Patient interface and method for manufacturing the same

Abstract

A patient interface for delivering a supply of pressurized air or breathable gas to an entrance of a patient's airways includes a cushion member including a retention structure and a seal-forming structure permanently connected to the retention structure, a frame member attachable to the retention structure, and a positioning and stabilizing structure attachable to the frame member.

Description

[0001] This application is a divisional application of Chinese patent application No. 202010139439.8, filed on July 26, 2013, entitled "Patient Interface and Method for Manufacturing It". Chinese patent application No. 202010139439.8 is a divisional application of Chinese patent application No. 201380050915.7, filed on July 26, 2013, entitled "Patient Interface and Method for Manufacturing It". Patent application No. 201380050915.7 is an application that entered the Chinese national phase of PCT international application PCT / AU2013 / 000830.

[0002] Cross-references to related applications

[0003] This application claims priority to U.S. Provisional Application No. 61 / 676,456, filed July 27, 2012; U.S. Provisional Application No. 61 / 817,674, filed April 30, 2013; U.S. Provisional Application No. 61 / 823,192, filed May 14, 2013; U.S. Provisional Application No. 61 / 837,521, filed June 20, 2013; and U.S. Provisional Application No. 61 / 839,916, filed July 27, 2013. This application claims priority to Australian Provisional Application No. 2012903504, filed August 15, 2012; 2012904378, filed October 8, 2012; 2013900132, filed January 16, 2013; 2013902305, filed June 24, 2013; and 2013900168, filed June 24, 2013. This application also claims priority to New Zealand Application No. 605907, filed January 16, 2013; 610823, filed May 21, 2013; and 605908, filed January 16, 2013. Each of the foregoing applications is incorporated herein by reference in its entirety. Technical Field

[0004] This technology relates to the diagnosis, treatment, and improvement of one or more respiratory diseases, and to procedures for preventing respiratory diseases. In particular, this technology relates to medical devices and their use in treating and preventing respiratory diseases. Background Technology

[0005] The body's respiratory system facilitates gas exchange. The nose and mouth form the entrances to the patient's airway.

[0006] The airways consist of a series of bronchi, which become narrower, shorter, and more numerous as they extend deeper into the lungs. The primary function of the lungs is gas exchange, allowing oxygen to move from the air into the venous blood and carbon dioxide to move out. The trachea divides into the right main bronchus and the left main bronchus, which further subdivide into terminal bronchioles. The bronchi form the airways and do not participate in gas exchange. Branches of the airways further connect to the respiratory bronchioles and eventually to the air bubbles. The air bubble region of the lungs is where gas exchange occurs and is known as the respiratory zone.

[0007] The scope of respiratory diseases.

[0008] Obstructive sleep apnea (OSA) is a form of sleep-disordered breathing (SDB) characterized by obstruction of the upper airway during sleep. OSA results from a combination of an abnormally small upper airway and the normal lack of muscle coordination in areas of the tongue, soft palate, and posterior oropharyngeal wall during sleep. This condition causes affected patients to stop breathing 200 to 300 times per night during cycles typically lasting 30 to 120 seconds. This often leads to excessive daydreaming, and can potentially cause cardiovascular disease and brain damage. While affected individuals may not be aware of the problem, this syndrome is a common disorder, especially among middle-aged, overweight men. See U.S. Patent 4,944,310 (Sullivan).

[0009] Cheyne-Stokes respiration (CSR) is a disorder of a patient's respiratory control, characterized by rhythmic alternations of increased and decreased ventilation, leading to repetitive deoxidation and reoxidation of the arterial vessels. Due to this repetitive oxygen deprivation, CSR can be harmful. In some patients, CSR is associated with repetitive awakenings from sleep, which result in multiple sleep interruptions, increased sympathetic activity, and increased afterload. See U.S. Patent 6,532,959 (Berthon-Jones).

[0010] Obesity hypoventilation syndrome (OHS) is defined as a combination of severe obesity and awakened chronic hypercapnia in the absence of other known causes of hypoventilation. Symptoms include shortness of breath, morning headache, and excessive daytime sleepiness.

