Respiratory device

Abstract

A mask device for respiratory therapy that allows the delivery of breathable gas to a user. In one embodiment, the mask may utilize a frame and a mask cushion to form a seal for both the mouth and nose. The frame is adjustable to couple to a respiratory therapy device such that pressurized gas flows from the respiratory therapy device. The mask cushion may be foam, and the mask cushion may have a substantially sub-nasal structure or a supra-nasal structure. The mask may have a common air cavity for both the nose and mouth. The cushion may further define a mid-open supra-lip region. The cushion is adjustable to couple directly to the frame or to couple to the frame together with a cushion support fixture. Various different features of the cushion may further contribute to the seal and comfort of the sub-nasal design.

Description

[0001] 1.1 Divisional Application Statement

[0002] This application is a divisional application of a Chinese patent application with the invention title "Respiratory Device", application number 201480007456.9, which entered the Chinese national phase on August 4, 2015. This Chinese patent application is a national phase entry of a PCT international application with an international filing date of February 4, 2014 and an international application number of PCT / AU2014 / 000077.

[0003] 1.2 Cross - reference to Related Applications

[0004] This application claims the priority date of the filing dates of Australian Provisional Patent Applications with application numbers 2013900348 filed on February 4, 2013 and 2013900349 filed on February 4, 2013. The contents of these two patent applications are incorporated herein by reference. Technical Background 2.1 Technical Field

[0006] This technology relates to one or more of the detection, diagnosis, treatment, prevention and improvement of respiratory - related disorders. More specifically, this technology relates to medical devices or apparatuses and their use. These devices may include an interface for guiding the treatment of a patient's respiratory system. 2.2 Background Art

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

[0009] The airway is composed of a series of branching tubes, 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 venous blood from the air and expelling carbon dioxide. The trachea divides into the right and left main bronchi, which finally divide into terminal bronchioles. The bronchi constitute the conducting airways and do not participate in gas exchange. Further branching of the airway leads to respiratory bronchioles and ultimately to alveoli. The alveolar region of the lungs is where gas exchange occurs and is called the respiratory zone. See "Respiratory Physiology: The Essentials", 9th Edition, published by John B. West, Lippincott Williams & Wilkins in 2011.

[0010] The Existence of Various Respiratory Disorders

[0011] Obstructive Sleep Apnoea (OSA) is a form of Sleep Disordered Breathing (SDB) characterized by upper airway obstruction during sleep. This is caused by a combination of predisposing factors: an abnormally small upper airway during sleep, and a normal loss of muscle tone in the tongue, soft palate and posterior pharyngeal wall regions. The condition causes affected patients to typically stop breathing for 30 to 120 seconds at a time, sometimes for 200 to 300 seconds, each night. This often causes excessive daytime sleepiness and may lead to cardiovascular disease and brain damage. Complications are common, especially in middle-aged overweight men, although affected individuals may not notice the problem. See U.S. Patent No. 4,944,310 (Sullivan).

[0012] Cheyne-Stokes Respiration (CSR) is a disorder of the patient's respiratory control system in which there are rhythmic alternating periods of waxing and waning ventilation, causing repeated hypoxia and reoxygenation of arterial blood. Cheyne-Stokes Respiration can be harmful because of the repeated lack of oxygen. In some patients, Cheyne-Stokes Respiration (CSR) is associated with repeated awakenings from sleep, which can cause severe sleep fragmentation, increased sympathetic nerve activity and increased afterload. See U.S. Patent No. 6,532,959 (Berthon-Jones).

[0013] Obesity Hyperventilation Syndrome (OHS) is defined as the combination of severe obesity and chronic hypercapnia while awake, without other known factors causing hypoventilation. Symptoms include dyspnea, morning headache and excessive daytime sleepiness.

[0014] Chronic Obstructive Pulmonary Disease (COPD) includes any of a number of lower airway diseases that share certain specific characteristics. These include increased resistance to air flow, prolonged expiratory phase of respiration, and loss of normal lung elasticity. Examples of COPD are emphysema and chronic bronchitis. COPD is caused by chronic tobacco smoking (the main risk factor), occupational exposure, air pollution and genetic factors. Symptoms include: exercise-induced dyspnea, chronic cough and sputum production.

[0015] Neuromuscular diseases (NMDs) can include many disorders and diseases that directly or indirectly impair muscle function via primary muscle pathology or neuropathy. Some NMD patients are characterized by progressive muscle damage leading to reduced mobility (wheelchair dependence), dysphagia, respiratory muscle failure, and ultimately, respiratory failure leading to death. Neuromuscular diseases can be classified as rapidly progressive or chronic progressive: (i) rapidly progressive disorders: characterized by muscle damage worsening over several months and resulting in death within a few years (e.g., amyotrophic lateral sclerosis (ALS) and Duchenne muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by muscle damage worsening over several years and only slightly reducing the average life expectancy (e.g., limb-girdle, facioscapulohumeral, and myotonic dystrophy). Respiratory failure symptoms in NMDs include: increasing general weakness, dysphagia, dyspnea during exercise and at rest, fatigue, drowsiness, morning headache, difficulty concentrating, and mood changes.

[0016] Thoracic disorders are chest disabilities that cause inefficient coupling between the respiratory muscles and the thorax. The disorders are typically characterized by a localized defect and a risk of chronic hypercapnic respiratory failure. Scoliosis and / or kyphosis may cause severe respiratory failure. Symptoms of respiratory failure include: dyspnea during exercise, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0017] In addition, healthy individuals can also use the systems and devices to avoid developing respiratory disorders.

[0018] 2.2.1 Treatments

[0019] Nasal continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). It is hypothesized that CPAP acts as an air splint and prevents upper airway obstruction by pushing the soft palate and tongue forward and away from the posterior pharyngeal wall.

[0020] Non-invasive ventilation (NIV) provides ventilatory support to patients via the upper airway, thereby performing part or all of the work of breathing to assist the patient in achieving full respiration and / or maintaining an adequate oxygen level in the body. The ventilatory support is provided via a patient interface. NIV has been used to treat OHS, COPD, MD, and thoracic disorders.

[0021] Invasive ventilation (IV) provides ventilation support to patients who are unable to breathe effectively on their own and is provided using a tracheostomy tube.

[0022] The ventilator can control the timing and pressure of the air delivered to the patient's breathing and monitor the patient's respiration. Methods of controlling and monitoring the patient typically include volume-cycled and pressure-cycled methods. Volume-cycled methods can include Pressure-Regulated Volume Control (PRVC), Volume Ventilation (VV), Volume Controlled Continuous Mandatory Ventilation (VC-CMV), and other techniques. Pressure-cycled methods can include Assist Control (AC), Synchronized Intermittent Mandatory Ventilation (SIMV), Controlled Mechanical Ventilation (CMV), Pressure Support Ventilation (PSV), Continuous Positive Airway Pressure (CPAP), or Positive End Expiratory Pressure (PEEP), and other techniques.

[0023] 2.2.2 System

[0024] A known device for treating sleep apnea is the S9 Sleep Therapy System, which is manufactured by ResMed. Ventilators (such as ResMed Stellar TM series adult and pediatric ventilators) can provide invasive and non-invasive non-dependent ventilation support to different patients for treating many conditions such as, but not limited to, neuromuscular diseases (NMD), obesity hypoventilation syndrome (OHS), and chronic obstructive pulmonary disease (COPD).

[0025] ResMed Elisée TM 150 ventilator and ResMed VS III TM The ventilators can provide invasive and non-invasive dependent ventilation support for adult and pediatric patients for treating many conditions. These ventilators provide volume-type and pressure-type ventilation modes with a single-limb circuit or a double-limb circuit.

[0026] A system may include a positive airway pressure (PAP) device / respirator, an air circuit, a humidifier, a patient interface, and a data manager.

[0027] 2.2.3 Patient Interface

[0028] A patient interface may be used to connect a breathing device to its user, for example, by providing breathable gas flow. The breathable gas flow may be provided to the nose and / or mouth via a breathing mask, to the mouth through a tube, or to the trachea of the user through a tracheostomy tube. Depending on the treatment to be performed, the patient interface may form a seal, for example, with the patient's facial area, and deliver gas at a pressure that varies with sufficient ambient pressure to be effective, such as a positive pressure of about 10 cmH2O. For other forms of treatment (such as delivering oxygen), the patient interface may deliver the airway gas supply without a sufficient seal, at a positive pressure of about 10 cm H2O.

[0029] The design of patient interfaces presents many challenges. The face has a complex three-dimensional shape. The size and shape of the nose vary highly among individuals. Since the head includes bones, cartilage, and soft tissue, different parts of the face will respond differently to mechanical forces. The jaw or mandible bone may move relative to other bones of the skull. The entire head may move during a breathing treatment.

[0030] Due to these challenges, some breathing masks may be objectionable, unaesthetic, expensive, inappropriate, difficult to use, and / or uncomfortable, especially when worn for long periods or when the patient is unfamiliar with the system. For example, masks designed only for pilots, masks designed as part of personal protective equipment (such as filters), SCUBA masks, or masks for administering anesthesia may be acceptable for their original applications but may be uncomfortable for extended wear (such as for several hours). If worn while sleeping, it may be even more severe. An uncomfortable breathing mask may affect patient compliance.

[0031] Nasal continuous positive airway pressure (CPAP) therapy is highly effective for treating certain breathing disorders and provides patient compliance for treatment. If the breathing mask is uncomfortable or difficult to use, the patient cannot comply with or accept the treatment. Since patients are often advised to clean the used breathing mask frequently, if the breathing mask is not easily replaceable or not easily cleaned (such as not easily assembled or disassembled), the patient is unlikely to replace or clean the used breathing mask, and this can affect patient compliance.

[0032] For these reasons, during sleep, a unique area is formed for the nasal continuous positive pressure (CPAP) breathing mask used for delivery.

[0033] 2.2.3.1 Seal Forming Portion

[0034] The patient interface may include a seal forming portion.

[0035] A patient interface can be locally characterized according to the design intent of the seal formation portion for engaging the face during use. In one form of the patient interface, a seal formation portion can include two sub-portions for engaging the left and right nostrils respectively. In one form of the patient interface, a seal formation portion can include a single piece that, during use, encircles both nostrils. This single piece can be designed to overlap, for example, a supra-labial region and a nasal column region of the face. In one form of the patient interface, a seal formation portion can include an element that, during use, encircles the mouth region, for example by forming a seal in the lower lip region of the face. In one form of the patient interface, a seal formation portion can include a single piece that, during use, encircles both nostrils and a mouth region. These different types of patient interfaces are known by different names depending on the manufacturer, including nasal masks, full face masks, nasal pillows, nasal tips, and oro-nasal masks.

[0036] One type of seal formation portion extends around the perimeter of the patient interface and, when a force is applied to the patient interface, is to seal the user's face with the seal formation portion facing and engaging the user's face. The seal formation portion can be composed of an inflatable or liquid-filled pad, or a molded or formed surface of an elastomeric sealing element made of an elastomer such as rubber. Using this type of seal formation portion, if there is improper fitting, there will be a gap between the seal formation portion and the face, and additional force is required to make the patient interface seal against the face.

[0037] Another type of seal formation portion incorporates a flap seal of a thin material located near the perimeter of the mask to provide a self-sealing action against the user's face when positive pressure is applied inside the mask. Similar to the previously described type of seal formation portion, if there is not a good match between the face and the mask, additional force is required to create a seal, or the mask may leak. Additionally, if the shape of the seal formation portion does not conform to the shape of the patient, creases or deformations may occur during use, causing leakage.

[0038] Another type of seal formation portion can include a frictionally adapted element, such as for insertion into the nostrils.

[0039] Another form of the seal formation portion can use an adhesive to create a seal. Some patients may find it inconvenient to frequently apply and remove the adhesive on their face.

[0040] Different patient interface seal formation portion techniques have been disclosed in the following patent applications assigned to ResMed Limited: WO1998 / 004,310, WO2006 / 074,513, and WO2010 / 135,785.

[0041] 2.2.3.2 Positioning and stabilization

[0042] The seal-forming portion of a patient interface for positive pressure therapy is subject to stresses from air pressure that can disrupt the seal. As such, a variety of techniques have been used to position the seal-forming portion and maintain its sealing relationship with the appropriate area of the face.

[0043] One technique is to use an adhesive. See, for example, U.S. Patent Application No. US 2010 / 0000534.

[0044] Another technique is to use one or more straps and stabilizing harnesses. Many such harnesses suffer from one or more of being inappropriate, bulky, uncomfortable, and awkward to use.

[0045] 2.2.3.3 Exhaust Port Technology

[0046] Some forms of patient interface systems may include an exhaust port to expel exhaled carbon dioxide. Many such exhaust ports are noisy. Others may become blocked during use and provide inadequate expulsion. Some exhaust ports may disrupt the sleep of a patient's (1000) bed partner (1100), for example, via noise or a concentrated air stream.

[0047] ResMeD Limited has developed a number of improved mask exhaust port technologies. See Patent Applications No. WO1998 / 034,665, No. WO 2000 / 078,381, US 6,581,594, U.S. Patent Application; US 2009 / 0050156, U.S. Patent Application No. 2009 / 0044808.

[0048] Previous noise table for breathing masks (ISO 17510-2:2007, at 1 m (meter) for 10 cmH 2 O pressure)

[0049]

[0050] (*Only one sample was in the CPAP mode at 10 cm H 2 O and was measured using the test method specified in ISO3744)

[0051] The sound pressure values of a variety of objects are listed below

[0052]

[0053] 2.2.3.4 Nasal Pillow Technology

[0054] One form of nasal pillow may refer to the Adam Circuit manufactured by Puritan Bennett Corporation. Another nasal pillow or Nasal Puff is the subject of U.S. Patent No. 4,782,832 (Trimble et al.) assigned to Puritan-Bennett Corporation.

[0055] ResMed Limited has manufactured the following products incorporating nasal pillows: SWIFT Nasal Pillow Mask, SWIFT II Nasal Pillow Mask, SWIFT LT Nasal Pillow Mask, SWIFT FX Nasal Pillow Mask, and LIBERTY Full Face Mask. The following patent applications assigned to ResMed describe nasal pillow masks: International Patent Application No. WO2004 / 073,778 (describing aspects of the ResMed SWIFT nasal pillow and others), U.S. Patent Application No. 2009 / 0044808 (describing aspects of the ResMed SWIFT LT nasal pillow and others), International Patent Application Nos. WO 2005 / 063,328 and WO 2006 / 130,903 (describing aspects of the ResMed LIBERTY full face mask and others), International Patent Application No. WO 2009 / 052,560 (describing aspects of the SWIFT FX nasal pillow and others).

[0056] 2.2.4 Respiratory devices (PAP devices / ventilators)

[0057] Examples of respiratory devices include ResMed S9 AutoSet TM PAP devices and ResMed Stellar TM 150 ventilators. PAP devices or ventilators typically include an air flow generator (such as a motor-driven blower) or a pressurized gas reservoir and are configured to provide a controlled supply of breathable gas (e.g., air) to a patient's airway. In some cases, an air flow or other breathable gas flow may be supplied to the patient's airway, and positive pressure air may be supplied to the patient's airway by a PAP device (such as a motor-driven blower). The outlet of the blower PAP device or ventilator is connected to the gas path of the patient interface through an elastic delivery tube, as described above.

[0058] Respirators or PAP devices typically include: an airflow generator; an inlet air filter; a patient interface; an air delivery tube for connecting the airflow generator to the patient interface; various sensors; and a microprocessor-based controller. The patient interface may include a mask or a tracheostomy tube, as described above. The airflow generator may include: a servo-controlled motor; a spiral housing; and a propeller, which forms a blower. In some cases, a brake for the motor may be implemented to more rapidly reduce the speed of the blower to overcome the inertia of the motor and the propeller. The braking enables the blower to reach a lower pressure condition more quickly in a timely manner, despite the inertia, for use in synchronization with exhalation. In some cases, the airflow generator may also include a discharge valve capable of discharging the generated air to the atmosphere, as a component for changing the pressure delivered to the patient, as an alternative to motor speed control. The sensors may measure motor speed, mass flow rate, and outlet pressure and others, such as using a pressure transducer or the like. The device may optionally include a humidifier and / or a heater element in the path of the air delivery line. The controller may include data storage capabilities, with or without integrated data retrieval and display functions. Summary of the Invention

[0059] The present technology relates to medical devices for diagnosing, improving, treating, or preventing respiratory disorders, having one or more characteristics of improving comfort, cost, effectiveness, ease of use, and manufacturability.

[0060] One aspect of the present technology relates to a device for treating or preventing respiratory disorders.

[0061] Another aspect of the present technology relates to a method for treating or preventing respiratory disorders.

[0062] One form of the present technology includes an interface for directing a treatment (such as positive pressure breathable gas) to a patient's respiratory system.

[0063] Another aspect of one form of the present technology includes such an interface for directing the treatment to the nostrils of a patient's respiratory system.

[0064] Another aspect of one form of the present technology is such an interface for directing the treatment to the nostrils and mouth of a patient's respiratory system, but maintaining a minimal facial contact profile to avoid contacting or covering most of the patient's nose.

[0065] Another aspect of one form of the present technology is a patient interface that is cast or formed using a clearly defined peripheral shape that conforms to the facial profile of the intended wearer.

[0066] Another aspect of some forms of the present technology is a patient interface using a foam pad. The foam can optionally be part of a pad assembly, which can further implement an elastic support fixture. In some such cases, the elastic support fixture can be configured with dimensions and material properties such that it both supports the foam pad and supplements the compliance of the foam pad. Thus, a relatively thin foam pad can provide compliance to address the delicate parts of the user's face, while the elastic fixture can address the coarser aspects of the facial structure. This configuration can reduce the amount of foam required for the comfort and seal efficiency of the mask. The reduced amount of foam can reduce the overall size of the mask, making it less obtrusive and improving its aesthetic appeal.

[0067] Another aspect of some forms of the present technology is to implement a patient interface of a mouth and nose mask having a substantially supra-nasal or sub-nasal seal structure.

[0068] For example, a mask device for respiratory therapy can include a frame adapted to couple to a respiratory therapy device to deliver pressurized gas from the respiratory therapy device to a respiratory system of a patient; and the mask device can include a pad adapted to couple to the frame, the foam pad forming a substantially sub-nasal seal and a mouth seal, the sub-nasal seal including a sub-nasal ridge that forms a semi-peripheral seal boundary near the patient's two nostrils.

[0069] In some cases, the pad can include a triangular loop having a common nose and mouth aperture. The pad can be foam. The pad and the frame can form a common air cavity for sealing near the nostrils and mouth. The pad can include a protrusion configured to conform to the patient's nasal alae. The pad can include left and right nasal alar protrusions.

[0070] In some variations, the mask device can further include a pad support fixture configured to couple to the pad and couple to the frame. The pad support fixture can include first and second opposing sides, wherein the fixture is configured to couple to the pad at the first opposing side and is configured to couple to the frame at the second opposing side. The pad support fixture can include a nasal respiratory region and a mouth perimeter region. The nasal respiratory region can be approximately perpendicular to the mouth perimeter region.

[0071] The pad support fixture can include a bend region between the nasal respiratory and the mouth perimeter regions. The bend region can form an approximate nasolabial angle between the nasal respiratory and the mouth perimeter regions. The bend region can include a set of inward nasal protrusions. The nasal protrusions can be elastic.

[0072] In certain variations, the cushion support fixture may include first and second cushion support portions that may provide different elastic characteristics. The first cushion support portion may be a nose support region, and the second cushion support portion may be a side mouth support region. The hardness characteristic of the first cushion support portion is higher than that of the second cushion support portion. Alternatively, the subnasal ridge includes a fan-shaped edge. In some cases, the cushion includes a generally flat sealing surface. The cushion may include a generally curved sealing surface.

[0073] In some cases, the mask device may further include a respiratory therapy device configured to produce a controllable supply of breathing gas at a pressure above atmospheric pressure, the respiratory therapy device including an air delivery tube coupled to the frame to direct breathable gas to the frame.

[0074] In some variations of the mask device, a cushion support fixture may be elastic. The cushion support fixture may be concave. The cushion support fixture may be made of a material other than or different from foam. The cushion may be foam and the foam is externally connected to an elastic fixture. In some cases, the foam surface of the cushion may be configured to directly contact the patient's skin. The foam of the cushion may be a semi-open cell foam having limited permeability.

[0075] Some variations of the present technology may include a respiratory mask for delivering respiratory gas therapy. The mask may include a frame and a cushion. The cushion may be adapted to be coupled to the frame. The cushion may form a substantially subnasal seal and a mouth seal. The cushion may further define a mid-open supra-lip region.

[0076] The cushion may include a nasal airway region and a mouth perimeter region. The cushion may form an approximate nasolabial angle between the nasal airway region and the mouth perimeter region. The cushion may be a triangular ring having a common nose and mouth aperture. The cushion may be foam. The cushion and the frame may form a common air cavity for sealing near the nostrils and mouth. The mid-open supra-lip region may be within the air cavity. The cushion may include a protrusion configured to conform to the patient's nasal wings. The cushion may include left and right nasal wing protrusions.

[0077] The respiratory mask may include a fixture for removably coupling the cushion to the frame. The fixture may include elastic nasal protrusions. The fixture may include first and second cushion support portions that provide different elastic characteristics.

[0078] In some variations of the present technology, such as when a mask is configured to seal the mouth and is on the nasal bridge, a foam cushion may be implemented.

[0079] For example, a foam pad assembly can be formed around the seal nozzle and on the nasal bridge and can achieve a comfortable and effective seal. This assembly can include a foam pad portion, an elastic clip portion, and a rigid clip portion. The elastic fixture can be configured to complement the compliance of the pad to reduce the size of the pad. Although the rigid clip portion is typically desired to be made of a generally rigid material, the term "rigid" is relative to the softer "elastic" clip portion (also known as a soft fixture or elastic fixture). Thus, the rigid portion (also known as a rigid fixture) can have some degree of elasticity. However, it should have sufficient hardness to facilitate engagement with the frame or the headband.

