latch portion 9012, and to allow engagement or disengagement between the first end 9002 and the second end 9004. While 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.

[0457] In the assembly, the stop 9030 and the latch portion 9012 can define a predetermined distance (stroke) by which 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 stop 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 and second axial distances will define a non-zero predetermined stroke. If the first and second axial distances are equal, no stroke is possible. However, there may be benefits associated with non-zero stroke, at least in terms of manufacturability, as non-zero stroke will allow for manufacturing tolerances, which can reduce costs. Therefore, it is also advantageous for the sealing portion 9008 to be configured to form a seal with the sealing surface 9016 under worst-case manufacturing tolerances and after predetermined wear and / or creep in the fluid connector 9000. The shape of the sealing portion 9008 discussed above allows the sealing portion 9008 to account for this worst-case scenario.

[0458] As in Figure 6B As best seen in the figure, the second end 9004 may include an inner portion 9024 and an outer portion 9026 rotatably connected to each other at an interface 9028. The inner portion 9024 may include a sealing portion 9008 and the outer portion 9026 may include a complementary latching portion 9014. As shown, the inner portion 9024 is rigidly or fixedly connected to the fluid conduit 9006 such 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 may be overlap-molded onto the inner portion 9024 to form a rigid connection therebetween. In other forms, the fluid conduit 9006 may be frictionally or interference-fitted into the inner portion 9024 to form a rigid connection.

[0459] As in Figure 6DAs best viewed, the outer portion 9026 may have a rounded outer contour with four sides, which may be uniquely identifiable compared to a typical rounded contour. The first end 9002 may include a recess of complementary shape. Thus, the first end 9002 includes a recessed portion, and the second end 9004 includes a protruding portion. Including protruding and recessed portions of the forms described above, or any other non-standard shape or construction, may provide benefits. First, fluid connectors 9000 that include non-standard shapes and / or constructions may not conform to industry standards (e.g., ISO 5356-1), which include the use of a circular socket including an introductory tapered shape, onto which a sheath (e.g., rubber) is inserted. While non-compliance with industry standards may seem counterintuitive, it may have advantages. For example, fluid connector 9000 can be used to connect RPT devices and patient interfaces designed to operate optimally together. For example, if the RPT device provides a low flow rate that can only be utilized through a patient interface designed to operate at a low flow rate, then having a fluid connector 9000 that does not conform to industry standards will ensure that only the correct RPT device and patient interface are used. Second, particularly for the outline shown, the first and second ends 9004 can mate with each other only in a predetermined number of relative orientations (e.g., four). The quadrilateral shape of the invention also provides well-defined sides that are easy to identify and hold for actuating the complementary latch portion 9014. Third, non-standard shapes such as those described herein or others allow the user to easily identify which end of the patient catheter 4170 is a connector complementary to another connector, such as the outlet of an RPT device.

[0460] Figure 6E Another example of the invention is shown, wherein port 9032 is included in the first end 9002. Port 9032 can be used to sense pressure downstream of the blower and outside the blower housing, such as by sensing pressure downstream of the RPT device. Port 9032 can be fluidly connected to the second end 9004 to determine the pressure of air in the second opening 9018.

[0461] In one configuration, port 9032 may be in fluid communication with the interior of the second opening 9018, such as through a fluid connection with an opening inside the sealing portion 9008. The opening inside the sealing portion 9008 may, in turn, be in fluid communication with the pressure measuring port 9036 to the second opening 9018. Thus, two fluid connections can be formed between the first end 9002 and the second end 9004 when they are connected to each other. Compared to measuring pressure in an RPT device, port 9032 offers the advantage of being able to measure pressure closer to the patient. Due to inherent pressure losses in the internal fluid flow and potential leakage along the entire air path from the blower to the patient, measuring pressure closer to the patient provides a more accurate measurement than pressure measurements taken further away from the patient.

[0462] Furthermore, 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 for delivering airflow and the other for 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. Additionally, this configuration also allows the user to connect the first end 9002 and the second end 9004 to each other in one of several rotational orientations while maintaining two fluid connections.

[0463] Figure 6F The first end 9002 integrated into the RPT device is shown, while the second end 9004 is disconnected. Figure 6F The first end 9002 integrated into the RPT device is shown, wherein the second end 9004 is connected.

[0464] Although the preceding descriptions have collectively outlined the two halves of the connector system, such as the first end 9002 and the second end 9004, it should be understood that the descriptions of either half can be considered separately.

[0465] Ensuring proper mask compatibility with membrane CFV-regulated vents can also be advantageous. Masks according to examples of this technology can be non-ventilated masks specifically designed for compatibility with the aforementioned CFV membrane-regulated vents. The system can be designed such that the airflow generator is also compatible with the ventilator, meaning the airflow generator will be programmed to work with a mask system having a constant airflow rate. That is, each mask type (nose pillow mask and full-face mask) can be connected to the same ventilator, and therefore, the ventilator should allow sufficient CO2 flushing for each mask type. Typically, the lowest CO2 flushing rate is seen in full-face masks due to the increased volume of the mask's dead space. Therefore, the ventilator must allow sufficient CO2 flushing for full-face masks (i.e., the worst-case scenario). Because the systems of this technology (including the airflow generator, ventilator, and each mask type) can be specifically designed to work together, preventing incompatible masks from being connected to the CFV connector can be advantageous.

[0466] In this way, the connection mechanism can be configured such that a seal is formed between the two removably connected components via the connection mechanism. As previously mentioned, the nasal pillow mask can be connected to the short tube connector and then to the ventilation adapter. Conversely, the full-face mask can be directly connected to the ventilation adapter 9100. In another example, the HME may include a separate removable housing that can be detached from the ventilation adapter. However, to reduce the overall size, the HME can be incorporated into the ventilation adapter along with the CFV unit, with the HME sliding 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.

[0467] In a full-face mask according to this technology, the end of the short tube connector can be formed as an inlet for the full-face mask. That is, the same bellows mating surface is designed as part of the mask housing, which can form part of the mask inflation chamber.

[0468] The bellows sealing diaphragm can be configured to move under pressure, causing the diaphragm to move toward a sealing surface on the opposite connector. A pressure-supported seal may mean that the seal between the CFV unit and the connector remains stable under high pressure.

[0469] Bellows seals allow for a seal between the CFV unit and the connector with minimal friction between the two components, enabling swivel connections. For example, using interference fits, lip seals, gasket configurations, or other forms of compression seals between components may not allow for sufficiently easy movement between the components to allow rotation while maintaining a secure seal.

[0470] 5.4.5 Exemplary Ventilation Adapter

[0471] Examples of the ventilation adapter 9100 and its components are shown in Figure 7A-14D The ventilation adapter 9100 according to this embodiment of the present technology may include a duct connector 9110, a ventilation housing 9120, a ventilation diffuser cover 9130, a partition 9140, a CFV ring 9150, a ventilation housing connector 9160, a heat and humidity exchanger (HME) clip 9170, an HME housing 9180, a bellows seal 9190, and a ventilation adapter connector 9200.

[0472] The ventilation housing 9120 may include an end portion 9121 having a protrusion 9122 for connecting the ventilation housing 9120 to the catheter connector 9110 at the ventilation adapter end portion 9112. The end portion 9121 may define a central orifice through which a flow of pressurized gas is provided to the patient. The ventilation housing 9120 may include an external vent 9125 and an internal vent 9126, which define a passage for discharging pressurized gas from the RPT system; that is, gas can be discharged from the internal vent 9126 through the passage to the external vent 9125 and out to the atmosphere. The ventilation housing 9120 may also include a tab 9123 engaging with a lip 9124 via a support 9128 for releasably attaching the ventilation housing 9120 to the ventilation housing connector 9160 and the ventilation adapter connector 9200. The patient can actuate tab 9123 to depress support 9128, causing lip 9124 to disengage from ventilator housing connector 9160 and ventilator adapter connector 9200. When attached, lip 9124 allows ventilator housing 9120 to rotate relative to ventilator adapter connector 9200 while maintaining connection. Ventilator housing 9120 may also be a shoulder 9127 to fit into a corresponding recess 9164 of ventilator housing connector 9160. Ventilator housing 9120 may also include a recess 9129 to receive a corresponding bellows seal connector 9191, which attaches bellows seal 9190 to ventilator housing 9120 to seal the interior of ventilator adapter 9100 against ventilator adapter connector 9200 during assembly.

[0473] The vent housing connector 9160 may include a first rod 9161 and a second rod 9162 forming a receptacle 9163, the receptacle 9163 receiving 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.

[0474] Bellows seal 9190 can be similar to the one mentioned above. Figures 6A-6H The bellows seal 9190 may have a shoulder surface 9194 with a bellows seal connector 9191 for attaching the bellows seal 9190 to a recess 9129 in the vent housing 9120. The bellows seal 9190 may also have an inner surface 9193 that, during assembly, contacts the pressurized gas and is pushed outward, causing the outer surface 9192 to abut against the vent adapter connector 9200 to form a seal.

[0475] The ventilation adapter connector 9200 may have an aperture 9201 through which pressurized gas passes from the ventilation adapter 9100 to the patient during treatment. Additionally, exhaled gas may be discharged into the ventilation adapter 9100 via the aperture 9201. The ventilation adapter connector 9200 may be connected to the patient interface via another tube (not shown) at the aperture 9201. The ventilation adapter connector 9200 may also have an edge 9202 to connect to a lip 9124 of the ventilation housing 9120, allowing the ventilation housing 9120 to connect to 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 housing.

[0476] As described above, the ventilation adapter 9100 may further include an HME clip 9170 and an HME housing 9180 to hold the HME material within the ventilation adapter 9100, in a position between the internal ventilation port 9126 and the patient. The HME material (not shown) may be a spiral or cylindrical structure that is inserted into the HME housing 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 shaft ends 9173 to receivers 9183 suspended on transverse members 9182 of the HME housing 9180 to secure the HME material inside the HME housing 9180. The HME housing 9180 may also include a pair of slots 9181 in the outer wall 9184 corresponding to and receiving the arm ends 9174, such that the HME clips 9170 do not rotate relative to the HME housing 9180 during assembly. Thus, the HME material will be secured between the arm 9171 and the transverse member 9182. The outer wall 9184 may include a plurality of cutouts 9185.