[0011] Chronic obstructive pulmonary disease (COPD) encompasses any one of a group of lower airway diseases that share certain common characteristics. These diseases include increased resistance to air movement, prolonged expiratory phase, and loss of normal lung elasticity. Examples of COPD include emphysema and chronic bronchitis. COPD is caused by chronic smoking (a major risk factor), occupational exposure, air pollution, and genetic factors. Symptoms include: shortness of breath during exercise, chronic cough, and white frothy sputum.

[0012] Neuromuscular diseases (NMD) are a broad term encompassing a wide range of conditions and disorders that impair muscle function directly through intrinsic muscular processes or indirectly through neurological processes. Some NMD patients are characterized by progressive muscle damage that leads to loss of mobility, confinement to a wheelchair, dysphagia, weakening of respiratory muscles, and ultimately death from respiratory atony. Neuromuscular dysfunction can be categorized as rapidly progressive or slowly progressive: (i) rapidly progressive disorders: characterized by monthly muscle damage leading to death within a few years (e.g., muscular atrophy (ALS) and progressive muscular dystrophy (DMD) in adolescents); (ii) variable or slowly progressive disorders: characterized by yearly muscle damage that only moderately reduces lifespan (e.g., limb girdle, face-shoulder-arm, and myotonic dystrophy). Symptoms of respiratory atony in NMD include: increased overall weakness, dysphagia, shortness of breath during movement and at rest, fatigue, somnolence, morning headaches, poor concentration, and mood changes.

[0013] Chest wall disorders are a group of thoracic deformities that result in insufficient connection between the respiratory muscles and the pleural cavity. These disorders are typically characterized by localized defects and have the potential to lead to chronic hypercapnia-related respiratory failure. Scoliosis and / or kyphosis can also cause severe respiratory failure. Symptoms of respiratory failure include: exertional dyspnea, peripheral edema, orthopnea, recurrent chest infections, morning headache, fatigue, poor sleep quality, and loss of appetite.

[0014] In addition, healthy individuals can use this system and equipment to prevent respiratory diseases.

[0015] 3.2.1 System

[0016] One known product for treating SDB is the S9 Sleep Therapy System manufactured by ResMed.

[0017] 3.2.1 Therapy

[0018] Nasal continuous positive airway pressure (CPAP) therapy has been used to treat obstructive sleep apnea (OSA). The premise is that continuous positive airway pressure acts as an inflatable splint, and upper airway obstruction can be prevented by pushing the soft palate and tongue forward and away from the posterior oropharyngeal wall.

[0019] Non-invasive ventilation (NIV) has been used to treat OHS, COPD, MD, and chest wall disorders.

[0020] 3.2.3 Patient Interface

[0021] The use of patient interfaces such as nasal masks, full-face masks, and nasal pillows facilitates the application of positive pressure air supply to the inlet of the patient's airway. A full-face mask includes a mask having one or more sealing portions covering at least the nostrils and mouth. Several patient interface devices are known, many of which suffer from one or more of the following: conspicuousness, unsightly appearance, poor fit, difficulty in use, and discomfort (especially during prolonged wear or when the patient is unfamiliar with the system). A mask designed solely for pilots as part of a personal protective device, or for the administration of anesthetics, may be tolerable for its initial application, but is undesirably uncomfortable for prolonged wear, such as during sleep.

[0022] 3.2.3.1 Sealing Formation Structure

[0023] Patient interfaces typically include a hermetically sealed structure.

[0024] One type of seal-forming structure extends around the periphery of a patient interface and is designed to seal against the user's face when force is applied to the patient interface, such that the seal-forming structure engages face-to-face with the user's face. The seal-forming structure may include an air- or fluid-filled gasket, or a molded or formed surface of an elastic sealing element supported by an elastomer such as rubber. With this type of seal-forming structure, if the fit is insufficient, a gap will exist between the seal-forming structure and the face, and additional force will be required to force the patient interface against the face to achieve a seal.

[0025] Another type of seal-forming structure includes a flap seal made of thin material, positioned around the periphery 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 previous type of seal-forming structure, additional force may be required to form a seal if the fit between the face and the mask is not good; otherwise, the mask may leak. Furthermore, if the shape of the seal-forming structure does not match the patient, it may wrinkle or bend under the user's skin, causing leakage.