[0080] From a comfort perspective, compared to a traditional silicone-based seal, the force exerted on the patient's face at the seal interface from the headband and the treatment pressure of the respiratory therapy can be distributed over a larger surface area, thus resulting in better comfort and improved sensory comfort. This has a positive effect on patient treatment acceptance and, therefore, higher compliance.

[0081] Any mask leakage can be dispersed over a wider area, creating a greater distributed flow, which reduces "jetting", considered to be typical of traditional silicone pads. This may improve patient engagement with the treatment and compliance with typical silicone seal technologies.

[0082] Some possible benefits of this foam pad or assembly can include:

[0083] A breathable foam pad assembly can be used as a cooling skin contact area and reduce discomfort in the sealed area.

[0084] The inclusion of a selectable elastic fixture allows for a reduction in the overall size of the pad foam component compared to a foam mask without this component. This can increase stability without compromising comfort and seal.

[0085] A foam pad assembly can be of a relatively small size, unobtrusive, and still be easily removable for cleaning and replacement.

[0086] Some variant versions of this technology include a foam pad assembly for a patient interface. The foam pad assembly can be adapted to couple to a patient interface frame. The pad assembly can include a substantially supra-nasal seal portion and a mouth seal portion. This pad assembly can include a foam pad configured to form a common air cavity with the frame and for sealing near the patient's nose and mouth, and it can include a pad support fixture configured to couple to the foam pad, wherein the pad support fixture is characterized in that the ratio of the height to the thickness is at least 3 near the entire perimeter of the pad.

[0087] The pad support fixture can be elastic. The elastic pad support fixture can be formed of a rigid material, and the elasticity can be formed by referring to one or more compliant zones. These compliant zones can be formed by introducing a weakened line or a weakened area.

[0088] The cushion support fixture may have a concave shape, dimensions, and material properties that, when pressure is applied to the patient interface, create an air spring effect. The cushion support fixture may be made of materials other than foam and silicone. The foam cushion may be externally connected to the cushion support fixture. The foam surface of the cushion may be configured to directly contact the patient's skin.

[0089] The foam cushion may be a semi-open cell foam with limited permeability. The foam cushion may have a permeability property in the range of about 0 to 20 liters per minute. The foam cushion may have an indentation hardness property in the range of about 110.48 to 303.11 Newtons. The foam cushion may have a compressive stress-strain property in the range of about 2.32 to 7.26 Kilo-pascals. The foam cushion may have an apparent density property in the range of about 24.3 to 117.85 kilograms per cubic meter. The foam cushion may have a compressive permanent deformation property in the range of about 0.16 to 17.30 percent (%).

[0090] The cushion support fixture may be in an L, C, and / or Z shape. The cushion support fixture may include: a foam cushion coupling portion for providing a contact surface for the cushion to engage thereon; an elastic support portion; and a base for attaching to a second support fixture or the frame. The foam cushion assembly may have the shape, dimensions, and material properties of the selected cushion support fixture such that at least a portion of the fixture acts as a cantilever spring.

[0091] The cushion assembly may also include a second support fixture configured to couple the cushion support fixture to the frame. The second support fixture may be harder than the cushion support fixture, and the cushion support fixture may be harder than the foam cushion. The foam cushion and the cushion support fixture may be integrally connected. The foam cushion, the cushion support fixture, and the second support fixture may be integrally connected.

[0092] The foam cushion assembly may be configured such that different degrees of support and compliance are provided at at least some portions along the perimeter of the cushion assembly. In some variations, one or more parameters are changed at at least some portions of the fixture perimeter, and such parameters may include: the spring constant of the fixture and / or the foam cushion; the cross-sectional profile of the fixture and / or the foam cushion; the wall thickness of the fixture; the angle of the contact surface of the fixture on which the cushion engages; the overhang of the cushion with respect to the support contact surface; and the foam thickness.

[0093] The foam cushion assembly may further include a protrusion configured to be depressed by a headband during use to apply pressure to an individual area of the foam cushion.

[0094] Some variations of the present technology may include a patient interface device for respiratory therapy. The patient interface device may include a frame adapted to couple to a respiratory therapy device to deliver pressurized gas from the respiratory therapy device to a patient's respiratory system, and may further include a cushion assembly adapted to couple to the frame of any variation described in this specification.

[0095] Some variations of the present technology may include a cushion assembly for a patient interface of a respiratory therapy device. The cushion assembly may include a peripheral foam pad adapted to seal the mouth. The peripheral foam pad may further be adapted to seal the nose. The cushion assembly may further include: an elastic support member peripherally engaging the foam pad; and a rigid support member coupled to the elastic support member, wherein the elastic support member is formed of an air-impermeable material. The elastic support member may be formed of an elastic material.

[0096] The elastic support member may be formed of a rigid material, wherein the elastic support member includes one or more compliant zones for forming elasticity. The compliant zones may be formed by introducing a weakened line or a weakened zone.

[0097] The rigid support member may include a mask frame. The rigid support member may include a clamp for coupling to a mask frame. The clamp may include at least one fastener. The elastic support member may include the inner periphery of the air chamber of the cushion assembly, which is adapted to increase the sealing force of the seal of the foam pad in response to the treatment pressure provided on the mask.

[0098] The elastic support member may include the inner periphery of the air chamber of the cushion, wherein the elastic support member constitutes different reaction forces in at least some regions of the periphery. The regions with different reaction forces may include a nasal region side and a mouth region side. The elastic support member may be configured to provide different curling responses in different regions of the periphery of the elastic support member. The different regions may include an upper cheek region and a mouth region side. The inner periphery may be formed at different angles in different regions, each angle being formed by a support portion and a foam pad coupling portion. The elastic support member may include one or more of a "C" cross-sectional geometry and an "L" cross-sectional geometry.

[0099] The foam pad coupling portion may include a peripheral lip along which the foam pad may be mounted. In some cases, the engagement of the peripheral lip with the foam pad forms an overhanging foam portion along at least some portions of the periphery of the lip. The foam pad may include a nasal column contact area. The nasal column contact area of the foam pad may include a nasal cavity.

[0100] The foam pad may include a substantially sub-nasal seal portion that includes a sub-nasal ridge that forms a semi-peripheral sealing boundary near the patient's two nostrils.

[0101] In some variations, the resilient support member may include a housing with an air cavity; and a connection port for coupling to an air circuit of a respiratory therapy device, and the rigid support member may include a headband frame that includes a housing aperture configured to fit around the housing.

[0102] In some variations, an elastic peripheral member of a cover member moves to engage and cover an inner surface of the foam pad, and the elastic peripheral member may be airtight.

[0103] In some variations, a peripheral foam pad may be generally planar, and when the resilient support member and / or the rigid support member engages the foam pad, it may cause the peripheral foam pad to form a three-dimensional (3D) contour. The foam may be a polyurethane semi-open cell foam with limited permeability.

[0104] In some cases, the spring constant of a foam pad of the resilient support member in the mouth region with a nasal cavity may be greater than that of the foam pad of the resilient support member in the nasal bridge region. Alternatively, the spring constant of the foam pad of the resilient support member in the cheek region may be similar to that of the nasal bridge region. The spring constant of an elastic clamp formed only in the mouth region may be greater than that of the zygomatic bone region, and the spring constant of the zygomatic bone region may be greater than that of the nasal bridge region.

[0105] The foam pad may have a compressive stress-strain characteristic in the range of about 2.32 to 7.26 kilopascals (kPa). The foam pad may have a coefficient of friction characteristic in the range of about 1.86 to 19.12 CF. The foam pad may have an elongation at break characteristic in the range of about 72.3 to 369.05 percent (%). The foam pad may have a permeability characteristic in the range of about 0 to 20 liters per minute. The foam pad may have an indentation hardness characteristic in the range of about 110.48 to 303.11 newtons (N). The foam pad may have a compressive stress-strain characteristic in the range of 2.32 to 7.26 kilopascals (kPa). The foam pad may have an apparent density characteristic in the range of about 24.3 to 117.85 kilograms per cubic meter. The foam pad may have a compressive set characteristic in the range of about 0.16 to 17.30 percent (%). The foam pad may have a tensile strength characteristic in the range of about 0.03 to 0.27 megapascals (MPa).

[0106] The resilient support member may be concave. The resilient support member may be made of materials other than foam. The pad may be made of foam and externally connected to the resilient support member. The foam surface of the pad may constitute direct contact with the patient's skin. One or more parameters may be changed in at least some portions of the periphery of the resilient support member, and such parameters may include: the spring constant of the resilient support member and / or the foam pad; the cross-sectional profile of the resilient support member and / or the foam pad; the wall thickness of the resilient support member; the angle of the contact surface of the resilient support member that engages the pad; the extension of the pad with respect to the support contact surface; and / or the foam thickness.

[0107] Some variant versions of the cushion assembly may further include a protrusion which, when in use, can be pressed down by a headband to apply pressure to an individual area of the foam pad.

[0108] Some variant versions of the present technology may include a cushion for a mask frame, which may include a foam pad. The cushion may include a peripheral portion adapted to seal the mouth. The peripheral portion may be further adapted to seal the nose. The foam pad may further include a stretchable joining side edge, whereby the foam pad may constitute a slip-on foam shield of a support structure.

[0109] Some variant versions of the present technology may include a cushion assembly for mask construction. The cushion assembly may include a foam pad, the foam pad may include a peripheral portion adapted to seal the mouth. The peripheral portion may be further adapted to seal the nose. The cushion assembly may further include an inner peripheral clamp and an outer peripheral clamp. Such clamps may constitute joining a foam support member. The inner peripheral clamp may be joined to the inner side of the foam pad, and the outer peripheral clamp may be joined to the outer side of the foam pad. Such clamps may clamp the foam pad to fix the foam pad to the foam support member. Such clamps may constitute clamping the foam to make the patient contact surface of the foam pad circular. Such clamps may further include an over-clamping portion which constitutes pressing down on the top side portion of the foam pad. The foam pad may further include a slit for receiving the over-clamping portion.

[0110] Of course, portions of such aspects may form sub-aspects of the present technology. At the same time, some of such sub-aspects and / or aspects can be combined in various different ways and also constitute additional aspects or sub-aspects of the present technology.

[0111] Other features of the present technology may be more apparent from the following "Detailed Description", "Abstract", "Brief Description of the Drawings", and "Claims". Brief Description of the Drawings

[0112] The present technology is illustrated by way of non-limiting examples and the accompanying drawings, in which like reference numerals represent like elements, wherein:

[0113] 4.1 Treatment System

[0114] Figure 1a Shows the components of a system for one example use of the present technology. A patient (1000) wears a patient interface (3000), such as a nasal cannula that only covers the patient's nose, and receives a positive pressure air supply from a PAP device (4000). The air from the PAP device is humidified in a humidifier (5000) and conducted along an air path (4170) to the patient (1000);

[0115] Figure 1b Shows a PAP device (4000) being used with a patient wearing a nasal mask type patient interface;

[0116] Figure 1c Shows a PAP device being used with a patient wearing a full face mask type patient interface;

[0117] 4.2 Treatment

[0118] 4.2.1 Respiratory System

[0119] Figure 2a Shows an overview of the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal cords, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm;

[0120] Figure 2b Shows a diagram of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilages, major alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea;

[0121] 4.2.2 Facial Anatomy

[0122] Figure 2c Is a front view of a face with some facial anatomical features marked, including the upper lip, vermilion border of the upper lip, vermilion border of the lower lip, lower lip, mouth width, inner canthus, alae nasi, nasolabial groove, and oral commissure;

[0123] Figure 2d Is a lateral view of a head with some facial anatomical features marked, including the glabella, nasion, nasal prominence, subnasale, upper lip, lower lip, supramenton (the indentation between the lower lip and the chin), nasal ridge, upper ear base point, and lower ear base point. Also indicates the directions of up and down, and front and back;

[0124] Figure 2e Is a further lateral view of the head. Indicates the approximate positions of the ear-eye level and the nasolabial angle;

[0125] Figure 2f Shows a bottom view of the nose;

[0126] Figure 2g Shows a lateral view of the surface features of the nose;

[0127] Figure 2h Display the subcutaneous structure of the nose, including lateral cartilage, nasal septum cartilage, major alar cartilage, minor alar cartilage and fibrofatty tissue;

[0128] Figure 2i The medial dissection of the nose is shown, about a few millimeters from the sagittal plane, which shows the medial crus of the nasal septum cartilage and the alar cartilage, among others;

[0129] Figure 2j Shows the front view of the skull, including the frontal, temporal, nasal, and zygomatic bones. Also indicates the nasal conchae, such as the maxilla, mandible, and mental protuberance;

[0130] Figure 2k A side view of the skull showing the surface outlines of the head along with some of the muscles. The following bones are shown: the jaw, sphenoid, nasal, zygomatic, maxillary, mandibular, parietal, temporal, and occipital bones. The mental protuberance is also indicated. The following muscles are shown: the digastric, masticatory, sternocleidomastoid, and trapezius muscles;

[0131] 4.3 PAP Devices

[0132] Figure 3 An exemplary PAP device suitable for implementation using embodiments of the present technology is shown;

[0133] 4.4 Patient Interface

[0134] Figure 4 , 5 and 6 shows an embodiment of a patient using a nasal patient interface of the present technology;

[0135] Figure 7 yes Figure 4 a patient side view or close up view of a cushion for a patient interface;

[0136] Figure 8 and 9 for Figure 4 A cross-sectional view of the patient interface, particularly showing Figure 7 The nasal area of ​​the patient interface;

[0137] Figure 10 Some examples of facial contact under a nasal mask are illustrated.

[0138] Figure 11 Some forms of patient interfaces employing the present technology, showing an exemplary frame, pad support fixture and pad components;

[0139] Figure 12 Example Figure 11 Exemplary frame components of;

[0140] Figure 13 Example Figure 11 An exemplary pad support fixture component of;

[0141] Figure 14 Illustrate another exemplary pad support fixture component;

[0142] Figure 15 and 16 Figures 16 and 17 show cross-sectional views of different pad support regions of a pad support fixture component;

[0143] Figure 18 Further illustrate another exemplary pad support fixture of the present technology;

[0144] Figure 19 Illustrate exemplary force characteristics achievable using some examples of the present technology;

[0145] Figure 20 and 21 show a perspective view of a pad support fixture component coupled to a frame component;

[0146] Figure 22 and 23 respectively illustrate a side view and a perspective view of a pad coupled to a pad support fixture;

[0147] Figure 24 Illustrate an exemplary flat contact surface pad suitable for implementation using some embodiments of the present technology; the figure also includes an illustration showing a cross-sectional view of the pad. In particular, due to the rectangular profile, the two surfaces for contacting the underlying support surface and the patient's face are flat;

[0148] Figure 25 Illustrate an exemplary curved surface pad suitable for implementation using some embodiments of the present technology; the figure also includes an illustration showing a cross-sectional view of the pad. The flat surface of the pad is for contacting the underlying support surface rather than the patient's face;

[0149] Figure 26 and 27 respectively illustrate a pad assembly having a frame of Figure 24 and 25 ;

[0150] Figure 28 Illustrate the fan-shaped nasal region of a pad in some examples of the present technology;

[0151] Figure 29 Illustrate a pad having left and right nasal support protrusions;

[0152] Figure 30 and 31 respectively show a plan view and a side view of the pad in the lower nasal mask assembly of the present technology with respect to Figure 29 ;

[0153] Figure 32A and 32BA fixture and frame connector illustrating some examples of the present technology;

[0154] Figure 33A and 33B Another fixture and frame connector illustrating some examples of the present technology;

[0155] Figure 34 Still further fixture and frame connectors illustrating some examples of the present technology; and

[0156] Figure 35A and 35B Still another fixture and frame connector illustrating some examples of the present technology;

[0157] Figure 36 and 37 Illustrating a foam cover with a headband configured to seal the mouth and on the nasal bridge;

[0158] Figure 38 For a foam cover without a headband Figure 36 Another diagram;

[0159] Figure 39 Illustrating individual components of a foam pad assembly, such as Figure 38 the foam cover;

[0160] Figure 40 Showing a foam pad assembly with Figure 39 coupling components;

[0161] Figure 41 Illustrating using Figure 39 a cover to form a cover seal with the foam pad in the nasal region;

[0162] Figure 42 Showing Figure 39 an area of a fixture component of a cover;

[0163] Figure 43 , 44 and 45 are cross-sectional views of a portion of a foam pad in some specific embodiments of the present technology, such as having a nasal bridge region, a nasal region side, and a mouth region side;

[0164] Figure 46 Illustrating several exemplary cross-sectional geometries of a foam pad of any of the foam pad patient interface specific embodiments of the present technology;

[0165] Figure 47 Illustrating the foam pad and fixture components as individual components and in the assembled structure of the present technology;

[0166] Figure 48 Is a cross-sectional view of a pad assembly in some variant versions of the present technology having multiple fixture components and a foam pad;

[0167] Figure 49 Showing different regions of an elastic fixture component of a foam pad cover;

[0168] Figure 50 Showing a Figure 49 fixture component having a selective foam positioning projection;

[0169] Figure 51 and 52 Examples 53 and 54 illustrate Figure 49 various different cross-sectional geometries of different regions of the fixture component, such as a nose column region, a side of the nose region, a side of the mouth region, and a bottom of the mouth region;

[0170] Figure 55 and 56 are cross-sectional views of several exemplary pad assemblies coupled to a cover frame;

[0171] Figure 57 Illustrating several exemplary retaining elements for coupling a foam cover pad assembly to a cover frame;

[0172] Figure 58A Is a side view of a pad and fixture assembly in some variant versions of the present technology;

[0173] Figure 58B Is Figure 58A a cross-sectional view of the pad assembly;

[0174] Figure 59 Is a cross-sectional view of a cover and foam pad assembly in some variant versions of the present technology;

[0175] Figure 60 Is a cross-sectional view of an elastic housing of a foam cover assembly;

[0176] Figure 61 Is a disassembled view of a component of a foam cover assembly having a Figure 60 housing;

[0177] Figure 62 Illustrating a foam cover assembly worn on a human body Figure 61 ;

[0178] Figure 63A and 63B Illustrating a foam pad and fixture assembly in some examples of the present technology;

[0179] Figure 64 and 65 Examples 66A and 66B illustrate a foam pad and cover frame assembly having various different fixtures;

[0180] Figure 67 and 68 Show a foam pad and fixture assembly having some variant versions of the present technology;

[0181] Figure 69 Illustrate a foam pad suitable for some specific embodiments of the present technology;

[0182] Figure 70 Show Figure 69 A cross-sectional view of the illustrated foam pad;

[0183] Figure 71 , 72 , 74 and 75 illustrate the cross-sectional geometry of an exemplary fixture, such as for Figure 69 The foam pad;

[0184] Figure 73 A side view of a further exemplary fixture assembly for a foam pad;

[0185] Figure 76 A cross-sectional view of a portion of a foam pad cover assembly;

[0186] Figure 77 A perspective view of an exemplary foam pad cover assembly of the present technology;

[0187] Figure 78 Is Figure 77 The bottom side view of the foam pad cover assembly of;

[0188] Figure 79 Is Figure 77 The perspective view of the cover frame member of the foam pad cover assembly of;

[0189] Figure 80 Is Figure 77 The perspective view of the pad assembly of the foam pad cover assembly of;

[0190] Figure 81 Illustrate Figure 79 And 80 The bottom side view of the assembly of the cover frame member and the pad assembly of;

[0191] Figure 82 A cross-sectional view of a portion of a foam pad cover assembly;

[0192] Figure 83 Illustrate the different performance zones of a foam pad of the present technology;

[0193] Figure 84 A side view of a foam pad assembly illustrating a pivot point;

[0194] Figure 85 Illustrate the pad pressure performance of an exemplary foam pad assembly of the present technology;

[0195] Figure 86 Illustrate the pad roll-up performance of an exemplary foam pad assembly of the present technology. Embodiment

[0196] Before describing the technology in more detail, it should be understood that the technology is not limited to the specific examples described in this specification, and the examples can be changed. It should also be understood that the terms used in the present invention only describe the specific examples discussed in this specification and are not restricted.

[0197] 5.1 Treatment system

[0198] In one form, the technology includes a device for treating respiratory disorders. The device may include an air flow generator or blower for supplying pressurized breathing gas (such as air) to a patient (1000) through a delivery tube (such as a tube) of a patient interface (3000).

[0199] 5.2 Treatment

[0200] In one form, the technology relates to a method for treating respiratory disorders by applying positive pressure to the inlet of the airway of a patient (1000).

[0201] 5.2.1 Nasal continuous positive airway pressure (CPAP) for obstructive sleep apnea (OSA)

[0202] In one embodiment, the technology relates to a method for treating obstructive sleep apnea by applying continuous positive airway pressure to a patient wearing the patient interface described in this specification. Other positive pressure treatments may also be provided (for example, bi-level continuous positive airway pressure (CPAP), etc.).

[0203] 5.3 PAP device (4000)

[0204] A exemplary PAP device (4000) according to one aspect of the technology may include mechanical and pneumatic components (4100), electrical components (4200), and be programmed to execute one or more control methods or algorithms, such as controlling any one or more of providing continuous positive airway pressure or positive pressure treatment therapies. The PAP device may include a housing (4010) formed using two components, an upper part (4012) of the housing (4010), and a lower part (4014) of the housing (4010). In an alternative form, the housing (4010) may include one or more faceplates (4015). The PAP device (4000) may include a base (4016) to support one or more internal components of the PAP device (4000). In one form, a pneumatic block (4020) is supported by a portion of the base (4016) or formed as part of the base. The PAP device (4000) may include a loop handle (4018).

[0205] The pneumatic path of the PAP device (4000) may include an intake air filter, an intake air muffler, a positive pressure controllable air source (preferably a blower (4142)), and an exhaust air muffler. One or more pressure sensors (4272) and airflow sensors may be included in the pneumatic path.

[0206] An exemplary pneumatic block (4020) may include a portion of the pneumatic path located within a housing (4010).

