Patient interface

Abstract

A seal-forming structure for a patient interface can include a patient contact surface configured to engage a patient's facial skin to form a seal, a posterior opening formed in the patient contact surface, the posterior opening configured to provide a flow of air at a therapeutic pressure to a patient's nares, and a support structure extending from the patient contact surface to an inner surface of the seal-forming structure, the support structure and the inner surface forming a continuous loop, wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without a flow of pressurized air through the plenum chamber inlet port, or the patient interface is configured to not cover the patient's mouth.

Description

[0001] This application is a divisional application of patent application No. 201880028656.0 (PCT / AU2018 / 050289), filed on October 30, 2019, with an international filing date of March 29, 2018, entitled "Patient Interface".

[0002] 1. Cross-references to related applications

[0003] This application claims the benefit of U.S. Provisional Application No. 62 / 480,059, filed March 31, 2017, the entire contents of which are incorporated herein by reference. Background Technology 2.1 Technical Field

[0005] This technology relates to the detection, diagnosis, treatment, prevention, and improvement of one or more respiratory-related disorders. This technology also relates to medical devices or equipment and their uses.

[0006] 2.2 Description of relevant technologies

[0007] 2.2.1 The Human Respiratory System and Its Disorders

[0008] The human respiratory system facilitates gas exchange. The nose and mouth form the airway entrance for the patient.

[0009] The airways consist of a series of branching tracheae, which become narrower, shorter, and more numerous as they penetrate deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to enter the venous blood from inhaled air and expelling carbon dioxide. The trachea divides into the left and right main bronchioles, which eventually branch into terminal bronchioles. The bronchi form the conduction airways but do not participate in gas exchange. Other branches of the airways lead to the respiratory bronchioles and ultimately to the alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See *Respiratory Physiology*, 9th edition, published in 2012 by John B. West, Lippincott Williams & Wilkins.

[0010] A range of breathing disorders are present. Some disorders can be characterized by specific events, such as respiratory arrest, insufficiency, and hyperventilation.

[0011] Examples of breathing disorders include obstructive sleep apnea (OSA), Cheyne-Stokes respiration (CSR), respiratory insufficiency, obesity hyperventilation syndrome (OHS), chronic obstructive pulmonary disease (COPD), neuromuscular disease (NMD), and chest wall disease.

[0012] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by events involving closure or obstruction of the upper airway during sleep. It arises from a combination of abnormally small upper airway size and normal loss of muscle tone in the areas of the tongue, soft palate, and posterior oropharyngeal walls during sleep. This condition causes the affected patient to stop breathing, typically for periods of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can result in cardiovascular disease and brain damage. Concomitant symptoms are common, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

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

[0014] Respiratory failure is a broad term encompassing respiratory disorders in which the lungs are unable to inhale enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may include some or all of the following disorders.

[0015] Patients with respiratory insufficiency (a form of respiratory failure) may experience abnormal shortness of breath during exercise.

[0016] Obesity hyperventilation syndrome (OHS) is defined as a combination of severe obesity and chronic hypercapnia at wakefulness, without other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0017] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that share certain common characteristics. These diseases include increased airflow resistance, prolonged expiratory phase of breathing, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include shortness of breath during exercise, chronic cough, and sputum production.

[0018] Neuromuscular disease (NMD) is a broad term encompassing many diseases and disorders that impair muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, wheelchair use, difficulty swallowing, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be classified as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage lasting more than several months and leading to death within a few years (e.g., juvenile amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD)); (ii) variable or slowly progressive diseases: characterized by worsening muscle damage lasting more than several years and only slightly shortening life expectancy (e.g., limb-girdle muscular dystrophy, facial-shoulder-arm muscular dystrophy, and myotonic dystrophy). Symptoms of respiratory failure in NMD include: progressive general weakness, difficulty swallowing, shortness of breath during exercise and at rest, fatigue, drowsiness, morning headache, difficulty concentrating, and mood changes.

[0019] Chest wall disorders are a group of chest wall deformities that result in inefficient connection between the respiratory muscles and the thoracic cavity. These disorders are typically characterized by restrictive defects and carry the potential for chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0020] A range of treatments have been used to treat or alleviate these conditions. Furthermore, these treatments can be used by other healthy individuals to prevent respiratory distress. However, these treatments have many drawbacks.

[0021] 2.2.2 Treatment

[0022] Various treatments, such as continuous positive airway pressure (CPAP), non-invasive ventilation (NIV), and invasive ventilation (IV), have been used to treat one or more of the above-mentioned respiratory diseases.

[0023] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that CPAP acts as an air splint and prevents upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment for OSA with CPAP can be voluntary; therefore, patients may choose not to comply if they find the device used to provide this treatment uncomfortable, difficult to use, expensive, or unsightly.

[0024] Non-invasive ventilation (NIV) provides ventilatory support to patients through the upper airway to help them breathe and / or maintain adequate oxygen levels in the body by performing some or all of the work of breathing. Ventilatory support is delivered via a non-invasive patient interface. NIV has been used to treat chronic respiratory failure (CSR) and respiratory failure in forms such as OHS, COPD, NMD, and chest wall diseases. In some forms, it can improve the comfort and effectiveness of these treatments.

[0025] Invasive ventilation (IV) provides ventilatory support for patients who are unable to breathe effectively on their own and can be delivered using a tracheostomy tube. In some forms, the comfort and effectiveness of these treatments can be improved.

[0026] 2.2.3 Treatment System

[0027] These treatments can be provided by treatment systems or devices. Such systems and devices can also be used to diagnose conditions without treating them.

[0028] The treatment system may include a respiratory pressure therapy device (RPT device), an air circuit, a humidifier, a patient interface, and data management.

[0029] Another type of treatment system is the mandibular repositioning device.

[0030] 2.2.3.1 Patient Interface

[0031] A patient interface can be used to attach a breathing device to its wearer, for example, by providing an airflow into the airway. The airflow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O into the airway.

[0032] Some other mask systems may not be functionally suitable for this field. For example, a purely decorative mask may not be able to maintain suitable pressure. Masks for underwater swimming or diving may be constructed to prevent water from flowing in from external high pressure, rather than maintaining air at a pressure higher than the environment inside.

[0033] Some masks may be clinically disadvantageous for this technology, for example, because they block airflow through the nose and only allow it to pass through the mouth.

[0034] If certain masks require patients to insert a portion of the mask structure into their mouths to form and maintain a seal through their lips, they may be uncomfortable or not feasible for this technology.

[0035] Some face masks may not be suitable for use while sleeping, such as when sleeping on your side with your head on a pillow.

[0036] The design of the patient interface presents several challenges. The face has a complex three-dimensional shape. The size and shape of the nose and head vary significantly from person to person. Because the head comprises bones, cartilage, and soft tissues, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to the other bones of the skull. The entire head can move during the duration of respiratory therapy.

[0037] Due to these challenges, some masks suffer from one or more of the following problems: protrusion, unsightly appearance, high cost, mismatched size, difficulty in use, and discomfort, especially when worn for extended periods or when the patient is unfamiliar with the system. Wrongly sized masks can lead to decreased compliance, reduced comfort, and adverse patient outcomes. Masks designed solely for pilots, masks designed as part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed for administering anesthetics are acceptable for their original purpose, but are not ideally comfortable for prolonged wear (e.g., several hours). This discomfort can lead to decreased patient compliance with treatment, especially if the mask is worn during sleep.

[0038] Assuming patient compliance, CPAP therapy is very effective in treating certain breathing difficulties. Patients may not comply if the mask is uncomfortable or difficult to use. Since patients are generally advised to wash their masks regularly, they may not wash their masks if they are difficult to clean (e.g., difficult to assemble or disassemble), which could affect patient compliance.

[0039] While masks designed for other applications (such as pilots) may not be suitable for treating sleep apnea, masks designed for treating sleep apnea may be suitable for other applications.

[0040] For these reasons, different fields have emerged for patient interfaces used to deliver CPAP during sleep.

[0041] 2.2.3.1.1 Sealing Formation Structure

[0042] Patient interfaces may include sealing structures. Because they come into direct contact with the patient's face, the shape and configuration of the sealing structure can directly affect the effectiveness and comfort of the patient interface.

[0043] The patient interface is partially characterized by the design intent of the sealing structure to engage with the face during use. In one form of patient interface, the sealing structure may include a first sub-part and a second sub-part, the first sub-part forming a seal around the left nostril and the second sub-part forming a seal around the right nostril. In another form of patient interface, the sealing structure may include a single element surrounding both nostrils during use. Such a single element may be designed, for example, to cover the upper lip region and the bridge of the nose region of the face. In another form of patient interface, the sealing structure may include an element surrounding the mouth region during use, for example, by forming a seal on the lower lip region of the face. In yet another form of patient interface, the sealing structure may include a single element surrounding both nostrils and the mouth region during use. These different types of patient interfaces may be given various names by their manufacturers, including nasal masks, full-face masks, nasal pillows, nasal sprays, and oronasal masks.

[0044] A sealing structure that works effectively in one area of ​​a patient's face may not be suitable for another, for example, due to the different shapes, structures, variations, and sensitive areas of the patient's face. For instance, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0045] Certain seal-forming structures can be designed for mass production, making a design suitable, comfortable, and effective for a wide range of different facial shapes and sizes. Depending on the degree of mismatch between the shape of the patient's face and the seal-forming structure of the mass-produced patient interface, one or both must be adapted to form a seal.

[0046] One type of seal-forming structure extends around the periphery of a patient interface and, when force is applied to the patient interface while the seal-forming structure engages face-to-face with the patient's face, the seal-forming portion serves to seal the patient's face. The seal-forming structure may include an air- or fluid-filled pad, or a molded or shaped surface of an elastic sealing element made of an elastomer (e.g., rubber). With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming portion and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0047] Another type of seal-forming structure includes a sheet-like seal of thin material positioned around the periphery of the mask to provide a self-sealing action against the patient's face when positive pressure is applied within the mask. Similar to the previous type of seal-forming section, if the fit between the face and the mask is poor, additional force may be required to achieve a seal, or the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient's shape, it may wrinkle or bend during use, leading to leakage.

[0048] Another type of sealing structure may include friction-fitting elements, for example, for insertion into the nostrils; however, some patients find these uncomfortable.

[0049] Another form of sealing can be achieved using adhesives. Some patients may find it inconvenient to constantly apply and remove adhesives from their face.

[0050] A series of patient interface sealing structure technologies are disclosed in the following patent applications assigned to ResMed Limited: WO 1998 / 004,310; WO 2006 / 074,513; WO 2010 / 135,785.

[0051] One form of nasal pillow is found in Adam Circuit, manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.), assigned to Puritan-Bennett.

[0052] ResMed Limited has manufactured the following products, including nose pillows: SWIFT TM Nose pillow mask, SWIFT TM II Nose pillow mask, SWIFT TM LT nose pillow mask, SWIFT TM FX Nose Pillow Mask and MIRAGE LIBERTY TMFull-face mask. The following patent application assigned to ResMed Ltd. describes an example of a nose pillow mask: International Patent Application WO2004 / 073,778 (which describes a ResMed Ltd. SWIFT mask). TM Other aspects of the nose pillow), U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc.'s SWIFT) TM Other aspects of the LT nose pillow); International patent applications WO2005 / 063,328 and WO 2006 / 130,903 (which describe ResMed Ltd. MIRAGE LIBERTY) TM Other aspects of full-face masks); International Patent Application WO 2009 / 052,560 (which describes ResMed Ltd.'s SWIFT) TM Other aspects of the FX nose pillow).

[0053] 2.2.3.1.2 Positioning and Stability

[0054] The sealing structure of the patient interface used in positive air pressure therapy is subjected to the corresponding force of air pressure that could disrupt the seal. Therefore, various techniques have been used to position the sealing structure and maintain it in a sealed relationship with the appropriate part of the face.

[0055] One technique involves using adhesives. See, for example, U.S. Patent Application Publication No. US2010 / 0000534. However, using adhesives may be uncomfortable for some people.

[0056] Another technique involves using one or more straps and / or stabilizing harnesses. Many such harnesses suffer from one or more of the following problems: unsuitability, bulkiness, discomfort, and difficulty in use.

[0057] 2.2.3.2 Respiratory Pressure Therapy (RPT) Device

[0058] Respiratory pressure therapy (RPT) devices can be used to deliver one or more of the aforementioned treatments, for example, by generating an airflow for delivery to the airway inlet. The airflow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0059] Air pressure generators are known in a range of applications, such as industrial-scale ventilation systems. However, medical air pressure generators have specific requirements that are not met by more general air pressure generators, such as the reliability, size, and weight requirements of medical devices. Furthermore, even devices designed for medical use may have disadvantages related to one or more of the following: comfort, noise, ease of use, efficiency, size, weight, manufacturability, cost, and reliability.