[0477] The conduit connector 9110 may include a ventilation adapter end 9112 and a conduit end 9111. As described above, the ventilation adapter end 9112 may be connected to the ventilation housing 9120 and the conduit end may be connected to a conduit (not shown), the other end of which is connected to an RPT device to receive a pressurized gas flow. The conduit connector 9110 may also include an anti-asphyxiation valve (AAV) opening 9113.

[0478] Another example of the ventilation adapter 9100 and its components is shown in Figure 15A-15F This example includes the text above. Figure 7A-14DSimilar possible features are shown in the example. In this example, the vent adapter connector 9200 includes an edge 9203 that connects to a tab 9123 of the vent housing 9120 to connect the vent adapter connector 9200 to the vent housing 9120. Additionally, this example shows an anti-asphyxiation valve (AAV) 9135 that can be mounted in a conduit connector 9110. The conduit connector 9110 may also have a ring 9115 for connection to a conduit (not shown). Additionally, in this example, a bellows seal 9190 is attached to the vent housing connector 9160. The vent housing connector 9160 also has a ridge to allow attachment to the vent housing 9120 via the tab 9123. Furthermore, examples of HME material 9145 and diffuser 9146 are shown.

[0479] Another example of the ventilation adapter 9100 and its components is shown in Figure 21A-21F This is depicted in the text. This example includes those described above. Figure 7A-14D and Figure 15A-15F The example shown has similar potential features. In this example, the HME housing 9180 is not fully housed within the vent adapter 9100. Instead, it is partially exposed, forming part of the structure that connects the vent housing 9120 to the vent adapter connector 9200.

[0480] Another example of the ventilation adapter 9100 and its components is shown in Figure 22 This example includes the text above. Figure 7A-14D and Figure 15A-15F Similar possible characteristics to the examples shown. Figure 22 It also includes a valve disc retaining structure 9141, which can be attached to the HME clip 9170 on one side and adjacent to the valve disc 9140 on the other side to retain the valve disc 9140 in the operating position relative to the vent housing 9120.

[0481] Another example of the ventilation adapter 9100 and its components is shown in Figures 24A-24B This example includes the text above. Figure 7A-14D and Figure 15A-15F Similar possible characteristics to the examples shown.

[0482] Figure 23The diagram illustrates methods by which the ventilation adapter 9100 can be attached to different patient interfaces. In the case of the nasal pad patient interface 3000A or the nasal pillow patient interface 3000B, the ventilation adapter 9100 can be engaged to either patient interface via a short tube 9210. One end of the short tube 9210 can be engaged to patient interfaces 3000A and 3000B, and the other end can be engaged to the aforementioned ventilation adapter connector 9200. Alternatively, in the case of the full-face patient interface 3000C, the ventilation adapter 9100 does not include the ventilation adapter connector 9200, and the ventilation adapter 9100 is directly connected to the full-face patient interface 3000C, thus eliminating the need for the short tube 9210.

[0483] Figures 33A to 33I Another example of a ventilation adapter 9100 according to an example of the present technology is depicted. For example... Figure 35 As shown, the ventilation adapter 9100 can be connected to the patient interface 3000 to provide, for example, the functionality of its components.

[0484] The ventilation adapter includes a bend assembly 9220 to provide a fluid connection to the patient interface 3000, for example, via a connection port 3600 on the inflation chamber 3200. This example of the bend assembly 9220 includes a bend frame 9222 and a bend overlap molding 9224. The bend assembly 9220 may provide a releasable connection to the inflation chamber 3200 at the connection port. The bend frame 9222 may include tabs that are resiliently deformable for the releasable connection, and the bend overlap molding 9224 may provide a fluid-impermeable seal around an opening in the bend frame 9222 and add resilience to the bend frame 9222. The bend assembly 9220 may also be rotatable relative to the inflation chamber 3200 to reduce the effects of tubing resistance from the ventilation adapter 9100 and other components of the air circuit 4170. The bend assembly 9220 may also be removably connected to the patient interface 3000 and may be rotatable relative to the patient interface 3000.

[0485] The ventilation adapter 9100 may also include a short tube assembly 9210. The short tube assembly 9210 decouples other components of the ventilation adapter 9110, such as the ventilation housing 9320 and the ventilation core structure 9300, from the bend assembly 9220, which is connected to the inflation chamber 3200. By decoupling the other components of the ventilation adapter 9110 in this way, the weight that must be carried directly over the patient's head via the patient interface 3000 is reduced, providing a more relaxed and comfortable experience for the patient. The short tube assembly 9210 may include a tube 9212, which may consist of one or more helical coils. The short tube assembly 9210 may include a tube-bend connector 9216 to provide a connection to the bend assembly 9220. The connection between the tube-bend connector 9216 and the bend assembly 9220 may include a snap-fit ​​engagement. The connection between the tube-bend connector 9216 and the bend assembly 9220 can be permanent – ​​in other words, the connection can only be separated in the event of damage to a component. The short tube assembly 9210 may include a tube-to-housing connector 9214 to provide connection with an exhaust housing connector 9160. The connection between the tube-to-housing connector 9214 and the exhaust housing connector 9160 may include a snap-fit ​​engagement. The connection between the tube-to-housing connector 9214 and the exhaust housing connector 9160 may be permanent—in other words, the connection may be detachable only in the event of damage to a component.

[0486] The vent adapter 9100 may include a vent housing connector 9160 to engage the short tube assembly 9210 with the vent housing 9320. As described above, the vent housing connector 9160 may engage with the short tube assembly 9210 via a tube-to-housing connector 9214, and this engagement may be snap-on or permanent. The vent housing connector 9160 may also include a bayonet connector 9166 to facilitate a releasable bayonet connection with the vent housing 9320 or the heat and humidity exchanger (HME) housing 9400, such as... Figures 38A to 39C Those shown. Therefore, the HME associated with the HME housing 9400 can be optional, and therefore is not shown in Figures 33A to 33F The bayonet connector 9166 can be either convex or concave. Additionally, removably connecting the vent housing 9320 to the exhaust vent housing connector 9160 allows the venting components to be removed and disassembled for cleaning.

[0487] The HME housing 9400 can also be at least partially enclosed within the vent adapter 9100. Figures 33G to 33I It shows Figures 33A to 33F An example of a ventilation adapter 9100, in which an HME housing 9400 is encapsulated. Figure 33G Cross-sectional view and Figure 33I The examples shown in the exploded diagram include Figures 38A to 38C HME housing 9400. In Figure 33H Examples depicted in the cross-sectional views include Figures 39A to 39C HME housing 9400. Figures 33G to 33I The example shown omits HME material 9145 so that the features of the ventilation adapter 9100 and HME housing 9400 are not obscured in the figures. However, it should be understood that HME material 9145 may be included therein when the ventilation adapter 9100 is used for treatment. Figure 33F A ventilation adapter 9100 without the HME housing 9400 is shown. Figure 33G and 33H A ventilator 9100 with an HME housing 9400 is shown. It should be understood that the ventilator housing connector 9160 and the ventilator housing 9320 are connected in the same manner as described above, regardless of whether the HME housing 9400 is present.

[0488] In these examples, the HME housing 9400 is shown mounted within a cavity 9167, which is at least partially defined by a vent housing connector 9160 and / or a vent housing 9320. The cavity 9167 is formed when the vent housing connector 9160 and the vent housing 9320 are joined together. Alternatively, the vent housing connector 9160 or the vent housing 9320 may comprise substantially all of the cavity 9167. If the HME housing 9400 is not provided, the cavity 9167 may be empty, as... Figure 33F As shown. The shape and size of the vent housing 9320 and the vent housing connector 9160 can be configured such that the outer surface of the HME housing 9400 is in direct contact with or adjacent to the inner surfaces of the vent housing 9320 and the vent housing connector 9160. When the HME housing 9400 is installed therein, the HME housing 9400 can occupy substantially all of the cavity 9167.

[0489] The vent housing 9320 or vent housing connector 9160 may also include structures that facilitate removable connection to a corresponding structure of the HME housing 9400. For example, the interior of the vent housing 9320 may also include an annular lip 9326 surrounding all or part of the inner circumference of the vent housing 9320. The annular lip 9326 may include at least one retaining protrusion 9328 to removably connect the HME housing 9400 to the vent housing 9320. Figure 34C An example of a vent housing 9320 with four retaining protrusions 9328 is shown. The retaining protrusions 9328 also surround... Figure 34CThe annular lip 9326 is spaced approximately evenly. The HME housing 9400 may also include an annular recess 9405 surrounding the outer periphery of the atmospheric-side HME housing portion 9404, which removably receives retaining protrusions 9328. The annular recess 9405 may be continuous around the outer periphery of the atmospheric-side HME housing portion 9404, which allows the HME housing 9400 to be attached to the vent housing 9320 regardless of the relative orientation of the components.

[0490] The removable connection between the annular recess 9405 and the retaining protrusion 9328 can be a snap-fit ​​or a friction fit. The removable connection between the annular recess 9405 and the retaining protrusion 9328 can adequately secure (e.g., due to friction) to prevent relative rotation between the HME housing 9400 and the ventilation housing 9320, while allowing the patient or clinician to manually separate the components for replacement and / or cleaning.

[0491] An alternative arrangement is also envisioned in the outer periphery of the HME housing 9400, which includes protrusions that can be removably received by recesses surrounding the inner periphery of the ventilation housing 9320. It is also envisioned that a removable connection interface between the HME housing 9400 and the ventilation adapter 9100 could be created between the patient-side HME housing portion 9402 and the ventilation housing connector 9160, rather than between the atmospheric-side HME housing portion 9404 and the ventilation housing 9320. Instead of the annular recess 9405 and the retaining protrusion 9328, it is also envisioned that the HME housing 9400 and the ventilation adapter 9100 could each have threads to provide a removable threaded connection. In another alternative, the HME housing 9400 could be bayoneted to either the ventilation housing connector 9160 or the ventilation housing 9320.

[0492] Alternatively, the HME housing 9400 can be held by the vent adapter 9100 by being sandwiched between the vent housing connector 9160 and the vent housing 9320. There may be no positive connection between the HME housing 9400 and the vent adapter 9100, and the HME housing 9400 may be held simply by being closed by the vent housing connector 9160 and the vent housing 9320.