[0207] The PAP device (4000) may have a power supply (4210), one or more input devices (4220), a processor, a pressure device controller, one or more protection circuits, memory, a converter, a data communication interface, and one or more output devices. The electrical components (4200) may be mounted on a single printed circuit board assembly (PCBA) (4202). In an alternative form, the PAP device (4000) may include more than one single printed circuit board assembly (4202).

[0208] The processor of the PAP device (4000) may be programmed to execute a series of algorithm modules during use, preferably including a preprocessing converter signal module, a therapy engine module, a pressure control module, and also preferably a fault condition module.

[0209] 5.4 Patient Interface (3000)

[0210] 5.4.0 Features

[0211] A patient interface (3000) in any variant of the present technology may typically include selectable features such as a seal-forming structure (3100), an air cavity (3200), positioning and stabilizing structures (3300), a ventilation port (3400), a decoupling structure (3510), a connection port (3600), a forehead support (3700), an anti-asphyxiation valve (3800), and / or one or more ports (3900). These features may be at least referenced Figure 4 and 36 for examples.

[0212] 5.4.0.1 Seal-Forming Structure (3100)

[0213] In one form of the present technology, a seal-forming structure (3100) provides a seal-forming surface and may additionally provide a cushioning function.

[0214] A seal-forming structure (3100) according to the present technology may be made of a soft, flexible, and elastic material, such as silicone or other materials and structures described in this specification.

[0215] In one form, the seal-forming structure (3100) can include a sealing rim and can further include a support rim. The sealing rim can be a relatively thin member extending around the vicinity of the air cavity (3200), having a thickness less than about 1 mm (millimeter), such as from about 0.25 mm (millimeter) to about 0.45 mm (millimeter). The support rim is relatively thicker than the sealing rim. The support rim can be disposed between the sealing rim of the air cavity (3200) and the edge, and extends at least partially in the vicinity of the periphery. The support rim is (or includes) a spring-like element and functions to support and prevent the sealing rim from being distorted in use. In use, the sealing rim can quickly respond to the system pressure in the air cavity (3200) below it so that the sealing rim tightly engages the face.

[0216] In one form, the seal-forming portion of the non-invasive patient interface (3000) includes a pair of nasal tips or nasal pillows, each nasal tip or nasal pillow being configured and arranged to form a seal with an individual nostril of the patient's nose.

[0217] The nasal pillow according to one aspect of the present technology can include: a frustoconical portion that forms a seal at least partially on the lower side of the patient's nose; a stem portion in an elastic region below the frustoconical portion and connecting the frustoconical portion to the stem portion. In addition, the structure connecting the nasal pillow of the present technology includes an elastic region adjacent to the base of the stem portion. The elastic regions can together contribute to a universal joint structure that can accommodate relative movement of both the displacement and the angle of the frustoconical portion and the structure connecting the nasal pillow. For example, the frustoconical portion can be axially displaced relative to the structure connecting the stem portion.

[0218] In one form of the non-invasive patient interface (3000), a seal-forming portion forms a seal with the supra-lip region (i.e., the upper lip) of the patient's face in use.

[0219] In one form, the non-invasive patient interface (3000) includes a seal-forming portion that forms a seal with the chin region of the patient's face in use.

[0220] Additional features of the seal-forming structure can be further referred to in the additional details section of this specification.

[0221] 5.4.0.2 Air Cavity (3200)

[0222] Preferably, the air cavity (3200) has a periphery whose shape is complementary to the surface profile of the average human face forming the sealing area. In use, the edge of the air cavity (3200) is close to the adjacent surface of the face. The actual contact with the face is provided by the seal-forming structure (3100). Preferably, the seal-forming structure (3100) extends around the entire periphery of the air cavity (3200) in use.

[0223] 5.4.0.3 Positioning and Stabilizing Structure (3300)

[0224] Preferably, the sealing formation structure (3100) of the patient interface (3000) of the present technology is held in the sealed position by the positioning and stabilization structure (3300) in use.

[0225] 5.4.0.4 Exhaust port (3400)

[0226] In one form, the patient interface (3000) includes an exhaust port (3400) configured and arranged to allow the expulsion of exhaled carbon dioxide.

[0227] One form of the exhaust port (3400) according to the present technology includes a plurality of holes, for example, about 20 to about 80 holes, or about 40 to about 60 holes, or about 45 to about 55 holes.

[0228] Preferably, the exhaust port (3400) is located in the air cavity (3200). Alternatively, the exhaust port (3400) is located in a decoupling structure (3510), such as a swivel ring.

[0229] 5.4.0.5 Decoupling structure (3510)

[0230] In one form, the patient interface (3000) includes at least one decoupling structure (3510), such as a swivel ring or a ball and socket.

[0231] 5.4.0.6 Connection port (3600)

[0232] The connection port (3600) allows connection of an air / gas line (4170).

[0233] 5.4.0.7 Forehead support (3700)

[0234] In one form, the patient interface (3000) includes a forehead support (3700).

[0235] 5.4.0.8 Anti-asphyxiation valve (3800)

[0236] In one form, the patient interface (3000) includes an anti-asphyxiation valve (3800).

[0237] 5.4.0.9 Port (3900)

[0238] In one form of the present technology, a patient interface (3000) may optionally include one or more ports to allow access to the body performance within the air cavity (3200). In one form, this allows a clinician to supply supplemental oxygen. In one form, this allows direct measurement of gas characteristics within the air cavity (3200), such as pressure.

[0239] 5.4.1 Sub-nasal seal

[0240] A non-invasive patient interface (3000) according to one example of the present technology may refer to Figures 4-7 . The patient interface may include any one of the following features: a seal-forming structure (3100), such as a pad (3110); an air cavity (3200); a positioning and stabilization structure (3300), such as one or more headband inertial vectors; and a connection port (3600) for connecting an air / gas line (4170). In some forms, one or more of these features may be provided by one or more physical components. In some forms, a physical component may provide one or more functional characteristics. In use, the seal-forming structure (3100) may be configured to directly contact the patient's skin and surround the entrance of the patient's airway, facilitating the supply of positive pressure air to the airway.

[0241] For example, as Figures 4-7 shown, the patient interface may form a mask to provide a sealed interface to the patient's mouth and nostrils, directing breathable gas under pressure to both the mouth and nostrils. This mask may form a basic nasal mask. As illustrated, the air cavity (3200) may be formed by a frame (3500) and a pad (3110). The pad (3110) may also be used as the seal-forming structure (3100). The frame may be adapted to couple to a respiratory therapy device to transmit pressurized gas from the respiratory therapy device to the patient's respiratory system. The pad may then be adapted to couple to the frame.

[0242] In some cases, as Figure 7 shown, the pad may form a seal of a basic nasal seal UNSP and a mouth seal MSP. This structure may refer to Figure 10 the description of. The nasal seal may be formed by a nasal ridge (3131) that forms a semi-peripheral seal boundary near the patient's two nostrils. In view of this, this seal can be achieved using both the nostrils and the mouth, and in some cases, avoiding a seal or other mask contact structure in the central region of the upper lip LS. Such as, when compared to a mouth mask that may incorporate a nasal cannula, this mask may provide a more open and comfortable feeling to the user while still providing an effective seal.

[0243] The seal obtained by using a single mask to seal both the mouth and the lower nostrils is difficult to achieve with a nasal stent design using standard silicone pad materials. It has generally been found that the human variation in facial features is relatively large. Some materials such as standard silicone may not be flexible enough to achieve both seal and comfort, especially with respect to the complex facial features around the nose and mouth.

[0244] In some cases, the use of foam can overcome this problem, such as a semi-open (or semi-closed) cell foam. In some examples, the gasket can be a foamed silicone material or a polyurethane foam, etc. In some cases, very low durometer thermoplastic elastomers (TPE), thermoplastic polyurethanes (TPU), thermoplastic vulcanizates (TPV), silicone or rubber materials can be implemented. The compliant nature of the foam allows it to press into complex facial features and form a good seal under relatively small tension. This combination of ease of fit and patient-perceivable softness provides relatively quick and easy mask installation. The porosity of the foam also presents better breathability than silicone and avoids facial moisture. Therefore, the use of foam results in better cooling and reduced discomfort in the contact or sealing area.

[0245] In some cases, the gasket and / or the frame can be defined in Figure 7 the illustrated single air chamber, such as the air cavity (3200), which encompasses the patient's mouth and the nostrils from below. As detailed discussion in this specification, the pad can have a substantially oval and / or triangular shape. The sealing surface can extend continuously in two planes substantially, that is, a plane that allows sealing of the mouth; and a second plane that facilitates sealing below the patient's nostrils. The second plane can form an angle with the first plane. The angle can be approximately close to 90 degrees or approximately perpendicular, but can be slightly larger or slightly smaller. This angle can be close to the nasolabial angle. This single-chamber foam pad can be designed to attach to a frame directly or via a fixture, as discussed in more detail in this specification.

[0246] The seal around the mouth and nostrils of this nasal mask is generated through the interaction between the combined response of the patient's face and the components (e.g., the frame, elastic fixture, and / or gasket) and the tension from the headband. The assembled component structures can work together to provide variable compression amounts around the nose and mouth, resulting in an effective seal in these areas.

[0247] Figure 8 With 9 A cross-sectional view showing a portion of the nasal region including an exemplary nasal sub-ridge (3131) with a seal. The figure illustrates a mechanism for achieving a seal in the nasal region.

[0248] When the nose is applied to the pad (e.g., foam) in the nasal sub-ridge area, the headband can be tightened. Through the combined pad (e.g., foam) and / or the pad support structure (8800) (e.g., the fixture (3535)), the headband inertial vector helps seal around the two nostrils, causing an inward roll (at Figure 9as indicated by arrow RR) and around the closed nostrils. The elasticity of the cushion and / or the cushion support structure combination enables the cushion to align the alar angle with the nasolabial angle of the nose. When the headband inertial vector is tightened more, a greater sealing force can be applied around the nostrils. The reaction forces caused by its rolling and compression between the cushion and the cushion support (e.g., the clamp and / or the frame) create an action vector, which is reflected (substantially perpendicular) back to the patient from the frame support. Moreover, the generated gas pressure (e.g., from an air flow generator coupled to the mask assembly) accumulated in the mask air cavity can push the cushion (e.g., the foam) outwards. This can ensure the opening of the air passage to the nostrils and can also compress the cushion upwards (towards the subnasal area of the patient), thus generating a sealing pressure around the nostrils.

[0249] In some cases, during combination or use, the nostrils may potentially be blocked by some mask cushions. When the seal around the nostrils is related to the compression of some foam, nasal blockage may occur before applying appropriate pressure to the mask. To reduce the likelihood of blockage, a balance can be achieved among the foam thickness, the foam profile near the nostrils, and the cantilever spring characteristics of the support structure (e.g., if a clamp is used).

[0250] In the case of a foam implementation, a thin foam portion (such as in the nasal area) may be appropriate. For example, a foam thickness of about 8 to 20 mm (millimeters) (e.g., 13 mm (millimeters)) can significantly improve / avoid installation blockage. In some cases, the inner profile of the foam can be arranged and / or shaped to conform to the nostrils, such as around the nostrils. A soft elastic material (such as silicone, TPE, TPU, etc.) can be implemented with a material such as that used for the cushion support. This material can constitute a slight cantilever spring action on the nose.

[0251] During pressure therapy (such as CPAP therapy), nostril blockage can be avoided. The inner profile of the foam cushion (as Figure 9 illustrated) can relieve discomfort around the nostrils. Generally, the foam may be compressed by the internal CPAP pressure that expands the nostrils near the nostrils. To achieve an appropriate and comfortable seal, the foam hardness should not be greater than the reaction force generated by the internal CPAP pressure that expands the nostrils. This situation can keep the nostrils open during CPAP and does not cause blockage.

[0252] The cantilever spring force of the cushion support (e.g., the clamp and / or the frame) can be soft enough to press the nose into the foam cushion during installation without blocking the nostrils. Conversely, the spring force of the cushion support can provide sufficient reaction force to press the foam cushion into all the sealing areas of the mask. This may be obvious for the areas at the corners of the nose.

[0253] Exemplary components of a mask assembly of this technology are further illustrated in Figures 11 to 23 the illustration. In some cases, such as Figure 11As shown, the frame (3500) can be a component separable from one of the fixture (3535) and the gasket. As Figure 12 shown, the frame can include a set of holders (3537). These holders can be applied to a headband (not shown) to position and support the mask assembly during use. The frame can also optionally include a vent (3400). In one form, the vent (3400) can be configured and arranged to exhaust exhaled carbon dioxide. The vent (3400) can be formed by 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. The vent (3400) can be located in the air cavity (3200). Alternatively, the vent (3400) can be located in a decoupling structure, such as a swivel or other coupler.

[0254] The frame can typically include a connection port (3600). The connection port (3600) allows connection of an air / gas line (4170), such as connection to a respiratory therapy device or a gas flow generator. This connection of the gas line can be achieved via a decoupling structure as described above. In some cases, the patient interface (3000) can include an anti-asphyxiation valve (not shown). Alternatively, the frame can include one or more additional ports. This additional port allows access to the cavity within the air cavity (3200). For example, this port allows the supply of supplemental oxygen. This port can also be used as a coupler or housing for a sensor for directly measuring gas characteristics, such as pressure, within the air cavity (3200).

[0255] The frame can include a flange (3515) near its posterior (patient-proximal) perimeter, such as Figure 12 shown. This flange can change the angle and width near the perimeter of the air cavity to follow the facial curvature where the seal occurs. The flange can generally extend parallel to where the seal occurs on the patient's face in these areas. A variable-angle flange can work together with the headband inertia vector to apply a desired amount of padding to the variable components around the mouth and nostrils to achieve comfort and an effective seal.

[0256] In some cases, the mask assembly can utilize a fixture (3535) as Figure 13 or Figure 14 shown. The fixture can releasably engage the frame to facilitate replacement of the gasket applied to the fixture. In view of this, Figure 20 and 21 illustrate the fixture (without a gasket) coupled to the frame. However, any one or more of the fixture features described in this specification can optionally be integrated with the structure of the frame itself and the gasket applied thereto.

[0257] In some cases, the profile of the fixture helps to form the gasket such that the gasket forms a multi-dimensional shape (e.g., multi-planar) suitable for conforming to the patient's face to form a good seal under the nasal structure. In view of this, as Figure 13 and 14As shown, the fixture can form a curved or angled region ABR. The angled region ABR allows for an angle between a nasal respiratory region NPR and a mouth perimeter region PR. An approximate nasolabial angle ANA can be formed by a plane of the mouth perimeter region and a plane of the nasal respiratory region. When the pad is applied to the fixture (and / or frame), such as Figure 22 and 23 as shown, in cases where the pad has not already formed in this region, the characteristics of these regions can be imparted to the pad.

[0258] Alternatively, a 2D flat fixture can be used. In this case, by engaging with a 3D-shaped frame, a 3D shape can be imparted to the elastic fixture / pad combination.

[0259] Generally, the fixture can be permanently coupled to the frame or include connectors (3536), such as Figure 13 、 22 and the example of 23, to enable removably coupling to the frame. These elements can be formed around one side (e.g., the lower perimeter or distal side) of the fixture, where that side interfaces with the frame. Additional examples of such connection elements are explained in more detail in this specification with reference to Figures 32A to 35B The opposite side portion of the fixture (e.g., the upper perimeter surface or patient proximal side) provides a connection or connection surface (e.g., a foam ring) for engaging the cushion pad. In view of this, the characteristics of the fixture can be used as a suspension for the pad.

[0260] When the thickness of the fixture is relatively small (i.e., a few millimeters), the fixture body may generally be close to the curved surface. The cross-sectional profile of the fixture near the perimeter may vary in different parts of the fixture to provide different elastic / hard regions for the pad. Examples can be referred to Figure 15 、 16 and the cross-sectional views of 17. For example, the fixture can be formed such that it has an opening or recessed wall (3535W) with a cross-section along the perimeter of the fixture, which can vary in geometry. These cross-sectional shapes can (e.g.) form a U shape (such as Figure 15 shown), an L shape (such as Figure 16 shown), or a C shape (such as Figure 17 shown). Other examples can include I-shaped or Z-shaped cross-sectional structures. In some cases, some or all of these walls can be used to form them. The opening of each shape (in Figure 13 、 15 、16 and 17, the relevant characters SO are shown) can face inwards towards the center or air cavity of the nasal mask. These different wall structures can have different elastic properties. This cross-sectional shape can enable the fixture to act as a spring or a cantilever-type spring. This spring structure allows the foam pad to further conform to the face and, once alignment is achieved, presses down on it to improve the conformity of the pad to the face.

[0261] Accordingly, the fixture (or frame) can be formed using an elastic peripheral lip of a variable support foam pad. The pressure within the air cavity formed between the mask frame, fixture, pad, and the patient's face acts on the clip portion (e.g., the shaped opening SO of the wall) and the interior of the pad, and pushes the peripheral lip and the pad towards the patient's face, thereby enhancing the seal established by the pad. When the pressure increases, this force creates the seal. Similarly, the wall portion of the fixture can also be selected to have a thickness and elasticity such that the air pressure creates an air spring effect, further contributing to the seal compliance.

[0262] As previously mentioned, the wall geometry in the vicinity around the fixture can vary to change the stiffness or elasticity around the nose and mouth seal areas. Different stiffnesses / hardnesses can be achieved at different parts of the face to achieve a balance between good seal, comfort, and stability. For example, around the nose, when the nose is pressure-sensitive, a softer seal can be achieved. However, the sides of the mouth can resist greater sealing pressure without discomfort. Therefore, the elasticity of the fixture (or frame) can incorporate these different elastic characteristics.

[0263] In some such examples, the support for the pad in the nose seal area can be formed in an elastic cross-sectional "U" geometry as Figure 15 illustrated. The fixture wall (the concave wall (3535W)) then has a pad support surface (3538) for the connector and a frame coupling surface (3539), as discussed in this specification. In certain cases, the pad support within the seal area on the sides of the mouth can be formed by an elastic wall having a cross-sectional shape similar to the Figure 16 illustrated "L" geometry. Moreover, the pad support in the seal area at the lower part of the mouth can be formed by an elastic wall having a cross-sectional shape similar to the Figure 17 shown "C" geometry.

[0264] Similarly, regarding Figure 14 、 18 and at least the exemplary fixtures shown in 19, two movable parts of the fixture structure are the peripheral lips (3540), and these movable parts form an effective cantilever extension and a middle cross-section (3541) of the fixture periphery between the frame coupling surface (3539) and the pad support surface (3538). These two components can act as springs and provide a sealing reaction force through their deformation. The distribution of the sealing force provided by the fixture around the mouth can be controlled by the fixture material and geometry. Moreover, this reaction force can be controlled by the user, depending on the tightness of the mask headband.

[0265] In view of this, the combination of a foam pad and an elastic support structure of the fixture can provide reasonable results. However, for optimal sealing comfort, the elastic fixture can have an oversized peripheral lip that increases the support of the foam pad width, which can be greater than the support surface of the peripheral lip. Variations in the peripheral lip width can generate different reaction forces near the perimeter of the mouth pad. The beam and bending principle can be demonstrated. In terms of isolation, a shorter peripheral lip will result in a stiffer mechanical system because the deflection of the fixture for a specific unit force is less than that of a fixture with a longer peripheral lip.

[0266] This fixture relates to Figure 14 、 18 and the pad support structure of 19. The dimensions of the peripheral lip width (as shown by arrow LW in Figure 18 ) also allow for the citation of sealing geometry variations. For example, different (e.g., narrower) widths in the peripheral lip regions near the nose and mouth help achieve different reaction sealing forces in these regions. As Figure 18 shown, the contour of the peripheral lip of the fixture can be changed as shown by the dashed line. The resulting fixture is illustrated in Figure 19 . As an illustration, a shorter lip width (shown by arrow SLW) can be provided at the top of the nasal respiratory region for less elasticity. A relatively longer lip width (such as arrow LL) can be provided near the center open lip upper region COLS for greater elasticity. As Figure 19 shown, the reaction force of this fixture can vary near the perimeter because of the varying width of the peripheral lip or cantilever. In some such cases, the pad width can also vary. However, despite the variation in the width of the support structure near its perimeter, the width of the pad can be relatively constant, as Figure 23 shown. In this sense, the geometric profile of the foam may not exactly follow the geometry of the fixture. Therefore, the final tension characteristics of the mask will be affected by the combination of the fixture and the compressed foam.

[0267] Adjusting the elasticity near the sealing perimeter can also be achieved by changing the lip thickness. For example, the lip thickness value along the mouth side towards the top of the nose can be approximately twice that along the bottom of the mouth. This ratio provides less elasticity in the nasal region and relatively greater elasticity in the lower lip region. In one such example, and depending on the fixture material, the peripheral lip thickness can range from approximately 1.5 mm (millimeters) to 2.5 mm (millimeters), such as approximately 2.2 mm (millimeters) (+ / - 0.1 mm (millimeters)), with a relatively constant thickness from the region near the mouth side to the nose top region. The region of the peripheral lip near the lower lip (around the mouth bottom) can range from approximately 0.75 mm (millimeters) to 1.25 mm (millimeters), such as a relatively constant 1.0 mm (millimeters) (+ / - 0.1 mm (millimeters)) thickness.

[0268] Generally, the body depth (as illustrated by arrow BD in Figure 14 ) can be relatively constant around the fixture. In Figure 14 、 18For examples of 19, the body depth of the fixture (the part not connected to the foam pad or frame) can be in the range (for example) from about 8 mm (millimeters) to 15 mm (millimeters) or, for example, a depth range of about 11 mm (millimeters) to 13 mm (millimeters).

[0269] In some cases, other features can be formed or applied to it using a pad support structure to more affect the sealing performance, such as an elastic nose projection. This example refers to Figure 13 the fixture illustrated, which also shows being applied to Figure 20 and 21 the frame. In Figure 13 the example of, the fixture also includes additional cantilever projections (3561), which can further be used as cantilever springs. The fixture can use these elements to press the foam into the hard sealing area, such as the nose corner, effectively providing varying degrees of pad compliance.

