Patient interface and positioning and stabilization structure

Abstract

The patient interface includes a plenum chamber and at least three plenum chamber inlet ports. The seal-forming structure is positioned to form a seal at the inlet to at least the patient's nares and maintain a therapeutic pressure within the plenum chamber throughout the patient's respiratory cycle. The interface includes a positioning and stabilizing structure including at least five straps, at least three of which define channels therein, with a conduit provided within each channel. Each conduit includes an interface connector for connecting the conduit to a respective one of the inlet ports and a connection port for connecting to an air circuit in use, the connection port being in fluid communication with each of the conduits. The plenum chamber is provided with at least one pressure measurement port. A positioning and stabilizing structure is also disclosed.

Description

Technical Field

[0001] The present technology is related to one or more of screening, diagnosis, monitoring, treatment, prevention, and improvement of respiratory-related diseases. The present technology also relates to medical devices or apparatuses, and their use.

Background Art

[0002] 1.2.1 Human Respiratory System and Its Diseases

[0003] The respiratory system of the body facilitates gas exchange. The nose and mouth form the entrance to the patient's airway.

[0004] The airway includes a series of tubes that branch out in a manner that becomes narrower, shorter, and more numerous as they penetrate deeper into the lungs. The main function of the lungs is gas exchange, which moves oxygen from inhaled air into venous blood and carbon dioxide in the opposite direction. The trachea divides into the right and left main bronchi, which ultimately further divide into terminal bronchioles. The bronchioles supplement the conducting airways and are not involved in gas exchange. The airway further differentiates and connects to respiratory bronchioles, which ultimately connect to alveoli. The alveolar region of the lungs is where gas exchange occurs and is referred to as the respiratory region. See Non-Patent Document 1 by John B. West.

[0005] There are a wide range of respiratory diseases. Certain diseases can be characterized by specific events, such as apnea, hypopnea, and hyperventilation.

[0006] Examples of respiratory diseases include obstructive sleep apnea syndrome (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hypoventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disorders.

[0007] Obstructive sleep apnea syndrome (OSA), a form of sleep-disordered breathing (SDB), is characterized by events that include obstruction or closure of the upper airway during sleep. This results from a combination of an abnormally small upper airway and the loss of normal muscle tone in the regions of the tongue, soft palate, and posterior pharyngeal wall during sleep. Due to this symptom, affected patients typically stop breathing for 30 to 120 seconds, and in some cases, 200 to 300 times per night. This often causes excessive daytime sleepiness and may lead to cardiovascular disease and brain damage. This syndrome is a disorder commonly seen in middle-aged, overweight men, but affected patients may not be aware of the problem. See Patent Document 1 (Sullivan).

[0008] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a respiratory control disorder in patients with rhythmic and alternating periods of ventilation increase and decrease known as the CSR cycle. CSR is characterized by the repetition of arterial blood deoxygenation and reoxygenation. Due to the repeated occurrence of the hypoxic state, CSR can be harmful. In some patients, CSR is associated with repeated awakenings from sleep, causing severe sleep disorders, increased sympathetic nerve activity, and increased afterload. See Patent Document 2 (Berthon-Jones).

[0009] Respiratory insufficiency is a general term for respiratory diseases in which the lungs are unable to take in sufficient oxygen or expel sufficient CO2 to meet the patient's needs. Respiratory insufficiency may include some or all of the following diseases.

[0010] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0011] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia during wakefulness without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0012] Chronic obstructive pulmonary disease (COPD) encompasses any of a group of lower airway diseases with specific common characteristics. These include an increased resistance to air movement, an extended expiratory phase of breathing, and a loss of normal lung elasticity. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (the main risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include shortness of breath during intense activity, chronic cough, and sputum production.

[0013] Neuromuscular disease (NMD) is a broad term encompassing many diseases and disorders that damage muscle function either directly through intrinsic muscle pathology or indirectly through neuropathy. Some NMD patients are characterized by progressive muscle impairment leading to immobility, wheelchair confinement, dysphagia, respiratory muscle weakness, and ultimately death due to respiratory failure. Neuromuscular diseases are divided into rapidly progressive and slowly progressive types. (i) Rapidly progressive diseases: characterized by muscle impairment that worsens over months and leads to death within years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in teenagers), (ii) Variable or slowly progressive diseases: characterized by muscle impairment that worsens over years and only slightly shortens the average lifespan (e.g., limb-girdle, facioscapulohumeral, and myotonic muscular dystrophy). Symptoms of respiratory failure in NMD include increased general weakness, dysphagia, shortness of breath during intense activity and at rest, fatigue, drowsiness, morning headache, difficulty with concentration and mood changes.

[0014] Chest wall disorders are a group of chest deformities that result in an inefficient coupling between the respiratory muscles and the thorax. These disorders are usually characterized by restrictive deficits and share the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include shortness of breath during intense activity, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, loss of appetite, etc.

[0015] To treat or improve such symptoms, a wide range of treatments have been used. Furthermore, healthy individuals may also use such treatments to prevent the occurrence of respiratory diseases. However, these have a number of drawbacks. 1.2.2 Treatments

[0016] Various respiratory treatments, such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), invasive ventilation (IV), and high-flow therapy (HFT), are used to treat one or more of the above-mentioned respiratory diseases. 1.2.2.1 Respiratory pressure treatment

[0017] Respiratory pressure treatment is to apply an air flow to the entrance of the user's airway at a controlled target pressure that is nominally positive pressure with respect to the atmosphere (in contrast to negative pressure treatment such as a tank ventilator or chest piece) throughout the user's respiratory cycle.

[0018] Continuous positive airway pressure (CPAP) treatment is used for the treatment of obstructive sleep apnea syndrome (OSA). The mechanism of action is that continuous positive airway pressure acts as an air splint, pushing the soft palate and tongue forward and away from the posterior wall of the oropharynx, etc., so as to prevent upper airway obstruction. Since the treatment of OSA by CPAP treatment may be optional, patients may choose not to comply with the treatment if they find one or more of the problems such as the device used for the provision of such treatment being uncomfortable, difficult to use, expensive, and not aesthetically appealing.

[0019] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway, assists the patient's breathing, and / or appropriately maintains the oxygen level in the body by performing part or all of the work of breathing. The ventilation support is provided through a non-invasive patient interface. NIV has been used for the treatment of CSR and respiratory failure in forms such as OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

[0020] Invasive ventilation (IV) provides ventilatory support to patients who can no longer breathe effectively on their own and can be provided using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved. 1.2.2.2 Flow therapy

[0021] Not all respiratory therapies are aimed at delivering a prescribed therapy pressure. Some respiratory therapies aim to deliver a defined tidal volume by delivering an inspiratory flow profile over a target period, sometimes superimposed on a baseline positive pressure. In some cases, the interface to the patient's airway is "open" (not sealed), and the respiratory therapy only supplements the patient's spontaneous breathing with a regulated or enriched gas flow. In one example, high-flow therapy (HFT) supplies a continuous flow of heated and humidified air to the airway inlet through an unsealed or open patient interface at a "therapy flow" that is approximately constant throughout the respiratory cycle. The therapy flow is nominally set to exceed the patient's peak inspiratory flow. HFT is used in the treatment of OSA, CSR, respiratory insufficiency, COPD, and other respiratory diseases. One mechanism of action is to improve ventilation efficiency by flushing or washing out CO2 exhaled from the patient's anatomic dead space due to the high air flow at the airway inlet. Thus, HFT is sometimes referred to as dead space therapy (DST). Other advantages may include improved warmth and humidification (which may aid in secretion management) and the potential for a modest increase in airway pressure. Instead of a constant flow, the therapy flow may follow a profile that varies over the respiratory cycle.

[0022] Another form of flow therapy is long-term oxygen therapy (LTOT) or oxygen supplementation therapy. A physician may prescribe a continuous flow of oxygen-supplemented gas to the patient's airway at a specified flow rate (e.g., 1 liter per minute (LPM), 2 LPM, 3 LPM, etc.) and a specified oxygen concentration (ranging from 21% to 100% of the oxygen fraction in ambient air). 1.2.2.3 Supplementary oxygen

[0023] In some patients, oxygen therapy can be combined with respiratory pressure therapy or HFT by adding supplemental oxygen to a flow of pressurized air. When oxygen is added to respiratory pressure therapy, this is referred to as RPT with supplemental oxygen. When oxygen is added to HFT, the resulting therapy is referred to as HFT with supplemental oxygen. 4.1 Respiratory Therapy System

[0024] These respiratory therapies can be provided by a respiratory therapy system or device. Such systems and devices can be used to screen, diagnose, or monitor symptoms without treatment.

[0025] A respiratory therapy system can include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, an oxygen source, and data management. 1.2.3.1 Patient Interface

[0026] A patient interface can interface between its wearer and respiratory equipment, for example, by providing a flow of air to an airway inlet. The flow of air can be provided to the nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment applied, the patient interface can, for example, form a seal with the area of the patient's face and facilitate delivery of gas at a pressure with sufficient variation from ambient pressure, such as a positive pressure of about 10 cmH2O relative to ambient pressure, to enable treatment. In other forms of treatment, such as delivery of oxygen, the patient interface may not be provided with a seal sufficient to facilitate delivery to the airway to supply gas at a positive pressure of about 10 cmH2O. In the case of flow therapies such as nasal HFT, the patient interface is configured to blow gas into the nostrils and is specifically configured to avoid a complete seal. An example of such a patient interface is a nasal cannula.

[0027] Certain other mask systems may be functionally unsuitable for the current field. For example, a purely decorative mask may not be able to maintain a suitable pressure. A mask system used for underwater swimming or diving may be configured to prevent water ingress from external high pressure, but may not be configured to maintain the internal air at a higher pressure than the surroundings.

[0028] Certain masks may be clinically unfavorable for this technology, for example, when they block the air flow through the nose and permit air flow only through the mouth.

[0029] Certain masks may be uncomfortable or impractical for this technology if the patient needs to insert a part of the mask structure into the mouth to create and maintain a seal through the lips.

[0030] Certain masks may not be practical for use during sleep, for example, when lying on the side in bed with the head on a pillow.

[0031] There are numerous challenges in the design of a patient interface. The face has a complex three-dimensional shape. The size and shape of the nose and head vary greatly among individuals. Since the head contains bone, cartilage, and soft tissue, the response to mechanical forces varies depending on the facial region. The jawbone or mandible can move relative to the other bones of the skull. The entire head may move during the course of respiratory therapy.

[0032] As a result of these problems, some masks suffer from one or more of the following issues: being obstructive, aesthetically unappealing, expensive, poorly fitting, difficult to use, uncomfortable, etc., especially when worn for long periods or when the patient is unfamiliar with the system. If the size of the mask is inappropriate, it can lead to a decrease in compliance, comfort, and patient outcomes. Masks designed specifically for pilots, masks designed as part of personal protective equipment (e.g., filter masks), SCUBA masks, or masks designed for the administration of anesthetics can withstand their original uses, but such masks can become unacceptably uncomfortable when worn for long periods, e.g., for several hours. This discomfort can lead to a decrease in patient compliance with treatment. This is especially true when the mask must be worn during sleep.

[0033] CPAP treatment is very effective in treating certain respiratory diseases as long as the patient adheres to the treatment. If the mask is uncomfortable or difficult to use, the patient may not comply with the treatment. Since patients are often recommended to wash the mask regularly, if mask cleaning is difficult (e.g., when assembly or disassembly is difficult, etc.), the patient may not wash the mask, which can affect patient compliance.

[0034] Masks for other uses (e.g., for pilots) may not be suitable for use in the treatment of sleep apnea, while masks designed for the treatment of sleep apnea may be suitable for other uses.

[0035] For these reasons, patient interfaces for CPAP delivery during sleep form a separate field. 1.2.3.1.1 Seal-forming structure

[0036] The patient interface may include a seal-forming structure. Since it comes into direct contact with the patient's face, the shape and configuration of the seal-forming structure can directly affect the effectiveness and comfort of the patient interface.

[0037] The patient interface can be partially characterized according to the design intent of where the seal-forming structure engages the face during use. In one form of the patient interface, the seal-forming structure can comprise a first sub-part that forms a seal around the left nostril and a second sub-part that forms a seal around the right nostril. In one form of the patient interface, the seal-forming structure can comprise a single element that surrounds both nostrils during use. Such a single element can be designed, for example, to cover the upper lip region and the nasal bridge region of the face. In one form of the patient interface, the seal-forming structure can comprise an element that surrounds the oral region during use, for example, by forming a seal in the lower lip region of the face. In one form of the patient interface, the seal-forming structure can comprise a single element that surrounds both the nostrils and the oral region during use. These different types of patient interfaces are known by various names by manufacturers, including nasal masks, full-face masks, nasal pillows, nasal puffs, and oro-nasal masks.

[0038] A seal-forming structure that can be effective in one region of a patient's face may be inappropriate in other regions, for example, because the shape, structure, variability, and sensitive areas of the patient's face are different. For example, the seal of a swimming goggle placed over a patient's forehead may not be suitable for use on the patient's nose.

[0039] A particular seal-forming structure can be designed for mass production such that one design is suitable for a wide range of different face shapes and sizes and is comfortable and effective. As long as there is a mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must adapt to form a seal.

[0040] Another seal-forming structure extends around the patient interface and is intended to seal against the patient's face when a force is applied to the patient interface in a state where the seal-forming structure engages facing the patient's face. The seal-forming structure may comprise a cushion filled with air or fluid, or a molded or formed surface of an elastic seal element made of an elastomer such as rubber. According to this type of seal-forming structure, if the fit is insufficient, a gap may form between the seal-forming structure and the face, and additional force is required to press the patient interface against the face to achieve a seal.

[0041] Another type of seal-forming structure incorporates a thin material flap seal positioned around the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. As with conventional style seal-forming parts, if the harmony between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. Further, if the shape of the seal-forming structure does not match the shape of the patient, it may crease or buckle during use, causing leakage.

[0042] Another type of seal-forming structure may comprise, for example, friction fit elements for insertion into the nostrils, but some patients may find these uncomfortable.

