Patient interface including seal-forming structures having different thicknesses

Abstract

A bumper assembly for a patient interface, comprising a resilient seal-forming portion, the resilient seal-forming portion comprising: a domed upper region (3180A); a saddle-shaped lower region (3180G); a first support region (3180E) having a constant wall thickness, preferably 2 mm, greater than the wall thickness of the dome-shaped upper region and the saddle-shaped lower region, preferably 0.3 mm; a second support region (3180D) having a varying wall thickness and defined proximally by the first support region (3180E) and having a distal side opposite the proximal side. In claim 1, the wall thickness in the second support region (3180D) increases from the distal side to the proximal side, preferably from 2 mm to 1.3 mm. Preferably, the third support region (3180F) has a wall thickness of 1.3 mm, the compliant region (3180C) has a thickness of 0.85 mm, and the sheet-like portion (3180H) has a thickness of 0.5 mm. Preferably, the flaps (3180H) move independently of the lacing (3110).

Description

[0001] This application is a divisional application of the patent application with application number 2020111322447, application date September 23, 2016, and invention name “PATIENT INTERFACE COMPRISING A SEAL-FORMING STRUCTURE WITH DIFFERENT THICKNESSES”, and the patent application with application number 2020111322447 is a divisional application of the patent application with application number 201680056156.9, application date September 23, 2016, and invention name “PATIENT INTERFACE COMPRISING A SEAL-FORMING STRUCTURE WITH DIFFERENT THICKNESSES”, and the patent application with application number 201680056156.9 is an application entering the Chinese national phase of the PCT international application with application number PCT / AU2016 / 050896. 1 Technical Background

[0002] This application claims priority to U.S. Application No. 62 / 377,217, filed on August 19, 2016, the entire contents of which are incorporated herein by reference in their entirety. 1.1 Technical Field

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

[0004] 1.2 Description of related technologies

[0005] 1.2.1 Human respiratory system and its disorders

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

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

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

[0009] 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 disorders.

[0010] Obstructive sleep apnea (OSA) is a form of sleep disordered breathing (SDB) characterized by events including occlusion or obstruction of the upper airway during sleep. It results from a combination of an abnormally small upper airway and normal loss of muscle tone in the area of ​​the tongue, soft palate, and posterior oropharyngeal wall during sleep. The symptom causes affected patients to stop breathing, usually for a period of 30 to 120 seconds, sometimes 200 to 300 times per night. This often leads to excessive daytime sleepiness and can lead to cardiovascular disease and brain damage. Complications are common disorders, especially in middle-aged overweight men, but those affected may not be aware of the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0011] Cheyne-Stokes respiration (CSR) is another form of sleep-disordered breathing. CSR is a disorder of the patient's respiratory controller in which there are rhythmic alternating cycles of rise and fall ventilation called CSR cycles. CSR is characterized by causing repeated hypoxia and reoxygenation of arterial blood. CSR can be harmful due to repeated hypoxia. In some patients, CSR is associated with repeated micro-awakenings from sleep, which leads to severe sleep disruption, increased sympathetic activity, and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0012] Respiratory failure is an umbrella term for breathing disorders in which the lungs cannot take in enough oxygen or exhale enough CO2 to meet the patient's needs. Respiratory failure may include some or all of the following disorders.

[0013] Patients with respiratory insufficiency, a form of respiratory failure, may experience abnormal shortness of breath during exercise.

[0014] Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia during wakefulness in the absence of other known causes of hypoventilation. Symptoms include dyspnea, morning headache, and excessive daytime sleepiness.

[0015] Chronic obstructive pulmonary disease (COPD) includes any of a group of lower airway diseases that have certain common features. These diseases include increased resistance to air flow, prolonged expiratory phase of breathing, and loss of normal elasticity of the lungs. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: difficulty breathing during exercise, chronic cough, and sputum production.

[0016] Neuromuscular disease (NMD) is a broad term that covers many diseases and disorders that damage muscle function directly through intrinsic muscle pathology or indirectly through neuropathology. Some NMD patients are characterized by progressive muscle damage, which leads to loss of mobility, the need for wheelchairs, dysphagia, respiratory muscle weakness, and ultimately death from respiratory failure. Neuromuscular disorders can be divided into rapidly progressive and slowly progressive: (i) rapidly progressive disorders: characterized by muscle damage over 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 over several years and only slightly shortening life expectancy (e.g., limb-girdle muscular dystrophy, facioscapulohumeral muscular dystrophy and myotonic dystrophy). Symptoms of respiratory failure in NMD include increasing general weakness, difficulty swallowing, dyspnea during exertion and at rest, fatigue, lethargy, morning headaches, and difficulty concentrating and mood changes.

[0017] Chest wall disorders are a group of thoracic deformities that result in inefficient connections between the respiratory muscles and the thorax. The disorder is usually characterized by a restrictive defect and carries the potential for long-term hypercapnic respiratory failure. Scoliosis and / or kyphoscoliosis can cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exertion, peripheral edema, orthopnea, recurrent chest infections, morning headaches, fatigue, poor sleep quality, and loss of appetite.

[0018] A range of treatments have been used to treat or alleviate such conditions. In addition, these treatments can be used to prevent breathing disorders in otherwise healthy individuals. However, these treatments have a number of disadvantages.

[0019] 1.2.2 Treatment

[0020] Various therapies such as continuous positive airway pressure (CPAP) therapy, non-invasive ventilation (NIV), and invasive ventilation (IV) have been used to treat one or more of the above breathing disorders.

[0021] Continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The mechanism of action is that continuous positive airway pressure ventilation acts as a pneumatic splint and can prevent upper airway occlusion by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall. Treatment of OSA by CPAP therapy can be voluntary, so if the patient finds any one or more of the devices used to provide such treatment: uncomfortable, difficult to use, expensive, and unsightly, the patient may choose not to comply with the treatment.

[0022] Non-invasive ventilation (NIV) provides ventilation support to the patient through the upper airway to help the patient breathe and / or maintain appropriate oxygen levels in the body by completing some or all of the work of breathing. Ventilatory support is provided via a non-invasive patient interface. NIV has been used to treat CSR and respiratory failure in the form of OHS, COPD, NMD, and chest wall disorders. In some forms, the comfort and effectiveness of these treatments can be improved.

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

[0024] 1.2.3 Treatment system

[0025] These treatments can be provided by a treatment system or device.Such systems and devices can also be used to diagnose a condition without treating the condition.

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

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

[0028] 1.2.3.1 Patient interface

[0029] The patient interface can be used to engage the respiratory apparatus to its wearer, for example by providing an air flow to the entrance of the airway. The air flow can be provided to the patient's nose and / or mouth via a mask, to the mouth via a tube, or to the patient's trachea via a tracheostomy tube. Depending on the treatment to be applied, the patient interface can form a seal with an area such as the patient's face, thereby causing gas to be delivered at a pressure that is sufficiently different from the ambient pressure (e.g., a positive pressure of approximately 10 cmH2O relative to the ambient pressure) to achieve the treatment. For other forms of treatment, such as oxygen delivery, the patient interface may not include a seal sufficient to deliver gas at a positive pressure of approximately 10 cmH2O to the airway.

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

[0031] Certain masks may be clinically disadvantageous for the present technology, for example in that they block airflow through the nose and only allow it through the mouth.

[0032] Certain masks may be uncomfortable or impractical for the present technology if they require the patient to insert a portion of the mask structure into their mouth to form and maintain a seal with their lips.

[0033] Certain masks may not be feasible for use while sleeping, such as when sleeping on one's side in bed with the head on a pillow.

[0034] The design of a 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 is composed of bone, cartilage, and soft tissue, different areas of the face respond differently to mechanical forces. The jaw or mandible can move relative to other bones of the skull. The entire head can move during a respiratory therapy session.

[0035] Due to these challenges, some masks face one or more of the following problems: obtrusive, unaesthetic, expensive, disproportionate, difficult to use, and uncomfortable, especially when worn for long periods of time or when the patient is not familiar with the system. The wrong size mask causes reduced compliance, reduced comfort, and poor patient outcomes. Masks designed only for pilots, masks designed to be part of personal protective equipment (e.g., filtering masks), SCUBA masks, or masks designed to apply anesthetics are acceptable for their original purpose, but for long periods of time (e.g., several hours), such masks are not as comfortable as ideal. This discomfort may lead to reduced patient compliance with treatment. This is even more true if the mask is worn during sleep.

[0036] CPAP therapy is very effective in treating certain breathing disorders, assuming the patient complies with the therapy. If the mask is uncomfortable or difficult to use, the patient may not comply with the therapy. Since patients are generally advised to clean their masks regularly, if the mask is difficult to clean (e.g., difficult to assemble or disassemble), the patient may not clean their mask, which may affect patient compliance.

[0037] While masks used in other applications (eg, pilots) may not be suitable for treating sleep disordered breathing, masks designed for treating sleep disordered breathing may be suitable for other applications.

[0038] For these reasons, a diverse field of patient interfaces for delivering CPAP during sleep has emerged.

[0039] 1.2.3.1.1 Seal forming part

[0040] The patient interface may include a seal-forming portion. Since it is in direct contact with the patient's face, the shape and configuration of the seal-forming portion may directly affect the effectiveness and comfort of the patient interface.

[0041] The patient interface is characterized in part according to the design intent of the seal-forming portion to engage with the face during use. In one form of patient interface, the seal-forming portion may include a first sub-portion that forms a seal around the left nostril and a second sub-portion that forms a seal around the right nostril. In one form of patient interface, the seal-forming portion may include a single element that surrounds both nostrils during use. Such a single element may be designed to, for example, cover the upper lip area and the bridge of the nose area of ​​the face. In one form of patient interface, the seal-forming portion may include an element that surrounds the mouth area during use, for example, by forming a seal on the lower lip area of ​​the face. In one form of patient interface, the seal-forming portion may include a single element that surrounds both nostrils and the mouth area 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.

[0042] A seal-forming portion that is effective in one area of ​​a patient's face may not be suitable in another area, for example, because of different shapes, structures, variations, and sensitive areas of a patient's face. For example, a seal on swimming goggles that covers a patient's forehead may not be suitable for use on a patient's nose.

[0043] Certain seal forming portions may be designed for mass manufacturing so that one design is suitable, comfortable and effective for a wide range of different face shapes and sizes. To the extent there is a mismatch between the shape of the patient's face and the seal forming portion of a mass manufactured patient interface, one or both must adapt to form a seal.

[0044] One type of seal forming portion extends around the periphery of the patient interface and is used to seal against the patient's face when a force is applied to the patient interface while the seal forming portion is in facing engagement with the patient's face. The seal forming portion may include an air or fluid filled buffer, or a molded or formed surface of a resilient sealing element made of an elastomer (e.g., rubber). With this type of seal forming portion, if the fit is inadequate, there will be a gap between the seal forming portion and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0045] Another type of seal forming portion includes a sheet 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 forms of seal forming portions, if the fit between the face and the mask is not good, additional force may be required to achieve a seal, or the mask may leak. In addition, if the shape of the seal forming portion does not match the shape of the patient, it may wrinkle or bend during use, causing leaks.

[0046] Another type of seal-forming portion may include friction fit elements, for example for insertion into a nostril, however some patients find these uncomfortable.

[0047] Another form of seal forming portion can use adhesive to achieve the seal. Some patients may find it inconvenient to constantly apply and remove adhesive to their face.

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

[0049] One form of nasal pillow is found in the Adam Circuit manufactured by Puritan Bennett. Another nasal pillow or nasal spray is the subject of U.S. Patent 4,782,832 (Trimble et al.) assigned to Puritan-Bennett Company.

[0050] ResMed Limited has manufactured the following products including nasal pillows: SWIFT TM Nasal pillow mask, SWIFT TM II nasal pillow mask, SWIFT TM LT nasal pillow mask, SWIFT TM FX Nasal Pillows Mask and SWIFT TMLIBERTY™ full face mask. The following patent applications assigned to ResMed Ltd. describe examples of nasal pillow masks: International Patent Application WO 2004 / 073,778 (which describes the SWIFT TM Other aspects of nasal pillows), U.S. Patent Application 2009 / 0044808 (which describes ResMed Inc. SWIFT TM LT nasal pillows); International Patent Applications WO 2005 / 063,328 and WO 2006 / 130,903 (which describe the MIRAGE LIBERTY TM Other aspects of full face mask); International patent application WO2009 / 052,560 (which describes ResMed Ltd. SWIFT TM Other aspects of the FX nasal pillows).

[0051] 1.2.3.1.2 Positioning and stabilization

[0052] The seal forming part of the patient interface for positive air pressure therapy is subjected to the corresponding force of air pressure to break the seal. Therefore, various techniques have been used to position the seal forming part and keep it in a sealing relationship with the appropriate part of the face.

[0053] One technique is to use an adhesive. See, for example, US Patent Application Publication No. US2010 / 0000534. However, the use of an adhesive may be uncomfortable for some people.

[0054] Another technique is to use one or more straps and / or stabilizing harnesses.Many of these harnesses suffer from one or more of being ill-fitting, bulky, uncomfortable, and difficult to use.

[0055] 1.2.3.2 Respiratory Pressure Therapy (RPT) Devices

[0056] Respiratory pressure therapy (RPT) devices can be used to deliver one or more of many of the above-mentioned therapies, such as by generating an air flow for delivery to the airway entrance. The air flow can be pressurized. Examples of RPT devices include CPAP devices and ventilators.

[0057] 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 reliability, size and weight requirements for medical devices. Furthermore, even devices designed for medical use may have disadvantages with respect to one or more of the following: comfort, noise, ease of use, efficacy, size, weight, manufacturability, cost and reliability.

[0058] An example of a special requirement for some RPT devices is noise.

[0059] Table of noise output levels of existing RPT devices (a sample only, measured at 10 cmH2O in CPAP mode using the test method specified in ISO 3744).

[0060] RPT device name A-weighted sound pressure level dB(A) Year(approx.) <![CDATA[C Series Tango TM > 31.9 2007 <![CDATA[C Series Tango with Humidifier TM > 33.1 2007 <![CDATA[S8 Escape TM II]]> 30.5 2005 <![CDATA[Equipped with H4i TM S8 Escape with humidifier TM > 31.1 2005 <![CDATA[S9 AutoSet TM ]]> 26.5 2010 <![CDATA[S9 AutoSet with H5i Humidifier TM > 28.6 2010

[0061] One known RPT device for treating sleep-disordered breathing is the S9 Sleep Therapy System manufactured by ResMed Inc. Another example of an RPT device is a ventilator. TM The range of adult and pediatric ventilators can provide support for invasive and non-invasive independent ventilation for a range of patients, for the treatment of a variety of conditions such as, but not limited to, NMD, OHS and COPD.

[0062] ResMed Elisée TM 150 ventilator and ResMed VS III TM Respirators can provide support for invasive and non-invasive dependent ventilation suitable for adult or pediatric patients for the treatment of a variety of conditions. These ventilators provide volume and air pressure ventilation modes with single 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 air flow to the patient's airway. In some cases, air flow can be supplied to the patient's airway under positive pressure. The outlet of the RPT device is connected to a patient interface such as the above via an air circuit.

[0063] The designer of the device may be provided with an infinite number of choices that can be made. Design criteria often conflict, which means that some design choices are far from conventional or unavoidable. In addition, some aspects of comfort and efficacy may be highly sensitive to small and subtle changes in one or more parameters.

[0064] 1.2.3.3 Humidifier

[0065] Delivering an air stream without humidification may result in airway drying. Using a humidifier with an RPT device and a patient interface produces humidified gas that minimizes drying of the nasal mucosa and increases patient airway comfort. Additionally, in colder climates, warm air typically applied to the facial area in and around the patient interface is more comfortable than cool air.

[0066] A range of artificial humidification devices and systems are known, however they may not meet the specific requirements of a medical humidifier.

[0067] Medical humidifiers are used to increase the humidity and / or temperature of an air stream relative to ambient air when needed, typically where a patient may be asleep or resting (e.g., in a hospital). Medical humidifiers for bedside placement can be very small. A medical humidifier can be configured to humidify and / or heat only the air stream delivered to the patient, without humidifying and / or heating the patient's surroundings. Room-based systems (e.g., saunas, air conditioners, or evaporative coolers), for example, can also humidify the air that the patient breathes, however these systems also humidify and / or heat the entire room, which can cause discomfort to the occupants. In addition, medical humidifiers may have more stringent safety restrictions than industrial humidifiers.

[0068] Although many medical humidifiers are known, they may have one or more disadvantages. Some medical humidifiers may provide inadequate humidification, and some may be difficult or inconvenient to use by patients.

[0069] 1.2.3.4 Data Management

[0070] There may be many clinical reasons to obtain data to determine whether a patient being prescribed a respiratory therapy is "compliant," such as if the patient has used their RPT device in accordance with certain "compliance rules." One example of a compliance rule for CPAP therapy is a requirement that the patient use the RPT device for at least four hours each night for at least 21 or 30 consecutive days in order to achieve patient compliance. To determine the patient's compliance, a provider of the RPT device, such as a healthcare provider, may manually obtain data describing the use of the RPT device for the patient's treatment, calculate usage over a predetermined time period and compare to the compliance rules. Once the healthcare provider has determined that the patient has used their RPT device in accordance with the compliance rules, the healthcare provider may inform the patient of the third part of compliance.

[0071] There are other aspects of patient treatment that may benefit from communication of treatment data to a third party or external system.

[0072] Existing methods of communicating and managing such data can be one or more of the following: expensive, time consuming, and error prone.

[0073] 1.2.3.5 Mandibular reduction

[0074] A mandibular repositioning device (MRD) or mandibular advancement device (MAD) is one of the treatment options for sleep apnea and snoring. It is an adjustable oral appliance available from a dentist or other supplier that holds the mandible (lower jaw) in a forward position during sleep. An MRD is a removable device that the patient inserts into their mouth before going to sleep and removes after sleep. Therefore, an MRD is not designed to be worn all the time. MRDs can be custom made or produced in a standard form and include a bite impression portion designed to allow fitting to the patient's teeth. This mechanical protrusion of the mandible expands the space behind the tongue, exerts tension on the pharyngeal walls to reduce collapse of the airway and reduce vibrations of the palate.

[0075] In some examples, the mandibular advancement device may include an upper splint intended to engage or cooperate with teeth on the upper jaw or maxilla and a lower splint intended to engage or cooperate with teeth on the upper jaw or mandible. The upper splint and the lower splint are laterally connected together by a pair of connecting rods. The pair of connecting rods are symmetrically fixed to the upper splint and the lower splint.

[0076] In this design, the length of the connecting rod is selected so that when the MRD is placed in the patient's mouth, the mandible remains in an anteriorly displaced position. The length of the connecting rod can be adjusted to change the degree of protrusion of the mandible. The dentist can determine the degree of protrusion of the mandible, which will determine the length of the connecting rod.

[0077] Some MRDs are constructed to push the mandible forward relative to the maxilla, while other MADs (e.g., ResMed Narval CC TM The MRD) is designed to hold the mandible in a forward position. The device also reduces or minimizes dental and temporomandibular joint (TMJ) side effects. Therefore, it is configured to minimize or prevent any movement of one or more teeth.

[0078] 1.2.3.6 Ventilation port technology

[0079] Some forms of patient interface systems may include a vent to allow flushing of exhaled carbon dioxide. The vent may allow gas to flow from an interior space (eg, a plenum) of the patient interface to a space outside the patient interface, such as to the environment.

[0080] The ventilation port may include an orifice through which gas may flow when the mask is used. Many such ventilation ports are noisy. Others may become blocked during use, thereby providing insufficient flushing. Some ventilation ports may disrupt the sleep of the bed partner 1100 of the patient 1000, for example, by making noise or by focusing airflow.

[0081] ResMed Ltd. has developed many improved mask ventilation technologies, see International Patent Application Publication No. WO1998 / 034,665; International Patent Application Publication No. WO2000 / 078,381; U.S. Patent No. 6,581,594; U.S. Patent Application Publication No. US2009 / 0050156; U.S. Patent Application Publication No. US2009 / 0044808.