[0270] As mentioned above, the pad support (fixture or frame), or parts thereof, can be cast using different grades of thermoplastic elastomer TPE. Different hardness grades can be used. Generally, a TPE material is more beneficial than silicone because it is easier to cast some foam pads (e.g., foams), and its processing time is faster than that of silicone. However, other flexible or elastic materials can be used, such as thermoplastic polyurethane (TPU), thermoplastic polyurethane TPV, or rubber, etc. By further example, in some cases, the elastic support structure (e.g., fixture) can be formed using silicone, such as a room temperature vulcanizing silicone RTV.

[0271] As mentioned above, due to its elastic nature, the pad and the pad support structure (e.g., fixture) can together respond to the compressive force applied to the frame by the headband inertia vector. However, the pad (such as using foam) can play an important role in conforming to the user's face, purely because it is a softer component and can therefore be compressed more. Finally, when the headband tension has been applied and the frame is pulled towards the patient's face, the foam and the elastic support structure that produce the seal will reach an equilibrium shape.

[0272] The exemplary pad of the hood assembly of the present technology is illustrated in Figure 24 and 25 examples. The foam pad can be foam and form a triangular or oval ring, and can have a common nose and mouth hole. The corners can be rounded. In Figure 24 the example of, the pad has a generally flat patient contact surface PCS. In some of these cases, the edges can be rounded. For example, as Figure 25 shown, the pad profile along the perimeter can have a generally curved patient contact surface PCS. Other foam pad profiles can also be implemented. The contact side of the frame or fixture of the pad can be generally flat or conform to the contact surface of the pad support structure.

[0273] With these exemplary generally single-plane pads, when connected to the fixture or frame, as Figure 26 and27 As shown, the gasket may deform into a multi-planar shape as previously discussed, which is better for sealing. When deformed in this way, the triangle allows the gasket to enter the nasal corners and around the sides and bottom of the mouth to create a seal near the outer perimeter of a portion of the nostril, while maintaining a basic sub-nasal structure and providing a mid-labial upper region. Thus, the nasal mask has a substantially non-contact region in the mid-labial upper region between the vermilion border of the upper lip and the columella in the sub-nasal region. Moreover, this non-contact region may be within the air cavity during use.

[0274] Although Figure 26 and 27 the foam gaskets of [[]] and [[]] are typically single-planar and can be deformed by a frame or fixture to have their multi-planar use structure (e.g., having a nasal-labial angle between the nasal respiratory region and the mouth perimeter region), in some cases, the gasket or foam can be preformed or pre-cut into a multi-planar shape that conforms to the shape of the fixture or frame.

[0275] Generally, there should be an airtight seal between the gasket and its support structure (e.g., the fixture). Various methods can be used to implement this gasket bonding. For example, the gasket can be bonded to the support structure using adhesives such as glue, spray glue, or hot melt glue, etc. In some cases, it can be bonded by ultrasonic welding. In some cases, the foam gasket can be sewn and bonded. The joint can also be implemented using an intermediate material such as tape (e.g., a double-sided tape). In some cases, the support structure (e.g., the fixture) can be overmolded on the foam gasket.

[0276] Similarly, this method can be used to bond the gasket to a frame, such as without an interface fixture. In view of this, the frame can provide a shape-forming structure and surface to hold the gasket (e.g., foam) in the desired contour for patient sealing. In this specific embodiment, the gasket foam can provide some or all of the necessary spring and softness to facilitate the seal and provide patient comfort. Otherwise, some of the previously described elastic characteristics (e.g., the cantilever member of the fixture) can be formed with the frame, contributing to the sealing and comfort effects. In some of these fixtureless cases, some of the elastic characteristics of the fixture can be imparted to the foam using a second cushion layer instead of the fixture. This second cushion layer can be applied to the patient-contact foam layer and can have different elastic / hardness characteristics compared to the first foam layer. In this case, the second layer of the double gasket can be directly applied to the frame without a fixture.

[0277] In some cases, the foam gasket can be a replaceable item (in some specific embodiments, the replaceable item can include a gasket / fixture combination). The gasket can be directly bonded to the frame through a mucosa located on the surface (elastic or hard) of the foam or the individual fixture. In this case, the gasket can simply be removed, and a different gasket with a new adhesive tape can then be bonded to the reusable frame (or reusable fixture). In some cases, the gasket and the frame can be co-molded. In some of these cases, the gasket and frame unit can then be discarded together.

[0278] In some examples, the cushion (3110) may include other features. For example, as Figure 28 shown, the cushion may include a nasal recess, such as a scalloped notch (3763), such as in the nasal airway region of the cushion, which serves as an alternative to a generally flat sealing surface. The nasal recess may be formed by a half-peripheral bevel of the cushion that seals the nose. In some examples, the bevel may form a rising edge from a mid-low position to a radially high position. This half-peripheral region may provide warping support around the nose. The warping geometry may provide a larger surface area (bearing surface). In view of this, the scalloped edge shape feature may replicate the morphology under the user's nose. Similarly, the scalloped notch may also improve the seal in the subnasal ridge region and may provide improved nasal comfort. It may also be used for nasal expansion. This feature may also provide a clearly perceivable attachment area for the patient to place their nose, resulting in a more intuitive fit. In some cases, the notch region or the nasal airway region may be marked to provide an indication of the nasal position for the user to fit. For example, this region may have a distinct color relative to the rest of the cushion.

[0279] The shape of this notch may be defined from any of the following anthropometric features: the width between the labial insertions at the base of the alae nasi; the length of the alae nasi; the alar slope angle; the inclination of the columella; the nasal tip prominence; the width of the nose. In some cases, the depth of the nasal recess details may be based on any of the following: the inclination of the columella; the patient sensitivity to provide sufficient indication of the lower part of the nose to be covered by the mask; sufficient surface to seal around the curvature of the nasal rim; sufficient support near the nasal perimeter to prevent nasal exhalation airflow, such as from the pressure of pressure therapy.

[0280] Other variant versions of the nasal recess geometry include a simple chamfered edge following the nasal perimeter. When the foam has sufficient compliance to be chamfered to fit the nose, improved sealing can be achieved. Similarly, other variations of the overall triangular shape of the scalloped nose feature can be achieved, as the foam has sufficient compliance to conform to different face sizes.

[0281] As previously mentioned, the nasal recess (such as the scalloped nose details) can effectively cup and cover the lower perimeter of the nose and can provide additional surface area for sealing and comfort. Therefore, the usage process can be used in conjunction with other components of the mask assembly (clamps and frames) for effective sealing. From the perspective of sealing and depending on the specific anthropology of the nose, the sealing interface can be changed or extended from under the nose to the subnasal side and / or the local upper nasal side or both. From the perspective of comfort, the force applied to the nose by the headband and the treatment pressure from the sealing interface can thereby be distributed over a larger surface area, resulting in better comfort.

[0282] The nasal cavity of the foam pad is geometrically variable to accommodate various nose sizes. The nose portion pressed into the fan-shaped detail (e.g., during mask installation) will displace the foam until the foam conforms to the nose. The resilient spring nature of the pad support structure (e.g., the clamp and / or the frame) provides resistance during this section, preventing the nose from completely pushing through the foam. Under the treatment pressure, the foam can be pressed backward against the nose, helping to provide an effective seal.

[0283] In some cases, the nasal cavity can be manufactured as part of the complete die-cutting process of the pad. Alternatively, the features can be manufactured using secondary processes, such as thermoforming, ultrasonic welding, or cutting. In some cases, the entire pad including the fan-shaped nose detail can be manufactured using a single compression cutting or thermoforming process.

[0284] In some further examples, the pad may also include one or more protrusions. These protrusions can be included on the surface of the pad. For example, one or more protrusions can be configured such that when the mask is worn on the patient's face, the protrusions further extend from the pad into the portion of the patient's face. Similarly, the protrusions can provide additional structural support and a better seal. For example, a set (e.g., a pair) of protrusions (3764) (such as one or more approximately elliptical protrusions or another shape) are illustrated in the Figure 29 , 30 and 31 pads and masks. These protrusions are configured to extend on the left and right sides of the nose (e.g., left and right alar protrusions). For example, each protrusion can form adjacent to the patient's alae nasi. Similarly, it helps to strengthen the pad seal in the difficult sealing areas on both sides of the nose. The nasal protrusions (when useful) are optional. Effective sealing of these difficult areas can also be achieved by other components, including increasing the thickness and changing the shape of the foam pad in these areas. For example, reduction can be cited on the side parts of the nasal area of the pad to facilitate a better seal.

[0285] As previously mentioned, the connection between the clamp and the frame can be implemented using various different structures. Some examples are illustrated in Figures 32A to 35B Generally, in the case of the clamp implementation, there should be airtightness between the clamp and the frame. The pad / clamp assembly can be separated from the frame, so in the case where the pad has a shorter service life compared to the frame, it allows the pad to be regularly replaced.

[0286] Some exemplary connection structures for anchoring the clamp to the frame can include: tongue and groove geometry; a stretchable peripheral edge that extends around the edge of the frame; a periphery that is connected by interference fit, such as a similar airtight food container; a tongue and groove interface with an auxiliary lip seal or gasket. In some cases, the connection structure of the clamp can conform to the existing mask frame to improve the pad design described in this specification with the existing mask frame.

[0287] In Figure 32A and 32BIn an example of a connector, the fixture and the frame can be coupled together using a flange (3572) and a recess (3574). For example, the frame can be formed with the recess, and the fixture can include the flange. The cross-sectional views of the flange and the recess can be a protruding sphere and a socket. A soft elastic (e.g., TPE, silicone, or other elastic material) flange can be pressed into a hard recessed frame (e.g., plastic) to provide a seal and mechanical retention. Alternatively, a finger latch (3576) can also assist in assembly and component demolding.

[0288] In Figure 33A and 33B In an example of a connector, the fixture and the frame can be coupled together using a side edge (3578) and a flange (3515), such as a flange that continuously extends around an air cavity of the frame (3500). In this case, the side edge (3578) of the fixture can be a semi-rigid element (e.g., TPE, polypropylene, or other similar semi-rigid materials) that continuously extends around the fixture ring. The mating side edge to cover the flange can then be regarded as a seal and provide mechanical retention.

[0289] In Figure 34 In an example of a connector, the fixture and the frame can be coupled together using a shoulder snap (3580) and an engagement cavity (3582) that continuously or semi-continuously extends around the perimeter of the fixture and the frame. This snap can be formed on the edge of the fixture (3535). The edge and the snap can be replaced with a harder frame when engaged, such as when the shoulder snap (which can be a semi-rigid material (e.g., polypropylene)) fits into the engagement cavity (3582). The engagement of the edge with the surface of the frame can provide a seal and the shoulder snap, and the coupling of the engagement cavity can provide mechanical retention.

[0290] In Figure 35A and 35B In an example of a connector, the fixture and the frame can be coupled together using a taper lock (shown in exploded view 3583). In this example, the perimeter (3702) of the frame, which can be rigid, can be held in the peripheral recess (3585) of the fixture. A taper element (3586) of the frame can be coupled to a taper receiving recess (3587) of the fixture, which can be elastic (e.g., silicone, TPE, etc.). The taper element and the taper receiving recess can be formed to continuously or semi-continuously extend near the perimeter of the fixture and the frame. The taper element and the taper receiving recess can then assist in the mechanical retention of the frame and fixture components.

[0291] 5.4.2 Nasal Seal

[0292] A traditional face mask (also known as a patient interface) seals the user's face via a silicone pad, which seals both around the mouth and the nasal bridge. The main issue here is that due to the nature of the silicone material, comfort issues are often experienced by the user (i.e., facial markings or other skin irritations).

[0293] This problem can be overcome using an implementation foam, such as the foam discussed previously. In some specific embodiments, the foam pad can be in direct contact with the patient's skin. The compliant nature of the foam allows it to be pressed into complex facial features under relatively little tension and affect a good seal. This combination of ease of adjustment and softness for the patient experience provides a fairly quick and easy mask installation. The foam also exhibits better breathability than silicone. Thus, the use of foam is associated with better permeability (which is related to the different feelings of many users "towards silicone on the face") and with reducing discomfort in the contact area of the seal zone.

[0294] The comfort related to foam permeability must be balanced with the increased leakage associated with high permeability. When in the case of a nasal mask structure, the foam pad is typically formed of open-cell foam (where most of the pores are open), closed-cell foam (where most of the pores are closed), or semi-open (or semi-closed) cell foam (which is formed by a mixture of open and closed cells). In one example, the techniques discussed can use semi-open-cell foam where the number of open pores is significantly higher than the number of closed pores. This ensures limited permeability through the pad and less leakage. Specific permeability values with this limited permeability and found suitable for the disclosed techniques are discussed later in this specification. Other ratios between the number of open and closed pores can also be used. In the case of higher permeability, various actions can be taken to mitigate the increased permeability. As discussed in this specification, one such action is to extend an elastic clamp or other non-permeable film to cover the inner surface of the foam pad and reduce the overall permeability. It is conceivable that open-cell foam or closed-cell foam can also be used according to the techniques discussed.

[0295] To achieve comfort, a current full-face foam mask with good seal and stability has a larger coverage area when compared to traditional silicone seal masks.

[0296] In the effort to achieve specific flow characteristics, some previously used foam pads were non-permeable or might include a second layer on the foam to stop air from passing through the foam. Both options remove the breathable benefits of the foam seal. Only traditional foam full-face masks with sealed or non-permeable foam pads are compatible with the current stage of respiratory therapy for obstructive sleep apnea (OSA).

[0297] Some previous foam masks also included separate individual components that together formed the pad. In one example, a foam layer could be joined to a silicone pad to improve the seal quality and the comfort of the mask. In some circumstances, this configuration might be larger in size and less comfortable, and it is more difficult for the user to disassemble, assemble, and clean the mask.

[0298] In some variant versions of this technology, when the mask is configured to seal the mouth and is on the nasal bridge, as Figure 36 and 37Examples show that a foam pad can be implemented.

[0299] For example, a foam pad assembly can form a seal around the mouthpiece and on the nasal bridge and can achieve a comfortable and effective seal. This assembly can include a foam pad portion and a pad support structure (e.g., a support clamp portion). Here, the term "on the nasal bridge" should be interpreted as "across the nasal bridge" rather than "on the nasal bridge". The support clamp portion can be an elastic (or soft) clamp portion that complements the compliance of the pad to reduce the pad size. The foam pad can be externally connected to the pad support clamp. This external connection allows the foam surface of the pad to come into direct contact with the patient's skin.

[0300] In one example, a foam pad (3810) made of foam can be defined to cover a single area encompassing the patient's mouth and nose (about midway across the nasal bridge, but this can vary according to the specific patient's facial profile). The foam pad can be made of any suitable material, such as one or more of the following exemplary materials: polyethylene, polyurethane, ethylene vinyl acetate (EVA). In some cases, the foam pad can be a semi-open cell foam, such as made of polyurethane. The semi-open cell foam pad can have a limited permeability, such as in the range described in more detail in this specification.

[0301] The foam pad (3810) can have a substantially triangular or pear-like sealing surface that follows the contour of the user's face. The single-chamber foam pad is designed to engage a first support (e.g., elastic) clamp (3812), which in turn engages a stiffer second clamp (3814) (as Figure 38 shown) or directly engages the mask frame (3816). In a specific embodiment, the first support clamp (3812) can be an elastic clamp that is stiffer than the foam pad but softer or more elastic than the second clamp (3814). It is a combination of the foam and an elastic clamp that defines the physical properties of the overall sealing interface. The elastic clamp allows the interface to accommodate major variations and successfully conforms to the contour of the patient's face. The compliant nature of the foam pad provides fine adjustment and forms a comfortable interface layer that interacts with the patient's skin.

[0302] In some variant versions where the pad assembly or the pad mask can include a protrusion, or a pair of alignment protrusions, when in use, it can be configured to be pressed down by a headband to apply pressure to individual areas of the foam pad. For example, a protrusion (3813) can be selectively included on the outer surface of the first support clamp (3812) (e.g., an elastic support clamp) on both sides of the mouth (e.g., symmetrically located near the mouth on both sides), in such a way that an individual headband can pass through each protrusion, as Figure 37As shown. When dealing with changes in facial width, this configuration allows for better sealing on the mouth side. When tightened, the headband can press the protrusion against the patient's face. This pressure will be transferred to the foam pad, pressing the pad against the patient's face and enhancing the seal in this mouth area. The additional pressure can be modified by changing the height of the protrusion, the tension of the headband, or both. Heights between 2 mm (millimeters) and 6 mm, 3 mm (millimeters) to 5 mm (millimeters), and preferably about 4 mm (millimeters) are considered sufficient for this modification. The protrusion can be located on the outer surface of the foam pad or the rigid fixture, rather than on the surface of the elastic fixture. Protrusions of different heights / thicknesses and located on different components (i.e., one on the rigid fixture and the other on the elastic fixture) can also be used, for example, to create a gradient of inward pressure along the side of the cover. In another specific embodiment, the protrusion can extend across both the foam pad and the elastic fixture. In still further specific embodiments, an edge can be formed extending from the frame to apply an inward force and enhance the seal in a similar manner.

[0303] In some examples, by directly applying only the foam pad assembly to the frame, the elastic fixture or even both the elastic and rigid fixtures can be omitted. However, this design may require the pad to be of a certain thickness and height. The implementation of a fixture (even a rigid fixture, and especially a combination of an elastic fixture or a soft and rigid fixture, as described in this specification) allows for reducing the size of the foam pad without compromising compliance, sealing, and comfort. One role of the rigid fixture is to facilitate the foam / fixture assembly to be attachable to the frame / or removable from the frame for cleaning or replacement. The components of a foam pad assembly (3901) are shown in Figure 39 . The assembly diagram of the foam pad assembly (3901) is shown in Figure 40 .

[0304] As Figure 39 and 40 illustrated, the frame coupling side FCS of a rigid second fixture (3814) includes coupling structures for removably coupling the second fixture to a cover frame (3816). For example, a coupling ridge (4022) can provide a corresponding structure for engaging the cover frame. The coupling ridge (4022) can help form a seal (such as an interference fit) to prevent leakage of treatment pressure at the contact surface of the cover frame and the second fixture on the frame coupling side FCS. One or more selective engagement fasteners (4024) can allow the second fixture to be snapped or locked to the cover frame. This fastener can have a resilient force to bend against the corresponding receptacle of the cover frame until a raised stop (4025) can engage the edge of the receptacle or the orifice of the cover frame. A cone (4027) at the top edge of the fastener can cause the fastener to bend during the coupling of the second fixture to the cover frame until the raised stop (4025) enters the receptacle or orifice of the cover frame and thereby locks into the receptacle or orifice of the cover frame. In some cases, the fastener can be formed on the cover frame, and a corresponding receptacle can be formed on the second fixture. Manual bending of the fastener then allows the second fixture to be removed from the cover frame.

[0305] In an exemplary implementation of the foam, the flexible clamp forms or permanently engages with the rigid clamp, such as Figure 40 shown, which forms an integral pad assembly. The foam and the flexible clamp form the compliant portion of the assembly, while the rigid clamp provides the mechanism to engage the pad assembly to the cover frame. This allows the removal of the pad assembly for cleaning and / or replacement. A rigid clamp may allow a rigid connection between the pad assembly and the cover frame, which makes the cover more convenient for handling and more durable. Thus, the components of the pad assembly (e.g., the foam pad, the flexible clamp, and the stiffer clamp) may be permanently joined in an integral assembly. However (or), they may be separate elements, as Figure 39 shown. If desired, these three elements may be separately configured, formed, assembled together, but may be disassembled and reassembled. Alternatively, the foam pad and the flexible clamp may be permanently joined to each other, but the rigid clamp may be detachably connected. In another example, the flexible clamp and the stiffer clamp may be permanently joined to each other, but are separably connected to the foam pad.

[0306] This removable engagement mechanism is known in the art and may include an adhesive layer (for joining the foam to the flexible clamp), an interference fit, and a snap engagement. The perimeter of the more flexible component (such as the flexible clamp) may also be stretched over the perimeter of the stiffer component (such as the frame or the rigid clamp).

[0307] Any combination of the three components is possible, and alternative design variations may include a pad assembly that includes only a foam pad, a foam pad and a flexible clamp, or a foam pad and a rigid clamp.

[0308] In some cases, a foam pad may itself form a slip-on foam cover component for one of the other cover parts, assemblies, or cover pads. For example, a foam pad cover may form or be formed with a stretchable engagement side edge. The side edge or the foam side edge may then be stretched over a base structure defined by any of the cover parts, such as a frame, a clamp, or even a silicone pad. Once the foam pad has been slip-on mated to the edge of the base component, it may be used as a comfortable sealing layer for contacting the patient's face. Similarly, the slip-on foam pad may even be used as an easily replaceable cover component to improve the comfort of existing silicone or foam pad covers.

[0309] 5.4.2.1 Sealing mechanism

[0310] Utilize Figure 36 and 37In the mask example, the foam pad is configured to directly contact the patient's skin. The seal around the mouth, and at the sides of the nose and nasal bridge, is created through the interaction of the headband tension between the reaction forces of the patient's face, the frame (which can be applied to the pad assembly via a rigid clamp), the elastic clamp, and the foam pad. Each of these three components is discussed in more detail below. When these components are assembled together, they work in concert to provide a variable amount of foam compression around the nose and mouth, creating an effective seal in these areas. In view of this, Figure 41 The illustrated display mechanism creates a seal through the combination of these three components.

[0311] As Figure 41 shown, by applying the foam pad to the user's face and tightening the headband inertial vector (see Figure 37 ), a seal can be created along the foam contact surface with the patient's face, such as around the nasal bridge and the sides of the nose and mouth. The seal is caused by a combination of foam compression and / or deflection and compression of the elastic clamp.

[0312] The elastic energy of the combination of the foam and the elastic clamp allows the foam mask to conform well to the contour of the patient's face.