[0043] Other forms of the seal-forming structure may achieve a seal using an adhesive. Some patients may find it inconvenient to constantly apply and remove the adhesive to their face.

[0044] The following patent applications assigned to ResMed Limited disclose the scope of the seal-forming structure technology of the patient interface. Patent Document 3, Patent Document 4, Patent Document 5.

[0045] One form of nasal pillows is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal puff is the subject of Patent Document 6 (Trimble et al.) assigned to the Puritan-Bennett Corporation.

[0046] ResMed Limited manufactures the following products incorporating nasal pillows: SWIFT® Nasal Pillow Mask, SWIFT® II Nasal Pillow Mask, SWIFT® LT Nasal Pillow Mask, SWIFT® FX Nasal Pillow Mask, MIRAGE LIBERTY® Full Face Mask. The following patent applications assigned to ResMed Limited describe examples of nasal pillow masks: Patent Document 7 (describing, inter alia, aspects of the ResMed SWIFT® Nasal Pillow), Patent Document 8 (describing, inter alia, aspects of the ResMed SWIFT® LT Nasal Pillow), Patent Documents 9 and 10 (describing, inter alia, aspects of the ResMed MIRAGE LIBERTY® Full Face Mask), Patent Document 11 (describing, inter alia, aspects of the ResMed SWIFT® FX Nasal Pillow). 1.2.3.1.2 Positioning and Stabilization

[0047] The seal-forming structure of a patient interface used for positive pressure therapy breaks the seal under the force of the corresponding air pressure. Accordingly, various techniques have been used to position the seal-forming structure and maintain it in a sealing relationship with the appropriate part of the face.

[0048] One technique is the use of adhesives. See, for example, Patent Document 12. However, the use of adhesives can be uncomfortable for some people.

[0049] Another technique is the use of one or more straps and / or stabilization harnesses. Many such harnesses suffer from one or more of the problems of non-conformity, bulkiness, discomfort, and difficulty of use. 1.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0050] A respiratory pressure therapy (RPT) device can be used individually or as part of a system to perform one or more of the above-mentioned numerous therapies, such as by operating the device to generate an air flow to be delivered to the airway interface. The air flow can be pressure-controlled (in the case of respiratory pressure therapy) or flow-controlled (in the case of flow therapy such as HFT). Therefore, an RPT device can also act as a flow therapy device. Examples of RPT devices include CPAP devices and ventilators.

[0051] Air pressure generators are known in a wide range of applications, such as industrial-scale ventilation systems. However, air pressure generators for medical purposes have specific requirements that are not satisfied by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have drawbacks regarding one or more of comfort, noise, ease of use, effectiveness, size, weight, manufacturability, cost, and reliability.

[0052] An example of a special requirement for a specific RPT device is acoustic noise.

[0053] Table of noise output levels of past RPT devices (the sample is only one, measured at 10 cmH2O in CPAP mode using the ISO-specified test method).

[0054] [Table 1]

[0055] As one of the known RPT devices used for the treatment of sleep apnea, there is the S9 Sleep Therapy System manufactured by ResMed. Another example of an RPT device is a ventilator. Ventilators such as those in the ResMed Stellar (registered trademark) series for adults and children, although not limited to this, support invasive and non-invasive and non-dependent ventilation for various patients to treat a number of conditions such as NMD, OHS, COPD, etc.

[0056] The ResMed Elisee (registered trademark) 150 ventilator and the ResMed VS III (registered trademark) ventilator can support invasive and non-invasive dependent ventilation suitable for adult or pediatric patients treating a number of conditions. These ventilators provide volume and pressure ventilation modes with single or double-limb circuits. RPT devices typically include a pressure generator such as a motor-driven blower or a compressed gas reservoir and are configured to supply an air flow to the patient's airway. In some cases, the air flow can be supplied to the patient's airway at positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0057] Designers of the device can be presented with countless options. It is common for design criteria to conflict, meaning that certain design choices are far from routine or inevitable. Furthermore, the comfort and effectiveness of a particular aspect can be very sensitive to small subtle changes in one or more parameters. 1.2.3.3 Air Circuit

[0058] The air circuit is a conduit or tube constructed and arranged to allow an air flow between two components of a respiratory therapy system, such as an RPT device and a patient interface, during use. In some cases, the air circuit may be branched for inhalation and exhalation. In other cases, a single-branch air circuit may be used for both inhalation and exhalation.

[0059] Obstruction of the air circuit (e.g., due to the patient lying on the conduit) must be avoided or mitigated. In some known patient interfaces, the manifold is positioned above the patient's head and the conduits extend from the manifold on either side of the patient's head to the plenum chamber. Since the patient may lie on one of these conduits, the conduits can be made collapsible so that the patient does not experience discomfort when lying on the conduit. Thus, each conduit must be sized to carry a flow rate of air sufficient to maintain the therapeutic pressure when the opposite conduit is blocked. This means that the conduits must be relatively large. Using large conduits means that the patient may perceive the interface as being overly "medical", which can result in reduced compliance with the treatment schedule. 1.2.3.4 Humidifier

[0060] Delivering an air flow without humidification can cause drying of the airway. Using a humidifier with an RPT device and patient interface produces a humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, it is usually more comfortable to provide warm air rather than cold air in and around the face area within the patient interface. Thus, humidifiers often have the ability not only to humidify the air flow but also to heat it.

[0061] Various artificial humidification devices and systems are known, but these may not meet the special requirements of medical humidifiers.

[0062] Medical humidifiers are used to increase the humidity and / or temperature of an air flow relative to ambient air, typically during a patient's sleep or rest (e.g., in a hospital, etc.), as needed. A medical humidifier placed beside a bed may be small. A medical humidifier can be configured to humidify and / or heat only the air flow delivered to a patient without humidifying and / or heating the area around the patient. For example, room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may humidify the air a patient breathes, but these systems also humidify and / or heat the entire room and can cause discomfort to co-inhabitants. Additionally, medical humidifiers may have more stringent safety constraints than industrial humidifiers.

[0063] A number of medical humidifiers are known, but these can have one or more drawbacks. Some medical humidifiers provide insufficient humidification, while others are difficult or inconvenient for patients to use. 1.2.3.5 Oxygen source

[0064] Experts in this field recognize that exercise for patients with respiratory insufficiency provides long-term benefits of slowing the progression of the disease, improving quality of life, and extending the patient's lifespan. However, most stationary exercise, such as on a treadmill or stationary bike, is too strenuous for these patients. As a result, the need for mobility has long been recognized. Until recently, this mobility has been facilitated by the use of small compressed oxygen tanks or cylinders mounted on carts with wheels. The drawbacks of these tanks are that the amount of oxygen they contain is limited, they are heavy, and the weight when loaded can be approximately 50 pounds.

[0065] Oxygen concentrators have been used for about 50 years to supply oxygen for respiratory therapy. Conventional oxygen concentrators were bulky and heavy, making normal walking activities while wearing them difficult and unrealistic. Recently, companies that manufacture large stationary oxygen concentrators have started developing portable oxygen concentrators (POCs). The advantage of POCs is that they can theoretically generate an unlimited supply of oxygen. To make these devices small for mobility, various systems required for generating the oxygen supply gas are condensed. POCs attempt to utilize the generated oxygen as efficiently as possible to minimize weight, size, and power consumption.

[0066] This is achieved by delivering oxygen as a series of pulses or "boluses", with each bolus timed to coincide with the start of inspiration. This treatment mode is known as pulse or demand (oxygen) delivery (POD), as opposed to the conventional continuous flow delivery more suitable for stationary oxygen concentrators. 1.2.3.6 Data Management

[0067] There may be clinical reasons to obtain data for determining whether a patient prescribed respiratory therapy is "compliant", e.g., whether the patient has used their RPT device according to one or more "compliance rules". As an example of a compliance rule for CPAP therapy, a patient is required to use the RPT device for at least 4 hours per night for at least 21 days out of 30 consecutive days to be considered compliant. To determine a patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data on the patient's use of the RPT device to explain the treatment, calculate the use over a given period, and compare it to the compliance rules. The healthcare provider may notify a third party that the patient is compliant if it determines that the patient has used their RPT device according to the compliance rules.

[0068] There may be other aspects to a patient's treatment that benefit from the communication of treatment data to a third party or external system.

[0069] Existing processes for communicating and managing such data can be costly, time-consuming, and error-prone. 1.2.3.7 Vent technology

[0070] Some forms of the treatment system may include a vent that allows for the washout of exhaled carbon dioxide. The vent can allow for the flow of gas, for example, from the internal space of the patient interface, such as a plenum chamber, to the outside of the patient interface, such as the surroundings.

[0071] The vent may include an orifice, and gas can flow through the orifice when using a mask. Many such vents produce noise. Since it is blocked during use, there may be insufficient flushing. Some vents may interfere with the sleep of the patient's 1000 bed partner 1100, for example, due to noise or airflow concentration.

[0072] ResMed Limited has developed a number of improved mask vent technologies. See Patent Document 13, Patent Document 14, Patent Document 15, Patent Document 16, Patent Document 8. 1.2.4 Screening, diagnosis, and monitoring systems

[0073] A polysomnogram (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually, the application of this system involves specialized clinical staff. In a PSG, it usually includes arranging 15 to 20 contact sensors on the patient to record various body signals such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. The PSG for sleep apnea includes two nights of patient observation in a clinic, one night of pure diagnosis, and titration of treatment parameters by a clinician on the second night. Therefore, the PSG is expensive and inconvenient. In particular, it is not suitable for home screening, diagnosis, and monitoring of sleep apnea.

[0074] In screening and diagnosis, it generally refers to identifying symptoms from signs and symptoms. Screening usually provides a true / false result indicating whether the patient's SDB is severe enough to justify further investigation, while diagnosis can yield clinically useful information. Although screening and diagnosis tend to be one-time processes, monitoring the progression of symptoms can be continued indefinitely. Some screening / diagnosis systems are suitable only for screening / diagnosis, while others can also be used for monitoring.

[0075] A clinician could appropriately screen, diagnose, or monitor a patient based on visual observation of PSG signals. However, there may be cases where a clinician is not available or where the cost is unaffordable for the patient. Different clinicians may have different opinions on a patient's symptoms. Additionally, a particular clinician may apply different criteria at different times.

Prior Art Documents

Patent Documents

[0076]

Patent Document 1

Patent Document 2

Patent Document 3

Patent Document 4

Patent Document 5

Patent Document 6

Patent Document 7

Patent Document 8

Patent Document 9

[0077] [Non-Patent Document 1] "Respiratory Physiology", Lippincott Williams & Wilkins, 9th Edition, published in 2012 [Summary of the Invention]

[0078] This technology aims to provide a medical device used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases, which exhibits one or more improvements in comfort, cost, effectiveness, ease of use, and manufacturability.

[0079] The first aspect of this technology relates to a device used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases.

[0080] Another aspect of this technology relates to a method used in the screening, diagnosis, monitoring, improvement, treatment, or prevention of respiratory diseases.

[0081] Aspect of a particular form of the present technology is to provide a method and / or apparatus for improving patient compliance with respiratory therapy.

[0082] One form of the technology is a patient interface, a plenum chamber that can be pressurized to a treatment pressure of at least 6 cmH2O higher than ambient pressure, at least three plenum chamber inlet ports sized and structured to receive each flow of air at the treatment pressure for breathing by the patient, a seal-forming structure constructed and arranged to form a seal with the area of the patient's face surrounding the entrance to the patient's airway, having holes such that the flow of air at the treatment pressure is delivered at least to the entrance to the patient's nostrils, and constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the patient's breathing cycle during use, and a positioning and stabilization structure comprising at least four straps, wherein at least three of the straps define channels internally, conduits are provided within each channel, each conduit comprises an interface connector for connecting the conduit to each one of the inlet ports during use, and the positioning and stabilization structure further comprises a connection port for connecting to an air circuit during use, the connection port being in fluid communication with each of the conduits, The plenum chamber is provided with at least one pressure measurement port.

[0083] Example: a) The diameter of each conduit is 5 mm or less, b) Each strap includes two material layers, the channel is provided between these layers, c) Each strap includes a joint along one edge of the strap, d) Each strap comprises a first joint along one edge of the strap and a second joint along the opposite edge of the strap, f) Each conduit is completely enclosed within each strap, g) The conduit is detached from the strap, and / or, h) The conduit does not contribute to the interface vector.

[0084] Another form of the technology includes a positioning and stabilization structure for a patient interface, the positioning and stabilization structure including at least four straps, each strap being connectable to the patient interface, each strap including two or more layers of material, the two or more layers being arranged to define a channel therebetween, a conduit being provided in each channel, each conduit including an interface connector for connecting the conduit to each inlet port of the patient interface during use, the positioning and stabilization structure further including a connection port for connecting to an air circuit during use, the connection port being in fluid communication with each of the conduits.

[0085] Example: a) the diameter of each conduit is 5 mm or less, b) each strap includes a junction along one edge of the strap, c) each strap includes a first junction along one edge of the strap and a second junction along an opposite edge of the strap, d) each conduit is completely enclosed within each strap, and / or e) the conduit is detached from the strap such that the conduit does not contribute to the interface vector during use.

[0086] Another form of the technology is a patient interface, including a plenum chamber pressurizable to a treatment pressure of at least 6 cmH2O higher than ambient pressure, a seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure having at least one aperture such that air flow at the treatment pressure is delivered to the patient's mouth and nostrils, the seal-forming structure being constructed and arranged to maintain the plenum chamber at the treatment pressure throughout the patient's breathing cycle during use, the plenum chamber being provided with at least one nasal inlet port and at least one oral inlet port, the nasal and oral inlet ports being sized and structured to receive each flow of air at the treatment pressure for breathing by the patient, each nasal inlet port being positioned closer to the patient's nostrils than each oral inlet port.

