Ventilation system and patient interface

Abstract

To provide a fluid connector for respiratory gas delivery from a respiratory pressure treatment device to a patient.SOLUTION: Provided is a fluid connector for respiratory gas delivery from a respiratory pressure therapy device to a patient, the fluid connector including: a first end including a first opening for fluid flow; a second end including a sealing portion extending around a perimeter of the first opening, a latching portion, and a second opening for fluid flow; a sealing surface extending azimuthally around the second opening and configured to engage the sealing portion to form a face seal; and a complementary latching portion configured to engage the latching portion; wherein the face seal allows the respiratory gas to travel between the first opening and the second opening, and engagement between the latching portion and the complementary latching portion secures the first end with the second end.SELECTED DRAWING: Figure 6B

Description

Technical Field

[0001] 1 Cross - reference to Related Applications This application claims the benefit of U.S. Provisional Application No. 62 / 222,604, filed on September 23, 2015, which is hereby incorporated by reference in its entirety.

Background Art

[0002] 2 Background of the Technology 2.1 Field of the Technology This technology relates to one or more of the detection, diagnosis, treatment, prevention, and amelioration of respiratory - related diseases. This technology also relates to medical devices or apparatuses and their use.

[0003] 2.2 Description of Related Technologies 2.2.1 The Human Respiratory System and Its Diseases The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0004] These airways include a series of branching tubes that become narrower, shorter, and more numerous as they progress deeper into the lungs. The main function of the lungs is gas exchange, taking in oxygen from the air into venous blood and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which further divide and ultimately become terminal bronchioles. The bronchi form the airways for conduction and are not involved in gas exchange. As the airways further divide, they become respiratory bronchioles and ultimately alveoli. Gas exchange occurs in the alveolar region of the lungs, which is called the respiratory zone. See the following: "Respiratory Physiology", by John B. West, Lippincott Williams & Wilkins, 9th edition published 2011.

[0005] A range of respiratory diseases exist. Certain diseases can be characterized by specific symptoms (e.g., apnea, hypopnea, and hyperpnea).

[0006] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by the onset of closure or obstruction of the upper airway during sleep. It results from an abnormally small upper airway and a normal lack of muscle tone in the lingual region, combined with the soft palate and posterior oropharyngeal wall. As a result, respiratory cessation in affected individuals typically lasts 30 to 120 seconds, sometimes as many as 200 to 300 times a night. This leads to excessive daytime sleepiness and can contribute to cardiovascular disease and brain injury. This condition is common, particularly prevalent in overweight middle-aged men, although patients often experience no symptoms. See U.S. Patent No. 4,944,310 (Sullivan).

[0007] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory regulator, characterized by alternating, cyclical increases and decreases in ventilation known as CSR cycles. CSR is characterized by repeated deoxygenation and re-aeration of arterial blood. Due to recurrent hypoxia, CSR can be harmful. In some patients, CCR is accompanied by recurrent sleep-wake cycles, which cause severe insomnia, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0008] Respiratory failure is a general term for respiratory diseases in which a patient's metabolic activity significantly exceeds that of rest, making it impossible for them to adequately ventilate their body to maintain a balance of CO2 in their blood. Respiratory failure can encompass some or all of the following conditions:

[0009] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia while awake, in the absence of any other clearly identifiable cause of hypopnea. Symptoms include shortness of breath, morning headaches, and excessive daytime sleepiness.

[0010] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower respiratory tract diseases that share certain common characteristics. These include increased resistance to air movement, prolonged expiratory phase of respiration, and reduced normal elasticity in the lungs. Examples of COPD include emphysema and chronic bronchitis. Causes of COPD include chronic smoking (the primary risk factor), occupational radiation exposure, air pollution, and genetic factors. Symptoms include exertional dyspnea, chronic cough, and sputum production.

[0011] Neuromuscular diseases (NMDs) are a broad term encompassing numerous illnesses and diseases that impair muscle function, either directly or indirectly through intrinsic muscle pathology. Some NMD patients are characterized by progressive muscle damage, which can lead to inability to walk, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified into rapidly progressive and slowly progressive types: (i) Rapidly progressive disorders: characterized by muscle damage that worsens over several months and leads to death within several years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers); (ii) Variable or slowly progressive disorders: characterized by muscle damage that worsens over several years and only slightly reduces life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include: increased general weakness, dysphagia, dyspnea at exertion and rest, fatigue, drowsiness, morning headache, and difficulty concentrating and changing mood.

[0012] Chest wall disorders are a group of thoracic deformities that cause dysfunction in the connection between the respiratory muscles and the rib cage. These disorders are primarily characterized by restrictive disorders and share the potential for long-term excess carbon dioxide respiratory failure. Scoliosis and / or kyphosis can develop into severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0013] A range of treatments are used to treat or improve such conditions. Furthermore, even otherwise healthy individuals can benefit from preventive treatments for respiratory diseases. However, these methods have several drawbacks.

[0014] 2.2.2 Treatment Continuous positive airway pressure (CPAP) therapy is used in the treatment of obstructive sleep apnea (OSA). Its mechanism of action involves, for example, the pushing of the soft palate and tongue forward or backward against the posterior oropharyngeal wall, allowing CPAP to function as an air splint, thereby preventing upper airway obstruction. Since CPAP treatment for OSA can be voluntary, patients may choose not to adhere to treatment if they notice one or more of the following regarding the device used to deliver the treatment: discomfort, difficulty of use, high cost, or lack of aesthetic appeal.

[0015] Non-invasive ventilation (NIV) provides ventilatory support to the patient through the upper airway, assisting with some or all of the respiratory function and / or maintaining adequate oxygen levels throughout the body. Ventilation support is provided through a non-invasive patient interface. NIV is used to treat forms of respiratory failure and pulmonary stenosis, such as OHS, COPD, MD, and chest wall disorders. In some forms, it can improve the comfort and effectiveness of these treatments.

[0016] Invasive ventilation (IV) provides ventilatory support to patients who are no longer able to breathe effectively on their own and may be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0017] 2.2.3 Treatment System These treatments may be provided by treatment systems or devices. Such systems and devices may also be used to diagnose symptoms without treating them.

[0018] The treatment system may include a respiratory pressure therapy device (RPT device), air circuitry, humidifier, patient interface, and data management.

[0019] Another form of treatment system is the mandibular repositioning device.

[0020] 2.2.3.1 Patient Interface A patient interface may be used to provide the wearer with an interface to a respiratory appliance, for example, by providing airflow to the airway inlet. Airflow may be provided via a mask to the nose and / or mouth, a tube to the mouth, or a tracheostomy tube to the patient's trachea. Depending on the therapy applied, the patient interface may form a seal with, for example, the area of ​​the patient's face, thereby facilitating gas delivery at a pressure of sufficient dispersion along with the ambient pressure for the administration of the therapy (for example, at a positive pressure of about 10 cmH2O relative to the ambient pressure). In other forms of therapy, such as oxygen delivery, the patient interface may not include a seal sufficient to facilitate the delivery of gas to the airway at a positive pressure of about 10 cmH2O.

[0021] Certain other mask systems may be functionally unsuitable in this field. For example, masks intended purely for decorative purposes may not be able to maintain adequate pressure. Mask systems used for underwater swimming or diving may be configured to protect against water ingress from higher external pressures and to prevent the retention of internal air at pressures higher than the ambient pressure.

[0022] Certain masks may be clinically undesirable in this technology (for example, if the mask blocks airflow through the nose and only allows airflow through the mouth).

[0023] In certain masks, if the patient must insert a portion of the mask structure into their mouth and create and maintain a seal through their lips, this technology may be uncomfortable or impractical.

[0024] Certain masks may be impractical for use during sleep (e.g., when sleeping in bed on one's side with the head on a pillow).

[0025] There are several challenges in the design of patient interfaces. The face has a complex three-dimensional shape. The size and shape of the nose vary widely among individuals. Since the head contains bone, cartilage, and soft tissue, different regions of the face exhibit different responses to mechanical forces. That is, the jaw or mandible can move relative to other bones of the skull. The entire head can move throughout the respiratory treatment period.

[0026] Due to these challenges, in the case of some masks, especially when the wearing time is long or the patient is unfamiliar with the system, there may be one or more of the reasons such as being overly pressing, aesthetically undesirable, costly, poor fit, difficult to use, and uncomfortable. For example, a mask designed for pilots, a personal protective device (e.g., a filter mask), a mask designed as part of a SCUBA mask, or an anesthesia mask, although tolerable for its original use, may be unacceptably uncomfortable for wearing over a long period (e.g., several hours). Due to such discomfort, the patient's commitment to treatment may decrease. This is especially true when the mask needs to be worn during sleep.

[0027] CPAP treatment is extremely effective in the treatment of certain respiratory diseases when the patient is committed to the treatment. If the mask is uncomfortable or difficult to use, the patient may not commit to the treatment. Since patients are often recommended to clean the mask regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not be able to clean the mask, which may affect the patient's commitment.

[0028] In the case of a mask for other uses (e.g., pilots), it may not be suitable for use in the treatment of sleep apnea. Therefore, a mask designed for use in the treatment of sleep apnea may be suitable for other uses.

[0029] For these reasons, patient interfaces for CPAP delivery during sleep form a distinct field.

[0030] 2.2.3.1.1 Sealing-forming portion The patient interface may include a sealing-forming portion. Since the patient interface comes into direct contact with the patient's face, the shape and configuration of the sealing-forming portion can directly affect the effectiveness and comfort of the patient interface.

[0031] The patient interface can be partially characterized according to the design intent of the location where the sealing-forming portion engages with the face during use. In one form of the patient interface, the sealing-forming portion can include two sub-portions that engage with each left and right nostril. In one form of the patient interface, the sealing-forming portion can include a single element that surrounds both nostrils during use. Such a single element can be designed to be placed, for example, on the upper lip region and the nasal bridge region of the face. In one form of the patient interface, the sealing-forming portion can include an element that surrounds the oral region by forming a seal, for example, on the lower lip region of the face during use. In one form of the patient interface, the sealing-forming portion can include a single element that surrounds both nostrils and the oral region during use. These different types of patient interfaces can be known by various names such as nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks by their manufacturers.

[0032] A sealing-forming portion that may be effective in one region of the patient's face may be inappropriate in another region, for example, due to different shapes, structures, variability, and sensitive regions of the patient's face. For example, the seal of a swimming goggle placed on the patient's forehead may be inappropriate for use on the patient's nose.

[0033] Specific sealing portions can be designed for mass production so that a single design fits a wide range of different face shapes and sizes, ensuring comfort and effectiveness. To form a sealing portion, one or both must be adapted to the patient's face shape and the sealing portion of the mass-produced patient interface to a certain extent, even if there is some mismatch.

[0034] One type of sealing portion extends around the periphery of the patient interface and is intended to seal the patient's face when force is applied to the patient interface while the sealing portion is engaged with the patient's face. This sealing portion may include an air or fluid-filled cushion, or it may include a molded or formed surface of an elastic sealing element made of an elastomer such as rubber. With this type of sealing portion, if the fit is improper, a gap will form between the sealing portion and the face, requiring additional force to press the patient interface against the face to achieve a seal.

[0035] Another type of sealing mechanism uses a thin flap seal positioned around the perimeter of the mask to provide a self-airtight seal against the patient's face when positive pressure is applied inside the mask. Similar to the previously mentioned type of sealing mechanism, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or leakage may occur from the mask. Furthermore, if the shape of the sealing mechanism does not conform to the patient's shape, creases or buckling may occur in the sealing mechanism during use, leading to leakage.

[0036] Other types of seal-forming components may include, for example, friction-fitting elements inserted into the nostrils, but some patients may find these seal-forming components uncomfortable.

[0037] Another form of sealing portion may use adhesive to achieve a seal. Some patients may find it inconvenient to constantly attach or remove the adhesive portion from their face.

[0038] The technology for forming a sealed portion of a patient interface within a certain range is disclosed in the following patent applications, which have been transferred to ResMed Limited: WO1998 / 004, 310; WO2006 / 074, 513; WO2010 / 135, 785.

[0039] One form of nasal pillow is found in the Adam circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is described in U.S. Patent No. 4,782,832 (Trimbl), which was transferred to Puritan-Bennett Corporation.

[0040] ResMed Limited manufactures the following products using nasal pillows: SWIFT® nasal pillow mask, SWIFT® II nasal pillow mask, SWIFT® LT nasal pillow mask, SWIFT® FX nasal pillow mask, and MIRAGELIBERTY® full-face mask. The following patent applications, assigned to ResMed Limited, describe examples of nose pillow masks: International Patent Application WO2004 / 073, 778 (in particular, describing the features of ResMed Limited's SWIFT® nose pillow); U.S. Patent Application 2009 / 0044808 (in particular, describing the features of ResMed Limited's SWIFT® LT nose pillow); International Patent Applications WO2005 / 063, 328 and WO2006 / 130, 903 (in particular, describing the features of ResMed Limited's MIRAGE LIBERTY® full-face mask); International Patent Application WO2009 / 052, 560 (in particular, describing the features of ResMed Limited's SWIFT® FX nose pillow).

[0041] 2.2.3.1.2 Positioning and Stabilization The seal-forming portion of the patient interface used in positive pressure air therapy is subjected to corresponding forces from the air pressure that interfere with the seal. Therefore, various techniques are used to position the seal-forming portion and maintain a seal on the appropriate part of the face.

[0042] In one technology, adhesive joints are used. For example, see U.S. Patent Application Publication US2010 / 0000534. However, the use of adhesive joints can sometimes cause discomfort.

[0043] In other technologies, one or more straps and / or stabilization harnesses are used. In many such harnesses, one or more of the following apply: poor fit, bulkiness, discomfort, and difficulty of handling.

[0044] 2.2.3.1.3 Ventilation Technology Some forms of patient interface systems may include vents to expel exhaled carbon dioxide. These vents may allow air to flow from the internal space of the patient interface (e.g., the plenum chamber) to the outside of the patient interface (e.g., the surroundings). These vents may include orifices, through which gas can flow when the mask is in use. Many such vents are noisy. Others may become blocked during use, resulting in insufficient expulsion. Some vents may disturb the sleep of the patient 1000 and their bedmate 1100, for example, due to noise or concentrated airflow.

[0045] ResMed Limited has developed several improved mask ventilation technologies. See below: International Patent Application Publication WO1998 / 034,665; International Patent Application Publication WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication US2009 / 0050156; U.S. Patent Application Publication 2009 / 0044808.

[0046] Table of noise levels for conventional masks (ISO 17510-2:2007, 10 cmH2O pressure at 1 m) [Table 1] JPEG0007900536000002.jpg142170

[0047] (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO3744) Various sound pressure values ​​for various subjects are shown in the list below. [Table 2]

[0048] 2.2.3.2 Respiratory Pressure Therapy (RPT) Devices Pneumatic generators are well known in a wide range of applications (e.g., industrial-scale ventilation systems). However, pneumatic generators for medical applications have specific requirements that cannot be met by more general pneumatic generators (e.g., reliability, size, and weight requirements for medical devices). In addition, even devices designed for medical treatment may not be free from defects related to one or more of the following: comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0049] One example of a specific requirement for a particular RPT device is acoustic noise.

[0050] Table of noise output levels for conventional RPT devices (measured using only one sample in CPAP mode at 10 cmH2O using the test method specified in ISO 3744). [Table 3]

[0051] One known RPT device used to treat sleep-disordered breathing is the S9 Sleep Therapy System (manufactured by ResMed Limited). Another embodiment of an RPT device is the ventilator. Ventilators (e.g., the ResMed Stellar® series of adult and pediatric ventilators) can provide assistance for invasive and non-invasive independent breathing for a range of patients for the treatment of multiple conditions (e.g., NMD, OHS, and COPD).

[0052] The ResMed Elisee® 150 and ResMed VSIII® ventilators can provide invasive and non-invasive dependent respiratory support suitable for adult or pediatric patients for the treatment of multiple conditions. These ventilators offer volumetric and pneumatic ventilation modes using single or dual limb circuits. RPT devices typically include a pressure generator (e.g., an electric blower or compressed gas reservoir) configured to supply airflow to the patient's airway. In some cases, the airflow may be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface as described above via an air circuit.

[0053] Device designers may be presented with countless options. Because design criteria often conflict, certain design choices may be far removed from convention, or even unavoidable. Furthermore, the comfort and effectiveness of a particular design can be significantly affected by even minor changes in one or more parameters.

[0054] 2.2.3.3 Humidifier Delivering airflow without humidification can lead to airway dryness. When a humidifier is used with the RPT device and patient interface, humidifying gas is generated, minimizing nasal mucosal dryness and increasing patient airway comfort. Additionally, in cooler climates, adding warm air to the facial area around the patient interface generally provides greater comfort than cool air. While a range of artificial humidification devices and systems are known, they do not meet the specific requirements of medical humidifiers.

[0055] Medical humidifiers are typically used to increase the humidity and / or temperature of an airflow relative to the ambient air as needed, when a patient is sleeping or at rest (e.g., in a hospital). Medical humidifiers placed by the bedside may be small in size. They may be configured to humidify and / or heat only the airflow delivered to the patient, and not the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) can humidify the air inhaled into the patient's body through breathing, but these systems also humidify and / or heat the entire room, which can be uncomfortable for the occupant. Furthermore, medical humidifiers may have stricter safety constraints than industrial humidifiers.

[0056] Although numerous medical humidifiers are publicly known, these humidifiers may suffer from one or more defects. Specifically, some medical humidifiers may not humidify properly, or they may be difficult or inconvenient for patients to use.

[0057] 2.2.3.4 Data Management For clinical reasons, data may be obtained to determine whether a patient prescribed respiratory therapy is "compliant" (for example, whether the patient is using their RPT device in accordance with specific "compliance rules"). For example, for CPAP therapy, a patient must use their RPT device for at least four hours per night for at least 21 consecutive days out of a 30-day period to be considered compliant. To determine patient compliance, an RPT device provider (e.g., a healthcare provider) may manually collect data describing the patient's treatment with the RPT device, calculate usage rates over a given period, and compare this to the compliance rules. Once a healthcare provider determines that a patient has used their RPT device in accordance with the compliance rules, the healthcare provider may notify third parties that the patient is compliant.

[0058] In patient treatment, there may be other ways in which communication of treatment data to third parties or external systems may be beneficial.

[0059] Existing processes for communicating and managing such data can be costly, time-consuming, and prone to errors.

[0060] 2.2.3.5 Repositioning of the mandible Mandibular repositioning devices (MRDs) or mandibular anterior fixation devices (MADs) are one of the treatment options for sleep apnea and snoring. These are adjustable oral appliances available from dentists or other suppliers that hold the mandible (lower jaw) in an anterior position during sleep. MRDs are removable devices, inserted into the patient's mouth before sleep and removed after sleep. Therefore, MRDs are not designed for continuous wear. MRDs may be custom-made or manufactured in standard forms and include an occlusal impression site designed to fit the patient's teeth. This mechanical projection from the mandible expands the space behind the tongue, adds tension to the pharyngeal wall, reduces airway collapse, and reduces palatal vibration.

[0061] In certain embodiments, the mandibular anterior fixation device may include an upper splint intended to engage with or interlock with teeth on the maxilla or maxilla, and a lower splint intended to engage with or interlock with teeth on the maxilla or mandible. The upper and lower splints are connected laterally to each other via a pair of connecting rods. This pair of connecting rods is fixed symmetrically on the upper and lower splints.

[0062] In this design, the length of the connecting rod is selected so that the mandible is held in an anterior position when the MRD is placed in the patient's oral cavity. The length of the connecting rod can be adjusted to change the level of mandibular protrusion. The dentist can determine the level of protrusion to match the mandible, and the length of the connecting rod is determined accordingly.

[0063] Some MRDs are configured to push the mandible forward relative to the maxilla, while others, like other MADs such as the ResMed Narval CC® MRD, are designed to hold the mandible in an anterior position. This device also reduces or minimizes dental and temporal / mandibular joint (TMJ) side effects. Therefore, the device is configured to minimize or prevent any movement of one or more teeth.

[0064] 2.2.4 Diagnostic and Monitoring Systems Clinical professionals can appropriately screen, diagnose, or monitor patients based on personal observation. However, there are situations where clinical professionals are unavailable or cannot be paid. In some situations, clinical professionals may have differing opinions on a patient's condition. A certain clinical professional may apply different criteria depending on the time period. When clinical practice is busy, clinicians may find it difficult to keep up with the development of patient management guidelines.

[0065] Polysomnography (PSG) is a conventional system for the diagnosis and prognosis of cardiopulmonary diseases, typically involving application and / or interpretation by a specialist clinical staff. In PSG, typically 15–20 tactile sensors are placed on the human body to record a variety of bodily signals (e.g., electroencephalography (EEG), electrocardiogram (ECG), electrooculography (EOG), and electromyography (EMG)). However, while these sensors may be suitable for normal use in a clinical setting, such systems can be complex and expensive, and / or uncomfortable or impractical for patients trying to sleep at home. [Overview of the project] [Means for solving the problem]

[0066] 3. A brief explanation of the technology This technology relates to the provision of medical devices used in the diagnosis, improvement, treatment, or prevention of respiratory diseases, which have one or more of the following advantages: improved comfort, cost, effectiveness, ease of use, and manufacturability.

[0067] A first aspect of this technology relates to a device used for the diagnosis, improvement, treatment, or prevention of respiratory diseases.

[0068] Another aspect of this technology relates to a method used in the diagnosis, improvement, treatment, or prevention of respiratory disorders.

[0069] One particular embodiment of this technology is to provide a method and / or apparatus for improving patient consent to respiratory therapy.

[0070] A first embodiment of this technology includes a connector set. The connector set comprises a compliant surface seal between a first end and a second end of the connector set, and a retaining mechanism for connecting the first end and the second end together.

[0071] A second embodiment of the present technology includes a fluid connector for the delivery of respiratory gas from a respiratory pressure therapy device to a patient. The fluid connector includes a first end containing a first opening for fluid flow, a sealing portion extending around the first opening, and a latching portion, a second end containing a second opening for fluid flow, a sealing surface extending oriented around the second opening and configured to engage with the sealing portion to form a surface seal, and a complementary latching portion configured to engage with the latching portion. The surface seal allows respiratory gas to move between the first and second openings, and the engagement between the latching portion and the complementary latching portion fixes the first end together with the second end.

[0072] A third embodiment of this technology includes a system for providing respiratory therapy to a patient. This system includes 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 connection.

[0073] A fourth embodiment of the present technology includes a method for providing a fluid connection to deliver respiratory gas from a respiratory pressure therapy device to a patient. The method includes engaging a latch between 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. One of the first end and the second end corresponds to a respiratory pressure therapy device.

[0074] A fifth embodiment of the present technology includes a first half of a fluid connector system for delivering respiratory gas from a respiratory pressure therapy device to a patient. The first half includes a connector portion having a first opening for fluid flow, a sealing portion extending around the first opening, and a latching portion. The sealing portion is configured to seal a sealed surface that extends around a second opening and together with a second half of the fluid connector system to form a surface seal, and the latching portion is configured to latch with another latching portion of the second half of the fluid connector system.

[0075] A sixth embodiment of the present technology includes a first half of a fluid connector system for respiratory gas delivery from a respiratory pressure therapy device to a patient. The first half includes a connector portion having a first opening for fluid flow, a sealing surface surrounding the first opening, and a latching portion. The sealing surface is configured to receive a sealing portion extending around a second opening and forming a surface seal together with a second half of the fluid connector system, and the latching portion is configured to latch together with another latching portion of the second half of the fluid connector system.

[0076] A seventh embodiment of the present technology includes a fluid connector for respiratory gas delivery from a respiratory pressure therapy device to a patient. The fluid connector includes a first end containing a first interior and a first retainer for fluid flow, a second end containing a second interior for fluid flow, and a complementary retainer configured to engage with the retainer. The first and second interiors have a first shape perpendicular to the flow direction, and the retainer and complementary retainer have a second shape perpendicular to the flow direction, and the first and second shapes are different.

[0077] An eighth embodiment of this technology includes a system for providing respiratory therapy to a patient. The system includes a respiratory pressure therapy device, an air circuit, and a patient interface connected to the air circuit, the patient interface being specially adapted to operate with the respiratory pressure therapy device, and means for ensuring that the patient interface is specially adapted to operate with the respiratory pressure therapy device connected to the respiratory pressure therapy device.

[0078] In at least one embodiment of the first to eighth embodiments of this technology, (a) the first end is connected to a respiratory pressure therapy device including a blower, and the second end is connected to a fluid conduit; (b) the respiratory pressure therapy device is configured to provide therapeutic pressure for sleep-related respiratory 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 beveled; (d) the sealing surface extends circumferentially around the second opening; (e) the sealing surface is radially separated from the tube defining the second opening. (f) The flange extends substantially perpendicularly from the pipe; (g) The pipe extends beyond the flange in the direction toward the seal; (h) When the complementary latching portion engages with the latching portion, the pipe extends at least partially through the seal; (i) The seal is compliant in the engagement direction between the first end and the second end; (j) The seal includes a frustoconical portion; (k) The frustoconical portion contacts the sealing surface to form a surface seal; (l) The seal includes a partially spherical surface; (m) The partially spherical surface contacts the sealing surface (n) The sealing portion includes a bellows-like or partially bellows-like portion; (o) The bellows-like or partially bellows-like portion contacts the sealing surface to form a surface seal; (p) When the first end and the second end are connected, the sealing portion is configured to engage with the sealing surface before the latching portion and complementary latching portion engage; (q) The sealing portion is compliant in the radial direction with respect to the axis defined by the engagement direction of the first end and the second end; (r) The sealing portion has no gap between the sealing portion and the sealing surface when unpressurized. If a gap exists, the seal portion is configured to expand due to internal pressure at the first end and engage with the sealing surface; (s) when the seal portion and the sealing surface come into contact, the seal portion is compressed against the sealing surface against the direction of airflow from the first opening to the second opening; (t) when the seal portion is compressed, no significant compressive force is generated; (u) the force required to compress the seal portion is less than the force required to engage the latching portion with the complementary latching portion; (v) the force required to compress the seal portion is less than half the force required to engage the latching portion with the complementary latching portion;(w) The force required to compress the seal portion is less than 1 / 10 of the force required to engage the latching portion with the complementary latching portion; (x) If the centers of the seal portion and the sealing surface are not aligned with each other, at least one of the seal portion and the sealing surface has a sufficient contact area to form a seal between the seal portion and the sealing surface; (y) The second end includes an inner portion and a lower portion, the inner portion being rotatably coupled to the lower portion; (z) The inner portion includes the sealing surface; (aa) The inner portion is firmly connected to the fluid conduit; (bb) The lower portion is a complementary latch (cc) The complementary latching portion includes a cantilever portion having a projection configured to engage with the latching portion; (dd) The structure of the cantilever portion is such that when the cantilever portion is pushed down, the complementary latching portion engages with or disengages from the latching portion, allowing engagement or disengagement between the first end and the second end; (ee) The first end includes a travel limit to restrict the second end from moving in the engagement direction between the first end and the second end; (ff) The travel limit is a flange around the first opening (gg) The second end includes a stop surface configured to contact the flange; (gg) The latching portion restricts the second end from moving in the direction opposite to the engagement direction, and the travel limit and the latching portion both define the travel distance of the second end when the first and second ends are engaged; (hh) The sealing portion is configured to seal against the sealing surface over the entire travel distance, the travel distance being non-zero distance; (ii) The sealing portion seals against the sealing surface with worst-case manufacturing tolerances and after a predetermined amount of wear and / or creep in the fluid connector (jj) The fluid connector is configured to form; (kk) The fluid connector is configured to provide a negligible pressure drop when air flows through the fluid connector throughout the patient's respiratory cycle and at pressures of 4 cmH2O to 40 cmH2O; (ll) The first end is a female connector and the second end is a male connector; (ll) The female and male connectors have non-circular profiles; (mm) The first end includes a port that is in fluid communication with the interior of the seal and is separated from the first and second openings; (nn) The first and second openings are inside 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 a fluid conduit connector; (pp) The fluid connector further includes an industry standard fluid connection, the industry standard fluid connection is in fluid communication with the first opening and is provided on the end opposite the sealing portion; (qq) The fluid connector further includes an industry standard fluid connection, the industry standard fluid connection is in fluid communication with the first opening and is provided on the end opposite the sealing surface; (rr) The first shape is circular, and the second shape includes the characteristics of both a circle and a square, and / or; (ss) One of the first interior and the second interior includes a first male part, the other of the first interior and the second interior includes a first female part, the first male part and the first female part include a first shape, one of the retaining part and the complementary retaining part includes a second male part, the other of the retaining part and the complementary retaining part includes a second female part, the second male part and the second female part include a second shape.

[0079] One embodiment of this technology is a portable RPT device, including a fluid connector, that can be carried by a person (for example, around their home).