[0313] When the headband inertial vector is tightened further, a greater sealing force SF will be applied.

[0314] The reaction forces of the pad and the elastic clamp caused by the deflection and compression of the pad and the clamp by the headband create a reaction vector that is directed from the frame support towards the patient.

[0315] The structure of the foam pad and the elastic clamp is such that the treatment pressure (e.g., CPAP) accumulated in the mask air chamber also acts on the inner surfaces of the elastic clamp and the foam, pushing them outwards and compressing the foam against the user's face. Thus, the configuration further utilizes the pressure in the air chamber and helps to maintain the sealing pressure. As described above, due to their elastic nature, the foam and the clamp can respond together to the compressive force applied to the frame by the headband inertial vector. Finally, when the necessary headband tension has been applied and the frame is pulled towards the patient's face, the foam and the clamp will reach an equilibrium shape, in which the seal is established and maintained. In some examples, through its greater stiffness, the clamp provides a reaction force that is substantially greater than the reaction force provided by the foam pad. The reaction forces of both the clamp and the foam pad can vary along their perimeters.

[0316] Similarly, the compressed foam can provide a relatively small elastic reaction force in some parts of the perimeter of the pad and a greater elastic reaction force in other parts.

[0317] Similar to the mask examples previously described in this specification (e.g., the sub-nasal mask), the elastic clamp can be peripherally concave to have a concave profile or a concave shape. This allows pressure to act on the inner surface of the clamp to enhance the mask seal.

[0318] The different parts of the elastic fixture can provide different functions. For example, the spring constant provided from the middle region of the shape (e.g., "C") can act as a support arm, which can establish a main reaction force in response to the tension applied by the headband. A peripheral lip for supporting the foam can be used as a cantilever, which presses the foam against the patient's face to enhance the sealed engagement. In addition, the overall open (concave, C-shaped or L-shaped) structure of the fixture allows the air pressure inside the mask to be applied to the inner surface of the peripheral lip. This inner surface is located opposite to the foam support (and sealing) surface. Therefore, the mask pressure pushes the peripheral lip, thus pressing the foam pad against the patient's face, further enhancing the sealed engagement and helping to reduce any air permeability of the foam. Without the fixture, pressure would still be applied to the foam pad. However, because of the semi-open cell type of foam used, the applied pressure can leak through the foam. Therefore, the concave shape of the fixture means that at least a portion of the lower surface of the foam pad (3810) is covered by the non-permeable material of the elastic fixture, as Figure 41 shown. This can be used to control leakage through the pad and increase the pressure in the mask air cavity. This concept can be further adopted, and the fixture can be extended to cover at least a portion of the outer sidewall of the foam pad (3810) (as long as it does not contact the patient's skin). On the other hand, for various reasons, one may want to expose some of the foam surface. As discussed later in this specification, one positive result of this design is that a portion of the foam is not supported by the elastic fixture, and therefore, when the headband is tightened, the foam may tend to "roll in". This rolling-in effect is beneficial for sealing, for example, the nasal region of the mask.

[0319] 5.4.2.2 Foam Pad

[0320] In Figure 42 the example of the pad shown, the foam has a varying cross-section from the nasal bridge to the bottom of the mouth and is symmetric about the central plane. During use, the geometry of the foam is affected by the overall design of the elastic fixture, as well as the anthropometric data used in the foam material specifications (e.g., hardness, compression set, permeability, compressive stress-strain, density, etc.).

[0321] The pad can be constructed with a varying cross-section, which can be divided into three zones, the nasal bridge MNBR, the nasal side MSNR, and the mouth side MMR, with a smooth transition between each of these zones. Each part is constructed with a contour optimized for sealing a specific facial region of the pad.

[0322] The cross-section of the foam is designed considering the following, and the geometry is designed to handle each of these zones:

[0323] (a) Comfort

[0324] Generally, it has been found that increasing the amount of foam (height and width) increases overall comfort. The first fixture becomes apparent and can be felt through foam with a height of less than (<) about 8.0 mm (millimeters), depending on the specific cross-section of the first fixture. At Figure 42 In the example of

[0325] (b) Sealing

[0326] Generally, it has been found that increasing the width of the foam surface in direct contact with the patient improves the seal.

[0327] (c) Stability

[0328] Generally, it has been found that the stability of the seal is negatively affected by increasing the foam height and positively affected by increasing the foam width.

[0329] (d) Infringement

[0330] The main risk of infringement is the possibility that the pad assembly interferes with / blocks the user's eyes. In some cases, the width of the foam in the eye area can be reduced.

[0331] By reducing one or both of the height and width of the foam pad within a specified range, the overall size of the mask can be reduced.

[0332] 5.4.2.2.1 Foam cross-section

[0333] (a) Nasal column area MNBR– Figure 43

[0334] In some examples, the nasal column area of the pad (such as Figure 43 shown) can be formed in a trapezoid (in its cross-section). This can provide good stability characteristics. For comfort and better aesthetics, the top corner edges can be rounded. For example, a width of about 12 mm (millimeters) (or in different ranges from 0 - 25 mm (millimeters)) is suitable for the surface part in contact with the user's nasal column. This can be kept substantially higher than other areas to increase the sealing surface in this area.

[0335] (b) Nasal area side MSNR– Figure 44

[0336] In some variants, the nasal area side of the pad (such as in Figure 44As shown, a trapezoidal configuration (in its cross-section) can be used. This can provide stable characteristics. For comfort, the top corner edge can be rounded. The width of the surface contact portion on the user's face can be approximately 6.35 mm (millimeters) (within a different range of approximately (0 - 14 mm (millimeters))) to avoid the pad intruding into the patient's eyes.

[0337] (c) Mouth region MMR - Figure 45

[0338] In some variations, the mouth region of the pad (such as Figure 45 As shown) can be configured with a trapezoid (in its cross-section), which can provide good stable characteristics. For comfort, the top corner edge can be rounded. A width of approximately 9 mm (millimeters) (within a different range of approximately 0 - 17 mm (millimeters)) is suitable for the surface contact portion and can compromise comfort / seal and the overall mask size.

[0339] Although a trapezoidal cross-sectional geometry has been used to illustrate these different regions, other cross-sectional geometries are shown in Figure 46 These can include; a dome geometry (4621 - A), a straight-edge dome geometry (4621 - B), a rectangular geometry (4621 - C), and a rectangular rounded-edge geometry (4621 - D). The dome geometry (4621 - A) is a cross-section of a full dome surface, which increases the space between the user and the foam and improves overall stability. The rectangular geometry (4621 - C) has a rectangular cross-section, which performs similarly to the trapezoidal geometry and, for performance purposes, is similar to a rectangular cross-section with rounded edges. The rounded edges increase the overall comfort of the pad as, unlike the foam, they are not pressed in these regions during mask use (by removing the sharp corner edges).

[0340] In some examples of the pad, a combination of geometries can be implemented within a single foam pad in different regions and / or between them. For example, the foam can be configured with a geometric transition between these regions. In one example, the pad can transition from a cross-sectional geometry with a flat top (e.g., a rectangular top for comfort and better seal) to a dome to increase the clearance in a specific facial region.

[0341] In Figure 45 and 46 each of the exemplary cross-sectional geometries shown has a foam height of approximately 12 mm (millimeters). However, in some examples, the height of the foam can also transition between and / or within regions with appropriate heights greater than or less than 12 mm (millimeters). The appropriate height can be selected to vary the performance according to the requirements of the individual parts of the pad.

[0342] 5.4.2.2.2 Foam products

[0343] One exemplary embodiment of the foam can be produced using die cutting, but can be produced by or using a combination of any of the following methods, including: die cutting machines, thermoforming, molding, grinding, die cutting, etc. For example, the foam can be die cut into a flat profile, such as Figure 47 as shown. In this flat profile, the shape of the foam is somewhat two-dimensional because its shape is mainly defined in two dimensions, but is planar in the third dimension. Once the foam engages one or both of the fixtures (e.g., soft / elastic fixtures), it not only changes its two-dimensional shape, but also bends in the third plane (dimension), becoming truly three-dimensional. Thus, when assembled, the fixtures can cause the foam to form a contour (such as improving the variation in face contact). In the Figure 47 example, the foam is held by the first fixture in a contoured shape. In the engagement structure, the best illustration of the three-dimensional (3D) aspect of the pad is shown in Figure 84 . At the same time, the pad itself can be formed in a 3D shape, or this can be imposed on either or both of the fixture and / or the pad by a frame, rather than having a 3D shape imposed on the pad by one of the fixtures.

[0344] 5.4.2.2.3 Assembly Method

[0345] The foam can be assembled to a fixture or other enclosure structure (such as a soft / elastic fixture) using the following means: adhesives (e.g., glue and / or tape), flame lamination, molding (e.g., the foam is molded to the fixture, or vice versa), welding, mechanical connection between the foam and the fixture, seams, etc. The foam can be formed or cut using a generally flat or planar profile. When used as an enclosure on a patient, although it has a face contour (e.g., see the face contour of the pads in Figure 58A and Figure 22 ). In some cases, the foam pads of any of the enclosures described in this specification can simply be bent or deformed to have a face contour that can conform to the contour of the installed fixture. Thus, the foam can have a face contour depending on the fixture. However, in some cases, the foam can be formed with a face contour, such as by molding or cutting the foam. In this case, the face contour of the foam can be independent of any fixture or other structure.

[0346] 5.4.2.3 First Elastic Fixture (e.g., also sometimes referred to as the "soft" fixture)

[0347] As Figure 48As shown in the cross-sectional view of the exemplary cushion assembly, the first soft / elastic fixture includes a cushion coupling portion (4840), a support portion (4842), and a base portion (4844). The cushion coupling portion (4840) provides a contact surface that indirectly engages the cover cushion. The support portion (4842) is elastic but has a specific hardness to provide perceptible responsive support to the cushion when stretching the headband and when using the cover. The base portion (4844) engages the rigid second fixture; alternatively, in some embodiments, it engages the frame. One or more additional support portions (4842) (e.g., having different hardness / elasticity characteristics) may be included between the cushion coupling portion (4840) and the base portion (4844).

[0348] Furthermore, since the walls of the fixture (a few millimeters) are of relatively small thickness, the general shape of the fixture body is a curved concave surface with an opening leading inward to the center of the air cavity of the cover. The shape of the cross-sectional profile of the elastic fixture may vary but is typically L or C, or even Z-shaped, a simple tongue flap, or a varying wall portion, etc. The opening or concave nature of the fixture allows the pressure in the cover air cavity to be applied to the cushion in a manner that improves the seal of the cushion to the patient ( Figure 48 as shown by arrow P4). The support portion (4842) may generally be perpendicular to the sealing surface SP-5 (e.g., see the C-shaped cross-section in Figure 56 and its individual support portions (4842)). The material properties of the fixture, the shape and dimensions of the support portion of the fixture (especially thickness and height) can be selected such that the elastic fixture provides perceptible support to the cushion but can change its structure and act as a cantilever spring when using the cover. The reaction force regarding the hardness of the fixture presses the engaged foam cushion against the patient's face, improving the seal to the face, and the cited compliance (i.e., the cantilever spring nature of the fixture) helps the foam cushion conform to the face. The hardness of the fixture, especially laterally (regarding the upper and lower, or lateral sides of the face) also provides lateral stability to the cover. This stability is particularly beneficial for wearing the cover at night when the patient's head movement easily disturbs the cover and compromises the seal engagement.

[0349] A minimum height of about 5 mm (millimeters) for the elastic fixture is desirable to allow sufficient movement during use so that the user does not "bottom out" on the elastic fixture. In this specification, "bottoming out" may occur when the elastic fixture has reached its deflection limit, or when it is completely flattened to a stop point and there is a significant tension acting on the user's face and the user can feel it. The height can be selected to be in the range of about 5 mm (millimeters) to 30 mm (millimeters), depending on the facial area covered by the fixture.

[0350] The entire resilient support fixture or central support portion (4842) can represent a curved surface having, for example, a "Z", "C", or "L" cross-sectional geometry. The pad coupling portion (4840) can be in the form of a peripheral lip that connects the foam to form an effective cantilever extension. Depending on the structure and material properties of different portions of the end view fixture cross-sectional profile (shown in Figure 48 ), the cantilever spring effect can be primarily limited to a specific portion of the resilient fixture, such as the pad coupling portion (4840) related to the top edge of the support portion (4842), or the extended lip formed by the combination of the pad coupling portion (4840) and the support portion (4842), and which is associated with the boundary of the resilient support portion (4842) and the frame engagement portion at the base (4844).

[0351] When the headband is stretched, the support portion (4842) of the fixture deforms and builds up a reaction force that attempts to return the fixture to its original shape. This force presses the foam against the patient's face, enhancing the sealing engagement.

[0352] The structure of the entire support fixture is configured to provide a balance between support and resilience. By varying the dimensions (primarily wall thickness and height), the stiffness, and the cross-sectional shape along the perimeter of the fixture, different degrees of support and resilience are provided in different portions of the mask. Although the support portion (4842) of the fixture is typically perpendicular to the sealing surface SP-5, as Figure 48 shown, in some embodiments, the support portion can form an angle α with a plane perpendicular to the sealing surface. In some examples of the technology, at least part of the cross-sectional shape of the resilient support fixture is characterized by the angle α and / or the relative length of the L, C, or Z-shaped arms. For example, as will be discussed later with reference to Figures 51-54 , where higher softness and lower support are required, such as in the sensitive area of the nasal bridge, the fixture can use one or more of the following characteristics: a tall support portion (4842), a thin support portion (4842), or an increased angle α. For example, an angle between 20° and 50°, and more specifically between 30° and 40°, can be suitable for this application. Variations in the overall physical structure of the first resilient fixture, such as changing the overall shape of the fixture (i.e., from a C-shape to an L-shape) or changing the relative lengths of different portions of the fixture (e.g., changing the relative lengths of the pad coupling portion (4840) or the support portion (4842)) can also be implemented to achieve a similar result.

[0353] The previous paragraphs have described the cantilever spring effect resulting from the elastic nature of the fixture. However, the elastic nature of the fixture can define a broader self-adjusting effect that is distributed along the length of the fixture and that exceeds the cantilever spring effect. In particular, this adjustment occurs when the mask is in its operating configuration, i.e., engaging the user, the headband is tightened, and the air cavity of the mask is pressurized. In this example, a specific balance is established among the forces acting on the fixture. For example, in a direction perpendicular to the contact plane SP-5, this force includes a downward fixture force (such as the tension applied by the headband via the mask frame, the applied pressure P4, and the reaction force applied by the foam pad) and the spring constant of the fixture, which is mainly defined by the support portion (4842). However, the pressure applied within the air cavity acts not only in the direction indicated as P1 but also on the entire inner surface of the fixture. Once the mask is in its operating configuration, the overall balance of the forces and elasticity of the fixture can cause dynamic changes to the entire structure of the cross-sectional profile of the fixture. Thus, the shape of the fixture (such as the L-shape typically shown in Figure 48 can undergo changes that vary in different peripheral portions of the fixture. Some of these changes can include any of the following: bending in an inward or outward direction in any part of the support portion (4842), modification of the angle between the pad coupling portion (4840) and the pad support portion (4842) (not shown in Figure 48 but complementary to the angle α), and change of the indicated angle with the pad support portion (4842). The inward rotation of the pad coupling portion (4840) (the pad support surface) into the air cavity defines the effect of the pad being drawn in. The changes can vary along the perimeter of the fixture. For example, in certain portions near the perimeter of the fixture, the fixture surface of the pad coupling portion (4840) (and thus, the pad) can be drawn in, while in other portions, it can be drawn out.

[0354] The direction and extent of the fixture structure modification will depend on the force balance, the patient's face profile, and the material properties of the fixture (such as its hardness / elasticity) discussed above. These properties can be modified by changing the shape, dimensions (e.g., thickness and / or height), and / or material properties of the fixture. When in use, the specific dimensions and material (more specifically, mechanical) properties of at least some embodiments of the fixture (which contribute to modifying the cross-sectional profile of the fixture) will be described in detail in this specification. The modification represents a self-adjusting mechanism that allows the elastic fixture and the engaged foam pad to adapt to different face geometries and features and provides a comfortable and reliable seal. The effect of this self-adjusting mechanism can be further enhanced by purposefully varying the mechanical properties and the general spatial relationship (or angle) between the pad coupling portion (4840) and the pad support portion (4842) near the perimeter of the elastic fixture, as discussed in Figures 51-54 .

[0355] In some examples, the support portion (4842) of the fixture can be selected to have dimensions (height and thickness) and mechanical properties (i.e., elasticity) that allow air pressure to create an air spring effect. That is, asFigure 48 As shown, due to the elasticity of the support fixture, the pressure P4 in the air chamber can contribute to the overall sealing of the cushion by pressing the foam pad against the patient's face. When the pressure increases, a force is established to create the seal. The spring effect can also vary near the perimeter of the fixture.

[0356] All of the effects described in the previous paragraphs allow the elasticity of the elastic fixture and the support fixture to be complementary. However, the effects are subject to the hardness of the fixture. The fixture needs to have sufficient overall hardness to provide support for the foam in an important structure.

[0357] In certain specific embodiments, for any reason, if basic compliance and softness are required, the size and material properties of the fixture can be selected so that the fixture can expand in a balloon-like manner under the pressure applied to the mask at least partially during use. This configuration will exhibit increased compliance but reduced stability.

[0358] In Figure 49 the example shown, the soft / elastic first clip has a varying cross-section from the nasal bridge to the bottom of the mouth and is symmetric about the central plane. The geometry of the elastic fixture will be mainly affected by the overall design of the foam and the fixture material specifications. For a particular embodiment, the thickness of the elastic fixture for both the pad coupling portion (4840) and the pad support portion (4842) can vary between approximately 1 mm (millimeter) and 2 mm (millimeter). However, other thicknesses can be implemented.

[0359] Figure 48 and Figure 50 the positioning protrusions (4845) shown can be included on the outer perimeter of the surface of the elastic fixture connecting the foam. This structure then helps to align the foam mounting surface provided by the coupling portion (4840) of the elastic fixture during the foam manufacturing process. The positioning protrusions are designed to be very small and do not contact the user's face. For example, their height and width are approximately 0.5 mm (millimeter) with a fully rounded tip. Other heights can be selected and can range from approximately 0.2 mm (millimeter) to 2 mm (millimeter).

[0360] 5.4.2.3.1 First Fixture Region

[0361] The first fixture can be implemented with different characteristics in different regions of the fixture. For example, different cross-sectional geometries and / or characteristics in various different parts of the fixture are to impart different characteristics to the relevant parts of the mask and allow for sufficient sealing of individual areas of the user's face, as described in detail below. The exemplary regions are shown in Figure 49 the illustration. These regions can include a nasal bridge region (FC-NBR), a nasal side region (FC-SNR), a mouth side region (FC-SMR), and a mouth bottom region (FC-BMR).

[0362] (a) Nasal Bridge Region – Figure 51

[0363] In Figure 51 The exemplary cross-sectional geometry of this area shown is "C"-shaped and allows the foam pad to move substantially vertically towards the user's face to accommodate different nasal column depths. It can be the softest / most elastic part of the first clamp and has a thickness of about 1 mm (millimeter) at its support part (4842). However, in some variant versions, this thickness can range from about 0.25 mm (millimeter) to 1.5 mm (millimeter). The movement is generated by the angle between the inner face (45° in this case) (range 0° to 90°) and the overall dimensions of the "C" part.

[0364] The surface of the foam where it joins at the pad coupling part can be the largest in this area (e.g., about 15 mm (millimeter)), but can range from about 10 mm (millimeter) to 25 mm (millimeter). This dimension is to reduce the possibility of air leakage at the nasal side seal as it restricts the outward movement of the elastic clamp in this area.

[0365] As Figure 51 shown, the height of the clamp measured from the boundary of the area used to join the elastic clamp to the rigid clamp to the boundary of the area used to join the foam is marked as 13 mm (millimeter). However, this can vary between 10 and 20 mm (millimeter). For a clamp marked thickness of about 0.25 mm (millimeter) to 1.5 mm (millimeter), this will define a height-to-thickness ratio between 5 and 80.

[0366] The combination of these values can define the overall sealing and comfort quality.

[0367] (b) Nasal area side – Figure 52

[0368] In Figure 52 The exemplary cross-sectional shape of the first clamp in this area shown is also "C"-shaped and allows the foam to pivot at the user's nasal side and match the facial geometry. This allows the foam contact surface to be parallel to the user's nose. The elastic clamp support part (4842) of this elastic clamp area can have a thickness of about 1 mm (millimeter). However, in some variant versions, this thickness can range from about 0.25 mm (millimeter) to 1.5 mm (millimeter). A height of about 12 mm (millimeter) can provide the range of movement required to conform to the user's nose. However, in some variant versions, this height can range from about 8 mm (millimeter) to 20 mm (millimeter).

[0369] As Figure 52 shown, the height of the clamp is measured from the boundary of the area used to join the elastic clamp to the rigid clamp to the boundary of the area used to join the clamp to the foam pad. The aforementioned thickness and height of this part of the clamp perimeter define a height-to-thickness ratio between 5 and 80.

[0370] (c) Mouth area side – Figure 53

[0371] In the area on both sides of the mouth Figure 53 The exemplary fixture cross-sectional geometry in the area on both sides of the mouth is "L"-shaped and can be the hardest part of the fixture, which effectively forms a certain site around the mouth side. The support part and the pad coupling part can also form an angle with each other (see Figure 55 "HA") to increase stability and better sealing. A harder structure is more suitable because these mouth areas on the face are considered to have no pressure sensitivity. In addition, this angular structure allows the foam to pivot to the user's face to allow for varying face contours. The elastic fixture and (more particularly) its support part (4842) can have a thickness of about 2 mm (millimeters), but other thicknesses in the range of about 1.5 mm (millimeters) to 3 mm (millimeters) can also be implemented to provide increased hardness. In some variants, a "C"-shaped geometry can also be implemented for these areas of the elastic fixture. However, this may increase the overall cover area of the mask.