[0082] Noise table of existing masks (ISO17510-2:2007, pressure of 10cmH2O at 1m)

[0083]

[0084] (* Only one sample, measured at 10cmH2O in CPAP mode using the test method specified in ISO3744) The sound pressure values ​​of various objects are as follows

[0085]

[0086] 1.2.4 Diagnostic and monitoring systems

[0087] Polysomnography (PSG) is a conventional system for diagnosing and monitoring cardiopulmonary diseases, and usually involves professional clinical medical staff to apply the system. PSG usually involves placing 15 to 20 contact sensors on the human body to record various body signals, such as electroencephalogram (EEG), electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), etc. PSG for sleep apnea has involved two nights of observation of the patient in the clinic, one night of pure diagnosis and the second night when the treatment parameters are determined by the clinician. PSG is therefore expensive and inconvenient. Specifically, it is not suitable for home sleep testing.

[0088] Clinical experts can appropriately diagnose or monitor patients based on visual observation of PSG signals. However, there are situations where clinical experts may not be available or where clinical experts may not be affordable. Different clinical experts may disagree on a patient's condition. In addition, a given clinical expert may apply different criteria at different times. 2. Summary of the invention

[0089] The present technology is directed to providing a medical device for diagnosing, ameliorating, treating or preventing respiratory disorders having one or more of improved comfort, cost, efficacy, ease of use and manufacturability.

[0090] A first aspect of the present technology relates to an apparatus for diagnosing, ameliorating, treating or preventing a respiratory disorder.

[0091] Another aspect of the present technology relates to methods for diagnosing, ameliorating, treating or preventing breathing disorders.

[0092] One aspect of some forms of the present technology is to provide methods and / or apparatus for improving patient compliance with respiratory therapy.

[0093] One aspect of the present technology relates to a patient interface comprising: an inflatable chamber that can be pressurized to at least 6 cmH2O above ambient air pressure, the inflatable chamber including a chamber inlet port, the inflatable chamber inlet port being sized and structured to receive an airflow at a therapeutic pressure for patient breathing; a sealing structure that is constructed and arranged to have a shape that forms a seal with a patient's facial area around the patient's airway entrance so that the air flow at the therapeutic pressure is delivered to at least the patient's nares entrance, the seal being formed to prevent air from escaping from the inflatable chamber between the sealing structure and the patient's facial area, the sealing structure being constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; a positioning and stabilizing structure that is positioned on the patient's head when the patient is in a side sleeping position. The sealing structure is maintained in a therapeutically effective position, and when the patient is sleeping in a supine sleeping position, the positioning and stabilizing structure includes a low-profile side portion and a low-profile rear portion; and a flushing ventilation port structure, which is configured to allow continuous ventilation from the interior of the inflatable chamber to the environment while the pressure in the inflatable chamber is positive relative to the environment, the ventilation port structure is configured so that the ventilation flow rate has a magnitude sufficient to help reduce the CO2 exhaled by the patient during patient inhalation and patient exhalation while maintaining the therapeutic pressure of the inflatable chamber in use, wherein the sealing structure includes a sealing surface formed against the patient's face during use, wherein the sealing structure includes a strap extending between a first internal surface area of ​​the sealing structure opposite the sealing surface and a second internal surface area of ​​the patient interface so that the strap resists deformation of the sealing structure.

[0094] In examples, (a) the sealing structure may include a second interior surface area that is spaced from the first interior surface area, (b) the inflatable chamber may include a second interior surface area that is spaced from the first interior surface area, (c) the strap and sealing structure may include a unitary structure formed of a uniform material, (d) the uniform material may be silicone rubber, (e) the silicone rubber may be liquid silicone rubber or compression molded silicone rubber, (f) the sealing structure may include a sealing flap at an edge region that is shaped and positioned to seal against at least one side of the patient's nose during use and is thinner than an adjacent region of the sealing structure, and (g) the first interior surface area may be spaced from the first interior surface area. The sealing flaps may be adjacent so that the tether is spaced inwardly from the sealing flaps, (h) the tether may extend continuously from the sealing structure at the edge region so that the tether forms an extension of the sealing surface, (i) the tether may include an inner surface and the sealing structure may include an inner surface, (j) the inner surface of the tether is adjacent to and separated from the inner surface of the sealing structure, (k) the inflatable chamber may be constructed of a transparent material, (l) the patient interface may be configured such that no portion of the patient interface structure enters the oral cavity during use, (m) the sealing structure may be configured so as not to extend inwardly from the patient's airway during use, (n) the sealing structure may be configured so as not to extend beneath the chin bulge area during use, and / or (o) the inflatable chamber may be configured so as not to cover the eyes during use.

[0095] Another aspect of the present technology relates to an assembly for a patient interface, comprising: an inflatable chamber that can be pressurized to a therapeutic pressure of at least 6 cmH2O above ambient air pressure, the inflatable chamber including an inlet port of the inflatable chamber, the size and structure of the inlet port of the inflatable chamber being suitable for receiving an air flow at the therapeutic pressure for patient breathing; and a sealing structure, which is constructed and arranged to have a shape that forms a seal with a patient's facial area around the patient's airway entrance so that the air flow at the therapeutic pressure is delivered to at least the patient's nasal entrance, the seal is formed to prevent air from being discharged from the inflatable chamber between the sealing structure and the area of ​​the patient's face, the sealing structure is constructed and arranged to maintain the therapeutic pressure in the inflatable chamber throughout the patient's breathing cycle during use; wherein the sealing structure includes a sealing surface formed against the patient's face during use, wherein the sealing structure includes a connecting portion extending between a first internal surface of the sealing structure opposite the sealing surface and a second internal surface area of ​​the assembly, so that the connecting portion resists deformation of the sealing structure.

[0096] In an example, (a) the sealing structure may include a second interior surface area that is spaced apart from the first interior surface area, (b) the plenum chamber may include a second interior surface area that is spaced apart from the first interior surface area, (c) the connecting portion and the sealing structure may include an integral structure formed of a uniform material, (d) the uniform material may be silicone rubber, (e) the silicone rubber may be liquid silicone rubber or compression molded silicone rubber, (f) the sealing structure may include a sealing flap at an edge region that is shaped and positioned to seal against at least one side of the patient's nose during use and is thinner than an adjacent region of the sealing structure, and (g) the first interior surface area may be spaced apart from the first interior surface area. The sealing flaps may be adjacent so that the connecting portion is spaced inwardly from the sealing flaps, (h) the connecting portion may extend continuously from the sealing structure at the edge region so that the connecting portion forms an extension of the sealing surface, (i) the connecting portion may include an inner surface and the sealing structure may include an inner surface, the inner surface of the connecting portion being adjacent to and separated from the inner surface of the sealing structure, (j) the inflatable chamber may be constructed of a transparent material, (k) the component may be configured so that no portion of the component enters the oral cavity during use, (l) the sealing structure may be configured so that it does not extend inwardly from the patient's airway during use, (m) the sealing structure may be configured so that it does not extend beneath the chin protuberance area during use, and / or (n) the inflatable chamber may be configured so that it does not cover the eyes during use.

[0097] One form of the present technology includes a sealing structure for sealing against a user's face around the user's airway. The sealing structure includes a flap or membrane extending inwardly toward the user's airway and includes an attachment structure that prevents the inner boundary of the flap or membrane from bursting outward (folding back on itself) due to internal pressure.

[0098] In an example, the attachment structure may include one or more ribs / ties / connecting portions / connecting structures, tabs extending from the membrane and folded inwardly and attached to another structure to form a tube or loop, or a tube beneath the membrane and attached to the membrane.

[0099] Another aspect of one form of the present technology is a sealing structure of a patient interface for sealingly delivering a flow of air to a patient's airway entrance (including at least a patient's nares entrance) at a continuous positive pressure relative to ambient air pressure. The patient interface is configured to maintain a therapeutic pressure in a range of about 3 cmH2O to about 40 cmH2O above ambient air pressure throughout the patient's breathing cycle during use while the patient is asleep to alleviate sleep-disordered breathing. The sealing structure includes: a sealing surface configured to form a seal around the patient's airway entrance and a ring of the sealing structure folded inwardly from an outer perimeter of the sealing structure to form a substantially tubular structure so that the ring is continuous, the ring including a portion of the sealing surface.

[0100] In an example, (a) the sealing structure further includes a sealing wing projecting toward an inner perimeter of the sealing structure, (b) the sealing wing is configured to form a seal against the sides of the nose above the patient's nasal bone, (c) the sealing wing is configured to avoid sealing against the wings of the nose, (d) a portion of the sealing surface has increased flexibility relative to the remainder of the ring, the portion of the sealing surface includes a wall segment that is thinner than the remainder of the ring, (e) the portion of the sealing surface includes a wall segment that is thicker than the remainder of the ring, (f) the ring is positioned to contact the side wall of the nose (including the wings of the nose), (g) the ring provides a continuous surface configured to maintain contact with the sides of the nose above the patient's nasal bone, (h) the ring includes at least one closed end, and (i) the ring folds the sealing structure inward to seal against the sides of the nose above the patient's nasal bone. The sealing structure has an attachment point formed on an inner surface thereof, (j) the attachment point is positioned relative to the sealing surface to provide sufficient tension in the ring to counteract outward bursting of the sealing structure when therapeutic pressure is applied to the inner surface of the ring, (k) the ring forms a predetermined angle at the attachment point and the predetermined angle determines the tension in the ring when therapeutic pressure is applied, (l) the attachment point is adjustable, (m) the attachment point is a releasable connection, (n) the sealing structure also includes a second attachment point, (o) the sealing surface includes a friction reducing area to reduce adhesion to a patient surface, (p) the friction reducing area is a frosted surface, (q) the friction reducing area is suitable for allowing the sides of the patient's nose to slide freely against the sealing surface, and / or (r) the ring provides an edgeless sealing surface.

[0101] Another aspect of one form of the present technology is a patient interface for delivering a flow of air to a patient's airway entrance (including at least a patient's nasal entrance) in a sealed manner at a continuous positive pressure relative to ambient air pressure. The patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O above ambient air pressure throughout the patient's breathing cycle when the patient is asleep in use to relieve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface to the patient's face. The sealing structure includes a sealing surface configured to form a seal around the patient's airway entrance and a ring that folds the sealing structure inward from the outer perimeter of the sealing structure to form a substantially tubular structure so that the ring is continuous, and the ring includes a portion of the sealing surface. The patient interface also includes a positioning and stabilizing structure that maintains the sealing structure in sealed contact with the patient's airway entrance surrounding area while maintaining the therapeutic pressure at the patient's airway entrance; a plenum chamber that is pressurized at a pressure higher than ambient pressure in use; and a gas-washed ventilator configured to allow CO2 exhaled by the patient to flow into the outside of the patient interface to minimize the patient's re-breathing of the exhaled CO2.

[0102] In examples, (a) the sealing flap projects toward the inner perimeter of the sealing structure, (b) the sealing flap is configured to form a seal against each side of the nose above the nasal bone and adjacent to each side of the nose above the maxillary bone, in a recess adjacent to the patient's inner canthus, (c) the sealing flap is configured to avoid sealing against the nasal wing, (d) a portion of the sealing surface has increased flexibility relative to the remainder of the ring, (e) a portion of the sealing surface includes a wall segment that is thinner than the remainder of the ring, (f) a portion of the sealing surface includes a wall segment that is thicker than the remainder of the ring, (g) the sealing surface includes a friction reducing area to reduce adhesion to the patient's face, (h) the friction reducing area is a frosted surface, (i) the friction reducing area is adapted to allow each side of the patient's nose to slide freely against the sealing surface, and (j) The first ring defines a sealing structure area suitable for contacting the patient's face, (k) the first portion and the second portion are portions of the sealing structure area suitable for contacting the patient's face, (l) the first ring is continuous, (m) the second ring is positioned to contact or be located next to the patient's nose, (n) the second ring is positioned so that the substantially tubular structure is suitable for contacting or being located next to the patient's nose, (o) the substantially tubular structure is suitable for being positioned substantially parallel to a side of the patient's nose, (p) the sealing structure also includes a second of the second ring, (g) the substantially tubular structure includes a hollow interior suitable for communicating with a pressure fluid above ambient pressure, (r) the substantially tubular structure includes two open ends, and / or (s) the second ring is suitable for preventing the second ring from bursting when the patient interface is internally pressurized and adjusted by the patient.

[0103] Another aspect of one form of the present technology relates to a patient interface for delivering a flow of air to the entrance of a patient's airway (including at least the entrance of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O above ambient air pressure during use throughout the patient's breathing cycle while the patient is asleep, to relieve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface against the patient's face. The sealing structure includes a facial contact portion adapted to contact the perimeter of the patient's airway entrance and at least one first substantially cylindrical region having an uninterrupted circumference, wherein a portion of the cylindrical region includes a portion of the facial contact portion. The patient interface also includes a positioning and stabilizing structure that maintains the sealing structure in sealed contact with the patient's airway entrance surrounding area while maintaining a therapeutic pressure at the patient's airway entrance; a plenum chamber pressurized at a pressure higher than ambient pressure during use; and a gas-washed ventilator configured to allow CO2 exhaled by the patient to flow to the outside of the patient interface to minimize the patient's re-breathing of the exhaled CO2.

[0104] In an example, (a) the sealing structure includes an unrestricted edge adjacent each end of the first substantially cylindrical region, (b) the sealing structure includes an unrestricted edge entirely around the circumference of the patient's airway entrance, except at the first substantially cylindrical region, (c) a portion of the face contact portion forms a convex surface suitable for contacting the patient's face, (d) the first substantially cylindrical region is positioned to contact or be located beside the patient's wing of the nose, (e) the first substantially cylindrical region is positioned substantially parallel to the patient's wing of the nose, (f) the patient interface also includes a second cylindrical region, (g) the cylindrical region includes a second substantially cylindrical region having an uninterrupted circumference, wherein a portion of the second cylindrical region includes a portion of the face contact portion, (h) wherein the first substantially cylindrical region includes a hollow interior suitable for communicating with a pressure fluid above ambient pressure, (i) the first substantially cylindrical region includes two open ends, and / or (j) the first substantially cylindrical region is suitable for preventing the face contact portion from bursting when the patient interface is internally pressurized and adjusted by the patient.

[0105] Another aspect of one form of the present technology relates to a patient interface for sealingly delivering a flow of air to an entrance of a patient's airway (including at least the patient's nares) at a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O above ambient air pressure during use throughout the patient's breathing cycle while the patient is asleep to relieve sleep-disordered breathing. The patient interface includes a sealing structure having a material that folds itself to form an uninterrupted tubular shape, wherein only a portion of the circumference of the tubular shape is configured to contact the patient's face; a positioning and stabilizing structure that maintains the sealing structure in sealing contact with an area surrounding the patient's airway entrance while maintaining a therapeutic pressure at the patient's airway entrance; an inflatable chamber that is pressurized at a pressure higher than ambient pressure during use; and a gas-flushed ventilator configured to allow CO2 exhaled by the patient to flow to the outside of the patient interface to minimize rebreathing of the exhaled CO2 by the patient, wherein the interior of the tubular shape is adapted to communicate with a pressure fluid higher than ambient pressure.

[0106] In an example, (a) the uninterrupted tubular shape has an interior surface of the tube and an exterior surface of the tube, the interior surface of the tube being adapted to be exposed to a pressure above ambient pressure during use, a first portion of the exterior surface of the tube being adapted to be exposed to ambient pressure during use, and a second portion of the exterior surface of the tube being adapted to be exposed to a pressure above ambient pressure during use, (b) the sealing structure further comprises a surface contacting around the circumference of the patient's airway and the portion of the uninterrupted tubular shape being a portion of the surface, (c) the uninterrupted tubular shape is open at at least one end, (d) the uninterrupted tubular shape is open at both ends, (e) the uninterrupted tubular shape is adapted to be located next to the nose of the patient, (f) the uninterrupted tubular shape is adapted to contact the nose of the patient, (g) the material is folded to form a second uninterrupted tubular shape, wherein only a portion of the circumference of the second uninterrupted tubular shape is configured to contact the patient's face, (h) the uninterrupted tubular shape is adapted to be on the opposite side of the patient's nose, and / or (i) the uninterrupted tubular shape is adapted to prevent the material from bursting when the patient interface is internally pressurized and adjusted by the patient.

[0107] Another aspect of one form of the present technology relates to a patient interface for delivering a flow of air to the entrance of a patient's airway (including at least the entrance of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O above ambient air pressure during use throughout the patient's breathing cycle when the patient is asleep, so as to relieve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface against the patient's face. The sealing structure includes a first face contact portion having an unconnected edge at the inner boundary of the sealing structure, a second face contact portion that is a part of a tubular structure, and the first face contact portion and the second face contact portion each form a part of a continuous membrane, which is configured to contact the patient's face around the perimeter of the patient's airway entrance. The patient interface also includes a positioning and stabilizing structure that maintains the sealing structure in sealed contact with the surrounding area of ​​the patient's airway entrance while maintaining the therapeutic pressure at the patient's airway entrance; a plenum chamber that is pressurized at a pressure higher than ambient pressure during use; and a gas-washed ventilator configured to allow CO2 exhaled by the patient to flow to the outside of the patient interface to minimize the patient's re-breathing of the exhaled CO2.

[0108] In an instance, (a) the patient interface further includes a plurality of second facial contact portions, (b) the second facial contact portions are adapted to contact the patient's face adjacent to or on the ala of the patient's nose, and / or (c) the tubular structure is adapted to prevent continuous membrane bursting when the patient interface is internally pressurized and adjusted by the patient.

[0109] Another aspect of one form of the present technology relates to a patient interface for delivering a flow of air to the entrance of a patient's airway (including at least the entrance of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O exceeding the ambient air pressure during use throughout the patient's breathing cycle when the patient is asleep, so as to relieve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface against the patient's face. The sealing structure includes a sealing film and a wing attached to the first end of the sealing film and attached to the second end of another structure to prevent the sealing film from being outward due to the therapeutic pressure. The patient interface also includes a positioning and stabilizing structure that maintains the sealing structure in sealing contact with the surrounding area of ​​the patient's airway entrance while maintaining the therapeutic pressure at the patient's airway entrance; an inflatable chamber pressurized at a pressure higher than the ambient pressure during use; and a gas-washed ventilator configured to allow the patient's exhaled CO2 to flow to the outside of the patient interface to minimize the patient's re-breathing of the exhaled CO2.

[0110] In examples, (a) the sealing membrane and the flap form part of the tubular structure, and / or (b) the sealing membrane is adapted to contact the patient's airway entrance around all of its circumference and the flap is provided only for a portion of that circumference.

[0111] Another aspect of one form of the present technology relates to a patient interface for delivering a flow of air to the entrance of a patient's airway (including at least the entrance of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O exceeding the ambient air pressure during use throughout the patient's breathing cycle when the patient is asleep, so as to relieve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface to the patient's face. The sealing structure includes a sealing film suitable for contacting the patient's face around the perimeter of the patient's airway entrance and a cylindrical area below the sealing film and attached to the sealing film. The patient interface also includes a positioning and stabilizing structure that maintains the sealing structure in sealed contact with the patient's airway entrance surrounding area while maintaining the therapeutic pressure at the patient's airway entrance; an inflatable chamber pressurized at a pressure higher than the ambient pressure during use; and a gas-washed ventilator configured to allow the patient's exhaled CO2 to flow to the outside of the patient interface to minimize the patient's re-breathing of the exhaled CO2.

[0112] In an example, (a) the cylindrical region is positioned adjacent to the patient's ala nasi, (b) the cylindrical region includes an axis substantially parallel to the patient's ala nasi, (c) the cylindrical region is adapted to prevent the sealing membrane from blowing away from the patient's airway entrance when the plenum chamber is pressurized at a pressure above ambient pressure, and / or (d) the sealing membrane includes an unconnected edge entirely around the circumference of the patient's airway entrance.