[0493] Figures 34A to 34G Examples are shown of a vent housing 9320, a valve disc or diaphragm 9140, a vent core structure 9300, a diffuser member 9146, a diffuser retaining ring 9148, and a vent diffuser cap 9330. These components can be assembled into sub-assemblies, such as... Figures 34A to 34G As shown in the figure, it is coupled to the vent housing connector 9160 for use. Figures 34A to 34GThe components of the sub-assemblies depicted may be inseparable via a permanent snap-fit, or these components may be detachable by the user. In the case of inseparability, the snap-fit ​​may be permanent, such that the components can only be separated if they are damaged.

[0494] The ventilation housing 9320 may also include a bayonet connector 9322 to correspondingly engage with a bayonet connector 9166 of the ventilation housing connector 9160 to removably connect the ventilation housing 9320 to the ventilation housing connector 9160. The ventilation port 9320 housing may also include a membrane retainer 9324 to hold the membrane 9140 against the ventilation core structure 9300 during assembly. The membrane retainer 9324 may include an open, radial, and cage-like structure to allow ventilation flow through the membrane retainer 9324 and out through the ventilation core structure 9300. The membrane retainer 9324 may also be open at its center to allow therapeutic flow to be delivered from the RPT device 4000 all the way to the patient.

[0495] The valve disc or diaphragm 9140 may be positioned between the diaphragm retainer 9324 and the venting core structure 9300. The diaphragm 9140 may be held in position between these two structures, but may also otherwise deform freely under pressure within the venting adapter 9100. The diaphragm 9140 may function similarly to other examples of the diaphragm 9140 disclosed above.

[0496] Ventilation core structure 9300 may include an inlet 9301 to allow gas flow generated by RPT device 4000 through ventilation adapter 9100 and all the way to the patient for treatment. Ventilation core structure 9306 may include a ventilation core extension 9306, through which the inlet 9301 may be defined. Ventilation core extension 9306 may extend axially and may include an air circuit connector 9302 to connect ventilation core 9300 to air circuit 4170. As can be seen, the shape and size of ventilation core extension 9306 are designed to extend through diffuser retaining ring 9148, diffuser 9146 and ventilation diffuser cap 9330 to align these components when ventilation adapter 9100 is assembled. Ventilation core structure 9300 may also include clips 9304 on alignment structure 9312 that are connected to connection surface 9334 of ventilation diffuser cap 9330. Clip 9304 can be attached to connecting surface 9334 via a snap-fit ​​connection to allow the vent diffuser cover 9330 to be removed for cleaning and / or replacement of vent adapter components 9100, such as diffuser 9146. Alignment structure 9312 can also facilitate axial alignment of vent core structure 9300 with diffuser 9146 and vent diffuser cover 9330 by means of corresponding shapes.

[0497] The ventilation core structure 9300 may further include a plurality of external orifices 9308 and a plurality of internal orifices 9310. The plurality of internal orifices 9310 may be configured such that, during use, airflow through the internal orifices 9310 to the atmosphere may be obstructed or restricted by the membrane 9140. The plurality of external orifices 9308 may be configured such that, during use, airflow through the external orifices 9308 to the atmosphere may not be obstructed or restricted by the membrane 9140. However, the membrane 9140 may also be configured such that it will not completely block the internal orifices 9310 at any pressure, at least within a typical therapeutic pressure range (e.g., between approximately 6 cm H2O and approximately 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 treatment pressure range, while the pressure within the ventilation adapter 9110 deforms the membrane 9140 to change the ventilation flow traveling through the outer orifice 9308 and the inner orifice 9310 to maintain a constant ventilation flow, as described above.

[0498] The diffuser 9146 may include a diffuser opening 9147 through which the core extension 9306 can pass. The diffuser 9146 may include features similar to those described above.

[0499] The diffuser 9146 can be held downstream of the inner orifice 9310 and outer orifice 9308 relative to the airflow through a diffuser retaining ring 9148 and a vent diffuser cap 9330. The diffuser retaining ring 9148 can be secured to the vent diffuser cap 9330, for example, by a snap-fit ​​engagement to retain the diffuser 9146. The diffuser retaining ring 9148 may include a radial diffuser retainer 9149 to hold the diffuser 9146 against the vent diffuser cap 9330. The diffuser retaining ring 9148 and the radial diffuser retainer 9149 define a rear vent outlet 9342 around the vent housing 9320. Airflow exiting the vent core structure 9300 can pass through the diffuser 9148 and exit through the rear vent outlet 9340. The vent diffuser cap 9332 may include a series of cap spacers 9332 radially spaced around the vent diffuser cap 9330 to define a front vent outlet 9342. The airflow leaving the ventilation core structure 9300 can pass through the diffuser 9148 and exit through the front ventilation outlet 9342.

[0500] The above is publicly available and in Figures 33A to 34G An exemplary ventilation adapter 9100 is shown as being connected to Figure 35The patient interface 3000 is included. In this example, the bend assembly 9220 is excluded because the inflation chamber 3200 includes a connection port 3600 that is angled to point downwards relative to the patient during use, thereby guiding the ventilation adapter 9100 away from the patient's head. Additionally, the short tube assembly 9210 can be permanently connected to the inflation chamber 3200 at the connection port 3600.

[0501] Figures 37A to 37E Another example of a ventilation adapter 9100 according to the present technology is depicted. The ventilation adapter 9100 may include an inflation chamber connector 9700 for directly connecting the ventilation adapter 9100 to the connection port 3600 of the inflation chamber 3200 and / or its protective cover 3305 (see [link to relevant documentation]). Figure 41 This provides a pressurized gas flow from the ventilation adapter 9100 to the inflation chamber 3200 via fluid connection.

[0502] The ventilation adapter 9100 may also include a baffle 9600. The baffle 9600 separates the pressurized gas flow entering from the RPT device 4000 from the outflow flow exiting through the outer orifice 9308 and inner orifice 9310 of the ventilation housing 9120. The baffle 9600 may be positioned inside the inflation chamber connector 9700. When the connection forms concentric circles, the baffle 9600 and the inflation chamber connector 9700 may be aligned.

[0503] The ventilation adapter 9100 may also include a lip seal 9500 that mates around the outer periphery of the inflation chamber connector 9700. The lip seal 9500 may seal the connection port 3600 of the inflation chamber 3200 and / or the inner periphery of its sheath 3305 to provide a pneumatic seal while allowing the ventilation adapter 9100 to rotate relative to the patient interface 3000.

[0504] According to the embodiments described above, for example Figures 33A to 34G As illustrated in the illustration, the ventilation adapter 9140 may also include a valve or diaphragm 9140 to regulate the ventilation flow rate of the inner orifice 9310 and outer orifice 9308 of the ventilation housing 9120.

[0505] The vent housing 9120 may include an inner orifice 9310 and an outer orifice 9308, and these orifices allow airflow from the vent adapter 9100 to the atmosphere, as in the examples above, such as in Figures 33A to 34G As illustrated in the examples.

[0506] The vent housing 9120 may further include a tab 9123 and a lip 9124 to provide a releasable and rotatable connection to the connection port 3600 of the inflation chamber 3200 and / or its shield 3305. The tab 9123 can be manually pressed down to release the lip 9123 from the corresponding annular protrusion (not shown) of the connection port 3600 of the inflation chamber 3200 and / or its shield 3305. When connected, the lip 9124 allows the vent adapter 9100 to remain connected to the connection port 3600 of the inflation chamber 3200 and / or its shield 3305 while remaining rotatable, thereby reducing the effects of tube resistance.

[0507] The vent housing 9120 can be connected to the conduit connector 9110, which in turn connects the vent adapter 9100 to the air circuit. The conduit connector 9110 can be in the form of a bend. 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 ​​engagement, which can be permanent such 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 may also include one or more anti-asphyxiation valve (AAV) openings 9113 for the AAV 9135.

[0508] The ventilation adapter 9100 may also include an air circuit connector 9116, which can be attached to the conduit end 9111 of the conduit connector 9110. The air circuit connector 9116 may include a bayonet connector 9117 for corresponding connection to... Figures 36A to 36C The exemplary air circuit 4170 has a connector 4175. The connection between the air circuit connector 9116 and the air circuit 4170 can be releasable.

[0509] Figures 37A to 37E The ventilation adapter depicted may exclude the heat and moisture exchanger (HME) material 9145. The absence of the HME material 9145, located within the ventilation airflow path, minimizes ventilation airflow resistance, thereby minimizing CO2 accumulation within the inflation chamber 3200. The depicted ventilation adapter 9100 may, for example, be adapted to... Figure 41 The full-face patient interface described is used together.

[0510] Figures 37A to 37E The ventilation adapter 9100 depicted can form a bend assembly that can be removably connected to the patient interface 3000, for example, as... Figure 41 As shown, it can be rotated relative to the patient interface.

[0511] Figure 40 and 41 A further example of a ventilation adapter 9100 that is coupled to a patient interface 3000 is shown.

[0512] Figure 40 A patient interface 3000 with a sealing formation structure 3100 is depicted, which forms a seal only around the patient's nose (i.e., a nasal mask) during use. A ventilation adapter 9100 is shown engaging with a shield 3305 covering a portion of the inflation chamber 3200. In this example, the ventilation adapter 9100 is characterized by incorporating a bend directly and rotatably attached to the shield 3305 to provide fluid connection with the inflation chamber 3200. However, it should be understood that... Figures 33A to 33I The ventilation adapter can be attached to the shield 3305 to form a fluid connection with the inflation chamber 3200 via the bend assembly 9220. The shield 3305 has a rigid arm 3301 engaged at a hinge 3307. The arm 3301 may include an upper attachment point 3302 and a lower attachment point 3304 for attaching straps to the positioning and stabilizing structure 3300. The upper attachment point 3302 may form a loop through which the upper strap can pass, and the lower attachment point 3304 may receive a clip 3306, which in turn receives the lower strap.