[0060] One example of a specific requirement for certain RPT devices is noise.

[0061] Noise output level table for existing RPT devices (for one sample only, measured at 10 cmH2O using the test method specified in ISO 3744 in CPAP mode).

[0062] RPT device name A-weighted sound pressure level dB(A) Year (approximately) <![CDATA[C Series Tango TM > 31.9 2007 <![CDATA[C-Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[Equipped with H4i TM S8 Escape with humidifier TM II]]> 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i humidifier TM > 28.6 2010

[0063] One known RPT device for treating sleep-disordered breathing is the ResMed S9 Sleep Therapy System. Another example of an RPT device is a ventilator, such as the ResMed Stellar. TM The range of adult and pediatric ventilators can provide invasive and non-invasive, non-dependent ventilation support for a range of patients to treat a variety of conditions, including but not limited to NMD, OHS, and COPD.

[0064] Elisée TM 150 ventilator and ResMed VS III TM Ventilators provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators offer volumetric and pressure-dependent ventilation modes with single-channel or dual-channel circuits. RPT devices typically include a pressure generator, such as an electric blower or a compressed gas reservoir, and are configured to supply airflow to the patient's airway. In some cases, airflow to the patient's airway can be supplied under positive pressure. The outlet of the RPT device is connected via an air circuit to a patient interface such as those described above.

[0065] The designer of the device may have provided an almost limitless number of options to make. Design standards often conflict, meaning that some design choices are far from conventional or unavoidable. In addition, certain aspects of comfort and efficiency may be highly sensitive to small and subtle changes in one or more parameters.

[0066] 2.2.3.3 Humidifier

[0067] Delivering an unhumidified airflow can lead to airway dryness. Using a humidifier with an RPT device and patient interface produces humidified gas, minimizing dryness of the nasal mucosa and increasing patient airway comfort. Furthermore, in colder climates, warm air applied to the patient interface and the facial area around the patient interface is generally more comfortable than cold air.

[0068] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of medical humidifiers.

[0069] Medical humidifiers are used to increase the humidity and / or temperature of an airflow relative to ambient air when needed, typically in areas where patients may sleep or rest (e.g., in hospitals). Medical humidifiers intended for bedside placement can be very small. Medical humidifiers can be configured to humidify and / or heat only the airflow delivered to the patient, without humidifying and / or heating the patient's surrounding environment. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers) may also humidify the air breathed by the patient; however, these systems also humidify and / or heat the entire room, which can cause discomfort to the occupant. Furthermore, medical humidifiers may have stricter safety restrictions than industrial humidifiers.

[0070] While many medical humidifiers are known, they may have one or more drawbacks. Some medical humidifiers provide insufficient humidification, and some may be difficult or inconvenient for patients to use.

[0071] 2.2.3.4 Data Management

[0072] There are many clinical reasons to obtain data to determine whether a patient is “compliant” with a prescription for respiratory therapy, such as if the patient has been using their RPT device according to certain “compliance rules.” One example of a compliance rule for CPAP therapy is that, in order to ensure patient compliance, the patient is required to use the RPT device for at least four hours each night for at least 21 or 30 consecutive days. To determine patient compliance, RPT device providers, such as healthcare providers, can manually obtain data describing the patient’s use of the RPT device, calculate usage over the predetermined time period, and compare it to the compliance rules. Once the healthcare provider has determined that the patient has been using their RPT device according to compliance criteria, the healthcare provider can inform the patient of the third part of the compliance process.

[0073] Patient treatment can benefit from other aspects of communication of treatment data to third parties or external systems.

[0074] Existing methods for communicating and managing such data may be one or more of the following: expensive, time-consuming, and error-prone.

[0075] 2.2.3.5 Mandibular repositioning

[0076] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance, available from a dentist or other vendor, that holds the lower jaw (mandible) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before falling asleep and removes after falling asleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom-made or manufactured in standard form and include occlusal impression portions designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, applies tension to the pharyngeal walls to reduce airway constriction, and reduces vibration of the hard palate.

[0077] In some instances, a mandibular advancement device may include an upper splint designed to engage or engage with teeth in the maxilla or mandible, and a lower splint designed to engage or engage with teeth in the maxilla or mandible. The upper and lower splints are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper and lower splints.

[0078] In this design, the length of the connecting rod is chosen so that the mandible remains in an advanced position when the MRD is placed in the patient's mouth. The length of the connecting rod can be adjusted to change the degree of mandibular protrusion. The dentist can determine the degree of mandibular protrusion, which will then determine the length of the connecting rod.

[0079] Some MRDs are constructed to push the mandible forward relative to the maxilla, while others (e.g., ResMed Narval CC) TM The MRD (Mandibular Joint Retention Device) is designed to keep the mandible in an forward position. This device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is constructed to minimize or prevent any movement of one or more teeth.

[0080] 2.2.3.6 Exhaust Port Technology

[0081] Some forms of patient interface systems may include vents to allow the flushing of exhaled carbon dioxide. Vents allow gas to flow from the internal space of the patient interface (e.g., an inflation chamber) to the external space of the patient interface, such as into the environment.

[0082] Exhaust vents may include orifices through which gas can flow when a mask is in use. Many such vents are noisy. Others may become blocked during use, thus providing insufficient flushing. Some vents can, for example, disrupt the sleep of the patient's bed partner by causing noise or congested airflow.

[0083] ResMed has developed numerous improved mask ventilation technologies. See International Patent Application Publication No. WO 1998 / 034,665; International Patent Application Publication No. WO 2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. 2009 / 0050156; and U.S. Patent Application Publication No. 2009 / 0044808.

[0084] The noise level of the existing face mask (ISO 17510-2:2007, pressure at 1m and 10cmH2O)

[0085]

[0086]

[0087] (*Only one sample was measured in CPAP mode at 10 cmH2O using the test method specified in ISO 3744)

[0088] The sound pressure levels of various objects are listed below.

[0089]

[0090]

[0091] 2.2.4 Diagnostic and Monitoring System

[0092] Polysomnography (PSG) is a routine system used for the diagnosis and monitoring of cardiopulmonary diseases and typically involves specialized clinical healthcare professionals applying the system. PSG usually involves placing 15 to 20 contact sensors on the patient to record various bodily signals, such as electroencephalograms (EEG), electrocardiograms (ECG), electrooculograms (EOG), and electromyograms (EMG). PSG for sleep-disordered breathing has involved two nights of observation in the clinic: one night for pure diagnosis and a second night for the clinician to determine treatment parameters. PSG is therefore expensive and inconvenient. Specifically, it is not suitable for home sleep testing.

[0093] Clinicians can appropriately diagnose or monitor patients based on visual observation of PSG signals. However, there are situations where clinicians may be unavailable or unaffordable. Different clinicians may have differing opinions on a patient's condition. Furthermore, a given clinician may apply different criteria at different times.

[0094] 3. Technical Overview

[0095] This technology aims to provide medical devices for diagnosing, improving, treating or preventing respiratory disorders, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0096] The first aspect of this technology relates to devices for diagnosing, improving, treating, or preventing respiratory disorders.

[0097] Another aspect of this technology relates to methods for diagnosing, improving, treating, or preventing respiratory disorders.

[0098] One aspect of this technology in certain forms is used to provide methods and / or devices for improving patient compliance with respiratory therapy.

[0099] One aspect of this technology relates to a sealing formation structure for a patient interface, the sealing formation structure being configured to form a seal with a patient's nostril, and the sealing formation structure including a support structure forming a continuous ring with an inner surface of the sealing formation structure, the ring structure supporting an upper portion of a patient contact surface of the sealing formation structure, and the upper portion of the patient contact surface having a single layer not supported by a base liner.

[0100] One aspect of this technology relates to a patient interface comprising: an inflatable chamber capable of being pressurized to a therapeutic pressure at least 6 cmH2O above ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow for patient respiration at the therapeutic pressure; a sealing-forming structure configured and arranged to form a seal with a patient facial region surrounding the patient's airway inlet, the sealing-forming structure configured and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use; a positioning and stabilizing structure providing force to hold the sealing-forming structure in a therapeutically effective position on the patient's head, the positioning and stabilizing structure including a strap configured and arranged such that, during use, at least a portion covers an area of ​​the patient's head above a supraaural basal point; and a ventilation structure allowing the patient to breathe from the inflatable chamber. Exhaled gas from inside the air chamber flows continuously into the environment. The size and shape of the exhaust port structure are configured to maintain therapeutic pressure in the air chamber during use. The patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized airflow through the air chamber inlet port, or the patient interface is configured not to cover the patient's mouth. The sealing structure further includes a patient contact surface configured to engage the patient's facial skin to form a sealed surface and a rear opening formed on the patient contact surface, the rear opening being configured to provide airflow at therapeutic pressure to the patient's nostrils. The sealing structure includes a support structure extending from a first position on the patient contact surface to a second position on an inner surface of the sealing structure, the support structure and the inner surface forming a continuous loop.

[0101] In the examples, (a) the sealing structure may include a front opening formed in a non-patient contact surface and a front band spanning the front opening, and a first end of the support structure may be connected to the front band; (b) the sealing structure may include an edge defining a rear opening in the patient contact surface, and a second end of the support structure may be connected to the patient contact surface at an upper region of the edge; (c) the sealing structure may include a base liner supporting the patient contact surface; (d) the lower portion of the sealing structure may include a base liner and the upper portion of the sealing structure may not include a base liner; (e) the length of the support structure in its undeformed state may be greater than a linear distance from a first position to a second position; (f) the support structure may be configured to be positioned adjacent to or in contact with the columella of a patient during use; (g) The support structure can be bent along its longitudinal axis in an undeformed state; (h) the support structure can have a different thickness than the patient contact surface; (i) the support structure can be thicker than the patient contact surface; (j) the support structure can not extend completely beyond the rear opening; (k) the sealing forming structure can at least partially form an air chamber, and the support structure can extend into the air chamber in an undeformed state; (l) the support structure can have a variable thickness in the longitudinal direction; (n) the support structure can have an increased thickness near the first and / or second positions; (n) a portion of the support structure can be bent away from the patient's nose along its longitudinal axis in an undeformed state; and / or (o) the underliner can be configured to support only the patient contact surface against the patient's upper lip.

[0102] One aspect of this technology relates to a sealing structure for a patient interface, the sealing structure being configured and arranged to form a seal with a patient facial region surrounding a patient airway inlet, the sealing structure being configured and arranged to maintain a therapeutic pressure in the inflatable chamber at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use. The sealing structure includes: a patient contact surface configured to engage the patient's facial skin to form a seal; a rear opening formed on the patient contact surface, the rear opening being configured to provide an airflow at therapeutic pressure to the patient's nostrils; and a support structure extending from a first location on the patient contact surface to a second location on an inner surface of the sealing structure, the support structure and the inner surface forming a continuous ring, wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth without pressurized airflow through the inflatable chamber inlet port, or the patient interface is configured not to cover the patient's mouth.

[0103] In the examples, (a) the sealing structure may include a front opening formed in a non-patient contact surface and a front band spanning the front opening, and a first end of the support structure may be connected to the front band; (b) the sealing structure may include an edge defining a rear opening in the patient contact surface, and a second end of the support structure may be connected to the patient contact surface at an upper region of the edge; (c) the sealing structure may include a base liner supporting the patient contact surface; (d) the lower portion of the sealing structure may include a base liner and the upper portion of the sealing structure may not include a base liner; (e) the length of the support structure in its undeformed state may be greater than a linear distance from a first position to a second position; (f) the support structure may be configured to be positioned adjacent to or in contact with the columella of a patient during use; (g) The support structure can be bent along its longitudinal axis in an undeformed state; (h) the support structure can have a different thickness than the patient contact surface; (i) the support structure can be thicker than the patient contact surface; (j) the support structure can not extend completely beyond the rear opening; (k) the sealing forming structure can at least partially form an air chamber, and the support structure can extend into the air chamber in an undeformed state; (l) the support structure can have a variable thickness in the longitudinal direction; (n) the support structure can have an increased thickness near the first and / or second positions; (n) a portion of the support structure can be bent away from the patient's nose along its longitudinal axis in an undeformed state; and / or (o) the underliner can be configured to support only the patient contact surface against the patient's upper lip.

[0104] One aspect of this technology relates to a patient interface comprising: an inflatable chamber capable of being pressurized to a therapeutic pressure at least 6 cmH2O higher than ambient air pressure, the inflatable chamber including an inflatable chamber inlet port sized and configured to receive an airflow for patient respiration at the therapeutic pressure; a sealing structure constructed and arranged to form a seal with a patient facial region surrounding the patient's airway inlet, the sealing structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's respiratory cycle during use; and a positioning and stabilizing structure providing forces to hold the sealing structure in a therapeutically effective position on the patient's head, for positioning. The stabilizing structure includes a band configured and arranged such that, in use, at least a portion of the band covers an area of ​​the patient's head above the ear base; a decoupling structure; and a ventilation structure that allows continuous flow of exhaled gas from the interior of the inflatable chamber into the environment, the size and shape of the ventilation structure being configured to maintain therapeutic pressure in the inflatable chamber in use, wherein the patient interface is configured to allow the patient to breathe from the environment through their mouth in the absence of a pressurized airflow through the inlet port of the inflatable chamber, or the patient interface is configured not to cover the patient's mouth, and wherein the exhaust port configuration further includes an opening through the decoupling structure and an opening through the inflatable chamber.