[0113] Another aspect of one form of the present technology relates to a patient interface for delivering a flow of air to the entrance of a patient's airway (including at least the entrance of the patient's nostrils) under a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 3 cmH2O to about 40 cmH2O above ambient air pressure during use throughout the patient's breathing cycle when the patient is asleep, so as to relieve sleep-disordered breathing. The patient interface includes a sealing structure for sealing the patient interface to the patient's face. The sealing structure includes a sealing membrane, which includes an inner surface and an outer surface suitable for contacting the patient's face around the perimeter of the patient's airway entrance; and a rib, which is below the inner surface and attached to the inner surface so that the rib resists the deformation of the sealing membrane when pressure is applied to the inner surface. The patient interface also includes a positioning and stabilizing structure that maintains the sealing structure in sealing contact with the area around the patient's airway entrance while maintaining the therapeutic pressure at the patient's airway entrance; an inflatable chamber pressurized at a pressure higher than the ambient pressure in use; and a gas-washed ventilator configured to allow the patient's exhaled CO2 to flow to the outside of the patient interface to minimize the patient's re-breathing of the exhaled CO2.

[0114] In an example, (a) the outer surface includes a convex portion, (b) the inner surface has a concave portion, (c) the concave portion and the convex portion are directly opposite each other on the outer surface and the inner surface, respectively, and a rib is attached to the inner surface at the concave portion, (d) the rib is easily squeezed by a force applied to the patient interface to hold the patient interface to the patient, (e) the patient interface further includes a plurality of ribs, (f) the rib is adapted to be adjacent to the patient's nose, (g) the rib is adapted to prevent a sealing membrane from bursting when the patient interface is internally pressurized and adjusted by the patient, and / or (h) the rib is substantially perpendicular to the inner surface.

[0115] Another aspect of one form of the present technology relates to a buffer assembly for a patient interface for sealingly delivering an air flow to a patient's airway entrance (including at least a patient's nares entrance) at a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure during use throughout the patient's breathing cycle while the patient is asleep, to relieve sleep-disordered breathing. The buffer assembly may include an elastic seal-forming portion shaped to be bisected by a sagittal plane, the sagittal plane including a line tangent to the elastic seal-forming portion at an upper tangent point and a lower tangent point. The elastic seal-forming portion may include a dome-shaped upper region spanning the sagittal plane near the upper tangent point and a saddle-shaped lower region spanning the sagittal plane and including a lower tangent point. The elastic seal-forming portion may also include a first support region extending from the saddle-shaped lower region to the dome-shaped upper region, the first support region having a consistent elastic wall thickness greater than the elastic wall thickness of the dome-shaped upper region and the saddle-shaped lower region. The elastic sealing forming portion may also include a second support area adjacent to the first support area extending from the saddle-shaped lower area to the dome-shaped upper area, the second support area being defined proximally by the first support area and having a distal side opposite to the proximal side, and the elastic wall thickness in the second support area increases from the distal side to the proximal side.

[0116] Another aspect of one form of the present technology relates to a buffer assembly for a patient interface for sealingly delivering an air flow to a patient's airway entrance (including at least a patient's nares entrance) at a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure during use throughout the patient's breathing cycle while the patient is asleep, to relieve sleep-disordered breathing. The buffer assembly may include an elastic seal-forming structure formed to be bisected by a sagittal plane, the sagittal plane including a line tangent to the elastic seal-forming structure at an upper tangent point and a lower tangent point. The elastic seal-forming structure may include a rear center opening and a front center opening opposite to the rear center opening and may include multiple closed paths coaxial with the rear center opening. The dome-shaped upper region may cross the sagittal plane near the upper tangent point, and the dome-shaped upper region is positioned on the outermost closed path. The saddle-shaped upper region may cross the sagittal plane near the upper tangent point, and the saddle-shaped upper region is positioned on the innermost closed path. The saddle-shaped lower region may span the sagittal plane and may include a lower tangent point, the saddle-shaped lower region being on the innermost closed path and the outermost closed path. The elastic wall thickness of the elastic seal-forming structure may be constant along a portion of the outermost closed path extending from the saddle-shaped lower region to the dome-shaped upper region. The elastic wall thickness of the elastic seal-forming structure may vary along a portion of the innermost closed path extending from the saddle-shaped lower region to the saddle-shaped upper region.

[0117] Another aspect of one form of the present technology relates to a buffer assembly for a patient interface for sealingly delivering an air flow to a patient's airway entrance (including at least a patient's nares entrance) at a continuous positive pressure relative to ambient air pressure, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure during use throughout the patient's breathing cycle while the patient is asleep, to relieve sleep-disordered breathing. The buffer assembly may include an elastic seal-forming structure shaped to be bisected by a sagittal plane, the sagittal plane having lines tangent to the elastic seal-forming structure at an upper tangent point and at a lower tangent point. A first nose bridge region of the elastic seal-forming structure may span the sagittal plane near the upper tangent point. A second nose bridge region of the elastic seal-forming structure may span the sagittal plane near the upper tangent point and be configured to seal against the patient's nose bridge when the buffer is mounted on the patient's face, the elastic wall of the second nose bridge region being thinner than the first nose bridge region. A chin region of the resilient seal-forming structure may span the sagittal plane and include a lower tangent point, the chin region being configured to engage the patient's chin when the bumper is mounted on the patient's face, the chin region having the same resilient wall thickness as the first nose bridge region. The first support region and the second support region may be positioned juxtaposed and both extend from the chin region to the first nose bridge region, the first support region having a uniform resilient wall thickness, and the second support region having a varying resilient wall thickness.

[0118]

[0013] Another aspect of one form of the present technology is a patient interface cast or otherwise constructed using a perimeter shape that is complementary to the shape of the intended wearer.

[0119] One aspect of one form of the present technology is a method of making a device.

[0120] One aspect of some forms of the present technology is a medical device that is easy to use, such as by individuals without medical training, individuals with limited dexterity, vision, or individuals with limited experience using medical devices of this type.

[0121] One aspect of one form of the present technology is a portable RPT device that can be carried by an individual (e.g., around the individual's home).

[0122] One aspect of one form of the present technology is a patient interface that can be cleaned in the patient's home (e.g., in soapy water) without the need for specialized cleaning equipment. One aspect of one form of the present technology is a humidifier tank that can be cleaned in the patient's home (e.g., in soapy water) without the need for specialized cleaning equipment.

[0123] The methods, systems, devices and apparatus described herein may provide improved functionality in a processor, such as a processor of a dedicated computer, a respiratory monitor and / or a respiratory therapy device. In addition, the methods, systems, devices and apparatus may provide improvements in the art of automated management, monitoring and / or treatment of respiratory conditions, including, for example, sleep disordered breathing.

[0124] Of course, parts of various aspects can form sub-aspects of the present technology. In addition, various aspects in sub-aspects and / or aspects can be combined in any manner and also constitute other aspects or sub-aspects of the present invention technology.

[0125] Other features of the inventive technology will become apparent by considering the information contained in the following detailed description, abstract, drawings, and claims. 3. Description of the drawings

[0126] The present technology is illustrated by way of example and not limitation in the figures of the accompanying drawings in which like reference numerals refer to similar elements, including:

[0127] 3.1 Treatment system

[0128] Figure 1A A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of nasal pillows receiving a supply of air at a positive pressure from an RPT device 4000. Air from the RPT device 4000 is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. A bed partner 1100 is also shown. The patient sleeps in a supine sleeping position.

[0129] Figure 1B A system is shown that includes a patient 1000 wearing a patient interface 3000 in the manner of a nasal mask receiving a supply of air at a positive pressure from a RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered to the patient 1000 along an air circuit 4170.

[0130] Figure 1C A system is shown that includes a patient 1000 wearing a patient interface 3000 in the form of a full face mask receiving a supply of air under positive pressure from an RPT device 4000. Air from the RPT device is humidified in a humidifier 5000 and delivered along an air circuit 4170 to the patient 1000. The patient sleeps in a side-lying sleeping position.

[0131] 3.2 Respiratory system and facial anatomy

[0132] Figure 2A Shown is a schematic diagram of the human respiratory system including the nasal and oral cavities, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0133] Figure 2B A view of the human upper airway including the nasal cavity, nasal bones, external nasal cartilages, alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, pharynx, tongue, epiglottic cartilages, vocal cords, esophagus, and trachea is shown.

[0134] Figure 2C is a front view of the face with several surface anatomical features identified, including the upper lip, upper lip vermilion, lower lip vermilion, lower lip, mouth width, medial canthus, nasal wing, nasolabial fold, and corner of mouth. The directions of superior, inferior, radially inward, and radially outward are also indicated.

[0135] Figure 2D It is a side view of the head with several surface anatomical features labeled, including the glabella, nasal bridge point, nasal prominence point, subseptal point, upper lip, lower lip, supramental point, nasal bridge, nasal wing apex, supra-auricular base point, and sub-auricular base point. The superior-inferior and anterior-posterior directions are also indicated.

[0136] Figure 2E This is another lateral view of the head. The approximate location of the Frankfort plane and nasolabial angle are indicated. The coronal plane is also indicated.

[0137] Figure 2F A bottom view of the nose is shown with several features identified, including the nasolabial folds, lower lip, vermillion, nostrils, subseptal point, columella, pronasal point, long axis of the nostrils, and the sagittal plane.

[0138] Figure 2G A side view of the nasal surface features is shown.

[0139] 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.

[0140] Fig.2I The medial anatomy of the nose is shown approximately a few millimeters from the sagittal plane, showing, among other things, the septal cartilage and the medial crus of the greater alar cartilage.

[0141] Figure 2J A frontal view of the skull is shown, including the frontal, nasal, and zygomatic bones. The nasal turbinates are also indicated, as well as the maxilla and mandible.

[0142] Figure 2K A side view of the skull with the outline of the head surface and several muscles is shown. The following bones are shown: frontal, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital. The mental protuberance is also indicated. The following muscles are shown: digastric, masseter, sternocleidomastoid, and trapezius.

[0143] Figure 2LAn anterolateral view of the nose is shown.

[0144] 3.3 Patient Interface

[0145] Figure 3A A patient interface in the form of a nasal mask is shown in accordance with one form of the present technology.

[0146] Figure 3B A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when Figure 3C The curvature magnitude shown is relatively large in comparison.

[0147] Figure 3C A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a positive sign and when Figure 3B The curvature magnitude shown is relatively small in comparison.

[0148] Figure 3D A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a value of zero.

[0149] Figure 3E A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when Figure 3F The curvature magnitude shown is relatively small in comparison.

[0150] Figure 3F A schematic diagram of a cross section through the structure at a point is shown. The outward normal at that point is indicated. The curvature at that point has a negative sign and when Figure 3E The curvature magnitude shown is relatively large in comparison.

[0151] Figure 3G A bumper for a mask including two pillows is shown. The outer surface of the bumper is indicated. The edge of the surface is indicated. The dome area and the saddle area are indicated.

[0152] Figure 3H A buffer for a face mask is shown. The outer surface of the buffer is indicated. The edge of the surface is indicated. The path on the surface between point A and point B is indicated. The straight-line distance between point A and point B is indicated. Two saddle areas and one dome area are indicated.

[0153] Fig. 3I The surface of a structure is shown, with a one-dimensional hole on the surface. The plane curve shown forms the boundary of the one-dimensional hole.

[0154] Figure 3J Shown through Fig. 3I The cross section of the structure is shown. The surface restraint Fig. 3I Two-dimensional holes in the structure.

[0155] Figure 3K Show Fig. 3I A perspective view of a structure comprising a two-dimensional hole and a one-dimensional hole. Also shown is the binding Fig. 3I The surface of the two-dimensional holes in the structure.

[0156] Figure 3L A mask with an inflatable bladder as a shock absorber is shown.

[0157] Figure 3M Shown through Figure 3L A cross section of a mask showing the interior surface of the airbag. The interior surface constrains the two-dimensional hole in the mask.

[0158] Figure 3N Shown through Figure 3L A cross section of a mask. The interior surface is also indicated.

[0159] Fig.3O The left-hand rule is shown.

[0160] Figure 3P The right-hand rule is shown.

[0161] Figure 3Q The left ear is shown, including the left ear helix.

[0162] Figure 3R The right ear is shown, including the right ear helix.

[0163] Figure 3S A right-hand helix is ​​shown.

[0164] Figure 3T A view of a mask is shown including torque signatures of spatial curves defined by the edge of the sealing membrane in different regions of the mask.

[0165] 3.4RPT device

[0166] Figure 3U One form of RPT device according to the present technology is shown.

[0167] 3.5 Humidifier

[0168] Figure 3V An isometric view of a humidifier according to one form of the present technology is shown.

[0169] Figure 3W An isometric view of a humidifier according to one form of the present technology is shown, showing the humidifier reservoir 5110 removed from the humidifier reservoir base 5130.

[0170] 3.6 Seal-forming structure and patient interface

[0171] Figure 4 A perspective view of a seal-forming structure is depicted.

[0172] Figure 5 A perspective view of a seal-forming structure is depicted.

[0173] Figure 5A A perspective view of a seal-forming structure is depicted wherein the ring includes a closed end.

[0174] Figure 6 A plan view of a seal-forming structure is depicted.

[0175] Figure 7 Depicts the Figure 6 A cross-sectional view taken along line 7-7.

[0176] Fig. 7A Depicted with Figure 7 Same cross-sectional view, but with the angle of the structure changed.

[0177] Figure 7B-7I Depicted in Figure 7 Cross-sectional view of the mechanical attachment.

[0178] FIG. 8A to FIG. 8G Depicts the Figure 6 The cross-sectional view is obtained by the corresponding line.

[0179] Fig. 9 A plan view of a seal-forming structure is depicted.

[0180] Fig.10 A perspective view of a seal-forming structure is depicted.

[0181] Fig.11 A simplified representation of the tubular structure and fins is depicted.

[0182] Fig.12 Depicted is a simplified representation of a tubular structure and fins attached to a seal-forming structure.

[0183] Fig.13 A simplified representation of the seal-forming structure is depicted for compliance.

[0184] Fig.14 A perspective view of a seal-forming structure is depicted.

[0185] Fig.15 Depicted is a cross-sectional view of the ribs showing the seal-forming structure.

[0186] Fig.16 Depicted is a cross-sectional view of a rib under compression.

[0187] Fig.17 Depicted is a cross-sectional view of a rib under tension.

[0188] Fig.18 and 19 A cross section of a seal forming structure is shown.

[0189] Fig. 20A The various regions of the seal-forming structure are depicted.

[0190] Fig. 20B Various regions of another seal-forming structure are depicted.

[0191] Fig. 20C It also shows Fig. 20A The sealing formation structure in.

[0192] FIG. 20D to FIG. 20G Shown along Fig. 20B Cross-sectional view taken along the corresponding line.

[0193] Fig.21 A seal-forming structure attached to a mask shell is depicted.

[0194] Fig. 22 An exploded view of the seal-forming structure and two clips is depicted.

[0195] Fig.23 A view of the bumper and clip is depicted.

[0196] Fig.23A Depicted Fig.23 A cross-sectional view taken along line 23A-23A in FIG.

[0197] Fig.24 A perspective view of a seal-forming structure is depicted.

[0198] Fig.25A Depicted Fig.24 A front view of a seal-forming structure.

[0199] Figures 25B-25G Depicts the Fig.25A The individual cross sections are obtained by the corresponding lines in .

[0200] Fig.26 Depicted Fig.24 A rear view of the seal-forming structure.

[0201] Fig. 27 Depicted Fig.24 The seal forms various areas of the structure.

[0202] Fig.28A A top perspective view of a seal-forming structure for a full facial patient interface according to one example of the present technology.

[0203] Fig.28B A front view of a seal-forming structure for a full facial patient interface according to an example of the present technology.

[0204] Fig.28C A rear view of a seal-forming structure for a full facial patient interface according to an example of the present technology.

[0205] Fig.28D A top view of a seal-forming structure for a full facial patient interface according to one example of the present technology.

[0206] Fig.28E A bottom view of a seal-forming structure for a full facial patient interface according to an example of the present technology.

[0207] Fig.28F A side view of a seal-forming structure for a full facial patient interface according to an example of the present technology.

[0208] Figure 28G A bottom perspective view of a seal-forming structure for a full facial patient interface according to an example of the present technology.

[0209] Fig.28H Another top perspective view of a seal-forming structure for a full facial patient interface according to an example of the present technology.

[0210] Fig.28I Another bottom view of a seal-forming structure for a full facial patient interface according to an example of the present technology.

[0211] Fig.28J A seal forming structure for a full facial patient interface according to an example of the present technology is provided through Fig.28B A cross-sectional view taken along line 28J-28J.

[0212] Figure 28K A seal forming structure for a full facial patient interface according to an example of the present technology is provided through Fig.28B A cross-sectional view taken along line 28K-28K.

[0213] Figure 28L A seal forming structure for a full facial patient interface according to an example of the present technology is provided through Fig.28B A cross-sectional view taken along line 28L-28L.

[0214] Figure 28M For use Figure 28L A perspective view of the seal-forming structure of a full facial patient interface is shown.

[0215] Fig.29A A top perspective view of an assembly of a seal-forming structure and an inflatable chamber for a full facial patient interface according to one example of the present technology.

[0216] Fig.29B A top perspective view of an assembly of a seal-forming structure and an inflatable chamber for a full facial patient interface according to one example of the present technology.

[0217] Fig.29C A seal forming structure and an inflatable chamber assembly for a full facial patient interface according to an example of the present technology is provided through Fig.29B A cross-sectional view taken along line 29C-29C.

[0218] Fig.29D A seal forming structure and an inflatable chamber assembly for a full facial patient interface according to an example of the present technology is provided through Fig.29B A cross-sectional view taken along line 29D-29D.

[0219] Fig.29E A seal forming structure and an inflatable chamber assembly for a full facial patient interface according to an example of the present technology is provided through Fig.29B A cross-sectional view taken along line 29E-29E.

[0220] Fig. 30A A top perspective view of a full facial patient interface according to one example of the present technology is shown.

[0221] Fig. 30B A top perspective view of a full facial patient interface according to one example of the present technology is shown.

[0222] Fig. 30C A top perspective view of a full facial patient interface according to another example of the present technology is shown.

[0223] Fig.30D For patients to wear Fig. 30C Perspective view of a patient interface.

[0224] Fig.30E for Fig. 30C Exploded view of the patient interface.

[0225] Fig.30F for Fig. 30C Another exploded view of the patient interface.

[0226] Figure 30G Fig. 30C Another exploded view of the patient interface.

[0227] Fig.31A A top perspective view of a seal-forming structure for a nasal patient interface according to one example of the present technology.

[0228] Fig.31B A front view of a seal-forming structure for a nasal patient interface according to one example of the present technology.

[0229] Fig.31C A rear view of a seal-forming structure for a nasal patient interface according to one example of the present technology.

[0230] Fig.31D A top view of a seal-forming structure for a nasal patient interface according to one example of the present technology.

[0231] Fig.31E A bottom view of a seal-forming structure for a nasal patient interface according to one example of the present technology.

[0232] Fig.31F A side view of a seal-forming structure for a nasal patient interface according to one example of the present technology.

[0233] Figure 31G A bottom perspective view of a seal-forming structure for a nasal patient interface according to one example of the present technology.

[0234] Fig.31H Another top perspective view of a seal-forming structure for a nasal patient interface according to an example of the present technology.

[0235] Fig.31I Another bottom view of a seal-forming structure for a nasal patient interface according to an example of the present technology.

[0236] Fig.31J A seal forming structure for a nasal patient interface according to an example of the present technology is provided through Fig.31B A cross-sectional view taken along line 31J-31J.

[0237] Figure 31K A seal forming structure for a nasal patient interface according to an example of the present technology is provided through Fig.31B A cross-sectional view taken along line 31K-31K.

[0238] Figure 31L A seal forming structure for a nasal patient interface according to an example of the present technology is provided through Fig.31B A cross-sectional view taken along line 31L-31L.

[0239] Figure 31M For use Figure 31L A perspective view of the seal-forming structure of a full facial patient interface is shown.

[0240] Fig.32AA top perspective view of an assembly of a seal-forming structure and a plenum chamber for a nasal patient interface according to one example of the present technology.