[0513] Figure 40 An exemplary patient interface 3000 is depicted, which may include a sealing forming structure 3100 to form a seal on a patient's nose and mouth during use. A ventilation adapter 9100, such as the examples depicted in 37A through 37E, may be connected to a shield 3305 to provide fluid connection to an inflation chamber 3200. The shield 3305 may engage with a rigid arm 3301, which may have an upper attachment point 3302 for attaching a strap to a positioning and stabilizing structure 3300. The shield 3305 may connect to a lower strap connector 3303, separate from the rigid arm 3301, to attach the strap of the positioning and stabilizing structure 3300 to a lower connection point 3304. The upper attachment point 3302 may form a loop through which the upper strap may pass, and the lower connection point 3304 may receive a clip 3306, which in turn receives the lower strap.

[0514] 5.5RPT device

[0515] According to one aspect of the present technology, an RPT device 4000 includes mechanical and pneumatic components 4100, electrical components 4200, and is configured to execute one or more algorithms 4300. The RPT device may have an outer housing 4010, which is configured in two parts: an upper portion 4012 and a lower portion 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0516] The pneumatic path of the RPT device 4000 may include one or more air path components and silencers 4120, such as inlet air filter 4112, inlet silencer 4122, pressure generator 4140 (e.g., blower 4142) capable of supplying positive pressure air, outlet silencer 4124, and one or more converters 4270, such as pressure sensors and flow sensors.

[0517] One or more air path elements may be housed within a removable separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0518] The RPT device 4000 may include a power supply 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. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.

[0519] 5.5.1 Mechanical and Pneumatic Components of the RPT Device

[0520] 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 configured as separate units.

[0521] 5.5.1.1 Air Filter

[0522] One form of RPT device according to the present technology may include one air filter 4110 or multiple air filters 4110.

[0523] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140. See also Figure 4B.

[0524] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the outlet of the pneumatic block 4020 and the patient interface 3000. See also Figure 4B .

[0525] 5.5.1.2 Muffler

[0526] In one embodiment of this technology, the inlet silencer 4122 is positioned in the pneumatic path upstream of the pressure generator 4140. See also Figure 4B .

[0527] In one embodiment of this technology, the outlet silencer 4124 is positioned in the pneumatic path between the pressure generator 4140 and the patient interface 3000. See also Figure 4B .

[0528] 5.5.1.3 Pressure Generator

[0529] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers housed in a volute. The blower may deliver the air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cm H2O to about 20 cm H2O, or in other forms up to about 30 cm H2O. 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.

[0530] The pressure generator 4140 is controlled by the treatment device controller 4240.

[0531] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0532] 5.5.1.4 Converter

[0533] The transducer can be located inside or outside the RPT device. An external transducer can be positioned, for example, on or as part of an air circuit such as a patient interface. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0534] In one embodiment of this technology, one or more converters 4270 may be located upstream and / or downstream of pressure generator 4140. One or more converters 4270 may be configured and arranged to measure characteristics such as flow rate, pressure, or temperature at that point in the pneumatic path.

[0535] In one form of this technology, one or more converters 4270 may be positioned proximal to the patient interface 3000.

[0536] In one embodiment, the signal from converter 4270 may be filtered, for example, by low-pass filtering, high-pass filtering, or band-pass filtering.

[0537] 5.5.1.4.1 Flow Sensor

[0538] The flow sensor based on this technology can be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION.

[0539] In one configuration, a signal representing flow rate, such as total flow rate Qt, is received from a flow sensor via a central controller 4230.

[0540] 5.5.1.4.2 Pressure Sensor

[0541] The pressure sensor according to this technology is positioned in fluid communication with the pneumatic path. An example of a suitable pressure transducer is the sensor from the HONEYWELL ASDX series. An alternative suitable pressure transducer is the sensor from the GENERALELECTRIC NPA series.

[0542] In one configuration, signals from the pressure sensor can be received via a central controller 4230.

[0543] 5.5.1.4.3 Motor speed converter

[0544] In one form of this technology, a motor speed converter is used to determine the rotational speed of motor 4144 and / or blower 4142. The motor speed signal from the motor speed converter can be provided to the treatment device controller 4240. The motor speed converter can be, for example, a speed sensor, such as a Hall effect sensor.

[0545] 5.5.1.5 Anti-overflow valve

[0546] In one embodiment of this technology, an anti-backflow valve 4160 is positioned between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve 4160 is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the electric motor 4144.

[0547] 5.5.1.6 Air Circuit

[0548] According to one aspect of the present technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow to travel between two components, such as a pneumatic block 4020 and a patient interface 3000.

[0549] Specifically, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, it may have separate branches for the inspiratory and expiratory circuits. In other cases, a single branch is used.

[0550] In some forms, air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. In other words, air circuit 4170 may be a heated air circuit 4171. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of air circuit 4170. The heating element may be connected to a controller such as a central controller 4230. An example of an air circuit 4170 including a heating wire circuit is described in U.S. Patent Application No. US / 2011 / 0023874, which is incorporated herein by reference in its entirety.

[0551] Figures 36A to 36C An example of an air circuit 4170 according to an embodiment of the present technology is depicted. Air circuit 4170 may include a tube 4172 comprising one or more helical coils. Air circuit 4173 may include an RPT device connector 4173 at one end, configured to connect to an RPT device 4000 to receive a pressurized gas flow. At the other end, air circuit 4170 may include a ventilation adapter connector 4174, which may connect to a ventilation adapter 9100, such as in… Figures 33A to 34G In the disclosed example, the ventilation adapter connector 4174 may include a connector 4175 to engage with a corresponding air circuit connector 9302 of the ventilation adapter 9300. The connector 4175 may be in the form of a concave bayonet connector corresponding to the air circuit connector 9302. The ventilation adapter connector 4174 may also include a gripping recess 4176 to allow a patient to grip the ventilation adapter connector 4174 and 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.

[0552] 5.5.1.7 Oxygen Delivery

[0553] In one form of this technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path (such as upstream of pneumatic block 4020), air circuit 4170 and / or patient interface 3000.

[0554] 5.5.2 Electrical components of the RPT device

[0555] 5.5.2.1 Power Supply

[0556] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0557] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of the invention, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0558] 5.5.2.2 Input Device

[0559] In one form of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one form, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another form, they can communicate wirelessly with a receiver electrically connected to a central controller 4230.

[0560] In one form, the input device 4220 may be configured or arranged to allow a person to select values ​​and / or menu options.

[0561] 5.5.2.3 Central Controller

[0562] In one form of this technology, the central controller 4230 is one or more processors adapted to control the RPT device 4000.

[0563] Suitable processors may include x86 Intel processors, based on those from ARM Holdings. Processors such as the STM32 series microcontrollers from ST Microelectronics. In some alternative forms of this technology, 32-bit RISC CPUs such as the STR9 series microcontrollers from ST Microelectronics, or 16-bit RISC CPUs such as the MSP430 series microcontrollers from Texas Instruments, are equally applicable.

[0564] In one form of this technology, the central controller 4230 is a dedicated electronic circuit.

[0565] In one form, the central controller 4230 is an application-specific integrated circuit (ASIC). In another form, the central controller 4230 includes discrete electronic components.

[0566] The central controller 4230 can be configured to receive input signals from one or more converters 4270, one or more input devices 4220, and humidifier 5000.

[0567] The central controller 4230 can be configured to provide output signals to one or more output devices 4290, treatment device controller 4240, data communication interface 4280 and humidifier 5000.

[0568] In some forms of this technology, the central controller 4230 is configured to implement one or more methods described herein, such as one or more algorithms 4300 represented as computer programs, which are stored in a non-transitory computer-readable storage medium such as memory 4260. In some forms of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed by a remote positioning device. For example, the remote positioning device may determine the control settings of the ventilator or detect respiratory-related events by analyzing stored data such as from any of the sensors described herein.

[0569] 5.5.2.4 Clock

[0570] The RPT device 4000 may include a clock connected to the central controller 4230.

[0571] 5.5.2.5 Treatment Device Controller

[0572] 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, which constitutes part of an algorithm 4300 executed by a central controller 4230.

[0573] In one embodiment of this technology, the treatment device controller 4240 is a dedicated motor control integrated circuit. For example, in one embodiment, an MC33035 brushless DC motor controller manufactured by ONSEMI is used.

[0574] 5.5.2.6 Protection Circuit

[0575] One or more protection circuits 4250 according to the present technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0576] 5.5.2.7 Memory

[0577] According to one embodiment of the present technology, the RPT device 4000 includes a memory 4260, such as non-volatile memory. In some embodiments, the memory 4260 may include battery-powered static RAM. In some embodiments, the memory 4260 may include volatile RAM.

[0578] The memory 4260 may be located on PCBA 4202. The memory 4260 may be in the form of EEPROM or NAND flash memory.

[0579] Alternatively or alternatively, the RPT device 4000 includes a removable memory 4260, such as a memory card made according to the Secure Digital (SD) standard.

[0580] In one form of this technology, memory 4260 is used as a non-transitory computer-readable storage medium storing computer program instructions representing one or more methods described herein, such as one or more algorithms 4300.

[0581] 5.5.2.8 Data Communication System

[0582] In one embodiment of this technology, a data communication interface 4280 is provided and connected to a 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.

[0583] In one embodiment, the data communication interface 4280 is part of the central controller 4230. In another embodiment, the data communication interface 4280 is separate from the central controller 4230 and may include an integrated circuit or a processor.

[0584] In one embodiment, the remote external communication network is the Internet. The data communication interface 4280 can connect to the Internet using wired communication (e.g., via Ethernet or fiber optic) or wireless protocols (e.g., CDMA, GSM, LTE).

[0585] In one form, the local external communication network utilizes one or more communication standards, such as Bluetooth or consumer infrared protocols.

[0586] In one form, the remote external device can be one or more computers, such as a cluster of networked computers. In another 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 appropriately authorized personnel, such as clinicians.

[0587] Local external devices can be personal computers, mobile phones, tablets, or remote control devices.

[0588] 5.5.2.9 Includes optional display and alarm output devices.

[0589] The output device 4290 according to this technology can take the form of one or more of visual, audio, and tactile units. The visual display can be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0590] 5.5.2.9.1 Display Driver

[0591] The display driver receives characters, symbols, or images as input for display on the display and converts them into commands that cause the display to show those characters, symbols, or images.