[0087] Another form of the present technology is a patient interface, a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O higher than the ambient pressure, a first seal-forming structure connected to the mouth portion of the plenum chamber, forming a seal with the region of the patient's face surrounding the entrance to the patient's mouth, constructed and arranged such that the flow of air at the treatment pressure is delivered to the mouth, and constructed and arranged to maintain the plenum chamber at the treatment pressure throughout the breathing cycle of the patient in use, connected to the nose portion of the plenum chamber, forming a seal with the region of the patient's face surrounding the entrance to the patient's nose, a second seal-forming structure constructed and arranged such that the flow of air at the treatment pressure is delivered to the nose, and constructed and arranged to maintain the plenum chamber at the treatment pressure throughout the breathing cycle of the patient in use, comprising, at least one nose inlet port is provided in the nose portion of the plenum chamber, and at least one mouth inlet port is provided in the mouth portion of the plenum chamber.

[0088] Another form of the present technology is a patient interface, a plenum chamber capable of being pressurized to a treatment pressure of at least 6 cmH2O higher than the ambient pressure, a first seal-forming structure connected to the mouth portion of the plenum chamber, forming a seal with the region of the patient's face surrounding the entrance to the patient's mouth, constructed and arranged such that the flow of air at the treatment pressure is delivered to the mouth, and constructed and arranged to maintain the plenum chamber at the treatment pressure throughout the breathing cycle of the patient in use, a second seal-forming structure connected to the nose portion of the plenum chamber, forming a seal with the region of the patient's face surrounding the entrance to the patient's nose, constructed and arranged such that the flow of air at the treatment pressure is delivered to the nose, and constructed and arranged to maintain the plenum chamber at the treatment pressure throughout the breathing cycle of the patient in use, comprising, The plenum chamber is provided with a nasal inlet port and an oral inlet port, and the nasal inlet port is provided above the oral inlet port.

[0089] Example: a) The patient interface is configured such that during use, the flow rate of air to the patient's nostrils is greater than the flow rate to the patient's mouth, b) the impedance of each said nasal inlet port is different from the impedance of each said oral inlet port, c) the interface includes a plurality of nasal inlet ports and a plurality of oral inlet ports, and the combined impedance of the nasal inlet ports is less than the combined impedance of the oral inlet ports, d) the flow rate through at least one of the inlet ports is adjustable, e) the flow rate through at least one of the inlet ports is continuously adjustable, f) at least one of the inlet ports includes a flow restrictor, g) the flow restrictor is releasably connectable to the patient interface, and / or h) the patient interface comprises a pressure measurement port.

[0090] A further form of the present technology is a system for providing air to a patient at a therapeutic pressure of at least 6 cmH2O higher than ambient pressure, a patient interface as defined in any of paragraphs 0086 - 0089 above, wherein the plenum chamber is provided with at least one pressure measurement port, and the patient interface further comprises a positioning and stabilization structure that supplies a force to hold a seal-forming structure in a therapeutically effective position on the patient's head, an RPT device, and an air circuit connecting the RPT device and the patient interface. The RPT device varies the flow rate through the air circuit and / or the flow rate through one of the inlet ports in response to fluctuations in the pressure measured at at least one pressure measurement port.

[0091] Example: a) The RPT device comprises at least one pressure sensor port, and each pressure measurement port of the patient interface is fluidly connected to each pressure sensor of the RPT device by each pressure signal conduit. b) The plenum chamber is provided with a first pressure measurement port for measuring the pressure of the air supplied to the patient's mouth during use and a second pressure measurement port for measuring the pressure of the air supplied to the patient's nostrils during use. c) The pressure transducer is mounted on each said pressure measurement port. d) The RPT device controls such that the total flow rate of the air supplied to each said nasal inlet port is greater than the total flow rate of the air supplied to each said oral inlet port, and / or f) At least one of the at least one nasal inlet port and / or at least one of the oral ports comprises an electronically adjustable valve, and the RPT device controls the setting of each valve.

[0092] Another aspect of one form of the present technology is a patient interface that is shaped in a peripheral shape that complements the peripheral shape of the target wearer or is otherwise constructed.

[0093] One aspect of one form of the present technology is a method of manufacturing the device.

[0094] One aspect of a particular form of the present technology is a medical device that can be easily used by, for example, a person who has not received medical training, a person with limited dexterity, a person with limited vision, or a person with limited experience in using this type of medical device.

[0095] One aspect of one form of the present technology is a patient interface that does not require a dedicated cleaning device and can be cleaned at the patient's home with, for example, soapy water. One aspect of one form of the present technology is a humidifier tank that does not require a dedicated cleaning device and can be cleaned at the patient's home with, for example, soapy water.

[0096] The described methods, systems, devices, and apparatuses can be implemented to improve the functionality of a processor, such as a processor of a special-purpose computer, a respiratory monitor, and / or a respiratory therapy device. Further, the described methods, systems, devices, and apparatuses can bring about improvements in the technical field of automatic management, monitoring, and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0097] Of course, some of these aspects may form secondary aspects of the present technology. Further, various secondary aspects and / or aspects can be combined in various ways, which can construct further aspects or secondary aspects of the present technology.

[0098] Other features of the present technology will become apparent by considering the information included in the following detailed description, summary, drawings, and claims.

Brief Description of the Drawings

[0099] The present technology is illustrated for purposes of example and not limitation, and in the accompanying drawings, like reference numerals indicate like elements. 3.1 Respiratory Therapy System

Figure 1A

Figure 1B

Figure 1C

Figure 2A

Figure 2B

Figure 2C

Figure 2D

Figure 2E

Figure 2F

Figure 2G

Figure 2H

Figure 2I

Figure 2J

Figure 2K

Figure 2L

Figure 3A

Figure 3B

Figure 3C

Figure 3D

Figure 3E

Figure 3F

Figure 3G

Figure 3H

Figure 3I

Figure 3J

Figure 3K

Figure 3L

Figure 3M

Figure 3N

Figure 3O

Figure 3P

Figure 3Q

Figure 3R

Figure 3S

Figure 3T

Figure 3U

Figure 3V

Figure 3W

Figure 3X

Figure 4A

Figure 4B

Figure 4C

Figure 5A

Figure 5B

Figure 6A

Figure 7

Figure 8

Figure 9

Figure 10

Figure 11

Figure 12

Figure 13

Embodiments for Carrying Out the Invention

[0100] Prior to further elaborating on the present technology, it should be understood that the present technology is not limited to the specific embodiments described herein and that it is subject to variation. It should also be understood that the terms used in the present disclosure are for the sole purpose of describing the specific embodiments under consideration herein and are not intended to be limiting.

[0101] The following description is provided with respect to various embodiments that may share one or more common properties and / or characteristics. It should be understood that one or more features of any one embodiment may be combined with one or more features of one or more other embodiments. Also, within any of the embodiments, any single feature or combination of features may be used to construct further embodiments. 4.1 Treatment

[0102] In one form, the present technology includes a method for treating a respiratory disease, comprising the step of applying positive pressure to the inlet of the airway of patient 1000.

[0103] In a particular example of the present technology, the supply of positive-pressure air is provided to the nasal passages of the patient via one or both nostrils.

[0104] In a particular example of the present technology, mouth breathing is limited, restricted, or prevented. 4.2 Respiratory Therapy System

[0105] In one form, the present technology includes a respiratory therapy system for treating a respiratory disease. The respiratory therapy system may comprise an RPT device 4000 for supplying an air flow to patient 1000 via an air circuit 4170 and a patient interface 3000. 4.3 Patient Interface

[0106] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects, namely, a seal-forming structure 3100, a plenum chamber 3200, a positioning and stabilization structure 3300, a vent 3400, a connection port 3600 as one form for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance to the patient's airway so as to maintain the entrance to the patient's airway at positive pressure. Thus, the sealed patient interface 3000 is suitable for the delivery of positive pressure therapy.

[0107] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may be unsuitable for respiratory pressure therapy.

[0108] A patient interface 3000 according to one form of the present technology is constructed and arranged to be able to supply air at a positive pressure of at least 6 cmH2O relative to the surroundings.

[0109] A patient interface 3000 according to one form of the present technology is configured and arranged to be able to supply air at a positive pressure of at least 10 cmH2O relative to the surroundings.

[0110] A patient interface 3000 according to one form of the present technology is configured and arranged to be able to supply air at a positive pressure of at least 20 cmH2O relative to the surroundings.

[0111] In an example of the present technology, the patient interface does not extend over the patient's nasal muscles. 4.3.1 Seal-forming structure

[0112] In one aspect of the present technology, the seal formation structure 3100 may provide a target seal formation area and further provide a cushioning function. The target seal formation area is an area on the seal formation structure 3100 where a seal can occur. The area where the seal actually occurs, i.e., the actual seal surface, may vary daily and from patient to patient within a given treatment session depending on a wide range of factors including, for example, the location where the patient interface is placed on the face, the tension in the positioning and stabilization structure, and the shape of the patient's face.

[0113] As best shown in FIG. 7, in a particular aspect of the present invention, the seal formation structure 3100 includes a first seal formation structure 3101 that is connected to the mouth portion 3201 of the plenum chamber 3200 and is constructed and arranged to form a seal with the area of the patient's face surrounding the patient's mouth entrance, and a second seal formation structure 3102 that is connected to the nose portion 3202 of the plenum chamber 3200 and is constructed and arranged to form a seal with the area of the patient's face surrounding the patient's nose entrance. As used herein, the phrase "connected" refers to a portion or component formed as a single piece, as well as a portion or component formed separately that is later joined together. In some cases, the components may be connected by intermediate components.

[0114] In some examples, the seal formation structure forms a seal with a portion of the user's nostrils below the user's nose and below the user's nasal muscles.

[0115] In one aspect, the target seal formation area is located on the outer surface of the seal formation structure 3100.

[0116] In a particular aspect of the present technology, the seal formation structure 3100 is constructed from a biocompatible material, such as silicone rubber.

[0117] The seal formation structure 3100 according to the present technology may be constructed from a soft and flexible elastic material such as silicone.

[0118] In certain embodiments of the present technology, a system is provided that includes more than one seal-forming structure 3100 configured to correspond to different size and / or shape ranges. For example, the system may include one form of the seal-forming structure 3100 that is suitable for a large head but not suitable for a small head, and another form that is suitable for a small head but not suitable for a large head. 4.3.1.1 Seal mechanism

[0119] In one form, the seal-forming structure includes a seal flange that utilizes a pressure-assisted seal mechanism. In use, the seal flange can readily respond to the positive system pressure inside the plenum chamber 3200, act on its underside, and be biased into a sealing engagement with the face. The pressure-assisted mechanism can cooperate with the elastic tension within the positioning and stabilization structure.

[0120] In one form, the seal-forming structure 3100 includes a seal flange and a support flange. The seal flange includes a relatively thin member that extends around the plenum chamber 3200 and has a thickness of less than about 1 mm, for example, about 0.25 mm to about 0.45 mm. The support flange may be relatively thicker than the seal flange. The support flange is disposed between the seal flange and the periphery of the plenum chamber 3200 and extends at least partially around. The support flange is a spring-like element or includes a spring-like element and functions to support the seal flange so that it does not buckle during use.

[0121] In one form, the seal-forming structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or the gasket seal portion is constructed and arranged to be compressed, for example, as a result of the elastic tension in the positioning and stabilization structure.

[0122] In one form, the seal-forming structure includes a tension portion. In use, the tension portion is held in tension, for example, by an adjacent region of the seal flange.

[0123] In one form, the seal-forming structure comprises a region having a sticky or adhesive surface.

[0124] In certain forms of the present technology, the seal-forming structure may comprise one or more of a pressure-assisted seal flange, a compression seal portion, a gasket seal portion, a tension portion, and a sticky or adhesive surface. 4.3.1.2 Nasal bridge or nasal muscle region

[0125] In one form, the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal over the nasal bridge region or nasal muscle region of the patient's face during use.

[0126] In one form, the seal-forming structure comprises a saddle-shaped region constructed to form a seal over the nasal bridge region or nasal muscle region of the patient's face during use. 4.3.1.3 Upper lip region

[0127] In one form, the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal over the upper lip region (i.e., the upper lip) of the patient's face during use.

[0128] In one form, the seal-forming structure comprises a saddle-shaped region constructed to form a seal over the upper lip region of the patient's face during use. 4.3.1.4 Jaw region

[0129] In one form, the non-invasive patient interface 3000 comprises a seal-forming structure that forms a seal over the jaw region of the patient's face during use.

[0130] In one form, the seal-forming structure comprises a saddle-shaped region constructed to form a seal over the jaw region of the patient's face during use. 4.3.1.5 Forehead region

[0131] In one form, the seal-forming structure forms a seal over the forehead region of the patient's face during use. In such a form, the plenum chamber may cover the eyes during use. 4.3.1.6 Nasal Pillow

[0132] In one form, the seal-forming structure of the non-invasive patient interface 3000 includes a pair of nasal pillows or nasal cushions, and each nasal pillow or nasal cushion is constructed and arranged to form a seal with each nostril of the patient's nose.

[0133] The nasal pillow according to one aspect of the present technology includes a frustum of a cone that at least partially forms a seal under the patient's nose, a shaft, and a flexible region below the frustum of the cone that connects the frustum of the cone to the shaft. Further, the structure to which the nasal pillow of the present technology is connected includes a flexible region adjacent to the base of the shaft. The flexible regions can cooperate to facilitate a universal joint structure that accommodates relative movement in both displacement and angle between the frustum of the cone and the structure to which the nasal pillow is connected. For example, the frustum of the cone can be displaced axially toward the structure to which the shaft is connected. 4.3.2 Prenum Chamber

[0134] The prenum chamber 3200 has an outer periphery shaped to complement the surface contour of an average human face in the region where a seal is formed during use. During use, the periphery of the prenum chamber 3200 is positioned close to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 can extend substantially around the entire circumference of the prenum chamber 3200 during use. In some forms, the prenum chamber 3200 and the seal-forming structure 3100 are formed from a single homogeneous piece of material.

[0135] In a particular form of the present technology, the prenum chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the prenum chamber. Such a form tends to be less obstructive and / or more comfortable for the wearer and can improve compliance with treatment.

[0136] In certain forms of the present technology, the plenum chamber 3200 is constructed from a transparent material, such as transparent polycarbonate. Using a transparent material can help reduce interference from the patient interface and improve treatment compliance. By using a transparent material, clinicians can be assisted in observing how the patient interface is arranged and functioning.