[0080] Another aspect of the present technology relates to a ventilation assembly for a respiratory pressure therapy (RPT) system. The ventilation assembly includes: a ventilation housing defining a central orifice for allowing pressurized gas to flow through the ventilation assembly from a delivery conduit to a patient interface, the ventilation housing having an annular surface around the central orifice, the annular surface having a plurality of holes for releasing the pressurized gas into the atmosphere; and a membrane disposed adjacent to the annular surface, the membrane being movable such that as the pressure of the pressurized gas in the ventilation assembly increases, the membrane is biased to press against the annular surface of the ventilation housing.

[0081] Another aspect of the present technology relates to an RPT system comprising: the ventilation assembly described in the preceding paragraph; an RPT device configured to generate a pressurized gas flow in the range of 4 to 20 cmH2O; a patient interface configured to deliver the pressurized gas flow to the 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 patient interface.

[0082] In the embodiment of the ventilation assembly and RPT system described in Section 2 above, (a) the plurality of holes may include a first group of holes and a second group of holes, the first group of holes being closer to the central orifice compared to the second group of holes, (b) the membrane may be shaped and sized such that the membrane does not cover the first group of holes, (c) the membrane may be constructed to cover more of the second group of holes as the pressure of the pressurized gas in the ventilation assembly increases, and (d) the first group of holes are opposite to the pressurized gas flow. (e) the ventilation assembly may be located upstream of the second group of holes, (f) the membrane may further include a retaining structure for holding the membrane in a position adjacent to the annular surface of the ventilation housing, (g) the membrane may be ring-shaped, (h) the membrane may not be joined to the ventilation housing, (i) the membrane may be shaped and sized such that the outer edge of the membrane is adjacent to the inner circumference of the ventilation housing, and / or, (j) each of the multiple holes may have a shape that converges from the inner surface of the ventilation housing to the outer surface of the ventilation housing.

[0083] Another aspect of the present technology relates to a ventilation adapter for a respiratory pressure therapy (RPT) system. The ventilation adapter includes a ventilation assembly comprising: a ventilation housing defining a central orifice for allowing pressurized gas to flow from a delivery conduit to a patient interface through the ventilation assembly, the ventilation housing having an annular surface around the central orifice, the annular surface having a plurality of holes for releasing the pressurized gas into the atmosphere, and a membrane positioned adjacent to the annular surface; and a diffusion member.

[0084] Another aspect of the present technology relates to an RPT system. The RPT system includes: the ventilation adapter described in the preceding paragraph; an RPT device configured to generate a pressurized gas flow in the range of 4 to 20 cmH2O; a patient interface configured to deliver the pressurized gas flow to the 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 patient interface.

[0085] In the embodiment of the ventilation adapter and RPT system described in paragraph 2 above, (a) the membrane may be movable such that it is biased against the annular surface of the ventilation housing as the pressure of the pressurized gas in the ventilation assembly increases, (b) the plurality of holes may include a first group of holes and a second group of holes, the first group of holes being closer to the central orifice than the second group of holes, (c) the membrane may be shaped and sized such that the membrane does not cover the first group of holes, and (d) the membrane is (i) The membrane may be constructed to cover more of the holes in the second group as the pressure of the pressurized gas in the ventilation assembly increases, (e) the holes in the first group may be positioned upstream of the holes in the second group relative to the pressurized gas flow, (f) the ventilation adapter may further include a retaining structure for holding the membrane in a position adjacent to the annular surface of the ventilation housing, (g) the membrane may further include an elastic material, (h) the membrane may be ring-shaped, (i) the membrane may not be bonded to the ventilation housing, and (j) the membrane may have an outer edge (k) The holes may be shaped and sized to be adjacent to the inner circumference of the ventilation housing, (l) the ventilation adapter may include a heat and moisture exchanger (HME) which may be positioned downstream of the holes relative to the pressurized gas flow, (m) the diffusion member may be positioned on the outside of the ventilation housing so as to at least partially cover the holes, and (n) the ventilation adapter may further include a barrier member having an air-impermeable material. (o) The blocking member prevents gases escaping from multiple holes from flowing through the diffusion member into the atmosphere in a straight path; (p) The diffusion member and the blocking member may be configured to direct the gases escaping from multiple holes outward from the diffusion member in a direction different from that of the multiple holes; (p) The diffusion member may provide a flow path parallel to the surface of the blocking member in contact with the diffusion member; (q) The diffusion member may be a porous material; (r) The diffusion member may be a foamed material; and / or (s) The diffusion member may be a fibrous material.

[0086] One aspect of this technology relates to a ventilation system used in conjunction with a patient interface during respiratory therapy for a patient using a therapeutic gas flow pressurized beyond ambient pressure. The ventilation system provides a ventilation gas flow from a pressurized volume to the exhaled gas exhaled by the patient, and the ventilation flow is continuous during respiratory therapy. The ventilation system includes a ventilation housing comprising: a base having an inlet for a therapeutic gas flow extending through the base; at least one first orifice extending through the base to allow gas from the pressurized volume to be released into the atmosphere; at least one second orifice to allow gas from the pressurized volume to be released into the atmosphere; and a membrane positioned adjacent to the base.

[0087] One aspect of the present technology relates to a ventilation system used in conjunction with a patient interface during respiratory therapy of a patient using a therapeutic gas flow pressurized beyond ambient pressure. The ventilation system provides a ventilation gas flow from a pressurized volume to the exhaled gas exhaled by the patient, and the ventilation flow is 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 from the pressurized volume to be released into the atmosphere; at least one second orifice to allow gas from the pressurized volume to be released into the atmosphere; and a membrane disposed adjacent to the base, wherein the pressurized volume is in fluid communication with the atmosphere through the at least one first orifice and the at least one second orifice throughout the therapeutic pressure range, and the membrane is elastically deformable due to the pressure in the pressurized volume distributing the ventilation flow between the at least one first orifice and the at least one second orifice throughout the therapeutic pressure range.

[0088] In the embodiment, (a) the ventilation housing may include an outer wall and an inner wall, the inner wall may define an inlet for therapeutic gas flow, and the base may be positioned between the outer wall and the inner wall; (b) the base may include an inner base and an outer base; (c) the outer base may be adjacent to the outer wall, the inner base may be adjacent to the outer base, and the inner base may be adjacent to the inner wall; (d) 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 a plurality of inner orifices (f) The orifice may pass between the outer base and the inner base, (g) The ventilation system may include a plurality of base connectors for joining the inner base and the outer base and dividing a plurality of inner orifices, (h) The ventilation system may include a plurality of membrane spacers extending from the inner base, (i) The ventilation housing may include a base divider between the inner base and the outer base, and the membrane may be supported on a plurality of inner orifices on the base divider and membrane spacers, ( j) Multiple membrane spacers may define multiple membrane spacer gaps between adjacent membrane spacers; (k) The membrane may include atmosphere sides adjacent to the inner and outer bases of the ventilation housing, and an inner surface defining a membrane opening and an inner base membrane passage for discharge flow may be defined between the atmosphere sides of the membrane and the inner base of the ventilation housing; (l) An inner wall membrane passage for discharge flow may be defined between the inner surface of the membrane and the inner wall of the ventilation housing; (m) The inner base may have multiple inner base slots between adjacent membrane spacers. (n) The outer base may include a plurality of lateral membrane supports configured to prevent the membrane from covering a plurality of outer orifices, (o) The ventilation housing may include a plurality of recesses opposite the outer base, at least one of the plurality of outer orifices may open to a corresponding one of the plurality of recesses, (p) The inner wall may extend above the inner and outer bases, (q) The inner wall may extend below the inner and outer bases, (r) The membrane may include an elastically deformable material, (s) The elastically deformable material may include silicone, (t) The ventilation housing isIt may be formed from a single, homogeneous 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 coaxial, and / or, (x) the membrane may not be attached to the ventilated housing such that the membrane is freely movable in the proximal and distal directions relative to the base.

[0089] Another aspect of the present technology relates to a patient interface comprising: a seal-forming structure; a plenum chamber joined to the seal-forming structure; a positioning and stabilizing structure for securing the patient interface on a patient during use; and a ventilation system from any of the embodiments disclosed in the preceding two sections. The patient interface may include a ventilation connector tube or a decoupling structure for fluidly connecting the ventilation system to the plenum chamber.

[0090] Another aspect of the present technology relates to a ventilation system used in conjunction with a patient interface during respiratory therapy for a patient using a therapeutic gas flow pressurized beyond ambient pressure. The ventilation system provides a ventilation gas flow from a pressurized volume to the exhaled gas exhaled by the patient, and the ventilation flow is continuous during respiratory therapy. The ventilation system includes a base having at least one first orifice extending through the base to allow gas from the pressurized volume of the ventilation housing to be released into the atmosphere, at least one second orifice to allow gas from the pressurized volume to be released into the surroundings, and a membrane positioned adjacent to the base. The pressurized volume is in fluid communication with the surroundings through at least one first orifice and at least one second orifice throughout the entire treatment pressure range, and the membrane is configured such that as the pressure in the pressurized volume increases, the membrane restricts a first airflow through at least one first orifice throughout the entire treatment pressure range, and when the first airflow through at least one first orifice is restricted, a second airflow through at least one second orifice increases, thereby making the airflow through at least one first orifice and at least one second orifice substantially constant throughout the entire treatment pressure range.

[0091] In the embodiment, (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 the base may be positioned between the outer wall and the inner wall; (b) the discharge flow may be greater than or equal to the sum of the first ventilation flow and the second ventilation flow; (c) the membrane may be elastically deformable toward the base during use such that the first ventilation flow is restricted as the membrane deforms toward the base; and (d) the membrane is configured to deform closer to the base when the therapeutic pressure increases and exceeds a threshold therapeutic pressure value. (e) The membrane may be configured to reduce a first aeration flow, thereby increasing a second aeration flow as the membrane deforms closer to the base due to the treatment pressure increasing beyond a threshold treatment pressure value; (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; (f) The base may include an inner base and an outer base; (h) The aeration system may include a plurality of membrane spacers extending from the inner base; (i) The membrane may be supported across the outer base and a plurality of inner orifices on the membrane spacers, thereby causing the membrane to deform toward the inner base as the treatment pressure increases beyond a threshold treatment pressure value; (j) The membrane may be configured such that a defined membrane-inner base gap between the membrane and the inner base is reduced as the treatment pressure increases beyond a threshold treatment pressure value; (k) The membrane may be configured such that the first aeration flow is reduced and the second aeration flow is increased as the membrane / inner base gap is reduced; (l) The membrane is elastically deformable (m) The elastically deformable material may include silicone, (n) the ventilated housing may be formed from a single, homogeneous 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 coaxial, and (r) the membrane may not be attached to the ventilated housing such that the membrane is freely movable in the proximal and distal directions relative to the base.

[0092] Another aspect of the present technology relates to a patient interface comprising: a seal-forming structure; a plenum chamber joined to the seal-forming structure; a positioning and stabilizing structure for securing the patient interface on a patient during use; and a ventilation system from any of the embodiments disclosed in the preceding two sections. The patient interface may include a ventilation connector tube or a decoupling structure for fluidly connecting the ventilation system to the plenum chamber.

[0093] Another aspect of the present technology relates to a patient interface which may include: a plenum chamber pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive airflow at the therapeutic pressure for the patient's respiration; a seal-forming structure constructed and positioned to form a seal over a region of the patient's face surrounding the entrance to the patient's airway, thereby delivering airflow at the therapeutic pressure to at least the entrance to the patient's nostrils, the seal-forming structure constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use; and a seal-forming structure positioned therapeutically over the patient's head. A positioning and stabilizing structure that provides elastic force to hold in an effective position, the positioning and stabilizing structure includes a connector, the connector being constructed and positioned such that at least a portion of it rests in a region of the patient's head above the upper earlobe when in use, and the portion of the connector being sized and constructed such that a portion of the patient's head engages within the region of the parietal bone when in use, wherein the positioning and stabilizing structure has a non-rigid release section; and a ventilation system used with a patient interface during respiratory therapy of a patient using a therapeutic gas flow pressurized beyond ambient pressure, the ventilation system providing a ventilation gas flow from a pressurized volume to the exhaled gas exhaled by the patient, the ventilation flow being continuous during the respiratory therapy, the ventilation system comprising: a base having at least one first orifice extending through the base to allow gas from a pressurized volume to be released into the atmosphere; at least one second orifice to allow gas from a pressurized volume to be released into the atmosphere; and a membrane positioned adjacent to the base.Here, the pressurized volume is in fluid communication with the atmosphere through at least one first orifice and at least one second orifice throughout the entire therapeutic pressure range, wherein the membrane is configured such that as the pressure in the pressurized volume increases, it restricts a first airflow through at least one first orifice throughout the entire therapeutic pressure range, and when the first airflow is restricted through at least one first orifice, it increases a second airflow through at least one second orifice so that the airflow through at least one first orifice and at least one second orifice remains substantially constant throughout the entire therapeutic pressure range, and the patient interface is configured such that the patient can breathe from the surroundings through their oral cavity when there is no flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's oral cavity exposed.

[0094] In the embodiment, (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 the base may be positioned between the outer wall and the inner wall, (b) the discharge flow may be greater than or equal to the sum of the first ventilation flow and the second ventilation flow, (c) the membrane may be elastically deformable toward the base during use such that the first ventilation flow is restricted as the membrane deforms toward the base, (d) the membrane may be configured to deform closer to the base when the therapeutic pressure increases and exceeds a threshold therapeutic pressure value, and (e) the membrane, The first airflow may be configured to reduce the second airflow as the membrane strains closer to the base due to the treatment pressure increasing beyond a threshold treatment 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, at least one second orifice may include a plurality of outer orifices, (h) the airflow system may include a plurality of membrane spacers extending from the inner base, and (i) the membrane may be on the outer base and membrane spacers. (j) The ventilation housing may be supported on multiple inner orifices, (k) the outer base may include a base divider between an inner base and an outer base, the membrane may be supported on multiple inner orifices on the base divider and membrane spacers, (l) the membrane may include an elastically deformable material, (m) the elastically deformable material may include silicone, (n) the ventilation housing may be a single homogeneous particle made of a relatively rigid material (o) a 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 coaxial, (r) the membrane may not be attached to the ventilation housing such that the membrane is freely movable in the proximal and distal directions relative to the base, and / or, (s) the patient interface may include a ventilation connector tube or a disconnection structure for fluidly connecting the ventilation system to the plenum chamber.

[0095] Another aspect of the present technology relates to a patient interface which may include: a plenum chamber pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the plenum chamber including a plenum chamber inlet port sized and constructed to receive an airflow at the therapeutic pressure for the patient's respiration; and a seal-forming structure constructed and positioned to form a seal over a region of the patient's face surrounding the entrance to the patient's airway, thereby delivering the airflow at the therapeutic pressure to at least the entrance to the patient's nostrils, the seal-forming structure constructed and positioned to maintain the therapeutic pressure within the plenum chamber for the entire respiratory cycle of the patient during use. A positioning and stabilizing structure that provides elastic force to hold a seal-forming structure in a therapeutically effective position on the head of a patient, wherein the positioning and stabilizing structure includes a connector, which is constructed and positioned such that at least a portion of the connector rests on a region of the patient's head above the upper earlobe when in use, and the portion of the connector is sized and constructed such that a portion of the patient's head engages within the region of the parietal bone when in use, wherein the positioning and stabilizing structure has a non-rigid release portion; and a ventilation system that provides a ventilation gas flow from a pressurized volume to the exhaled gas exhaled by the patient, wherein the ventilation flow is continuous during respiratory therapy, and the ventilation flow includes a first ventilation flow and a second ventilation flow. The ventilation system includes: 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.Here, the pressurized volume is in fluid communication with the atmosphere through at least one first orifice and at least one second orifice throughout the entire therapeutic pressure range, wherein the membrane is configured to be elastically deformable by the pressure in the pressurized volume, so that as the deformation increases due to the increase in pressure, the first airflow through at least one first orifice is reduced and the second airflow through at least one second orifice is increased, thereby maintaining a substantially constant airflow throughout the entire therapeutic pressure range, and the patient interface is configured to allow the patient to breathe from the surroundings through their own oral cavity when there is no flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to leave the patient's oral cavity exposed.

[0096] In the embodiment, (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 the base may be positioned between the outer wall and the inner wall, (b) the discharge flow may be greater than or equal to the sum of the first ventilation flow and the second ventilation flow, (c) the membrane may be elastically deformable toward the base during use such that the first ventilation flow is restricted as the membrane deforms toward the base, (d) the membrane may be configured to deform closer to the base when the therapeutic pressure increases and exceeds a threshold therapeutic pressure value, and (e) the membrane, The first airflow may be configured to reduce the second airflow as the membrane strains closer to the base due to the treatment pressure increasing beyond a threshold treatment 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, at least one second orifice may include a plurality of outer orifices, (h) the airflow system may include a plurality of membrane spacers extending from the inner base, and (i) the membrane may be on the outer base and membrane spacers. (j) The ventilation housing may be supported on multiple inner orifices, (k) the outer base may include a base divider between an inner base and an outer base, the membrane may be supported on multiple inner orifices on the base divider and membrane spacers, (l) the membrane may include an elastically deformable material, (m) the elastically deformable material may include silicone, (n) the ventilation housing may be a single homogeneous particle made of a relatively rigid material (o) a 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 coaxial, (r) the membrane may not be attached to the ventilation housing such that the membrane is freely movable in the proximal and distal directions relative to the base, and / or, (s) the patient interface may include a ventilation connector tube or a disconnection structure for fluidly connecting the ventilation system to the plenum chamber.

[0097] Of course, some of the above-mentioned modes can form sub-modes of this technology. Furthermore, various combinations of sub-modes and / or modes can be made to constitute further modes or sub-modes of this technology.

[0098] Other features of this technology will become apparent in light of the information contained in the following detailed description, abstract, drawings, and claims. [Brief explanation of the drawing]

[0099] 4. Brief Description of the Drawings This technology is illustrated in the attached drawings as a non-limiting embodiment. In the drawings, similar reference numerals include the following similar elements: 4.1 Treatment System [Figure 1A] Figure 1A shows a system including patient 1000 wearing patient interface 3000. This system takes the form of a nasal pillow and receives positive-pressure air supplied from RPT device 4000. The air from the RPT device is humidified by humidifier 5000 and travels to patient 1000 along air circuit 4170. A person sleeping with patient 1100 is also illustrated. [Figure 1B] Figure 1B shows a system including patient 1000 wearing patient interface 3000. This system takes the form of a nasal mask and receives positive-pressure air supplied from RPT device 4000. The air from the RPT device is humidified by humidifier 5000 and travels to patient 1000 along air circuit 4170. [Figure 1C] Figure 1C shows a system including patient 1000 wearing patient interface 3000. Patient interface 3000 takes a full-face mask and receives positive pressure air supply from RPT device 4000. The air from the RPT device is humidified by humidifier 5000 and travels to patient 1000 along air circuit 4170. 4.2 Respiratory system and facial anatomy [Figure 2A]Figure 2A shows an overview of the human respiratory system, including the nose and oral cavity, larynx, vocal cord folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm. [Figure 2B] Figure 2B is a diagram of the human upper respiratory tract, including the nasal cavity, nasal bone, lateral nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cord folds, esophagus, and trachea. [Figure 2C] Figure 2C is a frontal view of the face including several features of surface anatomical structures, including the upper lip, upper vermilion, lower vermilion, lower lip, oral cavity width, endocardium, nasal alae, nasolabial folds, and corners of the mouth. Superior, inferior, radial medial, and radial lateral directions are also indicated. [Figure 2D] Figure 2D is a lateral view of the head including several features of surface anatomical structures, including the glabella, selion, nasal tip, subnasal point, upper lip, lower lip, chin, nasal ridge, narrow apex, superior and inferior points of the ear. Superior and inferior, and anterior and posterior directions are also indicated. [Figure 2E] Figure 2E is a further lateral view of the head. The approximate positions of the Frankfort horizontal and nasolabial angles are indicated. The frontal plane is also shown. [Figure 2F] Figure 2F is a basal view of the nose, including several features such as the nasolabial folds, lower lip, upper lip, nostrils, subnasal point, columella, nasal tip, and the main axis and sagittal plane of the nostrils. [Figure 2G] Figure 2G is a lateral view of the surface features of the nose. [Figure 2H] Figure 2H shows the subcutaneous structure of the nose, 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 fibrous adipose tissue. [Figure 2I] Figure 2I shows the midline nasal incision, located approximately a few millimeters from the sagittal plane, and particularly shows the septal cartilage and the medial crura of the greater alar cartilage. [Figure 2J] Figure 2J is a frontal view of the skull, including the frontal, nasal, and zygomatic bones. The nasal conchae are shown together with the maxilla and mandible. [Figure 2K]Figure 2K is a lateral view of the skull showing the external shape of the head surface and several muscles. The following bones are illustrated: frontal, sphenoid, nasal, zygomatic, maxilla, mandible, parietal, temporal, and occipital bones. The mental protuberance is illustrated. The following muscles are illustrated: digastric, masseter, sternocleidomastoid, and trapezius muscles. [Figure 2L] Figure 2L shows the anterolateral aspect of the nose. 4.3 Patient Interface [Figure 3A] Figure 3A shows a patient interface in the form of a nasal mask according to one embodiment of this technology. [Figure 3B] Figure 3B is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively large compared to the curvature shown in 3C. [Figure 3C] Figure 3C is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a positive sign and is relatively small compared to the magnitude of curvature shown in Figure 3B. [Figure 3D] Figure 3D is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature value at this point is zero. [Figure 3E] Figure 3E is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively small compared to the magnitude of curvature shown in Figure 3F. [Figure 3F] Figure 3F is a schematic cross-sectional view of the structure cut at a single point. The outward normal at this point is shown. The curvature at this point has a negative sign and is relatively large compared to the curvature shown in Figure 3E. [Figure 3G] Figure 3G shows a mask cushion containing two pillows. The outer surface of the cushion is shown. The edges of the surface are shown. The dome region and saddle region are shown. [Figure 3H]Figure 3H shows the cushion for the mask. The outer surface of the cushion is shown. The edges of the surface are shown. The path on the surface between points A and B is shown. The straight-line distance between A and B is shown. Two saddle regions and a dome region are shown. 4.4 RPT device [Figure 4A] An RPT device 4000 conforming to one form of this technology is shown. [Figure 4B] This is a schematic diagram of the air circuit of the RPT device 4000, which conforms to one form of this technology. The upstream and downstream directions are indicated. [Figure 4C] This is a schematic diagram of the electrical components of an RPT device 4000 according to one aspect of this technology. [Figure 4D] Figure 4D is a schematic diagram of an algorithm executed in an RPT device according to one embodiment of this technology. [Figure 4E] This is a flowchart illustrating method 4500 performed by the treatment engine module 4320 in Figure 9D, according to one aspect of this technology. 4.5 Humidifier [Figure 5A] Figure 5A is an isometric view of a humidifier according to one embodiment of this technology. [Figure 5B] Figure 5B is an isometric view of a humidifier according to one embodiment of this technology, showing the humidifier reservoir 5110 removed from the humidifier reservoir dock 5130. [Figure 5C] Figure 5C is a schematic diagram of a humidifier according to one embodiment of this technology. 4.6 Ventilation Adapter [Figure 6A] Figure 6A is a side view of a fluid connector in which the first end and the second end are interlocked. [Figure 6B] Figure 6B is a side cross-sectional view of a fluid connector in which the first and second ends are not interlocked. [Figure 6C] Figure 6C is a side cross-sectional view of a fluid connector in which the first end and the second end are interlocked. [Figure 6D] Figure 6D is a perspective view of a fluid connector with a first end and a second end separated from each other, and the interior of the first end is not visible. [Figure 6E] Figure 6E is a cross-sectional view of a fluid connector with additional fluid ports. [Figure 6F] Figure 6F shows a fluid connector in which both the first and second ends are connected and the first end is integrated with an RTP device. [Figure 6G] Figure 6G shows a fluid connector in which the first and second ends are not connected and the first end is integrated with the RTP device. [Figure 6H] Figure 6H is a perspective view of a fluid connector with a first end and a second end separated from each other, and the sealing surface of the second end is visible. [Figure 7A] Figure 7A is a perspective view of a ventilation adapter according to one embodiment of this technology. [Figure 7B] Figure 7B is a side view of a ventilation adapter according to one embodiment of this technology. [Figure 7C] Figure 7C is a top view of a ventilation adapter according to one embodiment of this technology. [Figure 7D] Figure 7D is a cross-sectional view of a ventilation adapter according to one embodiment of the present technology, taken through the line 7D-7D in Figure 7C. [Figure 7E] Figure 7E is an exploded view of a ventilation adapter according to one embodiment of this technology. [Figure 7F] Figure 7F is another exploded view of a ventilation adapter according to one embodiment of this technology. [Figure 8A] Figure 8A is a perspective view of a ventilation housing according to one embodiment of this technology. [Figure 8B] Figure 8B is another perspective view of a ventilation housing according to one embodiment of this technology. [Figure 8C] Figure 8C is a side view of a ventilation housing according to one embodiment of this technology. [Figure 8D] Figure 8D is another side view of a ventilation housing according to one embodiment of this technology. [Figure 8E] Figure 8E is a top view of a ventilation housing according to one embodiment of this technology. [Figure 8F]Figure 8F is a cross-sectional view of a ventilation housing according to one embodiment of the present technology, taken through the line 8F-8F in Figure 8E. [Figure 9A] Figure 9A is a perspective view of a ventilation housing connector according to one embodiment of this technology. [Figure 9B] Figure 9B is another perspective view of a ventilation housing connector according to one embodiment of this technology. [Figure 9C] Figure 9C is a side view of a ventilation housing connector according to one embodiment of this technology. [Figure 9D] Figure 9D is another side view of a ventilation housing connector according to one embodiment of this technology. [Figure 9E] Figure 9E is a top view of a ventilation housing connector according to one embodiment of this technology. [Figure 10A] Figure 10A is a perspective view of a bellows seal according to one embodiment of this technology. [Figure 10B] Figure 10B is another perspective view of a bellows seal according to one embodiment of the present technology. [Figure 10C] Figure 10C is a side view of a bellows seal according to one embodiment of the present technology. [Figure 10D] Figure 10D is another side view of a bellows seal according to one embodiment of the present technology. [Figure 10E] Figure 10E is a bottom view of a bellows seal according to one embodiment of this technology. [Figure 11A] Figure 11A is a perspective view of a ventilation adapter connector according to one embodiment of this technology. [Figure 11B] Figure 11B is another perspective view of a ventilation adapter connector according to one embodiment of the present technology. [Figure 11C] Figure 11C is a side view of a ventilation adapter connector according to one embodiment of the present technology. [Figure 11D] Figure 11D is another side view of a ventilation adapter connector according to one embodiment of the present technology. [Figure 11E] Figure 11E is a bottom view of one embodiment of the ventilation adapter connector of this technology. [Figure 12A]Figure 12A is a perspective view of a heat and moisture exchanger (HME) clip according to one embodiment of this technology. [Figure 12B] Figure 12B is a side view of a heat and moisture exchanger (HME) clip according to one embodiment of this technology. [Figure 12C] Figure 12C is another side view of a heat and moisture exchanger (HME) clip according to one embodiment of the present technology. [Figure 12D] Figure 12D is another side view of a heat and moisture exchanger (HME) clip according to one embodiment of this technology. [Figure 13A] Figure 13A is a perspective view of a heat and moisture exchanger (HME) housing according to one embodiment of this technology. [Figure 13B] Figure 13B is a side view of a heat and moisture exchanger (HME) housing according to one embodiment of this technology. [Figure 13C] Figure 13C is another side view of a heat and moisture exchanger (HME) housing according to one embodiment of this technology. [Figure 13D] Figure 13D is a top view of a heat and moisture exchanger (HME) housing according to one embodiment of this technology. [Figure 14A] Figure 14A is a perspective view of a conduit connector according to one embodiment of this technology. [Figure 14B] Figure 14B is a top view of a conduit connector according to one embodiment of this technology. [Figure 14C] Figure 14C is a side view of a conduit connector according to one embodiment of this technology. [Figure 14D] Figure 14D is a front view of a conduit connector according to one embodiment of this technology. [Figure 15A] Figure 15A is a perspective view of a ventilation adapter according to one embodiment of this technology. [Figure 15B] Figure 15B is another perspective view of a ventilation adapter according to one embodiment of this technology. [Figure 15C] Figure 15C is an exploded view of a ventilation adapter according to one embodiment of this technology. [Figure 15D] Figure 15D is an exploded view of a ventilation adapter according to one embodiment of this technology. [Figure 15E]Figure 15E is a side view of a ventilation adapter according to one embodiment of the present technology. [Figure 15F] Figure 15F is a cross-sectional view of a ventilation adapter according to one embodiment of the present technology, taken through the line 15F-15F in Figure 15B. [Figure 16] Figure 16 is a graph comparing the airflow from a full-face mask with the airflow from a constant flow rate ventilation (CFV) using this technology, within a certain range of therapeutic pressures. [Figure 17] Figure 17 shows a patient receiving treatment according to one embodiment of this technology. [Figure 18] Figure 18 is a graph comparing the airflow from a full-face mask with the airflow from a constant flow rate ventilation (CFV) using this technology, within a certain range of therapeutic pressures. [Figure 19] Figure 19 is a graph showing the airflow from passive ventilation alone and constant flow rate ventilation (CFV) alone within a certain range of therapeutic pressures, and the combination of both using this technology. [Figure 20] Figure 20 shows an example of a constant flow rate permeable (CFV) membrane according to one embodiment of this technology. [Figure 21A] Figure 21A is a cross-sectional view of a ventilation adapter according to one embodiment of the present technology. [Figure 21B] Figure 21B is an exploded view of constant flow rate ventilation (CFV) of a ventilation adapter according to one embodiment of this technology. [Figure 21C] Figure 21C is a rear view of a constant flow rate ventilation (CFV) of a ventilation adapter according to one embodiment of this technology. [Figure 21D] Figure 21D is a perspective view of a constant flow rate (CFV) ventilation adapter according to one embodiment of this technology. [Figure 21E] Figure 21E is another perspective view of constant flow rate ventilation (CFV) of a ventilation adapter according to one embodiment of this technology. [Figure 21F] Figure 21F is a cross-sectional view of a constant flow rate ventilation (CFV) using a ventilation adapter according to one embodiment of this technology. [Figure 22] Figure 22 is an exploded view of a ventilation adapter according to one embodiment of this technology. [Figure 23] Figure 23 shows a chart illustrating an exemplary patient interface using this technology. [Figure 24A] Figure 24A is a cross-sectional view of a ventilation adapter according to one embodiment of the present technology. [Figure 24B] Figure 24B is a perspective view of a ventilation adapter according to one embodiment of this technology. [Figure 25A] Figure 25A is a cross-sectional view of an HME7000 including a single layer 7001 according to one embodiment of the present technology. [Figure 25B] Figure 25B shows an example of a single corrugation 7030 of HME7000 according to one aspect of the present technology. [Figure 25C] Figure 25C is a schematic diagram showing the HME7000, which includes multiple layers 7001 stacked along both the vertical and horizontal axes. [Figure 25D] Figure 25D shows the HME under preload to compress the corrugation to a constant volume so as to increase the number of layers 7001 within a constant volume. [Figure 25E] Figure 25E shows a corrugated structure 7002 containing multiple corrugations 7030. The corrugated structure is rolled up to form HME 7000. [Figure 26] Figure 26 shows the orifice, diffusion member, and blocking member that form part of the gas discharge vent. [Figure 27] Figure 27 shows an orifice, a diffusion member, and a blocking member that form part of the gas discharge vent, with a hole provided in the blocking member. [Figure 28] Figure 28 is an exploded view of the orifice, diffusion member, and blocking member that form part of the circular gas discharge vent around the central hole. [Figure 29] Figure 29 is a simplified diagram of the orifice, diffusion member, and blocking member that form part of the circular gas discharge vent around the central hole. [Figure 30] Figure 30 is a cross-sectional view taken through line 30-30 in Figure 29. [Figure 31A]Figure 31A is a partial view of an elbow with a gas discharge vent along with a single annular outlet. [Figure 31B] Figure 31B is an axial view of the orifice during gas discharge ventilation as shown in Figure 31B. [Figure 31C] Figure 31C is a cross-sectional view taken through the plane in Figure 31 that corresponds to the plane labeled 31C-31C in Figure 31B. [Figure 32A] Figure 32A shows an elbow with a ball-and-socket joint and gas discharge ventilation. [Figure 32B] Figure 32B is an exploded view of the elbow shown in Figure 32A. [Figure 32C] Figure 32C is a side view of the elbow. [Figure 32D] Figure 32D is a cross-sectional view taken through the line 32D-32D in Figure 32C. [Figure 33A] Figure 33A is a perspective view of a ventilation adapter according to one embodiment of this technology. [Figure 33B] Figure 33B is another perspective view of a ventilation adapter according to one embodiment of this technology. [Figure 33C] Figure 33C is an overhead view of a ventilation adapter according to one embodiment of this technology. [Figure 33D] Figure 33D is a downward view of a ventilation adapter according to one embodiment of this technology. [Figure 33E] Figure 33E is a lateral view of a ventilation adapter according to one embodiment of this technology. [Figure 33F] Figure 33F is a cross-sectional view of a ventilation adapter taken through the line 33F-33F in Figure 33C according to one embodiment of the present technology. [Figure 33G] Figure 33G is an exploded view of a ventilation adapter according to one embodiment of this technology. [Figure 34A] Figure 34A is a perspective view of a ventilation assembly for a ventilation adapter according to one embodiment of the present technology. [Figure 34B] Figure 34B is another perspective view of a ventilation assembly for a ventilation adapter according to one embodiment of the present technology. [Figure 34C]Figure 34C is a rear view of a ventilation assembly for a ventilation adapter according to one embodiment of the present technology. [Figure 34D] Figure 34D is a front view of a ventilation assembly for a ventilation adapter according to one embodiment of the present technology. [Figure 34E] Figure 34E is a lateral view of a ventilation assembly for a ventilation adapter according to one embodiment of the present technology. [Figure 34F] Figure 34F is a cross-sectional view of a ventilation assembly for a ventilation adapter taken through line 34F-34F in Figure 34C according to one embodiment of the present technology. [Figure 34G] Figure 34G is an exploded view of a ventilation adapter ventilation assembly according to one embodiment of the present technology. [Figure 35] Figure 35 is a perspective view of a ventilation adapter with a patient interface according to one embodiment of this technology. [Figure 36A] Figure 36A is a perspective view of an air circuit according to one embodiment of this technology. [Figure 36B] Figure 36B is another perspective view of an air circuit according to one embodiment of this technology. [Figure 36C] Figure 36C is an exploded view of an air circuit according to one embodiment of this technology. [Figure 37A] Figure 37A is a perspective view of a ventilation adapter according to one embodiment of this technology. [Figure 37B] Figure 37B is another perspective view of a ventilation adapter according to one embodiment of this technology. [Figure 37C] Figure 37C is a lateral view of a ventilation adapter according to one embodiment of this technology. [Figure 37D] Figure 37D is a cross-sectional view of a ventilation adapter taken through line 37D-37D in Figure 37B according to one embodiment of the present technology. [Figure 37E] Figure 37E is an exploded view of a ventilation adapter according to one embodiment of this technology. [Figure 38A] Figure 38A is a perspective view of a heat and moisture exchanger (HME) housing according to one embodiment of this technology. [Figure 38B]Figure 38B is another perspective view of an HME housing according to one embodiment of this technology. [Figure 38C] Figure 38C is an exploded view of an HME housing according to one embodiment of this technology. [Figure 39A] Figure 39A is a perspective view of a heat and moisture exchanger (HME) housing according to one embodiment of this technology. [Figure 39B] Figure 39B is another perspective view of an HME housing according to one embodiment of this technology. [Figure 39C] Figure 39C is an exploded view of an HME housing according to one embodiment of this technology. [Figure 40] Figure 40 is a perspective view of a ventilation adapter equipped with a patient interface according to one embodiment of this technology. [Figure 41] Figure 41 is a perspective view of a ventilation adapter equipped with a patient interface according to one embodiment of this technology. [Figure 42A] Figure 42A is a top perspective view of a ventilation housing according to another embodiment of the present technology. [Figure 42B] Figure 42B is a top view of a ventilation housing according to another embodiment of the present technology. [Figure 42C] Figure 42C is a bottom view of a ventilation housing according to another embodiment of the present technology. [Figure 42D] Figure 42D is a bottom perspective view of a ventilation housing according to another embodiment of the present technology. [Figure 42E] Figure 42E is a side view of a ventilation housing according to another embodiment of the present technology. [Figure 42F] Figure 42F is a cross-sectional view of a ventilation housing according to another embodiment of the present technology, taken through line 42F-42F in Figure 42B. [Figure 42G] Figure 42G is a cross-sectional view of a ventilation housing according to another embodiment of the present technology, taken through line 42G-42G in Figure 42B. [Figure 43A] Figure 43A is a top perspective view of a ventilation system according to another embodiment of the present technology. [Figure 43B]Figure 43B is a top view of a ventilation system according to another embodiment of the present technology. [Figure 43C] Figure 43C is a bottom view of a ventilation system according to another embodiment of this technology. [Figure 43D] Figure 43D is a bottom perspective view of a ventilation system according to another embodiment of the present technology. [Figure 43E] Figure 43E is a side view of a ventilation system according to another embodiment of the present technology. [Figure 43F] Figure 43F is a cross-sectional view of a ventilation system according to another embodiment of the present technology, taken through line 43F-43F in Figure 43B. [Figure 43G] Figure 43G is a cross-sectional view of a ventilation system according to one embodiment of the present technology, taken through line 43G-43G in Figure 43B. [Modes for carrying out the invention]