[0592] 5.5.2.9.2 Monitor

[0593] 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 that indicate whether the eight corresponding segments will be activated to display a specific character or symbol.

[0594] 5.5.3 RPT Device Algorithm

[0595] 5.5.3.1 Preprocessing Module

[0596] According to one form of the present technology, a preprocessing module 4310 receives a signal from a converter 4270 (e.g., a flow sensor or a pressure sensor) as input and performs one or more processing steps to calculate one or more output values ​​that will be used as input to another module (e.g., a treatment engine module 4320).

[0597] In one form of this technology, the output values ​​include interface or mask pressure Pm, breathing flow rate Qr, and leakage flow rate Ql.

[0598] In various forms of this technology, the preprocessing module 4310 includes one or more of the following algorithms: pressure compensation 4312, ventilation flow estimation 4314, leakage flow estimation 4316, and respiratory flow estimation 4318.

[0599] 5.5.3.1.1 Pressure Compensation

[0600] In one form of this technology, pressure compensation algorithm 4312 receives a signal indicating the pressure in the pneumatic path near the outlet of the pneumatic block as input. Pressure compensation algorithm 4312 estimates the pressure drop through air circuit 4170 and provides the estimated pressure Pm in patient interface 3000 as output.

[0601] 5.5.3.1.2 Ventilation flow rate estimation

[0602] In one form of this technology, the ventilation flow estimation algorithm 4314 receives the estimated pressure Pm in the patient interface 3000 as input and estimates the air ventilation flow Qv from the air vent 3400 in the patient interface 3000.

[0603] 5.5.3.1.3 Leakage Flow Estimation

[0604] In one form of this technology, the leakage flow estimation algorithm 4316 receives the total flow rate Qt and the exhaust flow rate Qv as inputs and provides an estimate of the leakage flow rate Ql as output. In another form, the leakage flow estimation algorithm estimates the leakage flow rate Ql by calculating the average of the difference between the total flow rate Qt and the ventilation flow rate Qv over a sufficiently long period of time that includes several respiratory cycles (e.g., about 10 seconds).

[0605] In one form, the leakage flow estimation algorithm 4316 receives the total flow rate Qt, the ventilation flow rate Qv, and the estimated pressure Pm from the patient interface 3000 as inputs, and provides the leakage flow rate Ql as output by calculating the leakage conductivity and determining the leakage flow rate Ql as a function of the leakage conductivity and pressure Pm. The leakage conductivity is calculated as the quotient of the low-pass filtered non-ventilation flow rate and the low-pass filtered square root of the pressure Pm, which is equal to the difference between the total flow rate Qt and the ventilation flow rate Qv, where the low-pass filter time constant has a sufficiently long time to include the value of several respiratory cycles (e.g., approximately 10 seconds). The leakage flow rate Ql can be estimated as the product of the leakage conductivity and the pressure Pm.

[0606] 5.5.3.1.4 Respiratory Flow Estimation

[0607] In one form of this technology, the respiratory flow estimation algorithm 4318 receives total flow rate Qt, ventilatory flow rate Qv, and leakage flow rate Ql as inputs, and estimates the air respiratory flow rate Qr to the patient by subtracting the ventilatory flow rate Qv and leakage flow rate Ql from the total flow rate Qt.

[0608] 5.5.3.2 Healing Engine Module

[0609] In one form of this technology, the treatment engine module 4320 receives one or more of the pressure Pm and the airflow rate Qr to the patient from the patient interface 3000 as inputs, and provides one or more treatment parameters as outputs.

[0610] In one form of this technique, the treatment parameter is the treatment pressure Pt.

[0611] In one form of this technique, the treatment parameters are one or more of pressure support level, baseline pressure, and target ventilation.

[0612] In various forms, the treatment engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow restriction determination 4324, apnea / insufficiency determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and treatment parameter determination 4329.

[0613] 5.5.3.2.1 Phase Determination

[0614] In one form of this technology, the RPT device has an uncertain phase of 4000.

[0615] In one form of this technology, the phase determination algorithm 4321 receives a signal indicating respiratory flow Qr as input and provides the phase Φ of the patient's current respiratory cycle as output.

[0616] In some forms known as discrete phase determination, the phase output Φ is a discrete variable. One implementation of discrete phase determination provides a dual-valued phase output Φ with an inspiratory or expiratory value, respectively, at the detection of the start of spontaneous inspiration and expiration, for example, values ​​of 0 and 0.5 revolutions, respectively. The RPT device 4000, which performs "triggering" and "cycling," effectively performs discrete phase determination because the trigger and cycling points are the moments of phase change from expiration to inspiration and from inspiration to expiration, respectively. In one implementation of dual-valued phase determination, when the respiratory flow rate Qr has a value exceeding a positive threshold, the phase output Φ is determined to be a discrete value of 0 (thus "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 be a discrete value of 0.5 revolutions (thus "cycling" the RPT device 4000).

[0617] Another implementation of discrete phase determination provides a three-valued phase output Φ, which has one of the values ​​for inhalation, midpoint of inhalation pause, and exhalation.

[0618] In other forms known as continuous phase determination, the phase output Φ is a continuous value, such as varying from 0 to 1 revolution or 0 to 2π radians. The RPT device 4000 performing continuous phase determination can be triggered and cycled when the continuous phase reaches 0 and 0.5 revolutions, respectively. In one embodiment of continuous phase determination, fuzzy logic analysis of the respiratory flow rate Qr is used to determine the continuous value of the phase Φ. The continuous value of the phase determined in this embodiment is generally referred to as the "fuzzy phase". In one embodiment of the fuzzy phase determination algorithm 4321, the following rule is applied to the respiratory flow rate Qr:

[0619] 1. If the respiratory flow is zero and increases rapidly, the phase is 0 revolutions.

[0620] 2. If the respiratory flow is large, positive, and stable, the phase is 0.25 revolutions.

[0621] 3. If the respiratory flow is zero and decreases rapidly, the phase is 0.5 revolutions.

[0622] 4. If the respiratory flow is significantly negative and stable, the phase is 0.75 revolutions.

[0623] 5. If the respiratory flow is zero and stable and the absolute value of the 5-second low-pass filter for the respiratory flow is large, then the phase is 0.9 revolutions.

[0624] 6. If the respiratory flow is positive and it is the expiratory phase, the phase is 0 revolutions.

[0625] 7. If the respiratory flow is negative and it is the inspiratory phase, the phase is 0.5 revolutions.

[0626] 8. If the absolute value of the 5-second low-pass filter for 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.

[0627] The output of each rule can be represented as a vector, with its phase being the result of the rule and its amplitude being the degree of ambiguity of the rule being true. The degree of ambiguity for respiratory flow such as "large" or "stable" is determined using an appropriate membership function. The results of the rules, represented as vectors, are then combined using certain functions, such as taking the centroid. In such combinations, the rules can be weighted equally or differently.

[0628] In another embodiment of continuous phase determination, the inspiratory time Ti and expiratory time Te are first estimated based on the respiratory flow rate Qr. The phase Φ is then determined as half the proportion of the inspiratory time Ti that has elapsed since the previous triggering moment, or 0.5 revolutions plus half the proportion of the expiratory time Te that has elapsed since the previous cycle moment (whichever is more recent).

[0629] 5.5.3.2.2 Waveform Determination

[0630] In one form of this technology, the treatment parameter determination algorithm 4329 provides an approximately constant treatment pressure throughout the patient's respiratory cycle.

[0631] In other forms of this technology, the treatment parameter determination algorithm 4329 controls the pressure generator 4140 to provide a treatment pressure Pt that varies throughout the patient's respiratory cycle based on a waveform template.

[0632] In one form of this technology, waveform determination algorithm 4322 provides a waveform template ∏(Φ) with a value in the range [0,1] on the domain of the phase value Φ provided by phase determination algorithm 4321 for use by treatment parameter determination algorithm 4329.

[0633] In a form suitable for discrete or continuous phase values, the waveform template П(Φ) is a square wave template with a value of 1 for phase values ​​up to and including 0.5 revolutions, and a value of 0 for phase values ​​greater than 0.5 revolutions. In a form suitable for continuous phase values, the waveform template П(Φ) includes two smoothly curved sections: a smooth curve (e.g., raised cosine) rising from 0 to 1 for phase values ​​up to 0.5 revolutions, and a smooth curve (e.g., exponential) decaying from 1 to 0 for phase values ​​greater than 0.5 revolutions. In a form suitable for continuous phase values, the waveform template П(Φ) is based on a square wave, but has a smooth rise from 0 to 1 for phase values ​​with a “rise time” significantly less than 0.5 revolutions, and a smooth fall from 1 to 0 for phase values ​​within the “fall time” after 0.5 revolutions.

[0634] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template П(Φ) from a waveform template library based on the settings of the RPT device. Each waveform template П(Φ) in the library can provide a lookup table for the value Ώ relative to the phase value Φ. In other forms, the waveform determination algorithm 4322 uses a predetermined functional form, possibly parameterized by one or more parameters (e.g., the time constant of the exponential curve portion), to calculate the “real-time” waveform template Π(Φ). The parameters of the functional form can be predetermined or depend on the current state of the patient 1000.

[0635] In some forms of the discrete dual-phase waveform applicable to inhalation (Φ = 0 rpm) or exhalation (Φ = 0.5 rpm) in this technique, waveform determination algorithm 4322 calculates the "real-time" waveform template Π as a function of both the discrete phase Φ measured since the most recent triggering moment and time t. In one such form, waveform determination algorithm 4322 calculates the waveform template Π(Φ,t) in both parts (inhalation and exhalation) as follows:

[0636]

[0637] Among them 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 ∏ i (t) of the waveform template is a smooth rise from 0 to 1 parameterized by a rise time, and the expiratory portion Π e (t) of the waveform template is a smooth decline from 1 to 0 parameterized by a fall time.

[0638] 5.5.3.2.3 Ventilation Volume Determination

[0639] In one form of the present technology, the ventilation volume determination algorithm 4323 receives the respiratory flow Qr as an input and determines a measurement value indicating the current patient ventilation volume Vent.