[0137] In certain forms of the present technology, the plenum chamber 3200 is constructed from a translucent material. Using a translucent material can help reduce interference from the patient interface and improve treatment compliance.

[0138] As described above, in some forms of the present technology, the plenum chamber may include an oral portion 3201 and a nasal portion 3202. 4.3.3 Inlet Ports

[0139] Next, referring to FIGS. 8 and 9, in some forms of the present technology, the plenum chamber 3200 is provided with a plurality of inlet ports. By way of example, the plenum chamber 3200 is provided with at least one nasal inlet port 3602 and at least one oral inlet port 3604. Each such nasal inlet port 3602 is positioned closer to the patient's nostrils than each such oral inlet port 3604 during use.

[0140] In some forms of the present technology, the nasal inlet port 3602 is provided above the oral inlet port 3604 during use.

[0141] By way of example, a plurality of nasal inlet ports 3602 and / or a plurality of oral inlet ports 3604 are provided. Each nasal inlet port 3602 can be located at substantially the same position in the vertical direction, i.e., at substantially the same "height". Each oral inlet port 3604 can be arranged at substantially the same position in the vertical direction as the other oral inlet ports 3604.

[0142] In one example, two nasal inlet ports 3602 and two oral inlet ports 3604 are provided. The nasal inlet ports 3602 may be above the oral inlet ports 3604.

[0143] In some examples, the oral inlet ports 3604 may be configured to provide a different impedance to the gas flow than the nasal inlet ports 3602. For example, the oral inlet ports 3604 may have a greater impedance than the nasal inlet ports 3602. The greater impedance may result from the oral inlet port(s) 3604 having a smaller cross-sectional area flow path.

[0144] In one example, the number of nasal inlet ports 3602 provided may be different from the number of oral inlet ports 3604. In such an example, the total impedance or aggregate impedance of the oral inlet ports 3604 may be different from the total impedance of the nasal inlet ports 3602. In one example (not shown), the plenum chamber 3200 may be provided with two nasal inlet ports 3602, but only a single oral inlet port 3604 may be provided. The nasal inlet ports 3602 may be configured to allow a greater total volume flow rate (e.g., the sum of the flows through both nasal inlet ports) than that flowing through the oral inlet port 3604 when air is supplied to all ports 3602, 3604 at the same pressure. According to this arrangement, for example, by increasing the pressure of the air at the patient's nasal openings relative to the pressure at the patient's oral opening, nasal breathing by the patient may be promoted and / or the flushing near the nasal openings may be improved.

[0145] In some examples, one or more of the nasal inlet ports 3602 and / or one or more of the oral inlet ports 3604 may be provided with a valve (not shown) configured to adjust the flow rate through the inlet ports 3602, 3604 as needed. The valve may be manually adjustable by the user or electronically adjustable, for example, in response to a measurement of the pressure in the plenum chamber, by, for example, a controller of the RPT device (e.g., continuously and electronically adjustable). As will be further described below, in other examples, the adjustable valve may be provided in a conduit supplying a single port or a group of ports (e.g., the oral inlet ports 3604 or the nasal inlet ports 3602). In one embodiment, each such valve may be adjusted based on the pressure in the plenum chamber 3200 or a related portion of the plenum chamber, such as the oral portion 3201 and / or the nasal portion 3202. In one example, the pressure may be measured at a plurality of locations within the plenum chamber 3200. For example, at one location, the pressure of the air supplied to the patient's nostrils may be measured, and at a second location, the pressure of the air supplied to the patient's mouth may be measured.

[0146] In one embodiment, one or more of the ports 3602, 3604 may be provided with a flow restrictor, such as a component having an orifice with a cross-sectional area smaller than the remaining portion of the flow path through the ports 3602, 3604. The flow restrictor may permanently or semi-permanently change the impedance of the port. In some such embodiments, the flow restrictor may be releasably connectable to the patient interface. In one embodiment, the flow restrictor may be selected and / or installed by a technician rather than the patient.

[0147] In an embodiment, one or more of the patient sides of the inlet ports 3602, 3604 may be shaped to direct the airflow in a particular direction. For example, the patient side of the nasal inlet port 3602 may be shaped to direct the flow towards the patient's nostrils.

[0148] In some forms of the technology, the inlet ports 3602, 3604 may be configured to improve the flushing into the plenum chamber or at least the portion of the plenum chamber that supplies air to the patient's airway. 4.3.4 Pressure Measurement

[0149] In one example, the patient interface may include a pressure measurement port 3606. In some examples, the plenum chamber may be provided with a pressure measurement port 3606. In some examples, the pressure measurement port 3606 is spaced apart from each inlet port. In one form of the technology, the pressure measurement port 3606 is provided on or adjacent to the mid-sagittal plane. In other examples, the pressure measurement port 3606 is provided adjacent to the patient's nostril.

[0150] In some forms of the technology, two pressure measurement ports 3606 may be provided. In some examples, one of the pressure measurement ports 3606 may be arranged to enable measurement of the pressure in the region adjacent to the patient's nostril, and the other may be arranged to enable measurement of the pressure in the region adjacent to the patient's mouth.

[0151] In some forms of the technology, the pressure measurement port 3606 may be in fluid communication with a remote pressure measurement sensor, such as a sensor provided in an RPT device. Each pressure signal conduit 3608 may fluidly connect each pressure measurement port 3606 to each pressure sensor port 4002 of the RPT device. In some examples, when the interface is in use, there is substantially no flow through the pressure signal conduit 3608. For example, the RPT does not supply pressurized air to the pressure signal conduit 3608 except to the extent that pressurized air enters the pressure signal conduit 3608 through the pressure measurement port 3606.

[0152] In other forms of the technology, the pressure sensor may be mounted directly on one or more of the pressure measurement ports 3606 and / or the pressure sensor may be provided within the plenum chamber 3200 at any of the positions described above as being suitable for the pressure measurement port 3606.

[0153] The RPT device varies the flow rate provided to one or more of inlet ports 3602, 3604, or a selected group of inlet ports (e.g., nasal inlet port 3602), as measured via pressure measurement port 3606 and / or by a transducer connected to the port or provided within plenum chamber 3200, in response to pressure variations within the plenum chamber. In some examples, the RPT device varies the flow rate to the inlet ports by varying the signal to an electronically variable valve. 4.3.5 Positioning and Stabilization Structure

[0154] The seal-forming structure 3100 of the patient interface 3000 of the present technology can be held in the seal position during use by a positioning and stabilization structure 3300.

[0155] In one form, the positioning and stabilization structure 3300 provides at least sufficient holding force to overcome the effect of the positive pressure within the plenum chamber 3200 that lifts it away from the face.

[0156] In one form, the positioning and stabilization structure 3300 provides a holding force to overcome the effect of gravity on the patient interface 3000.

[0157] In one form, the positioning and stabilization structure 3300 provides a holding force as a safety margin to overcome the potential effect of interfering forces on the patient interface 3000, such as tugging of the tubing or accidental interference with the patient interface.

[0158] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured in a manner consistent with how a patient wears it during sleep. In one example, the positioning and stabilization structure 3300 has a low profile or cross-sectional thickness to reduce the perceived or actual volume of the device. In one example, the positioning and stabilization structure 3300 includes at least one strap having a rectangular cross-section. In one example, the positioning and stabilization structure 3300 includes at least one flat strap.

[0159] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to prevent a patient from lying in a supine sleep position with the patient's head resting on the back region of the patient's head, and is not too large or bulky.

[0160] In one form of the present technology, a positioning and stabilization structure 3300 is provided that is configured to prevent a patient from lying in a lateral sleeping position with the patient's head resting on the side region of the patient's head, and is not too large or bulky.

[0161] In one form of the present technology, the positioning and stabilization structure 3300 is provided with a separation portion disposed between a front portion of the positioning and stabilization structure 3300 and a rear portion of the positioning and stabilization structure 3300. The separation portion is not resistant to compression and can be, for example, a flexible or soft strap. The separation portion is configured and arranged to prevent, when the patient is lying with the patient's head on the pillow, the force on the rear portion from being transmitted along the positioning and stabilization structure 3300 and breaking the seal due to the presence of the separation portion.

[0162] In one form of the present technology, the positioning and stabilization structure 3300 comprises a strap constructed from a laminate of a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous and moisture (e.g., sweat) can pass through the strap. In one form, the fabric outer layer includes a loop material that engages with a hook material portion.

[0163] In a particular form of the present technology, the positioning and stabilization structure 3300 comprises a strap that is stretchable, e.g., elastically stretchable. For example, the strap can be configured such that when in use, tension is applied and the force is directed to draw the seal formation structure and contact a portion of the patient's face. In one example, the strap can be configured as a tie.

[0164] In one embodiment of the present technology, the positioning and stabilization structure includes a first tie, which is constructed and arranged such that at least a part of its lower edge passes above the upper ear tip of the patient's head and overlaps a part of the parietal bone without overlapping the occipital bone during use.

[0165] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a second tie, which is constructed and arranged such that at least a part of its upper edge passes below the lower ear tip of the patient's head and overlaps or is located below the occipital bone of the patient's head during use.

[0166] In one embodiment of the present technology suitable for a nasal mask or a full-face mask, the positioning and stabilization structure includes a third tie that interconnects the first tie and the second tie and is constructed and arranged to reduce the tendency of the first tie and the second tie to separate from each other.

[0167] In a particular embodiment of the present technology, the positioning and stabilization structure 3300 comprises a flexible, e.g., non-rigid strap. The advantage of this aspect is that the strap is more comfortable even when the patient lies on top while sleeping.

[0168] In a particular embodiment of the present technology, the positioning and stabilization structure 3300 comprises a strap constructed to be breathable such that water vapor is transmitted through the strap.

[0169] In a particular embodiment of the present technology, a system is provided with more than one positioning and stabilization structure 3300 configured to provide holding forces corresponding to different size and / or shape ranges. For example, the system may comprise one form of the positioning and stabilization structure 3300 that is suitable for a large head but not suitable for a small head, and another form that is suitable for a small head but not suitable for a large head. 4.3.6 Conduit provided within the headgear

[0170] In one aspect of the technology, the positioning and stabilization structure 3300 includes a headgear 3302. In some examples, the headgear 3302 includes a pair of upper straps 3304 and a pair of lower straps 3306. The upper strap 3304 and the lower strap 3306 are connected to or connectable to the plenum chamber 3200 of the patient interface. In some examples, the lower straps 3306 may be connected to each other to form a loop. In some examples, the upper straps 3304 may be connected to each other to form a loop. Additionally or alternatively, the upper and / or lower straps 3304, 3306 may be connected to additional headgear components, such as a crown strap 3308, as best shown in FIG. 10.

[0171] In some examples, one or both of the upper and lower headgear straps 3304, 3306 define a channel 3310 therein. In an example shown in FIG. 11, the headgear straps 3304, 3306 include a first layer of material 3312 connected to a second layer of material 3314 by a joint 3316 extending along each side edge of the strap. Each layer 3312, 3314 may include a separate piece of material. In other examples, as shown in FIG. 12, two layers 3312, 3314 may be formed by folding a single piece of material such that the joint 3316 extends along only one side of the strap. Each joint 3316 may be achieved by any suitable joining technique, such as sewing, adhesion, or ultrasonic die cutting.

[0172] As shown in FIG. 13, in one aspect of the technology, one or more of the headgear straps 3304, 3306 may be formed by knitting and / or additive manufacturing techniques to define a channel therein without the need for a joint along its side. In some examples, a strap formed in this manner may be joined to one or more other straps by a suitable joining technique.

[0173] In some examples, the upper and lower headgear straps 3304, 3306 each have a conduit 3610 provided within a channel 3310 defined by the strap. In an embodiment, each conduit 3610 has a relatively small diameter, such as, for example, 4-5 mm. By using conduits 3610 of such a small diameter, the discomfort felt by a patient when lying on top of one of the conduits can be reduced. Each conduit 3610 may comprise an interface connector 3612 connectable to inlet ports 3602, 3604.

[0174] In an example where only three such small-diameter conduits 3610 are provided and are connected to three inlet ports 3602, 3604, as described herein, for example, if one of the conduits 3610 is blocked because the patient is lying on the conduit, at least one pressure measurement port 3606 may need to be provided in the plenum chamber 3200 to enable monitoring of the pressure within the plenum chamber so that sufficient airflow to maintain the treatment pressure is reliably supplied to the plenum chamber 3200. In an example where four inlet conduits 3610 are connected to four inlet ports 3602, 3604, when one conduit is blocked, the flow through the remaining three conduits may be sufficient such that pressure sensing of the plenum chamber 3200 via the pressure measurement port 3606 is not required. Thus, in some examples of the plenum chamber 3200 having four inlet ports 3602, 3604, a pressure measurement port may not be provided.

[0175] In some examples, the conduits 3610 within the upper and / or lower headgear straps 3304, 3306 are substantially fully contained within the headgear straps 3304, 3306. That is, substantially no portion of any of the conduits 3610 (optionally, other than connectors) is visible. This helps to prevent the patient interface 3000 from looking like a medical device and may thus improve patient compliance with the prescribed treatment.

[0176] In some examples, although the conduit 3610 is provided within the upper and lower headgear straps 3304, 3306, it is at least axially detached from each strap so that the conduit 3610 does not receive a tensile load during use, i.e., in some examples, the conduit 3610 does not contribute to the interface vector. In some examples, the conduit 3610 is disposed within the channel 3310 so that adjustment of the headgear does not affect the impedance of each conduit 3610.

[0177] The conduit 3610 can be directly connected to a manifold 3614 having a connection port 3600. In other examples, an intermediate conduit can be provided between the conduit 3610 and the manifold 3614. For example, the intermediate conduits are provided on each side of the patient's head, and each intermediate conduit is connected, on the same side of the head, to an upper conduit 3616 (e.g., the conduit 3610 within the upper strap 3304) and a lower conduit 3618 (e.g., the conduit 3610 within the lower strap 3304), and this connection is made, for example, by a Y-shaped connector.