[0026] Another form of sealing structure can be achieved using adhesives. Some may find it inconvenient to constantly apply and remove adhesives from their surfaces.

[0027] The scope of the patient interface sealing formation structure technology transferred to ResMed Ltd. is disclosed in the following patent applications: WO1998 / 004,310; WO2006 / 074,513; WO2010 / 135,785.

[0028] 3.2.3.1 Positioning and Stability

[0029] The sealing structure of the patient interface used in positive air pressure therapy is subjected to a force corresponding to the air pressure, which interrupts the seal. Therefore, various techniques have been used to position the sealing structure and to maintain a seal between the sealing structure and the appropriate part of the face.

[0030] One technique involves using an adhesive. See, for example, U.S. patent application US2010 / 0000534.

[0031] Another technique involves using one or more straps and stabilizing straps. Many of these devices suffer from one or more of being unsuitable, bulky, uncomfortable, or clumsy to use.

[0032] Rigid elements, also known as "rigid components," have been previously used in stretchable hoods. A known problem associated with this is that the permanent attachment (e.g., lamination or stitching) of the rigid component to a large area of ​​stretchable material restricts the material's stretch length, thus affecting the overall elastic properties of the hood. Another issue concerns cleaning the hood, as their permanent attachment may necessitate cleaning the rigid component along with the stretchable material.

[0033] 3.2.3.3 Ventilation port technology

[0034] Some forms of patient interface systems include vents to allow the exhaled carbon dioxide to escape. Many of these vents are noisy. Others may become clogged during use and provide insufficient flushing. Some vents may disrupt the sleep of the patient's bed partner, for example, through noise or concentrated airflow. Some vents cannot be properly cleaned and must be discarded once they become clogged. Some vents are designed for short-term use, less than three months, and are therefore made of brittle materials to prevent flushing or frequent flushing to encourage more frequent vent replacement.

[0035] ResMed Ltd. has developed numerous improved mask vent technologies. See WO1998 / 034,665, WO2000 / 078,381, US6,581,594, US Patent Application, US2009 / 0050156 and US Patent Application 2009 / 0044808.

[0036] Noise table for existing face shields (ISO17510-2:2007, 10cmH2O / 1m pressure)

[0037]

[0038]

[0039] (*Only one specimen was measured at 10 cmH2O using the test method specified in ISO 3744 within the CAPA model)

[0040] The following lists the sound pressure levels of various objects.

[0041]

[0042] 3.2.3.4 Nasal pillow technology

[0043] One form of nasal pillow was discovered in Adam circuits manufactured by TycoStar. Another nasal pillow, or nasal spray, is the subject of U.S. Patent 4,782,832 (Trimble et al.) to Puritan-Bennett Corporation.

[0044] ResMed Ltd. has manufactured the following products, including nose pillows: SWIFT TM Nose pillow mask, SWIFTII TM Nose pillow mask, SWIFTLT TM Nose pillow mask, SWIFTFX TM Nose pillow mask and LIBERTY full-face mask. The following patent application assigned to ResMed Ltd. describes the nose pillow mask: International Patent Application WO2004 / 073,778 (describes ResMedSWIFT among other things). TM (Regarding the nose pillow aspect), US Patent Application 2009 / 0044808 (describes aspects of the ResMedSWIFTLT nose pillow among other things); International Patent Applications WO2005 / 063,328 and WO2006 / 130,903 (describe aspects of the ResMedLIBERTY nose pillow among other things). TM (Regarding full-face masks), International Patent Application WO2009 / 052,560 (describes, among other things, ResMedSWIFTFX) TM (Regarding the nose pillow).

[0045] 3.2.4 PAP equipment

[0046] Positive pressure air is typically supplied to the patient's airway via a PAP device, such as an electric motor-driven blower. The blower outlet is connected to the patient interface as described above via a flexible delivery duct.

[0047] 3.2.5 Mandibular repositioning

[0048] A mandibular repositioning device (MRD) is one of the treatment options for sleep apnea. It is a custom-made, adjustable oral appliance available from a dentist that holds the mandible in a forward position during sleep. This mechanical protrusion expands the space behind the tongue, applies tension to the throat walls to reduce airway collapse, and reduces hard palate vibration. Summary of the Invention

[0049] The present invention relates to providing medical devices for diagnosing, improving, treating or preventing respiratory diseases, which have one or more of the following: improved comfort, cost, efficacy, ease of use and manufacturability.