[0640] In some embodiments, the ventilation volume determination algorithm 4323 determines a measurement value of the ventilation volume Vent, which is an estimate of the actual patient ventilation 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).

[0641] In other embodiments, the ventilation volume determination algorithm 4323 determines a measurement value of the ventilation volume Vent, which is approximately proportional to the actual patient ventilation 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 measurement values that are approximately proportional to the ventilation volume, provided that the flow waveform shape does not vary greatly (here, when the flow waveforms of normal breaths in terms of time and amplitude are similar, the shapes of two breaths are considered similar). Some simple examples include the median of the respiratory flow being 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 using both positive and negative coefficients, is approximately proportional to the ventilation volume. Another example is the average of the respiratory flow at 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 measurement values that are exactly proportional to the ventilation volume.

[0642] 5.5.3.2.4 Inspiratory Flow Limit Determination

[0643] In one form of the present technology, the central controller 4230 executes an inspiratory flow limit determination algorithm 4324 for determining the degree of inspiratory flow limit.

[0644] 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.

[0645] In one form of this technique, the inspiratory portion of each breath is identified by a zero-crossing detector. A plurality of evenly spaced points (e.g., sixty-five) representing time points are interpolated along the inspiratory flow-time curve for each breath using 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 varying respiratory rate and depth. The scaled breath is then compared in a comparator with a representation similar to... Figure 6A The breathing shown is compared to a pre-stored template of normal, unobstructed breathing during the inspiratory phase. Breaths from this template that deviate from the template by more than a specified threshold (typically one scaling unit) at any time during inspiration, as determined by the test element, are rejected. For the non-rejected data, a moving average of the first such scaling point is calculated by the central controller 4230 over a prior number of 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 a prior number of inspiratory events, such as three events. Hereinafter, the moving average of the continuously updated values ​​of the (e.g., sixty-five) points is referred to as the “scaling flow,” named Qs(t). Alternatively, a single inspiratory event can be used instead of a moving average.

[0646] Based on the scaled flow, two shape factors can be calculated to determine the partial blockage.

[0647] The shape factor 1 is the ratio of the mean of intermediate (e.g., 32) scaled flow points to the mean of the overall (e.g., 65) scaled flow points. If this ratio is greater than 1, breathing is considered normal. If the ratio is 1 or less, breathing is considered obstructed. A ratio of approximately 1.17 is considered the threshold between partially obstructed and unobstructed breathing and is equivalent to the degree of obstruction that would allow adequate oxygenation to be maintained in a typical patient.

[0648] The shape factor 2 is calculated as the RMS deviation from the unit scaled flow rate at the midpoint (e.g., 32). An RMS deviation of approximately 0.2 units is considered normal. Zero RMS deviation is considered a fully flow-limited breath. The closer the RMS deviation is to zero, the more restricted the breath will be considered.

[0649] Shape factors 1 and 2 can be used as alternatives or in combination. In other forms of this technique, the number of sampling points, respiratory counts, and intermediate points can differ from those described above. Furthermore, the thresholds can differ from those described.

[0650] 5.5.3.2.5 Determination of respiratory arrest and insufficiency

[0651] In one form of this technology, the central controller 4230 executes a breathing apnea / insufficiency determination algorithm 4325 to determine the presence of breathing apnea and / or insufficiency.

[0652] The apnea / insufficiency determination algorithm 4325 receives the respiratory flow signal Qr as input and provides a flag indicating that apnea or insufficiency has been detected as output.

[0653] In one form, apnea is considered detected when a function of respiratory flow Qr falls below a flow threshold within a predetermined time period. This function can determine peak flow, relatively short-term average flow, or an intermediate flow between relatively short-term average and peak flow (e.g., RMS flow). The flow threshold can be a measurement of flow over a relatively long period.

[0654] In one form, insufficiency is considered detected when a function of respiratory flow Qr falls below a second flow threshold within a predetermined time period. This function can be determined by peak flow, a relatively short-term average flow, or an intermediate flow between a relatively short-term average flow and peak flow (e.g., RMS flow). The second flow threshold can be a measurement of a relatively long-term flow. The second flow threshold is greater than the flow threshold used to detect respiratory arrest.

[0655] 5.5.3.2.6 Determining Snoring

[0656] In one form of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 for determining the degree of snoring.

[0657] In one form, the snoring determination algorithm 4326 receives a signal of respiratory flow Qr as input and provides a measure of the degree of snoring presence as output.

[0658] The snoring determination algorithm 4326 may include the step of determining the flow signal strength in the range of 30-300 Hz. Furthermore, the snoring determination algorithm 4326 may include the step of filtering the signal of the respiratory flow Qr to reduce background noise (e.g., the sound of airflow from the blower in the system).

[0659] 5.5.3.2.7 Determination of airway patency

[0660] In one form of this technology, the central controller 4230 executes one or more airway occupancy determination algorithms 4327 for determining airway occupancy.

[0661] In one form, the airway occupancy determination algorithm 4327 receives the respiratory flow signal Qr as input and determines the power of the signal in a frequency range of approximately 0.75 Hz to approximately 3 Hz. A peak in this frequency range is considered an indication of airway occupancy. The absence of a peak is considered an indication of airway closure.

[0662] In one approach, the frequency range in which the peak value is located is the frequency of small forced oscillations in the treatment pressure Pt. In one embodiment, the forced oscillation frequency is 2 Hz and the amplitude is approximately 1 cm H2O.

[0663] In one form, the airway occupancy determination algorithm 4327 receives the respiratory flow signal Qr as input and determines the presence or absence of a cardiac signal. The absence of a cardiac signal is considered an indication of airway closure.

[0664] 5.5.3.2.8 Determination of Target Ventilation Rate

[0665] In one form of this technology, the central controller 4230 takes the measured value of the current ventilation volume Vent as input and executes one or more target ventilation volume determination algorithms 4328 to determine the target value Vtgt for measuring the ventilation volume.

[0666] In some forms of this technology, there is no target ventilation determination algorithm 4328, and the target value Vtgt is predetermined, for example by hard coding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0667] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from the value Vtyp, which indicates the patient's typical recent ventilation.

[0668] In some forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated as a high percentage, but less than, of the typical recent ventilation volume Vtyp. This high percentage in such forms may be in the range of (80%, 100%), (85%, 95%), or (87%, 92%).

[0669] In other forms of adaptive servo ventilation, the target ventilation volume Vtgt is calculated to be several times larger than the typical recent ventilation volume Vtyp.

[0670] A typical recent ventilation volume (Vtyp) is a value in which current ventilation volume (Vent) measurements at multiple moments within a predetermined time range tend to cluster around their distribution; that is, it is a measure of the central tendency of the current ventilation volume measurements in recent history. In one implementation of the target ventilation volume determination algorithm 4328, the recent history is on the order of minutes, but should in any case be longer than the time range of the tidal crescendo and fading cycles. The target ventilation volume determination algorithm 4328 can use a variety of known measures of central tendency to determine the typical recent ventilation volume (Vtyp) from the current ventilation volume (Vent) measurement. One such measurement is the output of a low-pass filter on the current ventilation volume (Vent) measurement, with a time constant equal to 100 seconds.

[0671] 5.5.3.2.9 Determination of Treatment Parameters

[0672] In some forms of this 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.

[0673] In one form of this technology, the treatment parameter is the instantaneous treatment pressure Pt. In one embodiment of this form, the treatment parameter determination algorithm 4329 uses the following equation to determine the treatment pressure Pt.

[0674] Pt=AΠ(Φ,t)+P0 (1)

[0675] in:

[0676] A is the amplitude.

[0677] ·Π(Φ, t) is the waveform template value (ranging from 0 to 1) for the current phase value Φ and time t, and

[0678] P0 is the base pressure.

[0679] If the waveform determination algorithm 4322 provides a 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 current phase value Φ returned by the phase determination algorithm 4321, or by interpolation between two entries spanning the current phase value Φ.

[0680] Depending on the selected respiratory pressure treatment mode, the values ​​of amplitude A and baseline pressure P0 can be set by the treatment parameter determination algorithm 4329 in the following manner.

[0681] 5.5.3.3 Treatment Control Module

[0682] According to one aspect of the present technology, the treatment control module 4330 receives treatment parameters as input from the treatment parameter determination algorithm 4329 of the treatment engine module 4320, and controls the pressure generator 4140 to deliver an airflow according to the treatment parameters.

[0683] In one form of this technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 to deliver an airflow, wherein the mask pressure Pm of the airflow at the patient interface 3000 is equal to the treatment pressure Pt.

[0684] 5.5.3.4 Fault Condition Detection

[0685] In one form of this technology, the central controller 4230 executes one or more methods 4340 for detecting fault conditions. The fault conditions detected by the one or more methods may include at least one of the following:

[0686] • Power failure (no power, or insufficient power).

[0687] • Converter fault detection

[0688] The presence of the component could not be detected.

[0689] • Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2).

[0690] • The test alarm failed to generate a detectable alarm signal.

[0691] Upon detecting a fault, the corresponding algorithm signals the presence of a fault through one or more of the following methods:

[0692] • Activate auditory, visual, and / or dynamic (e.g., vibration) alarms

[0693] Sending messages to external devices

[0694] • Record events

[0695] 5.6 Humidifier

[0696] 5.6.1 Overview of Humidifiers

[0697] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0698] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0699] 5.6.2 Mechanical components of the humidifier

[0700] 5.6.2.1 Water Storage Tank

[0701] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) capacity for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water capacity to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 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.

[0702] According to one aspect, the water reservoir 5110 is configured to increase the humidity of an airflow from the RPT device 4000 as airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow's travel in a curved path through the reservoir 5110 while in contact with the water volume therein.

[0703] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B The lateral direction shown is removed from the humidifier 5000.

[0704] The reservoir 5110 may also be configured to prevent liquid from flowing out of it, such as through any hole and / or between its sub-components, when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to prevent loss of pneumatic pressure due to leakage and / or flow resistance.

[0705] 5.6.2.2 Conductive Component

[0706] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the conductive portion 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of 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, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.

[0707] 5.6.2.3 Humidifier reservoir dock

[0708] In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B As shown, it is configured to receive humidifier reservoir 5110. In some arrangements, humidifier reservoir base 5130 may include locking mechanisms, such as locking lever 5135 configured to retain reservoir 5110 in humidifier reservoir base 5130.