[0241] Fig.32B A front perspective view of an assembly of a seal-forming structure and a plenum chamber for a nasal patient interface according to one example of the present technology.

[0242] Fig.32C A seal-forming structure and an inflatable chamber assembly for a nasal patient interface according to an example of the present technology is provided through Fig.32B A cross-sectional view taken along line 32C-32C.

[0243] Fig.32D A seal-forming structure and an inflatable chamber assembly for a nasal patient interface according to an example of the present technology is provided through Fig.32B A cross-sectional view taken along line 32D-32D.

[0244] Fig.32E A seal-forming structure and an inflatable chamber assembly for a nasal patient interface according to an example of the present technology is provided through Fig.32B A cross-sectional view taken along line 32E-32E.

[0245] Fig.32F A cross-sectional view of an assembly of a seal-forming structure and a plenum chamber for a nasal patient interface according to one example of the present technology.

[0246] Fig.33A Shown is a top perspective view of a nasal patient interface according to one example of the present technology.

[0247] Fig.33B Shown is a top perspective view of a nasal patient interface according to one example of the present technology.

[0248] Fig.34A Detailed side view of a seal-forming structure for a full facial patient interface in which therapeutic pressure is applied according to the related art.

[0249] Fig.34B A detailed side view of a seal-forming structure for a full facial patient interface in which therapeutic pressure is applied according to another related art. 4. Specific implementation methods

[0250] Before further describing the present technology in detail, it should be understood that the present technology is not limited to the specific examples described herein, and the specific examples described herein may be changed. It should also be understood that the terms used in the present disclosure are only for the purpose of describing the specific examples described herein and are not intended to be limiting.

[0251] The following description is provided for various examples that may share one or more common features and / or characteristics. It should be understood that one or more features of any one example may be combined with one or more features of another example or other examples. In addition, in any one of the examples, any single feature or combination of features may constitute a further example.

[0252] 4.1 Treatment

[0253] In one form, the present technology includes a method of treating a breathing disorder, the method comprising the step of applying positive pressure to an entrance to the airway of a patient 1000 .

[0254] In certain embodiments of the present technology, a positive pressure supply of air is provided to the patient's nasal passages via one or both nostrils.

[0255] In certain embodiments of the present technology, mouth breathing is limited, restricted or prevented.

[0256] 4.2 Treatment system

[0257] In one form, the present technology includes an apparatus or device for treating a respiratory disorder. The apparatus or device may include an RPT device 4000 for supplying pressurized air to a patient 1000 via an air circuit 4170 leading to a patient interface 3000 .

[0258] 4.3 Patient Interface

[0259] A non-invasive patient interface 3000 according to one aspect of the present technology includes the following functional aspects: a seal-forming structure 3100, an inflatable chamber 3200, a positioning and stabilizing structure 3300, a ventilation port 3400, a connection port 3600 for connecting to a form of air circuit 4170, and a forehead support 3700. In some forms, the functional aspects may be provided by one or more physical components. In some forms, one physical component may provide one or more functional aspects. In use, the seal-forming structure 3100 is arranged to surround the entrance of the patient's airway so as to facilitate the supply of positive pressure air to the airway.

[0260] The inventors have discovered that if the patient interface 3000 is unable to comfortably deliver a minimum level of positive pressure to the airway, therapy may not be effective.

[0261] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 6 cmH2O relative to ambient.

[0262] A patient interface 3000 in accordance with one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 10 cmH2O relative to ambient.

[0263] A patient interface 3000 according to one form of the present technology is constructed and arranged to provide an air supply at a positive pressure of at least 20 cmH2O relative to ambient.

[0264] 4.3.1 Sealing structure

[0265] In one form of the present technology, the seal-forming structure 3100 provides a seal-forming surface and may additionally provide a cushioning function.

[0266] The seal-forming structure 3100 according to the present technology can be constructed of a soft, flexible and elastic material such as silicone.

[0267] In one form, the non-invasive patient interface 3000 includes a seal forming portion which, in use, forms a seal on the upper lip region (ie, upper lip) of the patient's face.

[0268] In one form, the non-invasive patient interface 3000 includes a seal forming portion which, in use, forms a seal over the chin region of the patient's face.

[0269] In some forms of the present technology, a system is provided that includes more than one seal-forming structure 3100, each of which is configured to correspond to a different range of sizes and / or shapes. For example, the system may include one form of seal-forming structure 3100 that is suitable for large-sized heads but not for small-sized heads and another form of seal-forming structure that is suitable for small-sized heads but not for large-sized heads.

[0270] In some forms of the present technology, the seal-forming structure 3100 is constructed of a biocompatible material, such as silicone rubber.

[0271] Figure 4 A perspective view of the seal-forming structure 3100 is shown separated from the rest of the patient interface 3000. The seal-forming structure includes a sealing surface 3105 configured to form a seal around the circumference of the patient's airway. The seal may be formed around the patient's nose or the patient's nose and mouth.

[0272] The seal-forming structure 3100 includes a tether, connecting portion or ring 3110 that folds the seal-forming structure 3100 inwardly from the outer perimeter 3115 of the seal structure 3100 (e.g., toward the patient's face in use). The outer perimeter 3115 can be generally defined as a wall that supports the sealing surface 3105 and / or is continuously formed with the sealing surface. In this way, the tether 3110 can form a substantially tubular structure 3120 so that the tether 3110 forms a continuous structure (e.g., a continuous circumference) with the sealing surface 3105 and the outer perimeter 3115. Therefore, the tether 3110 can include a portion of the sealing surface 3105, a portion of the outer perimeter 3115, and a portion that is neither the sealing surface 3105 nor the outer perimeter 3115. The portion that is neither the sealing surface 3105 nor the outer perimeter 3115 can be in the form of a flap or sheet that is attached or continuous with the sealing surface at one end and attached or continuous with the outer perimeter 3115 at the other end. The tether 3110 may be positioned beside the patient's nose, such as along the ala of the nose, over the nasal bone, or anywhere therebetween. Two tethers 3110 may be disposed on opposite sides of the patient's nose. The tether 3110 may be open inwardly, including at one or both ends, such that the tether 3110 is pressurized inwardly by the patient's treatment pressure (e.g., in fluid communication with the patient's treatment pressure) during use.

[0273] In one form of the present technology, the tether 3110 may extend only partially around the circumference of the seal-forming structure 3100.

[0274] In one form, the tether 3110 and the seal-forming structure 3100 do not form a closed pressurizable structure (eg, a bladder) such that the space between the tether 3110 and the seal-forming structure 3100 is open to pressure within the interior of the patient interface 3000 .

[0275] In one form, the seal-forming structure 3100 has an edge and the tether 3110 holds the edge to prevent bursting at the edge.

[0276] The area of ​​the sealing surface 3105 other than the tether 3110 may include a sealing flap 3125 that protrudes inwardly toward the inner perimeter of the sealing structure 3100. The sealing flap 3125 may have an unconnected edge at or near a radially inner portion of the sealing surface 3105. The sealing flap 3125 may include a portion 3125a configured to form a seal against each side of the nose above the patient's nasal bone. The sealing flap 3125 may be configured to avoid sealing against the ala of the nose, for example, by being spaced radially outwardly far enough relative to the ala of the nose to avoid or minimize contact with the ala of the nose.

[0277] Figure 5 Show except Figure 4 A substantially reverse perspective view of the seal-forming structure 3100 is shown. The substantially tubular structure 3120 may be easier to see than in this view. Figure 5A A tether 3110 is shown having a closed end 3111. This figure also shows the seal-forming structure 3100 without an underlying buffer and thus the seal-forming structure 3100 may be referred to as a single layer buffer.

[0278] Figure 6 A plan view of a seal forming structure 3100 is shown and acts as Figure 7 and two cross-sectional views of the basis shown in FIG8 .

[0279] Figure 7 31 is a cross section taken through the lace 3110. The substantially tubular structure 3120 may be more easily seen from this view. The lace 3110 includes a relatively thick portion 3130 and a relatively thin portion 3135. The relatively thick portion 3130 may be a thickness between 1 mm and 2 mm, or a thickness between 1.3 mm and 1.7 mm, or about 1.5 mm thick. The relatively thin portion 3135 may be a thickness between 0.2 mm and 0.8 mm, or a thickness between 0.4 mm and 0.6 mm, or about 0.5 mm thick. Alternatively, the relatively thick portion 3130 may be about 2.5 to 5 times the thickness of the relatively thin portion 3135, or about 2.8 to 3.3 times the thickness of the relatively thin portion 3135, or three times the thickness of the relatively thin portion 3135. The relatively thick portion 3130 shown includes an outer perimeter 3115 and a majority of the sealing surface 3105 at the lace 3110. The relatively thin portion 3135 folds the seal structure inwardly and connects back to the seal-forming structure 3100 at a connection point 3165 at or near the hinge structure 3140. The hinge structure 3140 is shown as a localized relatively thin strip or line that can provide a preferred bend or flex at a predetermined location, which can provide flexibility to the seal-forming structure 3100 to adapt to the patient's face. The relatively thick portion 3130 can provide sufficient resilience to provide an effective seal against the patient's face. The relatively thin portion 3135 can provide resilience to the seal-forming surface 3105 to burst under pressure without making the hardness and rigidity of the sealing surface 3105 too great to form an effective seal. Alternatively, the thickness of the relatively thick portion 3130 and the relatively thin portion 3135 can be Figure 7 Alternatively, the relatively thin portion 3135 may extend to encompass the sealing surface 3105. Any combination of thicknesses may be used to achieve the desired combination of sealing capability and resistance to bursting.

[0280] The connection point 3165 may be determined based on the desired force applied by the tether 3110 or the desired resilience of the tether. Fig. 7AAs shown, the angle 3170 formed by the relatively thin portion 3135 can change. As the angle 3170 changes, the tension in the relatively thin portion 3135 can also change. The angle 3170 can therefore be optimized to prevent bursting and / or provide patient comfort.

[0281] Angle 3170 can be predetermined in several ways. For example, if the seal-forming structure 3100 is a single molded part, the mold used to form the seal-forming structure 3100 will determine angle 3170. Different angles can be achieved using different molds. Alternatively, the relatively thin portion 3135 can be manufactured in an unconnected state so that the connection point 3165 is formed in a later assembly step. The connection point 3165 can be a mechanical connection or bonding. If bonding is used, the connection point 3165 can be continuously varied within an acceptable attachment range. Alternatively, mechanical attachment can be used. Figure 7B-7I An exemplary mechanical attachment is shown. Figure 7B-7E In the embodiment, the connection point 3165 is keyed so that different angles can be achieved at a single connection point 3165 . Figure 7B and Figure 7C A first connection orientation with a keyed connection is shown and Fig.7D and Fig. 7E A second connection orientation with a pin key connection is shown. Figure 7F-7I In the embodiment, a plurality of dispersed connection points 3165 are provided. The selected connection points 3165 will determine the angle 3170. Figure 7F and Figure 7G A first decentralized connection of a decentralized connection point is shown and Figure 7H and Fig.7I A second decentralized connection of the decentralized connection point is shown. Figure 7B-7I The specific geometry shown in is exemplary only and should not be construed as limiting. Other pinned or dispersed connection geometries may be used.

[0282] As Figure 7 As can be appreciated, the tie 3110 can be positioned to contact the lateral walls of the nose (including the wings of the nose). The tie 3110 can also provide a continuous surface to maintain contact with the sides of the nose above the patient's nasal bones.

[0283] Fig. 8A Shown through Figure 68, the lace 3110 is attached to the wall, thereby forming an outer perimeter 3115 at the attachment portion 3145. As shown, the attachment portion 3145 is a continuous portion of the lace 3110, which can be achieved by molding a one-piece seal-forming structure 3100. However, the attachment portion 3145 can also be achieved in any other conventional manner, such as by fastening the free end of the lace 3110 using some form of mechanical or chemical fastening adhesive. The overall length of the attachment portion 3145 together with the lace 3110 can be selected so that sufficient tension is provided to the lace 3110 to offset the bursting of the sealing surface 3105 when pressure (e.g., treatment pressure) acts on the inner surface of the lace 3110 and the seal-forming structure 3100 is pulled away from the patient's face and / or when there is insufficient headband tension.

[0284] Some or all of the sealing surface 3105 may be a friction (relative) reduced area. This may be achieved by providing a so-called frosted surface. Where friction reduced areas are used, the sealing surface may adhere less to the patient's face than where friction reduced areas are not used. The friction reduced area may be provided as part of the strap 3110 to allow the sides of the patient's nose to slide freely along the sealing surface 3105 and / or the strap 3110.

[0285] Figures 8A-8G It also shows Figure 6 , wherein the intersection of the cross sections shows that the seal-forming structure 3100 includes various saddle-shaped objects and dome-shaped objects. For simplicity, the intersection of various cross sections is represented by its two letter combination in this article. For example, the intersection of the cross section obtained along line 8A-8A and the cross section obtained along line 8B-8B is referred to as intersection AB in this article.

[0286] Cross AB is obtained at a first dome region configured to contact the patient's nose bridge below the patient's nose bridge point. Cross AC is obtained at a first saddle region configured to contact the patient's nose bridge at a position below cross AB. Cross AD is obtained at a second saddle region configured to contact the patient's lower lip and / or supramental point. Cross EF is obtained at a second dome region configured to contact the patient outside the patient's mouth but near the corner of the mouth of the mouth. Cross EG is obtained in a third saddle region configured to contact the patient's cheek adjacent to the patient's nose. Relative to each other, the first dome region has a relatively large curvature along two cross sections and the second dome region has a relatively small curvature along two cross sections. The first saddle region has a relatively large area along two cross sections and the third saddle region has a relatively small curvature along line 8E-8E and a relatively large curvature along line 8G-8G. The second saddle region has a curvature between the first saddle region and the third saddle region, and the curvature along line 8D-8D and line 8A-8A is similar to the curvature along line 8G-8G.

[0287] Fig. 9 Additional aspects of the present technology are shown. For example, instead of the tether 3110 being continuous with the sealing surface 3105, Fig. 9 A tether 3110 is shown below the sealing surface 3105. The tether 3110 is shown primarily as a dashed line. This configuration may be achieved by attaching or forming a strip or tube of material below the sealing surface 3105. This lower tether 3110 may be Fig.10 It is easier to see in.

[0288] Fig. 9 Also shown is a wing 3150 that can extend generally from the sealing surface 3105 to the tether 3110 and / or near the patient's nose. This wing 3150 can be above the maxilla and adjacent to the medial canthus to aid in sealing and / or comfort associated with the patient's nose. This area of ​​the patient's face can be difficult to seal using some known devices. Alternatively, the wing 3150 can extend from the tether 3110, which can fix the position of the wing 3150 relative to the tether 3110. Fig.11 The tether 3110 is shown as a simplified representation of a substantially tubular structure 3120 having a tab 3150 extending therefrom.

[0289] Fig.12 Shows Fig.11 A simplified representation of a substantially tubular structure 3120 attached to a seal-forming structure 3100 is shown. Fig.12 , essentially the tubular structure 3120 can be manufactured separately and fastened to the seal-forming structure 3100.

[0290] Fig.13It is shown how the substantially tubular structure 3120 provides compliance that allows the seal-forming structure 3100 to conform to the patient's face. Even when conforming, the present technology can prevent bursting.

[0291] Blast may be understood to refer to deformation of the seal-forming structure 3100 caused at least in part by a pressure differential created by applying pressure during treatment to cause the sealing surface 3105 to break away from non-sealing contact with the patient's face. For example, the patient may pull the patient interface 3000 away from the face during treatment (i.e., when pressure is applied) and when the patient disengages the patient interface 3000 from the patient's face, the force of the treatment pressure may cause the seal-forming structure 3100 to deform. Then when the patient applies the patient interface 3000 to the patient's face again, the sealing surface 3105 of the seal-forming structure 3100 disengages due to the deformation so that an ineffective seal is formed and pressurized gas leaks from the seal-forming structure 3100. During this repositioning of the seal-forming structure 3100, the internal pressurization of the plenum 3200 may be disturbed and cause a pressure gradient at the proximal end of the sealing flap 3125. The pressure gradient may provide a force that may ultimately cause the sealing flap to burst. Displacement of the seal flap during a blowout may move the seal flap to a position that may disrupt the seal by creating a leak path when the seal structure is again repositioned on the face. When a blowout of the seal-forming structure 3100 occurs at an area proximal to the patient's eye (e.g., when the sealing surface 3105 proximal to the frontal process of the maxilla moves), pressurized gas may flow toward the patient, which may be particularly disruptive and annoying to the patient. Therefore, reducing blowout is advantageous.

[0292] The deformation that may cause the seal-forming structure 3100 to undergo bursting may be in an outward direction, such as away from the patient's face. In fact, in extreme conditions under high internal pressure, bursting may include folding the seal-forming structure 3100 back on itself.

[0293] The contours of the sides of the nose (including the upper nasal bone, the proximal end of the maxillary frontal process, and the lateral cartilage) can be highly variable between users. In addition, in order to seal in this area, the inner edge of the sealing flap 3125 can be bent inward (e.g., bent into the inflation chamber and orthogonal to the Frankfurt level) and deformed to conform to the contours of the sides of the nose. In this way, this area can be particularly easy to seal the fracture after the burst. That is, if the sealing flap 3125 moves outward (e.g., away from the patient's face) during the burst, it is often difficult to return the sealing flap to the sealing position due to the resistance from the pressurized gas force.

[0294] However, blowouts may also occur in other areas that are less susceptible to sealing breaks, such as the cheek area or upper or lower lip area, but which have a generally flat profile along the coronal plane. During blowouts, the sealing flaps may not be able to move significantly from the position required for sealing along this plane and the sealing force provided by the headband carrier is usually sufficient to reposition the sealing flaps to the orientation required to regain a seal.

[0295] The rear surfaces of the sealing flaps at each side of the nose area and the sealing flap bottom corners provide a larger surface area that moves more easily under internal pressurization.

[0296] While a double-walled seal-forming structure 3100 may be susceptible to bursting, a single-walled seal-forming structure 3100 (such as those disclosed in examples of the present technology) may be particularly susceptible to bursting. The absence of an additional bottom buffer structure supporting the outer seal wall may be understood to allow the outer seal wall to deform and turn more easily. Additionally, the bottom buffer in a double-walled buffer may assist in repositioning the outer seal wall against the patient's face when repositioning the patient interface 3000, but this assistance is not present in a single-walled buffer.

[0297] Fig.34A and 34B An example of a related art patient interface 3000 in which a burst occurs is depicted. Fig.34A In FIG. 1 , it can be seen that the seal-forming structure 3100 is deformed so that the sealing surface 3105 at the burst region BR1 moves away from the patient's nose. In addition, it can be seen that the seal-forming structure 3100 is deformed so that the sealing surface 3105 at another burst region BR2 moves away from the side of the patient's nose, for example, from the proximal end of the maxillary frontal process (see FIG. 1 ). Figure 2H ). Similarly, Fig.34B Movement of the sealing surface 3105 of the seal-forming structure 3200 at the blowout region BR2 on one side of the patient's nose (eg, proximal to the frontal process of the maxilla).

[0298] In the above two examples of this burst, the patient interface 3000 is a full-face patient interface that seals around the nose and mouth. Such patient interfaces may be particularly susceptible to bursting because the relatively slender side portions may be less supported in the middle region and bursting may occur in these regions. In addition, the force vectors of the positioning and stabilizing structure 3300 may be oriented substantially parallel to the Frankfurt plane or sagittal plane. Therefore, these force vectors cannot be oriented to apply a force to the seal-forming structure 3100 that is substantially perpendicular to the maxillary frontal process in an inward direction, thereby resisting the deformation of the seal-forming structure 3100 that causes the burst. In other words, the force of the treatment pressure that causes the deformation of the seal-forming structure 3100 has an amplitude and direction that cannot be sufficiently opposite to the force vector from the positioning and stabilizing structure 3100. Although the bursting phenomenon may be particularly relevant to full-face patient interfaces, it should also be understood that nasal patient interfaces may also be susceptible to bursting based on the same theory. Therefore, the lace 3110 disclosed herein can be combined with nasal and full-face patient interfaces that resist bursting.