[0050] One aspect of this technology relates to a device for the diagnosis, improvement, treatment, or prevention of respiratory diseases.

[0051] Another aspect of this technology relates to methods used in the diagnosis, improvement, treatment, or prevention of respiratory diseases.

[0052] One aspect of this technology is a patient interface with a removable, washable sealing structure. The technology aims to provide a lighter, less conspicuous, and quieter patient interface compared to existing technologies. It also aims to provide a patient interface that is intuitive and easy for the patient to adjust and wear before treatment begins, when the mask portion is attached.

[0053] One aspect of this technology is a patient interface having a sealing structure that can be positioned at a suitable location on the patient interface via a hard-to-hard connection. Another aspect of this technology is a patient interface with a sealing structure that can be removed for cleaning without requiring the headgear portion of the patient interface to be disconnected.

[0054] One aspect of this technology includes a sealing structure, a pressurization chamber, and a patient interface with a connecting portion, wherein the sealing structure and the pressurization chamber are formed of a relatively soft material, and the connecting portion is formed of a relatively rigid material. In one embodiment, the connecting portion is removably connectable to the frame of the patient interface, for example via a quick-acting, switching, or bistabilizing mechanism. In another embodiment, the connecting portion is inserted into the pressurization chamber.

[0055] One aspect of this technology is a patient interface that reduces or avoids contact with the patient's septum and / or upper lip.

[0056] Another aspect of this technology is a patient interface, which is molded or otherwise constructed in a clearly defined peripheral shape intended to match the target wearer.

[0057] One aspect of this technology is a method for manufacturing the patient interface described herein. The aim of this technology is to provide a manufacturing method that is less complex than existing methods for manufacturing patient interfaces, thereby increasing manufacturing efficiency, using fewer raw materials, and requiring less assembly time by the operator.

[0058] Another aspect of this technology relates to a patient interface for delivering a supply of pressurized air or breathable gas to an inlet of a patient's airway. The patient interface may include a liner member comprising a retaining structure and a sealing-forming structure permanently connected to the retaining structure; and a frame member wherein the retaining structure and the frame member are repeatedly and removably attached to each other; wherein an air chamber is formed at least partially by engaging the liner member and the frame member; and wherein an increase in air pressure within the liner member causes an increase in the sealing force between the sealing-forming structure and the frame member.

[0059] In the examples, (a) the sealing forming structure can be co-molded with the retaining structure; (b) the gasket member can be repeatedly and removably attached to the frame member by contracting two opposing positions on the gasket member adjacent to the retaining structure; (c) the sealing forming structure can include a sealing lip that abuts against the frame member to seal when the retaining structure and the frame member are attached to each other, and the sealing lip offsets toward the frame member to increase the sealing force when the air pressure within the gasket member increases; (d) the sealing lip can be a continuous inner peripheral edge integral with the sealing forming structure; (e) the retaining structure and the frame member can be more rigid than the sealing forming structure; (f) the retaining structure can include a pair of hooks; (g) the frame member can include channels configured to receive corresponding mating features of the gasket member; (h) the gasket member can include channels configured to receive corresponding mating features of the frame member; (i) the sealing forming structure can include surrounding (j) The sealing flange extending peripherally from the sealing forming structure forms a seal at the entrance of the patient's airway; (k) The frame member may include a tongue configured and arranged to form a seal with the sealing flange; (k) The liner member may include a pressurization chamber having a rear wall configured and arranged to be positioned adjacent to the patient's upper lip in use, and the pressurization chamber may be positioned between the retaining structure and the sealing forming structure; (l) The patient interface may include a positioning and stabilizing structure or a connector for positioning and stabilizing the structure; (m) The patient interface may be directly connected to the gas delivery tube via a connection port; (n) The connection port may be integral with the frame of the patient interface; (o) The connection port may be angled relative to the frame; (p) The pressurization chamber may include a concave, drooping, or saddle-shaped region spanning the pressurization chamber between the nasal and occipital lobes; and / or (q) The saddle-shaped region may extend from the rear wall of the pressurization chamber to the front wall of the pressurization chamber.