[0178] In some examples, the upper conduit 3616 can have substantially the same impedance as the lower conduit 3618. However, in other forms of the technology, the upper conduit 3616 can have a different impedance from the lower conduit 3618. In one form of the technology, the upper conduit 3616 can have a lower impedance than the lower conduit 3618, for example, by having a relatively large inner diameter. This results in different flow rates being delivered to different regions of the plenum chamber 3200. For example, the conduit supplying the nasal inlet port 3602 of the plenum chamber can provide a greater flow rate than the conduit supplying the oral inlet port 3604 of the plenum chamber 3200.

[0179] In some examples, since the upper conduit 3616 and the lower conduit 3618 are spaced apart from each other, even if one conduit is blocked (e.g., because the patient is lying on it), the other conduit is less likely to be blocked, so that a sufficient total flow rate continues to be supplied to the plenum chamber. 4.3.7 Vent

[0180] In one form, the patient interface 3000 includes a vent 3400 constructed and arranged to allow for the flushing of exhaled gas, such as carbon dioxide.

[0181] In certain forms, the vent 3400 is configured to allow for a continuous airflow from the interior to the periphery of the plenum chamber 3200, and the pressure within the plenum chamber is positive relative to the ambient. The vent 3400 is sized, in use, to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure within the plenum chamber by the airflow.

[0182] One form of the vent 3400 according to the present technology includes a plurality of holes, such as from about 20 to about 80 holes, or from about 40 to about 60 holes, or from about 45 to about 55 holes.

[0183] The vent 3400 may be disposed within the plenum chamber 3200. Alternatively, the vent 3400 is disposed within a disconnect structure, such as a swivel, for example. 4.3.8 Disconnect Structure

[0184] In one form, the patient interface 3000 includes at least one separation structure, such as a swivel, or a ball and socket, for example. In some examples, the separation structure is provided between the connection port 3600 and the manifold. 4.3.9 Connection Port

[0185] The connection port 3600 enables connection to the air circuit 4170. 4.3.10 Forehead Support

[0186] In one form, the patient interface 3000 includes a forehead support 3700. In some examples, no forehead support is provided. 4.3.11 Anti - asphyxiation Valve

[0187] In one form, the patient interface 3000 includes an anti - asphyxiation valve. 4.3.12 Ports

[0188] In one form of the technology, the patient interface 3000 includes one or more ports that enable access to the volume within the plenum chamber 3200. In one form, this allows a clinician to supply supplemental oxygen. In one form, this enables direct measurement of properties of the gas within the plenum chamber 3200, such as pressure. 4,4 RPT Device

[0189] The RPT device 4000 according to one aspect of the technology includes mechanical, pneumatic, and / or electrical components and is configured to execute, in whole or in part, one or more algorithms, such as any of the methods described herein. The RPT device 4000 may be configured to generate an airflow of air to be delivered to a patient's airway, such as to treat one or more of the respiratory conditions described elsewhere in this document.

[0190] In one form, the RPT device 4000 is constructed and arranged to be able to deliver an airflow within the range of -20 L / min to +150 L / min while maintaining a positive pressure of at least 6 cmH2O, or at least 10 cmH2O, or at least 20 cmH2O.

[0191] The RPT device may have an external housing 4010 formed in two parts, namely an upper part 4012 and a lower part 4014. Further, 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. The pressure sensor port 4002 is provided in the external housing 4010 in some examples, and the pressure sensor port is in fluid communication with a pressure sensor.

[0192] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air under positive pressure, an outlet muffler 4124, and one or more transducers 4270 such as a pressure sensor 4272 and a flow sensor 4274.

[0193] One or more of the air path items may be arranged within a removable integrated structure referred to as a pneumatic block 4020. The pneumatic block 4020 may be arranged within an external housing 4010. In one form, the pneumatic block 4020 is supported by a part of the chassis 4016 or formed as a part of the chassis 4016.

[0194] The RPT device 4000 may have a power supply 4210, one or more input devices 4220, a central controller 4230, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, transducers 4270, a data communication interface, and one or more output devices. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA). In other forms, the RPT device 4000 may include more than one PCBA.

[0195] In one embodiment, the RPT device may include one or more pressure sensor ports 4002 configured to be connected to respective pressure signal conduits 3608. Each pressure sensor port 4002 is in fluid communication with a pressure transducer or each pressure transducer to enable measurement of the pressure within each pressure signal conduit 3608 and thus the pressure within or within a part of the plenum chamber. 4.4.1 Mechanical and Pneumatic Components of the RPT Device

[0196] The RPT device may include one or more of the following components within an integrated unit. In alternative forms, one or more of the following components may be arranged as separate units. 4.4.1.1 Air Filter

[0197] The RPT device according to one embodiment of the present technology may include an air filter 4110 or a plurality of air filters 4110.

[0198] In one embodiment, the inlet air filter 4112 is disposed at the starting point of the air pressure path upstream of the pressure generator 4140.

[0199] In one embodiment, the outlet air filter 4114, for example, an antibacterial filter, is disposed between the outlet of the air pressure block 4020 and the patient interface 3000. 4.4.1.2 Muffler

[0200] The RPT device according to one aspect of the present technology may include a muffler 4120 or a plurality of mufflers 4120.

[0201] In one embodiment of the present technology, the inlet muffler 4122 is disposed within the air pressure path upstream of the pressure generator 4140.

[0202] In one embodiment of the present technology, the outlet muffler 4124 is disposed within the air pressure path between the pressure generator 4140 and the patient interface. 4.4.1.3 Pressure Generator

[0203] In one embodiment of the present technology, the pressure generator 4140 for generating a flow or supply of positive-pressure air is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor having one or more impellers. The impellers may be arranged in a spiral shape. The blower can supply air at a positive pressure in the range of about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O, and at a flow rate of up to, for example, about 120 liters per minute, during the delivery of respiratory pressure therapy. The blower may be any one of the following patents or patent applications, the entire contents of 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 International Publication No. 2013 / 020167.

[0204] The pressure generator 4140 is under the control of the treatment device controller.

[0205] In other forms, the pressure generator 4140 can be a piston-driven pump, a pressure regulator connected to a high-pressure source (e.g., a pressurized air reservoir), or a bellows. 4.4.1.4 Transducer

[0206] The transducer may be inside the RPT device or outside the RPT device. An external transducer can be placed on the air circuit, for example, on a patient interface or the like, or can form part of the air circuit. The external transducer can be in the form of a non-contact sensor such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0207] In one form of the present technology, one or more transducers 4270 are disposed upstream and / or downstream of the pressure generator 4140. One or more transducers 4270 can be constructed and arranged to generate a signal representative of the characteristics of the air flow, such as flow rate, pressure, or temperature, at that point within the pneumatic path.

[0208] In one form of the present technology, one or more transducers 4270 can be disposed in proximity to the patient interface 3000.

[0209] In one form, the signal from the transducer 4270 can be filtered, such as by low-pass, high-pass, or band-pass filtering. 4.4.1.4.1 Flow Rate Sensor

[0210] The flow rate sensor according to the present technology can be based on a differential pressure transducer, for example, the SDP600 series differential pressure transducer of SENSIRION.

[0211] In one form, a signal representing the flow rate generated by the flow sensor is received by the central controller 4230. 4.4.1.4.2 Pressure Sensor

[0212] The pressure sensor according to the present technology is arranged in fluid communication with the pneumatic path. An example of a suitable pressure sensor is the HONEYWELL ASDX series transducer. An alternative suitable pressure sensor is the GENERAL ELECTRIC NPA series transducer.

[0213] In one form, the signal generated by the pressure sensor is received by the central controller 4230. 4.4.1.4.3 Motor Speed Transducer

[0214] In one form of the present technology, a motor speed transducer is used to determine the rotational speed of the motor 4144 and / or the blower 4142. The motor speed signal from the motor speed transducer can be provided to the treatment device controller. The motor speed transducer can be a speed sensor such as, for example, a Hall effect sensor. 4.4.1.5 Anti-Spill Valve

[0215] In one form of the present technology, an anti-spill valve 4160 is arranged between the humidifier 5000 and the pneumatic block 4020. The anti-spill valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000, for example, towards the motor 4144. 4.4.2 RPT Device Electrical Components 4.4.2.1 Power Supply

[0216] The power supply 4210 can be arranged inside or outside the external housing 4010 of the RPT device 4000.

[0217] In one embodiment of the present technology, the power supply 4210 provides power only to the RPT device 4000. In other embodiments of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000. 4.4.2.2 Input Device

[0218] In one embodiment of the present technology, the RPT device 4000 includes one or more input devices in the form of buttons, switches, or dials that allow a human to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessible via a touch screen. The buttons, switches, or dials may, in one embodiment, be physically connected to the external housing 4010, or in other embodiments, may communicate wirelessly with a receiver electrically connected to the central controller 4230.

[0219] In one embodiment, the input device can be constructed and arranged so that a human can select values and / or menu options. 4.4.2.3 Central Controller

[0220] In one embodiment of the present technology, the central controller 4230 is one or more processors suitable for controlling the RPT device 4000.

[0221] Suitable processors can include processors based on the ARM (registered trademark) Cortex (registered trademark)-M processor such as the STM32 series microcontrollers of ST MICROELECTRONIC and x86 INTEL (registered trademark) processors. In certain alternative embodiments of the present technology, 32-bit RISC CPUs such as the STR9 series microcontrollers from ST MICROELECTRONICS, or 16-bit RISC CPUs such as processors from the MSP430 family of microcontrollers manufactured by TEXAS INSTRUMENTS may also be suitable.

[0222] In one embodiment of the present technology, the central controller 4230 is a dedicated electronic circuit.

[0223] In one embodiment, the central controller 4230 is an application-specific integrated circuit. In other embodiments, the central controller 4230 comprises discrete electronic components.

[0224] The central controller 4230 may be configured to receive input signals from one or more transducers 4270, one or more input devices, and the humidifier 5000.

[0225] The central controller 4230 may be configured to provide output signals to one or more of the output device 4290, the therapy device controller, the data communication interface, and the humidifier 5000.

[0226] In some embodiments of the present technology, the central controller 4230 is configured to implement one or more methodologies described herein, such as one or more algorithms represented as a computer program stored in a persistent computer-readable storage medium such as a memory. In some embodiments of the present technology, the central controller 4230 may be integrated with the RPT device 4000. However, in some embodiments of the present technology, depending on the methodology, it may be implemented by a device located remotely. For example, a remotely located device may perform a determination of the control settings of a ventilator or detect a respiration-related event by analyzing stored data from any of the sensors described herein. 4.4.2.4 Clock

[0227] The RPT device 4000 may comprise a clock connected to the central controller 4230. 4.4.2.5 Therapy Device Controller

[0228] In one embodiment of the present technology, the therapy device controller is a therapy control module that forms part of an algorithm executed by the central controller 4230.

[0229] In one aspect of the present technology, the treatment device controller is a dedicated motor control integrated circuit. For example, in one aspect, the MC33035 brushless DC motor controller manufactured by ONSEMI is used. 4.4.2.6 Protection Circuit

[0230] One or more protection circuits according to the present technology may include an electrical protection circuit, a temperature and / or pressure safety circuit. 4.4.2.7 Memory

[0231] According to one aspect of the present technology, the RPT device 4000 may include a memory such as a non-volatile memory. In some aspects, the memory may include a battery-powered static RAM. In some aspects, the memory may include a volatile RAM.

[0232] The memory may be disposed on the PCBA 4202. The memory may be in the form of an EEPROM or a NAND flash.

[0233] Additionally or alternatively, the RPT device 4000 includes a removable form of memory such as, for example, a memory card compliant with the Secure Digital (SD) standard.

[0234] In one aspect of the present technology, the memory acts as a persistent computer-readable storage medium storing computer program instructions representing one or more methodologies described herein, such as one or more algorithms. 4.4.2.8 Data Communication System

[0235] In one aspect of the present technology, a data communication interface is provided and connected to the central controller 4230. The data communication interface 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.

[0236] In one form, the data communication interface is part of the central controller 4230. In other forms, the data communication interface is separated from the central controller 4230 and may include an integrated circuit or a processor.

[0237] In one form, the remote external communication network is the Internet. The data communication interface may connect to the Internet using a wired communication (e.g., Ethernet or optical fiber) or a wireless protocol (e.g., CDMA, GSM, LTE).

[0238] In one form, the local external communication network utilizes one or more communication standards such as Bluetooth (registered trademark) or the consumer infrared protocol.

[0239] In one form, the remote external device is one or more computers, such as a cluster of networked computers. In one form, the remote external device may be a virtual computer rather than a physical computer. In any case, such a remote external device may be accessible to a person with appropriate qualifications, such as a clinician.

[0240] The local external device may be a personal computer, a mobile phone, a tablet, or a remote control. 4.4.2.9 Output Devices including Optional Displays and Alarms

[0241] The output device 4290 according to this technology may take one or more forms of visual, auditory, and tactile units. The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display. 4.4.2.9.1 Display Driver

[0242] The display driver receives, as input, characters, symbols, or images to be displayed on the display and converts them into commands to display these characters, symbols, or images on the display. 4.4.2.9.2 Display

[0243] The display is configured to visually display characters, symbols, or images in response to commands received from a display driver. For example, the display may be an 8-segment display, in which case the display driver converts each character or symbol, such as the digit "0", into eight logic signals that indicate whether to activate each of the eight segments to display a specific character or symbol. 4.5 Air Circuit

[0244] The air circuit 4170 according to an aspect of the present technology is a conduit or tube constructed and arranged to allow air to flow between two components, such as the RPT device 4000 and the patient interface 3000, during use.

[0245] In particular, the air circuit 4170 can be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, the circuit may branch for inhalation and exhalation. In other cases, a single branch may be used.