[0299] In addition, there are also relevant distinctions in the context of the sealing surface 3105. It is understood that the sealing surface 3105 refers broadly to the area on the seal-forming structure 3100 where the seal is intended to occur. Since the anthropometric values ​​of the head and face of each patient are different, the shape and size of the seal-forming structure 3100 can be adapted to provide a comfortable fit and an effective seal in a certain range of patients. Therefore, it should be understood that the seal is intended to occur in various areas of the seal-forming structure 3100 and the sealing surface 3105 can broadly refer to such areas. Once the seal-forming structure 3100 is actually applied to a specific patient in use, a seal can be formed at a specific portion of a wider area where the seal is intended to occur. This area where the seal actually occurs in use can also be understood as the sealing surface 3105. The specific meaning of the sealing surface 3105 can be understood as the subject of the specific context in which the term is used, as described above.

[0300] Returning to the above burst discussion, the occurrence of burst can be understood to refer to a situation in which the sealing surface 3105 intended to seal moves from the patient's face. When such movement occurs, at least one effective seal can be prevented and more seriously, sealing contact may not occur at all.

[0301] Fig.14Another aspect of the present technology is shown, which can prevent the seal-forming structure 3100 from bursting. Here, two ribs 3155 are shown, but any number of ribs can be provided. For example, a single rib or three or more ribs can be provided. Similar to the lace 3110, each rib 3155 tends to prevent the seal-forming structure 3100 (e.g., the sealing surface 3105) from bursting. The ribs may have the same thickness or different thicknesses. For example, one or two ribs 3155 may be about 1 mm thick and one or two ribs 3155 may be about 0.5 mm thick. Alternatively, the ribs may have variable thickness. In the case where the ribs 3155 are attached, the sealing surface 3105 may be convex and in the case where the ribs 3155 are attached, the opposite side may be concave. Therefore, the convex surface and the concave surface define the material thickness in this area. The ribs 3155 can be provided near the patient's nose.

[0302] Fig.15 A cross section of the seal-forming structure 3100 is shown taken perpendicular to the plane of the rib 3155. The rib 3155 may be relatively compliant in compression or easily squeezed under the sealing load, thereby allowing the seal-forming structure 3100 and / or the sealing surface 3105 to conform to the patient's face. This is shown in FIG. Fig.16 However, if Fig.17 As shown, the ribs 3155 can provide a relatively large resistance to tension that can occur when pressure is applied to the interior of the seal-forming structure 3100 (e.g., the surface 3105a opposite the sealing surface 3105). In this manner, the ribs 3155 can tend to resist bursting of the seal-forming structure 3100, e.g., the ribs 3155 can become tensile members. For example, the ribs 3155 tend to maintain the seal-forming structure 3100 in a "molded" state or shape under bursting conditions.

[0303] Fig.18 and 19 An extended flap 3160 is shown that can allow for a larger distance D1 vs. D2 to accommodate facial variations where the distance between each side of the nose and the sealing flap is variable. The sealing surface 3105 of the extended flap 3160 can provide an effective seal against the cheek. The arrows indicate the possible contact area with the patient. This type of structure generally uses a membrane on a traditional silicone mask to seal and is prone to bursting when the position of the mask is readjusted. The tie 3110 or rib 3155 can prevent bursting from occurring while also allowing for distance variations due to facial differences to be effectively sealed.

[0304] Fig. 20A Shows something like Figure 6 , except that a pattern is included on the seal-forming structure 3100. The pattern indicates that the seal-forming structure 3100 has areas 3175 of similar thickness.

[0305] Area 3175A can be a relatively thin area, such as about 0.3 mm. For comfort and compliance at the nose bridge, this area can be thin.

[0306] Region 3175B may be a very thin region, for example, about 0.2 mm. This reduction in thickness relative to region 3175A may significantly reduce tension, which may cause minimal or no facial marking at the nose bridge. The nose bridge is quite bony for most patients and therefore may be prone to marking and / or discomfort.

[0307] Area 3175C can be a semi-thin area, for example about 1 mm. This area can be semi-thin to prevent irritation on the sides of the nose.

[0308] Region 3175D may be a semi-thick region, for example, about 1.5 mm. This region may seal on the cheeks beside the nose. This region on the face is typically oilier than the sides of the nose or nose bridge, which allows for a relatively greater sealing force to be applied without discomfort. The semi-thick region may also provide greater structural rigidity than the thinner region.

[0309] Region 3175E may be a thick region, for example, about 2.0 mm. This thicker surrounding region may provide a more rigid outer wall to provide support for the inner portion of the buffer. Region 3175E may function like the bottom buffer of an existing double-layer buffer design, for example, region 3175E may support the portion of the seal-forming structure 3100 that contacts the patient's face. For example, region 3175E may provide support for regions 3175D and / or 3175F (discussed below). The overall cross-sectional shape of the buffer may be curved to provide a gas (pressure) assist spring for sealing and compliance. This configuration may provide advantages relative to the previous thick bottom buffer of the existing mask, because the disclosed configuration with this thick region may still be able to compress to provide a level of compliance for support, thereby forming a seal. This may increase the overall distance range over which the buffer may be compressible when compared to the previous double-layer design.

[0310] Region 3175F may be a thin film region, e.g., about 0.3-0.5 mm. The portion that seals below the lower lip may be thin, e.g., about 0.3 mm, to allow for mandibular movement. This thin film region may also provide a lighter load on the patient's gums for comfort. The portion of region 3175F adjacent to region 3175D is where the frenulum 3110 is positioned. This portion of region 3175F may be thin, e.g., about 0.5 mm, to allow for compression of the frenulum 3110. The portion of region 3175F that is configured to contact each side of the patient's mouth may be about 0.5 mm and may act like a sealing film layer of a double layer buffer, which may maintain a seal with minimal changes in facial contours and movement during sleep.

[0311] Although different lines are shown between regions 3175, the regions may smoothly transition in relative thickness from region to region and thus the boundaries between regions are approximate. This may be advantageous because it limits the ability of the naked eye to discern thick and thin regions, which may also be more aesthetically pleasing. However, different transitions may also be provided.

[0312] Fig. 20B Another seal-forming structure 3100 is shown having similar elastic wall thickness areas of the seal-forming structure 3100.

[0313] Region 3180A can be a relatively thin region, for example, about 0.3 mm elastic wall thickness. This region can be thin to be comfortable and conformable at the nose bridge.

[0314] Region 3180B may be a very thin region, e.g., about 0.2 mm elastic wall thickness. This reduction in thickness relative to region 3180A may significantly reduce tension, which may cause minimal or no facial marking at the nose bridge. The nose bridge is quite bony for most patients and may therefore be prone to marking and / or discomfort. Additionally, region 3180A may extend from region 3180B to the mask shell 3816 attached to the front side of the seal-forming structure 3100.

[0315] Both regions 3180A and 3180B may span a sagittal plane 3185 that may bisect the seal-forming structure 3100 into a left side and a right side. The sagittal plane 3185 may include a line 3190 that may be tangent to the seal-forming structure 3100 at only two tangent points: a first tangent point (upper tangent point) 3195 and a second tangent point (lower tangent point) 3196. Either region 3180A or region 3180B may include the first tangent point 3195. If the first tangent point 3195 is not included, the region 3180A or 3180B may be located near the first tangent point 3195.

[0316] A portion of region 3180B may also be configured to seal against the sides of the nose above the nasal bones and / or lateral cartilages. This portion of region 3180B may be configured to contact the sides of the nose and / or lateral cartilages to form a seal before the seal-forming structure contacts the rest of the face during use. This portion of region 3180B may also be very thin to prevent excessive force and stinging at the sides of the nose to avoid airway occlusion.

[0317] Additionally, the central opening 3197 defined by the posterior side of the seal-forming structure 3100 may be narrower in region 3180B to make the seal-forming structure 3100 more compliant in directions toward and away from the sides of the patient's nose (i.e., along a plane orthogonal to the sagittal plane 3185).

[0318] Region 3180C may be a semi-thin region, for example, about 0.85 mm. This region may be semi-thin to prevent tingling on each side of the nose. In addition, region 3180C may be adjacent to region 3180A and region 3180B.

[0319] Region 3180D may be a transition region where the elastic wall thickness changes. Specifically, the elastic wall thickness of the seal-forming structure 3100 in region 3180D may increase in a direction toward the central opening 3197. For example, the elastic wall thickness may be reduced from about 2.0 mm to 1.3 mm. The change in elastic wall thickness may be gradual or sudden. In addition, region 3180D may abut regions 3180A and 3180C but not region 3180B.

[0320] The tether 3110 may extend from region 3180D and / or region 3180C.

[0321] Region 3180E may be a thick region, e.g., about 2.0 mm of elastic wall thickness. This thicker surrounding region may provide a more rigid outer wall to provide support for the inner portion of the buffer. Region 3180E may function like the bottom buffer of existing double-layer buffer designs, e.g., region 3180E may support the portion of the seal-forming structure 3100 that contacts the patient's face. Additionally, region 3180E may abut regions 3180D and 3180A but not abut regions 3180B and 3180C.

[0322] The overall cross-sectional shape of the bumper may be curved to provide a gas (pressure) assisted spring for sealing and compliance. This configuration may provide advantages over previous thick bottom bumpers of existing masks, as the disclosed configuration with this thick area may still be able to compress to provide a supportive level of compliance, thereby forming a seal. This may increase the overall range of distances in which the bumper may compress when compared to previous dual layer designs.

[0323] Region 3180F may be a semi-thick region, e.g., about 1.3 mm resilient wall thickness. This region may seal on the cheek next to the oral cavity. This region on the face is typically oilier than the sides of the nose or nose bridge, which allows for a relatively greater sealing force to be applied without discomfort. The semi-thick region may also provide greater structural rigidity than the thinner regions. Region 3180f may abut region 3180D and region 3180C but not abut region 3180A, 3180B, or 3180E.

[0324] Region 3180G may be a thin film region, e.g., about 0.3 mm elastic wall thickness. The portion sealed below the lower lip may be thin to allow for mandibular movement. This thin film region may also provide a lighter load on the patient's gums for comfort. Region 3180G may act like a sealing film layer of a double-layer buffer, which may maintain a seal with minimal changes in facial contour and movement during sleep. In addition, region 3180G may extend from the central opening 3197 to the mask shell 3816 attached to the front side of the seal-forming structure 3100. Region 3180G may be adjacent to region 3180D, region 3180E, and region 3180F but not adjacent to region 3180A, 3180B, or 3180C.

[0325] Region 3180H may be a flap region extending from tether 3110. The thickness of the elastic wall in region 3180H may be 0.5 mm. In addition, region 3180H may be configured to move independently of tether 3110. Region 3180H may be adjacent to region 3180B, region 3180C, and region 3180F but not adjacent to region 3180A, 3180D, 3180E, or 3180G.

[0326] Although different lines are shown between regions 3175, the regions may smoothly transition in relative thickness from region to region and thus the boundaries between regions are approximate. This may be advantageous because it limits the ability of the naked eye to discern thick and thin regions, which may also be more aesthetically pleasing. However, different transitions may also be provided.

[0327] exist Figures 8A-8G In the view of FIG. 3180A through FIG. 3180H, it should be understood that regions 3180A through 3180H have various curvatures. For example, at least a portion of region 3180A may be a dome-shaped region, while region 3180B may have a saddle shape. Additionally, various portions of regions 3180C, 3180D, 3180E, 3180F, and 3180H may be saddle-shaped, dome-shaped, or cylindrical. Additionally, region 3180G may be saddle-shaped.

[0328] Fig. 20C Sealing surface 3105 is shown. Area 3198A on the upper portion of sealing surface 3105 may have relatively reduced friction. This may be achieved by providing a so-called frosted surface. Where a friction reducing area is used, the sealing surface may adhere less to the patient's face than where a friction reducing area is not used. The friction reducing area may be provided as part of the strap 3110 to allow the sides of the patient's nose to slide freely along the sealing surface 3105 and / or strap 3110. Area 3198B in the remainder of the sealing surface 3105. A more tacky surface may prevent or reduce the possibility of leakage due to movement of the patient's chin.

[0329] Fig. 20CAlso shown are a plurality of closed paths 3199A on a continuous surface around the central opening 3197. The closed paths 3199A may be coaxial with the central opening 3197. For purposes of this disclosure, a path coaxial with the central opening 3197 may substantially follow the shape of the central opening 3197 and may be substantially the same when viewed from the front (i.e., Fig. 20C The viewing point shown) can be a specific distance from the center opening 3197 throughout the path. Fig. 20C Also shown is one of a plurality of open pathways 3199B extending from the central opening 3197 to the mask shell 3816.

[0330] International Patent Application Publication No. WO 2006 / 074513 discloses a buffer, which is incorporated by reference in its entirety. In this type of buffer, a thicker bottom buffer and a thinner film layer are disclosed. The thinner film provides a slight seal on the face under pressure (i.e., inflated), while the bottom buffer provides structural support to support the seal. The curved cross-section provides a pressure-assisted spring to support the seal under headband tension.

[0331] In contrast, a seal-forming structure 3100 having one or more of these regions 3175 may have only a single layer, which may combine the functions of the membrane and bottom buffer of WO 2006 / 074513. The maximum thickness of the cross section of region 3175 (e.g., region 3175E) may be thinner than the maximum thickness of the bottom buffer of WO 2006 / 074513. However, combining the bottom buffer and the membrane into a single layer allows sufficient structural rigidity to maintain the shape of the buffer and support the sealing action. In addition, the reduced maximum thickness allows the single layer of the seal-forming structure 3100 to be compressed a greater distance than the previous double-layer design, thereby allowing increased compliance before being reduced to the lowest point.

[0332] International Patent Application Publication No. WO 2014 / 117227, each of which is incorporated herein by reference in its entirety, discloses a system having a mask in which a foam buffer is supported by a flexible clip attached to a second, more rigid clip. Fig.21 A similar system is disclosed, but having two ribs 3155 that have been joined, wherein the ribs are configured to be on opposite sides of the patient's nose. Fig.21 Only one rib is visible in the figure. These ribs act as ties to prevent the flexible clip and attached foam seal from bursting. Although ribs 3155 are shown, ties 3110 can replace ribs 3155.

[0333] Thus, in another example of the present technology, the seal-forming structure 3100 may include a buffer 3810, which may be made using foam. The buffer is defined as a single area that peripherally covers the patient's nose in the case of a nasal mask and covers the nose and mouth in the case of a full facial mask. The foam buffer may be made, for example, of any suitable material such as one or more of the following exemplary materials: polyethylene, polyurethane, ethylene ethyl acrylate (EVA). In some cases, the foam buffer may be a semi-open closed cell foam, such as a foam made of polyurethane. The buffer of the semi-open cell foam may have a limited permeability, such as within the range described in more detail in International Patent Application Publication WO 2014 / 117227, wherein the permeabilities disclosed in that patent are incorporated herein by reference.

[0334] The bumper 3810 may have a substantially triangular or pear-like shape with a sealing surface that follows the contours of the user's face. The foam bumper is designed to be attached to a first supporting (e.g., flexible) clip 3812, which itself is attached to a second, more rigid clip 3814 (e.g., Fig. 22 3816). In one embodiment, the first support clip 3812 can be a flexible clip that is more rigid than the foam buffer but softer or more flexible than the second clip 3814. It is the combination of the foam and the flexible clip that defines the physical properties of the overall sealing interface. The flexible clip allows the interface to adapt to major changes and successfully adapt to the contours of the patient's face. The compliant nature of the foam buffer provides micro-adjustments and forms a comfortable interface layer that interacts with the patient's skin.

[0335] The first support clip 3812 can easily burst due to its flexible and compliant nature. Fig.21 Another aspect of the present technology is shown, which can prevent the first support clip 3812 and the attached buffer 3810 from bursting. Here, the configuration shown includes two ribs 3155 (only one is visible due to the symmetry and orientation of the figure) but any number of ribs can be provided. For example, a single rib or three or more ribs can be provided. Similar to the lace 3110, each rib 3155 tends to prevent the first support clip 3812 and the attached buffer 3810 from bursting by acting as a tensile member. The ribs can have the same thickness or different thicknesses. For example, one or two ribs 3155 can be about 1 mm thick and one or two ribs 3155 can be about 0.5 mm thick. Alternatively, the ribs can have variable thickness. The ribs 3155 can be provided near the patient's nose.

[0336] Fig.21A side view of a buffer assembly 3800 is shown including a seal-forming structure 3100 including a mask shell 3816, a permanently attached first support clip 3812, and a foam buffer 3810. As shown, the flexible first support clip can be secured to the mask shell 3816 by a pair of ribs 3155 that act as ties to prevent bursting. The ribs 3155 can be relatively compliant in compression or easily squeezed under the sealing load, allowing the seal-forming structure 3100 to conform to the patient's face. The tension provided by the ribs 3155 can be adjusted by changing any one or more of the material composition, geometry, or position of the ribs 3155.

[0337] Fig.23 The foam bumper 3810 and the flexible first support clip 3812 are shown with the patient contacting surface visible. Fig.23A To pass through Fig.23 A cross section is taken along the vertical plane of symmetry and illustrates the foam bumper, the flexible first support clip 3812 and the ribs 3155 .

[0338] In another example of the present technology, the seal-forming structure 3100 may include a pair of ties 3110 to prevent the first support clip 3812 from bursting. Each tether 3110 is formed by folding a flexible support clip 3812 having an outer perimeter inwardly to form a connection point 3165. In this way, the tether 3110 can form a substantially tubular structure 3120. The tether forms a resistance to bursting from internal pressurization of the inflatable chamber. The tension provided by the rib 3155 can be adjusted by changing any one or more of the material composition, geometry, or position of the connection point 3165 where the tether 3110 is located.

[0339] Figure 24-27 A seal-forming structure 6000 is shown that is similar to the seal-forming structure 3100 except as described herein. Like reference numerals are similar to those described above with respect to the seal-forming structure 3100 and thus are not further repeated herein. Figure 24-27 The seal-forming structure 6000 shown in FIG. 6 may have features generally suitable for use with a nasal mask.

[0340] Figures 25B-25G It also shows Fig.25A 6000, wherein the intersection of the cross sections shows that the seal forming structure 6000 includes various saddle-shaped objects and dome-shaped objects. For simplicity, the intersection of various cross sections is represented by its two letter combination in this article. For example, the intersection of the cross section obtained along line 25B-25B and the cross section obtained along line 25C-25C is referred to as intersection BC in this article.

[0341] Cross BC is obtained at a first saddle area configured to contact the patient's nose bridge below the patient's nose bridge point. Along line 25B-25B, the curvature is relatively small and along line 25C-25C, the curvature is relatively large. The curvature along line 25B-25B is large enough so that the first saddle area approaches a cylindrical area. If desired, the first saddle area can be a cylindrical area. Cross BD is obtained at a second saddle area configured to contact the patient's upper lip. The curvature along line 25B-25B is relatively small compared to along line 25D-25D. Cross CF is obtained at a first dome area configured to contact the patient's nose adjacent to the nose bridge. The curvature along line 25F-25F and along line 25C-25C are relatively similar. Cross FG is obtained at a third saddle area formed by the tether 3110, which is configured to contact the patient's nose. The curvature along line 25F-25F is relatively small and close to zero curvature. The curvature along line 25G-25G is relatively large compared to line 25F-25F. Therefore, the third saddle region is close to a cylindrical region and can be a cylindrical region if preferred. The intersection EF is obtained at the second dome region configured to contact the patient's nose side. The curvature along lines 22E-22D and 22F-22F are relatively similar.

[0342] Fig. 27 A view of a seal-forming structure 6000 is shown, except that a pattern is included on the seal-forming structure 6000. The pattern represents areas 6005 of the seal-forming structure 6000 having similar features and / or thicknesses.

[0343] The area 6005A, referred to herein as the nose area, may have a thickness of approximately 0.5 mm, which may prevent the seal-forming structure 6000 from wrinkling and / or folding in this area.