[0100] 5. Detailed Description of the Technology's Embodiments Before describing the technology in further detail, it should be understood that the technology is not limited to the specific embodiments which may differ as described herein. It should also be understood that the terms used in this disclosure are for the purpose of describing the specific embodiments described herein and are not limiting.

[0101] The following description is provided in relation to a variety of embodiments that may share one or more common properties and / or features. It should be understood that one or more features of any one embodiment may be combined with one or more features of another embodiment or any other embodiment. In addition, any single feature or combination of features in any of these embodiments may constitute a further embodiment.

[0102] 5.1 Treatment In one embodiment, the technology includes a method for treating respiratory diseases. The method includes the step of applying positive pressure to the airway entrance of 1000 patients.

[0103] In certain embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0104] In certain embodiments of this technology, mouth breathing is restricted, limited, or prevented. 5.2 Treatment System

[0105] In one embodiment, the technology includes an apparatus or device for the treatment of respiratory disorders. The apparatus or device may include an RPT device 4000 that supplies compressed air to a patient 1000 via an air circuit 4170 to a patient interface 3000.

[0106] 5.3 Patient Interface A non-invasive patient interface 3000 according to one aspect of this technology includes the following functional modes: a sealing forming structure 3100, a plenum chamber 3200, a positioning and stabilizing structure 3300, a vent 3400, a connection port 3600 in one form for connection to an air circuit 4170, and a forehead support 3700. In some embodiments, the functional modes may be provided by one or more physical components. In some embodiments, one physical component may provide one or more functional modes. When in use, the sealing forming structure 3100 is positioned to surround the entrance to the patient's airway to facilitate positive pressure air supply to the airway.

[0107] 5.3.1 Closed formation structure In one embodiment of this technology, the sealing structure 3100 provides a sealing surface and can further provide a cushioning function.

[0108] The sealed structure 3100 produced by this technology may be made of a soft, flexible, and elastic material (for example, silicone).

[0109] 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 (e.g., about 0.25 mm to about 0.45 mm). This member extends around the periphery length of the plenum chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is positioned between the sealing flange and the periphery of the plenum chamber 3200 and extends around at least a portion of the periphery length. The support flange is or includes a spring-like element and functions to support the sealing flange so as not to buckle during use. During use, the sealing flange may readily respond to the system pressure in the plenum chamber 3200 and act on its underside to form a tight sealing engagement with the surface.

[0110] In one embodiment, the sealing portion of the non-invasive patient interface 3000 includes a pair of nasal puffs or nasal pillows. Each nasal puff or nasal pillow is configured and positioned to form a seal with each nostril of the patient's nose.

[0111] A nasal pillow according to one aspect of this technology includes a frustum of a cone. At least a portion of the frustum of the cone forms a seal on the underside of the patient's nose, on the stalk, and on a flexible region on the underside of the frustum of the cone, connecting the frustum of the cone to the stalk. In addition, the structure to which the nasal pillow of this technology is connected includes a flexible region adjacent to the base of the stalk. The flexible region may function to facilitate a flexible connection structure. The flexible connection structure accommodates both the displacement and angle of the frustum of the cone and the mutual movement between the nasal pillow and the structure to which it is connected. For example, the frustum of the cone may be displaced axially toward the structure to which the stalk is connected.

[0112] In one embodiment, the non-invasive patient interface 3000 includes a sealing portion that forms a seal on the upper lip region of the patient's face (i.e., the upper lip).

[0113] In one embodiment, the non-invasive patient interface 3000 includes a sealing portion that forms a seal on the jaw region of the patient's face.

[0114] 5.3.2 Plenum Chamber The plenum chamber 3200 has a perimeter shape that is complementary to the surface contour of an average human face in the area where a seal is formed during use. During use, the peripheral edge of the plenum chamber 3200 is positioned close to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend around the entire perimeter of the plenum chamber 3200 during use.

[0115] 5.3.3 Positioning and stabilization structure The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position by the positioning and stabilizing structure 3300 during use.

[0116] In one embodiment of this technology, a positioning and stabilizing structure 3300 is provided, configured to be worn by a patient while sleeping. In one embodiment, the positioning and stabilizing structure 3300 has an inconspicuous shape or cross-sectional thickness to reduce the perceived or actual bulk of the device. In one embodiment, the positioning and stabilizing structure 3300 includes at least one strap having a rectangular cross-section. In one embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0117] In one embodiment of this technology, the positioning and stabilizing structure 3300 includes a strap composed of a laminate of a woven patient contact layer, a foamed inner layer, and a woven outer layer. In one embodiment, the foamed material is porous so that moisture (e.g., sweat) can pass through the strap. In one embodiment, the woven outer layer includes a loop material that engages with a hook material portion.

[0118] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes an extendable (e.g., extendable with elasticity) strap. For example, the strap may be configured to be taut when in use, directing the force that brings the cushion into close contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0119] In certain embodiments of this technology, the positioning and stabilizing structure 3300 includes a flexible and, for example, non-rigid strap. An advantage of this embodiment is that the strap is more comfortable when the patient lies down while sleeping.

[0120] 5.3.4 Ventilation In one embodiment, the patient interface 3000 includes a vent 3400 configured and positioned to allow the expulsion of exhaled gases (e.g., carbon dioxide).

[0121] One form of the ventilation section 3400 according to this technology includes a plurality of holes (for example, about 20 to 80 holes, or about 40 to 60 holes, or about 45 to 55 holes).

[0122] The ventilation section 3400 may be located within the plenum chamber 3200. Alternatively, the ventilation section 3400 may be located within a decoupling structure (e.g., a swivel joint).

[0123] 5.3.5 Decoupled Structures (Multiple) In one embodiment, it includes at least one decoupling structure (e.g., a swivel joint or a ball socket).

[0124] 5.3.6 Connection Ports Connection port 3600 allows connection to the air circuit 4170.

[0125] 5.3.7 Forehead support In one embodiment, the patient interface 3000 includes a forehead support portion 3700.

[0126] 5.3.8 Suffocation prevention valve In one embodiment, the patient interface 3000 includes an asphyxiation prevention valve.

[0127] 5.3.9 Ports In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one embodiment, this enables a clinician to supply supplemental oxygen. In one embodiment, this enables direct measurement of the gas (e.g., pressure) within the plenum chamber 3200.

[0128] 5.4 Ventilation Adapter 5.4.1 Ventilation at a constant flow rate Figure 16 shows a comparison of ventilator flow rates between regular ventilator flow (FFM·Nom flow) and constant flow rate ventilator flow (CFV). Regular ventilator flow is a standard molded ventilator (e.g., ventilator 3400 formed on patient interface 3000 in Figure 3A). As can be seen from the graph, the ventilator flow rates are compared over the mask pressure range of 4–20 cmH2O (which is the standard pressure range for respiratory pressure therapy for SDB and OSA). As can be understood, the ventilator flow rate increases logarithmically with increasing pressure. For comparison, CFV shows a flatter curve, where the ventilator flow rate appears to be more constant and lower over the same pressure range.

[0129] The vent flow needs to be at least 16 L / min to push out sufficient CO2 from the system to minimize CO2 rebreathing by the patient. It has been shown that when the vent flow rate is 20–27 L / min, breathing becomes easier (the patient does not wake up due to increased CO2 rebreathing) and safer (avoids suffocation due to excessive CO2 rebreathing). One aspect of this technology involves providing a minimum (or minimum range) of vent flow to ensure that sufficient CO2 is pushed out. If the vent flow exceeds such a minimum range even slightly, it may be considered wasteful. For example, looking at the graph shown in Figure 16, the area between the CFV vent flow and the FFM·Nom flow may be considered wasted flow. In the case of CFV, 16 L / min is achieved as the minimum required vent flow rate within the therapeutic pressure range, and this vent flow rate of 16–27 L / min is maintained within the H2O pressure range of 4–20 cm. For comparison, the FFM·Nom flow is 22–55 L / min. Therefore, unnecessary flow losses may increase due to the use of FFM·Nom flow ventilation.

[0130] To compensate for unwanted flow losses, flow generators or RPT devices may need to increase their flow to achieve the same pressure compared to CFVs. Therefore, more power is required to compensate for this aeration, and more complex flow generators are needed for larger flow swings (e.g., aeration flows of 16-55 L / min). However, with CFVs, it may be necessary to regulate the aeration flow under pressure changes to reduce the aeration flow rate as the pressure increases. Therefore, using CFVs can increase power savings with flow generators and is simpler because complex pressure / flow control is not required.

[0131] The constant flow rate ventilation (CFV) provided by this technology can be achieved by a ventilation flow control valve (movable membrane) 9140, which regulates the ventilation flow in response to the mask pressure. Exemplary CFVs are shown in Figures 21A to 21F. The valve 9140 can be adjusted so that the flow remains relatively constant within a given pressure range. That is, as the pressure in the mask / system increases, the flap 9140 covers more of the internal ventilation holes 9126, reducing the ventilation flow rate (the ventilation flow rate increases with increasing pressure). As the pressure in the mask / system decreases, the flap 9140 covers less of the ventilation holes, increasing the ventilation flow (compensating for the low ventilation flow rate at low pressure). Such adjustments can make it possible to keep a substantially constant ventilation flow within a certain pressure range. The graph in Figure 18 shows the flow changes under pressure changes with and without the CFV. The performance of the exemplary CFV in the graph in Figure 18 shows that as the pressure increases from 0 to 40 cmH2O, the flow rate increases up to 24 L / min.

[0132] In one embodiment of this technology, the CFV may include a movable flap or CFV membrane 9140, which may be made of an elastic material (e.g., silicone or other TPE (thermoplastic elastomer)). The configuration of the flap 9140 is such that increasing pressure in the mask biases the flap to cover more of the internal vent holes 9126, progressively reducing the flow rate. The flap 9140 may be positioned perpendicular to the pressurized gas flow to the patient. The vent passage of the internal vent holes 9126 may also run perpendicular to the flow and away from the patient, exiting into the atmosphere. The flap 9140 may be positioned such that pressure accumulation in the mask biases the flap toward the internal vent holes 9126.

[0133] Figure 21F is a cross-sectional view of an exemplary CFV configuration. The CFV units may be arranged linearly (within the air delivery conduit circuit). As shown in Figure 21F, when pressure builds up in the mask, the position of the flap 9140 is such that the flap 9140 can move toward the internal vent 9126. When the pressurized gas reaches the internal vent 9126, which is not blocked by the flap 9140, this gas can then be vented to the atmosphere through the external vent 9125.

[0134] CFVs offer a potential way to simplify RPT systems. Maintaining a substantially constant aeration flow rate within a constant pressure range effectively eliminates the need for pressure control to compensate for pressure loss changes due to aeration, thus reducing the complexity of the flow generator or RPT device. Furthermore, using CFVs eliminates the need for power to compensate for flow changes at different pressures, thus reducing power consumption. In other words, CFVs are passive (pressure-driven) and can regulate pressure resulting from aeration flow changes that are normally dynamically compensated by changes in pressure / flow delivery from the RPT device. Such simplification allows for simpler RPT devices for therapeutic delivery (e.g., fewer device components, smaller device size, potentially eliminating the need for electric humidification and / or reducing overall power consumption for therapeutic delivery) (this is due to the elimination of compensation for aeration flow changes). CFVs can also enable passive humidification via a heat and moisture exchanger (HME), as described below.

[0135] A known problem with the CFV concept is that related ventilation noise can be generated when regulating the ventilation flow. Specifically, the interaction between the flap 9140 and the internal ventilation hole 9126 can obstruct the ventilation flow and potentially cause noise. For example, assume that when the movable flap 9140 moves under pressure, it does not completely cover a portion of the internal ventilation hole 9126. Such interaction can cause turbulence and related noise because gas flows between the flap 9140 and the internal ventilation hole 9126.

[0136] One method to reduce turbulence and thus noise is to reduce the number of holes 9126 that interact with the flap 9140. However, minimizing the airflow required to prevent rebreathing of CO2 in the mask and to reduce the number of vent holes 9126 that interact with the flap 9140 may result in insufficient ventilation. Therefore, according to the solution of this technology, some of the vent holes 9126 may be regulated by the radial disc flap 9140, while other vent holes 9126 are not engaged with the flap 9140 and are left in a constantly open state. When some of the vent holes 9126 are kept constantly open (i.e., static ventilation), the airflow rate increases according to Bernoulli's principle as the pressure in the system increases.

[0137] To compensate for such an increase in airflow while maintaining a substantially constant overall airflow across the entire pressure treatment range, the airflow through the remaining vents (i.e., regulated airflow) can be reduced as the pressure increases. These vents 9126 can be regulated by movable flaps 9140, which progressively cover the vents 9126 as the pressure increases, thereby reducing the airflow. Subsequently, the overall flow rate of static airflow can be averaged together with the flow rate of regulated airflow so that a substantially constant flow rate is achieved overall across a certain range of treatment pressures. The reduction in airflow noise levels can also be attributed to molded airflow techniques that generate low levels of noise as pressure and airflow increase (e.g., by molding small vents with a convergent profile). When this technique is used in conjunction with airflow regulation, it may be possible to substitute for overall noise for constant flow rate airflow.

[0138] The ventilation adapter 9100 or fluid connector may include a constant flow ventilation (CFV) unit. The CFV unit may include a CFV ring 9150, a flat annular valve 9140, and a ventilation housing 9120. The CFV ring 9150 may hold the valve 9140 in place relative to the ventilation holes 9126. The ventilation housing 9120 may include an annular surface containing a plurality of ventilation holes 9126. The annular surface may include a central orifice for allowing a pressurized gas flow into the mask chamber (inlet flow). The annular surface may include a plurality of ventilation holes 9126 for enabling the ventilation flow. The valve 9140 may be adjacent to the ventilation holes 9126 and may be freely held (i.e., sandwiched) between the CFV ring 9150 and the annular surface of the ventilation housing 9120. That is, the flap 9140 is not fixed to the CFV ring 9150 or the ventilation housing 9120. As the mask pressure increases, the pressure increases towards the vents, pressing the valve 9140 toward the vent holes 9126 and covering more of them. In contrast, as the mask pressure decreases, the pressure applied to the valve 9140 also decreases, causing the valve 9140 to move away from the vent holes 9126 and covering fewer of them.

[0139] Reducing ventilation noise for constant flow rate ventilation designs can be achieved by changing the ventilation flow characteristics by using a flow control valve or membrane 9140. However, using membrane 9140 may increase ventilation noise compared to conventional molded or static ventilation (i.e., the ventilation holes do not change shape or form with pressure changes). This noise can be caused by several factors, including: 1) changes in the velocity of the flow through the regulated ventilation when the ventilation holes 9126 are opened or closed by membrane 9140, and / or 2) main flow turbulence caused by membrane 9140, resulting in noise (i.e., turbulence). For example, changing the direction of ventilation flow can cause turbulence, resulting in noise from several factors. This can be caused by gas impacting the surface of the ventilation (ventilation wall or CFV membrane) 9140 or air passing over the surface of the ventilation (ventilation wall and / or membrane) 9140. Therefore, partially closing the ventilation holes 9126 may generate more noise due to the factors 1) and / or 2) described above.

[0140] As described above, aspects of this technology include ventilation at a substantially constant flow rate within a therapeutic pressure range (i.e., 4–20 cmH₂O or 2–40 cmH₂O). To satisfy a desired ventilation flow curve under pressure changes, the flow curve of the vent holes 9126 can be dynamically changed with respect to the therapeutic pressure range. This can be achieved by changing the size, number, and / or shape of the vent holes. Changing such characteristics can alter the gas flow characteristics through the vent holes, potentially increasing ventilation noise. By using molded ventilation techniques that include a converging vent shape as the air exits from the ventilation to the atmosphere (i.e., a shape that converges from the internal vent holes 9126 to the external vent holes 9125), the noise of the ventilation flow can be minimized. However, it should be understood that molded vent holes do not change in size, shape, or number under pressure changes. Therefore, the flow through the vent holes 9126 can be altered using a deformable membrane or flap 9140 that moves under pressure to close or open the ventilation. However, if a deformable membrane or flap 9140 is used, undesirable noise levels may be generated due to changes in the flow velocity through the regulated vents caused by the opening or closing of the vent holes 9126 by the membrane 9140 and / or by the partial closure of the vent holes 9126.

[0141] Such noise can be reduced by providing membrane flaps 9140 that gradually close the vent holes 9126 as the pressure increases. The flaps 9140 are fixed at one end so that they deform when the pressure changes. A problem with this technique is that the membrane 9140 can only partially close a given vent hole 9126, so a flow can flow at high speed between the vent hole 9126 and the membrane 9140. As a result, noise is generated when the flow passes along the surface of the vent hole 9126 and the membrane 9140, or when it collides with these surfaces.

[0142] This problem can be resolved by reducing the number of regulated vents while maintaining a substantially constant airflow within the treatment pressure range to reduce vent noise. The desired noise level can be maintained using molded vents (i.e., static vents). However, with these vents, it may not be possible to achieve the desired flow curve (i.e., a substantially constant flow rate in the treatment pressure range of 4–20 cmH2O). This can be achieved by combining several regulated vents with static vents so that the overall airflow is substantially constant within the treatment pressure range. Increasing the number of static vents not regulated by the membrane can lead to a reduction in overall vent noise.

[0143] However, the introduction of molded vents in this way can lead to a new problem: it may become difficult to ensure a substantially constant airflow within the therapeutic pressure range using a combination of static and regulated vents. As shown in Figure 16, the airflow characteristics of molded static vents are known to be logarithmic, with the airflow increasing with increasing pressure. To compensate for the static vent flow, it is necessary to obtain an inverse flow curve from the regulated vent where the airflow decreases with increasing pressure. Therefore, the membrane 9140 that regulates the vent 9126 can be adjusted to provide such an airflow.

[0144] There are several ways to adjust the membrane 9140 to obtain an airflow that is the opposite of the logarithmic flow curve of the static molded airflow. For example, the shape / structure of the membrane 9140 can be changed to adjust the flow curve of the regulated airflow, or the material of the membrane 9140 can be changed to adjust the flow curve of the regulated airflow.

[0145] Using the annular disk membrane 9140 structure of the CFV membrane, it may be possible to adjust the membrane 9140 in multiple ways to change the regulated airflow, as shown in Figure 20. The regulated airflow can be changed by altering the ratio of covering / opening the vent holes 9126 under constant pressure. When the membrane 9140 covers a larger area of ​​air under constant pressure, the airflow will be lower than when the covering area is smaller. Using the annular disk structure 9140, it is possible to easily adjust the membrane 9140 to cover various amounts of air under constant pressure. One way to achieve this is by changing the diameter of the central orifice or the width of the air-engaging surface.

[0146] The overall size of the membrane 9140 is constrained by the size of the CFV unit housing 9120, but it is desirable to reduce the size of the CFV as much as possible. Therefore, the width of the ventilation hole engagement surface can be adjusted by adjusting the size of the central orifice. If the size of the central orifice is increased, the width of the ventilation hole engagement surface must also be reduced. When such a reduction is made, the surface area of ​​the membrane 9140 is reduced. When the surface area is reduced, the resistance to deformation under constant pressure decreases, and more ventilation holes are covered under constant pressure compared to a wider (i.e., larger surface area) membrane 9140. This principle applies to a given range of surface areas. That is, if the surface area is too small to obtain sufficient surface area (i.e., the width of the ventilation hole engagement surface is too narrow), the force required to deform (i.e., bottom out) the membrane 9140 becomes larger.

[0147] The thickness of the film 9140 can also be varied so that it deforms more easily under constant pressure. For example, when the mask pressure is 15 cmH2O, a thinner film 9140 deforms more easily than a thicker film 9140 of the same shape at the same pressure.

[0148] The membrane 9140 may be structured to be able to move freely to cover the ventilation holes 9126 under constant pressure. For example, in related technologies, if the membrane 9140 is fixed at one point (for example, on a ventilation housing 9120) and hinged relative to the fixing point, the membrane 9140 will deform around the fixing point due to pressure changes.

[0149] Using the design of the CFV membrane 9140 according to one embodiment of this technology, free movement between the retaining structure and the ventilation hole surface becomes possible. With this configuration, it may be possible to adjust the ventilation flow by adjusting the membrane 9140 more easily compared to a flap design (i.e., a design in which the membrane is fixed on one end and moves relative to the fixed end).