[0105] Another aspect of this technology is a patient interface that is cast or otherwise constructed using a peripheral shape that complements the shape of the intended wearer.

[0106] One aspect of this technology is a method for manufacturing equipment.

[0107] One aspect of certain forms of this technology is an easy-to-use medical device, for example, for use by an untrained individual, by an individual with limited sensitivity or vision, or by an individual with limited experience in using this type of medical device.

[0108] One aspect of this technology is a patient interface that can be cleaned at home (e.g., in soapy water) without requiring specialized cleaning equipment. Another aspect of this technology is a humidifier tank that can be cleaned at home (e.g., in soapy water) without requiring specialized cleaning equipment.

[0109] Of course, the parts of each aspect can form sub-aspects of the present invention. In addition, the sub-aspects and / or aspects of the aspects can be combined in any way and also constitute other aspects or sub-aspects of the present invention.

[0110] Other features of the invention will become apparent from consideration of the information contained in the following detailed description, abstract, drawings, and claims. Attached Figure Description

[0111] This technology is illustrated in the accompanying drawings by way of example rather than limitation, wherein the same reference numerals denote similar elements, including:

[0112] 4.1 Treatment System

[0113] Figure 1A A system is shown in which a patient 1000 wearing a patient interface 3000 via a nose pillow receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device 4000 is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. A bed companion 1100 is also shown. The patient is sleeping in a supine position.

[0114] Figure 1B A system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a nasal mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0115] Figure 1CA system is shown in which a patient 1000 wearing a patient interface 3000 in the form of a full-face mask receives a positive-pressure air supply from an RPT device 4000. The air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170. The patient is sleeping in a lateral decubitus position.

[0116] 4.2 Respiratory System and Facial Anatomy

[0117] Figure 2A A schematic diagram of the human respiratory system is shown, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0118] Figure 2B This diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, external nasal cartilage, greater alar cartilage, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0119] Figure 2C It is a frontal view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0120] Figure 2D It is a side view of the head with several marked surface anatomical features, including the glabella, bridge of the nose, nasal protuberance, lower nasal septum, upper lip, lower lip, mandibular alveolar fossa, bridge of the nose, apex of the nasal ala, lower auricular base, and upper auricular base. The vertical and anteroposterior directions are also marked.

[0121] Figure 2E This is another side view of the head. The approximate locations of the Frankfurt plane and the nasolabial angle are indicated. The coronal plane is also shown.

[0122] Figure 2F A bottom view of the nose with several identified features is shown, including the nasolabial groove, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0123] Figure 2G A side view showing the surface features of the nose.

[0124] Figure 2H The subcutaneous structures of the nose are shown, including the lateral cartilage, septal cartilage, greater alar cartilage, lesser alar cartilage, sesamoid cartilage, nasal bone, epidermis, adipose tissue, frontal process of the maxilla, and fibroadipose tissue.

[0125] Figure 2IThe diagram shows the medial anatomy of the nose, approximately a few millimeters from the central sagittal plane, and among other things, the medial crus of the septal cartilage and the greater alar cartilage.

[0126] Figure 2J A frontal view of the skull is shown, including the frontal bone, nasal bone, and zygomatic bone. The nasal conchae, as well as the maxilla and mandible, are also labeled.

[0127] Figure 2K A side view of the skull showing the surface contours of the head and several muscles is shown. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital bone. The mental protuberance is also marked. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0128] Figure 2L The frontal lateral view of the nose is shown.

[0129] 4.3 Patient Interface

[0130] Figure 3A A patient interface in the form of a nasal mask according to the present technology is shown.

[0131] Figure 3B A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3C The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0132] Figure 3C A schematic diagram of a cross-section of the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign, and when... Figure 3B The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0133] Figure 3D A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point is zero.

[0134] Figure 3E A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3F The curvature amplitude shown has a relatively small amplitude compared to that shown.

[0135] Figure 3F A schematic diagram of a cross-section of the structure at a single point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign, and when... Figure 3E The curvature amplitude shown has a relatively large amplitude compared to that shown.

[0136] Figure 3G A cushion for a face mask comprising two pillows is shown. The outer surface of the cushion is indicated. The edges of the surface are indicated. The dome-shaped and saddle-shaped areas are indicated.

[0137] Figure 3H The pad used for the face mask is shown. The outer surface of the pad is indicated. The edge of the surface is indicated. The path on the surface between points A and B is indicated. The straight-line distance between points A and B is indicated. Two saddle-shaped areas and one dome-shaped area are indicated.

[0138] Figure 3I The surface of the structure is shown, in which a one-dimensional hole is present. The planar curve shown forms the boundary of the one-dimensional hole.

[0139] Figure 3J It shows the way Figure 3I The cross-section of the structure. The surface defined is shown. Figure 3I Two-dimensional holes in the structure.

[0140] Figure 3K Show Figure 3I A perspective view of the structure, which includes two-dimensional holes and one-dimensional holes. A defined... Figure 3I The surface of a two-dimensional hole in a structure.

[0141] Figure 3L A face mask with an inflatable airbag as a cushion is shown.

[0142] Figure 3M It shows the way Figure 3L The cross-section of the mask is shown, and the inner surface of the airbag is also shown. The inner surface of the two-dimensional holes in the mask is defined.

[0143] Figure 3N It shows crossing Figure 3L Another cross-section of the mask. The inner surface is also indicated.

[0144] Figure 3O The left-hand rule is shown.

[0145] Figure 3P The right-hand rule is shown.

[0146] Figure 3Q The left ear is shown, including the left ear spiral.

[0147] Figure 3R The right ear is shown, including the right ear spiral.

[0148] Figure 3S The right-handed spiral is shown.

[0149] Figure 3T A view of the face mask is shown, which includes torsion marks of spatial curves defined by the edges of sealing membranes in different areas of the face mask.

[0150] Figure 3U A view of the air chamber (pad assembly) 3200 is shown, illustrating the sagittal plane and the intermediate contact plane.

[0151] Figure 3V It shows Figure 3U This is a view of the rear of the inflation chamber. The view is oriented perpendicular to the center contact plane. Figure 3V The sagittal plane divides the inflation chamber into the left and right sides.

[0152] Figure 3W It shows crossing Figure 3V The cross-section of the inflation chamber, which is taken from Figure 3V The sagittal plane is shown. The "intermediate contact" plane is shown. The intermediate contact plane is perpendicular to the sagittal plane. The orientation of the intermediate contact plane corresponds to the orientation of chord 3210, which lies on the sagittal plane and makes contact with the pad of the air chamber at two points on the sagittal plane: upper point 3220 and lower point 3230. Depending on the geometry of the pad in the region, the intermediate contact plane can be tangent at both the upper and lower points.

[0153] Figure 3X It shows Figure 3U The air chamber 3200 is positioned for use on the face. When the air chamber is in the use position, the sagittal plane of the air chamber 3200 typically coincides with the central sagittal plane of the face. When the air chamber is in the use position, the intermediate contact plane typically corresponds to the "plane of the face". Figure 3X In the middle, the inflation chamber 3200 is the inflation chamber of the nose mask, and the upper point 3220 is roughly located on the bridge of the nose, while the lower point 3230 is located on the upper lip.

[0154] 4.4 RPT device

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

[0156] Figure 4B This is a schematic diagram of the pneumatic path of one form of RPT device according to the present technology. The upstream and downstream directions are shown with reference to the blower and patient interface. The blower is defined upstream of the patient interface, and the patient interface is defined downstream of the blower, regardless of the actual flow direction at any given moment. Articles within the pneumatic path between the blower and the patient interface are located downstream of the blower and upstream of the patient interface.

[0157] 4.5 Humidifier

[0158] Figure 5A An isometric view of one form of humidifier according to the present technology is shown.

[0159] Figure 5B An isometric view of one form of humidifier according to the present technology is shown, illustrating the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0160] 4.6 Respiratory waveform

[0161] Figure 6 This shows a typical breathing waveform model when a person is sleeping.

[0162] 4.7 Patient Interface According to This Technology

[0163] Figure 7A A front perspective view showing the sealing formation structure of a patient interface according to an example of the present technology.

[0164] Figure 7B A front view of the sealing-forming structure of a patient interface according to an example of this technology is shown.

[0165] Figure 7C A side view showing the sealing structure of a patient interface according to an example of the present technology.

[0166] Figure 7D A rear view showing the sealing structure of a patient interface according to an example of the present technology.

[0167] Figure 7E A lower view shows a sealing structure for a patient interface according to an example of the present technology.

[0168] Figure 7F A top view showing a sealing structure for a patient interface according to an example of the present technology.

[0169] Figure 7G Examples of this technology are shown along the edge. Figure 7B A cross-sectional view of the sealing structure of the patient interface taken from line 7G-7G.

[0170] Figure 7H Examples of this technology are shown along the edge. Figure 7B A cross-sectional view of the sealing structure of the patient interface, taken from line 7H-7H.

[0171] Figure 7I Examples of this technology are shown along the edge. Figure 7B A cross-sectional view of the sealing structure of the patient interface, taken from line 7I-7I.

[0172] Figure 7J Examples of this technology are shown along the edge. Figure 7B A cross-sectional view of the sealing structure of the patient interface, taken from line 7J-7J.

[0173] Figure 7K Examples of this technology are shown along the edge. Figure 7C A cross-sectional view of the sealing structure of the patient interface, taken from line 7K-7K.

[0174] Figure 7L Examples of this technology are shown along the edge. Figure 7C A cross-sectional view of the sealing structure of the patient interface, taken from line 7L-7L.

[0175] Figure 7M Examples of this technology are shown along the edge. Figure 7C A cross-sectional view of the sealing structure of the patient interface, taken from line 7M-7M.

[0176] Figure 8A A rear perspective view showing the decoupled structure of a patient interface according to an example of this technology.

[0177] Figure 8B A front perspective view showing the decoupled structure of a patient interface according to an example of this technology.

[0178] Figure 9A A rear perspective view showing the decoupled structure of a patient interface according to an example of this technology.

[0179] Figure 9B A front perspective view showing the decoupled structure of a patient interface according to an example of this technology.

[0180] Figure 10 A top perspective view of the patient interface according to an example of this technology is shown.

[0181] Figure 11 A front perspective view of the patient interface according to an example of this technology is shown. Detailed Implementation

[0182] Before describing the invention in further detail, it should be understood that the invention is not limited to the specific examples described herein, and the specific examples described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein and is not intended to be limiting.

[0183] The following description is provided in relation to various instances that may share one or more common characteristics and / or features. It should be understood that one or more features of any instance may be combined with one or more features of another instance or other instances. Furthermore, in any instance, any single feature or combination of features may constitute a further instance.

[0184] 5.1 Treatment

[0185] In one form, the technology includes a method for treating respiratory distress, the method comprising the step of applying positive pressure to the inlet of the airway of a patient 1000.

[0186] In some embodiments of this technology, a positive pressure air supply is provided to the patient's nasal passages through one or both nostrils.

[0187] In some embodiments of this technology, mouth breathing is defined, restricted, or prevented.

[0188] 5.2 Treatment System

[0189] In one form, the technology includes an instrument or device for treating respiratory disorders. The instrument or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000.

[0190] 5.3 Patient Interface

[0191] According to one aspect of the present technology, a non-invasive patient interface 3000 includes the following functional aspects: a sealing-forming structure 3100, an inflation chamber 3200, a positioning and stabilizing structure 3300, an exhaust port 3400, a connection port 3600 for connection to an air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing-forming structure 3100 is arranged around an inlet to the patient's airway to facilitate a positive pressure air supply to the airway.

[0192] If the patient interface cannot comfortably deliver a minimum level of positive pressure to the airway, the patient interface may not be suitable for respiratory pressure therapy.

[0193] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 6 cmH2O relative to the environment.

[0194] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 10 cmH2O relative to the environment.

[0195] According to one form of the present technology, a patient interface 3000 is constructed and arranged to provide an air supply with a positive pressure of at least 20 cmH2O relative to the environment.

[0196] 5.3.1 Sealing Formation Structure

[0197] In one form of this technology, the seal-forming structure 3100 provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur. The actual area where a seal occurs—the actual sealing surface—may vary daily during a given treatment period and vary from patient to patient, depending on a range of factors, such as the position of the patient interface on the face, the tension in the positioning and stabilizing structure, and the shape of the patient's face.