[0372] As Figure 53 shown, the height of the fixture measured from the boundary of the area used to join the elastic fixture to the hard fixture to the boundary of the area used to join the foam pad is labeled as 15 mm (millimeters). However, this can vary between 10 and 20 mm (millimeters). For the indicated fixture thickness, this will define the ratio of the height to the thickness of the peripheral part of this fixture between 3 and 80.

[0373] (d) Bottom of the mouth area – Figure 54

[0374] Figure 54 The exemplary fixture cross-sectional geometry at the bottom of the mouth area is "L"-shaped and allows the elastic fixture to be rolled up. This allows the foam to move up and down relative to the face ( Figure 54 left and right), and maintain a parallel upper sealing surface with the user's face. This feature allows the user's jaw movement (i.e., the jaw moves down during use) without losing the seal between the pad and the patient. The elastic fixture has a thickness in this 1 mm (millimeter) (range of 0.25 to 1.5 mm (millimeters)) area. The rounded inner surface (RIS) may cause the rolling-up action, and this rolling-up action is more helpful by having a large enough radius (e.g., about 4 mm (millimeters), but can be any radius in the range of about 2 to 10 mm (millimeters)) to avoid the inner folding of the lip surface that joins the foam (pad coupling part (4840)). The elastic fixture can have a height of about 17 mm (millimeters), but can be in the height range of about 15 to 25 mm (millimeters). This height range allows sufficient movement of the foam pad. As Figure 54 shown, the height of the fixture is measured from the boundary of the area used to join the elastic fixture to the hard fixture to the boundary of the area used to join the foam. Although the "L" cross-section is illustrated, in some variants, this area can be configured with a "C"-shaped geometry, but this will result in an increased overall foam mask cover area.

[0375] The indicated thickness and height of the fixture will define the ratio of the height to the thickness of the peripheral part of this fixture between 10 and 100.

[0376] 5.4.2.3.2 First Fixture Interface

[0377] In some variations, the resilient fixture may include a lip seal (5550), such as in the Figure 55 and 56 illustrated example. The lip seal is used as part of the resilient fixture, which seals the resilient fixture and the cover frame. Thus, the lip seal (5550) is used between the resilient fixture and the cover frame to ensure maintaining the sealing property between the two components. The lip seal may be part of the resilient fixture and may extend near the inner periphery of the resilient fixture. The lip seal may be resilient. For example, when the resilient fixture is coupled to the cover frame, such as using the hard fixture engagement feature, the harder part of the cover frame may be pressed down by the more resilient lip seal to create a tight / effective seal therebetween. This may cause some movement or displacement of the more resilient lip seal (5550). In other configurations, the lip seal (5550) may not be part of the first support fixture (3812) (e.g., the resilient fixture), but may be part of the hard second fixture (3814) or the cover frame (3816).

[0378] The interface between the second fixture (or the harder fixture) and the cover frame is also shown in Figure 55 and 56 . The hard fixture can be used as a hard stop (5551) to prevent the pad assembly with the resilient fixture from pushing too far into the cover frame. Thus, the hard fixture can help ensure the correct alignment of the lip seal (5550). Incorrect assembly of the pad may result in the following deficiencies: leakage through the lip seal; the cover frame extending too far and contacting the patient; the headband attachment on the cover frame moving too far and contacting the patient.

[0379] Performance characteristics (behavior under load, e.g., increasing / decreasing sealing force) can be changed by modifying any one or more of the following: material properties, soft fixture thickness, overall resilient fixture height and width, and / or soft fixture geometry.

[0380] 5.4.2.3.3 First Fixture Material

[0381] Typically, unlike the breathable foam pad, the first fixture is not typically made of foam and may itself be airtight. The first fixture is considered "resilient" or "soft", being resilient in use or made of an elastic material that can deform under load. This includes but is not limited to silicone, TPE, TPU, and natural rubber.

[0382] TPE material is desirable because it has a higher likelihood of adhering / molding to the foam and / or the hard fixture.

[0383] 5.4.2.3.4 First Fixture Article

[0384] The process for the elastomeric fixture may include injection molding. It may be molded using any one or more of the following techniques. It can be molded as an individual part. It may be overmolded onto another part or parts, such as onto any one of a rigid fixture, a cover frame, and a foam pad. For example, it may be molded onto both the foam and the rigid fixture.

[0385] If the elastomeric fixture is made as an individual part, it can be assembled onto the rigid fixture using one or more techniques, depending on the process. For example, it may be joined such as using an adhesive, glue, or tape. Its assembly may utilize flame lamination, ultrasonic welding, injection molding, such as a 2K or two-shot co-injection molding process, which can utilize a single injection molding process with multiple (e.g., two) different polymers.

[0386] 5.4.2.4 Second Fixture (e.g., rigid fixture)

[0387] As Figure 56 and 57 shown, the selective second fixture (3814) (harder than the elastomeric clip) allows for easy assembly of the pad assembly onto the cover frame and disassembly of the pad assembly therefrom. This allows for easy cleaning of the cover frame and replacement of the pad assembly. Although different structures can be used as the mechanism for attaching the rigid fixture to the cover frame, Figure 56 and 57 represent examples of a plurality of retention features (e.g., fasteners (4024) or clips) locked to individual faces of the frame and closely supporting the rigid fixture (and the entire pad assembly) to the frame. These features of the retention mechanism have been described with reference to Figure 40 Alternative components are also possible.

[0388] Typically, the second fixture (3814) allows for a stiffer interface between the elastomeric fixture / foam assembly and the cover frame. Although using a rigid fixture can increase usability, it is not necessary for the operation of the cover. Alternative joining mechanisms can be used to attach the pad assembly to the cover frame. Similarly, a cover assembly can be designed not necessarily to include a non-elastomeric support fixture. As previously described in this specification, a larger amount of foam would be required in this case.

[0389] Alternative component mechanisms between the foam pad and the cover frame (some of which do not include a rigid fixture or even an elastomeric fixture) can include a tongue and groove geometry between the elastomeric fixture and the cover frame.

[0390] In some variations, a portion of the resilient clip may be configured to engage the face frame by stretching and gripping a coupling flange of the face frame. In some examples, the resilient clip may be configured to couple to the face frame or a rigid clip using a dry wrap device similar to an airtight food container. In some variations, there may be a tongue and groove interface between the resilient clip and the face frame, and a second lip seal or gasket may be provided to prevent air / pressure leakage. In some variations, the cushion assembly may be permanently joined to the face frame. In some variations, an adhesive such as tape may be applied between the cushion assembly and the face frame.

[0391] The rigid second clip may provide structural integrity to the cushion assembly due to the soft / elastic nature of the resilient clip and the foam cushion. Even when disassembled from the face frame, the rigid clip allows the cushion assembly to maintain its shape.

[0392] 5.4.2.4.1 Second Clip Material

[0393] The rigid clip may be made of any suitable rigid material. For example, the second clip may be made of a rigid thermoplastic material. This material may include, for example, acrylonitrile butadiene styrene (ABS), nylon, and / or polycarbonate.

[0394] The second clip may be made, for example, by injection molding.

[0395] 5.4.3 Additional Examples of Nasal Seal

[0396] Another exemplary foam face of the technology may be referred to Figures 69 to 86 . The face may be adapted to seal around the mouth and over the nose. The foam cushion (3810) is illustrated Figure 69 . The cross-sectional geometry of the cushion may generally be trapezoidal, with the corners that contact the patient's face rounded for comfort. This generally trapezoidal shape provides stability. As Figure 70 shown, a flat contact surface has been partially removed to form a nasal recess (6912) that is adapted to receive the user's nose and reduce the pressure exerted by the face on the nasal bridge area. The height of the nasal recess (in a vertical direction parallel to the height of the nose) may be about 17 mm (millimeters) (see Figure 70(cross-section). In certain variations, it can be any height up to the width of the foam, such as 25 mm (millimeters). Moving from vertical (along the length of the user's nose) to horizontal (the direction of the width of the user's nose), the nasal cavity gradually decreases until the concave surface starting from point 6910A joins the non-concave surface at point 6910B. The width 6910C of the nasal cavity in the horizontal direction is between approximately 10 and 35 mm (millimeters), but can be approximately 20 - 25 mm (millimeters). A well-designed nasal cavity allows the foam to conform to the user's nose. This increases the stability of the mask in this area. Increasing the width of the nasal cavity can provide additional reassurance / comfort to the user, but has a negative effect on sealing and stability. The depth of the nasal cavity is approximately 9 mm (millimeters), but can range up to the full height of the foam, such as 9 mm (millimeters). Increasing the depth of the nasal cavity will provide the user with improved visibility and additional reassurance / comfort, but may adversely affect the overall durability of the foam pad.

[0397] The cross-sectional geometry of the foam on the nose and mouth area side can be any of the variations of the foam pad described in this specification. However, there can also be a smooth transition between the new nasal column and the nose area side. The nasal cavity can be manufactured simultaneously with the foam pad compression shear process, but can also be formed during a secondary process such as additional compression shear, thermoforming, and / or polishing.

[0398] 5.4.3.1 First fixture (e.g., elastic fixture)

[0399] Similar to the previous example, the foam mask can include a first fixture (e.g., a soft / elastic fixture) that has a cross-sectional geometry that varies according to the fixture area (e.g., nasal column area (FC-NBR), nose area side (FC-SNR), mouth area side (FC-SMR), and mouth area bottom (FC-BMR)). The exemplary cross-sectional geometries of each of these areas are shown respectively in Figure 71 、 72 、74 and 75.

[0400] A. Elastic fixture nasal column area

[0401] Forming a nasal cavity in the foam pad can be compensated for by reducing the width of the elastic fixture surface used to support the foam pad in the nasal column area. The reduced support can increase compliance and allow the pad to roll up when pressure is applied, thus further improving user comfort in the nasal column area.

[0402] In the area around the fixture Figure 71The cross-section shown is typically "L" shaped and allows the foam to move substantially perpendicular to the user's face to accommodate various types of nasal column depths. It forms the softest (i.e., most elastic) part of the fixture and has a thickness (support portion (4842)) of about 0.5 mm (millimeters) (but suitable for a thickness in the range of about 0.25 - 1.5 mm (millimeters)). The elasticity is most evident in the bending of the support portion (4842) and the angular movement between the support portion (4842) and the portion with the foam contact surface. In this example, the support portion has a height of about 11.44 mm (millimeters), but can be suitable for a height in the range of about 8 mm (millimeters) - 20 mm (millimeters). Additionally, the width of the foam contact surface can be, for example, about 6.5 mm (millimeters), and can be in the range of about 3 - 12 mm (millimeters). Since the foam can be wider, this allows the foam pads to overlap the contact surfaces. The non-contact portion of the foam can be bent and is not related to the fixture. In some variants, in this cross-sectional portion, the fixture can be "c" shaped, but this will result in an increased overall foam cover area.

[0403] B. Elastic Fixture Side of the Nasal Region

[0404] As Figure 73 shown, on the nasal region side at position 7310H, there is an increase in the overall height of the foam compared to the surrounding area due to the support portions on both sides of the nose. This can provide better support and improved sealing in this specific region.

[0405] In the fixture cross-section of this cover region as Figure 72 shown, it is typically "L" shaped and allows the foam to pivot more easily and conform to the facial geometry on the side of the user's nose. The geometry allows the foam contact surface to be parallel to the user's nose. The elastic fixture in the support portion (4842) can have a thickness of about 0.75 mm (millimeters) in this region, but can be in the range of about 0.25 - 1.5 mm (millimeters) thickness.

[0406] A height of about 9.46 mm (millimeters) (but can be a suitable height in the range of about 8 mm (millimeters) - 20 mm (millimeters)) can provide the necessary range of motion to conform to the user's nose. Without changing the shape or thickness of the foam in this region, locally increasing the height of this region allows an additional sealing force to be applied to form a better seal around this important region.

[0407] Alternatively (or in addition to by combination), for the increased fixture height, a similar effect can be achieved by locally increasing the height of the foam pad in the Figure 73 fixture region shown, at position 7310H.

[0408] Or, a "c" shaped geometry can be implemented in this region, but this will result in an increased overall foam cover area.

[0409] C. Elastic Fixture Side of the Mouth Region

[0410] AsFigure 74 The shown nodal geometry can be implemented on the mouth area side. This area can form an angle β between the horizontal (perpendicular to the axis of the support part (4842)) and the foam support surface (support foam pad). This angle allows the foam contact surface to be rolled inwards to better adhere to this facial area when applying the foam pad. It can also improve the overall stability of the system.

[0411] In Figure 74 The cross-sectional geometry of this fixture showing the mouth side is generally "L"-shaped. The large angle β reduces the inward bending range of the fixture and increases the hardness of the fixture. This allows the mask part to better adhere to the face, effectively forming a certain site around the mouth side. The hardness of the elastic fixture may be the highest in this area. Reducing the elasticity in this facial area may be appropriate as it is the least pressure-sensitive area of the user. The cross-sectional geometry also allows the foam axis to turn into the user's face to fit different facial contours. The elastic fixture and (more particularly) its support part (4842) can have a thickness of about 1.2 mm (millimeters) (but can have a suitable thickness in the range of about 1 mm (millimeters) to 2 mm (millimeters)) to provide the desired hardness. The angle β can be about 37.1 degrees (but can be a suitable angle in the range of about 20 - 60 degrees).

[0412] Alternatively, a "C"-shaped geometry can be used in this area, but it will result in an increased overall foam mask coverage area.

[0413] D. Bottom of the elastic fixture in the mouth area

[0414] Figure 75 The cross-sectional geometry of the fixture showing the bottom of the mouth area is generally "L"-shaped and allows the elastic fixture to roll. A small (approaching zero) angle β allows the foam support surface to bend. This allows the foam to move up and down relative to the face (with respect to the Figure 75 illustrated left and right), while maintaining a parallel upper sealing surface with respect to the user's face. This feature allows the movement of the user's jaw without losing the seal (e.g., opening the lower jaw during use). The elastic fixture can have a thickness of 0.75 mm (millimeters) (but can have a suitable thickness in the range of about 0.25 mm (millimeters) - 1.5 mm (millimeters)). The rolling action can be assisted by a smooth circular inner surface RIS and a height of about 14.21 mm (millimeters) (but can have a suitable height in the range of about 12 - 25 mm (millimeters)).

[0415] Alternatively, a "C"-shaped geometry can be implemented in this area, but it will result in an increased overall foam mask coverage area.

[0416] 5.4.3.2 Second fixture (e.g., hard fixture)

[0417] Similar to other variants, such as Figure 76The resilient clip shown has a lip seal (5550) that extends beyond the edge (7660) of a rigid clip (e.g., the second clip (3814)) when the resilient clip is engaged with the rigid clip. The extending engagement causes this peripheral lip to seal against the clip edge. The angle G forming the horizontal lip seal can be small, e.g., about 5 degrees (with a suitable angular range of about 0 to 20 degrees). This ensures that when the frame is assembled onto the gasket, the lip seal will always be under tension when it is pressed against the rigid shroud frame portion (7662), which can improve the sealing engagement and reduce possible distortion variations in the lip seal.

[0418] The engagement of the soft and rigid clips causes the engagement ribs (7664) of the rigid clip to be received in the engagement slots (7666) of the shroud frame. Along the engagement slot there are a number of points where stop points (7668) are formed to limit the insertion of the engagement ribs into the recess. The hard stops can be a continuous ridge or a set of points (e.g., 6) near many locations around the frame. It can be configured such that when the clip is in the engaged configuration, the engagement ribs abut some or all of these stop points and prevent any further entry into the engagement slot. In addition to restricting insertion in the vertical direction, the hard stop points can also force the frame to move horizontally onto the gasket assembly. This can be achieved by having a nasal cavity that can receive at least one (preferably several) of the hard stop points of the engagement ribs. When the width of the opening is configured to closely engage the engagement ribs (7664), this configuration restricts the movement of the clip in the horizontal direction.

[0419] As Figures 77 to 82 shown, a top engagement fastener (8010-1) can engage an individual frame opening (8012). One method is to pivot the entire clip assembly so that the top engagement fastener (8010-1) at the top locking edge of the clip can be pivotally inserted into the individual frame opening (8012). This requires a minimum amount of control force on behalf of the user. The entire clip assembly is then pivoted back to be parallel to the frame, and the lower part of the clip / gasket is pressed against the frame until the bottom fastener (8010-2) clicks into engagement with the individual frame engagement portion. Alternatively, the entire clip assembly can be arranged in parallel and pressed against the frame until both the top and bottom fasteners of the clip assembly engage the frame. The engagement of the top attachment in this case requires slightly more force, which is approximately equal to the top headband tension. Because of this, in the situation where the top engagement is not fully engaged during assembly, it can self-engage when the user puts on the nasal mask.

[0420] The bottom fastener (8010-2) forms the main interface that the user manipulates during disassembly, and it is sized such that a finger can comfortably operate the mechanism. As Figure 81 best shown, the bottom fastener (8010-2) of the rigid clip has two rounded objects with guiding tapered edges that improve usability and act as guides for introducing the clip into the corresponding receiving slots (8014) of the shroud frame.

[0421] In this variant version, the engagement mechanism (the receiving groove (8014)) in the frame does not fully span across the bottom, which is a special design such that during disassembly, the user can slide their finger downwards while maintaining full contact with the hard fixture.

[0422] 5.4.3.3 Foam cover assembly operation

[0423] The operation / performance of the exemplary cover can be referred to in paragraphs 83 to 86. Figure 83 The performance areas near the periphery of the cushion assembly include the nasal bridge area ZA, the nasal side area ZB, the upper cheek area ZC, the mouth side area ZD, and the mouth bottom area ZE. The design intention of the cushion is further described in this specification from the perspective of how the cushion responds to the user's face.

[0424] The cushion is configured to apply different loads or reaction forces to individual areas of the user's face. The nasal bridge area ZA has the least load as it is the most sensitive area. Then, the load is increased in areas ZB and ZC because a better seal in these areas will reduce the likelihood of leakage into the user's eyes. In comparison, areas ZD and ZE have the heaviest loads and serve to fix the cushion to the user's face. There may be a uniform load across areas ZD and ZE, but this can vary due to the individual user's face contour.

[0425] The cushion has a pivoting motion as the top and bottom headbands are tightened or loosened. The approximate pivot is as shown by the arrow in Figure 84 By tightening the top headband, areas ZA, ZB, and ZC can pivot into the user's face, and areas ZD and ZE pivot away. When the headband is tightened, areas ZA, ZB, and ZC pivot away from the user's face, and areas ZD and ZE pivot into the user's face. The opposite occurs when the top and bottom headbands are loosened.

[0426] Figure 85 A general indication of the relative pressure / reaction force of different individual areas of the cover is provided. When the headband is stretched to support the cover on the user's face, the arrows indicate the pressure / force exerted by the cover on the user's face. The different arrow sizes indicate the relative pressure differences in each individual area. Thus, the cover can be configured (e.g., by means of clamps and / or foam cushions) to apply different reaction forces to different areas of the patient contact surface. In the Figure 85 exemplary example of, the cover is configured to apply a smaller force to the upper area of the cover (e.g., the sensitive nasal bridge area ZA, the nasal side area ZB, and / or the upper cheek area ZC). The cover can be configured to apply a larger force to the lower area of the cover (e.g., the mouth side area ZD and / or the mouth bottom area ZE). In this example, the cover is configured to apply the minimum force in the nasal bridge area ZA. These forces are generally symmetric on different sides as shown in Figure 85 (e.g., approximately the same on the left and right sides in individual areas). Other force distributions / variations can also be applied.

[0427] As previously described in this specification, when the cushion is applied to the user's face, the cushion can also exhibit a curling effect. When the region ZA is depressed by the user's nasal column, the region ZB can curl into the sides of the user's nose, which serves to increase the compliance of the cushion in sealing the user's face. When the region ZE is depressed by the user's chin, the region ZD curls into the sides of the user's mouth, creating a more effective fixation when it covers the perimeter of the user's face.

[0428] Figure 86 Shows the approximate curling response of individual regions of the breathing mask. The arrows indicate the relative extent of the curling response when the headband is stretched to support the mask on the user's face. The differences in the size of the arrows indicate the relative curling differences in each individual region.

[0429] Accordingly, the mask can be constructed with different degrees of curling in different regions of the patient contact surface (e.g., by virtue of the characteristics of the clamp and / or foam cushion). In Figure 85 the exemplary example, the mask is constructed with the maximum degree of curling applied to the side ZB of the nasal region and / or the side ZD of the mouth region, which can be approximately the same. The mask can be constructed with a smaller degree of curling applied to other regions (e.g., the nasal column region ZA, the upper cheek region ZC, and / or the bottom of the mouth region ZE), which can be approximately the same. These curling forces are typically Figure 85 symmetrical on the different sides shown (e.g., approximately the same on the left and right in individual regions). However, other force variations can also be constructed.

[0430] The degree of curling has been intended to be modified to contribute to comfort and effective sealing of the mask. There are certain methods to achieve a specific degree of curling.

[0431] Generally, near the perimeter of the cushion interface, the plane in which the foam cushion lies can be angled inward at different angles with the user's face in a manner that promotes the degree of curling. Some regions (such as the mouth side) have a more pronounced angle to contribute to a greater curling effect.

[0432] The elasticity of the flexible (e.g., TPE / silicone) clamp that assembles the foam cushion generally forms a right-angled beam, thus allowing inward curling (with a tendency to form an angle inward as described above).

[0433] The elastic clamp material is selected for elasticity and compliance, which also allows inward curling (as intended and described above).

[0434] The degree of support provided by the lower elastic clamp surface to the foam can be changed by ensuring that the support surface of the elastic clamp only partially extends below the foam surface. Thus, generally some of the foam surface on the inner side of the mask may not be supported (i.e., the foam extends beyond the elastic clamp). When pressure is applied to the foam, the non-supported surface can buckle and contribute to the curling effect.