[0150] A membrane 9140 with higher flexibility / compliance can deform more easily under constant pressure / load, thus covering more of the vent holes 9126 compared to a more rigid membrane. Therefore, if the material of a membrane 9140 with the same size and structure is changed to a more flexible material, the membrane 9140 will deform more easily under the same pressure, covering more of the vent holes 9126 and reducing the airflow. This makes it possible to adjust the membrane 9140 to obtain the desired airflow curve within the treatment pressure range.

[0151] As described above, there are several methods that can be used to provide a pressure-responsive membrane 9140 within a target therapeutic range to obtain a predetermined aeration flow curve (i.e., a substantially constant aeration flow rate overall when the H2O pressure is 4-30 cm). It may also be desirable to obtain such a constant aeration flow while minimizing aeration noise. One solution is to maximize the number of static non-membrane-regulated vents and minimize membrane-regulated vents that provide a substantially constant overall aeration flow average. This flow curve is shown in Figure 19 by a thicker solid line titled "Active Ventilation Only". In this embodiment, the dashed line represents static non-membrane-regulated vents, and the thinner solid line titled "CFV & Passive Ventilation Combination" represents the aeration flow combination. Note that the aeration flow of static vents increases progressively with increasing pressure, while the CFV membrane-regulated vents gradually decrease to a threshold.

[0152] Another possible cause of noise is interference with the vent flow due to the CFV membrane 9140, which can also affect the airflow through the static vent. In related technologies, the static vent is located near the CFV membrane regulated vent (i.e., the vent holes are located on the same surface as the CFV housing 9120). As a result, noise occurred even in the case of unregulated static vents because the membrane affected the flow characteristics of the static vent flow. Therefore, it is desirable to position the static vent away from the CFV membrane regulated vent so that the membrane 9140 does not affect the static vent flow passing through it. In one embodiment of this technology, the static vent holes are located on the distal surface from the CFV regulated vent holes. For example, the static vent holes may be located on a component different from the CFV housing 9120. The placement of the static vent may also be limited in that it cannot extrude CO2. The ability to extrude CO2 increases as the position of the static vent holes approaches the patient. However, static vents may be positioned on the opposite side of the HME from the patient to prevent moisture loss during exhalation, as described below.

[0153] 5.4.1.1 Ventilated Housing Figures 42A to 42G show an example of a ventilation system 13400 according to one embodiment of the present technology. The ventilation system 13400 includes a ventilation housing 13401 which may include an outer wall 13402. The outer wall 13402 may define the outer perimeter of the ventilation housing 13401. The ventilation housing 13401 may also include an inner wall 13410. The inner wall 13410 may define an inlet for gas generated by the RPT device 4000. This gas is directed to the plenum chamber 3200 and then directed to the patient for treatment. As can be understood, the outer wall 13402 and the inner wall 13410 are formed as coaxial circles in this embodiment.

[0154] A base is positioned between the outer wall 13402 and the inner wall 13410. The base may further include an outer base 13403 and an inner base 13406. The outer base 13403 may extend from the inner circumference of the outer wall 13402, and the inner base 13406 may extend from the outer circumference of the inner wall 13410. As can be understood, the outer base 13403 and the inner base 13406 are also formed as coaxial circles in this embodiment.

[0155] The outer base 13403 may include one or more outer orifices 13404 distributed radially around the outer base 13403. These outer orifices 13404 extend throughout the outer base 13403 to provide a flow path from the interior of the ventilation system 13400 to the atmosphere. The outer orifices 13404 may be provided linearly (i.e., perpendicular to the outer base 13403), or they may pass through the outer base 13403 along a curved or inclined path. The diameter of the outer orifices 13404 may be constant along their length, or their diameter may vary. The outer orifices 13404 may all be the same, or some may differ from others. The edges of the outer orifices 13404 may be chamfered or filleted. The outer base 13403 can at least partially support the membrane 13430 so as to prevent the inner orifice 13407 from being completely blocked by the membrane 13430. Therefore, the outer base 13403 can extend higher than the inner base 13406, as understood in Figures 42A to 42G.

[0156] The ventilation housing 13401 may also include lateral membrane supports 13405 distributed around the inner circumference of the outer base 13403 and outer wall 13402. The lateral membrane supports 13405 are adjacent to the membrane 13430 and may prevent the membrane 13430 from moving laterally during use, thereby covering the outer orifice 13404. As described below, it may be desirable not to obstruct the outer orifice 13404 so that the ventilation system 13400 can maintain a substantially constant airflow rate over most of the typical therapeutic pressure range. For this reason, the lateral membrane supports 13405 may project radially inward beyond the edge of the outer orifice 13404. The lateral membrane supports 13405 may be semicircular, as shown in Figures 42A to 42G. In the embodiments shown in Figures 42A to 42G, the outer orifice 13404 is evenly distributed among three groups of adjacent lateral membrane supports 13405 around the circumference of the outer base 13403.

[0157] The ventilation housing 13401 may be circular in shape. However, the ventilation housing 13401 may be elliptical in shape, or it may be polygonal in shape (e.g., triangular, square, rectangular, pentagonal, hexagonal). In any of these configurations, the membrane 13430 may be shaped to correspond to the shape of the ventilation housing 13401.

[0158] The inner base 13406 may be radially positioned inside the outer base 13403, and the inner base 13406 and the outer base 13403 may be joined by base connectors 13408 distributed radially between them. One or more inner orifices 13407 are provided between adjacent base connectors 13408 and between the inner base 13406 and the outer base 13403. In these embodiments, the inner orifices 13407 are formed as slots with an arc-shaped cross-section. However, the inner orifices 13407 may be circular, similar to the outer orifices 13404. The inner orifices 13407 extend entirely through the ventilation housing 13401 between the inner base 13406 and the outer base 13403. As described below, it may be desirable to at least partially occlude the inner orifice 3407 with the membrane 13430 so that the ventilation system 13400 can maintain a substantially constant airflow rate over most of the typical therapeutic pressure range. The edges of the inner orifice 13407 may be chamfered or filleted.

[0159] The inner base 13406 of the ventilation housing 13401 may also include several membrane spacers 13409. These membrane spacers 13409 may be evenly distributed radially around the inner base 13406. As shown in Figures 42A to 42G, the membrane spacers 13409 may be positioned on the edges of the inner base 13406 so as to blend into the inner wall 13410. The membrane spacers 13409 are provided to at least partially support the membrane 13430, as will be described in more detail below. The membrane spacers 13409 may extend from the inner base 13406 in a semicircular or rectangular shape, as shown in Figures 42A to 42G. The edges of the membrane spacers 13409 may be chamfered or filleted.

[0160] The ventilation housing 13401 may also include one or more recesses 13415. These one or more recesses 13415 are spaced apart around the opposite side of the outer base, as understood in Figures 42A to 42G. The recesses 13415 may be separated by recess dividers 13414. Outer orifices 13404 may extend through the outer base 13403 and open into the corresponding recesses 13415, and multiple outer orifices 13404 may open into a single recess 13415.

[0161] In another embodiment, the ventilation housing 13401 may include only one group of orifices similar to the internal orifice 13407 described above, in that the ventilation flow passing through it can be restricted by the position of the membrane 13430. Therefore, another group of orifices may be provided at any location on the patient interface 3000 similar to the external orifice 13404 described above (in that the ventilation flow passing through it is not restricted by the membrane 13430 regardless of its position). The latter group of orifices not restricted by the membrane 13430 may be located on any of the plenum chamber 3200, the seal-forming structure 3100, the decoupling structure 3500, the ventilation connector tube 4180, or any other component closer to the patient than the ventilation housing 13401. The operating principle of the ventilation system 13400 described above applies to such alternative configurations, but the ability to establish an orifice that is not restricted by the membrane 13430 closer to the patient may improve the release of exhaled CO2.

[0162] The ventilation housing 13401 may consist of a single piece of homogeneous material. The material of the ventilation housing 13401 may be relatively rigid. The material of the ventilation housing 13401 may be polycarbonate.

[0163] 5.4.1.2 Membrane Figures 43A to 43G also show an exemplary membrane 13430 equipped with a ventilation system 13400 and positioned adjacent to a ventilation housing 13401. The exemplary membrane 13430 can be used with any of the various configurations of the ventilation housing 13401 disclosed above. The shape of the membrane 13430 may be a flat disc. In other words, the thickness of the membrane 13430 (see Figures 43F and 43G) may be small compared to its outer diameter. The thickness of the membrane 13430 may be uniform overall, as shown in Figures 43F and 43G. Alternatively, the thickness of the membrane 13430 may be variable in the radial direction.

[0164] The membrane 13430 includes a membrane opening 13431, which allows the airflow passing through the inlet 13411 to reach the patient through the membrane opening 13431 when assembled onto the ventilation housing 13401. The membrane 13430 also includes a patient side 13432 that faces the patient during use and an atmosphere side 13433 opposite to the patient side 13432 that faces the atmosphere during use. Furthermore, the atmosphere side 13433 faces the ventilation housing 13401 when assembled. The membrane 13430 also includes an inner surface 13434 defining the membrane opening 13431 and an outer surface 13435 opposite to the inner surface 13434.

[0165] 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) may be selected so that the membrane 13430 can be positioned on the inner orifice 13407 during use without covering the outer orifice 13404. The inner and outer radii may also be selected so that the membrane 13430 is close to the inner surface 13434 and covers a substantial portion of the inner base 13406 while being supported on a membrane spacer 13409 provided on the outer base 13403.

[0166] The membrane 13430 may consist of a single piece of homogeneous material. Since this material may be elastically deformable, the membrane 13430 may deform under pressure from airflow during use. This material may be silicone. The membrane 13430 may be "adjusted" to deform in a desired manner by changing one or more of the following: thickness, length, material, shape, inner radius and / or outer radius.

[0167] 5.4.1.3 Constant flow rate ventilation system Figures 43A to 43G show several diagrams of an exemplary ventilation system 13400, in which the membrane 13430 is assembled with the ventilation housing 13401. In Figures 43A to 43G, the inner wall 13410 does not extend above the inner base 13406. In embodiments in which the inner wall 13410 extends above the inner base 13406, the inner wall 13410 may provide a baffling function that separates the gas flow moving into the ventilation system 13400 through the inlet 13411 from the ventilation flow exiting the ventilation system 13400, thereby reducing the amount of gas flowing into the inlet 13411 and directly exiting the ventilation system 13400.

[0168] In the embodiments shown in Figures 43A to 43G, it can be seen that a portion of the outer surface 13435 of the membrane 13430 is supported on the inner portion of the outer base 13403. A portion of the inner surface 3434 of the membrane 13430 is supported directly above the membrane spacer 13409. However, since the membrane 13430 can deform toward the membrane spacer 13409 due to its own weight, the membrane 13430 is also supported on the membrane spacer 13409 even when there is no air pressure to cause deformation.

[0169] Figures 43A to 43G also show the position of the membrane 13430 restricted by the lateral membrane support 13405. As described above, the membrane 13430 can be shaped and sized to cover only the inner orifice 13407 and not the outer orifice 13404. However, since the membrane 13430 cannot be directly attached to the ventilation housing 13401, it can move freely. Therefore, a sufficient number of lateral membrane support 13405 can be used to prevent the lateral movement of the membrane 13430, so that the membrane 13430 cannot cover one or more of the outer orifices 13404 when in use.

[0170] The reverse of these embodiments is also possible. That is, the outer orifice 13404 may be covered by the film 13430, while the inner orifice 13407 is not blocked by the film 13430. Therefore, the lateral film support portion 13405 may be provided to prevent the film 13430 from being covered by the inner orifice 13407.

[0171] As described above, the exemplary ventilation system 13400 may include a membrane 13430. The membrane 13430 is disposed over the inner orifice 13407 such that the ventilation flow passing through the outer orifice 13404 is not restricted by the membrane 13430 and at least partially restricts the gas flow passing through the inner orifice 13407.

[0172] 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 may be employed in any of the ventilation adapters 9100 disclosed in Section 5.4.5.

[0173] 5.4.2 Ventilation Diffuser The ventilation adapter 9100 may also include a portion that houses a diffuser 9146. The diffuser 9146 may be removable for replacement. The diffuser 9146 may have an annular disk shape that compensates for the shape of the annular surface of the ventilation housing 9120 on the side facing the atmosphere (i.e., the exterior to the inlet flow). The diffuser 9146 may cover the ventilation holes 9125 and may diffuse the ventilation flow after the ventilation flow exits the plurality of ventilation holes 9125. That is, the ventilation flow passing through the molded ventilation holes 9125 may reach the atmosphere after passing through the diffuser 9146.

[0174] The diffuser 9146 may function as a sound-absorbing material and may reduce a portion of the noise generated by the regulated CFV membrane 9140 and the static ventilation.

[0175] Figure 26 is a cross-sectional view through a portion of the orifice 3402. The orifice 3402 is exemplified as a hole through the wall 3404 of the plenum chamber 3200. However, the orifice 3402 may be located elsewhere than the wall 3404. For example, the orifice 3402 may be located between the uncoupling structure 3500 and the connection port 3600, or preferably within a portion of the air circuit 4170, near the connection port 3600, or in the vent adapter 9100. These holes are illustrated as having a diameter smaller than the axial length of the hole. The length and / or diameter may be selected so as to generate an appropriate flow rate when the plenum chamber 3200 is pressurized to the treatment pressure. The flow through the orifice 3402 may become blocked (e.g., at a Mach number of 1) at the treatment pressure (e.g., at a pressure of 4 cmH2O or higher), or the flow may generate a pressure drop that is not sufficient to cause blockage. If the flow becomes blocked, virtually all of the pressure drop in the vent 3400 is caused by the orifice 3402. The arrow conceptually indicates the flow direction when the plenum chamber 3200 is pressurized beyond the ambient pressure.

[0176] The orifices 3402 are formed through the thickness of the material of the wall 3404. Each orifice 3402 defines an axis (for example, along the orifice center). This axis forms an acute angle with the normal to the surface of the wall 3404. This angle can be 15 to 75 degrees or 30 to 60 degrees (for example, any integer within the range described). For example, the angle may be approximately 45 degrees.

[0177] Since the orifice 3402 is covered by the diffusion member 3406, the flow exiting the orifice 3402 collides with the diffusion member 3406 and flows at least partially into the diffusion member 3406. The diffusion member 3406 may be formed from a material (e.g., a porous material) that allows gas to pass through it and diffuses any injectors or other flow formations exiting the 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 identical to the filter medium. The diffusion member 3406 may reduce the perceptible noise generated by the vent 3400 during use (e.g., when therapeutic pressure is applied).

[0178] The diagram shows how the diffusion member 3406 is covered by the barrier member 3408. The barrier member 3408 prevents gas from flowing out of the orifice 3402 and directly passing through the diffusion member 3406. The barrier member 3408 can be constructed at least partially from an air-impermeable material. The air-impermeable material can be any suitable flexible or rigid material. For example, the air-impermeable material can 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 diffusion member 3406, or may be separately from the diffusion member 3406 and permanently fixed to the diffusion member 3406, or may be formed separately from the diffusion member 3406 and in removable contact, or a combination of these may be used. The diagram shows how the barrier member 3408 is located on the opposite side of the outlet orifice 3402 relative to the thickness of the diffusion member 3406.

[0179] Due to the blocking member, the flow changes direction (relative to the direction through the orifice 3402) and then exits from the diffusion member 3406. The blocking member 3408 and / or the diffusion member 3406 may be configured such that the flow from the orifice 3402 flows through the diffusion member 3406 for at least a predetermined distance before flowing into the ambient atmosphere. The blocking member 3408 may also be configured such that the flow exiting the vent 3400 is directed in a specific direction and / or orientation, thereby minimizing any disturbance to the wearer and / or cohabitants caused by the flow. For example, the blocking member 3408 may allow gas to flow through the diffusion member 3406 and may be generally parallel to the surface of the blocking member 3408 closest to the diffusion member 3406.

[0180] In Figure 26, the orifice 3402 and the diffusion member 3406 are oriented relative to each other so that the central axis of each orifice is not perpendicular to the nearest surface of the diffusion member 3406. However, a vertical arrangement configuration as shown in Figure 8 is also possible.

[0181] The channel 3410 may be provided on the outer surface of the wall 3404. Although the channel 3410 is shown with a V-shaped cross-section, it may be formed with any suitable cross-section (e.g., U-shaped). The channel 3410 may be configured to allow liquid to be discharged from one or more outlets of the orifice 3402. The orifice 3402 may be formed as a V-shaped or U-shaped leg portion.

[0182] Figure 27 shows another configuration of the blocking member 3408. In Figure 27, the blocking member 3408 includes a hole 3412. The hole 3412 can direct the flow from the diffusion member 3406 to the opposite side of the orifice 3402 and in a different direction. Therefore, the flow path is not linear through the orifice 3402 and the diffusion member 3406. The arrows associated with the hole 3412 are shown as parallel, solely for the sake of illustration. The hole 3412 may be configured to redirect the flow in multiple directions.

[0183] Each hole 3412 defines an axis that is aligned with or parallel to the axis defined by each orifice 3402. Looking at the cross-sectional view in Figure 27, an angle is formed by any one axis defined by the holes 3412 and any one axis defined by the orifice 3402. This angle can be 15 to 75 degrees or 30 to 60 degrees (e.g., any integer within the range described). For example, the angle could be approximately 45 degrees.

[0184] Figures 28 to 30 show alternative configurations of the vent 3400. Figure 28 is a partially exploded view, Figure 29 is a simplified assembly view, and Figure 30 is a cross-sectional view taken along line 30-30 in Figure 29. In these figures, the orifice 3402 is illustrated as a circular array around the central hole 3414. The circular array is illustrated as containing three circular rows of holes, the two innermost circular rows being closer together than the outermost circular row, but any number of circular rows may be provided, and the spacing between these rows may be uniform. The central hole 3414 allows for fluid communication between the plenum chamber 3200 and the connection port 3600 and thus the air circuit 4170. The arrangement of the diffusion member 3406 and the blocking member 3408 around the central hole 3414 is also illustrated. In this configuration, the blocking member 3408 may be detachably attached (e.g., by a detachable snap-fit ​​or screw engagement) or fixedly attached (e.g., by permanent adhesive or snap-fit ​​that requires destruction during disassembly). The diffusion member 3406 may be fixed to the blocking member 3408 or it may not be fixed to the blocking member 3408 but be held by the blocking member 3408. A radial opening 3416 is provided to allow the gas to escape radially from the diffusion member 3406 through the central hole 3414, as best shown in Figure 29.

[0185] Figures 31A to 31C show another alternative configuration of the vent 3400. Figure 31A is a partial view of a flow passage in the form of an elbow 3418. This flow passage may be located between the disconnection structure 3500 and the connection port 3600 and includes the vent 3400. Since this configuration largely covers the features of the vent 3400, the remainder of this description will refer to Figures 31B and 9C.

[0186] Figure 31B is an axial view, and the cap 3422 and diffusion member 3406 are omitted. This allows for a clear illustration of the outlet orifice 3402. Three annular rows are shown, each containing 40 outlet orifices 3402. These orifices are offset so that the outlet orifices 3402 in the inner and outer rows are not aligned radially. This configuration allows for a narrower radial spacing between the annular rows. Although two rows are shown in the illustration, any number of rows may be provided, for example, one or three or more rows may be used. While 40 outlet orifices 3402 are shown in each annular row, more or fewer may be provided as needed to maintain an appropriate gas discharge level. For example, the number of exit orifices 3402 in each ring sequence can be 1, 5, 10, 15, 20, 25, 30, 35, 40, 45, 50 or more exit orifices 3402, or any number in between these.

[0187] In Figure 31C, the annular array of orifices 3402 can be viewed as a cross-sectional view through wall 3420. Wall 3420 is similar to wall 3404 except that it is shown distal to the plenum chamber 3200, although wall 3420 may be part of the plenum chamber 3200.

[0188] The diffusion member 3406 is shown as a ring-shaped element with a rectangular cross-section. The blocking member 3408 is shown as a relatively thin, sheet-like ring on the side of the diffusion member 3406 opposite the orifice 3402. The blocking member 3408 can be fixed to the diffusion member 3406 by any suitable means (e.g., adhesive).

[0189] The figure shows how the cap 3422 covers the diffusion member 3406 and the blocking member 3408. The cap 3422 may come into contact with the blocking member 3408 so that the diffusion member 3406 is pressed against the wall 3420. Alternatively, the diffusion member 3406 does not need to be pressed against the wall 3420. The cap 3422 may function as the blocking member 3408, in which case the ring-shaped blocking member 3408 shown in Figure 31C may be omitted.

[0190] The cap 3422 may include an angled annular flange 3424. The angled annular flange 3424 may be spaced apart from the wall 3420 to form an annular gap 3426. The annular flange 3424 may be considered skirt-shaped or frustoconical. The annular gap 3426 may provide a flow path to the ambient atmosphere such that the gas discharge flow is not excessively restricted. Alternatively, one or more openings (e.g., radial openings 3416) may be provided in the annular flange 3424 to provide a flow path to the ambient atmosphere, thereby making the annular gap 3426 entirely or partially unnecessary.

[0191] The cap 3422 is shown as having an annular groove 3428. The annular groove 3428 engages with an annular projection 3430 to hold the cap 3422 in a predetermined position. The annular projection may be continuous to form a snap fit or may be a plurality of annular projections spaced annularly apart, whereby a configuration is obtained in which, after axial insertion, twisting provides axial interference and the interference is minimized or zero when the cap 3422 is held in a predetermined position. In FIG. 31C, the annular projection 3430 is shown as three annular projections spaced annularly apart. The lip 3432 of the annular groove 3428 may be omitted at three corresponding positions and sizes to reduce or eliminate interference of the cap 3422 during axial insertion. Other attachment forms are also possible. For example, a screw fastening arrangement may be provided, and the cap 3422 may be provided in a predetermined position by an adhesive or welding. For example, when damage, clogging or contamination occurs in the diffusion member, the diffusion member 3406 can be arranged by a releasable fastening (for example, the illustrated configuration or a screw connection).

[0192] Although the ventilation 3400 is shown provided on one side (for example, upstream with respect to the exhalation direction) of the bent portion within the elbow 3418, the ventilation 3400 may be provided upstream or downstream of the bent portion.

[0193] FIGS. 32A to 32C show another alternative configuration of the ventilation 3400. Similar reference numerals are the same as those described above, and thus detailed description is omitted except for what is described below. The ventilation 3400 in these figures is formed around an embodiment of a disengagement structure 3500. The disengagement structure 3500 includes a ball 3434 and a socket 3436 that are part of the elbow 3418. In the illustrated form, the ball 3434 and the socket 3436 provide three degrees of rotational freedom. However, the degree of rotational freedom may be made less (for example, one or two degrees of rotational freedom).

[0194] As best shown in Figure 32D, the cap 3422 is connected to a first half 3440 positioned on the cap 3422 and a second half 3442 on a mating component by a snap-fit ​​connection 3438. The first half 3440 and the second half 3442 are each provided between six radial openings 3416. Three of these six radial openings 3416 are shown in Figure 32A. However, more or fewer may be provided as needed to provide adequate retention and / or flow.

[0195] As best shown in Figure 32C, 44 orifices 3402 are arranged at equal intervals within a single annular row. However, the number and spacing of the orifices 3402 can take other configurations. For example, fewer orifices 3402 may be provided if a lower flow rate is desired, and more orifices 3402 may be provided if a higher flow rate is desired. As mentioned above, more rows may be provided. Also, the orifices do not have to be in an annular array. For example, if the orifices are placed in positions other than those shown, they may be arranged in a grid based on Cartesian coordinates. Alternatively, the orifices 3402 do not have to be placed in any type of row, but may be placed in random or pseudo-random positions.

[0196] 5.4.3 Heat and Humidity Exchanger (HME) A heat and moisture exchanger (HME) may contain materials with moisture-retaining properties. Respiratory pressure therapy (RPT) can result in airway dryness, potentially causing breathing discomfort to the patient. To prevent this, a humidifier can be used in conjunction with the respiratory pressure device to deliver humidified air to the patient. Adding a humidifier in this way may increase the size and power requirements of the RPT device.

[0197] It is known that the level of humidified air generated by a patient during exhalation originates from the airway mucosa. Using a HME, this exhaled moisture can be recycled by capturing the moisture from the humidified air during exhalation and then re-delivering it to the patient. One problem with using an HME is its effectiveness (i.e., its ability to capture sufficient heat and moisture) and its impact on treatment (i.e., the fact that HMEs may be placed in flow circuits, thus causing flow impedance).

[0198] One approach to improve effectiveness is to reduce any loss of heat and moisture captured by the HME. A potential problem when using an HME in RPT is that heat and moisture exhaled from the patient may reach the HME after being lost through the vent. To minimize such losses, the HME may be positioned near the patient's airway (i.e., the source of moisture) and the vent on the opposite side of the HME (i.e., distal to the patient). This configuration can ensure that the exhaled moisture-containing gas passes through the HME, and that the moisture is captured by the HME before exiting through the vent. The vent adapter may be configured such that the HME is positioned between the patient's airway and a constant flow rate of vent.

[0199] The ventilation adapter may also include a removable HME unit. That is, the ventilation adapter may or may not be used with the HME. The HME unit may include a housing that holds the HME in place. The housing can be opened when the HME is removed (the housing may include front and rear components).

[0200] HMEs can be designed to maximize surface area per unit volume for heat and moisture exchange. In addition, HMEs may be designed to reduce their impact on flow impedance. The design may include multiple corrugations to allow flow through the interior. HMEs can be formed as coil layers of HME material containing corrugations.

[0201] As described above, CFV can reduce flow waste by adjusting the airflow to a level above the minimum required for airflow. Reduced flow waste can also reduce the level of moisture loss in the treatment system. It is known in this field that when patients exhale humidified air, it can lead to mucosal dryness. When RPT treatment is applied to SDB, this dryness may worsen. Therefore, reducing the flow required to achieve the treatment pressure while simultaneously reducing the level of humidified air loss from the system can lead to a reduction in mucosal dryness.

[0202] One method to increase the level of humidified air delivered to the patient is the use of electrically driven humidification. Another method for humidifying the air delivered to the patient is the use of a heat and moisture exchanger (HME). A heat and moisture exchanger (HME) captures water vapor in the air so that it can be returned to the patient. An HME can be used to capture moisture from the patient's exhaled breath, and this moisture can then be re-delivered to the patient. The HME needs to be positioned so that it can capture sufficient moisture from the exhaled gas flow and re-deliver this moisture through the therapeutic flow, as shown in Figure 17. The HME needs to be placed between the patient and the vent to ensure that the moisture captured from the exhaled gas flow is maximized. If the vent is placed between the patient and the HME, the moisture in the exhaled gas flow reaches the HME for capture and re-delivery after being vented. However, in the configuration shown in Figure 17, moisture may be lost along the way because the vent exits directly from the vent (and is later delivered to the patient) after passing through the HME through the therapeutic flow. This flow is labeled "HME vent flow" in Figure 17. The HME vent flow becomes more problematic when the therapeutic flow rate increases. As shown in the graph in Figure 18, the flow rate can increase with increasing mask pressure. This flow can be increased to compensate for vent flow losses. As the flow rate increases, the therapeutic flow increases, and as a result, the therapeutic flow can penetrate deeper into the HME. However, once some of this penetrating flow is delivered to the patient, some of this flow is also directed towards venting before being sent to patient delivery (as indicated by the HME vent flow). Therefore, even in the case of the HME vent flow, this can lead to moisture loss due to HME drying.

[0203] As shown in the graph in Figure 18, CFV can reduce the airflow rate at the same pressure range compared to standard FFM·Nom flow aeration. This reduction in flow can lead to a decrease in HME aeration flow, which in turn reduces moisture loss. In other words, compared to a standard aeration system, the flow generated at the same pressure in a CFV system is reduced, resulting in a decrease in HME aeration flow. This decrease in HME aeration flow improves the HME's ability to capture and redeliver moisture from the exhaled gas flow, thereby synergistically improving the HME's effect in reducing mucosal dryness.

[0204] Another way to reduce HME vent flow is to redirect the flow so that the flow through the vent is reduced and redirected back into the system. Such redirection can be achieved by a structure (e.g., a baffle) placed between the flow path and the HME and the vent so that less flow is directed from the vent to the atmosphere.

[0205] This technology can achieve humidification levels close to those of power-driven humidification without using power-driven humidification. Because power-driven humidification is unnecessary, the water reservoir and heating mechanism required to deliver power-driven humidification to the treatment flow are also eliminated, potentially simplifying the flow generator further. Therefore, both CFV and HME can enable flow generators associated with this technology to be effective in providing RPT treatment for OSA and other SDBs (without the need for complex pressure / flow control and power-driven humidification), ultimately benefiting patients by providing substantially smaller flow generators with less control.