[0198] In one configuration, the target sealing area is located on the outer surface of the sealing structure 3100.

[0199] In some forms of this technology, the sealing structure 3100 is made of a biocompatible material (e.g., silicone rubber).

[0200] The sealing structure 3100 according to this technology can be constructed from a soft, flexible, and elastic material such as silicone.

[0201] In some forms of this technology, a system is provided that includes more than one sealing formation structure 3100, each sealing formation structure 3100 configured to correspond to a different size and / or shape range. For example, the system may include one form of sealing formation structure 3100 suitable for large-sized heads but not for small-sized heads, and another form suitable for small-sized heads but not for large-sized heads.

[0202] 5.3.1.1 Sealing Mechanism

[0203] In one embodiment, the sealing structure includes a sealing flange utilizing a pressure-assisted sealing mechanism. In use, the sealing flange readily responds to the system positive pressure acting on its bottom surface within the inflation chamber 3200, thereby forming a tight seal with the face. The pressure-assisted mechanism can work in conjunction with elastic tension in the positioning and stabilizing structure.

[0204] In one embodiment, the sealing structure 3100 includes a sealing flange and a support flange. The sealing flange includes a relatively thin member with a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm, extending around the periphery of the inflation chamber 3200. The support flange may be relatively thicker than the sealing flange. The support flange is disposed between the sealing flange and the edge of the inflation chamber 3200 and extends for at least a portion of the path around the periphery. The support flange is or includes a spring-like element and functions to support the sealing flange and prevent it from bending during use.

[0205] In one form, the sealing structure may include a compression seal portion or a gasket seal portion. In use, the compression seal portion or gasket seal portion is constructed and arranged to be compressed, for example, due to elastic tension in the positioning and stabilizing structure.

[0206] In one form, the sealing structure includes a tension section. During use, the tension section maintains tension, for example, through adjacent areas of the sealing flange.

[0207] In one form, the sealing structure includes a region having an adhesive or bonding surface.

[0208] In some forms of this technology, the sealing structure may include one or more of a pressure-assisted sealing flange, a compression sealing portion, a gasket sealing portion, a tension portion, and a portion having an adhesive or bonding surface.

[0209] 5.3.1.2 Bridge of the nose or nasal bridge area

[0210] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the bridge of the nose area of ​​the patient's face during use.

[0211] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the bridge of the nose area of ​​the patient's face during use.

[0212] 5.3.1.3 Upper lip area

[0213] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the upper lip region (i.e., the upper lip) of the patient's face during use.

[0214] In one form, the seal-forming structure includes a saddle-shaped region configured to form a seal on the upper lip area of ​​the patient's face during use.

[0215] 5.3.1.4 Chin region

[0216] In one embodiment, the non-invasive patient interface 3000 includes a sealing-forming structure that forms a seal on the chin region of the patient's face during use.

[0217] In one form, the sealing structure includes a saddle-shaped region configured to form a seal on the chin area of ​​the patient's face during use.

[0218] 5.3.1.5 Forehead area

[0219] In one form, the sealing structure forms a seal on the forehead area of ​​the patient's face during use. In this form, the inflatable chamber can cover the eyes during use.

[0220] 5.3.1.6 Nasal pillow

[0221] In one embodiment, the sealing structure of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows, each of which is constructed and arranged to form a seal with the corresponding nostril of the patient's nose.

[0222] A nasal pillow according to one aspect of the present invention includes: a truncated cone, at least a portion of which forms a seal on the bottom surface of the patient's nose; a handle; and a flexible region on the bottom surface of the truncated cone and connecting the truncated cone to the handle. Furthermore, the nasal pillow-connecting structure of the present invention includes a flexible region adjacent to the bottom of the handle. The flexible regions can work together to facilitate the formation of a universal connection structure, which is adjustable with relative movement of displacement and angular motion between the truncated cone and the nasal pillow-connecting structure. For example, the position of the truncated cone can be axially moved toward the handle-connecting structure.

[0223] 5.3.1.7 Sealing structure with supporting structure

[0224] Figures 7A to 7M A sealing structure 3100 according to an example of the present technology is shown. The sealing structure 3100 may feature a nasal support pad. The sealing structure 3100 can be configured to seal against the patient's face around the nostrils to provide pressurized, breathable air to the patient's nasal airway without covering the patient's mouth.

[0225] The lower portion of the sealing structure 3100 can engage the patient's upper lip to form a seal, and the sealing structure 3100 may not extend beyond the vermilion border of the patient's upper lip. In one example, the upper portion of the sealing structure 3100 can be configured to engage below the patient's nose to the patient's nasal bone to form a seal. In another example, the upper portion of the sealing structure 3100 can be configured to engage below the patient's nose to the patient's nasal protuberance to form a seal. The lateral portions of the sealing structure 3100 can be configured to engage the patient's face between the patient's alar and the patient's cheek to form a seal. The lateral portions of the sealing structure 3100 can be configured to extend beyond the apex of the alar to engage the patient's face and form a seal.

[0226] The sealing structure 3100 according to the present technology may include the features of the nasal support pad disclosed in International Application No. WO2014 / 110626 filed on January 16, 2014 and No. WO2015 / 070289 filed on November 14, 2014, each of which is incorporated herein by reference in its entirety.

[0227] according to Figures 7A to 7M The sealing structure 3100 of the illustrated example includes a connection region 3102 on its front side. The connection region 3102 is configured to connect the sealing structure 3100 to the inflation chamber 3200. The connection region 3102 provides an interface for engaging with the inflation chamber 3102. The connection region 3102 can be connected to the inflation chamber 3200 via a mechanical connection (e.g., friction fit, snap-fit ​​fit, or mechanical interlocking of corresponding overhang portions). The connection region 3102 can provide a detachable connection to the inflation chamber 3200. The detachable connection allows the sealing structure 3100 to be removed for cleaning or replacement.

[0228] In this example, the connecting region 3102 surrounds the front opening 3104 or orifice. The front opening 3104 is in fluid communication with the inflation chamber 3200 to receive a pressurized, breathable gas flow, and exhaled gas from the patient can reach the inflation chamber 3200 through the front opening 3104 to be discharged through the exhaust port 3400. In this example, the front opening 3104 is also separated by a front band 3108, which crosses the front opening 3104 vertically between the lower and upper portions of the connecting region 3102.

[0229] The sealing structure 3100 of this example also includes a non-patient contact surface 3116 surrounding the connection region 3102. The non-patient contact surface 3116 is away from the patient's face and does not contact the patient's face during use. The non-patient contact surface 3116 may also at least partially contact the inflation chamber 3200.

[0230] The sealing structure 3100 of this example also includes a patient contact surface 3114. In use, the patient contact surface 3114 faces the patient's face. In use, the patient contact surface 3114 can at least partially seal the patient's facial skin. The patient contact surface 3114 is arranged such that the patient's facial skin contacts the patient contact surface 3114 in use. The patient's facial skin may contact only a portion of the patient contact surface 3114, or the patient's facial skin may contact all of the patient contact surface 3114 in use. The patient contact surface 3114 may be adjacent to a non-patient contact surface 3116. The patient contact surface 3114 may also be in close contact with the non-patient contact surface 3116.

[0231] The sealing structure 3100 of this example also includes an air chamber 3120 defined at least partially by the inner surface 3112 of the sealing structure 3100. The air chamber 3120 can be pressurized to 30 cmH2O by pressurized breathable gas received from the inflation chamber 3200 during use.

[0232] like Figure 7DAs shown in the rear view, a rear opening 3106 or orifice is formed in the patient contact surface 3114. Pressurized breathable gas in the air chamber 3120 of the sealing structure 3100 communicates with the patient's nostrils through the rear opening 3106. Gas exhaled from the patient's nostrils communicates with the air chamber 3120 through the rear opening 3106 to be discharged via the exhaust port 3400. The rear opening 3106 may be a single opening formed in the patient contact surface 3114, or the rear opening 3106 may be divided into two separate openings, each communicating with the corresponding nostril of the patient. The rear opening 3106 may be defined by an edge 3118 of the patient contact surface 3114.

[0233] The sealing structure 3100 in this example also includes... Figure 7C , 7J The support structure 3110 is visible in the 7M. The support structure 3110 is connected at one end to the front band 3108, and this connection is to the interior of the front band 3108 facing the air chamber 3120 or to the rearward surface facing relative to the sealing formation structure 3100. The other end of the support structure 3110 is connected at edge 3118 to the patient contact surface 3114. (As can be seen in...) Figures 7G to 7K As seen in the 7M cross-sectional view, the upper portion of the patient contact surface 3114 of the seal-forming structure 3100 is not supported by a base liner. The patient contact surface 3114 of the seal-forming structure 3100 can be a single layer that engages with the patient's nose near the nasal protuberance. Compared to a double-walled arrangement (i.e., an arrangement with a base liner), a single layer of the seal-forming structure 3100 in this region can be more flexible, as the double-walled arrangement can provide a more comfortable and effective seal for a wider range of nasal shapes. However, this single-layer arrangement may be more prone to bursting, for example, in cases where pressurized breathable gas causes the patient contact surface 3114 of the seal-forming structure 3100 to detach from the patient's nose. The support structure 3110 counteracts this effect by attaching the edge 3118 of the patient contact surface 3114 to another portion of the seal-forming structure 3100.

[0234] The support structure 3110 may be adjacent to or partially in contact with the patient's columella to prevent the patient's nose from protruding into the air chamber 3120 of the sealing structure 3100. Depending on the size and shape of the individual patient's nose, the support structure 3110 may be close to the patient's columella but not in direct contact with it. The support structure 3110 may also support the patient contact surface 3114 and facilitate engagement of the patient contact surface 3114 with the patient's nose near the nasal protuberance to ensure an effective seal. For example, Figure 7J It is also shown that the support structure 3110 does not cross the rear opening 3106 and does not extend between the upper and lower parts of the edge 3118.

[0235] The support structure 3110 may have a different thickness than the patient contact surface 3114. The support structure 3110 may be thicker than the patient contact surface 3114. The support structure 3110 may have a variable thickness in the longitudinal direction. The support structure 3110 may have increased thickness at one or both of the locations adjacent to where the support structure 3110 is connected to the sealing forming structure 3100.

[0236] The support structure 3110 can form a continuous ring together with the inner surface 3112 of the sealing structure 3100 and the front band 3108, such as Figure 7G As shown. In an alternative embodiment, the support structure 3110 may be connected to the inner surface 3112 of the sealing forming structure 3100 instead of the front band 3108. In such an alternative embodiment, the front band 3108 may be omitted. The length of the support structure 3110 in its undeformed state may be greater than the linear distance from the two locations where the support structure 3110 is connected to the sealing forming structure 3110, in order to provide a degree of relaxation in the support structure.

[0237] Figure 7G The diagram also shows the support structure 3110 slightly curved inward into the air chamber 3120 in its undeformed state. This curvature allows the support structure 3110 to better adapt to the patient's nose, including the nasal protuberance. Alternatively, the support structure 3110 can be straight in its undeformed state in another instance. Furthermore, Figure 7G The patient contact surface 3114 is shown in close contact with the outer or rear surface of the support structure 3110. In an alternative embodiment, the support structure 3110 may be connected to the inner surface 3112 of the sealing forming structure 3100 opposite to the patient contact surface 3114, such that the edge 3118 separates the patient contact surface 3114 and the support structure 3110.

[0238] The sealing structure 3100, and particularly the support structure 3110, may include the entire contents of International Application Publication No. WO 2016 / 149769, filed on March 24, 2016, which is incorporated herein by reference.

[0239] The sealing structure 3100 may also include a base liner 3122 that supports a portion of the patient contact surface 3114, such as Figures 7G to 7M As shown. The underlay 3122 may support only the lower portion of the underlay 3122. The underlay 3122 may be disposed only on the lower half of the seal-forming structure 3100. In these examples, the underlay 3122 may be configured to support the patient contact surface 3114 against the patient's upper lip to ensure an effective seal. A similar underlay layer 3105 is disclosed in U.S. Provisional Application No. 62 / 328,988, filed April 28, 2016, the entire contents of which are incorporated herein by reference.

[0240] The connecting region 3102 of the sealing structure 3100 can have a shape similar to an infinite loop (∞) or the number eight (8). It can also be described as having an "hourglass" shape. The connecting region 3102 can be shaped such that its narrowest point is located at the centerline of the sealing structure 3100. Then, the connecting region 3102 can be widened vertically in either direction away from the centerline, for example, as... Figure 7B As shown.

[0241] 5.3.2 Inflation Chamber

[0242] In the area formed during use, the air chamber 3200 has a periphery whose shape complements the surface contour of a typical human face. During use, the boundary edges of the air chamber 3200 are in close proximity to the adjacent surfaces of the face. Actual contact with the face is provided by the sealing structure 3100. The sealing structure 3100 may extend along the entire periphery of the air chamber 3200 during use. In some forms, the air chamber 3200 and the sealing structure 3100 are formed from a single, uniform sheet of material.