[0435] Accordingly, in certain examples, the foam cushion assembly can have parameters that can be changed in at least some parts of the clamp and / or the perimeter of the assembly, such as:

[0436] The spring constant of the clamp and / or the foam pad;

[0437] The cross-sectional profile of the clamp and / or the foam pad;

[0438] The wall thickness of the clamp;

[0439] The angle of the contact surface contacting the foam pad;

[0440] The protrusion of the foam pad supporting the contact surface; and / or

[0441] The foam thickness.

[0442] 5.4.4 Further optional foam cover features

[0443] As previously mentioned, the cover can be implemented using a foam pad, whether it is above or below the nasal mask (as previously mentioned), or even just the nasal mask. Generally, it is desired to achieve maximum comfort and compliance / sealing performance for the cover. Various foam seal forming pad structures can be configured to achieve this desire. However, when designing a comfortable foam pad, other trade-offs need to be considered. Some of these trade-offs are permeability, and are closely related to foam flexibility and compliance. To achieve the desired seal and comfort, a relatively thick foam layer can be implemented on the cover. In addition to being heavier and objectionable, a larger layer or foam, even with limited permeability, may increase leakage and compromise the pressure treatment provided. To address the issues of size and permeability, some modified versions of the present technology as previously mentioned can utilize an elastic intermediate structural member (e.g., a clamp) between the foam layer and the frame. This structure (such as the above-mentioned elastic clamp) is attached to the foam seal forming layer. The balance of hardness and elasticity of this intermediate structure (e.g., the elastic clamp) can be selected such that it is suitable for use with certain foam pads. Therefore, a non-bulky foam layer can be used. In addition, the clamp is typically formed of a non-permeable material. Because of this and because of the specific concave structure, as previously discussed in this specification, at least a portion of the clamp covers a portion of the foam pad and can reduce the overall leakage regarding the foam pad. Then, the elastic clamp can maintain the benefits of support and compliance while reducing leakage. Some additional optional features of the intermediate structure can be considered to achieve some of the objectives of the previously described elastic clamp.

[0444] 5.4.4.1 Clamp elasticity

[0445] One drawback of providing only a foam sealing forming layer for a rigid fixture or frame / casing of a mask is that there is a risk of compressing the rigid / hard part to the end. Compression to the end occurs when the foam is compressed to the extent that the patient begins to feel the hardness or stiffness of the underlying fixture or frame / casing of the mask. To address this issue, some of the examples described in this specification refer to a soft / elastic fixture that bends under the pressure applied to the mask. This configuration allows the elasticity and compliance of the elastic fixture to match those of the foam layer to improve the overall compliance of the mask.

[0446] However, the elastic nature of these elastic fixtures is not necessarily the result of a particularly elastic material. For example, the function of the elastic fixture can be achieved not by using foam but by using a semi-rigid or even rigid fixture or mask frame / casing. In this case, the elastic response can be introduced by structural features, such as local thinning or embossments, to form a hinge or flap on the rigid fixture or frame that engages the foam. Thus, the foam sealing forming layer can be directly joined to a rigid fixture that has been designed with structural features to incorporate elasticity at the locations where compliance is required. Therefore, the elastic support fixture can be formed using a rigid material, and the elasticity can be formed by referring to one or more compliant zones, such as by referring to one or more weakening lines or one or more weakening zones.

[0447] Two different examples of this structure are referenced Figure 58A and 58B illustrated. Figure 58B Showing Figure 58A a cross-section of a foam pad assembly having a foam pad (3810) and a rigid fixture (5858). The rigid fixture (5858) then engages a frame (not shown in Figure 58). This rigid fixture (5858) is elastic due to the design of its structural features that facilitate bending. As Figure 58B shown, the wall of the fixture includes the outline of a flap implemented at the enlarged view 5859-A, but the thickness of the wall does not change. Another example shown in the enlarged view 5859-B is the introduction of one or more weakening lines near the perimeter of the fixture where the wall is thinner. Each line can be a continuous line or an interrupted line, for example, a series of soft points. In this case, the result can be to increase the degree of elasticity of the wall of the rigid or semi-rigid fixture or frame. These structural features can also be implemented to modify the elasticity and spring constant of an already elastic fixture, such as any of the fixtures described in this specification.

[0448] Another example of adding elasticity to a rigid or semi-rigid mask air chamber can be implemented in a buckling portion defined in a concave rigid fixture (6758) or mask casing. For example, this rigid fixture that couples the foam pad (3810) is shown in Figure 67 and 68Exemplary description. As an example, the frame / fixture may have one or more weakened regions caused by removal of hard material portions at one or more fixture recesses (6770). This makes the hard fixture / housing easier to compress under load. Thus, these nasal recesses can be located in uncomfortable areas that require more elasticity or compliance, such as near the nasal bridge or nasal sides. The nasal recesses can be filled with another elastic (but impermeable) material, such as a recess membrane (6772) made of (for example) silicone or TPE. Alternatively, the nasal recesses created by the removed portions can be covered by a single elastic sheet. This elastic sheet can (for example) represent a silicone membrane that engages the interior of the hard fixture.

[0449] 5.4.4.2 Fixture alternatives

[0450] Among the various different components described in this specification, a fixture is described as an intermediate structure for applying foam to a cover frame. For example, a foam cover design has been described as having a foam seal forming layer that engages an elastic fixture, which then engages a hard fixture. The hard fixture is removably engaged to the cover frame. In this case, the cover frame can be the hard part of the cover, providing a certain degree of shape and support to the cover structure and allowing headband tension to be transferred to the seal forming portion to seal the face.

[0451] Another structure of a foam cover can include an elastic housing or chamber made of an elastic material such as TPE or silicone. This component can be referred to Figure 61 、 60 and 60. An elastic chamber or housing (6160) can be used in part as an elastic fixture, where the elasticity of the housing provides compliance when pressure is applied to the cover. In this case, a headband frame (6162) can include a housing hole (6163), and the headband frame is mounted on the housing (6160) as a separate removable structure made of a hard material to provide support. Although the concave silicone chamber of the housing (6160) can be used in part as a C-shaped elastic fixture, the substantial difference is that the elastic housing also more fully forms part of a cover chamber or air chamber (3200). For example, optionally included can be: a connection port (3600) for coupling an air / gas line (4170); and / or a ventilation port (3400).

[0452] Although Figure 60 shows a deformed version of the housing (6160) of the fixture that engages the foam pad, in some cases, a further intermediary mechanism can be implemented, such as Figure 63A 、 63BExamples illustrated with 59. Variations of these cover assemblies implement a foam pad that directly attaches to a rigid fixture (6314). The rigid fixture (6314) can then be coupled to the housing (6160) or other cover frame using engagement features (6319). The foam can be semi-permeable, which is associated with softness and breathability. However, a permeable foam layer will leak air and air pressure.

[0453] In this case, the housing (6160) or other cover frame can include an additional elastic member (6320) whose perimeter is located within the cover air cavity and configured to cover at least a portion of the foam pad when the rigid fixture is assembled / coupled to the housing or cover frame, as Figure 63B shown. This elastic member (6320) can be an airtight perimeter, flap, or layer located within the cover cavity that can be moved to engage and cover the inner surface of the foam pad.

[0454] The elastic member (6320) can be an elastic film made of (for example) TPE or silicone and can be joined to the cavity-forming wall of the cover housing / frame or to a rigid fixture (6314) that engages the cover housing / frame. This elastic film forms a flap that can interact with the foam, at least under pressure, and covers at least a portion of the lower surface of the foam layer when pressure is applied to the cover. Preferably, the flap does not interact with the patient's face. The implementation of this non-permeable layer improves the overall seal quality, which, in other respects, can compromise at least in part at least a portion of the permeable foam layer.

[0455] This sealing layer (elastic member (6320)) can also enhance the air spring effect within the cavity. When the foam seal extends out to engage the edge of the rigid fixture or frame, any force applied to the flap also acts on the foam seal. When pressure from an air flow generator is applied to the cover cavity, with the non-permeable elastic flap covering the lower surface of the foam (the air cavity side of the foam), it will allow pressure to build up and push the foam into a better sealing engagement.

[0456] Variations of the elastic member (6320) are further illustrated as Figure 59 shown. In this variation, the elastic member more fully covers the foam pad by extending internally beyond the support surface of the underlying rigid fixture. Similarly, it also extends to at least partially cover the inner side surface of the foam pad. In this position, it may be more affected by the air flowing through the cover from the air flow generator and move, as Figure 59 illustrated. The length of the flap can be selected based on the thickness of the foam layer and whether the flap is desired to contact the face. Thus, in some variations, it can extend to contact the face while in other variations it does not contact the face. This film can be applied to any of the covers described in this specification to reduce foam air leakage (i.e., leakage through the foam sealing formation layer).

[0457] As is generally required, the shape of the foam layer should provide maximum comfort and sealing effect by matching the patient's facial contours or facial shape. Therefore, the foam sealing layer can preferably form a desired 3D space or desired facial contour.

[0458] In one example, the elastic clamp is molded into a desired 3D shape or facial contour to shape a generally flat foam seal forming layer when the foam is joined. Alternatively, a 3D shaped hard clamp can impose a 3D shape (e.g., facial contour) on the elastic clamp and the foam seal foam joined thereto.

[0459] Figure 64 , 65 , 66A and 66B illustrate additional cover examples showing alternative methods of providing a desired shape of foam. One such example is to provide one or more rigid clamps that can compress or clamp the foam cushion into a desired three-dimensional (3D) contour, such as when snapping or fastening a foam support member, such as a cover frame (3816) or shell with fasteners. For example, it has been shown that a foam seal forming layer with a circular seal forming surface is desired. Therefore, if Figure 64 , 65 As shown in , 66A and 66B, multiple clamps (e.g., two individual clamps (6470-1, 6470-2)), such as an inner perimeter clamp (clamp (6470-1)) and an outer perimeter clamp (clamp (6470-2)) can press down or clamp opposite perimeters / sides of a foam body to effectively round the patient contacting edge of the foam layer. Alternatively, only one of the illustrated clamps may be used, or both clamps may be configured in a single clamp.

[0460] like Figure 65 As shown in the example of , the clamp may have one or more clamping portions (6580) to squeeze the edge and one or more top or inner portions of the foam layer toward the mask frame (3816), shell or other mask component structure. For example, Figure 65 In the example of the embodiment of the present invention, the center of the gap (6582) is selected in the nose bridge and lower lip area (partially through the top side of the foam) to be used as the concave edge of the clamp. Therefore, the foam can be raised in certain parts of the mask and pressed down in other parts of the mask. This can improve the flexibility and / or comfort of the foam sealing layer.

[0461] Alternatively, it has been illustrated that one or more of the clips may have a 3D shape (eg, the contours of the face) that may provide the same effect (allowing the foam to bulge out in certain areas and to depress the foam in other areas).

[0462] 5.4.5 Further foam pad characteristics

[0463] Although this specification describes that the foam pad of the mask can be implemented using many different foam materials, when implemented for respiratory therapy to meet the important requirements of promoting patient compliance and ensuring effective delivery of medical treatment, foams with specific properties may be particularly best suited. In view of this, in particular, the characteristics of a suitable foam may be any one or more of the following: air permeability (liters / minute), indentation hardness (Newtons (N)), compressive stress strain (kilopascals (Kpa)), density (kilograms per cubic meter (kg / m 3 )), coefficient of dynamic friction (calculated friction (cf)), compression set (percentage (%)), tensile strength (megapascals (Mpa)), elongation at break (percentage (%)), and / or peel strength (Newtons / mm (N / mm)).

[0464] 5.4.5.1 Air Permeability

[0465] For example, the foam pad can be configured to have a particular air permeability characteristic. The air permeability characteristic of the foam can be a measure of the rate of air flow through a specific sample in units of "liters / minute". This air permeability can be determined by the following air permeability test. A test piece can be cut from a block of foam into a ring shape (i.e., an annular geometric foam sample or a square cross-section toroidal shape) using a mold or a sharp knife. The test piece is cut from a foam sample that was manufactured at least 72 hours earlier, nominally cut in the direction of cell appearance. The ring has a height of 25 mm (millimeters) from the bottom to the top of the ring in the direction of cell appearance (plus or minus 1.0 mm (millimeters)). The inner cylindrical surface of the foam ring has this height and a diameter of 70 mm (millimeters) (plus or minus 1.0 mm (millimeters)). The outer edge of the foam ring has a diameter of 110 mm (millimeters) (plus or minus 1.0 mm (millimeters)). The test piece has no film voids and no densification lines. The test piece will be in good condition without any visible defects such as rough cell edges, delamination, peeling, etc. The test then measures the air flow through the annulus of the foam ring with a constant cross-section. The circular shape ensures an even distribution of pressure and uniform expansion of the foam. Before the test, the foam test ring is conditioned, non-deviated, and non-distorted at an atmospheric temperature of 23 ± 2 °C and a relative humidity of 50 ± 5% for at least 16 hours. The foam test ring can be compressed between plates during the air flow test using a method to reduce the ring height from 25 mm (millimeters) to 17.5 mm (millimeters). A constant air pressure of 20 cmH2O (such as an air flow generator) is applied to the center of the foam ring. Then, the air flowing out of the center of the foam and through the ring is measured using an air flow meter in units of "liters / minute". A foam pad suitable for this technology can have an air permeability characteristic in the range of approximately 0 to 20 L / m, and preferably has an air permeability characteristic in the range of approximately 0 to 3 L / m.

[0466] 5.4.5.2 Indentation Hardness

[0467] The foam pad can be configured to have a special indentation hardness (IDF) characteristic. This characteristic relates to the firmness or hardness of the material. This characteristic has an important relevance to comfort, sealing and stability. Generally, the lower the IDF, the softer the material. The test can usually be carried out according to BS EN ISO 2439:2008 (Method C), which determines the 40% indentation hardness check by compressing the sample by 40% of the sample thickness and recording the maximum force (N). The foam pad suitable for this technology can have an indentation hardness (IDF) characteristic in the range of about 110.48 to 303.11 N, and preferably have an indentation hardness (IDF) characteristic in the range of about 122.76 to 275.55 N, and still further, better have an indentation hardness (IDF) characteristic in the range of about 143.1 - 198.88 N.

[0468] 5.4.5.3 Compressive stress-strain

[0469] The foam pad can be configured to have a special compressive stress-strain characteristic. This characteristic relates to the degree of deflection of the foam material under pressure or load. This characteristic has an important relevance to comfort, sealing and stability. The compressive stress-strain can be determined according to BS EN ISO 3386:1997 + A1:210. The test speed can be 100 mm / minute. The stress at 40% compression can be calculated. The foam pad suitable for this technology can have a compressive stress-strain characteristic in the range of about 2.32 to 7.26 Kpa, and preferably have a compressive stress-strain characteristic in the range of about 2.574 to 6.6 Kpa, and still further, better have a compressive stress-strain characteristic in the range of about 3.15 to 4.29 Kpa.

[0470] 5.4.5.4 Apparent density

[0471] The foam pad can be configured to have a special density characteristic. This characteristic is related to the weight, firmness, "velvet" or tactile "feel" of the material. This characteristic has an important relevance to comfort, sealing and stability. The apparent density can be determined according to BS EN ISO 845:2009. The density (kg / m 3 ) can be calculated using the measured dimensions (mm) and weight (g). The foam pad suitable for this technology can have a density characteristic in the range of about 24.3 to 117.85 kg / m 3 , and still further, better have a density characteristic in the range of about 27 to 107.14 kg / m 3 , and still further, better have a density characteristic in the range of about 50.76 to 66.11 kg / m 3 .

[0472] 5.4.5.5 Dynamic coefficient of friction

[0473] The foam pad can be configured to have a particular dynamic coefficient of friction characteristic. This characteristic is related to facial comfort and the tactile sensation of the hand. This characteristic has an important correlation with the surface feel or texture of the material. This characteristic has a moderate correlation with sealing and stability due to the relationship between the patient's skin and the smoothness of the material surface. The dynamic coefficient of friction can be determined in accordance with BS EN ISO8295:2004. The test piece can be tested at a temperature of 37°C to 39°C, on a glass substrate, under a load of 1.96 N and a speed of 30 mm (millimeters) per minute. The force readings can be measured and the friction can be calculated. The foam pad suitable for this technology can have a dynamic coefficient of friction characteristic in the range of approximately 1.86 to 19.12 CF, and preferably has a dynamic coefficient of friction characteristic in the range of approximately 2.07 to 17.38 CF, and still further, more preferably has a dynamic coefficient of friction characteristic in the range of approximately 2.43 to 2.97 CF.

[0474] 5.4.5.6 Compression set

[0475] The foam pad can be configured to have a particular compression set characteristic. This characteristic is related to the ability of the foam to recover to its original state after compression and handling. If the foam has a high / poor compression set, the foam will no longer function as a dynamic seal. If the foam has no compression set, coupling a strong elastic resistant to deformation will allow for long-term use. The compression set can be determined in accordance with BS EN ISO 1856:2001. The test spacer can be selected to provide a rated 50% and 75% compression for each sample. Compression can occur for a period of time (e.g., 22 hours) at a specific temperature and relative humidity (e.g., at 23°C (plus or minus 2°C) for 22 hours and 10% relative humidity; and at 70°C (plus or minus 1°C) for 22 hours). After unclamping the test sample, allow the sample to recover for 30 minutes at 23°C (plus or minus 2°C) before re-measuring and calculating the compression set percentage. The foam pad suitable for this technology can have a compression set characteristic in the range of approximately 0.16 to 17.3%, and preferably has a compression set characteristic in the range of approximately 0.18 to 15.73%, and still further, more preferably has a compression set characteristic in the range of approximately 3.06% to 4.4%.

[0476] 5.4.5.7 Tensile strength

[0477] The foam pad can be configured to have a particular tensile strength characteristic. This characteristic is related to the force required to break the foam. This has a moderate correlation with stability and sealing. If the foam pad has poor tensile strength, it will not function properly and cause leakage and poor stability. The tensile strength can be determined according to BS EN ISO1798:2008 at a draw test speed of "500 mm (millimeters) / minute". The load can be recorded, and the elongation can be determined by laser extensometry. A foam pad suitable for this technology can have a tensile strength characteristic in the range of approximately 0.03 to 0.27 Mpa, and preferably has a tensile strength characteristic in the range of approximately 0.036 to 0.242 Mpa, and still further preferably has a tensile strength characteristic in the range of approximately 0.117 to 0.143 Mpa.

[0478] 5.4.5.8 Elongation at break

[0479] The foam pad can be configured to have a particular elongation at break characteristic. This characteristic is related to the ability of the foam to extend before failure. Depending on the tensile strength, this characteristic has a moderate correlation with stability and sealing. A foam pad suitable for this technology can have an elongation at break characteristic in the range of approximately 72.9 to 369.05%, and preferably has an elongation at break characteristic in the range of approximately 81 to 335.5%, and still further preferably has an elongation at break characteristic in the range of approximately 243 to 335.5%.

[0480] 5.4.5.9 Peel strength

[0481] The foam pad can be configured to have a particular peel strength characteristic. This characteristic is related to the ability of the foam to prevent peeling under tension. Depending on the tensile strength and elongation at break, this characteristic has a moderate correlation with stability and sealing. The peel strength can be determined according to BS EN ISO 8067:2008 (Method A) at a test speed of "50 mm (millimeters) / minute". A foam pad suitable for this technology can have a peel strength characteristic in the range of approximately 0.07 to 0.69 N / mm (millimeters), and preferably has a peel strength characteristic in the range of approximately 0.081 to 0.627 N / mm (millimeters), and still further preferably has a peel strength characteristic in the range of approximately 0.225 to 0.297 N / mm (millimeters).

[0482] 5.4.6 Further clamp characteristics

[0483] Although many different materials can be used to implement the pad assembly with clamps for the mask described in this specification, when implementing respiratory therapy to promote patient compliance and ensure the important need for effective delivery of treatment, a combination of foam and clamps with specific performance characteristics can be particularly well-suited. In view of this, a particularly suitable foam pad assembly is characterized by a spring constant characteristic.

[0484] In view of this, the spring rate of the cushion assembly of the present technology (which can be felt as the cushion assembly being hard) exceeds the total number of its components. The components (e.g., elastic fixtures and foam cushions) cooperate to produce a final multiplicative effect. Both the foam and the basic elastic fixture can be tuned to each other. For example, if the characteristics of one change, the performance of the entire assembly / system changes. Moreover, the spring rate characteristics of the cushion and fixture assembly (e.g., cushion and elastic fixture) may be different at the set positions. The spring rate, also known as the spring constant or "k value", can be the force generated per millimeter of linear spring deformation and can be determined using the equation F = kX. For example, the spring rate can be determined by aligning a probe acting on a special test position of the cushion / fixture assembly and can be linear to the frame surface. The probe can be driven into this position (such as using 50 mm (millimeters) / min (minutes)). When the force exceeds some limit (e.g., 10 N), the probe can stop. The force / displacement results can be recorded and graphed.

[0485] Regarding this spring constant, the exemplary covers of the present technology are generally described in the following table. These include: an elastic fixture + foam cushion assembly, which is represented by FC and is similar to Figure 47 that shown; another elastic fixture + cushion assembly, which is represented by FF, where the fixture is replaced with a foam contour block, which is the same as the contour block of the cushion; a further elastic fixture + cushion assembly (labeled K1) is similar to assembly FF but has a sculpted nasal cavity, as Figure 69 shown. These measure the measurements of other cover components, in particular, an elastic fixture without foam SC, and a reference 25 mm (millimeters) thick foam block, which is represented by "foam" in the table.