[0206] Figures 25A to 25D show embodiments of HME according to the present technology. Figure 25A shows a cross-section of HME 7000. HME 7000 includes a corrugated structure 7002. The corrugated structure 7002 includes a plurality of corrugations 7030 between a substantially planar substrate top structure 7010 and a substantially planar substrate base structure 7020 to form a Concertina 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. In addition, layer 7001 includes a plurality of lower channels 7022 between the lower surface of the corrugated structure 7002 and the base structure 7020. HME 7000 allows breathable and exhaled gas flows to move along the surface of the corrugated structure through the plurality of upper 7012 and lower 7022 channels, thereby exchanging heat and moisture. Moisture is absorbed from the exhaled gas exhaled by the patient and retained in the material of the corrugated structure 7002. The materials of the corrugation 7030, the superstructure 7010, and / or the base structure 7020 may include paper or paper-based material capable of absorbing water and / or heat. The materials of the corrugation 7030, the superstructure 7010, and / or the base structure 7020 may be porous, permeable to water, and / or permeable to air. The retained moisture can then be re-delivered to the patient by humidifying the flow of breathable gas delivered to the patient's airway. In other words, once the flow of breathable gas is delivered to the patient's airway, moisture can be absorbed from the HME 7000. Figure 25B shows various dimensions of the HME according to these embodiments.

[0207] The multiple corrugations 7030 increase the surface area of ​​the corrugated structure 7002, thereby increasing the active surface area for heat and moisture exchange (which occurs between the corrugated structure 7002 and the surrounding volume provided by the multiple upper 7012 and lower 7022 channels). The upper structure 7010 and base structure 7020 may also be formed from the same heat and moisture exchange material as the corrugated structure 7022. Alternatively, the upper structure 7010 and / or base structure 7020 may be formed from a rigid or semi-rigid material that does not absorb moisture in order to support the corrugated structure 7002.

[0208] The humidification performance of the HME7000 depends on the effective surface area of ​​the HME7000 provided within a given volume of space. The effective surface area is the surface area of ​​the HME7000, which is exposed to the flow of breathable gases that flow along the surface of the HME where heat and moisture exchange occurs. The surface area per unit volume of the HME7000 can be adjusted by providing corrugations 7030 within the heat / moisture exchange section of the HME7000. Furthermore, the surface area per unit volume can also be adjusted by changing at least one of the fin thickness, pitch, or height of the corrugations or flutes, which can affect the surface area per unit volume of the HME7000.

[0209] The HME7000 may include multiple layers 7001 stacked along the vertical axis of the HME7000, as shown in Figure 25C. These layers 7001 may be stacked vertically such that the base structure 7020 is stacked on the corrugated structure 7002 of the adjacent lower layer 7001. There may also be several layers 7001 of the HME stacked horizontally. By providing multiple layers 7001, including the corrugated structure 7002, stacked along the vertical axis of the HME7000, the surface area per unit volume of the HME is further increased. Increasing the surface area in this way within a predetermined volume increases the efficiency of heat and moisture exchange of the HME7000. Furthermore, by compressing the layers 7001 under preload, as shown in Figure 25D, the number of layers within a given volume can be increased, thereby increasing the surface area per unit volume. The preload is calculated by the following formula:

[0210]

number

[0211] Here, P is the preload, hstart is the corrugation or flute height before compression, and hfinal is the corrugation height after compression.

[0212] Alternatively, the final three-dimensional shape of the HME7000 may be formed by combining layers 7001 of different sizes and shapes to produce an irregularly shaped HME7000 adapted to fit within the plenum chamber 3200 of the patient interface 3000. The layers 7001 can be laser-cut to the desired shape and size.

[0213] As shown in Figure 25E, which illustrates another embodiment, the HME 7000 can be rolled from a single strip layer 7001 that includes a corrugated structure 7002 extending from the surface of a base structure 7020 and forming a plurality of corrugations 7030. The single strip layer 7001 can be rolled such that the upper bent portions 7031 of the corrugations 7030 engage with the lower surface of the base structure 7020. This configuration ensures that a plurality of channels 7012 are maintained between each roll of the single strip layer 7001.

[0214] As described above, CFV can reduce the airflow rate over the same pressure range compared to standard FFM·Nom flow ventilation. This reduction in flow can lead to a decrease in HME airflow, which in turn reduces moisture loss. In other words, compared to a standard ventilation system, the flow generated in the CFV system at the same pressure is reduced, resulting in a decrease in HME airflow. This reduction in HME airflow can improve the HME's ability to capture and redeliver moisture from the exhaled gas flow, which in turn can synergistically improve the HME's effect of reducing mucosal dryness.

[0215] The CFV membrane can maintain the aeration flow at a minimum level required within the treatment pressure range, and can also be adjusted to a level below that which occurs with standard static aeration. Therefore, CO2 discharge remains at a sufficient level. The aeration flow can be adjusted to obtain the minimum level required for CO2 discharge. As a result, the aeration flow is minimized, and consequently, moisture loss from the HME is also minimized.

[0216] Another method for reducing HME vent flow is to redirect the flow direction so as to reduce the flow that passes through the vent and is redirected back into the air delivery circuit. That is, the flow can be redirected to minimize vent flow, where the flow, after passing through the HME, flows directly out of the vent. Such flow redirection can be achieved by structures (e.g., baffles) placed in the flow path between the HME and the vent so as to reduce the flow that is redirected from the vent to the atmosphere.

[0217] Figures 38A to 38C show one embodiment of the HME housing 9400 according to one embodiment of the present technology. The HME housing 9400 may have a two-part structure including a patient-side HME housing section 9402 and an atmosphere-side HME housing section 9404. The patient-side HME housing section 9402 and the atmosphere-side HME housing section 9404 may be assembled together to hold HME material inside. The patient-side HME housing section 9402 may include a patient-side HME housing crossbar 9406 for holding the HME material axially toward the patient when in use, and the atmosphere-side HME housing section 9404 may include an atmosphere-side HME housing crossbar 9408 for holding the HME material axially toward the atmosphere when in use. The atmosphere-side HME housing section 9404 may also include one or more openings 9410 for connecting to corresponding tabs 9412 of the patient-side HME housing section 9402 to join the two sections together. The connection between the opening 9410 and the tab 9412 may include a snap fit and may be able to be opened to allow disassembly of the HME housing 9400 so that the HME material can be removed for cleaning or replacement.

[0218] Figures 39A to 39C show another example of an HME housing 9400 according to one embodiment of the present technology. The HME housing 9400 may have a two-part structure including a patient-side HME housing section 9402 and an atmosphere-side HME housing section 9404. The patient-side HME housing section 9402 and the atmosphere-side HME housing section 9404 may be assembled together to hold HME material inside. The patient-side HME housing section 9402 may include a patient-side HME housing crossbar 9406 for holding the HME material axially toward the patient when in use, and the atmosphere-side HME housing section 9404 may include an atmosphere-side HME housing crossbar 9408 for holding the HME material axially toward the atmosphere when in use. The atmosphere-side HME housing section 9404 may also include one or more openings 9410 for connecting to corresponding tabs 9412 of the patient-side HME housing section 9402 to join the two sections together. The connection between the opening 9410 and the tab 9412 may include a snap fit and may be able to be opened to allow disassembly of the HME housing 9400 so that the HME material can be removed for cleaning or replacement. The atmosphere-side HME housing portion 9404 may also include an atmosphere-side HME housing portion ring 9414, and an HME inner housing 9416, which may contain the HME material, extends from the atmosphere-side HME housing portion ring 9414. The HME inner housing 9416, together with the patient-side HME housing portion 9402 and the atmosphere-side HME housing portion 9404, may form an HME bypass passage 9418. The HME bypass passage 9418 allows some of the flow moving within the HME housing 9400 to bypass the HME material.

[0219] 5.4.4 Custom Connection Figure 6a is a side view of the fluid connector 9000, in which the first end 9002 and the second end 9004 interlock. Part of the fluid conduit 9006 may be part of the air circuit 4170 and is connected to the second end 9004. Instead of the fluid conduit 9006, an adapter or connector to the fluid conduit may be provided. The outlet of the RPT device 4000 may include the second end 9004 in some embodiments of this technology.

[0220] The fluid connector 9000 may be configured to be detachable from a sealed connection, allowing airflow to flow through its interior (for example, from the RPT device 4000 to the patient interface 3000). The fluid connector 9000 may include multiple components (e.g., a first end 9002 and a second end 9004) that can be connected to each other in a manner that allows them to be detached from one another to form and / or break a sealed connection.

[0221] The first end 9002 and the second end 9004 may form a pneumatic path between them via a complementary sealing portion and may be held together by a complementary retaining portion which may be separate from the complementary sealing portion. Thus, the first end 9002 and the second end 9004 may each include separate sealing portions and retaining portions which may be described in more detail elsewhere in this document.

[0222] When sealing and holding functions are performed by separate, complementary parts, each of these functions can be more easily optimized to address one or more of the competing design requirements. For example, if a pair of complementary parts function to seal and hold two components, the formation of an airtight seal may generate high frictional forces, which may reduce the ease of connecting and / or disconnecting the components.

[0223] Furthermore, if the ease of connection / disconnection is improved, the seal may become less robust when the two components are subjected to forces and / or torque of varying directions and magnitudes. In the case of fluid connectors as described in this document, if a patient wearing the patient interface 3000 moves around while sleeping or trying to fall asleep, the fluid connector may be pulled and / or twisted in various directions.

[0224] Therefore, one aspect of this technology relates to a fluid connector 9000. In the fluid connector 9000, the first end 9002 and the second end 9004 are connected to each other by a complementary sealing portion and a complementary holding portion.

[0225] In one embodiment, the first end 9002 and the second end 9004 may include complementary sealing portions that form an air seal when connected. The air seal may be configured to form and maintain a sealed engagement so that airflow can move through the interior. The sealed engagement may be sufficient to allow a pressurized airflow to pass through the interior at a pressure of, for example, 4 cmH2O to 40 cmH2O so that respiratory therapy can be provided.

[0226] In some embodiments, the first end 9002 and the second end 9004 may include complementary portions for holding the first end 9002 and the second end 9004. The holding portion may maintain the first end 9002 and the second end 9004 in a sealed engagement with each other, for example, by preventing accidental disengagement. The holding portion may include a latching mechanism as further described in this document.

[0227] Figure 6b is a cross-sectional view of the fluid connector 9000, where the first end 9002 and the second end 9004 are not connected to each other. In this figure, the seal portion 9008 is visible. The seal portion 9008 may be formed from any material suitable for forming a seal within the air path of a device that delivers breathing gas to a patient (e.g., silicone). The seal portion 9008 extends around the first opening 9010, which is shown as the interior of the first tube 9022. The latching portion 9012 may take the form of a recess and is located within the first end 9002. The latching portion 9012 may be located on one side or the entirety of the first end 9002, on opposing sides as shown in Figure 6b. As shown, the latching portion 9012 is an undercut substantially perpendicular to the central axis of the first end 9002. Other angles are possible depending on the desired retaining force.

[0228] The second end 9004 includes a sealing surface 9016. The sealing surface 9016 may be formed circumferentially around the second opening 9018, which is shown as the interior of the second pipe 9020. The sealing surface 9016 is shown as a substantially annular surface extending radially perpendicular (i.e., at 90°) in the direction away from the second pipe 9020. As a result, the sealing surface 9016 is substantially perpendicular to the direction of fluid flow from the first end 9002 to the second end 9004. However, the sealing surface 9016 may extend outward in a direction such that the sealing surface 9016 is angled, for example. For example, the sealing surface may be provided at a positive or negative angle of 85°, 80°, 75°, 70°, 65°, 60°, 55°, 50° or 45°, or any value between these values. As can be seen in Figure 6b, the second pipe 9020 may include an overhang 9034 that extends beyond the sealing surface 9016 to the seal portion 9008. As a result, the overhang 9034 of the second pipe 9020 extends through the seal portion 9008 as shown in Figure 6c. It should be understood that in some embodiments of the present art, the second pipe 9020 does not have to include an overhang.

[0229] The overhang portion may be configured to align with the first end 9002 with the second end 9004 provided in one or more directions. The overhang portion 9034 may be configured to be inserted as a pull-in wire into the guide portion 9038 knack on the first end 9002, aligning the second end 9004 with the first end 9002 in a radial (or transverse) direction. Thus, the first end 9002 and the second end 9004 may have a male / female relationship. Furthermore, a stop portion 9030 may be provided to restrict the movement of the second pipe 9020, for example by pressing the overhang portion 9034 against a movement restriction portion. Although the overhang portion 9034 is illustrated as a pipe, the overhang portion cannot extend continuously around the circumference of the second end 9004 because it is inside the seal (seal portion 9008 and sealing surface 9016) created by the complementary sealing portion. The overhang portion may only extend partially through the sealing portion 9008, such as castrated extensions, tabs, or ribs.

[0230] In the configuration shown in Figure 6c, the internal flow path of the fluid connector 9000, defined by the first pipe 9022, the second pipe 9020, and the stopper 9030, is substantially identical to that of the fluid conduit 9006, as can be assessed, for example, by its cross-sectional shape and size, thus providing very little flow restriction. Therefore, as air flows through the fluid connector 9000 throughout the patient's respiratory cycle and treatment pressure (for example, at pressures of 4 cmH2O to 40 cmH2O), the pressure drop in the fluid connector 9000 can be negligibly small.

[0231] The sealing portion 9008 may include a portion that contacts the sealing surface 9016 in any form suitable for forming a surface seal (e.g., using tangent contact between the two). As shown in the figure, the sealing portion 9008 contacts the substantially frustoconical sealing surface 9016, which is similar to a bellows or partially bellows. Alternatively, a partially spherical or partially toroidal surface may be provided on the sealing portion 9008. Using any of these shapes, the sealing portion 9008 contacts the sealing surface 9016, after which the latching portion 9012 and the complementary latching portion 9014 are fully or 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 scenario, due to internal pressure, the sealing portion 9008 moves to contact the sealing surface 9016 and form a seal.

[0232] The seal portion 9008 may include an elastic and compliant material so that it can deform under load and maintain its original configuration when the load is removed. The seal portion 9008 may be configured to deform easily under load, thereby forming and / or maintaining a seal 9016 with the sealing surface. In some embodiments, the seal portion 9008 may include a silicone film. The silicone film seal portion 9008 is sufficiently compliant so that it deforms and moves due to pressure caused by airflow and comes into contact with the sealing surface 9016. Additionally or alternatively, the silicone film seal portion 9008 may be sufficiently compliant so that it maintains a sealed engagement with the sealing surface 9016 even when compressed from its non-deformable configuration.

[0233] The proposed configuration of the seal portion 9008 makes it possible to obtain a seal that is compliant with the meshing direction between the first end 9002 and the second end 9004 (e.g., leftward in Figure 6b) and / or compliant in the radial direction with respect to the axis defined by the engagement direction between the first end 9002 and the second end 9004 (e.g., upward and downward in Figure 6b).

[0234] The force required to compress the seal portion 9008 (for example, if compression is required for the formation and / or maintenance of the seal) may be sufficiently small so as not to result in a significant compressive force. For example, the force required to compress the seal portion 9008 may be lower than the force required to engage the latching portion 9012 with the complementary latching portion 9014 (for example, to overcome any friction when connecting the second end 9004 and the first end 9002). Alternatively, the force required to compress the seal portion 9008 may be less than half the force required to engage the latching portion 9012 with the complementary latching portion 9014. Or, the force required to compress the seal portion 9008 may be less than one-tenth of the force required to engage the latching portion 9012 with the complementary latching portion 9014. Therefore, in a configuration in which the latching portion 9012 and the complementary latching portion 9014 fully engage after the seal portion 9008 contacts the sealing surface 9016, the user will not encounter any significant force that could be mistaken for full engagement. In some embodiments, all forces generated due to the compression of the seal portion 9008 for the connection of the second end 9004 and the first end 9002 can be small enough to be substantially imperceptible to the user. That is, the force perceived by the user in a configuration in which the seal portion 9008 is detached from the first end 9002 may be substantially the same as in a configuration in which the seal portion 9008 needs to be compressed for connection.

[0235] The shape of the seal portion 9008 according to this technology makes it possible to obtain a seal that is compliant in the direction opposite to the interlocking direction between the first end 9002 and the second end 9004 (e.g., to the right in Figure 6b). This makes it possible to obtain a seal portion 9008 that can seal the sealing surface 9016 even if there is a gap between the seal portion 9008 and the sealing surface 9016 when the fluid connector 9000 is unpressurized. When pressure is supplied to the inside of the fluid connector 9000 (e.g., the first tube 9022), the seal portion 9008 can expand toward the sealing surface 9016 and come into contact with the sealing surface 9016 to form a seal. With this configuration, the user should not encounter any additional force beyond the force required to engage the latching portion 9012 and the complementary latching portion 9014 when connecting the first end 9002 to the second end 9004.

[0236] While specific configurations of the seal portion 9008 have been described above, other configurations are possible. For example, some forms of the seal portion 9008 may include an O-ring or gasket material.

[0237] The sealing portion 9008, the sealing surface 9016, or both can be configured so that a seal is obtained between the sealing portion 9008 and the sealing surface 9016 even if the alignment between the sealing portion 9008 and the sealing surface 9016 is improper. For example, the sealing portion 9008 and / or the sealing surface 9016 can be configured to form a seal between them while allowing a certain range of misalignment in the radial (or transverse) direction and / or axial direction.

[0238] For example, the sealing surface 9016 may include an annular shape (as shown in Figure 6H) configured to form a surface seal with the surface of the sealing portion 9008 at multiple radial positions. That is, the sealing portion 9008 and the sealing surface 9016 can form a seal between them even if the axes of the first pipe 9022 and the second pipe 9020 are misaligned by, for example, 0.5 mm, 1 mm, 1.5 mm, 2 mm, 3 mm, or 4 mm. In one embodiment, the sealing surface 9016 may include a sufficiently wide annular portion, thereby allowing the sealing portion 9008 to form a seal with respect to this annular portion.

[0239] The second end 9004 also includes a complementary latching portion 9014. The complementary latching portion 9014 is illustrated as a cantilever hook including a projection that meshes with or engages with the latching portion 9012. Similar to the latching portion 9012, the complementary latching portion 9014 may be provided on multiple (e.g., opposing) sides or on a single side, as shown in Figure 6b. The complementary latching portion 9014 may take the form of a U-shape or C-shape in cross-section, as shown in Figure 6d. When the complementary latching portion 9014 is pressed down, it may engage or disengage with the latching portion 9012, and may enable engagement or disengagement between the first end 9002 and the second end 9004. While it is possible to provide more than two complementary latching portions 9014, in such cases, disengaging the second end 9004 from the first end 9002 may become unnecessarily complicated.

[0240] The stop portion 9030 and the latching portion 9012 can both define a predetermined distance (travel) by which the second end 9004 can move relative to the first end 9002 with the two ends connected. For example, if the first axial distance between the stop portion 9030 and the latching portion 9012 exceeds the second axial distance between the end of the second pipe 9020 and the projection on the complementary latching portion 9014, the difference between the first axial distance and the second axial distance defines a predetermined non-zero travel distance. If the first and second axial distances are equal, no travel is possible. However, if the travel is non-zero, there may be associated benefits, such as cost reduction due to manufacturing tolerances, and at least easier manufacturing. Therefore, benefits may also be obtained by configuring the seal portion 9008 to form a seal 9016 with the sealing surface, along with a worst-case manufacturing tolerance after a predetermined amount of wear and / or creep in the fluid connector 9000. The shape of the seal portion 9008 described above makes it possible for the seal portion 9008 to take such worst-case scenarios into consideration.

[0241] As best shown in Figure 6b, the second end portion 9004 may include an inner portion 9024 and a lower portion 9026 that are rotatably coupled to each other at the interface 9028. The inner portion 9024 may include a sealing portion 9008, and the lower 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 so that the inner portion 9024 and the fluid conduit 9006 can rotate together with respect to the lower portion 9026. A rigid connection may be formed between the two by overmolding at least a portion of the fluid conduit 9006 onto the inner portion 9024. In other embodiments, the fluid conduit 9006 may be friction-fitted or interlock-fitted into the inner portion 9024 to form a rigid connection.

[0242] As best shown in Figure 6d, the profile of the lower portion 9026 may be a profile having four sides and also having some circular features, which can be uniquely identified compared to a typical circular profile. The first end 9002 may include a concave shape of complementary shape. Thus, the first end 9002 includes a female part and the second end 9004 includes a male part. Benefits may be obtained from providing male and female parts of the above shapes or any other non-standard shapes or configurations. A fluid connector 9000 including the first, non-standard shapes and / or configurations may not conform to industry standards (e.g., ISO 5356-1) (e.g., the use of a circular spigot (e.g., retractable taper) into which a cuff (e.g., rubber) is inserted on top). While non-conformity to industry standards may seem counterintuitive, it can also be beneficial. For example, a fluid connector 9000 may be used to connect RPT devices and patient interfaces designed to work optimally together. For example, if the RPT device provides a lower flow rate, which may only be advantageous when used with a patient interface designed for lower flow rates, providing a fluid connector 9000 that does not conform to industry standards allows for verification that the correct RPT device and patient interface are being used together. Secondly, particularly when using the illustrated profile, the first and second ends 9004 can interlock with each other in only a predetermined number of relative orientations (e.g., four orientations). Using this four-sided shape also provides well-defined sides that are easily identifiable and can be easily gripped when the complementary latching portion 9014 is in operation. Thirdly, using non-standard shapes, such as those described herein, allows the user to easily identify which ends of the patient conduit 4170 are complementary connectors to other connectors (e.g., the outlet of the RPT device).

[0243] Figure 6e shows another embodiment of the present technology, where port 9032 is located within the first end 9002. Port 9032 may be used to sense the pressure downstream of the blower and outside the blower housing, for example, by sensing the pressure downstream of the RPT device. Port 9032 may be fluidly connected to the second end 9004 to determine the air pressure in the second opening 9018.

[0244] In one embodiment, port 9032 can be in fluid communication with the interior of the second opening 9018 by forming a fluid connection to, for example, an opening inside the seal portion 9008. This allows the opening inside the seal portion 9008 to be in fluid communication with the pressure tap 9036 to the second opening 9018. Therefore, when the first end 9002 and the second end 9004 are connected to each other, two fluid connections can be formed between them. Port 9032 may offer the advantage of being able to measure pressure closer to the patient (than when measuring pressure within the RPT device). Measuring pressure closer to the patient may allow for more accurate measurements than when pressure measurements are taken more distally from the patient, due to inherent pressure losses in the internal fluid flow and leakage throughout the air path from the blower to the patient.

[0245] Furthermore, this configuration allows the second end 9004 to rotate relative to the first end 9002 while maintaining two fluid connections (i.e., one for airflow delivery and the other for pressure measurement). This is advantageous because it allows the fluid conduit 9006 to rotate relative to the lower section 9026, thereby reducing the torque applied to the fluid conduit and / or the lower section 9026. Moreover, this configuration allows the user to connect the first end 9002 and the second end 9004 in one of several relative rotation directions while maintaining the two fluid connections.

[0246] Figure 6f shows the first end 9002 integrated with the RPT device, with the second end 9004 disconnected. Figure 6g shows the first end 9002 integrated with the RPT device, with the second end 9004 connected.

[0247] In the above description, both bisecting sections of the connector system (for example, the first end 9002 and the second end 9004) are described together, but it should be understood that the description of either bisecting section may be considered separately.

[0248] It may also be advantageous to ensure that the appropriate mask is used in conjunction with CFV membrane regulated ventilation. A mask according to one embodiment of this technology may be a non-ventilated mask designed to be specifically compatible with the CFV membrane ventilation regulation described above. The system may be designed so that the flow generator is also compatible with the ventilation adapter (i.e., the flow generator is programmed with a mask system that has a constant ventilation flow). That is, since each mask type (nose, pillow, and full face) may be connected to the same ventilation adapter, the ventilation adapter must enable sufficient CO2 discharge for each mask type. Minimum CO2 discharge is mainly seen in full-face masks due to the increased volume of mask dead space. Therefore, the ventilation adapter must enable sufficient CO2 discharge in full-face masks (i.e., the worst-case scenario). Since the system of this technology (e.g., flow generator, ventilation adapter, and each mask type) may be specifically designed to work together, it may be advantageous to prevent incompatible masks from being connected to the CFV connector.

[0249] Therefore, a connecting mechanism may be provided such that a seal formed between two detachably connected components is achieved by the connecting mechanism. As described above, the nose mask and pillow mask may be connected to a short tube connector, which then connects to the ventilation adapter. In contrast, the full-face mask may be connected directly to the ventilation adapter 9100. In another embodiment, the HME may include a separate detachable housing that can be removed from the ventilation adapter. However, to reduce the overall size, the HME may be integrated with the ventilation adapter together with the CFV unit, and the HME may be slid into the same housing as the CFV. Such a design may create unused space within the CFV housing of the ventilation adapter 9100 when the HME is removed.

[0250] In the case of a full-face mask using this technology, the end of the short pipe connector can be formed as the entrance to the full-face mask. That is, the same bellows engagement surface is designed as part of the mask shell, which can form part of the mask plenum chamber.

[0251] The bellows sealing membrane can be constructed to move under pressure so that the membrane moves toward the sealing surface on the opposite connector. A pressure-supported seal may mean that the seal between the CFV unit and the connector remains robust under high pressure.

[0252] A bellows seal can make it possible to form a seal between the CFV unit and the connector while minimizing friction between the two components, enabling a swivel connection. For example, in a sealed configuration using interlocking fits, lip seals, gasket configurations, or other forms of compression seals between components, it may not be easy to provide sufficient movement between components to allow them to rotate while maintaining a robust seal.

[0253] 5.4.5 Exemplary ventilation adapters Examples of the ventilation adapter 9100 and its components are shown in Figures 7A to 14D. The ventilation adapter 9100 according to this embodiment of the technology may include a conduit connector 9110, a ventilation housing 9120, a ventilation diffuser cover 9130, a membrane 9140, a CFV ring 9150, a ventilation housing connector 9160, a heat and moisture exchanger (HME) clip 9170, an HME housing 9180, a bellows seal 9190, and a ventilation adapter connector 9200.

[0254] The ventilation housing 9120 may include an end 9121 with a projection 9122 for connecting the ventilation housing 9120 to the conduit connector 9110 at the ventilation adapter end 9112. The end 9121 may define a central orifice of the ventilation housing 9120 through which a pressurized gas flow is provided to the patient. The ventilation housing 9120 may include an external vent 9125 and an internal vent 9126 that define passages for the ventilation of pressurized gas from the RPT system. That is, the gas can be released through these passages into the internal vent 9126 and then released into the external vent 9125 and the atmosphere. The ventilation housing 9120 may also include a tab 9123. The tab 9123 is joined to a lip 9124 via a support 9128 for releasably mounting the ventilation housing 9120 to the ventilation housing connector 9160 and the ventilation adapter connector 9200. When the patient activates tab 9123 and pushes down support portion 9128, lip 9124 is disengaged from vent housing connector 9160 and vent adapter connector 9200. Once installed, lip 9124 allows vent housing 9120 to rotate relative to vent adapter connector 9200 while remaining connected. Ventilation housing 9120 may also include a shoulder portion 9127 that fits into a corresponding notch 9164 of vent housing connector 9160. Ventilation housing 9120 may also include a notch 9129. The notch 9129 receives a corresponding bellows seal connector 9191 that, during assembly, attaches bellows seal 9190 to vent housing 9120 to seal the inside of vent adapter 9100 relative to vent adapter connector 9200.

[0255] The ventilation housing connector 9160 may include a first bar 9161 and a second bar 9162 that form a receptacle 9163. The receptacle 9163 receives a corresponding lip 9124 of the ventilation housing 9120 for attaching the ventilation housing connector 9160 to the ventilation housing 9120. The notch 9164 also receives a shoulder portion 9127 of the ventilation housing 9120 as described above. The ventilation housing connector 9160 may also include a curved outer surface 9165.

[0256] The bellows seal 9190 may be a bellows seal similar to the features described above in relation to Figures 6A to 6H. The bellows seal 9190 may have a shoulder surface 9194 together with a bellows seal connector 9191 for attaching the bellows seal 9190 to the notch 9129 of the ventilation housing 9120. The bellows seal 9190 may also have an inner surface 9193. When the inner surface 9193 comes into contact with pressurized gas during assembly, it is biased outward so that the outer surface 9192 forms a seal with respect to the ventilation adapter connector 9200.

[0257] The ventilation adapter connector 9200 may have an orifice 9201. Through the orifice 9201, pressurized gas moves from the ventilation adapter 9100 to the patient during treatment. Exhaled gas can also be discharged into the ventilation adapter 9100 through the orifice 9201. The ventilation adapter connector 9200 may be connected to a patient interface via another tube (not shown) at the orifice 9201. The ventilation adapter connector 9200 may also have a rim 9202. The rim 9202 connects the lips 9124 of the ventilation housing 9120 to the ventilation adapter connector 9200 and rotates relative to the ventilation adapter connector 9200. In another embodiment of this technology, it should be understood that the ventilation adapter connector 9200 may be directly connected to the patient interface or may be integrally formed with the patient interface (e.g., a mask shell).