[0243] In some forms of this technology, the air chamber 3200 does not cover the patient's eyes during use. In other words, the eyes are outside the pressurized volume defined by the air chamber. Such a form tends to be less conspicuous and / or more comfortable for the wearer, which can improve treatment compliance.

[0244] In some forms of this technology, the air chamber 3200 is made of a transparent material, such as transparent polycarbonate. The use of transparent materials reduces the prominence of the patient interface and helps improve treatment compliance. The use of transparent materials also helps clinicians observe how the patient interface is positioned and functions.

[0245] In some forms of this technology, the air chamber 3200 is made of a translucent material. The use of a translucent material can reduce the protrusion of the patient interface and help improve compliance with treatment.

[0246] 5.3.3 Positioning and Stabilizing Structure

[0247] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by positioning and stabilizing structure 3300.

[0248] In one configuration, the positioning and stabilizing structure 3300 provides a holding force that is at least sufficient to overcome the effects of the positive pressure in the inflation chamber 3200 to lift the face away.

[0249] In one configuration, the positioning and stabilizing structure 3300 provides holding forces to overcome the effects of gravity on the patient interface 3000.

[0250] In one configuration, the positioning and stabilizing structure 3300 provides a holding force as a safety margin to overcome the potential effects of forces acting on the patient interface 3000 that could cause damage, such as those from tube resistance or accidental interference with the patient interface.

[0251] In one form of this technology, a positioning and stabilization structure 3300 is provided, constructed in a manner consistent with that worn by a patient while sleeping. In one embodiment, the positioning and stabilization structure 3300 has a small side or cross-sectional thickness to reduce the sensing or actual volume of the instrument. In one embodiment, the positioning and stabilization structure 3300 includes at least one strip with a rectangular cross-section. In one embodiment, the positioning and stabilization structure 3300 includes at least one flat strip.

[0252] In one form of this technology, a positioning and stabilizing structure 3300 is provided, configured not to be too large or bulky to prevent the patient from lying in a supine sleeping position, wherein the posterior region of the patient's head is located on a pillow.

[0253] In one form of this technology, a positioning and stabilizing structure 3300 is provided, configured not to be too large or bulky to prevent the patient from lying in a side-lying position, wherein the lateral area of ​​the patient's head is located on a pillow.

[0254] In one form of this technology, the positioning and stabilizing structure 3300 is provided with a decoupling portion located between the front and rear portions of the positioning and stabilizing structure 3300. The decoupling portion does not resist compression and may be, for example, a flexible band or soft band. The decoupling portion is constructed and arranged such that when the patient lies on the head pillow, the presence of the decoupling portion prevents forces acting on the rear portion from being transmitted along the positioning and stabilizing structure 3300 and breaking the seal.

[0255] In one form of this technology, the positioning and stabilizing structure 3300 includes a band constructed of laminated material comprising a fabric patient contact layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the band. In another form, the fabric outer layer includes a loop material for engagement with a hook material portion.

[0256] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, for example, elastically extendable. For instance, the strap may be configured to withstand tensile forces during use and to guide forces to bring the sealing structure into sealed contact with a portion of the patient's face. In one embodiment, the strap may be configured as a tie.

[0257] In one form of this technology, the positioning and stabilizing structure includes a first band, which is constructed and arranged such that, in use, at least a portion of the lower edge of the first band passes over the patient's head above the supraatrial base and covers a portion of the parietal bone but not the occipital bone.

[0258] In one form of the technology applicable to nasal masks or full-face masks only, the positioning and stabilizing structure includes a second band, which is constructed and arranged such that, in use, at least a portion of the upper edge of the second band passes under the patient's head below the ear base point and covers or is located under the occipital bone of the patient's head.

[0259] In one form of this technology applicable to nose-only or full-face masks, the positioning and stabilizing structure includes a third band configured and arranged to interconnect the first and second bands to reduce the tendency for the first and second bands to separate from each other.

[0260] In some forms of this technology, the positioning and stabilizing structure 3300 includes a strap that is flexible, for example, non-rigid. An advantage of this is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0261] In some forms of this technology, the positioning and stabilizing structure 3300 includes a belt configured to be breathable to allow moisture to pass through it.

[0262] In some forms of this technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each configured to provide a holding force corresponding to a range of sizes and / or shapes. For example, the system may include one form suitable for large-sized heads but not for small-sized heads, and another form suitable for small-sized heads but not for large-sized heads.

[0263] 5.3.4 Exhaust Port

[0264] In one form, the patient interface 3000 includes an exhaust port 3400 constructed and arranged to allow flushing of exhaled gases such as carbon dioxide.

[0265] In some configurations, the exhaust port 3400 is configured to allow a continuous exhaust flow from the interior of the inflation chamber 3200 to the environment, while the pressure within the inflation chamber is positive relative to the environment. The exhaust port 3400 is configured such that the exhaust flow rate is sufficient to reduce rebreathing of exhaled CO2 by the patient while maintaining the therapeutic pressure within the inflation chamber during use.

[0266] One form of the exhaust port 3400 according to the present invention includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0267] The exhaust port 3400 may be located in the inflation chamber 3200. Alternatively, the exhaust port 3400 may be located in a decoupling structure, such as a rotating shaft.

[0268] The exhaust port 3400 provided to the inflation chamber 3200 may include multiple openings 3402. The openings 3402 may be arranged in two sets symmetrically with respect to the centerline of the inflation chamber 3200. Multiple openings 3402 can reduce noise and diffuse the exhaust flow concentration.

[0269] The opening 3402 can be positioned close enough to the centerline of the inflation chamber 3200 so that it is not obstructed when the patient is sleeping on their side. To avoid weakening the chassis in a relatively narrow section, the opening 3402 can be spaced apart from the centerline.

[0270] Opening 3402 can have a circular profile.

[0271] 5.3.5 Decoupling Structure

[0272] In one form, the patient interface 3000 includes at least one decoupling structure 3500, such as a swivel or a ball-and-socket joint. Figure 8A , 8B Images 9A and 9B depict examples of a decoupling structure 3500 according to the present technology. The decoupling structure 3500 may be in the form of a bend. The decoupling structure 3500 may have a rotating shaft 3501 connected to an air circuit 4170 and a patient interface connector 3502 connected to a patient interface 3000. The patient interface connector 3502 may allow the tube 3503 of the decoupling structure 3500 to rotate relative to the patient interface 3500. The decoupling structure 3500 may also include an exhaust port 3400. The exhaust port 3400 of the decoupling structure 3500 may include at least one opening 3401 passing through a portion of the tube 3503 and / or through a portion of the patient interface connector 3502.

[0273] 5.3.6 Connection Port

[0274] Connection port 3600 allows connection to air circuit 4170.

[0275] 5.3.7 Forehead Stent

[0276] In one configuration, the patient interface 3000 includes a forehead support 3700.

[0277] 5.3.8 Anti-asphyxiation valve

[0278] In one configuration, the patient interface 3000 includes an anti-asphyxiation valve.

[0279] Port 5.3.9

[0280] In one embodiment of this technology, the patient interface 3000 includes one or more ports that allow access to the volume within the inflation chamber 3200. In one embodiment, this allows a clinician to provide supplemental oxygen. In another embodiment, this allows for direct measurement of the properties of the gas within the inflation chamber 3200, such as pressure.

[0281] 5.3.10 Patient Interface of this Technology

[0282] Figure 10 and 11 A patient interface 3000 according to an example of the present technology is shown. The patient interface 3000 includes a sealing structure 3100 according to the example described in section 4.3.1 above. The sealing structure 3100 may also be connected to an inflation chamber 3200 as described above. The inflation chamber 3200 may be provided with one or more vents 3400.

[0283] The patient interface 3000 may include a positioning and stabilization structure 3300, which includes a catheter 3301. The catheter 3301 serves two purposes: 1) to position and stabilize the patient interface 3000 in a therapeutically effective position on the patient's head during use, and 2) to supply pressurized breathable gas to the inflation chamber 3200. Thus, the catheter 3301 may be constructed of a flexible, biocompatible material and may also be formed into a hollow structure. The catheter 3301 can be connected to the inflation chamber 3200 using a clip 3303 to provide a pneumatic connection between them. The catheter 3301 may also include a strap connector 3302 for connection to a strap (not shown) that passes behind the patient's head during use. The catheter 3301 may also include a flexible portion 3304 that provides flexibility to adapt to different sizes and shapes of the patient's head. A bend connector 3305 is also included.

[0284] 5.4 RPT device

[0285] According to one aspect of the present technology, an RPT device 4000 includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms. The RPT device 4000 can be configured to generate an airflow for delivery to a patient's airway, for example, for treating one or more respiratory conditions described elsewhere in this document.

[0286] In one embodiment, the RPT device 4000 is constructed and arranged to deliver an airflow in 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.

[0287] The RPT device may have an outer housing 4010, which is composed of two parts: an upper part 4012 and a lower part 4014. Furthermore, the outer housing 4010 may include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 may include a handle 4018.

[0288] The pneumatic path of the RPT device 4000 may include one or more air path components, such as an inlet air filter 4112, an inlet silencer 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying positive pressure air, an outlet silencer 4124, and one or more converters 4270, such as pressure sensors and flow sensors.

[0289] One or more air path components may be housed within a detachable, separate structure, referred to as pneumatic block 4020. Pneumatic block 4020 may be housed within an outer housing 4010. In one embodiment, pneumatic block 4020 is supported by, or forms part of, a chassis 4016.

[0290] The RPT device 4000 may include a power supply 4210, one or more input devices 4220, a central controller, a treatment device controller, a pressure generator 4140, one or more protection circuits, a memory, a converter 4270, a data communication interface, and one or more output devices. Electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative embodiment, the RPT device 4000 may include more than one PCBA 4202.

[0291] 5.4.1 Mechanical & Pneumatic Components of the RPT Unit

[0292] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be configured as separate units.

[0293] 5.4.1.1 Air Filter

[0294] One form of RPT device according to the present technology may include one air filter 4110 or multiple air filters 4110.

[0295] In one configuration, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140.

[0296] In one configuration, an outlet air filter 4114, such as an antibacterial filter, is positioned between the pneumatic block 4020 and the patient interface 3000.

[0297] 5.4.1.2 Muffler

[0298] One form of RPT device according to the present technology may include one or more mufflers 4120.

[0299] In one embodiment of this technology, the inlet silencer 4122 is disposed in the pneumatic path upstream of the pressure generator 4140.

[0300] In one embodiment of this technology, the outlet silencer 4124 is disposed in the pneumatic path between the pressure generator 4140 and the patient interface 3000.

[0301] 5.4.1.3 Pressure Generator

[0302] In one form of this technology, the pressure generator 4140 for generating a positive pressure airflow or air supply is a controllable blower 4142. For example, the blower 4142 may include a brushless DC motor 4144 having one or more impellers enclosed in a volute. The blower is capable of delivering an air supply, for example, at a rate up to about 120 liters per minute and at a positive pressure ranging from about 4 cmH2O to about 20 cmH2O, or in other forms up to about 30 cmH2O. The blower may be as described in any of the following patents or patent applications, the contents of which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO2013 / 020167.

[0303] The pressure generator 4140 is under the control of the treatment device controller.

[0304] In other words, the pressure generator 4140 can be a piston-driven pump, a pressure regulator (e.g., a compressed air reservoir) connected to a high-pressure source, or a bellows.

[0305] 5.4.1.4 Converter

[0306] The transducer can be located inside or outside the RPT device. An external transducer can be located on, for example, the air circuit, such as the patient interface, or be part of it. An external transducer can be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0307] In one form of this technology, one or more converters 4270 are disposed upstream and / or downstream of pressure generator 4140. The one or more converters 4270 may be configured and arranged to generate signals representing characteristics of airflow, such as flow rate, pressure, or temperature, at that point in the pneumatic path.

[0308] In one form of this technology, one or more converters 4270 may be located adjacent to the patient interface 3000.

[0309] In one configuration, the signal from converter 4270 can be filtered by low-pass filtering, high-pass filtering, or band-pass filtering.

[0310] 5.4.1.4.1 Flow Sensor

[0311] The flow sensor based on this technology can be based on a differential pressure converter, such as the SDP600 series differential pressure converter from SENSIRION.

[0312] In one configuration, a central controller receives signals representing flow rate from flow sensors.

[0313] 5.4.1.4.2 Air Pressure Sensor

[0314] The pressure sensor according to this technology is configured in fluid communication with the pneumatic path. An example of a suitable pressure sensor is the converter from the HONEYWELL ASDX series. Alternatively, a suitable pressure sensor is the converter from the GENERAL ELECTRIC NPA series.