[0060] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface may include: a pressurization chamber having a pressurization connection area; a sealing formation disposed on the pressurization chamber; a frame including a frame connection area and a headgear connection area; and a gas delivery tube; wherein the gas delivery tube is inserted into the frame.

[0061] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface may include: a pressurization chamber having a pressurization connection area; a sealing formation disposed on the pressurization chamber; a frame including a frame connection area and a headgear connection area; and a connection port for receiving a gas delivery tube, wherein the connection port is connected to the frame in a limited portion or multiple portions around its periphery.

[0062] Another aspect of this technology relates to a patient interface for delivering breathable gas to a patient. The patient interface may include: a pressurization chamber having a pressurization connection region; a sealing formation structure disposed on the pressurization chamber; and a frame including a frame connection region and a headgear connection region; wherein the frame connection region is configured to attach to the pressurization chamber at the pressurization connection region, and wherein a sealing lip is adapted to form a pneumatic seal between the pressurization connection region and the frame connection region.

[0063] In the example, (a) the sealing structure may include a pair of nasal pillows configured and arranged to provide a substantially sealed path for breathable gas to the nostrils and to form a seal at least partially on the columellar region of the patient's nose; (b) each of the nasal pillows may include a truncated cone portion pneumatically connected to the pressurization chamber via a handle; (c) the truncated cone portion may include a sealing flange and a support flange, which may be connected to the handle via a flexible region; (d) the support flange may be adapted to press the sealing flange against a peripheral region of the patient's nostrils; (e) the pressurization chamber may include a sealing lip positioned in the pressurization connection region; (f) the sealing lip may be arranged annularly in the pressurization connection region. (g) A sealing lip may be arranged around the inner periphery of the pressurization chamber; (h) A sealing lip may be arranged around the outer periphery of the pressurization chamber; (i) The sealing lip may be angled from the pressurization chamber and suspended in a direction substantially opposite to the sealing structure; (j) The sealing lip may be constructed and arranged such that it is deformable in a direction substantially toward the sealing structure, such that a pneumatic seal is formed between the pressurization chamber and the frame when the frame is attached to the pressurization chamber via the pressurization connection area; (k) A sealing lip may be arranged around the entire inner periphery of the pressurization chamber; (l) A sealing lip may be arranged around the entire inner periphery of the pressurization chamber; (m) The sealing lip and the pressurization chamber may comprise one piece; (n) Pressurization connection The pressure-connecting region and the pressure chamber can be fixedly attached by co-molding or injection molding; (o) the pressure-connecting region and the pressure chamber can include different materials; (p) the pressure chamber can include a material that is softer than the pressure-connecting region; (q) the pressure chamber can include an elastic material and the pressure-connecting region can include polycarbonate, high-hardness silicone, or thermoplastic elastomer; (r) the materials contained in the pressure-connecting region and the materials contained in the frame can be the same; (s) the pressure-connecting region can include at least one retaining feature to facilitate connection with the frame, and the frame can include at least one complementary frame connection region to accommodate at least one corresponding retaining feature; (t) at least one retaining feature can include a hook-like portion, which can have a front Each of the along-the-edge surface and the trailing-edge surface, and at least one frame connection region, may include an introduction surface and a retaining surface; (u) the leading-edge surface may be configured to contact the corresponding introduction surface of the at least one frame connection region during the attachment of the pressurized connection region to the frame such that the at least one retaining feature deforms along a direction generally opposite to the introduction surface; (u) the complete engagement of the at least one retaining feature with the at least one frame connection region when the pressurized connection region is attached to the frame and the leading-edge surface passes through the introduction surface can produce an audible click; (v) the hook-like portion may dangle from the at least one retaining feature opposite to the other surface of the at least one retaining feature;(w) The trailing edge surface of the hook portion may be oriented away from each other and at an angle relative to the other surfaces; (x) The leading edge surface of the hook portion may be at approximately 60 degrees relative to the other surfaces; (y) The trailing edge surface of the hook portion may be at approximately 75 degrees relative to the other surfaces; (z) The trailing edge surface may be angled closer to the leading edge surface to be perpendicular to the other surfaces such that the force required to attach the pressurized connection area to the frame is greater than the force required to remove the pressurized connection area from the frame; (aa) During attachment, the lead surface of the at least one frame connection area may be angled to be flush with the leading edge surface of the at least one retaining feature; (bb) When the at least one frame connection area is fully engaged with the at least one retaining feature, the retaining surface of the at least one frame connection area may be angled to be flush with the trailing edge surface of the at least one retaining feature; (cc) The at least one retaining feature may include a first retaining feature and a second retaining feature, and the at least one frame connection area may include a first frame connection area and a second frame connection area; (dd) The dimensions of the first retaining feature may be The design is complementary to the first frame connection area such that the second retaining feature cannot engage with the first frame connection area; (ee) the frame may include a port adapted to connect to a conduit to supply supplemental oxygen or measure pressure within the pressurization chamber; (ff) the port may be substantially cylindrical; (gg) the port and frame may be a single piece; (hh) the port may extend from the frame in a direction substantially opposite to the pressurization chamber; (ii) the port may extend downward from the frame; (jj) the frame may include at least one vent; (kk) at least one vent may include a mesh; (ll) to The absence of one airway may comprise a pair of airways, each positioned on opposite sides of the front surface of the frame; (mm) a sealing structure may serve both nostrils of the patient through a single perforation; (nn) the patient interface may be directly connected to the gas delivery tube via a connection port; (oo) the connection port may be integral with the frame of the patient interface; (pp) the connection port may be angled relative to the frame; (qq) the pressurization chamber may comprise a concave, sloping, or saddle-shaped region spanning the pressurization chamber between the nasal occiputs; and / or (rr) the saddle-shaped region may extend from the rear wall of the pressurization chamber to the front wall of the pressurization chamber.