[0258] The ventilation adapter 9100 may also include an HME clip 9170 and an HME housing 9180 for holding the HME material within the ventilation adapter 9100 in a position between the internal ventilation hole 9126 and the patient, as described above. The HME material (not shown) may be in a coiled or cylindrical form and is inserted into the HME housing 9180 and held internally by the HME clip 9170. The clip 9170 may have a pair of arms 9171 extending from a central shaft 9172. The central shaft 9172 extends from the center of the HME material and can secure the HME material within the HME housing 9180 by fixing the shaft end 9173 in a receiver 9183 suspended on a cross member 9182 of the HME housing 9180. The HME housing 9180 may also include a pair of slots 9181 within its outer wall 9184. These slots 9181 correspond to the arm 9171 and receive the arm end 9174 so that the HME clip 9170 does not rotate relative to the HME housing 9180 when assembled. Thus, the HME material is fixed between the arm 9171 and the cross member 9182. The outer wall 9184 may include a number of notches 9185.

[0259] 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 a ventilation housing 9120, and the conduit end may be connected to a conduit (not shown) connected to an RPT device to receive a pressurized gas flow at the other end. The conduit connector 9110 may also include an anti-choking valve (AAV) opening 9113.

[0260] Another embodiment of the ventilation adapter 9100 and its components is shown in Figures 15A to 15F. This embodiment may include similar features to the example shown in Figures 7A to 14D above. In this embodiment, the ventilation adapter connector 9200 includes a rim 9203. The rim 9203 connects to a tab 9123 of the ventilation housing 9120, thereby connecting the ventilation adapter connector 9200 to the ventilation housing 9120. This embodiment also shows an anti-suffocation valve (AAV) 9135 that can be installed inside the conduit connector 9110. The conduit connector 9110 may also have a ring 9115 that connects to a conduit (not shown). This embodiment also shows how the bellows seal 9190 is attached to the ventilation housing connector 9160. The ventilation housing connector 9160 also has a protrusion that allows attachment to the ventilation housing 9120 using the tab 9123. Furthermore, examples of the HME material 9145 and diffuser 9146 are illustrated.

[0261] Another embodiment of the ventilation adapter 9100 and its components is illustrated in Figures 21A to 21F. This embodiment may include similar features to the embodiments shown in Figures 7A to 14D and 15A to 15F above. In this embodiment, the HME housing 9180 is not fully housed within the ventilation adapter 9100. That is, the HME housing 9180 is partially exposed and forms part of the structure that connects the ventilation housing 9120 to the ventilation adapter connector 9200.

[0262] Another embodiment of the ventilation adapter 9100 and its components is shown in Figure 22. This embodiment may include similar features to the embodiments shown in Figures 7A to 14D and 15A to 15F above. Figure 22 also includes a flap retaining structure 9141. The flap retaining structure 9141 may be attached to the HME clip 9170 on one side and pressed against the flap 9140 on the other side to maintain the flap 9140 in an operable position relative to the ventilation housing 9120.

[0263] Another embodiment of the ventilation adapter 9100 and its components is shown in Figures 24A to 24B. This example may have similar features to the embodiments shown in Figures 7A to 14D and 15A to 15F above.

[0264] Figure 23 illustrates how the ventilation adapter 9100 can be attached to different patient interfaces. In the case of the nasal cushion patient interface 3000A or the nasal pillow patient interface 3000B, the ventilation adapter 9100 can be connected to either patient interface via a short tube 9210. One end of the short tube 9210 can be connected to the patient interfaces 3000A and 3000B, and the other end can be connected to the ventilation adapter connector 9200 described above. 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 connected directly to the full-face patient interface 3000C, so the short tube 9210 is not provided.

[0265] Figures 33A to 33G show another embodiment of the ventilation adapter 9100 according to one embodiment of the present technology. This ventilation adapter 9100 may be connected to the patient interface 3000, as shown in Figure 35, to provide, for example, the functionality of its components.

[0266] The ventilation adapter includes an elbow assembly 9220. The elbow assembly 9220 provides a fluid connection to the patient interface 3000 (for example, via a connection port 3600 on the plenum chamber 3200). This embodiment of the elbow assembly 9220 includes an elbow frame 9222 and an elbow overmolded 9224. The elbow assembly 9220 may provide a releasable connection to the plenum chamber 3200 at the connection port. The elbow frame 9222 may include an elastically deformable tab for the releasable connection, and the elbow overmolded 9224 may provide a fluid airtight seal around the opening in the elbow frame 9222 and may provide greater elasticity for the elbow frame 9222. The elbow assembly 9220 may also be rotatable relative to the plenum chamber 3200, thereby reducing the effects of tube traction from the ventilation adapter 9100 and other components of the air circuit 4170. The elbow assembly 9220 may also be detachably connected to the patient interface 3000 and may be rotatable relative to the patient interface 3000.

[0267] The ventilation adapter 9100 may also include a short tube assembly 9210. The short tube assembly 9210 can disconnect other components of the ventilation adapter 9110 (e.g., the ventilation housing 9320 and the ventilation core structure 9300) from the connection with the plenum chamber 3200 of the elbow assembly 9220. By disconnecting the other components of the ventilation adapter 9110 in this way, the mass that needs to be directly transported over the patient's head via the patient interface 3000 can be reduced, resulting in a lighter and more comfortable patient experience. The short tube assembly 9210 may include a tube 9212 which may contain one or more helical coils. The short tube assembly 9210 may include a tube elbow connector 9216 that provides connection to the elbow assembly 9220. The connection between the tube elbow connector 9216 and the elbow assembly 9220 may include a snap fit. The connection between the pipe elbow connector 9216 and the elbow assembly 9220 may be permanent. In other words, this connection may be disconnected without damaging the components. The short pipe assembly 9210 may include a pipe housing connector 9214 that provides a connection to the ventilation housing connector 9160. The connection between the pipe housing connector 9214 and the ventilation housing connector 9160 may include a snap fit. The connection between the pipe housing connector 9214 and the ventilation housing connector 9160 may be permanent. In other words, this connection may be disconnected without damaging the components.

[0268] The ventilation adapter 9100 may include a ventilation housing connector 9160 for connecting a short pipe assembly 9210 to a ventilation housing 9320. As described above, the ventilation housing connector 9160 may be joined to the short pipe assembly 9210 by a pipe housing connector 9214. The pipe housing connector 9214 may be snap-fit ​​and permanent. The ventilation housing connector 9160 may also include a bayonet connector 9166. The bayonet connector 9166 facilitates a releasable bayonet connection to the ventilation housing 9320 or a heat and humidity exchanger (HME) housing 9400, for example, as shown in Figures 38A to 39C. Therefore, the HME associated with the HME housing 9400 may become operational and is not shown in Figures 33A to 33G. The bayonet connector 9166 may be male or female. Furthermore, by making the ventilation housing 9320 removable and connectable to the ventilation housing connector 9160, the ventilation components can be removed and disassembled for cleaning.

[0269] Figures 34A to 34G show embodiments of a ventilation housing 9320, a flap or membrane 9140, a ventilation core structure 9300, a diffusion member 9146, a diffuser retaining ring 9148, and a ventilation diffuser cover 9330. These components may be assembled into a subassembly as shown in Figures 34A to 34G and joined to a ventilation housing connector 9160 for use. The components of the subassembly shown in Figures 34A to 34G may be inseparable via permanent snap fasteners, or these components may be separable by the user. If inseparable, the snap fasteners may be permanent so that the components cannot be separated without damage.

[0270] The ventilation housing 9320 may also include a bayonet connector 9322. The bayonet connector 9322 connects to the bayonet connector 9166 of the ventilation housing connector 9160, thereby detachably connecting the ventilation housing 9320 to the ventilation housing connector 9160. The ventilation housing 9320 may also include a membrane retainer 9324 that holds the membrane 9140 against the ventilation core structure 9300 during assembly. The membrane retainer 9324 may include an open radial cage-like structure. This cage-like structure allows the ventilation flow to move through the membrane retainer 9324 and be discharged from the ventilation core structure 9300. The membrane retainer 9324 is also open at the center, allowing therapeutic flow to pass through and reach the patient from the RPT device 4000.

[0271] The flap or membrane 9140 may be positioned between the membrane retainer 9324 and the ventilation core structure 9300. The membrane 9140 may be held in place between these two structures, or it may be freely deformed by the pressure within the ventilation adapter 9100. The membrane 9140 may function similarly to other embodiments of the membrane 9140 disclosed above.

[0272] The ventilation core structure 9300 may include an inlet 9301 that allows the gas flow generated by the RPT device 4000 to be delivered to the patient through the ventilation adapter 9100 for therapeutic purposes. The ventilation core structure 9306 may include a ventilation core extension 9306 through which the inlet 9301 may be defined. The ventilation core extension 9306 may extend axially and may include an air circuit connector 9302 that connects the ventilation core 9300 to the air circuit 4170. As understood, the ventilation core extension 9306 is shaped and dimensional such that it extends through the diffuser retaining ring 9148, the diffuser 9146 and the ventilation diffuser cover 9330 to align these components during assembly of the ventilation adapter 9100. The ventilation core structure 9300 may also include a clip 9304 on a aligning structure 9312 that connects to a connecting surface 9334 of the ventilation diffuser cover 9330. The clip 9304 may be connected to the connecting surface 9334 by a snap fit so that the ventilation diffuser cover 9330 can be removed for disassembly in order to clean and / or replace the ventilation adapter component 9100 (e.g., diffuser 9146). The matching structure 9312 may also facilitate axial alignment of the ventilation core structure 9300 with the diffuser 9146 and the ventilation diffuser cover 9330 by corresponding shapes.

[0273] The ventilated core structure 9300 may also include a plurality of outer orifices 9308 and a plurality of inner orifices 9310. The plurality of inner orifices 9310 may be configured so that the ventilated flow to the atmosphere through the inner orifices 9310 can be blocked or restricted by the membrane 9140 during use. The plurality of outer orifices 9308 may be configured so that the ventilated flow to the atmosphere through the outer orifices 9308 cannot be blocked or restricted by the membrane 9140 at any point during use. However, the membrane 9140 may be configured not to completely block the inner orifices 9310 at any pressure within at least a typical therapeutic pressure range (e.g., about 6 cmH2O to about 20 cmH2O). In other words, the ventilated flow can be released through both the inner orifices 9310 and the outer orifices 9308 at any pressure within a typical therapeutic pressure range. The pressure inside the ventilation adapter 9110 deforms the membrane 9140 so as to change the ratio of the airflow passing through the outer orifice 9308 and the inner orifice 9310 in order to maintain a constant airflow rate as described above.

[0274] The diffuser 9146 may include a diffuser opening 9147 through which the ventilation core extension 9306 can pass. The diffuser 9146 may include features similar to those of the diffuser described above.

[0275] The diffuser 9146 may be held in a predetermined position downstream of the inner orifice 9310 and the outer orifice 9308, facing the airflow through the diffuser retaining ring 9148 and the vented diffuser cover 9330. The diffuser retaining ring 9148 may be fixed to the vented diffuser cover 9330, for example, by snap-fitting, to hold the diffuser 9146. The diffuser retaining ring 9148 may include a radial diffuser retainer 9149 that holds the diffuser 9146 against the vented diffuser cover 9330. The diffuser retaining ring 9148 and the radial diffuser retainer 9149 may define a rear vent outlet 9342 around the vent housing 9320. The airflow exiting the vent core structure 9300 may pass through the diffuser 9148 and exit through the rear vent outlet 9340. The vent diffuser cover 9332 may include a series of cover spacers 9332. These cover spacers 9332 are arranged radially spaced around the vent diffuser cover 9330 to define the front vent outlet 9342. The vent flow exiting the vent core structure 9300 may pass through the diffuser 9148 and exit through the front vent outlet 9342.

[0276] The exemplary ventilation adapter 9100 disclosed in Figures 33A to 34G above is shown connected to the patient interface 3000 in Figure 35. In this embodiment, the elbow assembly 9220 is excluded because the plenum chamber 3200 includes a connection port 3600. The connection port 3600 is angled to face downward relative to the patient's head when in use, thus orienting the ventilation adapter 9100 away from the patient's head. Additionally, the short tube assembly 9210 can be permanently connected to the plenum chamber 3200 at the connection port 3600.

[0277] Figures 37A to 37E show another embodiment of the ventilation adapter 9100 according to the present technology. The ventilation adapter 9100 may include a plenum chamber connector 9700. The plenum chamber connector 9700 provides a fluid connection for the pressurized gas flow from the ventilation adapter 9100 to the plenum chamber 3200 by directly connecting the ventilation adapter 9100 to the connection port 3600 and / or its shroud 3305 (see Figure 41) of the plenum chamber 3200.

[0278] The ventilation adapter 9100 may also include a baffle 9600. The baffle 9600 can separate the pressurized gas flow entering from the RPT device 4000 from the outward ventilation flow exiting through the outer orifice 9308 and inner orifice 9310 of the ventilation housing 9120. The baffle 9600 may be located inside the plenum chamber connector 9700. The baffle 9600 and the plenum chamber connector 9700 may be aligned to form a coaxial circle when connected.

[0279] The ventilation adapter 9100 may also include a lip seal 9500 that fits around the outer circumference of the plenum chamber connector 9700. The lip seal 9500 may form a seal with the internal circumference of the connection port 3600 of the plenum chamber 3200 and / or its shroud 3305 to provide a pneumatic seal while allowing rotation of the ventilation adapter 9100 relative to the patient interface 3000.

[0280] The ventilation adapter 9140 may also include a flap or membrane 9140 to regulate the airflow through the inner orifice 9310 and outer orifice 9308 of the ventilation housing 9120, as described above (for example, in the embodiments shown in Figures 33A to 34G).

[0281] The ventilation housing 9120 may include an internal orifice 9310 and an external orifice 9308. These orifices allow the ventilation flow to exit the ventilation adapter 9100 into the atmosphere, as described in the above embodiments (for example, the examples in Figures 33A to 34G).

[0282] The ventilation housing 9120 may also include tabs 9123 and lips 9124 that provide a releasable and rotatable connection to the connection port 3600 of the plenum chamber 3200 and / or its shroud 3305. By manually pressing down these tabs 9123, the lips 9123 can be released from the corresponding annular projection (not shown) of the connection port 3600 of the plenum chamber 3200 and / or its shroud 3305. When connected, the lips 9124 allow the ventilation adapter 9100 to maintain a connection to the connection port 3600 of the plenum chamber 3200 and / or its shroud 3305 while remaining rotatable to reduce the effects of pipe traction.

[0283] The ventilation housing 9120 may be connected to a conduit connector 9110, which may connect a ventilation adapter 9100 to an air circuit. The conduit connector 9110 may take the form of an elbow. The conduit connector 9110 may have a conduit end 9111 for connecting to an air circuit 4170 and a ventilation adapter end 9112 for connecting to the ventilation housing 9120. The connection between the ventilation adapter end 9112 of the conduit connector 9110 and the ventilation housing 9120 may include a snap fit and may be permanent so as not to disconnect the connection without damaging at least one of the components and / or may be non-rotatable so as not to contact the tab 9123. The conduit connector 9110 may also include one or more anti-choking valve (AAV) openings 9113 for AAV 9135.

[0284] The ventilation adapter 9100 may also include an air circuit connector 9116 that can be attached to the conduit end 9111 of the conduit connector 9110. The air circuit connector 9116 may include a bayonet connector 9117 that connects corresponding to connector 4175 of the exemplary air circuit 4170 shown in Figures 36A to 36C. The connection between the air circuit connector 9116 and the air circuit 4170 may be detachable.

[0285] The ventilation adapters shown in Figures 37A to 37E do not necessarily include the heat and moisture exchanger (HME) material 9145. If the heat and moisture exchanger material 9145 is not placed in the ventilation channel, the ventilation flow impedance may be minimized, thereby minimizing the accumulation of CO2 in the plenum chamber 3200. The ventilation adapter 9100 described is suitable for use with a full-face patient interface, such as the one shown in Figure 41.

[0286] The ventilation adapter 9100 shown in Figures 37A to 37E can form an elbow assembly. This elbow assembly can be detachably connected to the patient interface 3000, for example, as shown in Figure 41, and can rotate relative to the patient interface.

[0287] Figures 40 and 41 show further embodiments of the ventilation adapter 9100 connected to the patient interface 3000.

[0288] Figure 40 shows a patient interface 3000 equipped with a seal-forming structure 3100. The seal-forming structure 3100 forms a seal only around the patient's nose when in use (i.e., a nasal mask). The ventilation adapter 9100 is shown joined to a shroud 3305 that covers a portion of the plenum chamber 3200. In this embodiment, the ventilation adapter 9100 is assembled in an elbow that is directly and rotatably attached to the shroud 3305 to provide a fluid connection with the plenum chamber 3200. However, it should be understood that the ventilation adapters in Figures 33A to 33G may be attached to the shroud 3305 via an elbow assembly 9220 to form a fluid connection with the plenum chamber 3200. The shroud 3305 has a more rigid arm 3301 joined to the shroud 3305 at a hinge 3307. The lateral arm 3301 may include an upper mounting point 3302 and a lower mounting point 3304 for attaching the straps of the positioning and stabilizing structure 3300. The upper mounting point 3302 may form a loop through which the upper strap can be fed, the lower mounting point 3304 may receive a clip 3306, and the clip 3306 receives the lower strap.

[0289] Figure 40 shows an exemplary patient interface 3000 which may include a seal-forming structure 3100 for forming a seal to the patient and oral cavity when in use. For example, a ventilation adapter 9100, as in the embodiments shown in Figures 37A to 37E, may be connected to a shroud 3305 to provide a fluid connection to a plenum chamber 3200. The shroud 3305 may be joined to a more rigid arm 3301 which may have an upper mounting point 3302 for attaching the straps of the positioning and stabilizing structure 3300. The shroud 3305 may be connected to a more rigid arm 3301 and a separate lower strap connector 3303 so that the straps of the positioning and stabilizing structure 3300 are attached at a lower mounting point 3304. The upper mounting point 3302 may form loops through which the upper straps can be fed, the lower mounting point 3304 may receive a clip 3306 which receives the lower strap.

[0290] 5.5 RPT Devices An RPT device 4000 according to one aspect of this technology includes mechanical and pneumatic components 4100 and electrical components 4200, and is configured to execute one or more algorithms 4300. The RPT device may have an external housing 4010. The external housing 4010 is formed by two parts, an upper part 4012 and a lower part 4014. Furthermore, the external 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.

[0291] The pneumatic path of the RPT device 4000 may include one or more air path items and a muffler 4120 (e.g., an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at positive pressure, an outlet muffler 4124, and one or more transducers 4270 (e.g., a pressure sensor and a flow sensor)).

[0292] One or more of the air passage items may be housed within a removable, integrated structure called a pneumatic block 4020. The pneumatic block 4020 may be housed within an external housing 4010. In one embodiment, the pneumatic block 4020 is supported by or formed as part of the chassis 4016.

[0293] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a therapeutic device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a transducer 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In one alternative configuration, the RPT device 4000 may include more than one PCBA 4202.

[0294] 5.5.1 RPT Devices: Mechanical and Pneumatic Components An RPT device may include one or more of the following components in a single unit. In one alternative configuration, one or more of the following components may be arranged as separate units.

[0295] 5.5.1.1 Air filters (multiple) An RPT device according to one embodiment of this technology may include an air filter 4110 or a plurality of air filters 4110.

[0296] In one embodiment, the inlet air filter 4112 is positioned at the beginning of the upstream air pressure path of the pressure generator 4140. See Figure 4B.

[0297] In one embodiment, the outlet air filter 4113 (e.g., antimicrobial factor) is positioned between the outlet of the pneumatic block 4056 and the patient interface 3000. See Figure 4B.

[0298] 5.5.1.2 Mufflers (multiple) In one embodiment of this technology, the inlet muffler 4122 is positioned above the pressure generator 4140 within the pneumatic path. See Figure 4B.

[0299] In one embodiment of this technology, the outlet muffler 4124 is positioned within the pneumatic path between the pressure generator 4140 and the patient interface 3000. See Figure 4B.

[0300] 5.5.1.3 Pressure Generator In one embodiment of this technology, a pressure generator 4140 that generates an airflow or supply at positive pressure is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers housed in a volute. The blower can deliver the air supply at a speed of, for example, up to about 120 liters / minute at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other embodiments up to about 30 cmH2O. The blower may be described in any one of the following patents or patent applications, which are incorporated herein by reference: U.S. Patent No. 7,866,944, U.S. Patent No. 8,638,014, U.S. Patent No. 8,636,479 and PCT Patent Application Publication WO2013 / 020167.

[0301] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0302] In other forms, the pressure generator 4140 may be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a compressed air reservoir), or a bellows.

[0303] 5.5.1.4 Converters (multiple) The converter may be located inside the RPT device or outside the RPT device. The external converter may be located on an air circuit, for example, or form part of an air circuit (e.g., a patient interface). The external converter may take the form of a non-contact sensor (e.g., a Doppler radar motion sensor that transmits or moves the data RPT device).

[0304] In one embodiment of this technology, one or more transducers 4270 may be positioned upstream and / or downstream of the pressure generator 4140. The one or more transducers 4270 may be constructed and positioned to measure characteristics (e.g., flow rate, pressure, or temperature at that point in the pneumatic path).

[0305] In one embodiment of this technology, one or more transducers 4270 may be located near the patient interface 3000.

[0306] In one embodiment, the signal from the converter 4270 may be filtered (for example, by low-pass, high-pass, or band-pass filtering).

[0307] 5.5.1.4.1 Flow Sensor The flow sensor using this technology can be obtained based on a differential pressure transducer (for example, the SDP600 series differential pressure transducer from SENSIRION).

[0308] In one configuration, a signal representing the flow rate (e.g., the total flow rate Qt from the flow sensor) may be received by the central controller 4230.

[0309] 5.5.1.4.2 Pressure Sensor Pressure sensors using this technology can be positioned in communication with both pneumatic and fluid pathways. One example of a suitable pressure transducer is a sensor from the HONEYWELL ASDX series. Another suitable pressure transducer is a sensor from the GENERAL ELECTRIC NPA series.

[0310] In one configuration, the signal from the pressure sensor can be received by the central controller 4230.

[0311] 5.5.1.4.3 Motor Speed ​​Converter In one embodiment of this technology, a motor speed converter may be used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed converter may be provided to the treatment device controller 4240. The motor speed converter may be, for example, a speed sensor (e.g., a Hall effect sensor).

[0312] 5.5.1.5 Anti-spillback valve In one embodiment of this technology, an anti-spillback valve 4160 may be positioned between the humidifier 5000 and the pneumatic block 4020. The anti-spillback valve 4160 is constructed and positioned to reduce the risk of water flowing upstream from the humidifier 5000 (for example, to the blower motor 4144).

[0313] 5.5.1.6 Air Circuit According to one aspect of this technology, the air circuit 4170 is a conduit or tube and is constructed and arranged so that, during use, airflow moves between two components (e.g., a pneumatic block 4020 and a patient interface 3000).

[0314] In detail, the air circuit 4170 may be fluidly connected to the outlet and patient interface of the pneumatic block. The air circuit may be called an air delivery tube. In some cases, there may be separate limbs of the circuit for inhalation and exhalation. In other cases, a single limb is used.

[0315] In some embodiments, the air circuit 4170 may include one or more heating elements configured to heat the air in the air circuit (for example, to maintain or raise the air temperature). In other words, the air circuit 4170 may be a heated air circuit 4171. The heating elements may take the form of a heating wire circuit and may include one or more transducers (e.g., temperature sensors). In one embodiment, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may communicate with a controller (e.g., a central controller 4230). One embodiment of the 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.

[0316] Figures 36A to 36C show an example of an air circuit 4170 according to one embodiment of the present technology. The air circuit 4170 may include a tube 4172 containing one or more helical coils. The air circuit 4173 may include an RPT device connector 4173 at one end. The RPT device connector 4173 is configured to connect to an RPT device 4000 to receive a pressurized gas flow. At the other end, the air circuit 4170 may include a vent adapter connector 4174. The vent adapter connector 4174 may connect to a vent adapter 9100, for example, as disclosed in the embodiments shown in Figures 33A to 34G above. The vent adapter connector 4174 may include a connector 4175 for joining the corresponding air circuit connector 9302 of the vent adapter 9300. The connector 4175 may take the form of a female bayonet connector corresponding to the air circuit connector 9302. The ventilation adapter connector 4174 may also include a grip recess 4176 for the 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 that forms a pneumatic seal between the ventilation adapter connector 4174 and a tube connector 4178 that connects the ventilation adapter connector 4174 to a tube 4172.

[0317] 5.5.1.7 Oxygen Delivery In one embodiment of this technology, supplemental oxygen 4180 can be delivered to one or more points in the pneumatic pathway (e.g., upstream of the pneumatic block 4020), the air circuit 4170 and / or the patient interface 3000.

[0318] 5.5.2 RPT Device Electrical Components 5.5.2.1 Power supply The power supply 4210 may be located inside or outside the external housing 4012 of the RPT device 4000.

[0319] In one embodiment of this technology, the power supply 4210 supplies power only to the RPT device 4000. In another embodiment of this technology, power is supplied from the power supply 4210 to both the RPT device 4000 and the humidifier 5000.

[0320] 5.5.2.2 Input Devices In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to enable human interaction with the device. The buttons, switches, or dials may be physical or software devices accessible via a touchscreen. The buttons, switches, or dials may, in one embodiment, be physically connected to an external housing 4010, or in another embodiment, be wirelessly connected to a receiver electrically connected to a central controller 4230.

[0321] In one embodiment, the input device 4220 may be constructed and configured to allow a human to select a value and / or a menu option.

[0322] 5.5.2.3 Central Controller In one embodiment of this technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0323] Suitable processors may include x86 Intel processors based on ARM® Cortex®-M processors from ARM Holdings (e.g., S®32 series microcontrollers from ST Microelectronics). In certain alternative forms of this technology, 32-bit RISC CPUs (e.g., STR9 series macrocontrollers from ST Microelectronics) or 16-bit RISC CPUs (e.g., processors from the MSP430 family of macrocontrollers manufactured by Texas Instruments) may also be suitable.

[0324] In one embodiment of this technology, the central controller 4230 is a dedicated electronic circuit.

[0325] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In another embodiment, the central controller 4230 includes discrete electronic components.

[0326] The central controller 4230 may be configured to receive input signals(s) from one or more transducers 4270, one or more input devices 4220, and a humidifier 5000.

[0327] The central controller 4230 may be configured to provide output signals (multiple) to one or more of the output devices 4290, the treatment device controller 4240, the data communication interface 4280, and the humidifier 5000.

[0328] In some embodiments of this technology, the central controller 4230 is configured to embody one or more methods described herein (e.g., one or more algorithms 4300 expressed as computer programs recorded in a non-temporary computer-readable recording medium (e.g., memory 4260)). In some embodiments of this technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some embodiments of this technology, some methods may be performed by a remotely located device. For example, a remotely located device may determine ventilator control settings or detect respiratory-related events by analyzing recorded data (e.g., from any of the sensors described herein).

[0329] 5.5.2.4 Clocks The RPT device 4000 may include a clock connected to the central controller 4230.

[0330] 5.5.2.5 Treatment device controller In one embodiment of this technology, the therapeutic device 4350, the therapeutic device controller 4240, and the therapeutic control module 4330 form part of the algorithm 4300 executed by the central controller 4230.

[0331] 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.

[0332] 5.5.2.6 Protection circuit One or more protection circuits 4250 in this technology may include electrical protection circuits, temperature and / or pressure safety circuits.

[0333] 5.5.2.7 Memory In one embodiment of this technology, the RPT device 4000 includes a memory 4260 (e.g., 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.

[0334] Memory 4260 may be located on PCBA4202. Memory 4260 may take the form of EEPROM or NAND flash.

[0335] Additionally or alternatively, the RPT device 4000 includes removable memory 4260 (for example, a memory card manufactured in accordance with the Secure Digital (SD) standard).

[0336] In one embodiment of this technology, the memory 4260 functions as a recording medium readable by a non-temporary computer. Computer program instructions (e.g., one or more algorithms 4300) representing one or more methods described herein are recorded on this recording medium.

[0337] 5.5.2.8 Data Communication System 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 may be connectable to a remote external communication network and / or a local external communication network. The remote external communication network may be connectable to a remote external device. The local external communication network may be connectable to a local external device.

[0338] 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 processor.

[0339] In one embodiment, the remote external communication network is the Internet. The data communication interface 4280 may use wired communication (e.g., via Ethernet or optical fiber) or wireless protocols (e.g., CDMA, GSM, LTE) to connect to the Internet.

[0340] In one configuration, the local external communication network uses one or more communication standards (e.g., Bluetooth® or Consumer Infrared Protocol).

[0341] In one form, the remote external device is one or more computers (e.g., a cluster of networked computers). In another form, the remote external device may be a virtual computer rather than a physical computer. In either case, such a remote external device may be accessible by a properly authorized person (e.g., a clinician).

[0342] A local external device can be a personal computer, mobile phone, tablet, or remote control.

[0343] 5.5.2.9 Optional output devices including displays and alarms The output device 4290 according to this technology may take the form of one or more of visual, auditory, and haptic units. The visual display may be a liquid crystal display (LCD) or a light-emitting diode (LED) display.