[0709] 5.6.2.4 Water level indicator

[0710] Humidifier reservoir 5110 may include, for example Figures 5A-5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide a user (such as a patient 1000 or a caregiver) with one or more indications regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0711] 5.6.3 Humidifier Electrical & Thermal Components

[0712] The humidifier 5000 may include several electrical and / or thermal components, such as those listed below.

[0713] 5.6.3.1 Humidifier Converter

[0714] The humidifier 5000 may include one or more humidifier converters (sensors) 5210, other than or in addition to the converter 4270 described above. For example... 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 can communicate with a controller (such as a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier converter may be externally located to the humidifier 5000 (such as in the air circuit 4170) when communicating the output signal to the controller.

[0715] 5.6.3.1.1 Pressure Transmitter

[0716] In addition to or in addition to the pressure sensor provided in the RPT device 4000, one or more pressure converters 5212 may be provided to the humidifier 5000.

[0717] 5.6.3.1.2 Flow Converter

[0718] In addition to the flow sensor provided in the RPT device 4000, one or more flow converters 5214 may be provided to the humidifier 5000.

[0719] 5.6.3.1.3 Temperature Converter

[0720] The humidifier 5000 may include one or more temperature transducers 5216. The one or more temperature transducers 5216 may be configured to measure one or more temperatures, such as the temperature of the heating element 5240 and / or the temperature of the airflow downstream of the humidifier outlet 5004. In some forms, the humidifier 5000 may further include a temperature sensor 5216 for detecting the ambient air temperature.

[0721] 5.6.3.1.4 Humidity Converter

[0722] In some forms, the humidifier 5000 may include one or more humidity sensors 5218 for detecting 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.

[0723] 5.6.3.2 Heating element

[0724] In some cases, heating element 5240 may be provided to humidifier 5000 to provide heat input to one or more of the water capacity in humidifier reservoir 5110 and / or to airflow. Heating element 5240 may include heating components such as resistive electric heating rails. A suitable example of heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0725] In some configurations, the heating element 5240 may be housed within the humidifier base 5006, such as... Figure 5B The heat shown can be supplied to the humidifier reservoir 5110 primarily through conduction.

[0726] 5.6.3.3 Humidifier Controller

[0727] According to one arrangement of this technology, such as Figure 5C The humidifier 5000 shown may include a humidifier controller 5250. In one embodiment, the humidifier controller 5250 may be part of a central controller 4230. In another embodiment, the humidifier controller 5250 may be a standalone controller that can communicate with the central controller 4230.

[0728] In one embodiment, the humidifier controller 5250 may receive, for example, measurements of characteristics (such as temperature, humidity, pressure, and / or flow rate) of airflow and water flow in the reservoir 5110 and / or humidifier 5000 as input. The humidifier controller 5250 may also be configured to execute or implement humidifier algorithms and / or deliver one or more output signals.

[0729] like Figure 5C As shown, the humidifier controller 5250 may include one or more controllers, such as a central humidifier controller 5251, a heating air circuit controller 5254 configured to control the temperature of the heating air circuit 4170, and / or a heating element controller 5252 configured to control the temperature of the heating element 5240.

[0730] 5.7 Respiratory Pressure Therapy Mode

[0731] In one form of this technology, the RPT device 4000 can implement various respiratory pressure therapy modes by determining the values ​​of parameters A and P0 in the treatment pressure equation (1) used by the treatment parameter determination algorithm 4329.

[0732] 5.7.1 CPAP Therapy

[0733] In some embodiments of this form of the technology, the amplitude A is consistently zero, therefore the treatment pressure Pt is consistently equal to the baseline pressure P0 throughout the respiratory cycle. Such embodiments are typically grouped under the heading of CPAP therapy. In this embodiment, the treatment engine module 4320 does not need to determine the phase Φ or the waveform template Π(Φ).

[0734] In CPAP therapy, the basal pressure P0 can be a constant value, either hard-coded or manually entered 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 method called titration. During titration, clinicians typically adjust the treatment pressure Pt in response to observations of flow restriction, apnea, hypopnea, openness, and snoring during the titration phase. The titrated basal pressure P0 can then be calculated as a statistical summary of the treatment pressure Pt during the titration phase.

[0735] Alternatively, the treatment parameter determination algorithm 4329 can continuously calculate the basal pressure P0 during CPAP treatment. In this alternative approach, the treatment parameter determination algorithm 4329 continuously calculates the basal pressure P0 as a function of an indicator or measurement of sleep apnea (such as flow restriction, apnea, hypopnea, open breathing, and snoring, or one or more) returned by the corresponding algorithm in the treatment engine module 4320. This alternative approach is sometimes referred to as APAP treatment. Because the continuous calculation of the basal pressure P0 is similar to a clinician manually adjusting the treatment pressure Pt during titration, APAP treatment is sometimes also referred to as automated titration CPAP.

[0736] 5.7.2 Bilevel therapy

[0737] In other embodiments of this form of the present technology, the value of amplitude A in equation (1) can be positive. This type of embodiment is called bilevel therapy because when determining the treatment pressure Pt using equation (1) with a positive amplitude A, the treatment parameter determination algorithm 4329 oscillates the treatment pressure Pt between two values ​​or levels synchronized with the patient's spontaneous respiratory effort of 1000. That is, based on the typical waveform template Π(Φ, t) described above, the treatment parameter determination algorithm 4329 will increase the treatment pressure Pt to P0+A (referred to as IPAP) at the start of treatment or during treatment or during inspiration and decrease the treatment pressure Pt to the baseline pressure P0 (referred to as EPAP) at the start of treatment or during treatment or during inspiration.

[0738] In certain forms of bilevel therapy, IPAP is a prescribed therapeutic pressure that serves the same purpose as the therapeutic pressure in CPAP therapy, and EPAP is IPAP minus amplitude A, which has a “small” value (a few cm H2O), sometimes referred to as expiratory pressure relief (EPR). This type of therapy is sometimes referred to as CPAP therapy with EPR and is generally considered more comfortable than direct CPAP therapy. In CPAP therapy with EPR, one or both of IPAP and EPAP can be constant values ​​that are hard-coded or manually entered into the RPT device 4000. Alternatively, the treatment parameter determination algorithm 4329 can continuously calculate IPAP and / or EPAP during CPAP with EPR. In this alternative approach, the treatment parameter determination algorithm 4329 continuously calculates EPAP and / or IPAP as a function of an index or measurement of sleep apnea returned by a corresponding algorithm in the treatment engine module 4320, similar to the calculation of basal pressure P0 in the aforementioned APAP therapy.

[0739] In other forms of bilevel therapy, the amplitude A is large enough that the RPT device 4000 performs some or all of the work of the patient's breathing 1000. In this type of therapy called pressure support ventilation, the amplitude A is referred to as pressure support or oscillation. In pressure support ventilation, IPAP is the baseline pressure P0 plus pressure support A, while EPAP is the baseline pressure P0.

[0740] In some forms of pressure support ventilation therapy known as fixed pressure support ventilation therapy, pressure support A is fixed at a predetermined value, for example, 10 cm H2O. The predetermined pressure support value is a setting of the RPT device 4000 and can be set, for example, by hard coding during the configuration of the RPT device 4000 or by manual input via the input device 4220.

[0741] In some forms of pressure support ventilation therapy known as servo ventilation, the treatment parameter determination algorithm 4329 takes the current measured ventilation value Vent and the target ventilation value Vtgt provided by the target ventilation determination algorithm 4328 as inputs, and continuously adjusts the parameters of equation (1) to adjust the current measured ventilation value Vent toward the target ventilation value Vtgt. In a form of servo ventilation known as adaptive servo ventilation (ASV), which has been used to treat CSR, the target ventilation value Vtgt is calculated by the target ventilation determination algorithm 4328 based on a typical recent ventilation value Vtyp, as described above.

[0742] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method to continuously calculate the pressure support A so that the current measured ventilation value Vent is adjusted towards the target ventilation value Vtgt. One such control method is proportional-integral (PI) control. In one implementation of PI control, suitable for an ASV mode where the target ventilation value Vtgt is set slightly less than the typical recent ventilation value Vtyp, the pressure support is calculated as follows:

[0743] A=G∫(Vent-Vtgt)dt (2)

[0744] Here, G is the gain value controlled by PI. A larger gain G value can lead to positive feedback in the treatment engine module 4320. A smaller gain G value can allow for 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 can vary between treatment phases, starting with a small value and gradually increasing between phases until a value is reached that almost eliminates the CSR. In such implementations, conventional methods for retrospectively analyzing parameters of the treatment phases to assess the severity of the CSR during the treatment phase can be employed. In yet another implementation, the gain G can vary based on the difference between the current measurement of ventilation and the target ventilation Vtgt.

[0745] Other servo ventilation control methods that can be applied to algorithm 4329 by determining treatment parameters include proportional (P), proportional-derivative (PD), and proportional-integral-derivative (PID).

[0746] The pressure support A calculated by formula (2) can be limited to a range defined as [Amin, Amax]. In this implementation, the pressure support A is set at the minimum pressure support Amin by default until the current ventilation measurement Vent is lower than the target ventilation Vtgt, at which point A begins to increase, and only falls back to Amin when Vent exceeds Vtgt again.

[0747] The pressure support limits Amin and Amax are settings for the RPT device 4000, for example, by hard coding during configuration of the RPT device 4000 or by manual input via the input device 4220. The minimum pressure support value Amin at 3 cm H2O is approximately 50% of the pressure support required to perform all breathing work of a typical patient in a steady state. The maximum pressure support Amax at 12 cm H2O is approximately twice the pressure support required to perform all breathing work of a typical patient, and is therefore sufficient to support the patient's breathing if any effort is stopped, but below values ​​that would cause discomfort or danger.

[0748] In pressure support ventilation therapy, EPAP is the baseline pressure P0. Similar to the baseline pressure P0 in CPAP therapy, EPAP can be a constant value specified or determined during titration. This constant EPAP can be set, for example, by hard coding during the configuration of the RPT device 4000 or by manual input via the input device 4220. This alternative approach is sometimes referred to as fixed EPAP pressure support ventilation therapy. EPAP titration for a given patient can be performed by the clinician during the titration phase using a PSG to prevent obstructive apnea, thereby maintaining an open airway for pressure support ventilation therapy, in a manner similar to the titration of baseline pressure P0 in constant CPAP therapy.