[0344] Region 6005B, referred to herein as the base region, can have a thickness between about 2.9 mm and 3.45 mm, for example, the thickness can be 2.9 mm at 6005B2, 3.0 mm at 6005B1 and 6005B3, and 3.45 mm at 6005B4. Region 6005B can provide support or a base for the sealing flap 3125 and can provide and maintain the overall shape of the seal-forming structure 6000.

[0345] Region 6005C, referred to herein as the bottom bumper region, may have a thickness ranging from 0.95 mm to 2.1 mm. As shown, this region may be the primary region of the bumper. For example, region 6005C may be approximately 50% of the bumper. The upper portion of region 6005C1 may have a thickness between 0.95 mm and 1.6 mm, while the lower portion of region 6005C2 may have a thickness between 1.25 mm and 2.1 mm. The thickness may vary continuously between these values ​​to provide a smooth appearance.

[0346] The area 6005D, referred to herein as the membrane area, may form approximately one-third of the seal-forming structure 6000 and may include the tether 3110. The thickness may be approximately 0.35 mm. This area may be relatively thin so that it may act as an agitated (e.g., pressure agitated) seal against the patient's face. The side segments 6005D1 may be substantially parallel to the patient's face, which may reduce the likelihood of wrinkling and, therefore, causing leaks. Such wrinkling may be more likely to occur during dynamic conditions, such as when sealing under movement.

[0347] Region 6005F, referred to herein as the spring region, may have a thickness ranging from 1.1 mm to 1.8 mm. This region may act as a spring and allow compression on the upper lip to reduce pressure thereon. This region may gradually become stiffer from the center of the upper lip to the corner of the nose (e.g., the apex of the nose wing), with region 6005F being the stiffest.

[0348] Region 6005G, referred to herein as the nose tip region, may be relatively deeper to better accommodate patients with relatively high nose bridges and / or to provide a more comfortable seal. The thickness of this region may be similar to the thickness of region 6005D (e.g., about 0.35 mm) and may therefore be a sub-region of region 6005D.

[0349] When used in this specification to describe the first support clip 3812, the expressions "soft" and "flexible" and their derivative expressions are intended to have the meaning of expressing "resilient", as specifically defined in the section "Terms Related to Patient Interface". That is, the flexible support clip is capable of substantially elastic deformation and quickly releases substantially all of its energy after deflation.

[0350] The seal-forming structure 3100 may have advantages in one or more forms of the present technology. For example, human facial structure may include variations from person to person, which is challenging when designing a seal for use with many facial variations. The variations may include different shapes of facial structure (e.g., different shaped noses and / or different curves of cheeks) and / or different tissue contents (e.g., more or less fatty tissue). These variations may cause an existing seal-forming structure to work well for one person but poorly for another. Moreover, independent of facial structure, perceived comfort may vary from person to person. In the case of the seal-forming structure 3100 described herein, a higher percentage of users may effectively use the seal-forming structure 3100 (e.g., a higher percentage of users may cause the seal-forming structure 3100 to form an effective seal and / or a higher percentage of users may perceive the seal-forming structure 3100 to be comfortable) compared to existing seal-forming structures.

[0351] Figures 28A to 28MAn exemplary full face seal forming structure 3100 is depicted, which includes a tether 3110. Figure 28K As can be seen in, for example, the tether 3110 can extend between a first interior surface area 3180 and a second interior surface area 3185. The first interior surface area 3180 can be understood to be opposite the sealing surface 3105 of the seal-forming structure. The second interior surface area 3185 can be understood to be located at any position. Figure 28K In the depicted example, the second interior surface area 3185 is located inside the seal-forming structure 3100. In other examples, the second interior surface area 3185 can be located inside the plenum 3200 such that the tether 3110 extends between the seal-forming structure 3100 and the plenum 3200. The location of the second interior surface area 3185 can be based on the desired directional component of the tension vector of the tether 3100 to resist the burst force.

[0352] Figure 28L and 28M A detailed cross-sectional view is shown and specifically illustrates the connection point 3165 where the tether 3110 extends from the second interior surface region 3165. The connection point 3165 may be curved in this example to reduce stress concentrations in this area, thereby reducing the tendency of the tether 3110 to tear. Additionally, the tether 3110 may extend from the second interior surface region 3185 at a distance from the bonding area 3190 where the seal-forming structure 3100 is bonded to the plenum 3200 during production. This may prevent damage to the tether 3110 when the seal-forming structure 3100 is bonded to the plenum 3200. Figures 29C to 29E The tether 3110 is also shown extending from the second interior surface region 3185 at a distance from the bonding area 3190 and the inflatable chamber 3200.

[0353] Figures 28J to 28L The cross-sectional views of FIG. 31 also show that the tether 3110 can extend from the first interior surface area 3180. As can be seen in these examples, the tether 3110 extends from the first interior surface area 3110 near the sealing flap 3125 rather than at the edge of the sealing flap. However, in alternative examples, the tether 3110 can extend from the first interior surface area 3180, closer to the sealing flap 3125, or at the edge of the sealing flap.

[0354] Fig. 30A and 30B An example of a full facial patient interface 3000 is depicted that includes a seal-forming structure 3100 having features of the present technology but without the depicted positioning and stabilizing structure 3300 .

[0355] Figures 31A to 31M Another example of the present technology is depicted as a nose seal forming structure 3100. Figure 31KAs can be seen in the figure, for example, the tether 3110 extends continuously from the sealing flap 3125. Therefore, there may be no defined edge in this area. In addition, it should also be understood that in this arrangement at least a portion of the tether 3110 may form a portion of the seal-forming structure 3105 during use, depending on the patient's facial anthropometric values.

[0356] Figures 32C to 32E In the example of a nasal patient interface 3000 shown, the strap 3110 can extend from the second interior surface region 3185 a greater distance from the bonding region 3190 than in a full facial patient interface 3000 .

[0357] 4.3.2 Inflatable chamber

[0358] In the area where the seal is formed in use, the plenum 3200 has a perimeter that is shaped complementary to the surface contour of an average human face. In use, the boundary edge of the plenum 3200 is in close proximity to the adjacent surface of the face. Actual contact with the face is provided by the seal-forming structure 3100. The seal-forming structure 3100 may extend along the entire perimeter of the plenum 3200 in use.

[0359] In some forms of the present technology, the plenum chamber 3200 is constructed of a transparent material (e.g., transparent polycarbonate). The use of a transparent material can reduce the inconvenience of the patient interface and help improve compliance with the use of the treatment. The use of a transparent material can help the clinician observe how the patient interface is positioned and functions.

[0360] In some forms of the present technology, the plenum chamber 3200 is constructed of a translucent material. The use of a translucent material can reduce the inconvenience of the patient interface and help improve compliance with the use of the therapy.

[0361] 4.3.3 Positioning and stabilizing the structure

[0362] The seal-forming structure 3100 of a patient interface 3000 of the present technology may be maintained in a sealed position during use by a positioning and stabilising structure 3300 .

[0363] In one form, the positioning and stabilizing structure 3300 provides a retaining force at least sufficient to overcome the face-unfolding effect of the positive pressure in the inflatable chamber 3200.

[0364] In one form, the positioning and stabilising structure 3300 provides a retaining force on the patient interface 3000 that overcomes the effects of gravity.

[0365] In one form, the positioning and stabilising structure 3300 provides a holding force as a safety margin against the potential effects of damaging forces on the patient interface 3000, such as from tube resistance or accidental interference with use of the patient interface.

[0366] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is constructed in a manner consistent with being worn by a patient while sleeping. In one example, the positioning and stabilizing structure 3300 has a small side or cross-sectional thickness to reduce the sensed or actual volume of the instrument. In one embodiment, the positioning and stabilizing structure 3300 includes at least one strap that is rectangular in cross-section. In one embodiment, the positioning and stabilizing structure 3300 includes at least one flat strap.

[0367] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured not to be too large and bulky to prevent a patient from sleeping in a supine sleeping position with the back area of ​​the patient's head resting on a pillow.

[0368] In one form of the present technology, a positioning and stabilizing structure 3300 is provided that is configured not to be too large and bulky to prevent a patient from sleeping in a side sleeping position with the side area of ​​the patient's head resting on a pillow.

[0369] In one form of the present technology, the positioning and stabilizing structure 3300 comprises a strap constructed from a laminate of a fabric patient contacting layer, a foam inner layer, and a fabric outer layer. In one form, the foam is porous to allow moisture (e.g., sweat) to pass through the strap. In one form, the fabric outer layer comprises a lacing material for engaging with a hook material portion.

[0370] In some forms of the present technology, the positioning and stabilizing structure 3300 includes a strap that is extendable, such as elastically extendable. For example, the strap can be configured to withstand tension during use and direct the force to seal the bumper to a portion of the patient's face. In one example, the strap can be configured as a tie.

[0371] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a strap that is flexible, e.g., non-rigid. An advantage of this aspect is that the strap makes it more comfortable for the patient to lie on while sleeping.

[0372] In some forms of the present technology, the positioning and stabilizing structure 3300 comprises a belt configured to be breathable to allow moisture vapor to be transmitted through the belt.

[0373] In some forms of the present technology, a system is provided that includes more than one positioning and stabilizing structure 3300, each of which is configured to provide a retention force to correspond to a different range of sizes and / or shapes. For example, the system may include one form of positioning and stabilizing structure 3300 that is suitable for large-sized heads but not for small-sized heads and another form of positioning and stabilizing structure that is suitable for small-sized heads but not for large-sized heads.

[0374] 4.3.4 Ventilation port

[0375] In one form, the patient interface 3000 includes a ventilation port 3400 constructed and arranged to allow flushing of exhaled gases, such as carbon dioxide.

[0376] One form of vent 3400 in accordance with the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0377] The ventilation port 3400 may be located in the plenum chamber 3200. Alternatively, the ventilation port 3400 is located in a decoupling structure such as a swivel.

[0378] 4.3.5 Decoupling structure

[0379] In one form, the patient interface 3000 includes at least one decoupling structure, such as a swivel or a ball and socket.

[0380] 4.3.6 Connection Port

[0381] The connection port 3600 allows connection to the air circuit 4170 .

[0382] 4.3.7 Forehead support

[0383] In one form, the patient interface 3000 includes a forehead support 3700 .

[0384] 4.3.8 Anti-asphyxia valve

[0385] In one form, patient interface 3000 includes an anti-asphyxia valve.

[0386] 4.3.9 Ports

[0387] In one form of the present technology, the patient interface 3000 includes one or more ports that allow access to the volume within the plenum chamber 3200. In one form, this allows the clinician to provide supplemental oxygen. In one form, this allows direct measurement of properties of the gas within the plenum chamber 3200, such as pressure.

[0388] 4.4RPT device

[0389] The RPT device 4000 according to one aspect of the present technology includes mechanical, pneumatic, and / or electrical components and is configured to execute one or more algorithms 4300. The RPT device 4000 may be configured to generate an air flow for delivery to a patient's airway, such as to treat one or more of the respiratory conditions described anywhere else in this document.

[0390] The RPT device can have an outer housing 4010 that is constructed in two parts: an upper portion 4012 and a lower portion 4014. In addition, the outer housing 4010 can include one or more panels 4015. The RPT device 4000 includes a chassis 4016 that supports one or more internal components of the RPT device 4000. The RPT device 4000 can include a handle 4018.

[0391] The pneumatic path of the RPT device 4000 may include one or more air path items, such as an inlet air filter 4112, an inlet muffler 4122, a pressure generator 4140 (e.g., a blower 4142) capable of supplying air at a positive pressure, an outlet muffler 4124, and one or more converters 4270, such as a pressure sensor 4272 and a flow rate sensor 4274.

[0392] One or more air path items may be disposed within a removable separate structure, which will be referred to as a pneumatic block 4020. The pneumatic block 4020 may be disposed within the outer housing 4010. In one form, the pneumatic block 4020 is supported by, or forms part of, the chassis 4016.

[0393] The RPT device 4000 may have a power source 4210, one or more input devices 4220, a central controller 4230, a treatment device controller 4240, a pressure generator 4140, one or more protection circuits 4250, a memory 4260, a converter 4270, a data communication interface 4280, and one or more output devices 4290. The electrical components 4200 may be mounted on a single printed circuit board assembly (PCBA) 4202. In an alternative form, the RPT device 4000 may include more than one PCBA 4202.

[0394] 4.4.1 Mechanical and pneumatic components of RPT device

[0395] The RPT device may include one or more of the following components in an integral unit. In an alternative form, one or more of the following components may be provided as separate units.

[0396] 4.4.1.1 Air filter

[0397] An RPT device according to one form of the present technology may include an air filter 4110, or multiple air filters 4110.

[0398] In one form, the inlet air filter 4112 is positioned at the beginning of the pneumatic path upstream of the pressure generator 4140 .

[0399] In one form, an outlet air filter 4114 , such as an antimicrobial filter, is disposed between the pneumatic block 4020 and the patient interface 3000 .

[0400] 4.4.1.2 Silencer

[0401] An RPT device according to one form of the present technology may include a silencer 4120 or a plurality of silencers 4120 .

[0402] In one form of the present technology, an inlet muffler 4122 is disposed in the pneumatic path upstream of the pressure generator 4140 .

[0403] In one form of the present technology, an outlet muffler 4124 is disposed in the pneumatic path between the pressure generator 4140 and the patient interface 3000 .

[0404] 4.4.1.3 Pressure generator

[0405] In one form of the present technology, the pressure generator 4140 for generating a positive pressure air flow 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 of up to about 120 liters per minute and at a positive pressure in the range of about 4 cm H2O to about 20 cm H2O or in other forms up to about 30 cm H2O. The blower may be as described in any of the following patents or patent applications, which are incorporated herein by reference in their entirety: U.S. Patent No. 7,866,944; U.S. Patent No. 8,638,014; U.S. Patent No. 8,636,479; and PCT Patent Application Publication No. WO2013 / 020167.

[0406] The pressure generator 4140 is under the control of the treatment device controller 4240.

[0407] In other words, the pressure generator 4140 may be a piston driven pump, a pressure regulator connected to a high pressure source (eg, a compressed air reservoir), or a bellows.

[0408] 4.4.1.4 Converter

[0409] The transducer may be internal to the RPT device, or external to the RPT device. An external transducer may be disposed on or form part of, for example, an air circuit such as a patient interface. An external transducer may be in the form of a non-contact sensor, such as a Doppler radar motion sensor that transmits or transfers data to the RPT device.

[0410] 4.4.2 RPT device electrical components

[0411] 4.4.2.1 Power supply

[0412] The power source 4210 may be disposed inside or outside the outer housing 4010 of the RPT device 4000 .

[0413] In one form of the present technology, the power supply 4210 provides power only to the RPT device 4000. In another form of the present technology, the power supply 4210 provides power to both the RPT device 4000 and the humidifier 5000.

[0414] 4.4.2.3 Input device

[0415] In one form of the present technology, the RPT device 4000 includes one or more input devices 4220 in the form of buttons, switches, or dials to allow a person to interact with the device. The buttons, switches, or dials may be physical devices or software devices accessed via a touch screen. In one form, the buttons, switches, or dials may be physically connected to the external housing 4010, or in another form, the buttons, switches, or dials may be in wireless communication with a receiver that is electrically connected to a central controller.

[0416] 4.4.2.3 Output devices including optional displays and alarms

[0417] Output devices according to the present technology may take the form of one or more of visual, auditory and tactile units.The visual display may be a liquid crystal display (LCD) or a light emitting diode (LED) display.

[0418] 4.5 Air circuit

[0419] The air circuit 4170 according to one aspect of the present technology is a conduit or tube that is constructed and arranged to allow air flow to flow between two components, such as the RPT device 4000 and the patient interface 3000, in use.

[0420] In particular, the air circuit 4170 may be fluidly connected to the outlet of the pneumatic block 4020 and the patient interface. The air circuit may be referred to as an air delivery tube. In some cases, the circuit may have separate branches for inspiration and exhalation. In other cases, a single branch is used.

[0421] In certain forms, the air circuit 4170 may include one or more heating elements that are configured to heat the air in the air circuit, for example to maintain or increase the temperature of the air. The heating element may be in the form of a heating wire loop and may include one or more transducers, such as a temperature sensor. In one form, the heating wire loop may be helically wound around the axis of the air circuit 4170. The heating element may be in communication with a controller such as a central controller. An example of an air circuit 4170 including a heating wire loop is described in U.S. Patent 8,733,349, which is incorporated herein by reference in its entirety.

[0422] 4.6 Humidifier

[0423] 4.6.1 Overview of Humidifiers

[0424] In one form of the present technology, a humidifier 5000 (e.g., Figure 3V and 3W ) to change the absolute humidity of the air or gas for delivery to the patient relative to the ambient air. Typically, the humidifier 5000 is used to increase the absolute humidity of the air flow and increase the temperature of the air flow (relative to the ambient air) before delivery to the patient's airway.

[0425] The humidifier 5000 may include a humidifier reservoir 5110, a humidifier inlet 5002 for receiving an air flow, and a humidifier outlet 5004 for delivering a humidified air flow. Figure 3V and Figure 3W As shown, the inlet and outlet of the humidifier reservoir 5110 can be a humidifier inlet 5002 and a humidifier outlet 5004, respectively. The humidifier 5000 can also include a humidifier base 5006, which can be adapted to receive the humidifier reservoir 5110 and include a heating element 5240.

[0426] 4.6.2 Humidifier components

[0427] 4.6.2.1 Water storage tank

[0428] According to one arrangement, the humidifier 5000 may include a water reservoir 5110 configured to hold or retain a volume of liquid (e.g., water) to evaporate for humidifying the air flow. The water reservoir 5110 may be configured to hold a predetermined maximum volume of water so as to provide adequate humidification for at least the duration of a respiratory therapy session, such as a night of sleep. Typically, the reservoir 5110 is configured to hold several hundred milliliters of water, for example, 300 milliliters (ml), 325 ml, 350 ml, or 400 ml. In other forms, the humidifier 5000 may be configured to receive a supply of water from an external water source, such as a building's water supply.

[0429] According to one aspect, the water reservoir 5110 is configured to add humidity to the air flow from the RPT device 4000 as the air flow passes therethrough. In one form, the water reservoir 5110 may be configured to encourage the air flow to travel in a tortuous path through the reservoir 5110 when in contact with the water content therein.

[0430] According to one form, the reservoir 5110 may be arranged, for example, along a Figure 3V and Figure 3W The lateral orientation shown is removed from the humidifier 5000.

[0431] The reservoir 5110 may also be configured to prevent liquid from flowing out through any aperture and / or among its subassemblies, such as when the reservoir 5110 is displaced and / or rotated from its normal operating orientation. Since the air flow 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.

[0432] 4.6.2.2 Conducting part

[0433] According to one arrangement, the reservoir 5110 includes a conductive portion 5120 that is configured to allow efficient transfer of heat from the heating element 5240 to the liquid content in the reservoir 5110. In one form, the conductive portion 5120 may be configured as a plate, but other shapes may also be equally suitable. All or a portion of the conductive portion 5120 may be made of a thermally conductive material, such as aluminum (e.g., having a thickness of 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 with a material of appropriate geometry that has a lower conductivity.

[0434] 4.6.2.3 Humidifier reservoir base

[0435] In one form, the humidifier 5000 may include a humidifier reservoir base 5130 (eg, Figure 3V ), which is configured to receive the humidifier reservoir 5110. In certain arrangements, the humidifier reservoir base 5130 may include a locking structure, such as a locking rod 5135 configured to hold the reservoir 5110 in the humidifier reservoir base 5130.

[0436] 4.6.2.4 Water level indicator

[0437] The humidifier reservoir 5110 may include Figure 3V-3W 5150. In some forms, the water level indicator 5150 may provide a user (e.g., patient 1000 or a caregiver) with one or more indications of the amount of water capacity in the humidifier reservoir 5110. The one or more indications provided by the water level indicator 5150 may include an indication of a maximum predetermined capacity of water, any portion thereof, such as 25%, 50%, 75%, or a capacity such as 200 ml, 300 ml, or 400 ml.