[0344] 5.5.2.9.1 Display Driver The display driver receives characters, symbols, or images to be displayed on the display as input and converts them into commands to display these characters, symbols, or images on the display.

[0345] 5.5.2.9.2 Display A 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 8-segment display, in which case the display driver translates each character or symbol (e.g., the number "0") into eight logical signals indicating whether each of the eight segments should be activated to display a particular character or symbol.

[0346] 5.5.3 RPT Device Algorithm 5.5.3.1 Preprocessing Module A pre-processing module 4310, in one form of this technology, receives a signal from a transducer 4270 (e.g., a flow sensor or pressure sensor) as input and performs one or more process steps to calculate one or more output values. These output values ​​are used as input to another module (e.g., a therapeutic engine module 4320).

[0347] In one embodiment of this technology, the output values ​​include interface or mask pressure Pm, breathing flow rate Qr, and leakage flow rate Ql.

[0348] In various forms of this technology, the pre-processing module 4310 includes one or more of the following algorithms: pressure compensation 4312, airflow estimation 4314, leakage flow estimation 4316, and breathing flow estimation 4318.

[0349] 5.5.3.1.1 Pressure Compensation In one embodiment of this technology, the pressure compensation algorithm 4312 receives as input a signal indicating the pressure in the pneumatic path near the outlet of the pneumatic block. The pressure compensation algorithm 4312 estimates the pressure drop through the air circuit 4170 and provides the estimated pressure Pm in the patient interface 3000 as output.

[0350] 5.5.3.1.2 Estimation of airflow rate In one embodiment of this technology, the airflow rate estimation algorithm 4314 receives an estimated pressure Pm in the patient interface 3000 as input and estimates the airflow rate Qv from the vent 3400 in the patient interface 3000.

[0351] 5.5.3.1.3 Estimation of leakage flow rate In one embodiment of this technology, the leakage flow rate estimation algorithm 4316 receives a total flow rate Qt and an aeration flow rate Qv as inputs and provides an estimate of the leakage flow rate Ql as an output. In one embodiment, the leakage flow rate estimation algorithm estimates the leakage flow rate Ql by calculating the average difference between the total flow rate Qt and the aeration flow rate Qv over a sufficiently long period of time, including several breathing cycles (e.g., about 10 seconds).

[0352] In one embodiment, the leakage flow rate estimation algorithm 4316 receives the total flow rate Qt, the permeable flow rate Qv, and the estimated pressure Pm in the patient interface 3000 as inputs, by providing the leakage flow rate Ql as output, calculating the leakage conductance, and determining that the leakage flow rate Ql is a function of the leakage conductance and the pressure Pm. The leakage conductance is calculated as the low-pass filtered square root of the pressure Pm and the quotient of the low-pass filtered non-permeable flow rate equal to the difference between the total flow rate Qt and the permeable flow rate Qv, where the low-pass filtered time constant has a sufficient value to include several respiratory cycles (e.g., about 10 seconds). The leakage flow rate Ql can be estimated as a function of the product of the leakage conductances and the pressure Pm.

[0353] 5.5.3.1.4 Respiratory flow estimation In one embodiment of this technology, the respiratory flow rate estimation algorithm 4318 receives the total flow rate Qt, the inlet flow rate Qv, and the leakage flow rate Ql as inputs, and estimates the air breathing flow rate Q to the patient by subtracting the inlet flow rate Qv and the leakage flow rate Ql from the total flow rate Qt.

[0354] 5.5.3.2 Treatment Engine Module In one embodiment of this technology, the treatment engine module 4320 receives one or more of the pressure Pm and the air breathing flow rate Qr to the patient as inputs from the patient interface 3000, and provides one or more treatment parameters as outputs.

[0355] In one form of this technology, the treatment parameter is the treatment pressure Pt.

[0356] In one embodiment of this technology, the treatment parameters are one or more of the following: level of pressure support, base pressure, and target ventilation.

[0357] In various forms, the therapeutic engine module 4320 includes one or more of the following algorithms: phase determination 4321, waveform determination 4322, ventilation determination 4323, inspiratory flow limitation determination 4324, apnea / respiratory depression determination 4325, snoring determination 4326, airway patency determination 4327, target ventilation determination 4328, and therapeutic parameter determination 4329.

[0358] 5.5.3.2.1 Phase Determination In one embodiment of this technology, the RPT device 4000 does not determine the phase.

[0359] In one embodiment of this technology, the phase determination algorithm 4321 receives a signal indicating the respiratory flow rate Qr as input and provides the phase of the current respiratory cycle of patient 1000 as output Π.

[0360] In some forms, the phase output Π, known as discrete phase determination, is a discrete variable. In one embodiment of discrete phase determination, a binary phase output Π is obtained that has inhalation or exhalation values. These values ​​are represented, for example, as 0 turns and 0.5 turns, respectively, when the onset of spontaneous inspiration and exhalation are detected. The RPT device 4000, which "triggers" and "cycles," effectively performs discrete phase determination because the trigger point and cycle point are the moments when the phase changes from exhalation to inhalation and from inhalation to exhalation, respectively. In one embodiment of binary phase determination, when the respiratory flow rate Qr has a discrete value of 0 and 0.5 turns (which causes the RPT device 4000 to "cycle"), the phase output Φ is determined to have a discrete value of 0 (which causes the RPT device 4000 to "trigger") when the respiratory flow rate Qr has a discrete value of 0 (which causes the RPT device 4000 to "trigger").

[0361] Another embodiment of discrete phase determination yields a tri-phase output Φ with one of the following values: inhalation, pause during inhalation, and exhalation.

[0362] In other forms, the phase output Φ, known as continuous phase determination, is a continuous variable, for example, fluctuating between 0 and 1 revolution or 0 and 2Φ radians. The RPT device 4000 performing continuous phase determination can be triggered and cycled when the continuous phase reaches 0 revolutions and 0.5 revolutions, respectively. In one embodiment of continuous phase determination, the continuous value Φ of the phase is determined using fuzzy logic analysis of the respiratory flow rate Qr. The continuous value of the phase performed in this embodiment is often called the "fuzzy phase". In one embodiment of the fuzzy phase determination algorithm 4321, the following rules apply to the respiratory flow rate Qr: 1. If respiratory flow rate drops to zero and then increases rapidly, the phase is 0 rotations. 2. When the respiratory flow rate is a large positive value and stable, the phase is 0.25 rotations. 3. If the respiratory flow is zero and rapidly decreases, the phase is 0.5 rotations. 4. When the respiratory flow rate is a large negative value and stable, the phase is 0.75 rotations. 5. If the respiratory flow rate is zero and stable, and the absolute value of the respiratory flow rate after 5 seconds of low-pass filtering is large, then the phase is 0.9 rotations. 6. When the respiratory flow rate is positive and the phase is exhalation, the phase is 0 revolutions. 7. The respiratory flow rate is negative, the phase is inspiration, and the phase is 0.5 turns. 8. If the absolute value of the respiratory flow filtered by the low-pass filter over 5 seconds is large, the phase increases at a constant rate equal to the patient's respiratory rate filtered by the low-pass filter with a time constant of 20 seconds.

[0363] The output of each rule can be represented as a vector where the phase is the result of the rule and the magnitude is the fuzzy range in which the rule is true. Fuzzy ranges such as "large" or "stable" for respiratory flow rate are determined by an appropriate membership function. The results of the rules are represented as vectors and then combined by several functions, such as taking the centroid. In such combinations, the rules may be weighted equally or in different ways.

[0364] In another embodiment of continuous phase determination, the inspiratory time Ti and expiratory time Te are first estimated from the respiratory flow rate Qr. Subsequently, the phase Φ is determined as half the proportion of the inspiratory time Ti elapsed since the preceding trigger moment, or 0.5 cycles, plus the proportion of the expiratory time Te elapsed since the preceding cycle moment (the more recent of these).

[0365] 5.5.3.2.2 Waveform Determination In one embodiment of this technology, the treatment parameter determination algorithm 4329 provides a nearly constant treatment pressure throughout the patient's entire respiratory cycle.

[0366] In another form of this technology, the treatment parameter determination algorithm 4329 controls the pressure generator 4140 to provide a treatment pressure Pt that fluctuates throughout the entire phase of the patient's respiratory cycle according to a waveform template.

[0367] In one embodiment of this technology, the waveform determination algorithm 4322 provides a waveform template Π(Φ). The waveform template has a range of values ​​within [0, 1] for the phase value Φ provided by the phase determination algorithm 4321, which is to be used by the treatment parameter determination algorithm 4329.

[0368] In one form, suitable for discrete or continuous phases, the waveform template Π(Φ) is a square wave template with a value of 1 for phase values ​​up to 0.5 turns and a value of 0 for phase values ​​beyond 0.5 turns. In one form, suitable for continuous phases, the waveform template Π(Φ) includes two smoothly curved portions (i.e., a smoothly curved rise from 0 to 1 (e.g., rising cosine) for phase values ​​up to 0.5 turns, and a smoothly curved fall from 1 to 0 (e.g., exponential) for phase values ​​beyond 0.5 turns). In one form, suitable for continuous phases, the waveform template Π(Φ) is based on a square wave but has a smooth rise from 0 to 1 for phase values ​​up to a "rise time" substantially lower than 0.5 turns, and a smooth fall from 1 to 0 for phase values ​​within the "fall time" after 0.5 turns.

[0369] In some forms of this technology, the waveform determination algorithm 4322 selects a waveform template Π(Φ) from a library of waveform templates, depending on the settings of the RPT device. Each waveform template Π(Φ) in the library may be provided as a lookup table value Π for a phase value Φ. In other forms, the waveform determination algorithm 4322 calculates the waveform template Π(Φ) "on the fly" using a predetermined function form (possibly parameterized by one or more parameters (e.g., the time constant of the exponential curve portion)). The parameters of the function form may be predetermined or dependent on the current state of patient 1000.

[0370] In some forms of this technique suitable for discrete binary phases of inhalation (Φ=0 rotations) or exhalation (Φ=0.5 rotations), the waveform determination algorithm 4322 calculates the waveform template Π "on the fly" as a function of the discrete phase Φ and time t measured from the most recent trigger moment. In one such form, the waveform determination algorithm 4322 calculates the waveform template Π(Φ, t) in two parts (inhalation and exhalation) as follows:

[0371]

number

[0372] Here, Πi(t) and Πe(t) are the inspiratory and expiratory portions of the waveform template Π(Φ, t). In one such form, the inspiratory portion Πi(t) of the waveform template is a smooth rise from 0 to 1, parameterized by the rise time, and the expiratory portion Πe(t) of the waveform template is a smooth fall from 1 to 0, parameterized by the fall time.

[0373] 5.5.3.2.3 Ventilation Decision In one embodiment of this technology, the ventilation determination algorithm 4323 receives respiratory flow rate Qr as input and determines a measurement that indicates the current patient ventilation Vent.

[0374] In some embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is an estimate of actual patient ventilation. As one such embodiment, it may take half the absolute value of the respiratory flow rate Qr, which is optionally filtered by a low-pass filter (e.g., a second-order Bessel low-pass filter with a corner frequency of 0.11 Hz).

[0375] In other embodiments, the ventilation determination algorithm 4323 determines a measurement of ventilation Vent that is substantially proportional to actual patient ventilation. In one such embodiment, the peak respiratory flow rate Qpeak is estimated at the inspiratory portion of the cycle. Through the above and many other procedures including sampling of the respiratory flow rate Qr, measurements that are substantially proportional to ventilation are obtained, but in the case of these measurements, the fluctuations in the flow waveform shape are not so large (where the shapes of two breaths are taken as being similar when the flow waveforms of the breaths normalized in terms of time and amplitude are similar). To give some simple examples, there are the median of the positive respiratory flow rates, the median of the absolute values of the respiratory flow rates, and the standard deviation of the flow rates. Any linear combination of any order statistics of the absolute value of the respiratory flow rate using positive coefficients (and even some using both positive and negative coefficients) is generally proportional to ventilation. As another example, it is the average of the respiratory flow rate at the central K -th percentage (with respect to time) of the inspiratory portion, where 0 < K < 1. When the flow shape is constant, there are any number of measurements that are highly proportional to ventilation.

[0376] 5.5.3.2.4 Determination of Inspiratory Flow Limitation In one form of the present technology, the central controller 4230 executes an inspiratory flow limitation determination algorithm 4324 for determining the range of inspiratory flow limitation.

[0377] In one form, the inspiratory flow limitation determination algorithm 4324 receives the respiratory flow rate signal Qr as an input and provides, as an output, a measure of the range in which the inspiratory portion of a breath indicates an inspiratory flow limitation.

[0378] In one embodiment of this technology, the inspiratory portion of each breath is identified by a zero-crossing detector. Multiple (e.g., 65) points, spaced evenly apart, represent time points and are interpolated along the inspiratory flow-time curve for each breath by an interpolator. The curve described by these points is then scaled by a scaler to have a unit length (duration / period) and unit area, thereby removing the effects of changes in respiratory rate and depth. Next, the scaled breath is compared in a comparator to a pre-stored template representing normal non-obstructive breathing (similar to the inspiratory portion of the breath shown in Figure 6A). At any point during inspiration, if the deviation of the breath from this template, such as due to coughing, exhalation, swallowing, or hiccups as determined by the test elements, exceeds a specified threshold (typically 1 scale unit), the breath is rejected. For data that were not rejected, the moving average of the first such scaled points is calculated by the central controller 4230 for several preceding inspiratory events. This is repeated for a second such point over the same inspiratory event, and so on. Therefore, for example, 65 scaled data points are generated by the central controller 4230, representing a moving average of several preceding inspiratory events (e.g., three events). Hereafter, the moving average of the continuously updated (e.g., 65) point values ​​will be referred to as the "scaled flow rate" and denoted by Qs(t). Alternatively, a single inspiratory event may be used instead of the moving average.

[0379] From the scaled flow rate, two geometry elements relevant to the determination of partial blockage can be calculated.

[0380] Shape element 1 is the ratio of the average of intermediate (e.g., 32) scaled flow points to the average of overall (e.g., 65) scaled flow points. If this ratio is greater than 1, respiration is considered normal. If this ratio is less than 1, respiration is considered to have obstruction. A ratio of approximately 1.17 is considered the threshold between partial and non-obstructive respiration and is equivalent to a certain level of obstruction that allows for the maintenance of adequate oxygenation in a typical patient.

[0381] Shape element 2 is calculated as the mean squared deviation from the flow rate scaled to a unit across intermediate points (e.g., 32 points). A mean squared deviation of approximately 0.2 units is considered normal. A mean squared deviation of zero is considered a breath with restricted flow overall. The closer the mean squared deviation is to zero, the more restricted the flow is considered to be in that breath.

[0382] Shape elements 1 and 2 may be used as substitutes or in combination. In other forms of this technology, the number of sampled points, breaths, and intermediate points may differ from those described above. Furthermore, the threshold may also differ from those described above.

[0383] 5.5.3.2.5 Determination of apnea and respiratory depression In one embodiment of this technology, the central controller 4230 executes an apnea / respiratory depression determination algorithm 4325 to determine the presence of apnea and / or respiratory depression.

[0384] The apnea / respiratory depression detection algorithm 4325 receives a respiratory flow signal Qr as input and provides a flag as output indicating whether apnea or respiratory depression has been detected.

[0385] In one form, apnea is detected when the respiratory flow rate (Qr) falls below a flow threshold over a predetermined period. This function can determine the peak flow rate, the average flow rate over a relatively short period, or the flow rate median between the average and peak flow rates over a relatively short period (e.g., RMS flow rate). The flow threshold may be a relatively long-term measurement of the flow rate.

[0386] In one embodiment, respiratory depression is detected when the respiratory flow rate Qr falls below a second flow threshold over a predetermined period. This function can determine the peak flow rate, the average flow rate over a relatively short period, or the flow rate median of the average and peak flow rates over a relatively short period (e.g., RMS flow rate). The second flow threshold may be a relatively long-term measurement of the flow rate. The second flow threshold is higher than the flow threshold used to detect apnea.

[0387] 5.5.3.2.6 Determining Snoring In one embodiment of this technology, the central controller 4230 executes one or more snoring determination algorithms 4326 to determine the snoring range.

[0388] In one embodiment, the snoring detection algorithm 4326 receives a respiratory flow signal Qr as input and provides a measured value as output for the range in which snoring is present.

[0389] The snoring detection algorithm 4326 may include a step of determining the intensity of the flow signal within the range of 30 to 300 Hz. Furthermore, the snoring detection algorithm 4326 may include a step of filtering the respiratory flow signal Qr to reduce background noise (e.g., airflow noise in the system from a blower).

[0390] 5.5.3.2.7 Determining airway patency In one embodiment of this technology, the central controller 4230 executes one or more airway patency determination algorithms 4327 to determine the range of airway patency.

[0391] In one configuration, the airway patency determination algorithm 4327 receives a respiratory flow signal Qr as input and determines the signal output within a frequency range of approximately 0.75 Hz to approximately 3 Hz. The presence of a peak within this frequency range is considered to indicate airway openness. The absence of a peak is considered to indicate airway obstruction.

[0392] In one embodiment, the frequency range for which the peak is required is the frequency range that corresponds to the frequency of small forced oscillations at the therapeutic pressure Pt. In one specific example, the forced oscillation has an amplitude of approximately 1 cmH2O and a frequency of 2 Hz.

[0393] In one configuration, the airway patency determination algorithm 4327 receives a 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 obstruction.

[0394] 5.5.3.2.8 Determining the Target Ventilation In one embodiment of this technology, the central controller 4230 takes the current ventilation measurement Vent as input and executes one or more target ventilation determination algorithms 4328 to determine the target value Vtgt for ventilation measurement.

[0395] In some forms of this technology, the target ventilation determination algorithm 4328 does not exist, and the target value Vtgt is predetermined and obtained, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220.

[0396] In other forms of this technology, such as adaptive servo ventilation (ASV), the target ventilation determination algorithm 4328 calculates the target value Vtgt from a value Vtyp that represents the patient's typical recent ventilation.

[0397] In some forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a high percentage and less than the typical recent ventilation Vtyp. High percentages in such forms can fall within the ranges of (80%, 100%), (85%, 95%), or (87%, 92%).

[0398] In other forms of adaptive servo ventilation, the target ventilation Vtgt is calculated as a value slightly above a multiple of 1 of the typical recent ventilation Vtyp.

[0399] A typical recent ventilation Vtyp is a value where current ventilation Vent measurements are distributed close together across multiple temporal moments over several predetermined timescales, and tend to cluster (i.e., a measurement of the central trend of current ventilation measurements in recent history). In one embodiment of the target ventilation determination algorithm 4328, the recent history is on the order of minutes, but in any case must be longer than the timescale of the Cheyne-Stokes increasing and decreasing cycles. The target ventilation determination algorithm 4328 can determine a typical recent ventilation Vtyp from current ventilation Vent measurements using one of a variety of well-known measurements of central trend. One such measurement is the low-pass filter output for current ventilation Vent measurements with a time constant equal to 100 seconds.

[0400] 5.5.3.2.9 Determination of treatment parameters In some forms of this technology, the central controller 4230 uses values ​​returned from one or more other algorithms in the treatment engine module 4320 to execute one or more treatment parameter determination algorithms 4329 for determining one or more treatment parameters.

[0401] In one embodiment of this technology, the treatment parameter is the instantaneous treatment pressure Pt. In one embodiment of this embodiment, the treatment parameter determination algorithm 4329 determines the treatment pressure Pt using the following equation.

[0402]

number

[0403] Here: A is the amplitude, ·Π(Φ, t) is the waveform template value (in the range of 0 to 1) at the current phase value Φ and time t. P0 is the base pressure.

[0404] If the waveform determination algorithm 4322 provides a waveform template Π(Φ, t) as a lookup table of values ​​Φ indexed by phase, the treatment parameter determination algorithm 4329 applies equation (1) by either locating the nearest lookup table input to the current value Φ of the phase returned from the phase determination algorithm 4321, or by using two inputs that span the current value Φ of the phase.

[0405] The values ​​of amplitude A and base pressure P0 can be set by the treatment parameter determination algorithm 4329, depending on the selected respiratory pressure treatment mode.

[0406] 5.5.3.3 Treatment Control Module In one aspect of this technology, the treatment control module 4330 receives treatment parameters from the treatment parameter determination algorithm 4329 of the treatment engine module 4320 as input, and controls the pressure generator 4140 to deliver airflow from the pressure generator 4140 according to these treatment parameters.

[0407] In one embodiment of this technology, the treatment parameter is the treatment pressure Pt, and the treatment control module 4330 controls the pressure generator 4140 so that the mask pressure Pm at the patient interface 3000 is equal to the treatment pressure Pt and the airflow is delivered from the pressure generator 4140.

[0408] 5.5.3.4 Detection of Fault Conditions In one embodiment of this technology, the central controller 4230 performs one or more methods for detecting a fault condition 4340. The fault condition detected by one or more methods may include at least one of the following: • Power outage (no power or insufficient power) • Detection of converter failure • Cannot detect the presence of the component. • Operating parameters are outside the recommended range (e.g., pressure, flow rate, temperature, PaO2). • Failure to perform a test warning to generate a detectable warning signal.

[0409] When a fault condition is detected, the corresponding algorithmic signal signals the presence of the fault by one or more of the following: • Initiation of audible, visual, and / or dynamic (e.g., vibrational) warnings • Sending messages to external devices • Incident logging

[0410] 5.6 Humidifier 5.6.1 Overview of Humidifiers In one embodiment of this technology, a humidifier 5000 is provided for changing the absolute humidity of air or gas to be delivered to a patient relative to the ambient air (for example, as shown in Figure 5A). Typically, the humidifier 5000 is used to increase the absolute humidity (relative to the ambient air) and temperature of the airflow before it is delivered to the patient's airway.

[0411] 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 embodiments, such as those shown in Figures 5A and 5B, the inlet and outlet of the humidifier reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006. The humidifier base 5006 may be adapted to receive the humidifier reservoir 5110 and may include a heating element 5240.

[0412] 5.6.2 Humidifier Mechanical Components 5.6.2.1 Water Reservoir In one configuration, the humidifier 5000 may include a water reservoir 5110 configured to contain or hold a certain amount of liquid (e.g., water) to be evaporated for humidifying the airflow. The water reservoir 5110 may be configured to contain a predetermined maximum amount of water to provide adequate humidification for at least the duration of a respiratory therapy session (e.g., an overnight sleep). Typically, the reservoir 5110 is configured to contain several hundred milliliters of water (e.g., 300 milliliters (ml), 325 ml, 350 ml, or 400 ml). In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source (e.g., a building's water supply system).

[0413] In one embodiment, the water reservoir 5110 is configured to humidify the airflow from the RPT device 4000 as the airflow passes through the RPT device 4000. In one embodiment, the water reservoir 5110 may be configured to facilitate the movement of the airflow along a meandering path within the reservoir 5110 while the airflow comes into contact with a certain amount of water in the reservoir 5110.

[0414] In one embodiment, the reservoir 5110 may be removable from the humidifier 5000 in the lateral direction, for example, as shown in Figures 5A and 5B.

[0415] The reservoir 5110 may also be configured to suppress liquid discharge from the reservoir 5110 when the reservoir 5110 is displaced and / or rotated from its normal operating direction (e.g., through any aperture and / or between its subcomponents). Since the airflow to be humidified by the humidifier 5000 is often pressurized, the reservoir 5110 may also be configured to prevent leakage and / or loss of air pressure through flow impedance.

[0416] 5.6.2.2 Conductive parts In one configuration, the reservoir 5110 includes a conductive portion 5120 configured to enable efficient heat transfer from the heating element 5240 to a fixed amount of liquid in the reservoir 5110. In one embodiment, the conductive portion 5120 may be arranged as a plate, but other shapes may also be appropriate. The conductive portion 5120, in whole or in part, may be made of a thermally conductive material such as aluminum (e.g., approximately 2 mm thick (e.g., 1 mm, 1.5 mm, 2.5 mm, or 3 mm)), another thermally conductive metal, or some plastic. In some cases, adequate thermal conductivity may be achieved by a less conductive material in an appropriate geometry.

[0417] 5.6.2.3 Humidifier reservoir dock In one embodiment, the humidifier 5000 may include a humidifier reservoir dock 5130 (as shown in Figure 5B) configured to receive a humidifier reservoir 5110. In some configurations, the humidifier reservoir dock 5130 may include a locking function (for example, a locking lever 5135 configured to hold the reservoir 5110 within the humidifier reservoir dock 5130).

[0418] 5.6.2.4 Water Level Indicator The humidifier reservoir 5110 may include a water level indicator 5150 as shown in Figures 5A and 5B. In some forms, the water level indicator 5150 may provide a user, such as a patient or caregiver, with one or more indications of the amount of water in the humidifier reservoir 5110. These one or more indications provided by the water level indicator 5150 may include notification of the maximum predetermined amount of water, any portion thereof (e.g., 25%, 50%, or 75%, or by volume (e.g., 200 ml, 300 ml, or 400 ml)).

[0419] 5.6.3 Humidifier Electrical & Thermal Components The humidifier 5000 may include several electrical and / or thermal components, such as those listed below.

[0420] 5.6.3.1 Humidifier Converter (Multiple) The humidifier 5000 may include one or more humidifier transducers (sensors) 5210 in place of or in addition to the transducer 4270 described above. The humidifier transducer 5210 may include one or more of the following: an air pressure sensor 5212, an air flow transducer 5214, a temperature sensor 5216, or a humidity sensor 5218, as shown in Figure 5C. The humidifier transducer 5210 may generate one or more output signals. These output signals may be communicated to a controller (e.g., a central controller 4230 and / or a humidifier controller 5250). In some forms, the humidifier transducer may be located outside the humidifier 5000 (e.g., within the air circuit 4170) while communicating the output signals to the controller.

[0421] 5.6.3.1.1 Pressure Converter One or more pressure transducers 5212 may be provided in the humidifier 5000 in addition to or instead of the pressure sensors provided in the RPT device 4000.

[0422] 5.6.3.1.2 Flow Converter In addition to or instead of the flow sensor provided in the RPT device, one or more flow converters 5214 may be provided in the humidifier 5000.

[0423] 5.6.3.1.3 Temperature Converter 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 (for example, the temperature of the heating element 5240 and / or the temperature downstream of the airflow at the humidifier outlet 5004). In some embodiments, the humidifier 5000 may further include a temperature sensor 5216 for detecting the temperature of the ambient air.

[0424] 5.6.3.1.4 Humidity Converter In one embodiment, the humidifier 5000 may include one or more humidity sensors 5218 that detect the humidity of a gas, such as ambient air. In some embodiments, the humidity sensors 5218 may be positioned toward the humidifier outlet 5004 to measure the humidity of the gas delivered from the humidifier 5000. The humidity sensors may be absolute humidity sensors or relative humidity sensors.

[0425] 5.6.3.2 Heating elements In some cases, the heating element 5240 may be provided in a humidifier 5000 that provides a heat input to one or more of the water volume in the humidifier reservoir 5110 and / or the water volume to the airflow. The heating element 5240 may include a heat-generating component such as an electrical resistance heating track. One suitable embodiment of the heating element 5240 is the layered heating element described, for example, in PCT Patent Application Publication WO2012 / 171072, which is incorporated herein by reference.

[0426] In some configurations, the heating element 5240 may be located within the humidifier base 5006. Within the humidifier base 5006, heat can be transferred to the humidifier reservoir 5110 primarily by conduction, as shown in Figure 5B.

[0427] 5.6.3.3 Humidifier Controller In one configuration of this technology, the humidifier 5000 may include a humidifier controller 5250 as shown in Figure 5C. 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 separate controller capable of communicating with the central controller 4230.

[0428] In one embodiment, the humidifier controller 5250 may receive measurements of characteristics (e.g., temperature, humidity, pressure, and / or flow rate) as input (e.g., measurements of airflow and water in the reservoir 5110 and / or humidifier 5000). The humidifier controller 5250 may also be configured to execute or perform humidifier algorithms and / or deliver one or more output signals.

[0429] As shown in Figure 5C, the humidifier controller 5250 may include one or more controllers (for example, a central humidifier controller 5251, a heated air circuit controller 5254 configured to control the temperature of the heated air circuit 4170, and / or a heated element controller 5252 configured to control the temperature of the heated element 5240).

[0430] 5.7 Respiratory pressure therapy modes Depending on the values ​​of parameters A and P0 in the therapeutic pressure equation (1) used by the therapeutic parameter determination algorithm 4329 in one embodiment of this technology, a variety of respiratory pressure therapy modes can be performed by the RPT device 4000.

[0431] 5.7.1 CPAP treatment In some embodiments of this form of the technology, since the amplitude A is always zero, the therapeutic pressure Pt is similarly equal to the base pressure P0 throughout the entire respiratory cycle. Such embodiments are mainly grouped under the heading of CPAP therapy. In such embodiments, the therapeutic engine module 4320 for determining the phase Φ or waveform template Π(Φ) is not required.