[0749] Alternatively, the treatment parameter determination algorithm 4329 can continuously calculate the basal pressure P0 during pressure support ventilation therapy. In such alternative methods, the treatment parameter determination algorithm 4329 continuously calculates EPAP as a function of indicators or measurements of sleep apnea (such as flow restriction, apnea, hypopnea, open breathing, and snoring, or one or more) returned by the corresponding algorithm in the treatment engine module 4320. Because the continuous calculation of EPAP is similar to a clinician manually adjusting EPAP during EPAP titration, this process is sometimes referred to as automatic EPAP titration, and the overall treatment is referred to as automatic titration EPAP pressure support ventilation therapy, or automatic EPAP pressure support ventilation therapy.

[0750] 5.8 Glossary

[0751] To achieve the purposes of this technical disclosure, one or more of the following definitions may be applied in certain forms of this technology. Alternative definitions may be applied in other forms of this technology.

[0752] 5.8.1 General Rules

[0753] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0754] Environment: In some forms of this technology, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0755] For example, relative to the environment of the humidifier humidity This could be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0756] In another instance, the environment pressureIt can be pressure directly around the body or pressure outside the body.

[0757] In some forms, the environment (e.g., acoustics) noise This can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0758] Respiratory pressure therapy (RPT): Applying air supply to the airway inlet at a therapeutic pressure that is typically positive relative to the atmosphere.

[0759] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in response to the absence of such an indication.

[0760] Patient: A person, whether or not they have a respiratory illness.

[0761] Automated positive airway pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjusted between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0762] 5.8.2 Aspects of the respiratory cycle

[0763] Apnea: According to some definitions, apnea is considered to occur when the flow rate drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Obstructive apnea is considered to occur when some obstruction of the airway prevents airflow even with patient effort. Central apnea is considered to occur when apnea is detected due to reduced or absent respiratory effort, even though the airway is patent. Mixed apnea is considered to occur when reduced or absent respiratory effort occurs simultaneously with airway obstruction.

[0764] Respiratory rate: The rate at which a patient breathes spontaneously, usually measured in breaths per minute.

[0765] Duty cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0766] Effort (breathing): Breathing effort will be described as the work done by a spontaneous breather in attempting to breathe.

[0767] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0768] Flow restriction: Flow restriction is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow restriction occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow restriction. Flow restriction occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow restriction.

[0769] Types of flow-limited inhalation waveforms:

[0770] (i) Flattened: It has an upward movement, followed by a relatively flat section, and then a downward movement.

[0771] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat section between the two peaks.

[0772] (iii) Chair-shaped: It has a single local peak at the leading edge, followed by a relatively flat section.

[0773] (iv) Inverted chair shape: with a relatively flat section followed by a single local peak at the trailing edge.

[0774] Insufficient breathing: Preferably, insufficient breathing is considered as a reduction in flow rate, rather than a cessation of flow rate. In one form, insufficient breathing can be considered to have occurred when the flow rate drops below a threshold and persists for a period of time. Central insufficient breathing is considered to have occurred when insufficient breathing is detected due to a reduction in respiratory effort. In one form for adults, any of the following can be considered insufficient breathing:

[0775] (i) The patient’s respiratory rate decreases by 30% for at least 10 seconds plus a related 4% desaturation; or

[0776] (ii) The patient’s breathing is reduced (but less than 50%) for at least 10 seconds, accompanied by at least 3% desaturation or arousal.

[0777] Hyperventilation: Increased airflow to above normal levels.

[0778] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0779] Airway openness: The degree to which the airway is open or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, with a value (1) for open and a value of zero (0) for closed (obstructed).

[0780] Positive end-expiratory pressure (PEEP): Pressure above atmospheric pressure present in the lungs at the end of expiration.

[0781] Peak flow (Q peak): The maximum flow rate during the inspiratory portion of the respiratory flow waveform.

[0782] Respiratory flow, air flow, patient air flow, respiratory air flow (Qr): These synonymous terms can be understood as the RPT device’s estimate of respiratory air flow, as opposed to “real respiratory flow” or “real respiratory air flow”, which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0783] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort.

[0784] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0785] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0786] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of a subsequent respiratory flow waveform.

[0787] Typical recent ventilation: The ventilation value that tends to cluster around its recent values ​​within a predetermined time range, which is a measure of the central tendency of recent ventilation values.

[0788] Upper airway obstruction (UAO): This includes partial and complete upper airway obstruction. This may be associated with a state of flow restriction, where the flow level increases only slightly or even decreases as the pressure differential in the upper airway increases (Starling resistance behavior).

[0789] Ventilation: A measurement of the total amount of gas exchanged by a patient's respiratory system. A measurement of ventilation can include one or both of inspiratory and expiratory flow rates (per unit of time). When expressed as volume per minute, this quantity is often referred to as "minute ventilation." Minute ventilation is sometimes simply given as volume and understood as volume per minute.

[0790] 5.8.3 RPT Device Parameters

[0791] Flow rate: The instantaneous volume (or mass) of air delivered per unit time. Flow rate is measured over a shorter time period when flow rate and ventilation rate have the same volume or mass scale per unit time. In some cases, the reference to flow rate will be a scalar reference, i.e., a quantity that has only magnitude. In other cases, the reference to flow rate will be a vector reference, i.e., a quantity that has both magnitude and direction. In its scalar case, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated to 'flow'. Total flow rate Qt is the air flow rate leaving the RPT device. Tidal flow rate Qv is the air flow rate leaving the ventilator to allow flushing of exhaled gas. Leakage flow rate Ql is the leakage flow rate from the patient interface system. Respiratory flow rate Qr is the air flow rate received into the patient's respiratory system.

[0792] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one instance, leakage can occur due to an incomplete seal between the mask and the patient's face. In another instance, leakage can occur in a bend in the conduit leading to the surrounding environment.

[0793] Noise, conducted (acoustic): In this document, conducted noise refers to noise delivered to the patient through pneumatic pathways, such as air circuits and patient interfaces, and the air therein. In one form, conducted noise can be quantified by measuring the sound...

Claims

1. A ventilation system for use with a patient interface during patient respiratory therapy using a pressurized therapeutic gas flow at above ambient pressure, the ventilation system providing a ventilation gas flow to expel exhaled gases from the pressurized volume, the ventilation gas flow being continuous during the respiratory therapy, the ventilation system comprising: A venting housing, the venting 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 released from the pressurized volume into the atmosphere; A ventilation housing connector having a central aperture configured to direct the therapeutic gas flow to a patient interface; A heat and moisture exchanger (HME), the heat and moisture exchanger comprising an HME housing and HME material within the HME housing, and The membrane positioned adjacent to the base. The vent housing and the vent housing connector are configured to be at least partially connected to form a cavity, and When the ventilation system is assembled, the HME is positioned within the cavity. The pressurized volume is in fluid communication with the atmosphere via at least one first orifice and at least one second orifice throughout the entire treatment pressure range, and The membrane is capable of elastically deforming due to pressure within the pressurized volume to distribute the ventilation gas flow between the at least one first orifice and the at least one second orifice throughout the entire treatment pressure range.

2. The ventilation system of claim 1, further comprising an annular lip extending from the inner periphery of the ventilation housing and at least one retaining protrusion extending from the annular lip.

3. The ventilation system according to claim 2, further comprising an annular recess extending around the outer periphery of the HME housing. The at least one retaining protrusion and the annular recess are configured to removably attach the HME housing to the vent housing.

4. The ventilation system according to claim 3, wherein, The HME housing is removably connected to the ventilated housing via a snap-fit ​​connection.

5. The ventilation system according to claim 4, wherein, The HME housing includes a patient-side HME housing portion and an atmospheric-side HME housing portion, and The ventilation component is configured such that the patient-side HME housing portion is positioned closer to the patient during use than the atmospheric-side HME housing portion.

6. The ventilation system according to claim 5, wherein, The annular recess is provided on the atmospheric side HME housing portion.

7. The ventilation system of claim 1, wherein the ventilation housing comprises an outer wall and an inner wall, the inner wall defining an inlet for the therapeutic gas flow, and The base is located between the outer wall, the inner wall, and the base.

8. The ventilation system of claim 7, wherein the base further comprises an inner base and an outer base.

9. The ventilation system of claim 8, wherein the outer base is adjacent to the outer wall, the inner base is adjacent to the outer base, and the inner base is adjacent to the inner wall.

10. The ventilation system according to claim 9, wherein the at least one first orifice further comprises a plurality of inner orifices, and the at least one second orifice further comprises a plurality of outer orifices.

11. The ventilation system of claim 10, wherein the plurality of external orifices pass through the outer base and the plurality of internal orifices pass between the outer base and the inner base.

12. The ventilation system of claim 8, wherein the membrane comprises an elastically deformable material.

13. The ventilation system of claim 12, wherein the elastically deformable material comprises silicone resin.

14. The ventilation system of claim 8, wherein the ventilation housing is formed from a single uniform element of a relatively rigid material.

15. The ventilation system of claim 14, wherein the relatively rigid material is polycarbonate.

16. The ventilation system of claim 8, wherein the outer wall, the inner wall, the inner base, the outer base, and the membrane are circular.

17. The ventilation system of claim 16, wherein the outer wall, the inner wall, the inner base, the outer base, and the membrane are concentric.

18. The ventilation system of claim 1, wherein the membrane is not attached to the ventilation housing, allowing the membrane to move freely toward and away from the base.

19. The ventilation system according to claim 1, wherein, The HME, including the HME housing and HME material, can be removed from the cavity.

20. A patient interface, comprising: Sealing forms a structure; An air chamber combined with the sealing structure; Positioning and stabilizing structures to secure the patient interface to the patient during use; as well as The ventilation system according to any one of claims 1 to 19.

21. The patient interface of claim 20, further comprising a ventilation connection tube or decoupling structure for fluidly connecting the ventilation system to the inflation chamber.

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