[0246] In some forms, the air circuit 4170 may include one or more heating elements configured to heat the air within the air circuit, for example, to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire circuit and may include one or more transducers, such as a temperature sensor. In one form, the heating wire circuit may be wound helically around the axis of the air circuit 4170. The heating element can communicate with a controller, such as the central controller 4230. An example of an air circuit 4170 with a heating wire circuit is described in U.S. Patent No. 8,733,349, which is incorporated herein by reference in its entirety. 4.5.1 Auxiliary Gas Delivery

[0247] In one embodiment of the present technology, for example, an auxiliary gas 4180 such as oxygen is delivered to one or more points within the pneumatic path, such as upstream of the pneumatic block 4020, the air circuit 4170, and / or the patient interface 3000. 4.6 Humidifier 4.6.1 Overall view of the humidifier

[0248] In one embodiment of the present technology, a humidifier 5000 (illustrated in FIG. 5A, for example) is provided to change the absolute humidity of the air or gas delivered to the patient with respect to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity and raise the temperature of the air flow (with respect to the ambient air) prior to delivery to the patient's airway.

[0249] The humidifier 5000 may include a humidifier water reservoir 5110, a humidifier inlet 5002 for receiving the air flow, and a humidifier outlet 5004 for delivering the humidified air flow. In some embodiments, as shown in FIGS. 5A and 5B, the inlet and outlet of the humidifier water reservoir 5110 may be the humidifier inlet 5002 and the humidifier outlet 5004, respectively. The humidifier 5000 may further include a humidifier base 5006, may be adapted to receive the humidifier water reservoir 5110, and may include a heating element 5240. 4.6.2 Humidifier components 4.6.2.1 Water reservoir

[0250] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of liquid (e.g., water) that is evaporated for humidifying the air flow. The water reservoir 5110 may be configured to hold a predetermined maximum amount of water so as to provide sufficient humidification for at least the duration of a respiratory therapy session, such as overnight sleep. Typically, the water reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml of water. In other embodiments, the humidifier 5000 may be configured to receive water supply from an external water source, such as a building water supply system.

[0251] According to one aspect, the water storage part 5110 is configured to impart humidity to the air flow from the RPT device 4000 when the air flow passes through. In one form, the water storage part 5110 can be configured to facilitate the air flow to pass through a tortuous path through the water storage part 5110 while contacting a certain volume of water inside.

[0252] According to one aspect, the water storage part 5110 can be removably detached horizontally from the humidifier 5000, for example, as shown in FIGS. 5A and 5B.

[0253] The water storage part 5110 can also be configured to prevent liquid from draining out when it is displaced and / or rotated from its normal operating direction, such as at any opening degree and / or between its sub-components. Since the air flow humidified by the humidifier 5000 is usually pressurized, the water storage part 5110 can also be configured to prevent the air pressure from being impaired through leakage and / or flow impedance. 4.6.2.2 Conductive part

[0254] According to one arrangement, the water storage part 5110 includes a conductive part 5120 configured to efficiently transfer heat from the heating element 5240 to a certain volume of liquid in the water storage part 5110. In one form, the conductive part 5120 may be arranged as a plate, but other shapes may also be suitable. All or part of the conductive part 5120 can be made of a heat-conductive material such as aluminum (for example, with a thickness of about 2 mm such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), other heat-conductive metals, or plastic. In some cases, suitable heat conduction can be achieved with a less conductive material of a suitable geometry.

[0255] 4.6.2.3 Humidifier water storage dock

[0256] In one form, the humidifier 5000 may include a humidifier water reservoir dock 5130 (shown in FIG. 5B) configured to receive the humidifier water reservoir 5110. In some arrangements, the humidifier water reservoir dock 5130 may include locking features such as a locking lever 5135 configured to hold the water reservoir 5110 within the humidifier water reservoir dock 5130. 4.6.2.4 Water level indicator

[0257] The humidifier water reservoir 5110 may include a water level indicator 5150 as shown in FIGS. 5A and 5B. In some forms, the water level indicator 5150 may provide one or more indications to a user, such as the patient 1000 or a caregiver, regarding the amount of water at a certain volume within the humidifier water reservoir 5110. The one or more indications provided by the water level indicator 5150 may include indications of a maximum predetermined volume of water, any portion thereof such as 25%, 50%, or 75%, or volumes such as 200 ml, 300 ml, or 400 ml. 4.7 Respiratory waveform

[0258] FIG. 6A shows a typical respiratory waveform as a model of a human during sleep. The horizontal axis is time and the vertical axis is respiratory flow rate. Although the parameter values vary, in a normal breath, they may have approximate values as follows: tidal volume Vt: 0.5 L, inspiratory time Ti: 1.6 s, peak inspiratory flow rate Qpeak: 0.4 L / s, expiratory time Te: 2.4 s, peak expiratory flow rate Qpeak: -0.5 L / s. The total duration of respiration Ttot is about 4 s. A human typically breathes at a rate of about 15 breaths per minute (BPM) with a ventilation volume of about 7.5 L / min. The normal duty cycle, that is, the ratio of Ti to Ttot, is about 40%. 4.8 Respiratory therapy modes

[0259] The respiratory therapy system of the present disclosure may implement various respiratory therapy modes, including CPAP and bilevel therapy. 4.9 General

[0260] Air: According to certain forms of the present technology, air may be regarded as meaning the atmosphere. In other forms of the present technology, air may be regarded as, for example, a combination of any other breathable gas such as oxygen-supplemented air.

[0261] Ambient: In certain forms of the present technology, the term ambient is interpreted to mean (i) outside the treatment system or the patient, and (ii) in the immediate vicinity of the treatment system or the patient.

[0262] For example, the ambient humidity regarding a humidifier may be the humidity of the air in the immediate vicinity of the humidifier, for example, the humidity in the room where the patient is sleeping. Such ambient humidity may be different from the humidity outside the room where the patient is sleeping.

[0263] In other examples, the ambient pressure may be the pressure immediately around or outside the body.

[0264] In certain forms, ambient (e.g., acoustic) noise may be considered to be, for example, the background noise level in the room where the patient is located, other than the noise generated by, for example, an RPT device or the noise emitted from a mask or patient interface. Ambient noise may originate from sources outside the room.

[0265] Auto Positive Airway Pressure (APAP) therapy: For example, a CPAP therapy in which the treatment pressure is automatically adjustable, for example, between breaths, between maximum and minimum values, depending on the presence or absence of something suggesting an SDB event.

[0266] Continuous Positive Airway Pressure (CPAP) therapy: A respiratory pressure therapy in which the treatment pressure is substantially constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure varies between different respiratory cycles of the patient, for example, increasing in response to detecting something suggesting a partial upper airway obstruction and decreasing when there is no suggestion of a partial upper airway obstruction.

[0267] Flow rate: The volume (or mass) of air delivered per unit time. The flow rate can refer to an instantaneous quantity. In some cases, referring to the flow rate means referring to a scalar quantity, i.e., a quantity having only magnitude. In other cases, referring to the flow rate means referring to a vector quantity, i.e., a quantity having both magnitude and direction. The flow rate may be given the symbol Q. "Flow rate" may simply be abbreviated as "flow" or "airflow".

[0268] In an example of a patient's breathing, the flow rate may be nominally positive for the inhalation portion of the patient's breathing cycle and thus negative for the exhalation portion of the patient's breathing cycle. The device flow rate Qd is the flow rate of air exiting the RPT device. The total flow rate Qt is the flow rate of air and any supplemental gas reaching the patient interface via the air circuit. The vent flow rate Qv is the flow rate of air exiting the vent to flush out the exhaled gas. The leak flow rate Ql is the flow rate of leakage from the patient interface system or other locations. The breathing flow rate Qr is the flow rate of air taken into the patient's respiratory system.

[0269] Flow therapy: A respiratory therapy that includes delivering a flow of air to the airway inlet with a controlled flow rate, typically positive throughout the patient's breathing cycle, referred to as the therapeutic flow rate.

[0270] Humidifier: The term "humidifier" is interpreted to mean a humidifying device constructed and arranged, or composed of a physical structure, that can supply a therapeutically beneficial amount of water (H2O) vapor to the air flow to improve the medical condition of the patient's respiratory tract.

[0271] Leak: The term "leak" is interpreted as an unintended flow of air. In one example, a leak can result when the seal between the mask and the patient's face is incomplete. In another example, a leak can occur at a swivel elbow to the surroundings.

[0272] Conductive noise (acoustic): Conductive noise in this document refers to the noise transmitted to the patient by the air circuit, the pneumatic path such as the patient interface, and the air inside thereof. In one form, the conductive noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0273] Radiated noise (acoustic): Radiated noise in this document refers to the noise delivered to the patient by the ambient air. In one form, the radiated noise can be quantified by measuring the acoustic power / pressure level of the object in accordance with ISO3744.

[0274] Ventilation noise (acoustic): Ventilation noise in this document refers to the noise generated by the flow of air through any vent such as the ventilation holes of the patient interface.

[0275] Patient: A human being, regardless of the presence or absence of respiratory symptoms.

[0276] Pressure: Force per unit area. Pressure can be expressed in a range of units including cmH2O, g-f / cm 2 , and hectopascals. 1 cmH2O is equal to 1 gf / cm 2 and is approximately 0.98 hectopascals (1 hectopascal = 100 Pa = 100 N / m 2 = 1 millibar ~ 0.001 atmospheres). In this specification, unless otherwise indicated, pressure is given in the unit of cmH2O.

[0277] The pressure inside the patient interface is represented by the symbol Pm, and the treatment pressure representing the target value achieved by the interface pressure Pm at the present time is represented by the symbol Pt.

[0278] Respiratory pressure therapy (RPT): Performing the supply of air to the inlet of the airway with a treatment pressure that is normally a positive pressure with respect to the atmosphere.

[0279] Ventilator: A mechanical device that provides pressure support to a patient in order to perform part or all of the patient's breathing work. 4.9.1.1 Materials

[0280] Silicone or silicone elastomer: a synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC from Dow Corning (included in the range of products sold under this trademark). Another manufacturer of LSR is Wacker. Unless otherwise indicated to the contrary, the form as an example of LSR has a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 when measured using ASTM D2240.

[0281] Polycarbonate: a thermoplastic polymer of bisphenol A carbonate. 4.9.1.2 Mechanical properties

[0282] Resilience: the ability of a material to absorb energy when elastically deformed and release energy when unloaded.

[0283] Elasticity: substantially all energy is released when unloaded. For example, certain silicones and thermoplastic elastomers are included.

[0284] Hardness: the ability of a material itself to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured with a standardized sample size). · "Soft" materials include silicone or thermoplastic elastomer (TPE), for example, can be easily deformed by finger pressure. · "Hard" materials include polycarbonate, polypropylene, steel, or aluminum, for example, may not be easily deformed by finger pressure.

[0285] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, e.g., compression, tension, bending, or torsion. A structure or component can exhibit different resistance in different directions. The inverse of stiffness is flexibility.

[0286] Flexible structure or component: A structure or component that changes its shape, for example, bends, when supporting its own weight within a relatively short period of time such as 1 second.

[0287] Rigid structure or component: A structure or component that does not substantially change its shape when a load that normally occurs during use is applied. An example of such use could be, for example, setting up and maintaining a patient interface in a sealed relationship with the inlet to the patient's airway under a pressure load of about 20 - 30 cmH2O.

[0288] As an example, an I - beam may have different bending rigidities (resistance to bending loads) in a first direction compared to a second orthogonal direction. In other examples, a structure or component may be flexible in a first direction and rigid in a second direction. 4.9.2 Respiratory cycle

[0289] Apnea: According to some definitions, apnea is said to occur when the flow falls below a predetermined threshold for a certain period, for example, 10 seconds. Obstructive apnea is said to occur when the air flow is obstructed by some blockage in the airway despite the patient's efforts. Central apnea is said to occur when apnea is detected due to a decrease in respiratory effort or due to the absence of respiratory effort even though the airway is open. Mixed apnea occurs when a decrease or absence of respiratory effort coincides with an obstruction of the airway.

[0290] Respiratory rate: The rate of a patient's spontaneous breathing, usually measured as the number of breaths per minute.

[0291] Duty cycle: The ratio of the inspiratory time Ti to the total respiratory time Ttot.

[0292] Effort (respiratory): The work done by a person attempting to breathe spontaneously.

[0293] The expiratory part of the respiratory cycle: The period from the start of the expiratory flow to the start of the inspiratory flow.

[0294] Flow limitation: Flow limitation is interpreted as a situation in a patient's respiration where an increase in effort by the patient does not result in a corresponding increase in flow. When flow limitation occurs during the inspiratory portion of the respiratory cycle, it can be described as inspiratory flow limitation. When flow limitation occurs during the expiratory portion of the respiratory cycle, it can be described as expiratory flow limitation.

[0295] Types of inspiratory waveforms with flow limitation: (i) Flattening: There is a relatively flat portion following the rise, followed by a decline. (ii) M-shaped: There are two local peaks, one at the leading edge and one at the trailing edge, with a relatively flat portion between the two peaks. (iii) Chair-shaped: There is a single local peak, which is at the leading edge, followed by a relatively flat portion. (iv) Reverse chair-shaped: There is one local peak following a relatively flat portion, and the peak is at the trailing edge.

[0296] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow, but not a cessation of flow. In one form, hypopnea can be considered to occur when the flow decreases below a threshold for a certain period of time. Central hypopnea is considered to occur when hypopnea due to a decrease in respiratory effort is detected. In one form in adults, any of the following can be considered hypopnea. (i) The patient's respiration decreases by 30% for at least 10 seconds, and an additional 4% of the relevant portion desaturates. (ii) The patient's respiration decreases (but by less than 50%) for at least 10 seconds, and at least 3% of the relevant portion desaturates or awakens.

[0297] Hyperpnea: An increase in flow to a higher level than normal.

[0298] The inspiratory portion of the respiratory cycle: The period from the start of inspiratory flow to the start of expiratory flow is interpreted as the inspiratory portion of the respiratory cycle.

[0299] Patency (airway): The degree to which the airway is open or the extent over which the airway is open. The patent airway is open. The patency of the airway can be quantified, for example, such that a value of 1 is patent and a value of 0 is closed (obstructed).

[0300] Positive end-expiratory pressure (PEEP): The pressure above atmospheric pressure present in the lungs at the end of expiration.

[0301] Peak flow (Qpeak): The maximum value of the flow in the inspiratory portion of the respiratory flow waveform.