[0315] In one configuration, signals from pressure sensors are received via a central controller.

[0316] 5.4.1.4.3 Motor Speed ​​Converter

[0317] In one embodiment of this technology, a motor speed converter is used to determine the rotational speed of motor 4144 and / or blower 4142. The motor speed signal from the motor speed converter can be provided to the treatment device controller. The motor speed converter can be, for example, a speed sensor, such as a Hall effect sensor.

[0318] 5.4.1.5 Anti-overflow valve

[0319] In one embodiment of this technology, an anti-backflow valve 4160 is disposed between the humidifier 5000 and the pneumatic block 4020. The anti-backflow valve is constructed and arranged to reduce the risk of water flowing upstream from the humidifier 5000 to, for example, the motor 4144.

[0320] 5.4.2 Electrical Components of RPT Unit

[0321] 5.4.2.1 Power Supply

[0322] The power supply 4210 can be located inside or outside the outer housing 4010 of the RPT device 4000.

[0323] In one embodiment of this technology, power supply 4210 supplies power only to RPT device 4000. In another embodiment of the invention, power supply 4210 supplies power to both RPT device 4000 and humidifier 5000.

[0324] 5.4.2.2 Input Device

[0325] In one embodiment of this technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow personnel to interact with the device. The buttons, switches, or dials can be physical devices or software devices accessed via a touchscreen. In one embodiment, the buttons, switches, or dials can be physically connected to an external housing 4010, or in another embodiment, the buttons, switches, or dials can communicate wirelessly with a receiver electrically connected to a central controller.

[0326] In one form, the input device 4220 may be configured or arranged to allow a person to select values ​​and / or menu options.

[0327] 5.4.2.3 Central Controller

[0328] In one form of this technology, the central controller is one or more processors suitable for controlling the RPT device 4000.

[0329] Suitable processors may include x86 Intel processors, based on those from ARM Holdings. -M processors, such as the STM32 series microcontrollers from STMicroelectronics. In some alternative forms of this technology, 32-bit RISC CPUs such as the STR9 series microcontrollers from STMicroelectronics, or 16-bit RISC CPUs such as the MSP430 series microcontrollers from Texas Instruments, are equally applicable.

[0330] In one form of this technology, the central controller is a dedicated electronic circuit.

[0331] In one form, the central controller is an application-specific integrated circuit (ASIC). In another form, the central controller comprises discrete electronic components.

[0332] The central controller can be configured to receive input signals from one or more converters 4270, one or more input devices 4220, and humidifier 5000.

[0333] The central controller can be configured to provide output signals to one or more output devices, treatment device controllers, data communication interfaces, and humidifiers 5000.

[0334] In some forms of this technology, the central controller is configured to implement one or more methods described herein, such as one or more algorithms represented as computer programs stored in a non-transitory computer-readable storage medium, such as memory. In some forms of this technology, the central controller may be integrated with the RPT device 4000. However, in some forms of this technology, some methods may be performed via a remote positioning device. For example, the remote positioning device may determine the ventilator's control settings or detect respiratory-related events by analyzing stored data from, for example, any of the sensors described herein.

[0335] 5.5 Air Circuit

[0336] According to one aspect of the present technology, the air circuit 4170 is a conduit or tube that is constructed and arranged in use to allow airflow between two components, such as the RPT device 4000 and the patient interface 3000.

[0337] Specifically, 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, a circuit with separate branches may be used for inhalation and exhalation. In other cases, a single branch is used.

[0338] In some forms, the air circuit 4170 may include one or more heating elements configured to heat air in the air circuit, for example, to maintain or raise the temperature of the air. The heating elements may be in the form of a heating wire circuit and may include one or more transducers, such as temperature sensors. In one form, the heating wire circuit may be helically wound around the axis of the air circuit 4170. The heating elements may be connected to a controller, such as a central controller. An embodiment of a control circuit 4170 including a heating wire circuit is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0339] 5.5.1 Oxygen Delivery

[0340] In one form of this technology, supplemental oxygen 4180 is delivered to one or more points in the pneumatic path, such as upstream of pneumatic block 4020, and then to air circuit 4170 and / or patient interface 3000.

[0341] 5.6 Humidifier

[0342] 5.6.1 Overview of Humidifiers

[0343] In one form of this technology, a humidifier 5000 is provided (e.g., such as...). Figure 5A (As shown), to change the absolute humidity of the air or gas used to deliver to the patient relative to ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the airflow and increase the temperature of the airflow (relative to ambient air) before it is delivered to the patient's airway.

[0344] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving airflow, and a humidifier outlet 5004 for delivering humidified airflow. In some forms, such as Figure 5A and Figure 5B As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 may also include a humidifier base 5006, which is adapted to receive the humidifier reservoir 5110 and includes a heating element 5240.

[0345] 5.6.2 Humidifier Assembly

[0346] 5.6.2.1 Water Storage Tank

[0347] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to maintain or retain a liquid (e.g., water) volume for evaporation to humidify the airflow. The water reservoir 5110 may be configured to maintain a predetermined maximum water volume to provide adequate humidification for at least the duration of a respiratory therapy session, such as one night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 ml, 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a water supply from an external water source, such as a building's water supply system.

[0348] According to one aspect, the water reservoir 5110 is configured to add moisture to the airflow from the RPT device 4000 when airflow passes through it. In one form, the water reservoir 5110 may be configured to facilitate the airflow traveling in a curved path through the reservoir 5110 when in contact with the water volume therein.

[0349] According to one form, the storage 5110 can, for example, be along such a path. Figure 5A and Figure 5B Remove from humidifier 5000 in the lateral direction shown.

[0350] The reservoir 5110 may also be configured to prevent liquid from flowing out through any orifice and / or from its sub-assemblies when the reservoir 5110 is displaced and / or rotated from its normal operating direction. Since the airflow to be humidified by the humidifier 5000 is typically pressurized, the reservoir 5110 may also be configured to avoid loss of pneumatic pressure through leakage and / or flow resistance.

[0351] 5.6.2.2 Air Guide Section

[0352] According to one arrangement, the reservoir 5110 includes a vent 5120 configured to allow efficient heat transfer from the heating element 5240 to the liquid volume within the reservoir 5110. In one form, the vent 5120 may be arranged as a plate, but other shapes are equally applicable. All or part of the vent 5120 may be made of a thermally conductive material, such as aluminum (e.g., with a thickness of about 2 mm, such as 1 mm, 1.5 mm, 2.5 mm, or 3 mm), another thermally conductive metal, or some plastics. In some cases, suitable thermal conductivity may be achieved using materials with appropriate geometries and lower thermal conductivity.

[0353] 5.6.2.3 Humidifier reservoir base

[0354] In one embodiment, the humidifier 5000 may include a humidifier reservoir base 5130 (e.g., Figure 5B (as shown), which is configured to receive humidifier reservoir 5110. In some arrangements, humidifier reservoir base 5130 may include a locking mechanism, such as a locking lever 5135 configured to hold reservoir 5110 in humidifier reservoir base 5130.

[0355] 5.6.2.4 Water level indicator

[0356] Humidifier reservoir 5110 may include, for example Figures 5A-5B The water level indicator 5150 is shown. In some forms, the water level indicator 5150 may provide one or more indications to a user (such as a patient 1000 or a caregiver) regarding the amount of water in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of the maximum predetermined volume of water, any portion thereof, such as 25%, 50%, 75%, or a volume such as 200 ml, 300 ml, or 400 ml.

[0357] 5.6.2.5 Heating element

[0358] In some cases, heating element 5240 may be provided to humidifier 5000 to provide heat input to one or more of the water capacity in humidifier reservoir 5110 and / or to airflow. Heating element 5240 may include heat-generating components, such as resistive electric heating rails. A suitable example of heating element 5240 is a layered heating element, such as the layered heating element described in PCT patent application publication number WO 2012 / 171072, which is incorporated herein by reference in its entirety.

[0359] In some forms, the heating element 5240 may be provided in the humidifier base 5006, wherein, for example Figure 5B The heat shown can be supplied to the humidifier reservoir 5110 primarily through conduction.

[0360] 5.7 Respiratory waveform

[0361] Figure 6 This diagram illustrates a typical breathing waveform model during sleep. The horizontal axis represents time, and the vertical axis represents respiratory flow. While parameter values ​​can vary, typical breathing can be approximated by the following: tidal volume (Vt) 0.5 L, inspiratory time (Ti) 1.6 s, peak inspiratory flow (Qpeak) 0.4 L / s, expiratory time (Te) 2.4 s, and peak expiratory flow (Qpeak) -0.5 L / s. The total duration of breathing (Ttot) is approximately 4 s. Humans typically breathe at a rate of approximately 15 breaths per minute (BPM), with a ventilation volume of approximately 7.5 L / min. The typical work cycle (the ratio of Ti to Ttot) is approximately 40%.

[0362] 5.8 Terminology

[0363] To achieve the purpose of disclosing the technology of this invention, one or more of the following definitions may be applied in certain forms of the invention. In other forms of the invention, alternative definitions may be applied.

[0364] 5.8.1 Summary

[0365] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-rich atmospheric air.

[0366] Environment: In some forms of the present invention, the term environment may have the following meanings: (i) outside the treatment system or the patient, and (ii) directly surrounding the treatment system or the patient.

[0367] For example, the ambient humidity relative to the humidifier can be the humidity of the air directly surrounding the humidifier, such as the humidity inside the patient's sleeping room. This ambient humidity can differ from the humidity outside the patient's sleeping room.

[0368] In another instance, environmental stress can be stress that is directly around the body or outside the body.

[0369] In some forms, ambient (e.g., acoustic) noise can be considered as the background noise level in the patient's room, excluding noise generated by, for example, the RPT device or from the mask or patient interface. Ambient noise can be generated by sound sources outside the room.

[0370] Automated Positive Airway Pressure (APAP) therapy: CPAP therapy in which the treatment pressure is automatically adjustable between a minimum and a maximum, for example, varying with each breath, depending on the presence of an indication of an SBD event.

[0371] Continuous positive airway pressure (CPAP) therapy: In this therapy, the treatment pressure can be approximately constant throughout the patient's respiratory cycle. In some forms, the pressure at the airway inlet will be slightly higher during expiration and slightly lower during inspiration. In other forms, the pressure will vary between different respiratory cycles, for example, increasing in response to an indication of partial upper airway obstruction and decreasing in the absence of such an indication.

[0372] Flow rate: The volume (or mass) of air delivered per unit time. Flow rate can refer to an instantaneous quantity. In some cases, the reference to flow rate will be a scalar quantity, i.e., a quantity that has only quantity. In other cases, the reference to flow rate will be a vector quantity, i.e., a quantity that has both quantity and direction. Flow rate can be given by the symbol Q. 'Flow rate' is sometimes simply abbreviated as 'flow' or 'airflow'.

[0373] In the context of patient breathing, flow rate can be nominally positive for the inspiratory portion of the patient's respiratory cycle and therefore negative for the expiratory portion. Total flow rate (Qt) is the airflow leaving the RPT device. Ventilation flow rate (Qv) is the airflow leaving the exhaust port to allow exhaled gas flushing. Leakage flow rate (Ql) is the leakage flow rate from the patient interface system. Respiratory flow rate (Qr) is the airflow received into the patient's respiratory system.

[0374] Humidifier: The term humidifier is considered to refer to a humidification device that is constructed and arranged or configured to have a physical structure capable of providing a therapeutically beneficial amount of water (H2O) vapor to an airflow to improve the patient’s medical respiratory condition.

[0375] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one instance, a leak can occur due to an incomplete seal between the mask and the patient's face. In another instance, a leak can occur in a bend in the conduit leading to the surrounding environment.

[0376] Noise, conducted (acoustic): In this article, conducted noise refers to noise delivered to the patient through a pneumatic path (such as the air circuit and the patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0377] Noise, radiated (acoustic): In this article, radiated noise refers to noise transmitted to the patient through the ambient air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object under discussion according to ISO 3744.

[0378] Noise, ventilation (acoustic): Ventilation noise in this article refers to the noise generated by the flow of air through any exhaust port (e.g., an exhaust port in a patient interface).

[0379] Patient: A person, whether or not they have a respiratory illness.

[0380] Pressure: Force per unit area. Pressure can be expressed in units, including cmH2O and gf / cm². 2 And hetopascal. 1 cmH2O equals 1 g-f / cm 2 The pressure is approximately 0.98 hectopascals. Unless otherwise stated, pressure is given in cmH2O throughout this specification.

[0381] The pressure in the patient interface is given by the symbol Pm, while the treatment pressure is given by the symbol Pt, which represents the target value obtained at the current moment through the mask pressure Pm.

[0382] Respiratory pressure therapy (RPT): Air is supplied to the airway at a therapeutic pressure, which is usually positive relative to atmospheric pressure.

[0383] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the breathing work.