[0064] Another aspect of this technology is a patient interface, which is molded or otherwise constructed in a clearly defined peripheral shape intended to match the target wearer.

[0065] One aspect of this technology relates to a positioning and stabilization structure for a patient interface device. The positioning and stabilization structure may include: at least one strip; and at least one reinforcing arm; wherein the positioning and stabilization structure may be arranged to position at least one strip and at least one reinforcing arm relative to each other such that at least one reinforcing arm imparts a desired shape to at least one strip at a rigid portion of at least one strip and allows the rigid portion of at least one strip to move relative to at least one reinforcing arm.

[0066] In the example, (a) at least one reinforcing arm can be secured to at least one strip within a defined area of ​​at least one strip; (b) the defined area can be adjacent to the opening of the pouch or cannula; (c) the positioning and stabilizing structure can include a headband for the patient interface device to deliver a supply of pressurized air or breathable gas to the inlet of the patient's airway; (d) the at least one reinforcing arm can be crescent-shaped; (e) the at least one strip can be made of an elastic fabric material and the positioning and stabilizing structure can be arranged such that the at least one strip can move substantially freely relative to the at least one reinforcing arm by elastically expanding and / or contracting, and along the at least one strip and / or reinforcing arm; (f) in the absence of at least one reinforcing arm (g) The stretchable length of at least one strip can remain substantially constant relative to at least one strip; (h) The elastic fabric material can be any one of the group consisting of elastic fibers, TPE, nylon, and silicone; (i) The positioning and stabilizing structure can be stretched along its substantially full length; (j) At least one strip can be stretchable and can be arranged in the form of a bushing to slide over the at least one reinforcing arm, the arrangement such that the at least one strip maintains its substantially fully stretchable length and can be stretched substantially freely over the at least one reinforcing arm; (e) At least one strip can include a hollow bushing for receiving the at least one reinforcing arm in place and for... (k) The at least one reinforcing arm receives at least one opening in the bushing; (l) the bushing and the at least one reinforcing arm may be arranged to allow the at least one reinforcing arm to move substantially axially within the bushing; (m) the end portion of the at least one reinforcing arm may be secured to at least one strip; (n) the at least one reinforcing arm may be secured to the at least one strip by stitching, welding, bonding, heat fusion, clamping, fastening, fastening a cover over the end, and / or fastening to the outer portion; (n) if the at least one reinforcing arm is secured to the at least one strip by engaging with the outer portion, it may be secured by aligning the at least one strip with the at least one reinforcing arm and pushing the at least one reinforcing arm within the bushing to allow engagement. The at least one reinforcing arm is received, and the bushing and the reinforcing arm are secured to the external portion to achieve engagement on the external portion; (o) the external portion may be an external clamp holding the corresponding ends of the bushing and at least one reinforcing arm, the clamp being adapted to attach the end of the positioning and stabilizing structure to the corresponding end of the mask frame, and the clamp may be part of the mask frame itself; (p) the given desired shape can guide the pressure of the positioning and stabilizing structure to a predetermined portion of the wearer's face; (q) multiple attachment points may be provided for attachment such that at least one fixed position can be selected and changed to allow adjustment of the elastic length of at least one strip; (r) at least one reinforcing arm may not extend and may