[0302] Respiratory flow, patient air flow, breathing air flow (Qr): These terms can be understood to refer to the estimated value of the respiratory flow by the RPT device, as opposed to the "true respiratory flow", i.e., the actual respiratory flow experienced by the patient, which is typically expressed in liters per minute.

[0303] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort. In principle, the inspiratory volume Vi (the volume of air inhaled) is equal to the expiratory volume Ve (the volume of air exhaled), and thus a single tidal volume Vt can be defined as equal to either volume. In practice, the tidal volume Vt is estimated as some combination of the inspiratory volume Vi and the expiratory volume Ve, for example, as their average.

[0304] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0305] (Expiratory) time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0306] (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.

[0307] Typical recent ventilation: A ventilation value to which the recent ventilation value Vent tends to concentrate over a given time scale, i.e., a measure of the central tendency of the recent ventilation values.

[0308] Upper airway obstruction (UAO): This includes both partial and total obstruction of the upper airway. This may be associated with a state of flow limitation (Starling resistor behavior) where flow increases only slightly or may even decrease as the pressure difference across the upper airway increases.

[0309] Ventilation: A measure of the amount of gas exchanged by a patient's respiratory system. Measurements of ventilation may include one or both of the inspiratory and expiratory flows per unit time. When expressed as a volume per minute, this amount is often referred to as the "minute ventilation." The minute ventilation may also be given as a simple volume understood as the amount of ventilation per minute. 4.9.3 Ventilation

[0310] Adaptive servo - ventilator (ASV): A servo - ventilator in which the target ventilation is not fixed but can be changed. The changeable target ventilation can be learned from some characteristic of the patient, such as a characteristic of the patient's breathing.

[0311] Backup rate: A parameter of the ventilator that establishes the minimum respiratory rate (usually breaths per minute) that the ventilator will supply to the patient when not induced by the patient's spontaneous breathing effort.

[0312] Cycle: The end of the inspiratory phase of the ventilator. When the ventilator delivers a breath to a patient who is breathing spontaneously, at the end of the inspiratory portion of the respiratory cycle, the ventilator is said to cycle and stop delivering the breath.

[0313] Expiratory positive airway pressure (EPAP): The baseline pressure to which a pressure that varies within the breath is added to produce the desired interface pressure that the ventilator attempts to reach at a given time.

[0314] End - expiratory pressure (EEP): The desired interface pressure that the ventilator attempts to reach at the end of the expiratory portion of the breath. If the pressure waveform template Π(φ) is zero at the end of expiration, i.e., Π(φ) = 0 when φ = 1, then EEP is equal to EPAP.

[0315] Inspiratory Positive Airway Pressure (IPAP): The maximum desired interface pressure that the ventilator attempts to reach during the inspiratory part of breathing.

[0316] Pressure support: A numerical value indicating the increase in the pressure of the ventilator during inspiration relative to the pressure during expiration of the ventilator, and usually means the pressure difference between the maximum value during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). Depending on the context, pressure support may mean the difference that the ventilator attempts to reach rather than what it actually reaches.

[0317] Servo ventilator: A ventilator that measures the patient's ventilation, has a target ventilation volume, and adjusts the level of pressure support to bring the patient's ventilation closer to the target ventilation volume.

[0318] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect the start of breathing in a spontaneously breathing patient. However, if the device cannot detect breathing within a predetermined period, the device automatically starts delivering breaths.

[0319] Swing: A synonym for pressure support.

[0320] Trigger: When the ventilator delivers air to a spontaneously breathing patient, it is assumed to be triggered to deliver at the start of the inspiratory part of the breathing cycle by the patient's effort. 4.9.4 Anatomy 4.9.4.1 Facial Anatomy

[0321] Ala: The outer wall or "wing" of each nostril (plural: alar)

[0322] Alare: The outermost point of the alae nasi.

[0323] Ala curvature (or alar ridge) point: The most posterior point of the curved baseline of each wing, seen in the crease formed by connecting the wing to the cheek.

[0324] Auricle: The entire outer visible part of the ear.

[0325] (Nasal) bone skeleton: The nasal bone skeleton is composed of the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0326] (Nasal) cartilage skeleton: The nasal cartilage skeleton is composed of the septum, the lateral, and the major and minor cartilages.

[0327] Columella: A band of skin that separates the nostrils and extends from the tip of the nose to the upper lip.

[0328] Columella angle: The angle between a line drawn through the midpoint of the nostril opening and a line drawn perpendicular to the Frankfurt horizontal line while intersecting the subnasale.

[0329] Frankfurt horizontal plane: A line extending from the lowest point of the orbital margin to the left tragus. The tragus point is the deepest point of the notch above the tragus of the auricle.

[0330] Glabella: Located in the soft tissue, it is the most prominent point on the median sagittal plane of the forehead.

[0331] Lateral nasal cartilage: A generally triangular plate of cartilage. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the major alar cartilage.

[0332] Lower lip (labrale inferius):

[0333] Upper lip (labrale superius):

[0334] Major alar cartilage: A cartilage plate located beneath the lateral nasal cartilage. It curves around the entire perimeter of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane that includes three or four small cartilages of the alae.

[0335] Nostril (nasal aperture): An approximately elliptical opening that forms the entrance to the nasal cavity. The singular form of nares is naris. The nostrils are separated by the nasal septum.

[0336] Nasolabial groove or nasolabial fold: A skin fold or groove that extends from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0337] Nasolabial angle: The angle between the nasal column and the upper lip when crossing the lower nose.

[0338] Lower auricular apex: The lowest point where the auricle touches the facial skin.

[0339] Upper auricular apex: The highest point where the auricle touches the facial skin.

[0340] Accessory nose: The most prominent point or tip of the nose, distinguishable in the side view of the rest of the head.

[0341] Philtrum: The groove of the midline running from the lower boundary of the nasal septum to the upper part of the lip in the upper lip area.

[0342] Pogonion: In the soft tissue, which is the most anterior intermediate point of the jaw.

[0343] Ridge (nose): The nasal muscle is a midline elevation of the nose, extending from the edge to the tip of the nose.

[0344] Sagittal plane: A vertical plane passing from the front (anterior) to the back (posterior). The median sagittal plane is the sagittal plane that divides the body into right and left halves.

[0345] Margin: The most concave point located in the soft tissue, covering the area of the anterior nasal suture.

[0346] Septal cartilage (nose): The septal cartilage forms part of the nasal septum and divides the anterior part of the nasal cavity.

[0347] Accessory alar: A point on the lower edge of the alar base where the alar base joins the skin of the upper lip.

[0348] Nasal spine point: Located on the soft tissue, the point where the nasal column converges with the upper lip in the median sagittal plane.

[0349] Menton: The point of maximum concavity on the midline of the lower lip between the lower lip point and the soft tissue pogonion. 4.9.4.2 Anatomy of the Skull

[0350] Frontal bone: The frontal bone includes the frontal squama, which is a large vertical portion corresponding to the area known as the forehead.

[0351] Mandible: The mandible forms the lower jaw. The mental eminence is a bony prominence of the jawbone that forms the jaw.

[0352] Maxilla: The maxilla forms the upper jawbone and is located below the eye socket and above the mandible. The frontal process of the maxilla projects upward from the side of the nose and forms part of the lateral boundary.

[0353] Nasal bones: The nasal bones are two small rectangular bones that vary in size and shape from person to person. They are arranged side by side in the center and upper part of the face, and their junction forms the "bridge" of the nose.

[0354] Nasion: The intersection of the frontal bone and the two nasal bones, a sunken area between the eyes and above the bridge of the nose.

[0355] Occipital bone: The occipital bone is located at the posterior and lower part of the skull. It includes the oval opening, the foramen magnum, through which the cranial cavity communicates with the spinal canal. The curved plate behind the foramen magnum is the occipital squama.

[0356] Orbit: The bony cavity of the skull that houses the eyeball.

[0357] Parietal bone: The parietal bones are bones that, when joined, form the roof and sides of the skull.

[0358] Temporal bone: The temporal bones are located at the base and sides of the skull and support the part of the face called the temple.

[0359] Zygomatic bone: There are two zygomatic bones on the face, located in the upper and lateral parts of the face, forming the cheek prominences. 4.9.4.3 Anatomy of the Respiratory System

[0360] Diaphragm: A single muscle that extends across the bottom of the rib cage. The diaphragm separates the abdominal cavity from the thoracic cavity, which contains the heart, lungs, and ribs. When the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0361] Larynx: The larynx, or voice box, houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0362] Lungs: The respiratory organs of humans. The conducting zone of the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0363] Nasal cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two by a vertical ridge called the nasal septum. On the sides of the nasal cavity are three horizontal projections called nasal conchae (singular "concha") or nasal turbinate bones. In front of the nasal cavity is the nose, and behind it is connected to the nasopharynx through the posterior nasal cavity.

[0364] Pharynx: The part of the throat that is directly below the nasal cavity and directly above the esophagus and larynx. The pharynx is conventionally divided into three sections: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (midpharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx). 4.9.5 Patient Interface

[0365] Anti-asphyxia 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.

[0366] Elbow: An elbow is an example of a structure that directs the axis of the air flow passing through it and changes direction at an angle. In one form, the angle can be about 90 degrees. In other forms, the angle may be greater than 90 degrees or less than 90 degrees. The elbow may have a substantially circular cross-section. In other forms, the elbow may have an elliptical or rectangular cross-section. In certain forms, the elbow may be rotatable, for example, about 360 degrees with respect to a mating component. In certain forms, the elbow may be removable from a mating component, for example, via a snap connection. In certain forms, the elbow may be assembled to a mating component by snapping only once during manufacture, but is not removable by the patient.

[0367] Frame: The frame is construed to mean a mask structure that withstands a tensile load between two or more connection points with the headgear. The mask frame can be a non-airtight load-bearing structure within the mask. However, depending on the form of the mask frame, it may be airtight.

[0368] Headgear: The headgear is considered to mean a form of positioning and stabilization structure designed to be worn on the head. For example, the headgear comprises an assembly of one or more struts, ties, and reinforcements configured to position and hold a patient interface in a fixed position on the patient's face to provide respiratory therapy. Depending on the tie, it is formed of a soft, flexible, and stretchable material such as a laminate composite of foam and fabric.

[0369] Membrane: The membrane is considered to mean a typically thin element that preferably has substantially no resistance to bending but has resistance to stretching.

[0370] Prenum Chamber: The mask prenum chamber is considered to mean a portion of the patient interface having a wall portion that at least partially surrounds a volume of space having pressurized air inside that is pressurized to exceed ambient pressure during use. The shell can form part of the wall portion of the mask prenum chamber.

[0371] Seal: It can be in the form of a noun referring to a structure (''seal''), or a verb referring to an effect (''sealing''). Two elements can be constructed and / or arranged so that they ''seal'' between them, or exhibit the effect of ''sealing'', essentially without the need for separate ''seal'' elements.

[0372] Shell: The shell is understood to mean a curved, relatively thin structure having bending, tensile, and compressive stiffness. For example, the curved structural wall of a mask may be a shell. In some forms, the shell may have faceted surfaces. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0373] Reinforcement: Reinforcement is interpreted to mean a structural element designed to increase the bending resistance of other components in at least one direction.

[0374] Strut: A strut is interpreted to be a structural element designed to increase the compressive resistance of other components in at least one direction.

[0375] Swiivel (noun): A sub-assembly of components configured to rotate preferably independently, preferably under low torque, about a common axis. In one form, the swivel can be constructed to rotate through an angle of at least 360 degrees. In other forms, the swivel can be constructed to rotate through an angle less than 360 degrees. When used in the context of an air delivery conduit, the sub-assembly of components preferably comprises a mating pair of cylindrical conduits. The air flow leaking from the swivel during use is negligible or non-existent.

[0376] Tie (noun): A structure designed to resist tension.

[0377] Vent (noun): A structure that allows air to flow from inside a mask or conduit to the surrounding air in order to clinically effectively flush out exhaled gas. For example, clinically effective flushing may include a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and treatment pressure. 4.9.6 Shape of the structure

[0378] The product according to the present technology may include one or more three-dimensional mechanical structures, such as a mask cushion or an impeller, for example. The three-dimensional structure may be bounded by two-dimensional surfaces. These surfaces may be distinguished using labels that describe the orientation, position, function, or other characteristics of the associated surface. For example, the structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In other examples, the seal-forming structure may include a face contact (e.g., outer) surface and another non-face contact (e.g., lower or inner) surface. In other examples, the structure may include a first surface and a second surface.

[0379] To facilitate the description of the shape of the three-dimensional structure and the surface, first consider a cross-section passing through the surface of the structure at a point p. Refer to FIGS. 3B to 3F, which show an example of the cross-section at point p on the surface and the resulting planar curve. FIGS. 3B to 3F also show the outward normal vector at p. The outward normal vector at p points in the direction away from the surface. In some examples, the surface is described from the perspective of a hypothetical small person standing upright on the surface. 4.9.6.1 Curvature in one dimension

[0380] The curvature of the planar curve at p can be described as having a sign (e.g., positive, negative) and a magnitude (e.g., the radius of the circle that just touches the curve at 1 / p).

[0381] Positive curvature: When the curve at p bends towards the outward normal, the curvature at that point is considered positive (if a fictional small person were to leave point p, they would need to walk uphill). See FIGS. 3B (relatively large positive curvature compared to FIG. 3C) and 3C (relatively small positive curvature compared to FIG. 3B). Such curves are often referred to as concave.

[0382] Zero curvature: When the curve at p is a straight line, the curvature is considered zero (if a fictional small person were to leave point p, they could walk horizontally without going up or down). See FIG. 3D.

[0383] Negative curvature: When the curve at p bends away from the outward normal, the curvature in that direction at that point is considered negative (if a fictional small person were to leave point p, they would need to walk downhill). See FIGS. 3E (relatively small negative curvature compared to FIG. 3F) and 3F (relatively large negative curvature compared to FIG. 3E). Such curves are often referred to as convex curves. 4.9.6.2 Curvature of a two-dimensional surface

[0384] The description of the shape at a given point on the two-dimensional surface according to the present technology may include a plurality of normal sections. The plurality of sections are obtained by cutting the surface with a plane (the "normal plane") including the outward normal, and each section may be taken in a different direction. Each section results in a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. The curvatures at that point each have, for example, a relatively small magnitude. The planar curves in FIGS. 3B to 3F may be examples of such a plurality of sections at a specific point.