[0438] 4.6.2.5 Heating elements

[0439] In some cases, a heating element 5240 can be provided to the humidifier 5000 to provide heat input to one or more of the water volumes in the humidifier reservoir 5110 and / or to the air flow. The heating element 5240 can include a heat generating component, such as a resistive electric heating rail. A suitable example of a heating element 5240 is a layered heating element, such as the layered heating element described in PCT Patent Application Publication No. WO2012 / 171072, which is incorporated herein by reference in its entirety.

[0440] In some forms, the heating element 5240 may be provided in the humidifier base 5006, such as Figure 5A As shown in , heat can be provided to the humidifier reservoir 5110 primarily by conduction.

[0441] 4.7 Glossary

[0442] For the purposes of the present invention disclosure, one or more of the following definitions may apply in certain forms of the present invention. In other forms of the present invention, alternative definitions may apply.

[0443] 4.7.1 General

[0444] Air: in some forms of the present technology, air may be considered to mean atmospheric air, and in other forms of the present technology, air may be considered to mean some other combination of breathable gases, such as atmospheric air enriched with oxygen.

[0445] Environment: In certain forms of the present technology, the term environment can have the meaning of (i) external to the treatment system or patient, and (ii) directly surrounding the treatment system or patient.

[0446] For example, the ambient humidity relative to the humidifier may be the humidity of the air directly surrounding the humidifier, such as the humidity within the room that the patient is sleeping in. This ambient humidity may be different from the humidity outside the room that the patient is sleeping in.

[0447] In another example, ambient pressure can be the pressure immediately surrounding or external to the body.

[0448] In some forms, ambient (e.g., acoustic) noise may be considered to be the background noise level in the room the patient is in, in addition to noise generated, for example, by the RPT device or from a mask or patient interface. Ambient noise may be generated by sound sources outside the room.

[0449] Automatic Positive Airway Pressure (APAP) Therapy: CPAP therapy in which the therapy pressure is automatically adjustable between a minimum and a maximum limit, e.g., with each breath, depending on whether there is an indication of an SBD event.

[0450] Continuous Positive Airway Pressure (CPAP) therapy: A breathing pressure therapy in which the treatment pressure can be approximately constant throughout the patient's breathing cycle. In some forms, the pressure at the airway entrance will be slightly higher during exhalation and slightly lower during inspiration. In some forms, the pressure will vary between different breathing cycles of the patient, for example, increasing in response to detecting an indication of partial upper airway obstruction, and decreasing in the absence of an indication of partial upper airway obstruction.

[0451] Flow: Volume (or mass) of air delivered per unit time. Flow may refer to an instantaneous quantity. In some cases, references to flow will be to a scalar quantity, i.e. a quantity having only magnitude. In other cases, references to flow will be to a vector quantity, i.e. a quantity having both magnitude and direction. Flow may be given by the symbol Q. 'Flow' is sometimes simply abbreviated to 'flow'.

[0452] In the example of a patient breathing, the flow may be nominally positive for the inspiratory portion of the patient's breathing cycle, and therefore negative for the expiratory portion of the patient's breathing cycle. Total flow (Qt) is the air flow leaving the RPT device. Ventilation flow (Qv) is the air flow leaving the ventilator port to allow for flushing of exhaled gases. Leakage flow (Ql) is the leakage flow from the patient interface system. Respiratory flow (Qr) is the air flow received into the patient's respiratory system.

[0453] Humidifier: The word humidifier shall mean a humidifying device constructed and arranged or configured to have the ability to provide therapeutically beneficial amounts of water (H2O) vapor to an air stream to relieve a medical respiratory condition of a patient.

[0454] Leakage: The word leak is to be considered as undesired air flow. In one example, a leak may occur due to an incomplete seal between the mask and the patient's face. In another example, a leak may occur in the return elbow to the ambient environment.

[0455] Noise, Conducted (Acoustic): Conducted noise in this context refers to the noise brought to the patient through the pneumatic path (such as the air circuit and patient interface and the air therein). In one form, conducted noise can be quantified by measuring the sound pressure level at the end of the air circuit.

[0456] Noise, radiated (acoustic): Radiated noise in this context refers to the noise that is carried to the patient through the surrounding air. In one form, radiated noise can be quantified by measuring the sound power / pressure level of the object in question according to ISO 3744.

[0457] Noise, ventilation (acoustic): Ventilation noise in this context refers to the noise generated by the flow of air through any ventilation openings, such as the ventilation openings in a patient interface.

[0458] Patient: A person, whether or not they have a respiratory illness.

[0459] Pressure: Force per unit area. Pressure can be expressed in units including cm H2O, gf / cm 2 1 cm H2O is equal to 1 g-f / cm 2 and is about 0.98 hectopascals. In this specification, unless otherwise stated, pressures are given in cm H2O.

[0460] The pressure in the patient interface is given the symbol Pm, while the therapy pressure is given the symbol Pt, which represents the target value to be achieved by the mask pressure Pm at the current moment.

[0461] Respiratory Pressure Therapy (RPT): The application of an air supply to the entrance of the airway at a therapy pressure, which is usually positive relative to atmospheric pressure.

[0462] Ventilator: A mechanical device that provides pressure support to a patient to perform some or all of the work of breathing.

[0463] 4.7.1.1 Materials

[0464] Silicone or Silicone Elastomer: Synthetic rubber. In this specification, references to silicone refer to liquid silicone rubber (LSR) or compression molded silicone rubber (CMSR). One form of commercially available LSR is SILASTIC (included in the range of products sold under this trademark), which is manufactured by Dow Corning. Another manufacturer of LSR is Wacker. Unless otherwise specified to the contrary, exemplary forms of LSR have a Shore A (or Type A) indentation hardness in the range of about 35 to about 45 as measured using ASTM D2240.

[0465] Polycarbonate: A thermoplastic polymer of bisphenol A carbonate.

[0466] 4.7.1.2 Mechanical properties

[0467] Resilience: The ability of a material to absorb energy when it is elastically deformed and release that energy when it is deflated.

[0468] Resilient: Releases substantially all of its energy when deflated. Includes some silicones and thermoplastic elastomers.

[0469] Hardness: The ability of a material to resist deformation by itself (e.g., as measured by Young's modulus, or the indentation hardness scale measured for a standard sample size).

[0470] 'Soft' materials may include silicone or thermoplastic elastomers (TPEs), and may deform easily, for example under finger pressure.

[0471] 'Hard' materials may include polycarbonate, polypropylene, steel or aluminium, and may not deform easily under finger pressure, for example.

[0472] Stiffness (or rigidity) of a structure or component: The ability of a structure or component to resist deformation in response to an applied load. The load can be a force or a moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistance in different directions.

[0473] Flexible structure or component: A structure or component that will change shape, such as bend, when made to support its own weight for a relatively short period of time, such as 1 second.

[0474] Rigid structure or component: A structure or component that will not substantially change shape when subjected to loads typically encountered in use. One example of this use may be to place and maintain a patient interface in sealing relationship with an entrance to a patient's airway, for example under a load of about 20 to 30 cm H2O pressure.

[0475] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in a first direction compared to a second, orthogonal direction. In another example, a structure or assembly is floppy in a first direction and rigid in a second direction.

[0476] 4.7.2 Respiratory cycle

[0477] Apnea: According to some definitions, an apnea is considered to occur when flow drops below a predetermined threshold for a sustained period of time (e.g., 10 seconds). Apnea will be said to have occurred when some obstruction of the airway prevents air from flowing despite the patient's efforts. Central apnea will be said to have occurred when cessation of breathing is detected due to reduced or absent breathing effort despite an open airway. Mixed apnea is considered to have occurred when a reduction or absence of breathing effort occurs simultaneously with an obstructed airway.

[0478] Respiratory rate: The patient's spontaneous breathing rate, usually measured in breaths per minute.

[0479] Duty cycle: The ratio of inspiratory time (Ti) to total breathing time (Ttot).

[0480] Effort (breathing): The work done by a spontaneous breather in an attempt to breathe.

[0481] Expiratory portion of the respiratory cycle: the time period from the start of expiratory flow to the start of inspiratory flow.

[0482] Flow Limitation: Flow limitation will be considered as a state of affairs in a patient's breathing where an increase in the patient's effort does not produce a corresponding increase in flow. Where flow limitation occurs during the inspiratory portion of the breathing cycle, it may be described as inspiratory flow limitation. Where flow limitation occurs during the expiratory portion of the breathing cycle, it may be described as expiratory flow limitation.

[0483] Type of flow rate limiting inspiratory waveform:

[0484] (i) Flat: Having a rise followed by a relatively flat portion and then a fall.

[0485] (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.

[0486] (iii) Chair shape: has a single local peak at the leading edge followed by a relatively flat section.

[0487] (iv) Reverse chair shape: has a relatively flat portion followed by a single local peak at the trailing edge.

[0488] Hypopnea: According to some definitions, hypopnea is considered a decrease in flow, but not a cessation of flow. In one form, hypopnea is said to have occurred when flow drops below a threshold for a period of time. Central hypopnea is said to have occurred when hypopnea is detected due to a decrease in respiratory effort. In one form in adults, any of the following may be considered hypopnea:

[0489] (i) A 30% decrease in the patient's breathing lasting at least 10 seconds with an associated 4% desaturation; or

[0490] (ii) A decrease (but at least 50%) in the patient's breathing lasting at least 10 seconds, with an associated desaturation or arousal of at least 3%.

[0491] Hyperpnea: Increased flow to a level above normal flow.

[0492] Inspiratory portion of the breathing cycle: The time period from the start of inspiratory flow to the start of expiratory flow will be considered the inspiratory portion of the breathing cycle.

[0493]

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

[0494] Positive End Expiratory Pressure (PEEP): The pressure above atmospheric pressure in the lungs that exists at the end of exhalation.

[0495] Leak flow (Qpeak): The maximum value of the flow during the expiratory portion of the respiratory flow waveform.

[0496] Respiratory flow, patient air flow, respiratory air flow (Qr): These terms may be understood to refer to the RPT device's estimate of the respiratory air flow, as opposed to "true respiratory flow" or "true respiratory air flow", which is the actual respiratory flow experienced by the patient, usually expressed in liters per minute.

[0497] Tidal volume (Vt): The volume of air inspired or exhaled during normal breathing when no extra effort is exerted.

[0498] (Inspiratory) Time (Ti): Duration of the inspiratory portion of the respiratory flow waveform.

[0499] (Expiratory) Time (Te): Duration of the expiratory portion of the respiratory flow waveform.

[0500] (Total) Time (Ttot): The total duration between the start of the inspiratory portion of a respiratory flow waveform and the start of the inspiratory portion of the subsequent respiratory flow waveform.

[0501] Typical recent ventilation: The ventilation value around which recent values ​​on some predetermined time scale tend to cluster, that is, a measure of the central tendency of recent values ​​of ventilation.

[0502] Upper airway obstruction (UAO): includes both partial and total upper airway obstruction. This can be associated with a state of flow limitation, where flow increases only slightly or can even decrease as the pressure difference across the upper airway increases (Starling impedance behavior).

[0503] Ventilation (Vent): A measure of the flow of gases exchanged by a patient's respiratory system. Measurements of ventilation may include either or both of the inspiratory and expiratory flow per unit time. When expressed in volumes per minute, this quantity is often referred to as "minute ventilation". Minute ventilation is sometimes given as volume only, understood to be volume per minute.

[0504] 4.7.3 Ventilation volume

[0505] 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 may be learned from some characteristics of the patient, such as the patient's breathing characteristics.

[0506] Backup Rate: A parameter of the ventilator that establishes the minimum respiratory rate (typically in breaths per minute) that the ventilator will deliver to the patient if not elicited by spontaneous respiratory effort.

[0507] Cycling: Termination of the inspiratory phase of a ventilator. When a ventilator is delivering a breath to a spontaneously breathing patient, the ventilator is said to be cycled to cease delivering breaths at the end of the inspiratory portion of the respiratory cycle.

[0508] Expiratory Positive Airway Pressure (EPAP): The base pressure to which the varying pressures during a breath are added to produce the desired mask pressure that the ventilator will try to achieve at a given time.

[0509] End-expiratory pressure (EEP): The desired mask pressure that the ventilator will attempt to achieve at the end of the expiratory portion of the breath. If the pressure waveform template Π(Ф) is zero valued at the end of exhalation, i.e., Π(Ф) = 0 when Ф = 1, then EEP is equal to EPAP.

[0510] Inspiratory Positive Airway Pressure (IPAP): The maximum desired mask pressure the ventilator will attempt to achieve during the inspiratory portion of a breath.

[0511] Pressure Support: A number that indicates the increase in pressure during ventilator inspiration over the pressure during ventilator expiration, and usually means the difference in pressure between the maximum and base pressure during inspiration (e.g., PS = IPAP - EPAP). In some cases, pressure support means the difference that the ventilator plans to achieve, not the difference that it actually achieves.

[0512] Servo ventilator: A ventilator that measures the patient's ventilation, has a target ventilation volume, and adjusts the pressure support level to bring the patient's ventilation volume toward the target ventilation volume.

[0513] Spontaneous / Timed (S / T): A mode of a ventilator or other device that attempts to detect breath activation in a spontaneously breathing patient. However, if the device cannot detect a breath within a predetermined period of time, the device will automatically initiate the delivery of a breath.

[0514] Swing differential: An equivalent term for pressure support.

[0515] Induced: When a ventilator delivers a breath of air to a spontaneously breathing patient, it is said to be induced to do so at the beginning of the breathing portion of the breathing cycle by the patient's effort.

[0516] Typical recent ventilation: Typical recent ventilation Vtyp is the value around which recent measurements of ventilation on some predetermined time scale tend to cluster. For example, a measure of the central tendency of ventilation measurements in recent history may be a suitable value for typical recent ventilation.

[0517] 4.7.4 Anatomy

[0518] 4.7.4.1 Facial anatomy

[0519] The outer wall or "wing" of each nostril (plural: alars)

[0520] Alar tip: The outermost point on the wing of the nose.

[0521] Alar bend (or alar apex) point: The most posterior point in the base line of the curvature of each ala, found in the crease formed by the union of the ala and cheek.

[0522] Auricle: The entire external visible part of the ear.

[0523] (Nose) Framework: The nasal framework includes the nasal bones, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0524] (Nose) Soft skeleton: The nasal soft skeleton includes the septal, lateral, major and minor cartilages.

[0525] Columella: The strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0526] Columellar angle: the angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfurt plane (where both lines intersect at the lower point of the nasal septum).

[0527] Frankfurt plane: A line extending from the lowest point of the orbital rim to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0528] Glabella: The most prominent point on the forehead in the midsagittal plane located on the soft tissue.

[0529] External nasal cartilage: A generally triangular plate of cartilage with its upper edge attached to the nasal bones and the frontal process of the maxilla and its lower edge connected to the greater alar cartilage.

[0530] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end is connected to the frontal process of the maxilla by a tough fibrous membrane containing three or four small cartilages of the alar.

[0531] Nostril: The approximately oval-shaped hole that forms the entrance to the nasal cavity. The singular nostril is nostril. The nostrils are separated by the nasal septum.

[0532] Nasolabial folds or nasolabial wrinkles: Folds or grooves of skin that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0533] Nasolabial angle: the angle between the columella and the upper lip (which intersect at the lower point of the nasal septum).

[0534] Auricular base: The lowest point where the auricle attaches to the facial skin.

[0535] Auricular base: The highest point where the auricle attaches to the facial skin.

[0536] Nasal prominence: The most prominent point or tip of the nose that can be identified in a side view of the rest of the head.

[0537] Philtrum: The midline groove that extends from the lower border of the nasal septum to the top of the lip in the upper lip area.

[0538] Mental point: The midpoint of the frontmost part of the chin located on the soft tissue.

[0539] Ridge (nose): The nasal ridge is the midline protrusion of the nose extending from the nasal bridge point to the nasal protuberance point.

[0540] Sagittal Plane: A vertical plane that passes from anterior (front) to posterior (back) and divides the body into right and left halves.

[0541] Nasal point: The most concave point on the soft tissue covering the frontonasal suture area.

[0542] Septal Cartilage (Nose): The septal cartilage forms part of the septum and divides the front of the nasal cavity.

[0543] Posterior superior lateral flap: The point at the inferior edge of the alar base where the alar base joins the skin of the upper (upper) lip.

[0544] Subnasal point: The point on the soft tissue where the columella meets the upper lip in the midsagittal plane.

[0545] Mandibular alveolar seat point: The point of maximum concavity on the midline of the lower lip between the midpoint of the lower lip and the premental point of the soft tissue.

[0546] 4.7.4.2 Anatomy of the skull

[0547] Frontal Bone: The frontal bone includes a large vertical portion (the squama) which corresponds to the area called the forehead.

[0548] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the lower jaw that forms the chin.

[0549] Maxilla: The maxilla forms the upper jaw and lies above the mandible and below the eye sockets. The frontal process of the maxilla projects upward from the sides of the nose and forms part of the lateral border.

[0550] Nasal Bones: The nasal bones are two oval bones that vary in size and form in different individuals; they lie side by side in the middle and upper parts of the face and form the "bridge" of the nose at their junction.

[0551] Nasion: The intersection of the frontal bone and the two nasal bones, the concave area directly between the eyes and on the upper part of the bridge of the nose.

[0552] Occipital Bone: The occipital bone is located at the back and lower part of the skull. It contains the oval hole (foramen magnum) through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the squama occipitalis.

[0553] Orbit: The bony cavity in the skull that holds the eyeball.

[0554] Parietal bones: The parietal bones are the bones that when joined together form the roof and sides of the skull.

[0555] Temporal Bones: The temporal bones are located at the base and sides of the skull and support the part of the face called the temples.

[0556] Zygomatic bones: The face includes two zygomatic bones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0557] 4.7.4.3 Anatomy of the respiratory system

[0558] Diaphragm: A sheet of muscle that extends across the base of the rib cage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0559] Larynx: The larynx or voice box houses the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0560] Lung: The respiratory organ of humans. The conducting zone of the lungs contains the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory zone contains the respiratory bronchioles, alveolar ducts, and alveoli.

[0561] Nasal Cavity: The nasal cavity (or nasal fossa) is a large air-filled space above and behind the nose in the middle of the face. The nasal cavity is divided into two parts by a vertical wing called the nasal septum. On the sides of the nasal cavity are three horizontal branches called the turbinates (singular "nasal conchae") or nasal conchae. The front of the nasal cavity is the nose, while the back connects to the nasopharynx via the internal nostrils.

[0562] Pharynx: The part of the throat located just below (under) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (epipharynx) (nasal portion of the pharynx), the oropharynx (mesopharynx) (oral portion of the larynx), and the hypopharynx (hypopharynx).

[0563] 4.7.5 Patient interface

[0564] Anti-Asphyxia Valve (AAV): A component or sub-assembly of a mask system that reduces the risk of excessive CO2 rebreathing by the patient by opening to atmosphere in a fail-safe manner.

[0565] Elbow: An elbow is an example of a structure that directs the axis of an air flow to change direction through a certain angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be greater than or less than 90 degrees. The elbow can have a cross-section that is approximately circular. In another form, the elbow can have an elliptical or rectangular cross-section. In some forms, the elbow can be rotated, for example, about 360 degrees relative to a mating component. In some forms, the elbow can be removable from a mating component, such as by a snap connection. In some forms, the elbow can be assembled to the mating component during the manufacturing process via a disposable snap, but cannot be removed by the patient.

[0566] Frame: A frame will be considered to mean the mask structure that carries the tension load between two or more connection points with the headband. A mask frame may be a non-airtight load-bearing structure in a mask. However, some forms of mask frames may also be airtight.

[0567] Headgear: A headgear will be considered to mean a form of positioning and stabilizing structure designed for use on the head. For example, a headgear may include a collection of one or more support bars, straps, and reinforcing bars configured to position and maintain a patient interface in position on a patient's face for delivery of respiratory therapy. Some straps are formed of soft, pliable, resilient materials, such as a laminate composite of foam and fabric.