be relatively more rigid than at least one strip;(s) At least one strip may include an elastic wall, said elastic wall being from any of the group consisting of: textile, knitting, weaving, molding, and extrusion; (t) The positioning and stabilizing structure may include two or more reinforcing arms symmetrically arranged on opposite sides of the patient's face; (u) At least one reinforcing arm is completely removable from at least one strip; (v) The positioning and stabilizing structure can maintain its full operating length and is free to extend along at least one reinforcing arm; (w) At least one strip may include two side strip portions arranged to extend from the patient interface along the side of the patient's head, and two rear strip portions arranged to extend along the back of the patient's head; (x) The two rear strip portions may be non-adjustable except by means of the elasticity of said rear strip portions or by means of increasing the tension of said rear strip portions, equivalently by shortening said longitudinal length of said positioning and stabilizing structure. (y) The positioning and stabilizing structure may include three, four, or more individual strips connected by two or more joints; (z) At least one strip may include two pouches, each pouch receiving a reinforcing arm to releasably secure at least one strip to the reinforcing arm; (aa) The positioning and stabilizing structure may include at least one retaining device comprising a ring, a sleeve, and / or a pouch to receive at least one reinforcing arm and hold at least one reinforcing arm in place; (bb) At least one retaining device may be formed on or in at least one strip; (cc) At least one reinforcing arm may be secured to a guide element disposed on at least one strip; (dd) At least one reinforcing arm may be secured to at least one strip only at a local point or area; (ee) The guide element may be an annular or sleeve-like portion, channel, or pouch through which at least one reinforcing arm extends; (ff) The guide element may allow at least one strip to expand or retract relative to at least one reinforcing arm and / or may allow At least one reinforcing arm is substantially free to move or float relative to at least one strip; (ff) at least one strip may include a rear portion split into at least two rear strips; (hh) at least two rear strips may include a first rear strip adapted to engage with the patient at the top adjacent to the head and a second rear strip adapted to engage with the patient at the rear adjacent to the head; (ii) each of the at least two rear strips is adapted to hold the patient interface against the patient's nose with substantially equal tension; (jj) each of the at least two rear strips can be tensioned with substantially equal forces when worn by the patient; (kk) wherein each of the at least two rear strips may be symmetrical and non-independently adjustable such that the at least two rear strips are naturally centered on the respective sides of the top of the head; (lli) a split region may be defined between the at least two rear strips and this split region is about 200 mm long, and / or (mm) the patient interface system may include: a positioning and stabilizing structure according to any of the above examples;And a patient interface, comprising any one of the following groups: a nasal cannula, a nasal plug, and a breathing mask covering the wearer's nose and / or mouth to the patient's face.

[0067] Another aspect of this technology relates to a patient interface system for delivering breathable gas to a patient. The patient interface system may include: a patient interface comprising a sealing-formed structure providing a pneumatic connection to a patient's airway; and a positioning and stabilizing structure comprising at least one strip and at least one reinforcing arm and configured to releasably hold the patient structure on the patient, wherein a shaped portion of the at least one strip is adapted to adopt the shape of the at least one reinforcing arm, the shaped portion being arranged to move along the longitudinal axis of the at least one reinforcing arm.