[0385] Principal curvature and principal direction: The direction of the normal plane in which the curvature of the curve takes on its maximum and minimum values is called the principal direction. In the examples of FIGS. 3B to 3F, since the maximum curvature occurs in FIG. 3B and the minimum curvature occurs in FIG. 3F, FIGS. 3B and 3F are sections in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0386] Surface area: A set of points connected on a surface. The set of points within the area may have similar characteristics, such as curvature or sign.

[0387] Saddle region: A region where the principal curvatures have opposite signs at each point, that is, one is positive and the other is negative (depending on the direction in which a fictional person bends, one has to walk uphill or downhill).

[0388] Dome region: A region where the principal curvatures have the same sign at each point, for example, both positive ("concave dome") or both negative ("convex dome").

[0389] Cylindrical region: A region where one of the principal curvatures is zero (or, for example, within manufacturing tolerances), and the other principal curvature is non-zero.

[0390] Plane region: A region of a surface where both principal curvatures are zero (or, for example, within manufacturing tolerances).

[0391] Edge of a surface: The boundary or limit of a surface or region.

[0392] Path: In a particular form of the present technology, a "path" is considered to mean a path in the mathematical-topological sense, such as a continuous space curve from f(0) to f(1) on a surface. In a particular form of the present technology, a "path" can be described as a route or course that includes, for example, a set of points on a surface. (The path for a fictional person is where that person walks on the surface and is similar to a garden path).

[0393] Path length: In a particular form of the present technology, "path length" is considered to mean the distance along the surface from f(0) to f(1), that is, the distance along a path on the surface. There can be more than one path between two points on a surface, and such paths can have different path lengths. (The path length for a fictional person is the distance that has to be walked on the surface along the path).

[0394] Straight-line distance: The straight-line distance is the distance between two points on a surface that is independent of the surface. In a planar region, there exists a path on the surface that has the same path length as the straight-line distance between two points on the surface. On a non-planar surface, there may not exist a path that has the same path length as the straight-line distance between two points. (For an imaginary person flying, the straight-line distance corresponds to the "distance a crow flies.") 4.9.6.3 Space curve

[0395] Space curve: Unlike a planar curve, a space curve is not necessarily confined to a specific plane. A space curve can be closed, i.e., it may have no end points. A space curve can be considered as a one-dimensional part of a three-dimensional space. An imaginary person walking along the DNA helix strand walks along a space curve. A typical human left ear contains a helix, which is a left-handed helix. Refer to Figure 3Q. A typical human right ear contains a helix, which is a right-handed helix. Refer to Figure 3R. Figure 3S shows a right-handed helix. The edges of a structure, e.g., the edge of a membrane or an impeller, can follow a space curve. In general, a space curve can be described by the curvature and torsion at each point on the space curve. Torsion measures how much the curve bends out of a plane. Torsion has a sign and a magnitude. The torsion at a point on a space curve can be characterized with reference to the tangent vector, normal vector, and binormal vector at that point.

[0396] Tangent unit vector (or unit tangent vector) For each point on a curve, the vector at that point specifies the direction and magnitude from that point. The tangent unit vector is a unit vector that points in the same direction as the curve at that point. If an imaginary person is flying along the curve and falls off the vehicle at a particular point, the direction of the tangent vector is the direction in which the person moves).

[0397] Unit normal vector: As an imaginary person moves along a curve, the tangent vector itself changes. The unit vector that points in the same direction as the changing tangent vector is called the unit principal normal vector. This is perpendicular to the tangent vector.

[0398] Binormal unit vector: The binormal unit vector is perpendicular to both the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, for example, Figure 3P), or alternatively by the left-hand rule (Figure 3O).

[0399] Contact plane: A plane containing the unit tangent vector and the unit principal normal vector. See Figures 3O and 3P.

[0400] Torsion of a space curve: The torsion at a point on a space curve is the magnitude of the rate of change of the binormal unit vector at that point. This measures how much the curve deviates from the contact plane. A space curve lying in a plane has zero torsion. A space curve with a relatively small deviation from the contact plane has a relatively small magnitude of torsion (for example, a gently inclined helical path). A space curve with a relatively large deviation from the contact plane has a relatively large magnitude of torsion (for example, a steeply pitched helical path). Referring to Figure 3S, since T2 > T1, the magnitude of the torsion near the upper coil of the helix in Figure 3S is greater than the magnitude of the torsion of the lower coil of the helix in Figure 3S.

[0401] Referring to the right-hand rule of Figure 3P, a space curve that bends in the direction of the right-hand binormal can be considered to have a right-hand positive torsion (for example, the right-hand helix in Figure 3S). A space curve that bends away from the direction of the right-hand binormal can be considered to have a right-hand negative torsion (for example, a left-hand helix).

[0402] Similarly, referring to the left-hand rule (see Figure 3O), a space curve that bends in the direction of the left-hand binormal can be considered to have a left-hand positive torsion (for example, a left-hand helix). Thus, the left-hand positive is equivalent to the right-hand negative. See Figure 3T. 4.9.6.4 Hole

[0403] The surface may have one-dimensional holes, such as holes bounded by, for example, planar or spatial curves. A thin structure (e.g., a film) with holes can be described as having one-dimensional holes. Refer, for example, to the one-dimensional holes on the surface of the structure shown in FIG. 3I, which are bounded by a planar curve.

[0404] The structure may have two-dimensional holes, such as holes bounded by a surface, for example. An inflatable tire, for example, has two-dimensional holes bounded by the inner surface of the tire. In other examples, a bladder with cavities for air or gel can have two-dimensional holes. Refer, for example, to the cushion of FIG. 3L and the cross-sectional examples of the cushions of FIGS. 3M and 3N. The inner surface bounding the two-dimensional holes is shown. In still other examples, a conduit can have a one-dimensional hole (e.g., its inlet or its outlet) and a two-dimensional hole bounded by the inner surface of the conduit. Refer to the two-dimensional hole passing through the structure shown in FIG. 3K, which is bounded by a surface. 4.10 Other Matters

[0405] Part of the disclosure of this patent document includes materials subject to copyright protection. The copyright owner does not object to the reproduction by any person of this patent document or any patent disclosure as set forth in the patent files or records of the Patent Office, but reserves all copyrights in other cases.

[0406] Unless the context clearly dictates otherwise and when a range of values is provided, each value intervening between the upper and lower limits of that range, down to one-tenth of the unit of the lower limit, and any other recited value or intervening value within the recited range are to be understood as being within the scope of the technology. The upper and lower limits of such intervening ranges may independently be included within the intervening range, but these are also within the scope of the technology and are subject to any limits specifically excluded within the recited range. If one or both of these limits are included in the recited range, ranges excluding either or both of these included limits are also included in the technology.

[0407] Furthermore, when values are referred to in this specification as being part of the present technology, such values may, unless otherwise indicated, be approximate, and such values may be used to any suitable significant digits to the extent that the actual technical implementation may permit or require it.

[0408] Unless defined otherwise, all technical and scientific terms used in this specification have the same meaning as commonly understood by one of ordinary skill in the art to which this technology belongs. Any methods and materials similar to or equivalent to those described herein can be used in practice or in the tests of this technology, and only a limited number of example methods and materials are described herein.

[0409] When a particular material is specified as being used to construct a component, obvious alternative materials with similar properties may be used instead. Furthermore, unless otherwise specified, any and all components described in this specification are understood to be manufacturable, and thus can be manufactured together or separately.

[0410] As used in this specification and the appended claims, it should be noted that singular forms such as "a", "an", and "the" also include their plural equivalents unless the context clearly dictates otherwise.

[0411] All publications referred to in this specification are hereby incorporated by reference in their entirety for the purpose of disclosing and describing the methods and / or materials of which they are the subject. The publications discussed in this specification are provided solely for their disclosure prior to the filing date of the present application. Nothing in this specification should be construed as an admission that the present technology does not antedate such publications as prior art. Furthermore, the given publication date may differ from the actual publication date, which may need to be independently verified.

[0412] The terms "comprising" and "comprised of" are to be interpreted non-exclusively as referring to elements, components, or steps, indicating that the referenced elements, components, or steps may be present, utilized, or combined with other elements, components, or steps not explicitly stated.

[0413] The headings of the subject matter used in the detailed description are included only for the convenience of the reader and should not be used to limit the subject matter found throughout the disclosure or the claims. The headings of the subject matter should not be used in the interpretation of the claims or limitations of the claims.

[0414] Although the techniques herein have been described with reference to specific examples, it must be understood that these examples are merely illustrative of the principles and applications of the technology. In some instances, the terms and reference numerals may imply specific details not necessary for the implementation of the technology. For example, the terms "first" and "second" may be used, but unless otherwise specified, are not intended to indicate any order and may be used to distinguish between other elements. Further, the process steps in the methodology may be described or illustrated in a certain order, but such ordering is not required. One skilled in the art will recognize that such ordering can be changed and that the aspects can also be implemented simultaneously or synchronously.

[0415] Accordingly, it must be understood that numerous changes may be made to the illustrated examples and other arrangements may be devised without departing from the spirit and scope of the technology.

Description of Reference Numerals

[0416] 4.11 List of Reference Numerals 1000 Patient 1100 Bed Partner 3000 Patient Interface 3100 Seal Forming Structure 3101 First Seal Forming Structure 3102 Second seal formation structure 3200 Plenum chamber 3201 Mouth part 3202 Nose part 3210 Chord 3220 Upper point 3230 Lower point 3300 Positioning and stabilization structure 3302 Head gear 3304 Upper strap 3306 Lower strap 3308 Crown strap 3310 Channel 3312 First layer 3314 Second layer 3316 Joint part 3400 Vent 3600 Connection port 3602 Nose inlet port 3604 Mouth inlet port 3606 Pressure measurement port 3608 Pressure signal conduit 3610 Conduit 3612 Interface connector 3614 Manifold 3616 Upper conduit part 3618 Lower conduit part 3700 Forehead support 4000 RPT device 4002 Pressure sensor port 4010 External housing 4012 Upper part 4014 Lower part 4015 Panel 4016 Chassis 4018 Handle 4020 Pneumatic block 4110 Air filter 4112 Inlet air filter 4114 Outlet air filter 4120 Muffler 4122 Inlet muffler 4124 Outlet muffler 4140 Pressure generator 4142 Blower 4144 Motor 4160 Spill prevention valve 4170 Air circuit 4180 Make-up gas 4200 Electrical components 4202 PCBA 4210 Power supply 4220 Input device 4230 Central controller 4270 Transducer 4272 Pressure sensor 4274 Flow sensor 4276 Motor speed transducer 4290 Output device 4292 Display driver 4294 Display 5000 Humidifier 5002 Humidifier inlet 5004 Humidifier outlet 5006 Humidifier base 5110 Humidifier water storage part 5120 Conductive part 5130 Water storage part dock 5135 Locking lever 5150 Water level indicator 5240 Heating element

Claims

**Claim 1** A patient interface, comprising: Pressurizable up to a treatment pressure at least 6 cmH ２ O higher than the ambient pressure, and a plenum chamber At least three plenum chamber inlet ports sized and structured to receive each air flow at the treatment pressure for breathing by a patient; A seal-forming structure constructed and arranged to form a seal with a region of the patient's face surrounding an inlet to the patient's airway, the seal-forming structure having apertures such that the air flow at the treatment pressure is delivered at least to an inlet to the patient's nostrils, and constructed and arranged to maintain the treatment pressure within the plenum chamber throughout the breathing cycle of the patient during use; A positioning and stabilization structure comprising at least four straps, at least three of the straps defining channels therein, each channel having a conduit provided therein, each conduit comprising an interface connector for connecting the conduit to each one of the inlet ports during use, the positioning and stabilization structure further comprising a connection port for connecting to an air circuit during use, the connection port being in fluid communication with each of the conduits; And The patient interface, wherein the plenum chamber is provided with at least one pressure measurement port. **Claim 2** The patient interface according to claim 1, wherein the diameter of each conduit is 5 mm or less. **Claim 3** The patient interface according to claim 1, wherein each strap comprises a two-layer material, and the channel is provided between these layers. **Claim 4** The patient interface according to claim 3, wherein each strap comprises a joint along one edge of the strap. **Claim 5** Each strap Comprises a first joint along one edge of the strap; and A second joint along an opposite edge of the strap. The patient interface according to claim 3. **Claim 6** The patient interface according to claim 1, wherein each conduit is completely enclosed within each strap. **Claim 7** The patient interface according to claim 1, wherein the conduit is detached from the strap. **Claim 8** The patient interface according to claim 7, wherein the conduit does not contribute to the interface vector. **Claim 9**: At least one of the inlet ports includes a nasal inlet port, at least one of the inlet ports includes an oral inlet port, and the nasal inlet port and the oral inlet port are sized and structured to receive each flow of air at the treatment pressure for breathing by a patient. The patient interface according to any one of claims 1 to 8. **Claim 10** The patient interface according to claim 9, wherein the patient interface is configured such that a flow rate of air to the patient's nostrils is greater than a flow rate to the patient's mouth. **Claim 11** The patient interface according to claim 9, wherein an impedance of each nasal inlet port is different from an impedance of each oral inlet port. **Claim 12** A plurality of nasal inlet ports, A plurality of oral inlet ports, Comprising, The patient interface according to claim 9, wherein a combined impedance of the nasal inlet ports is lower than a combined impedance of the oral inlet ports. **Claim 13** The patient interface according to claim 9, wherein a flow rate through at least one of the inlet ports is adjustable. **Claim 14** The patient interface according to claim 13, wherein a flow rate through at least one of the inlet ports is continuously adjustable. **Claim 15** The patient interface according to claim 9, wherein any one of the inlet ports comprises a flow restrictor. **Claim 16** The patient interface according to claim 15, wherein the flow restrictor is releasably connectable to the patient interface.

Images