[0486] The spring constant is determined at different positions of the foam cushion, including the bottom center, the side of the mouth area (points "corner 1" and "corner 2" are on the same side of the mouth that are offset from each other laterally by approximately 0.5 cm (centimeters)), the cheekbone area, and three vertically arranged points along the nasal column area (points "nasal column 1", "nasal column 2", and "nasal column 3" are offset from each other vertically by approximately 0.5 cm (centimeters)). The spring constant data in the following table is expressed in Newtons per millimeter (N / mm). The following table indicates that for the (foam + fixture) assembly with a sculpted nasal cavity, the spring constant in the mouth area (e.g., the side of the mouth area) is greater than the spring constant in the nasal area (e.g., the nasal column area), and similar spring constants in the nasal area and the cheekbone area. For the elastic fixture of the unique structure (SC), the following table indicates similar spring constants in the nasal area and the corners of the mouth area. Further illustrated, the spring constant in the cheek area is greater than the spring constant in the nasal area (e.g., the nasal column area), but the spring constant in the cheek area (e.g., the cheekbone area) is less than the spring constant in the mouth area (e.g., the side of the mouth area).

[0487] The average values in the following table are the averages of several samples. Each of the minimum and maximum values corresponds to a single measurement showing the minimum or maximum value at a particular position.

[0488]

[0489] 5.5. Vocabulary

[0490] For the purposes of the present disclosure, in certain forms of the present technology, one or more of the following definitions may apply. In other forms of the present technology, other definitions may apply.

[0491] 5.5.1 General Principles

[0492] Air: In certain forms of the present technology, the air supplied to the patient may be ambient air, and in other forms of the present technology, ambient air may be supplemented with oxygen.

[0493] Continuous Positive Airway Pressure (CPAP): Administering CPAP therapy means applying a supply of air or breathable gas to the airway inlet under continuous ambient positive pressure and preferably approximately constant, through the patient's respiratory cycle. In some forms, the airway inlet pressure will vary by a few centimeters of water during a single respiratory cycle, for example, being higher during inhalation and lower during exhalation. In some forms, the airway inlet pressure is slightly higher during exhalation and slightly lower during inhalation. In some forms, the pressure will vary between different respiratory cycles of the patient, for example, increasing with an indication of a detected partial upper airway obstruction and decreasing with no indication of a partial upper airway obstruction.

[0494] 5.5.2 Facial Anatomy

[0495] Ala / Alar: The outer wall or "wing" of each nostril.

[0496] Alare: The outermost point on the ala of the nose.

[0497] Alar Curvature / Alar Crest Point: The final point of the curved baseline of each ala of the nose, the crease formed by the union of the ala of the nose and the cheek.

[0498] Auricula / Pinna: The entire outer visible part of the ear.

[0499] (Nose) Bony Framework: The bony framework of the nose includes the nasal bones, the frontal processes of the maxillae, and the nasal parts of the palatine bones.

[0500] Nose Cartilaginous Framework: The nose cartilaginous framework includes the septal cartilage, the lateral nasal cartilages, the major alar cartilages, and the minor alar cartilages.

[0501] Columella: The skin area that separates the nostrils and extends from the tip of the nose to the upper lip.

[0502] Columella Angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort horizontal plane when intersecting the subnasale point.

[0503] Frankfort Horizontal Plane: A line extending from the lowest point of the orbital margin to the tragion point of the left ear. The tragion point is the deepest point in the notch of the tragus above the external ear.

[0504] Glabella: The most prominent soft tissue point located on the mid-sagittal plane of the forehead.

[0505] Lateral Nasal Cartilage: Usually a small angular plate of cartilage, whose upper edge connects to the nasal bone and the frontal process of the maxilla, and whose lower edge connects to the greater alar cartilage.

[0506] Greater Alar Cartilage: A small plate of cartilage located below the lateral nasal cartilage, which curves around the front part of the nostril, and whose posterior end connects to the frontal process of the maxilla through the fibrocartilaginous membrane, including three or four lesser alar cartilages.

[0507] Nares / Naris: Forms an approximately oval aperture leading to the nasal cavity. The nares are separated by the nasal septum.

[0508] Naso-labial Sulcus / Naso-labial Fold: A skin fold or depression from each side of the nose to the corner of the mouth, separating the cheek from the upper lip.

[0509] Naso-labial Angle: The angle between the columella and the upper lip when intersecting the subnasale point.

[0510] Otobasion Inferior: The lowest point connecting the external ear to the facial skin.

[0511] Otobasion Superior: The highest point connecting the external ear to the facial skin.

[0512] Pronasale: The most convex point or tip of the nose, which can be identified from the lateral view of other parts of the head.

[0513] Philtrum: The median depression from the lower border of the nasal septum to the top of the upper lip region.

[0514] Pogonion: The soft tissue at the frontmost midpoint of the chin.

[0515] Nasal Ridge: The midline prominence of the nose that extends from the bridge to the tip of the nose.

[0516] Sagittal plane: The vertical plane that divides the body into left and right halves from the front to the back.

[0517] Sellion: The soft tissue at the most concave point above the fronto-nasal suture area.

[0518] Septal Cartilage (Nasal): The septal cartilage forms part of the nasal septum and separates the front part of the nasal cavity.

[0519] Subalare: The lower edge point at the base of the alar cartilage, where the base of the alar cartilage joins the skin of the upper lip.

[0520] Subnasal Point: The point on the soft tissue where the columella nasi merges with the upper lip in the median sagittal plane.

[0521] Supramentale: The deepest concavity on the midline of the lower lip between the midpoint of the lower lip and the soft tissue pogonion.

[0522] 5.5.3 Skull Dissection

[0523] Frontal Bone: The frontal bone includes a large vertical part (frontal squama), corresponding to the area known as the forehead.

[0524] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony prominence that forms the chin of the mandible.

[0525] Maxilla: The maxilla is the bone that forms the upper jaw and is located above the mandible and below the orbital region. The frontal process of the maxilla projects upward along the side of the nose and forms part of its lateral boundary.

[0526] Nasal Bone: The nasal bones are two small elongated bones, the size and shape of which vary in different individuals. They are arranged side by side in the central and upper parts of the face and join together to form the nasal "bridge".

[0527] Nasion: The junction of the frontal bone and the two nasal bones, the depressed area is located between the eyes and is higher than the nasal bridge.

[0528] Occipital Bone: The occipital bone is located at the back and lower part of the skull, and includes an oval hole (foramen magnum). Through this oval hole, the cranial cavity can communicate with the spinal canal. The curved small plate behind the foramen magnum is the occipital squama.

[0529] Orbit: The bony cavity in the skull that houses the eyeball.

[0530] Parietal Bone: The parietal bones are the bones that (when joined together) form the top and sides of the skull.

[0531] Temporal Bone: The temporal bones are located at the base and sides of the skull and support the area of the face known as the temple.

[0532] Zygomatic Bone: The face includes two zygomatic bones, which are located at the upper and side parts of the face and form the prominence of the cheek.

[0533] 5.5.4 Dissection of the Respiratory Organ System

[0534] Diaphragm: A sheet of muscle that extends across the bottom of the thoracic cavity. The diaphragm separates the thoracic cavity from the abdominal cavity, including the heart, lungs, and ribs. When the diaphragm contracts, the volume of the thoracic cavity increases and air enters the lungs.

[0535] Larynx: The larynx, or voice box, houses the vocal cords and connects the lower part of the laryngopharynx (hypopharynx) to the trachea.

[0536] Lung: The respiratory organ of humans. The conducting segment of the lung includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory segment of the organ includes respiratory bronchioles, alveolar ducts, and alveoli.

[0537] Nasal cavity: The nasal cavity (or nasal fossa) is the large air-filled space above and behind the nose in the center of the face. The nasal cavity is divided into two parts by a vertical flap called the nasal septum. Along the sides of the nasal cavity are three horizontal outgrowths called nasal meatuses or nasal conchae. As for the front part of the nasal cavity is the nose, and the back of the nasal cavity mixes into the nasopharynx through the posterior nasal aperture.

[0538] Pharynx: The throat region located directly below (beneath) the nasal cavity and above the esophagus and larynx. The pharynx is conventionally divided into three parts: the nasopharynx (epipharynx) (the nasal part of the pharynx), the oropharynx (midpharynx) (the oral part of the pharynx), and the laryngopharynx (hypopharynx).

[0539] 5.5.5 Materials

[0540] Silicone or Silicone Elastomer: A synthetic rubber. In this specification, the silicone referred to is a liquid silicone rubber (LSR) or a compression molded silicone rubber (CMSR). One form of commercial LSR is SILASTIC (including various products sold under this trademark), which is manufactured by Dow Corning Corporation. Another LSR manufacturer is Wacker Corporation. Unless otherwise stated, a preferred form of LSR has a Shore A (or Type A) indentation hardness measured using ASTM D2240 in the range of approximately 35 to approximately 45.

[0541] Polycarbonate: A typical transparent thermoplastic polymer (Bisphenol-A Carbonate).

[0542] 5.5.6 Aspects of the Patient Interface

[0543] Anti-asphyxia Valve (AAV): A component or sub-assembly of a facemask system that reduces the risk of the patient re-breathing excessive CO by providing a fail-safe connection to the atmosphere. 2 risk.

[0544] Elbow: A conduit through which the air flow axis changes direction by an angle. In one form, the angle can be approximately 90 degrees. In another form, the angle can be less than 90 degrees. The conduit can have an approximately circular cross-section. In another form, the conduit can have an elliptical or rectangular cross-section.

[0545] Frame: The frame means a facemask structure that maintains a tension load between two or more connection points with a positioning and stabilizing structure. A nasal mask frame can be a non-airtight load-bearing structure in the facemask. However, some forms of nasal mask frames can also be airtight.

[0546] Headgear: Headgear means a form of positioning and stabilizing structure designed specifically for use on the head. Preferably, the headgear includes a collection of one or more load-bearing members, fasteners, and reinforcements that hold the patient interface in position on the patient's face for delivering respiratory therapy. Some fasteners are formed using soft, elastic, and resilient materials such as laminated composites of foam and fabric.

[0547] Membrane: A membrane means a typically thin element that preferably has substantially no resistance to bending but can prevent stretching.

[0548] Plenum Chamber: A plenum chamber of a face mask means a portion of the patient interface having walls enclosing a volume of space, which, when in use, contains a volume of air at a pressure above atmospheric pressure. A housing may form the walls of the plenum chamber. In one form, an area of the patient's face forms one of the walls of the plenum chamber.

[0549] Seal: A seal means a structure or barrier that prevents air flow across an interface between two surfaces; alternatively, enclosure means preventing air circulation.

[0550] Shell: A shell specifically means a flexure structure having bending, stretchable, and compressive stiffness, e.g., a portion of a face mask forms the flexure structure walls of the face mask. Specifically, it is relatively thin compared to its overall dimensions. In some forms, a shell may be faceted. Specifically, this wall is airtight and impermeable, although in some forms, the wall may be air-permeable.

[0551] Stiffener: A stiffener means a structured component designed to increase the bending resistance of another component in at least one direction.

[0552] Strut: A strut means a structured component designed to increase the compressive resistance of another component in at least one direction.

[0553] Swivel: A sub-assembly of components is configured to rotate about a common axis, preferably independently, specifically at low torques. 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 less than 360 degrees. When used in the context of an air delivery tube, the sub-assembly of components preferably includes mating cylindrical ducts. Specifically, there is no leakage of air flow from the swivel during use.

[0554] Tie: A tie is a structured component designed for tensile resistance.

[0555] Vent: A structure that allows air to leak from the interior of the face mask, or a conduit, to ambient air at a deliberately controlled leakage rate to expel carbon dioxide (CO 2 ) and supply oxygen (O 2 ).

[0556] 5.5.7 Terms Used for Patient Interfaces

[0557] (Surface) Curvature: A surface area has a saddle shape that curves in one direction and bends downward in a different direction, and has negative curvature. A surface area has a dome shape that curves in the same way in two principal directions and has positive curvature. A flat surface has zero curvature.

[0558] Floppy: A quality of a material, structure, or composition that combines the following characteristics:

[0559] □ Easily conforms to finger pressure.

[0560] □ Unable to maintain its shape when supporting its own weight.

[0561] □ Not hard.

[0562] □ Can be elastically stretched or bent with a small force.

[0563] The quality of being flappy may have an associated direction. A particular material, structure, or composition may be flappy in a first direction but stiff or hard in a second direction, such as a second direction at a right angle to the first direction.

[0564] Resilient: Can be elastically deformed sufficiently and can substantially release all energy in a relatively short period, such as 1 second, when unloaded.

[0565] Rigid: When establishing and maintaining the sealing relationship between the patient interface and the patient airway inlet, it is typically not easily deformed by finger pressure, and / or tension or load.

[0566] Semi-rigid: Means hard enough not to be substantially distorted under the effect of mechanical forces typically applied during positive pressure ventilation therapy.

[0567] 5.6 Other Supplementary Notes

[0568] The exposed portions of this patent document include content subject to copyright protection. The copyright owner has no objection to the facsimile reproduction of either the patent document or the patent disclosure, as the patent document or the patent disclosure appears in the patent and trademark office patent file or records, but reserves all copyrights in other respects.

[0569] Unless otherwise clearly stated in the text and a number of values are provided, it should be understood that each intermediate value that is one tenth of the lower unit between the upper and lower limits of the range, and any other description or intermediate value within the described range is included within the scope of the present technology. The upper and lower limits of these intermediate ranges (which may independently be included within the intermediate range) are also included within the present technology, subject to any specific exclusions described within the described range. Where one or both of such limitations are included within the range, ranges that exclude either or both of such included limitations are also covered within the present technology.

[0570] In addition, in cases where a value or numerical value is described herein as being part of the implementation of the present technology, it should be understood that unless specifically stated, this value may be approximate, and this value may be used with any appropriate number of significant figures that the actual technology implementation permits or requires.

[0571] Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. Although any methods and materials similar or equivalent to those described herein may also be used to implement or test the present technology, only a limited number of exemplary methods and materials are described herein.

[0572] When a particular material is considered best for constructing a component, an obvious alternative material with similar properties may be used as a substitute.

[0573] It must be noted that as used in this specification and the claims that follow, unless specifically stated otherwise herein, the articles "a" and "the" are to be construed to imply a plural number.

[0574] All publications discussed in this specification are incorporated by reference and describe the methods and articles of the subject matter of these publications. The publications discussed in this specification are provided only to disclose publications prior to the filing date of the present application, and should not be construed as an admission that the present invention is not entitled to antedate such disclosure by virtue of a prior invention. In addition, the publication dates provided may differ from the actual publication dates, which may require individual verification.

[0575] Moreover, in interpreting the present invention, all terms should be construed in the broadest reasonable manner consistent with this specification. In particular, the terms "comprising" and "including" should be construed in a non-exclusive sense to refer to the referenced elements, components, or steps, indicating that the referenced elements, components, or steps may be provided, or may be associated or combined with other elements, components, or steps not expressly mentioned.

[0576] When the terms "soft" and "elastic", and their derivatives are used in this specification to describe the first support fixture (3812)( Figure 40 ), it can have the meaning of the term "elastic" as defined in the unit "Terms related to patient interfaces". That is to say, the elastic support fixture can be elastically deformed sufficiently and substantially quickly release all the energy after the load is removed.

[0577] The headings used in the embodiments are included only to make it easier for the reader to refer and are not used to limit the subject matter of the present invention or the scope of the patent application that follows. The subject matter should not be used to constitute a limitation to the scope of the patent application that follows.

[0578] Although the present technology has been described herein with reference to specific particular embodiments, it should be understood that these specific embodiments are merely illustrative of the principles and applications of the present technology. In some instances, the terms and symbols may imply that no particular details are required to implement the technology. For example, although ordinal words "first" and "second" may be used, unless otherwise specified, no order is specified and they may be used to distinguish different elements. Additionally, although the processing steps in a method can be described or illustrated in sequence, this order is not necessarily required. Those skilled in the art should understand that this order can be modified and / or aspects thereof can be carried out simultaneously or even synchronously.

[0579] Therefore, it should be understood that many modifications can be made to the illustrated specific embodiments and other configurations can be designed without departing from the spirit and scope of the present technology.

[0580] 5.7 Parts List

[0581] 1000 Patient

[0582] 1100 Bedmate

[0583] 3000 Patient Interface

[0584] 3100 Seal Forming Structure

[0585] 3110 Pad

[0586] 3131 Subnasal Ridge

[0587] 3200 Air Cavity

[0588] 3300 Positioning and Stabilizing Structure

[0589] 3400 Vent

[0590] 3500 Frame

[0591] 3510 Decoupling Structure

[0592] 3515 Flange

[0593] 3535 Clamp

[0594] 3535W Concave Wall

[0595] 3536 Connector

[0596] 3537 Fixator

[0597] 3538 Pad support surface

[0598] 3539 Frame coupling surface

[0599] 3540 Peripheral lip

[0600] 3541 Middle horizontal part

[0601] 3561 Additional cantilever protrusion

[0602] 3572 Flange

[0603] 3574 Concave flange

[0604] 3576 Finger snap

[0605] 3578 Side edge

[0606] 3580 Shoulder pad snap fastener

[0607] 3582 Joining cavity

[0608] 3583 Exploded view

[0609] 3585 Peripheral concave flange

[0610] 3586 Tapered element

[0611] 3587 Tapered receiving concave flange

[0612] 3600 Connection port

[0613] 3700 Forehead support

[0614] 3702 Periphery

[0615] 3763 Sector notch

[0616] 3764 Protrusion

[0617] 3800 Anti-asphyxiation valve

[0618] 3810 Foam pad

[0619] 3812 First support fixture

[0620] 3813 Protrusion

[0621] 3814 Second fixture

[0622] 3816 Cover frame

[0623] 3900 Port

[0624] 3901 Foam pad assembly

[0625] 4000 PAP device

[0626] 4010 Housing

[0627] 4012 Upper Part

[0628] 4014 Lower Part

[0629] 4015 Front Panel

[0630] 4016 Base

[0631] 4018 Ring Handle

[0632] 4020 Pneumatic Module

[0633] 4022 Coupling Ridge

[0634] 4024 Fastener

[0635] 4025 Raised Brake

[0636] 4027 Cone

[0637] 4100 Pneumatic Components

[0638] 4142 Blower

[0639] 4170 Air / Gas Pipeline

[0640] 4200 Electrical Components

[0641] 4202 Printed Circuit Board Assembly (PCBA)

[0642] 4210 Power Supply

[0643] 4220 Input Device

[0644] 4272 Pressure Sensor

[0645] 4621-A Dome Geometry

[0646] 4621-B Straight-Edge Dome Geometry

[0647] 4621-C Rectangular Geometry

[0648] 4621-D Rectangular Round-Edge Geometry

[0649] 4840 Coupling Part

[0650] 4842 Support Part

[0651] 4844 Base

[0652] 4845 Positioning Projection

[0653] 5000 Humidifier

[0654] 5550 Lip Seal

[0655] 5551 Hard stop

[0656] 5858 Hard fixture

[0657] 5859-A Enlarged view

[0658] 5859-B Enlarged view

[0659] 6160 Housing

[0660] 6162 Headband frame

[0661] 6163 Housing hole

[0662] 6314 Hard fixture

[0663] 6319 Joining feature

[0664] 6320 Elastic member

[0665] 6470-1 Fixture

[0666] 6470-2 Fixture

[0667] 6580 Fixture part

[0668] 6582 Gap

[0669] 6758 Hard fixture

[0670] 6770 Fixture recess

[0671] 6772 Recess film

[0672] 6910A Point

[0673] 6910B Point

[0674] 6910C Width

[0675] 6912 Nasal cavity

[0676] 7310H Position

[0677] 7660 Edge

[0678] 7662 Hard cover frame part

[0679] 7664 Joining rib

[0680] 7666 Joining groove

[0681] 7668 Point

[0682] 8010-1 Top joining fastener

[0683] 8010-2 Bottom fastener

[0684] 8012 Frame opening

[0685] 8014 Receiving groove

[0686] 8800 Pad support structure

Claims

1. A mask device for respiratory therapy, comprising: a foam pad adapted to be coupled to a frame, the frame adapted to be coupled to a respiratory therapy device to allow pressurized gas to be transmitted from the respiratory therapy device to a patient's respiratory system, the foam pad forming a substantially sub-nasal seal and a mouth seal, the substantially sub-nasal seal including (a) a sub-nasal ridge and (b) a mid-open supra-lip region, the sub-nasal ridge being formed as a semi-peripheral seal boundary surrounding two nostrils of the patient.

2. The mask device according to claim 1, wherein, the foam pad and the frame form a common air cavity for sealing around the nostrils and the mouth.

3. The mask device according to claim 1, wherein, (a) the foam pad includes a protrusion configured to fit against a patient's nasal alae, or (b) the foam pad includes left and right nasal alae protrusions.

4. The mask device according to claim 1, wherein, it further includes a pad support clamp configured to couple the foam pad and to couple the frame.

5. The mask device according to claim 4, wherein, the pad support clamp includes a first opposite side and a second opposite side, and wherein the pad support clamp is configured to couple the foam pad at the first opposite side and to couple the frame at the second opposite side.

6. The mask device according to claim 4, wherein, the pad support clamp includes a nasal respiratory region and a mouth perimeter region, wherein the nasal respiratory region is substantially perpendicular to the mouth perimeter region.

7. The mask device according to claim 6, wherein, the pad support clamp includes a curved region between the nasal respiratory region and the mouth perimeter region, the curved region forming an approximate nasolabial angle between the nasal respiratory region and the mouth perimeter region, and the curved region including a set of elastic inward nasal protrusions.

8. The mask device according to claim 4, wherein, the pad support clamp includes a first pad support portion and a second pad support portion, the first pad support portion and the second pad support portion being configured to provide different elastic characteristics, and the first pad support portion includes a nasal support region, and the second pad support portion includes a lateral mouth support region, the first pad support portion having a higher hardness characteristic relative to the second pad support portion.

9. The mask device according to claim 1, wherein, the sub-nasal ridge includes a fan-shaped edge, and the foam pad includes (a) a flat sealing surface or (b) a curved sealing surface.

10. The mask device according to claim 1, wherein, it further includes the frame and the respiratory therapy device, the respiratory therapy device being configured to produce a controlled supply of breathable gas at a pressure above atmospheric pressure, the respiratory therapy device including an air delivery tube, the air delivery tube being coupled to the frame to transmit breathable gas to the air cavity formed with the foam pad.

Images