[0384] 5.8.1.1 Materials

[0385] Silicone resin or silicone elastomer: synthetic rubber. In this specification, reference to silicone resin refers to liquid silicone rubber (LSR) or molding silicone rubber (CMSR). One commercially available form of LSR is SILASTIC (included in the range of products sold under this trademark), manufactured by Dow Corning. Another manufacturer of LSR is Wacker Chemie. Unless otherwise specified, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0386] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0387] 5.8.1.2 Mechanical properties

[0388] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during release.

[0389] 'Resilient': When decelerated, it releases virtually all of its energy. This includes some silicones and thermoplastic elastomers.

[0390] Hardness: The ability of a material to resist deformation (e.g., as described by Young's modulus, or an indentation hardness scale measured on a standard sample size).

[0391] • 'Soft' materials may include silicone or thermoplastic elastomers (TPEs) and may be easily deformed, for example, under finger pressure.

[0392] · 'Hard' materials can include polycarbonate, polypropylene, steel or aluminum, and can be, for example, not easily deformed under finger pressure.

[0393] 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 moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistances in different directions.

[0394] 'Soft' structures or components: Structures or components that will change shape, such as bending, when subjected to a relatively short period of time, such as 1 second, to support their own weight.

[0395] 'Rigid' structures or components: Structures or components that will not change shape substantially when subjected to the loads typically encountered during use. One example of this use is setting and maintaining a patient interface in a sealed relationship with the inlet of the patient's airway, for example, under a load of approximately 20 to 30 cmH2O.

[0396] As an example, an I-beam can exhibit different flexural stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component is flexible in the first direction and rigid in the second direction.

[0397] 5.8.2 Respiratory and Circulatory Systems

[0398] Breathing apnea: According to some definitions, breathing apnea is said to have occurred when airflow drops below a predetermined threshold for a sustained period (e.g., 10 seconds). Breathing apnea is also said to have occurred when, despite the patient's efforts, some obstruction of the airway prevents airflow. Central breathing apnea is said to have occurred when breathing apnea is detected due to reduced or absent breathing effort, even though the airway is open. Mixed breathing apnea occurs when reduced or absent breathing effort coincides with airway obstruction.

[0399] Respiratory rate: The patient’s spontaneous respiratory rate, usually measured in breaths per minute.

[0400] Duty cycle: The ratio of inspiratory time (Ti) to total respiratory time (Ttot).

[0401] Effort (breathing): The work done by a spontaneously breathing person in trying to breathe.

[0402] The expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0403] Flow limitation: Flow limitation is considered a state of breathing in which increased effort by the patient does not result in a corresponding increase in flow. Flow limitation occurring during the inspiratory portion of the respiratory cycle can be described as inspiratory flow limitation. Flow limitation occurring during the expiratory portion of the respiratory cycle can be described as expiratory flow limitation.

[0404] Inspiratory waveforms with flow rate type limitations:

[0405] (i) Flat: having an upward section followed by a relatively flat section, followed by a downward section.

[0406] (ii) M-shape: has two local peaks, one at the leading edge and one at the trailing edge, and a relatively flat portion between the two peaks.

[0407] (iii) Chair-shaped: has a single local peak at the leading edge, followed by a relatively flat portion.

[0408] (iv) Inverted chair shape: with a relatively flat portion followed by a single local peak at the trailing edge.

[0409] Insufficient breathing: By some definitions, insufficient breathing is considered a decrease in flow, but not a cessation of flow. In one form, insufficient breathing can be said to have occurred when the flow rate drops below a threshold for a sustained period of time. Central insufficient breathing is said to have occurred when insufficient breathing is detected due to reduced respiratory effort. In one form in adults, any of the following can be considered insufficient breathing:

[0410] (i) A 30% reduction in the patient's breathing lasts for at least 10 seconds, plus a corresponding 4% reduction in saturation; or

[0411] (ii) The patient’s breathing is reduced (but at least 50%) for at least 10 seconds, accompanied by a decrease in saturation of at least 3% or arousal.

[0412] Hyperventilation: The flow rate increases to a level higher than normal.

[0413] The inspiratory portion of the respiratory cycle: The time period from the start of inspiratory flow to the start of expiratory flow is considered the inspiratory portion of the respiratory cycle.

[0414] Airway openness: The degree to which the airway is open, or the extent to which the airway is open. An open airway is an open airway. Airway openness can be quantified, for example, by using a value of -1 for open and a value of zero (0) for closed (obstructed).

[0415] Positive end-expiratory pressure (PEEP): The pressure in the lungs above atmospheric pressure at the end of expiration.

[0416] Peak flow (Q peak): The maximum flow rate during the expiratory portion of the respiratory flow waveform.

[0417] Respiratory flow, patient air flow, and respiratory air flow (Qr): These terms can be understood as the RPT device's estimate of respiratory flow, as opposed to "true respiratory flow" or "real respiratory flow," which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0418] Tidal volume (Vt): The volume of air inhaled or exhaled during normal breathing without additional effort.

[0419] (Inspiratory) time (Ti): The duration of the inspiratory portion of the respiratory flow waveform.

[0420] (Exhalation) Time (Te): The duration of the expiratory portion of the respiratory flow waveform.

[0421] (Total) Time (Ttotal): The total duration between the start of the inspiratory portion of the respiratory flow waveform and the start of the subsequent inspiratory portion of the respiratory flow waveform.

[0422] Typical recent ventilation: Recent values ​​on some predetermined time scale tend to cluster around the ventilation values; that is, a measure of the central tendency of recent ventilation values.

[0423] Upper airway obstruction (UAO): This includes both partial and complete upper airway obstruction. This can be associated with a state of flow restriction, where the flow rate increases only slightly or even decreases with an increase in the pressure gradient across the upper airway (Starling resistance behavior).

[0424] Ventilation volume (Vent): A measurement of the flow rate of gases exchanged by a patient's respiratory system. A measurement of ventilation volume can include one or both of the inspiratory and expiratory flow rates per unit time. When expressed in volumes per minute (V / min), this quantity is often referred to as "minute ventilation volume." Minute ventilation volume is sometimes given only in volume form and is understood as volumes per minute.

[0425] 5.8.3 Ventilation

[0426] Adaptive Servo Ventilator (ASV): A servo ventilator with a variable target ventilation volume instead of a fixed target ventilation volume. The variable target ventilation volume can be determined from some characteristics of the patient, such as the patient's respiratory characteristics.

[0427] Standby frequency: The parameters that establish the minimum respiratory rate (typically measured in breaths per minute) that the ventilator will deliver to the patient if not caused by spontaneous breathing effort.

[0428] Cyclic: Termination of the inspiratory phase of a ventilator. When a ventilator delivers breaths to a patient who is breathing spontaneously, the ventilator is said to be cyclic at the end of the inspiratory portion of the respiratory cycle to stop delivering breaths.

[0429] Positive expiratory airway pressure (EPAP): Baseline pressure, to which the pressure that varies during breathing is added to produce the desired mask pressure that the ventilator will attempt to achieve at a given time.

[0430] End-expiratory pressure (EEP) is the desired mask pressure that a ventilator attempts to achieve at the end of the expiratory phase of breathing. If the pressure waveform template Π(Φ) is zero at end-expiratory, i.e., Π(Φ) = 0 when Φ = 1, then EEP equals EPAP.

[0431] Inspiratory positive airway pressure (IPAP): The maximum desired mask pressure that the ventilator will attempt to achieve during the inspiratory phase of breathing.

[0432] Pressure support: Indicates the pressure increase during inspiratory breathing that exceeds the pressure increase during expiratory breathing, and generally refers to the pressure difference between the maximum pressure during inspiration and the baseline pressure (e.g., PS = IPAP - EPAP). In some cases, pressure support refers to the difference planned for the ventilator, rather than the actual difference it achieves.

[0433] Servo ventilator: A ventilator that measures the patient’s ventilation volume, has a target ventilation volume, and adjusts the pressure support level to bring the patient’s ventilation volume toward the target ventilation volume.

[0434] Spontaneous / Timed (S / T): A mode of ventilator or other device that attempts to detect spontaneous breathing in a patient. However, if the device fails to detect breathing within a predetermined time period, it will automatically initiate the delivery of breaths.

[0435] Swing difference: an equivalent term for pressure support.

[0436] Triggered: When a ventilator delivers air to a patient who is breathing spontaneously, it is said to be triggered at the beginning of the respiratory phase of the respiratory cycle by the patient's effort.

[0437] Typical recent ventilation: Typical recent ventilation (Vtyp) is a value around which recent measurements of ventilation on a predetermined time scale tend to cluster. For example, a measurement of the central tendency of recent historical ventilation measurements can be a suitable value for typical recent ventilation.

[0438] 5.8.4 Anatomy

[0439] 5.8.4.1 Facial Anatomy

[0440] Alar: The outer wall or "wing" of each nostril (plural: alar).

[0441] Nasal alar angle:

[0442] Alar tip: the outermost point on the ala of the nose.

[0443] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0444] Auricle: The entire visible external part of the ear.

[0445] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0446] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0447] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0448] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (the two lines intersect at the lower point of the nasal septum).

[0449] Frankfurt plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0450] The glabella: Located on the soft tissue, it is the most prominent point in the sagittal plane of the center of the forehead.

[0451] External nasal cartilage: generally a triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0452] Lip, lower lip (midpoint of the lower lip):

[0453] Lip, upper lip (midpoint of the upper lip):

[0454] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0455] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril is nostril (or nasal eye). Nostrils are separated by the nasal septum.

[0456] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0457] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0458] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0459] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0460] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0461] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0462] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0463] The nasal ridge (nose): The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0464] Central sagittal plane: A vertical plane that runs from the front (anterior) to the back (posterior) and divides the body into the right and left halves.

[0465] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0466] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and divides into the anterior part of the nasal cavity.

[0467] Posterosuperior lateral segment: The point at the lower edge of the base of the nasal ala, where the base of the nasal ala connects with the skin of the upper (superior) lip.

[0468] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the central sagittal plane.

[0469] Mandibular alveolar seat: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior mental point.

[0470] 5.8.4.2 Anatomical Structure of the Skull

[0471] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0472] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0473] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla extends upward from the side of the nose and forms part of the lateral boundary.

[0474] Nasal bones: The nasal bones are two oval-shaped bones whose size and shape vary among individuals; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0475] Nasal root: the intersection of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0476] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0477] The eye socket is the bony cavity in the skull that houses the eyeball.

[0478] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0479] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0480] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protruding parts of the cheeks.

[0481] 5.8.4.3 Anatomical Structure of the Respiratory System

[0482] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0483] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0484] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0485] Nasal cavity: The nasal cavity (or nasal socket) is a large, air-filled space located above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called nasal conchae (singular: "nasal conchae"). The front of the nasal cavity is the nasal part, while the back connects to the nasopharynx via the internal nasal openings.

[0486] Pharynx: The pharynx located below the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (hyperpharynx) (the nasal part of the pharynx), the oropharynx (middle pharynx) (the oral part of the larynx), and the laryngopharynx (hypopharynx).

[0487] 5.8.5 Patient Interface

[0488] Anti-asphyxiation valve (AAV): A component or sub-component of a mask system that reduces the risk of excessive CO2 rebreathing by opening to the atmosphere in a fail-safe manner.

[0489] Bend: A bend is an example of a structure in which the axis guiding airflow changes direction by an angle. In one form, this angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The bend can have an approximately circular cross-section. In another form, the bend can have an elliptical or rectangular cross-section. In some forms, the bend can rotate relative to the mating assembly, for example, about 360 degrees. In some forms, the bend can be detachable from the mating assembly, for example, by a snap-fit ​​connection. In some forms, the bend can be assembled to the mating assembly during manufacturing using a one-time snap-fit, but cannot be removed by the patient.

[0490] Frame: The frame is generally considered to refer to a mask structure that bears tensile loads between two or more connection points with head straps. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0491] Functional dead space: (Explanation to be inserted here)

[0492] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, straps, and reinforcing bars configured to position and hold the patient interface on the patient's face for delivery of respiratory therapy. Some straps are formed from soft, flexible, and resilient materials, such as laminated composites of foam and fabric.

[0493] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0494] Inflation chamber: The mask inflation chamber is considered to be part of a patient interface having walls that surround a volume of space, which, when in use, contains air pressurized to above atmospheric pressure. A housing may form part of the walls of the mask inflation chamber.

[0495] Seal: can be the noun form indicating structure ("seal") or the verb form indicating function ("to seal"). Two elements can be constructed and / or arranged to seal between them or to achieve a "seal" between them without the need for a separate "seal" element itself.

[0496] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0497] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0498] Support: A support is considered to be a structural component designed to increase the compressibility of another component in at least one direction.