[0432] In CPAP therapy mode, the base pressure P0 can be a constant value and is either hardcoded or manually entered into the RPT device 4000. This alternative is sometimes referred to as constant CPAP therapy. A constant value for the base pressure P0 can be selected for a given patient through a process known as titration. During titration, the clinician typically adjusts the therapeutic pressure Pt in response to observations of flow limitation, apnea, respiratory depression, patency, and snoring during the titration session. The titrated base pressure P0 can then be calculated as a statistical summary of the therapeutic pressure Pt during the titration session.

[0433] Alternatively, the treatment parameter determination algorithm 4329 may continuously calculate the base pressure P0 during CPAP treatment. In this alternative, the treatment parameter determination algorithm 4329 continuously calculates the base pressure P0 as a function of sleep disorder respiratory indicators or measurements (e.g., one or more of flow limitation, apnea, respiratory depression, patency, and snoring) returned from each algorithm in the treatment engine module 4320. This alternative is also called APAP treatment. Because such continuous calculation of base pressure P0 is similar to manual adjustment of treatment pressure Pt by a clinician, APAP treatment is also called automated titration CPAP.

[0434] 5.7.2 Bilevel Therapy In other embodiments of this form of the technology, the value of amplitude A in equation (1) may be positive. Such implementation is known as bilevel therapy. This is because, when the therapeutic pressure Pt is determined using equation (1) with a positive amplitude A, the therapeutic parameter determination algorithm 4329 oscillates the therapeutic pressure Pt between two values ​​or levels in synchronization with the spontaneous respiratory effort of patient 1000. That is, based on the typical waveform template Π(Φ,t) described above, the therapeutic parameter determination algorithm 4329 increases the therapeutic pressure Pt to P0+A (known as IPAP) at the start of inspiration or during respiration, and decreases the therapeutic pressure Pt to the base pressure P0 (known as EPAP) at the start of expiration or during expiration.

[0435] In some forms of bilevel therapy, IPAP is a prescribed therapeutic pressure for the same purpose as the therapeutic pressure in CPAP therapy mode, and EPAP is the value obtained by subtracting amplitude A from IPAP, and has a “small” value (a few cmH2O) also called expiratory pressure release (EPR). This form is also called CPAP therapy with EPR and is generally considered to be more comfortable than direct CPAP therapy. In CPAP therapy with EPR, either or both IPAP and EPAP can be constant values ​​and are hardcoded or manually entered into the RPT device 4000. Alternatively, the therapy parameter determination algorithm 4329 may continuously calculate IPAP and / or EPAP during CPAP with EPR. In this alternative example, the therapy parameter determination algorithm 4329 continuously calculates EPAP and / or IPAP as a function of sleep disorder breathing indices or measurements returned from each algorithm in the therapy engine module 4320. This is done similarly to the calculation of the base pressure P0 in APAP therapy described above.

[0436] In other forms of bilevel therapy, the amplitude A is large enough for the RPT device 4000 to perform some or all of the patient's breathing motion. In such forms known as pressure-assisted ventilation therapy, the amplitude A is called pressure assist or swing. In pressure-assisted ventilation therapy, IPAP is base pressure P0 + pressure assist A, and EPAP is base pressure P0.

[0437] In some forms of pressure-assisted ventilation known as constant-pressure assisted ventilation therapy, the pressure assist A is fixed to a predetermined value (e.g., 10 cmH2O). The predetermined pressure assist value is a setting of the RPT device 4000, which can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220.

[0438] In some forms of pressure-assisted ventilation therapy known as servo ventilation, the treatment parameter determination algorithm 4329 takes the current measured 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) so that the current measured value Vent approaches the target ventilation value Vtgt. In forms of servo ventilation known as adaptive servo ventilation (ASV) used in CSR therapy, the target ventilation Vtgt is calculated by the target ventilation determination algorithm 4328 from a typical recent ventilation Vtyp as described above.

[0439] In some forms of servo ventilation, the treatment parameter determination algorithm 4329 applies a control method to continuously calculate pressure assist A so that the current ventilation measurement Vent approaches the target ventilation Vtgt. One such control method is proportional-integral (PI) control. In one embodiment of PI control suitable for an ASV mode set so that the target ventilation Vtgt is slightly lower than a typical recent ventilation Vtyp, the pressure assist is calculated as follows:

[0440]

number

[0441] Here, G is the gain of PI control. A larger gain G value may result in positive feedback in the treatment engine module 4320. A smaller gain G value may result in a certain amount of remaining untreated CSR or central sleep apnea. In some embodiments, the gain G is fixed at a predetermined value (e.g., -0.4 cmH2O / (L / min) / sec). Alternatively, the gain G may be changed between treatment sessions until a value is reached that almost completely eliminates CSR (starting at a low value and increasing between sessions). Conventional methods for retrospectively analyzing treatment session parameters to assess the severity of CSR during a treatment session may be used in such embodiments. In yet other embodiments, the gain G may vary depending on the difference between the current ventilation measurement Vent and the target ventilation Vtgt.

[0442] Other servo ventilation control methods that can be applied by the treatment parameter determination algorithm 4329 include proportional (P), proportional-difference (PD), and proportional-integral-difference (PID).

[0443] The value of pressure assist A calculated via equation (2) can be clipped to a range defined as [Amin, Amax]. In this embodiment, pressure assist A is set by default to minimum pressure assist Amin until the current ventilation measurement Vent falls below the target ventilation Vtgt. A begins to increase when the current ventilation measurement Vent falls below the target ventilation Vtgt, and only decreases to Amin when Vent exceeds Vtgt again.

[0444] The pressure assist limits Amin and Amax are settings of the RPT device 4000, which are set either hardcoded during the configuration of the RPT device 4000 or manually entered via the input device 4220. A minimum pressure assist Amin at 3 cmH2O is on the order of 50% of the pressure assist required to perform all breathing movements of a typical patient in a steady state. A maximum pressure assist Amax at 12 cmH2O is approximately twice the pressure assist required to perform all breathing movements of a typical patient, so it is sufficient to assist the patient's breathing when the patient interrupts any effort, but is lower than a value that would be uncomfortable or dangerous.

[0445] In pressure-assisted ventilation therapy mode, EPAP is the base pressure P0. Similar to the base pressure P0 in CPAP therapy, EPAP can be a constant value and is defined or determined during titration. Such a constant EPAP can be set, for example, by hardcoding during the configuration of the RPT device 4000 or by manual input through the input device 4220. This alternative is also called fixed EPAP pressure-assisted ventilation therapy. Titration of EPAP for a given patient may be performed by a clinician during a titration session using PSG for the purpose of preventing obstructive apnea, thereby maintaining airway security for pressure-assisted ventilation therapy in a manner similar to the titration of base pressure P0 in constant CPAP therapy.

[0446] Alternatively, the treatment parameter determination algorithm 4329 may continuously calculate the base pressure P0 during pressure-assisted ventilation therapy. In such an embodiment, the treatment parameter determination algorithm 4329 continuously calculates EPAP as a function of sleep-disordered breathing indicators or measurements (e.g., one or more of flow limitation, apnea, respiratory depression, patency, and snoring) returned from each algorithm in the treatment engine module 4320. Because the continuous calculation of EPAP is analogous to the manual adjustment of EPAP by a clinician during EPAP titration, this process is also called automated titration of EPAP, and the overall treatment is known as automated titrated EPAP pressure-assisted ventilation therapy or automated EPAP pressure-assisted ventilation therapy.

[0447] 5.8 Glossary For the purposes of disclosing this technology, one or more of the following definitions may apply in certain forms of this technology. Other definitions may also apply in other forms of this technology.

[0448] 5.8.1 General Air: In certain forms of this technology, air may mean the atmosphere, and in other forms of this technology, air may mean a combination of other breathable gases (e.g., an oxygen-rich atmosphere).

[0449] Atmosphere: In certain forms of this technology, the term “atmosphere” should be understood to mean (i) the area outside the treatment system or patient, and (ii) the area directly surrounding the treatment system or patient.

[0450] For example, ambient humidity for a humidifier can be the humidity of the air directly surrounding the humidifier (e.g., the humidity inside the room where the patient is sleeping). This ambient humidity may differ from the humidity outside the room where the patient is sleeping.

[0451] In another embodiment, the ambient pressure may be the pressure directly surrounding or outside the body.

[0452] In certain forms, ambient (e.g., acoustic) noise can be considered the background noise level in the patient's room, excluding noise originating from, for example, RPT devices or masks or patient interfaces. Ambient noise may originate from sources outside the room.

[0453] Respiratory pressure therapy (RPT): Addition of air supply to the airway inlet at therapeutic pressure, which is typically positive pressure relative to the atmosphere.

[0454] Continuous positive airway pressure (CPAP) therapy is a respiratory pressure therapy in which the therapeutic pressure remains nearly constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway entrance increases slightly during exhalation and decreases slightly during inhalation. In some forms, the pressure fluctuates between different respiratory cycles of the patient (e.g., increased in response to the detection of signs of partial upper airway obstruction and decreased in the absence of such indications).

[0455] Patient: A person who has or does not have a respiratory illness.

[0456] Automatic positive airway pressure (APAP) therapy: CPAP therapy that can automatically adjust the therapeutic pressure between minimum and maximum limits between breaths, for example, depending on the presence or absence of signs of SDB onset.

[0457] 5.8.2 Patterns of the respiratory cycle Apnea: According to some definitions, apnea is said to occur when airflow falls below a certain threshold for a duration of, for example, 10 seconds. Obstructive apnea is said to occur when airflow is not permitted due to some airway obstruction despite the patient's exertion. Central apnea is said to refer to a condition in which apnea is detected due to decreased or absent respiratory effort, even though the airway is open. Mixed apnea is said to refer to a condition in which decreased or absent respiratory effort occurs simultaneously with airway obstruction.

[0458] Respiratory rate: This is the patient's spontaneous breathing rate, usually measured as the number of breaths per minute.

[0459] Load cycle: The ratio of inspiratory time Ti to total respiratory time Ttot.

[0460] Breathing Effort: Breathing effort is said to refer to the movements performed by a person's spontaneous breathing as they attempt to breathe.

[0461] The exhalation portion of the respiratory cycle: the period from the start of the exhalation flow to the start of the inhalation flow.

[0462] Flow limitation: Flow limitation is interpreted as a situation in a patient's respiration where increased exertion by the patient does not result in a corresponding increase in flow rate. If flow limitation occurs during the inspiratory portion of the respiratory cycle, it may be called inspiratory flow limitation. If flow limitation occurs during the expiratory portion of the respiratory cycle, it may be called expiratory flow limitation.

[0463] Types of flow-restricted intake waveforms: (i) Flattening: A period of rising followed by a relatively flat section, after which a descent occurs. (ii) M-shaped: It has two local peaks, one at the rise and one at the fall, with a relatively flat area between these two peaks. (iii) Chair-shaped: Has a single localized peak, which rises from the beginning and is followed by a relatively flat area. (iv) Inverted chair shape: A relatively flat area is followed by a single localized peak, and this peak occurs in the sloping portion.

[0464] Respiratory depression: Preferably, respiratory depression means a decrease in flow, rather than an interruption of flow. In one morphology, respiratory depression is said to have occurred if a decrease in flow below a threshold velocity persists for a period of time. If respiratory depression is detected due to a decrease in respiratory effort, it is said to have occurred. In one morphology of an adult, respiratory depression may be considered if any of the following occurs: (i) A 30% decrease in patient respiration lasting at least 10 seconds + associated 4% desaturation, or (ii) The patient's respiration decreases by less than 50% for at least 10 seconds, and associated desaturation is at least 3% or awakening occurs.

[0465] Hyperventilation: A condition in which blood flow increases to a level higher than normal.

[0466] The inspiratory portion of the respiratory cycle: The period from the start of the inspiratory flow to the start of the expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0467] Patency (airway): The degree to which the airway is open or the extent to which the airway is open. Airway patency is defined as opening. Airway patency can be quantified using values ​​(1) indicating patency and values ​​(0) indicating closure (obstruction).

[0468] Positive end-respiratory pressure (PEEP): This is the pressure in the lungs that exceeds the atmospheric pressure, and is present at the end of exhalation.

[0469] Peak flow rate (Qpeak): The maximum flow rate in the inspiratory portion of the respiratory flow waveform.

[0470] Respiratory airflow, airflow, patient airflow, respiratory airflow (Qr): These synonyms may be understood to refer to the estimation of respiratory airflow by an RPT device and are used in contrast to "true respiratory flow" or "true respiratory airflow," which is the patient's actual respiratory flow, usually expressed in liters / minute.

[0471] Tidal volume (Vt): The amount of air inhaled or exhaled during normal breathing without extra effort.

[0472] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0473] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0474] (Total) Time (Ttot): The total duration between the start of one inspiratory portion of the respiratory flow waveform and the start of the next inspiratory portion of the respiratory flow waveform.

[0475] Typical recent ventilation: Ventilation values ​​that tend to cluster together over a given time scale (i.e., the degree of the central trend of recent ventilation values).

[0476] Upper airway obstruction (UAO): This includes both partial and total upper airway obstruction. This may be associated with a flow-limiting condition in which flow rate may slightly increase or decrease as the pressure difference in the upper airway increases (Stirling register behavior).

[0477] Ventilation: A measurement of the total volume of gas exchange performed by a patient's respiratory system. Ventilation measurements may include either or both inspiratory and expiratory airflow per unit time. When expressed as volume per minute, this volume is often called "minute ventilation." Minute ventilation may also simply be given as volume and understood as volume per minute.

[0478] 5.8.3 RPT Device Parameters Flow rate: The instantaneous amount (or mass) of air delivered per unit time. Flow rate and tidal volume have the same magnitude of quantity or mass per unit time, although flow rate is measured over a considerably shorter period of time. In some cases, when flow rate is mentioned, it refers to a scalar quantity (i.e., a quantity that has only magnitude). In other cases, when flow rate is mentioned, it refers to a vector quantity (i.e., a quantity that has both magnitude and direction). When mentioned as a signed quantity, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and negative for the expiratory portion of the patient's respiratory cycle. Flow rate is assigned the sign Q. "Flow rate" is sometimes abbreviated as "flow". Total flow rate Qt is the flow rate of air exiting the RPT device. Vent flow rate Qv is the flow rate of air exiting the vent to allow the exhaled gas to escape. Leakage flow rate Ql is the flow rate of leakage from the patient interface system. Respiratory flow rate Qr is the flow rate of air received into the patient's respiratory system.

[0479] Leakage: The term "leakage" is taken to mean an unintended flow of air. In one embodiment, leakage may occur due to an incomplete seal between the mask and the patient's face. In another embodiment, leakage may occur at the circumferential elbow to the surroundings.

[0480] Conducted Noise (Acoustics): In this document, conducted noise refers to noise transmitted to a patient via pneumatic pathways (e.g., air circuits and patient interfaces and the air within them). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0481] Noise Radiation (Acoustic): In this document, radiated noise refers to noise transmitted to the patient by the surrounding air. In one form, radiated noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO 3744.

[0482] Noise from ventilation (acoustics): In this document, ventilation noise refers to noise generated by airflow through any ventilation (e.g., ventilation holes in a patient interface).

[0483] Pressure: Force per unit area. Pressure can be measured in various units (e.g., cmH2O, gf / cm2, hectopascal). 1 cmH2O is equal to 1 g-f / cm2, which is approximately 0.98 hectopascals. In this specification, unless otherwise specified, pressure is given in units of cmH2O. Pressure in the patient interface is denoted by the symbol Pm, and therapeutic pressure, which represents the target value that the mask pressure Pm should achieve at the present time, is denoted by the symbol Pt.

[0484] Acoustic power: The energy carried by sound waves per unit time. Acoustic power is proportional to the square of the value obtained by multiplying the sound pressure by the wavefront area. Acoustic power is usually expressed in decibels (SWL) (i.e., decibels relative to a reference power of 10-12 watts).

[0485] Sound pressure: The local deviation from ambient pressure at a given time that occurs as a result of sound waves passing through a medium. Sound pressure is usually expressed in decibels (SPL) (i.e., decibels relative to a reference power, usually taken as 20 × 10⁻⁶ Pascals (Pa), which is considered the threshold of human hearing).

[0486] 5.8.4 Terminology related to mechanical ventilation Adaptive servo ventilators (ASVs): Servo ventilators that have a variable target ventilation rather than a fixed target ventilation. The variable target ventilation can be learned from some characteristic of the patient (e.g., the patient's respiratory characteristics).

[0487] Backup rate: A ventilator parameter that establishes the minimum respiratory rate (typically respiratory rate per minute) delivered from the ventilator to the patient (when not triggered by spontaneous respiratory effort).

[0488] Cycle: The end of the inspiratory phase of a ventilator. When a ventilator delivers air to a patient who is breathing spontaneously, it is said that the ventilator cycles to stop delivering air at the end of the inspiratory portion of the respiratory cycle.

[0489] Positive expiratory airway pressure (EPAP): The base pressure to which varying pressures within respiration are added in order for a ventilator to generate the desired mask pressure that it attempts to achieve at a given time.

[0490] End-of-Expiratory Pressure (EEP): The desired mask pressure that the ventilator aims to achieve at the end of the expiratory portion of respiration. When the pressure waveform template Π(Φ) is zero at the end of exhalation (i.e., Π(Φ)=0 when Φ=1), EEP is equal to EPAP.

[0491] Positive Inspiratory Airway Pressure (IPAP): The maximum desired mask pressure that a ventilator attempts to achieve during the inspiratory portion of breathing.

[0492] Pressure assist: A number indicating the pressure increase during exhalation of a ventilator from the inspiratory phase, primarily representing the pressure difference between the maximum inspiratory pressure and the baseline pressure (e.g., PS = IPAP - EPAP). In some contexts, pressure assist refers to the difference the ventilator aims to achieve (rather than the difference it actually achieves).

[0493] Servo ventilator: A ventilator that has both patient ventilation and target ventilation, and adjusts the pressure support level to bring patient ventilation closer to the target ventilation.

[0494] Spontaneous / Timing (S / T): A mode of a ventilator or other device that attempts to detect the start of breathing in a patient who is breathing spontaneously. However, if the device fails to detect breathing within a predetermined period, the device automatically initiates respiratory delivery.

[0495] Swing: A term equivalent to pressure assistance.

[0496] Trigger: When a ventilator delivers air to a patient who is breathing spontaneously, the ventilator is said to be triggered to deliver air when the patient initiates the respiratory portion of the respiratory cycle.

[0497] Typical Recent Ventilation: Typical recent ventilation (Vtyp) is a range of values ​​over a given time scale in which recent ventilation measurements tend to cluster. For example, measuring the central trend of ventilation measurements over recent history may be a good value for typical recent ventilation.

[0498] Ventilator: A mechanical device that provides pressure assistance to help a patient perform some or all of the breathing motion.

[0499] 5.8.5 Anatomical structure of the face Wings: The outer walls or "wings" of each nostril (plural: alar)

[0500] Alare: The outermost point on the nasal ala.

[0501] Wing curvature (or wing apex) point: The furthest point on the curved reference line of each wing, found at the fold formed by the joining of the wing and cheek.

[0502] Auricle: The entire visible part of the ear.

[0503] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal portion of the frontal bone.

[0504] (Nasal) cartilage: The cartilage of the nose includes the septal cartilage, lateral cartilage, macrocartilage, and microcartilage.

[0505] Columella: A piece of skin that separates the nostrils, extending from the tip of the nose to the upper lip.

[0506] Columella angle: The angle between a line drawn through the midpoint of the nostrils and a line drawn perpendicular to the Frankfurt horizontal, intersecting the subnasal point.

[0507] Frankfort horizontal plane: A line extending from the lowest point of the orbital rim to the left auricle. The auricle is the deepest point from the upper side of the notch to the tragus of the auricle.

[0508] Glabella: Located in soft tissue, it is the most prominent point in the midline sagittal direction of the forehead.

[0509] Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper margin is attached to the nasal bone and the frontal process of the maxilla, and its lower margin is connected to the greater alar cartilage.

[0510] Greater alar cartilage: A plate of cartilage located beneath the lateral nasal cartilage. It curves around the anterior portion of the nostril. Its posterior end connects to the frontal process of the maxilla by a tough fibrous membrane containing three or four alar cartilages.

[0511] Nostrils (or alae): Generally, these are ellipsoidal wing-shaped openings that form the entrance to the nasal cavity. The singular form of nostril is nostril (alae). These nostrils are separated by the nasal septum.

[0512] Nasolabial fold or groove: A fold or groove of skin that extends from each side of the nose to the corners of the mouth, separating the cheek from the upper lip.

[0513] Nasolabial angle: The angle between the columella and the upper lip, which intersects with the subnasal point.

[0514] Inferior auricle: The lowest point where the auricle attaches to the facial skin.

[0515] Inferior auricle point: The highest point where the auricle attaches to the facial skin.

[0516] Nasal tip: The most prominent point or tip of the nose, which can be seen in a lateral view of the rest of the head.

[0517] Philtrum: The midline groove extending from the lower boundary of the nasal septum to the upper part of the lip in the upper lip region.

[0518] Pogonion: The anterior midpoint of the jaw, located on soft tissue.

[0519] Nasal bridge (nose): The nasal ridge is the midline elevation of the nose, extending from the therion to the nasal tip.

[0520] Sagittal plane: A vertical plane that extends from the front (front) to the back (back), dividing the main body into a right half and a left half.

[0521] Serion: The most concave point located on soft tissue within the region of the frontonasal suture.

[0522] Septal cartilage (nose): The nasal septum cartilage is part of the septum and divides the anterior part of the nasal cavity.

[0523] The lowest point of the nasal ala: This is a point on the lower periphery of the wing base, where the wing base joins the skin of the upper lip.

[0524] Subnasal point: Located on soft tissue, this is the point where the columella merges with the upper lip in the midline sagittal direction.

[0525] Supramentare: The most concave point on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue pogonion.

[0526] 5.8.6 Anatomical structure of the skull Frontal bone: The frontal bone includes the frontal squama, a large vertical portion that corresponds to the area known as the forehead.

[0527] Mandible: The mandible forms the lower jaw region. The mental protuberance is a bony protuberance in the jaw region and forms the jaw.

[0528] Maxilla: The maxilla forms the upper jaw and is located below the mandible and below the orbit. The frontal process of the maxilla protrudes upward from the side of the nose, forming its lateral boundary.

[0529] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from person to person. The nasal bones are located side by side in the middle and upper parts of the face, and their joint forms the "bridge" of the nose.

[0530] Nasion: The intersection of the frontal bone and the two nasal bones, a recessed area directly located between the upper part of the bridge between the eye and the nose.

[0531] Occipital bone: The occipital bone is located in the posterior and inferior part of the skull. The occipital bone contains the foramen magnum, an oval opening through which the intracranial cavity is connected to the vertebral canals. The curved plate on the posterior side of the foramen magnum is the occipital squama.

[0532] Orbit: A bony cavity within the skull that contains the eyeball.

[0533] Parietal bone: The parietal bones are bones that, when joined together, form the top and sides of the skull.

[0534] Temporal bone: The temporal bone is located on the base and sides of the skull and supports the part of the face known as the temple.

[0535] Cheekbones: The two cheekbones in the face are located in the upper and outer parts of the face, forming the cheekbones.

[0536] 5.8.7 Anatomical structure of the respiratory system The diaphragm is a sheet of muscle that extends over the lower part of the rib cage. It separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. When the diaphragm contracts, the volume of the thoracic cavity increases, drawing air into the lungs.

[0537] Larynx: The larynx or vocal organ that houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0538] Lungs: The respiratory organ in humans. The conductive zone of the lungs includes the trachea, bronchi, terminal bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchi, alveolar ducts, and alveoli.

[0539] Nasal cavity: The nasal cavity (or nasal fossa) is a large, air-filled space located in the center of the face, above and behind the nose. The nasal cavity is divided into two by a vertical fin called the nasal septum. On the sides of the nasal cavity are three horizontal extensions called the nasal conchae or nasal bones. The nose is located anterior to the nasal cavity, and posteriorly it connects to the nasopharynx via the posterior nostrils.

[0540] Pharynx: The part of the throat located directly below the nasal cavity and above the esophagus and larynx. The pharynx is traditionally divided into the following three parts: nasopharynx (upper pharynx) (the nasal part of the pharynx), oropharynx (the oral part of the pharynx), and pharynx (lower pharynx).

[0541] 5.8.8 Materials Silicone or silicone elastomer: synthetic rubber. In this specification, when silicone is referred to, it refers to liquid silicone rubber (LSR) or compression-molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the product line sold under this registered trademark), manufactured by Dow Corning. Another LSR manufacturer is Wacker. Unless otherwise specified, the Shore A (or Type A) indentation hardness of exemplary forms of LSR, as measured by ASTM D2240, is approximately 35 to approximately 45.

[0542] Polycarbonate: Typically, it is a transparent thermoplastic polymer of bisphenol A carbonate.

[0543] 5.8.9 Patient Interface Configuration Anti-choking valve (AAV): A component or subassembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to the atmosphere in a fail-safe manner.

[0544] Elbow: A conduit that directs the airflow axis so as to change angle through a certain angle. In one form, the angle may be approximately 90 degrees. In another form, the angle may be less than 90 degrees. The conduit may have a nearly circular cross-section. In another form, the conduit may have an elliptical or rectangular cross-section.

[0545] Frame: The term "frame" is taken to mean a mask structure that supports tensile loads between two or more points connecting the headgear. The mask frame can be an airtight load-supporting structure within the mask. However, some forms of mask frames may be airtight.

[0546] Headgear: Headgear is taken to mean a form of positioning and stabilizing structure designed for use on the head. For example, headgear may include a collection of one or more struts, ties, and stiffeners co...

Claims

1. A ventilation housing comprising an outer wall, an inner wall defining an inlet for the flow of therapeutic gas, and a base located between the outer wall and the inner wall, The aforementioned base is To release the gas exhaled by the patient from the pressurized volume inside the patient interface, a gas flow is maintained during respiratory therapy, and at least one first orifice extending through the base is provided to allow the gas flow to be released into the atmosphere, A second orifice extending through the base, which allows the gas from the pressurized volume to be released into the atmosphere, A ventilation housing having the base having the above, The patient interface includes a ventilation housing connector having an outlet opening configured to guide a therapeutic flow of gas pressurized to a pressure higher than the ambient pressure, A heat and moisture exchanger (HME) comprising an HME housing and HME material within the HME housing, A membrane made of an elastic material is positioned adjacent to the base between the outer wall and the inner wall, A ventilation system for a patient interface worn by a patient during respiratory therapy, comprising: The ventilation housing and the ventilation housing connector are configured to be connected to each other such that they form at least a partial cavity. Once the ventilation system is assembled, the heat and moisture exchanger (HME) is placed inside the cavity. The pressurized volume is in fluid communication with the atmosphere through the at least one first orifice and the at least one second orifice throughout the entire therapeutic pressure range. A ventilation system in which the membrane is elastically deformable by the pressure in the pressurized volume and distributes a gas flow between the at least one first orifice and the at least one second orifice over the entire therapeutic pressure range.

2. The ventilation system according to claim 1, wherein the membrane is made of silicone.

3. The ventilation system according to claim 1, wherein the ventilation housing is formed from a single, homogeneous component of a material harder than silicone.

4. The ventilation system according to claim 3, wherein the material is polycarbonate.

5. The ventilation system according to any one of claims 1 to 4, wherein the base further comprises an inner base and an outer base.

6. The ventilation system according to claim 5, 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.

7. The ventilation system according to claim 6, 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.

8. The ventilation system according to claim 7, wherein the plurality of outer orifices pass through the outer base, and the plurality of inner orifices pass between the outer base and the inner base.

9. The ventilation system according to any one of claims 5 to 8, wherein the outer wall, the inner wall, the inner base, the outer base, and the membrane are circular.

10. The ventilation system according to claim 9, wherein the outer wall, the inner wall, the inner base, the outer base, and the membrane are concentric.

11. The ventilation system according to any one of claims 1 to 10, wherein the membrane is not attached to the ventilation housing, and the membrane can move freely toward the base and move freely away from the base.

12. The ventilation system according to any one of claims 1 to 11, wherein the heat-moisture exchanger (HME), comprising an HME housing and HME material, is removable from the cavity.

13. It is a patient interface, seal-forming structure, A plenum chamber joined to the seal-forming structure, A positioning and stabilizing structure for securing the patient interface to the patient during use, A ventilation system according to any one of claims 1 to 10, A patient interface comprising the above.

14. The patient interface according to claim 13, further comprising a ventilation connector tube or separation structure for fluidly connecting the ventilation system to the plenum chamber.

15. It is an RPT system, A ventilation system according to any one of claims 1 to 14, An RPT device configured to generate a therapeutic flow of gas at a pressure higher than the ambient pressure, A patient interface configured to deliver a gas therapy flow at a pressure higher than the ambient pressure to the patient's airway, and which is a non-ventilated patient interface, A delivery conduit configured to deliver a therapeutic flow of gas pressurized to a pressure higher than the ambient pressure from the RPT device to the ventilation system, An RPT system comprising the following.

16. The RPT system according to claim 15, wherein the RPT system does not include a humidifier.

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