[0568] Film: A film shall be taken to mean a typically thin element which preferably has substantially no resistance to bending, but has resistance to stretching.

[0569] Plenum: A mask plenum will be taken to mean a portion of the patient interface having walls enclosing a volume of space which, in use, has air pressurized therein to above atmospheric pressure. The housing may form part of the walls of the mask plenum.

[0570] Seal: can be a noun indicating structure ("seal") or a verb indicating action ("to seal"). Two elements can be constructed and / or arranged to seal between them or achieve a "seal" between them without the need for a separate "sealing" element itself.

[0571] Shell: Shell will be taken to mean a curved and relatively thin structure having bendable, stretchable and compressible stiffness. For example, a curved structural wall of a mask may be a shell. In some forms, the shell may be multi-faceted. In some forms, the shell may be multi-faceted. In some forms, the shell may be airtight. In some forms, the shell may not be airtight.

[0572] Reinforcement: A reinforcement will be taken to mean a structural component designed to increase the bending resistance of another component in at least one direction.

[0573] Bracing: Bracing will be taken to mean a structural component designed to increase the compression resistance of another component in at least one direction.

[0574] Swivel (n): A subassembly of an assembly configured to rotate about a common axis, preferably independently, preferably under low torque. In one form, the swivel may be configured to rotate through an angle of at least 360 degrees. In another form, the swivel may be configured to rotate through an angle of less than 360 degrees. When used in the context of an air delivery conduit, the subassembly of the assembly preferably comprises a pair of matching cylindrical conduits. There may be little or no air flow leakage from the swivel in use.

[0575] Tie (noun): A structure designed to resist tension.

[0576] Ventilation port (noun): A structure that allows air flow from the interior of a mask or conduit to ambient air to allow clinically effective flushing of exhaled gases. For example, clinically effective flushing may involve a flow rate of about 10 liters per minute to about 100 liters per minute, depending on the mask design and the treatment pressure.

[0577] 4.7.6. Shape of the structure

[0578] Products according to the present technology may include one or more three-dimensional mechanical structures, such as a mask buffer or thruster. The three-dimensional structures may be combined by two-dimensional surfaces. These surfaces may be distinguished using markings to describe the relative surface orientation, position, function, or some other characteristics. 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, the buffer structure may include a face-contacting (e.g., external) surface and a separate non-face-contacting (e.g., underside or internal) surface. In another example, the structure may include a first surface and a second surface.

[0579] To help describe the shape of three-dimensional structures and surfaces, we first consider a cross section through a point p on the surface of the structure. FIG. 3B to FIG. 3F , which show examples of cross sections at a 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 points away from the surface. In some examples, the surface is described from the point of view of an imaginary person standing upright on the surface.

[0580] 4.7.6.1 Curvature in one dimension

[0581] The curvature of a plane curve at p can be described as having a sign (eg, positive, negative) and a magnitude (eg, the inverse of the radius of a circle that touches the curve only at p).

[0582] Positive curvature: If the curve at p turns toward the outward normal, then the curvature at that point will be positive (if the imaginary person were to leave that point p, they would have to walk uphill). Figure 3B (and Figure 3C Compared with the relatively large positive curvature) and Figure 3C (and Figure 3B Such curves are often called concave.

[0583] Zero curvature: If the curve at point p is a straight line, then the curvature will be zero (if the imaginary person leaves point p, they can walk horizontally without going up or down). Figure 3D .

[0584] Negative curvature: If the curve at point p turns away from the outward normal, then the curvature in that direction at that point will be negative (if the imaginary person were to leave that point p, they would have to go downhill). Figure 3E (and Figure 3F Compared to the relatively small negative curvature) and Figure 3F (and Figure 3E Such curves are often called convex.

[0585] 4.7.6.2 Curvature of a Two-Dimensional Surface

[0586] A description of a shape at a given point on a two-dimensional surface according to the present technology may include multiple normal cross sections. Multiple cross sections may cut the surface in a plane that includes the outward normal ("normal plane"), and each cross section may be taken in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at the point may have the same sign or different signs. Each curvature at the point has a magnitude, such as a relatively small magnitude. FIG. 3B to FIG. 3F The plane curve in can be an example of such multiple cross sections at specific points.

[0587] Principal curvatures and principal directions: The directions of the normal planes where the curvature of the curve takes its maximum and minimum values ​​are called principal directions. FIG. 3B to FIG. 3F In the example of Figure 3B and the minimum value appears at Figure 3F ,therefore Figure 3B and Figure 3F is the cross section in the principal direction. The principal curvature at p is the curvature in the principal direction.

[0588] Region of a surface: A connected set of points on a surface. The points in a region can have similar characteristics, such as curvature or sign.

[0589] Saddle region: A region where at each point the principal curvatures have opposite signs, ie one sign is positive and the other sign is negative (depending on the direction the imagined individual is turning, they can be walking up or down).

[0590] Dome region: The region where at every point the principal curvatures have the same sign, e.g. two positive ("concave dome") or two negative ("convex dome").

[0591] Cylindrical region: A region where one of the principal curvatures is zero (or is zero, for example, within manufacturing tolerances) and the other principal curvature is non-zero.

[0592] Planar region: A surface region where both principal curvatures are zero (or are zero within manufacturing tolerances, for example).

[0593] Edge of a surface: The boundary or limit of a surface or area.

[0594] Path: In some forms of the present technology, 'path' will mean a path in a mathematical-topological sense, e.g. a continuous spatial curve from f(0) to f(1) on a surface. In some forms of the present technology, a 'path' may be described as a route or course comprising, e.g., a set of points on a surface. (An imagined individual's path is one in which they walk on a surface and is similar to a garden path).

[0595] Path length: In some forms of the present technology, the 'path length' will be the distance along the surface from f(0) to f(1), i.e. the distance along the path on the surface. There may be more than one path between two points on the surface and such paths may have different path lengths. (The path length of an imaginary individual would be the distance they walked along the path on the surface).

[0596] Straight-line distance: Straight-line distance is the distance between two points on a surface, but regardless of the surface. In a planar region, there may be a path on the surface that has the same path length as the straight-line distance between two points on the surface. In a non-planar surface, there may not be a path that has the same path length as the straight-line distance between two points. (For an imaginary individual, straight-line distance would correspond to the distance as a 'straight line'.)

[0597] 4.7.6.3 Space curve

[0598] Space curves: Unlike plane curves, space curves do not have to lie in any particular plane. Space curves can be thought of as one-dimensional slices of three-dimensional space. An imaginary individual walking on a DNA helix walks along a space curve. A typical human left ear consists of a helix, the left side of which is shown in Figure 1. Figure 3Q The typical human right ear includes a helix, the right helix of which is shown in Figure 3R . Figure 3S A right-handed spiral is shown. The edge of a structure, such as the edge of a membrane or propeller, can follow a space curve. In general, a space curve can be described by the curvature and torque at each point on the space curve. Torque is a measure of how the curve departs from the surface. Torque has a sign and a magnitude. The torque at a point on a space curve can be characterized with reference to the tangent plane, normal, and binormal vectors at that point.

[0599] Tangent unit vector (or unit tangent vector): For each point on a curve, the vector at that point indicates the direction from that point as well as the amount. The tangent unit vector is a unit vector pointed in the same direction as the curve at that point. If an imaginary individual were flying along the curve and stopped at a particular point, the direction of the tangent vector is the direction it would be traveling.

[0600] Unit Normal Vector: As the imaginary individual moves along the curve, this tangent vector itself changes. The unit vector pointing in the same direction that the tangent vector is changing is called the unit principal normal vector. It is perpendicular to the tangent vector.

[0601] Binormal unit vector: The binormal unit vector is perpendicular to the tangent vector and the principal normal vector. Its direction can be determined by the right-hand rule (see, e.g. Figure 3P ) or alternatively by the left-hand rule ( Fig.3O ) to determine.

[0602] Osculating plane: The plane containing the unit tangent vector and the unit principal normal vector. Fig.3O and 3P .

[0603] Torque of a space curve: The torque at a point on a space curve is the amount of change in the rate of change of the binormal vector at that point. It measures how much the curve deviates from the osculating plane. A space curve that lies on a plane has zero torque. A space curve that deviates from the osculating plane by a relatively small amount will have a relatively small amount of torque (e.g., a slightly tilted spiral path). A space curve that deviates from the osculating plane by a relatively large amount will have a relatively large amount of torque (e.g., a sharply tilted spiral path). Figure 3S , although T2>T1, in Figure 3S The torque near the top spiral coil is greater than Figure 3S The amount of torque on the bottom spiral coil.

[0604] refer to Figure 3P According to the right-hand rule, a space curve that turns in the direction of the right-hand binormal can be considered to have a right-hand positive torque (e.g., Figure 3S A space curve that deviates away from the right-handed binormal direction can be considered to have a right-handed negative torque (e.g., a left-handed spiral).

[0605] Similarly and referring to the left-hand rule (see Fig.3O ), a space curve that turns in the direction of the left-handed binormal can be considered to have a left-handed positive torque (e.g., a left-handed helix). Thus, a left-handed positive torque is equivalent to a right-handed negative torque. Figure 3T .

[0606] 4.7.6.4 Holes

[0607] A surface may have one-dimensional pores, for example pores defined by a plane curve or by a space curve. A thin structure (e.g., a membrane) having pores may be described as having one-dimensional pores. For example, see Fig. 3I A one-dimensional hole in the surface of the structure shown in , which is defined by a plane curve.

[0608] The structure may have a two-dimensional aperture, such as an aperture defined by a surface. For example, an inflatable tire has a two-dimensional aperture defined by the interior surface of the tire. In another example, a bladder having a cavity for air or gel has a two-dimensional aperture. See, for example, Figure 3L The buffer and Figure 3M and Figure 3N An exemplary cross section through a conduit, wherein the interior surface defines the indicated two-dimensional aperture. In another example, a conduit can include a one-dimensional aperture (e.g., at its inlet or at its outlet) and a two-dimensional aperture defined by the conduit interior surface. See also Figure 3K The two-dimensional pores of the structure shown are defined by the surfaces as shown.

[0609] 4.8 Other Notes

[0610] A portion of the disclosure of this patent document contains material that is subject to copyright protection. The copyright owner has no objection to the facsimile reproduction by anyone of the patent document or the patent disclosure as it appears in the Patent Office patent file or records, but otherwise reserves all copyright rights whatsoever.

[0611] Unless the context clearly states and provides a numerical range, it should be understood that each intermediate value between the upper and lower limits of the range, to one tenth of the lower limit unit, and any other such value or intermediate value within the range are broadly included in the present invention. The upper and lower limits of these intermediate ranges may be independently included in the intermediate ranges and are also included in the present invention, but are subject to any explicitly excluded limits within the range. When the range includes one or two of the limits, the range excluding one or two of the limits of those included restrictions is also included in the present invention.

[0612] Furthermore, where a value or values ​​of the present invention are implemented as part of the present invention, it should be understood that such values ​​may be approximate unless otherwise indicated, and that such values ​​may be used to any appropriate number of significant digits to the extent permitted or required by practical technical implementation.

[0613] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those commonly understood by those of ordinary skill in the art to which the present invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, a limited number of exemplary methods and materials are described herein.

[0614] When a specific material is identified for configuring a component, obvious alternative materials with similar properties are used as substitutes. In addition, unless otherwise specified, any and all components described herein are understood to be capable of being manufactured and thus can be manufactured together or separately.

[0615] It must be noted that as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural equivalents unless the context clearly dictates otherwise.

[0616] All publications mentioned herein are incorporated by reference, to disclose and describe methods and / or materials as the themes of those publications. The publications discussed herein are only provided for disclosures prior to the filing date of the present application. This paper cannot be interpreted as acknowledging that the technology of the present invention is not entitled to be earlier than such publications by virtue of prior invention. In addition, the publication date provided may be different from the actual publication date, and the publication date may need to be confirmed independently.

[0617] The terms “comprises” and “comprising” should be interpreted as meaning that the referenced elements, components or steps may be present, used or combined with other elements, components or steps not explicitly referenced in a non-exclusive manner.

[0618] The main headings used in the detailed description are included only for the convenience of the reader's reference and should not be used to limit the inventive subject matter found in the entire disclosure or claims. The subject headings should not be used to interpret the scope of the claims or claim limitations.

[0619] Although the technology of the present invention has been described with reference to specific embodiments, it should be understood that these examples only illustrate the principles and applications of the technology of the present invention. In some instances, proper noun terms and symbols may imply specific details that are not required for practicing the technology of the present invention. For example, although the terms "first" and "second" may be used, unless otherwise specified, they are not intended to indicate any order, but may be used to distinguish different elements. In addition, although the process steps in the method may be described or illustrated in a certain order, this order is not required. Those skilled in the art will recognize that this order may be modified, and / or its aspects of the order may be performed simultaneously or even synchronously.

[0620] It is therefore to be understood that numerous modifications may be made to the illustrative examples and that other arrangements may be devised without departing from the spirit and scope of the present technology.

[0621] 4.9 List of reference numerals

[0622] 1000 patients

[0623] 1100 Bed Partner

[0624] 3000 Patient Interface

[0625] 3100 Seal forming structure

[0626] 3105 Sealing surface

[0627] 3110 Lace-up

[0628] 3111 Terminal

[0629] 3115 Outer Circumference

[0630] 3120 Tubular Structure

[0631] 3125 Sealing flap

[0632] 3130 Thick part

[0633] 3135 Thin section

[0634] 3140 hinge structure

[0635] 3145 Attachment

[0636] 3150 Wing

[0637] 3155 Ribs

[0638] 3160 Wing

[0639] 3165 Connection Point

[0640] 3170 Corner

[0641] 3175 Area

[0642] Area 3175A

[0643] Area 3175B

[0644] 3175C Area

[0645] 3175D Area

[0646] 3175E Area

[0647] 3175F Area

[0648] 3180A Area

[0649] 3180B Area

[0650] 3180C Area

[0651] 3180D Area

[0652] 3180E Area

[0653] 3180F Area

[0654] 3180G Area

[0655] 3180H Area

[0656] 3185 Sagittal plane

[0657] 3190 lines

[0658] 3195 The first cut point

[0659] 3196 Second tangent point

[0660] 3197 Center Opening

[0661] Area 3198A

[0662] 3198B Area

[0663] 3199A Closed Path

[0664] 3199B Open Path

[0665] 3200 Inflatable Chamber

[0666] 3210 Circumference

[0667] 3220 Boundary Edge

[0668] 3300 Structure

[0669] 3400 Ventilation port

[0670] 3600 port

[0671] 3700 Forehead Support

[0672] 3800 Buffer Assembly

[0673] 3810 Buffer

[0674] 3810 Foam Buffer

[0675] 3812 Flexible Support Clip

[0676] 3814 Second Clip

[0677] 3816 Mask Shell

[0678] 4000 RPT device

[0679] 4170 Air Circuit

[0680] 5000 Humidifier

[0681] 6000 Structure

[0682] 6005 Area

[0683] Area 6005A

[0684] Area 6005B

[0685] 6005C Area

[0686] 6005D Area

[0687] 6005F Area

[0688] 6005G area.

Claims

1. A buffer assembly for a patient interface for sealingly delivering a flow of air to a patient's airway entrance at a continuous positive pressure relative to ambient air pressure, the patient's airway entrance including at least a patient's nares entrance, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle during use while the patient is sleeping to relieve sleep-disordered breathing, the buffer assembly comprising: an elastic seal forming portion shaped to be bisected by a sagittal plane including lines tangent to the elastic seal forming portion at upper and lower tangent points, Wherein the elastic seal forming part comprises: a dome-shaped superior region spanning the sagittal plane proximate the superior tangent point; a subsaddle area spanning the sagittal plane and including the inferior incision point; a first support region extending from the saddle-shaped lower region to the dome-shaped upper region, the first support region having a constant elastic wall thickness greater than the elastic wall thicknesses of the dome-shaped upper region and the saddle-shaped lower region; and A second support region adjacent to the first support region extending from the saddle-shaped lower region to the dome-shaped upper region, the second support region having a distal side defined proximally by the first support region and opposite to the proximal side, the elastic wall thickness in the second support region increasing from the distal side to the proximal side.

2. The buffer assembly according to claim 1, wherein: The elastic wall thickness of the second support region at the distal side is smaller than the elastic wall thickness of the second support region at the proximal side.

3. A patient interface, comprising: The buffer assembly according to claim 1; a rigid housing removably connected to the bumper assembly; as well as A headband is removably attached to the rigid shell.

4. A continuous positive airway pressure ventilation system, comprising: The patient interface according to claim 3; an airflow generator configured to pressurize the airflow; as well as An air delivery tube is configured to deliver pressurized gas to the patient interface.

5. A buffer assembly for a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to a patient's airway entrance, the patient's airway entrance including at least a patient's nares entrance, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle during use while the patient is sleeping to alleviate sleep disordered breathing, the buffer assembly comprising: An elastic seal-forming structure shaped to be bisected by a sagittal plane including lines tangent to the elastic seal-forming structure at upper and lower tangent points, the elastic seal-forming structure comprising: a rear central opening and a front central opening opposite the rear central opening, and the resilient seal-forming structure includes a plurality of closed paths coaxial with the rear central opening; a dome-shaped upper region spanning the sagittal plane proximate the upper tangent point, the dome-shaped upper region being positioned on an outermost closed path; a saddle-shaped inferior region that spans the sagittal plane near the superior tangent point, the saddle-shaped superior region being positioned on the innermost closed path; a saddle-shaped subregion spanning the sagittal plane and including the lower cut point, the saddle-shaped subregion being on the innermost closed path and the outermost closed path; wherein the thickness of the resilient wall of the resilient seal-forming structure is constant along a portion of an outermost closed path extending from the saddle-shaped lower region to the dome-shaped upper region; The thickness of the elastic wall of the elastic seal-forming structure varies along a portion of the innermost closed path extending from the saddle-shaped lower region to the saddle-shaped upper region.

6. A patient interface comprising: The buffer assembly according to claim 5; a rigid housing removably connected to the bumper assembly; as well as A headband is removably attached to the rigid shell.

7. A continuous positive airway pressure ventilation system, comprising: The patient interface according to claim 6; an airflow generator configured to pressurize the airflow; as well as An air delivery tube is configured to deliver pressurized gas to the patient interface.

8. A buffer assembly for a patient interface for sealingly delivering a flow of air at a continuous positive pressure relative to ambient air pressure to a patient's airway entrance, the patient's airway entrance including at least a patient's nares entrance, wherein the patient interface is configured to maintain a therapeutic pressure in the range of about 4 cmH2O to about 30 cmH2O above ambient air pressure throughout the patient's breathing cycle during use while the patient is asleep to alleviate sleep disordered breathing, the buffer assembly comprising: an elastic seal-forming structure shaped to be bisected by a sagittal plane having lines tangent to the elastic seal-forming structure at upper and lower tangent points, wherein a first nose bridge region of the resilient seal-forming structure spans the sagittal plane near the superior tangent point; wherein a second nose bridge region of the resilient seal-forming structure spans the sagittal plane proximate the superior tangent point and is configured to seal against a patient's nose bridge when the bumper is mounted on the patient's face, the resilient wall of the second nose bridge region being thinner than the first nose bridge region; a chin region of the resilient seal-forming structure spanning the sagittal plane and including the lower cut point, the chin region being configured to engage the patient's chin when the bumper is mounted on the patient's face, the chin region having the same resilient wall thickness as the first nose bridge region; Wherein a first support region and a second support region are positioned juxtaposedly and both extend from the chin region to the first nose bridge region, the first support region has a consistent elastic wall thickness, and the second support region has a varying elastic wall thickness.

9. A patient interface comprising: The buffer assembly according to claim 8; a rigid housing removably connected to the bumper assembly; as well as A headband is removably attached to the rigid shell.

10. A continuous positive airway pressure ventilation system, comprising: The patient interface according to claim 9; an airflow generator configured to pressurize the airflow; as well as An air delivery tube is configured to deliver pressurized gas to the patient interface.

Images