[0499] Rotary shaft: (noun) a sub-assembly of an assembly configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the rotary shaft may be configured to rotate through an angle of at least 360 degrees. In another form, the rotary shaft may be configured to rotate through an angle of less than 360 degrees. When used in the case of air delivery ducts, the sub-assembly of the assembly preferably comprises a pair of mating cylindrical ducts. During use, there may be little or no airflow leakage from the rotary shaft.

[0500] Lacing (noun): A structure designed to resist tension.

[0501] Exhaust port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to allow for effective flushing of exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0502] 5.8.6 Shape of the structure

[0503] Products according to this technology may include one or more three-dimensional mechanical structures, such as face mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another example, a structure may include a first surface and a second surface.

[0504] To aid in describing the shape of three-dimensional structures and surfaces, we first consider a cross-section through a point p on the surface of the structure. See [link to documentation]. Figures 3B to 3F They show an example of a cross-section at point p on the surface and the resulting planar profile. Figures 3B to 3F The outward normal vector at point p is also shown. The outward normal vector at point p is away from the surface. In some instances, the surface is described from the viewpoint of an imaginary little person standing upright on the surface.

[0505] 5.8.6.1 Curvature in one dimension

[0506] The curvature of a plane curve at p can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at p).

[0507] Positive curvature: If the curve at point p turns outward toward the normal, then the curvature at that point will be positive (if the figures in the image were to leave point p, they would have to walk uphill). See also Figure 3B (and Figure 3C Compared to relatively large positive curvature) and Figure 3C (and Figure 3B (Compared to relatively small positive curvature). Such curves are often referred to as concave surfaces.

[0508] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if you imagine a little person leaving point p, they can walk horizontally without going up or down). See also Figure 3D .

[0509] Negative curvature: If the curve at point p deviates from the outward normal, then the curvature in that direction at that point will be negative (if you imagine little figures leaving point p, they must go downhill). See also Figure 3E (and Figure 3F Compared to relatively small negative curvature) and Figure 3F (and Figure 3E (Compared to relatively large negative curvature). Such curves are often referred to as convex surfaces.

[0510] 5.8.6.2 Curvature of Two-Dimensional Surfaces

[0511] A description of the shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. These cross sections may cut through the surface in a plane including an outward normal (“normal plane”), and each cross section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity. Figures 3B to 3F A planar curve in a plane can be an instance of multiple cross-sections at a specific point.

[0512] Principal curvature and principal direction: The direction of the normal plane to which the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction. Figures 3B to 3F In the example, the maximum curvature occurs Figure 3B In the middle, and the minimum value appears Figure 3F ,therefore Figure 3B and Figure 3F It is the cross-section in the principal direction. The principal curvature at point p is the curvature in the principal direction.

[0513] A region of a surface: a set of points connected on the surface. The points in a region may have similar characteristics, such as curvature or sign.

[0514] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0515] Dome region: A region in which the principal curvature has the same sign at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0516] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0517] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0518] Edge of a surface: the boundary or limit of a surface or region.

[0519] Path: In some forms of this technique, 'path' will mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or process, including, for example, a set of points on a surface. (Imagined individual paths are those in which they travel on a surface and resemble garden paths).

[0520] Path length: In some forms of this technique, 'path length' will mean the distance along the surface from f(0) to f(1), i.e., the distance along a path on the surface. There can be more than one path between two points on the surface and such paths can have different path lengths. (The path length of an imagined individual would be the distance they walk along the path on the surface).

[0521] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. In a planar region, a path with the same length as the straight-line distance between two points on the surface can exist on the surface. In a non-planar surface, a path with the same length as the straight-line distance between two points may not exist. (For an imagined individual, straight-line distance will correspond to the distance as a 'straight line'.)

[0522] 5.8.6.3 Space Curves

[0523] Space curves: Unlike planar curves, space curves do not necessarily lie in any particular plane. Space curves can be closed, meaning they have no endpoints. A space curve can be thought of as a one-dimensional sheet of three-dimensional space. Imagine an imaginary individual walking along a space curve on a DNA helix. The typical human left ear includes a helix, i.e., the left-hand helix, see [link to related diagram]. Figure 3Q A typical human right ear includes a spiral, specifically a right-side spiral, see [link / reference]. Figure 3R . Figure 3S The right-hand spiral is shown. The edges of structures, such as membranes or thrusters, can follow space curves. Generally, space curves can be described by the curvature and torsion at each point on the space curve. Torsion is a measure of how the curve detaches from the surface. Torsion has a sign and a quantity. The torsion at a point on a space curve can be characterized by reference to the tangent, normal, and binormal vector at that point.

[0524] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point indicates both the direction and the amount of travel from that point. The tangent unit vector is a unit vector pointing in the same direction as the curve at that point. If you imagine an individual flying along the curve and stopping at a specific point, the direction of the tangent vector is the direction it would have traveled.

[0525] Unit normal vector: As an imagined individual moves along the curve, this tangent vector itself changes. The unit vector pointing in the same direction in which the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0526] 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 Alternatively, it can be done via the left-hand rule. Figure 3O To determine.

[0527] Oscillating plane: A plane containing both a unit tangent vector and a unit principal normal vector. See also Figure 3O and Figure 3P .

[0528] Twist of a space curve: Twist at a point on a space curve is the rate of change of the binormal vector at that point. It measures the degree to which the curve deviates from its osculating plane. A space curve lying on a plane has zero twist. A space curve deviating slightly from its osculating plane will have a relatively small amount of twist (e.g., a slightly inclined spiral path). A space curve deviating significantly from its osculating plane will have a relatively large amount of twist (e.g., a sharply inclined spiral path). Reference Figure 3S Although T2 > T1, in Figure 3S The number of twists near the top helical coil is greater than Figure 3S The number of twists in the bottom spiral coil.

[0529] refer to Figure 3P According to the right-hand rule, a space curve turning in the direction of the right-hand binormal can be considered to have a right-hand positive twist (e.g., as...). Figure 3S (As shown in the right-handed spiral). A space curve deviating from the direction of the right-handed binormal can be considered to have right-handed negative twist (e.g., a left-handed spiral).

[0530] Similarly, and referring to the left-hand rule (see...) Figure 3O A space curve that turns in the direction of the left-hand secondary normal can be considered to have a positive left-hand twist (e.g., a left-hand spiral). Therefore, a positive left-hand twist is equivalent to a negative right-hand twist. See also Figure 3T .

[0531] 5.8.6.4 holes

[0532] Surfaces can have one-dimensional pores, such as pores defined by planar curves or spatial curves. Thin structures with pores (e.g., films) can be described as having one-dimensional pores. See, for example, [link to relevant documentation]. Figure 3I The one-dimensional hole in the structural surface shown is defined by a planar curve.

[0533] The structure can have two-dimensional pores, such as pores defined by a surface. For example, an inflatable tire has two-dimensional pores defined by the inner surface of the tire. In another example, a capsule having a cavity for air or gel has two-dimensional pores. See example Figure 3L padding and Figure 3M and Figure 3N An exemplary cross-section passing through it is shown, illustrating the inner surface defining the two-dimensional orifice. In another example, the conduit may include a one-dimensional orifice (e.g., at its inlet or outlet) and a two-dimensional orifice defined by the conduit's inner surface. See also via Figure 3K The two-dimensional hole of the structure shown is defined by the surface shown.

[0534] 5.9 Other Notes

[0535] This patent document contains a portion of copyrighted material. Because it appears in the patent office's patent documents or records, the copyright holder does not object to any person making a copy of this patent document or the patent disclosure, but otherwise retains all copyright rights.

[0536] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within the scope of this invention. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this invention, but are subject to any explicitly excluded boundaries within the range. When the range includes one or both of these boundaries, the range excluding one or both of those included boundaries is also included within the scope of this invention.

[0537] Furthermore, in cases where one or more values ​​described in the present invention are implemented as part of the present invention, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used to the extent permitted or required by the practical implementation of the technology for any suitable valid number of digits.

[0538] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While any methods and materials similar to or equivalent to those described herein may be used in the practice or testing of the techniques of this invention, a limited number of exemplary methods and materials are described herein.

[0539] When a particular material is deemed preferably used for constructing a component, an obvious alternative material with similar properties is used as its substitute. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0540] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a” and “the” as used herein and in the appended claims include their plural equivalents.

[0541] All publications mentioned herein are incorporated by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein provide only disclosures prior to the filing date of this application. None of this document should be construed as an admission by prior invention that the present invention was not entitled to pre-existing technology in such publications. Furthermore, the publication dates provided may differ from the actual publication dates, and independent verification may be required.

[0542] The terms “comprising” and “including” should be interpreted as meaning that an element, component or step referenced in a non-exclusive manner may be presented, used or combined with other elements, components or steps not explicitly referenced.

[0543] The main headings used in the detailed description are included for the reader's convenience only and should not be used to limit the subject matter of the invention as found throughout the disclosure or claims. These headings should not be used to interpret the scope or limitation of the claims.

[0544] Although the invention has been described with reference to specific embodiments, it should be understood that these examples are merely illustrative of the principles and applications of the invention. In some instances, proper nouns, terms, and symbols may imply specific details not required for practicing the invention. For example, although the terms "first" and "second" may be used, they are not intended to indicate any order unless otherwise specified, but rather to distinguish different elements. Furthermore, although the process steps in a method may be described or illustrated in a certain order, this order is not necessary. Those skilled in the art will recognize that this order can be modified, and / or aspects of the order can be performed simultaneously or even concurrently.

[0545] Therefore, it should be understood that various modifications can be made to the exemplary instances and other arrangements can be designed without departing from the spirit and scope of the present invention.

[0546] 5.10 List of Reference Symbols

[0547]

[0548]

[0549]

Claims

1. A sealing structure for a patient interface, the sealing structure being configured and arranged to form a seal with a patient facial region surrounding a patient airway inlet, the sealing structure being configured and arranged to maintain a therapeutic pressure in an inflatable chamber at least 6 cmH2O higher than ambient air pressure throughout the patient's respiratory cycle during use, the inflatable chamber having an inflatable chamber inlet port configured to receive an airflow pressurized at the therapeutic pressure, the sealing structure comprising: An outer surface, the outer surface including a patient contact surface configured to engage the patient’s facial skin to form a seal; The inner surface is opposite to the outer surface; A rear opening is formed in the patient contact surface, the rear opening being configured to provide the airflow under the treatment pressure to the patient's nostrils; A front opening, wherein the front opening is formed such that a non-patient contact area on the outer surface is opposite to the rear opening; Front band, the front band spanning the front opening; and A support structure extending from the edge of the rear opening to the front band, such that the inner surface of the support structure and the inner surface of the sealing structure form a continuous ring. The patient interface is configured to allow the patient to breathe from the environment through their mouth without a pressurized airflow through the inlet port of the inflation chamber, or the patient interface is configured not to cover the patient's mouth. The upper part of the sealing structure is configured to engage the area below the patient's nose to the patient's nasal bone.

2. The sealing structure as described in claim 1, wherein, The first end of the support structure is connected to the front band.

3. The sealing structure as described in claim 1, wherein, The length of the support structure in its undeformed state is greater than the linear distance from the first position to which the support structure is connected on the patient contact surface to the second position to which the support structure is connected on the inner surface of the sealing structure.

4. The sealing structure as described in claim 1, wherein, The support structure is configured to be positioned adjacent to or in contact with the patient's columella during use.

5. The sealing structure as described in claim 1, wherein, The support structure bends in the longitudinal direction without deformation.

6. The sealing structure as described in claim 1, wherein, The support structure has a different thickness than the patient's contact surface.

7. The sealing structure as described in claim 1, wherein, The support structure is thicker than the patient contact surface.

8. The sealing structure as described in claim 1, wherein, The support structure does not extend completely through the rear opening.

9. The sealing structure as described in claim 1, wherein, The sealing structure at least partially forms an air chamber, and In its undeformed state, the support structure extends into the air chamber.

10. The sealing structure as claimed in claim 1, wherein, The support structure has a variable thickness in the longitudinal direction.

11. The sealing structure as claimed in claim 3, wherein, The support structure has increased thickness near the first and / or second positions.

12. The sealing structure as claimed in claim 1, wherein, A portion of the support structure curves away from the patient's nose along the longitudinal axis of the support structure in an undeformed state.

13. The sealing structure of claim 1, further comprising a base liner supporting the patient contact surface.

14. The sealing structure as described in claim 13, wherein, The lower part of the sealing structure includes the bottom liner, and the upper part of the sealing structure does not include the bottom liner.

15. The sealing structure as described in claim 14, wherein, The underlay is configured to support only the patient contact surface on the patient's upper lip.

16. The sealing structure as claimed in claim 1, wherein, The upper part of the sealing structure is configured to engage the area below the patient's nose to the patient's nasal protuberance.

17. The sealing structure as claimed in claim 1, wherein, The lower part of the sealing structure is configured to engage the patient's upper lip such that the sealing structure does not extend beyond the vermilion border of the patient's upper lip.

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