[0068] In the example, (a) at least one reinforcing arm can be secured to at least one strip within a defined area of ​​at least one strip; (b) the defined area can be adjacent to the opening of the pouch or cannula; (c) the positioning and stabilizing structure can include a headgear; (d) the at least one reinforcing arm can be crescent-shaped; (e) at least one strip can be made of an elastic fabric material and the positioning and stabilizing structure can be arranged such that the at least one strip can move substantially freely relative to the at least one reinforcing arm by elastically expanding and / or contracting, and along the at least one strip and / or reinforcing arm; (f) the stretchable length of at least one strip can remain substantially constant relative to the at least one strip in the absence of at least one reinforcing arm; (g) elasticity The fabric material may be any one of the group consisting of: elastic fibers, TPE, nylon, and silicone; (h) the positioning and stabilizing structure may be able to extend along its substantially full length; (i) at least one strip may be stretchable and may be arranged in the form of a bushing to slide over the at least one reinforcing arm, the arrangement such that the at least one strip maintains its substantially fully stretchable length and is able to extend substantially freely over the at least one reinforcing arm; (j) at least one strip may include a hollow bushing for receiving the at least one reinforcing arm in place and at least one opening for receiving the at least one reinforcing arm in the bushing; (k) the bushing and the at least one reinforcing arm may be fabricated... The at least one reinforcing arm is positioned to allow substantially axial movement within the bushing; (l) the end portion of the at least one reinforcing arm can be secured to at least one strip; (m) the at least one reinforcing arm can be secured to at least one strip by stitching, welding, bonding, heat fusion, clamping, fastening, fastening a cover over the end, and / or fastening to the outer portion; (n) if the at least one reinforcing arm is secured to the at least one strip by engaging it to the outer portion, engagement can be achieved by aligning the at least one strip with the at least one reinforcing arm, pushing the at least one reinforcing arm within the bushing to receive the at least one reinforcing arm, and securing the bushing and the reinforcing arm to the outer portion; (o) outer portion (a) An external clamp may be provided to hold the bushing and the corresponding end of at least one reinforcing arm, the clamp being adapted to attach the end of the positioning and stabilizing structure to the corresponding end of the mask frame, and the clamp may be part of the mask frame itself; (b) A forming portion may direct pressure of the positioning and stabilizing structure to a predetermined portion of the wearer's face; (c) A plurality of attachment points may be provided such that at least one fixed position can be selected and changed to allow adjustment of the elastic length of at least one strip; (d) At least one reinforcing arm may be non-extendable and relatively more rigid than at least one strip; (e) At least one strip may include an elastic wall, said elastic wall being from any of the group consisting of: textile, knitting, weaving, molding, and extrusion.(t) The patient interface system may include two or more reinforcing arms symmetrically arranged on opposite sides of the patient's face; (u) at least one reinforcing arm is completely removable from at least one strip; (v) the positioning and stabilizing structure can maintain its full operating length and can extend freely along at least one reinforcing arm; (w) at least one strip may include two side strip portions arranged to extend from the patient interface along the side of the patient's head, and two rear strip portions arranged to extend along the back of the patient's head; (x) the two rear strip portions may be non-adjustable except by means of the elasticity of the rear strip portions or by means of increasing the tension of the rear strip portions, equivalently by shortening the longitudinal length of the positioning and stabilizing structure. (y) The patient interface system may include three, four, or more individual strips connected by two or more joints; (z) At least one strip may include two pouches, each pouch receiving a reinforcing arm to releasably secure at least one strip to the reinforcing arm; (aa) The positioning and stabilization structure may include at least one retaining device comprising a ring, a sleeve, and / or a pouch to receive at least one reinforcing arm and hold at least one reinforcing arm in place; (bb) At least one retaining device may be formed on or in at least one strip; (cc) At least one reinforcing arm may be secured to a guide element disposed on at least one strip; (dd) At least one reinforcing arm may be secured to at least one strip only at a local point or area; (ee) The guide element may be an annular or sleeve-like portion, channel, or pouch into which at least one reinforcing arm extends or through; (ff) The guiding element may allow at least one strip to expand or retract relative to at least one reinforcing arm and / or may allow at least one reinforcing arm to move or float substantially freely relative to at least one strip; (gg) at least one strip may include a rear portion split into at least two rear strips; (hh) at least two rear strips may include a first rear strip adapted to engage with the patient at the top adjacent to the head and a second rear strip adapted to engage with the patient at the rear adjacent to the head; (ii) each of the at least two rear strips is adapted to hold the patient interface against the patient's nose with substantially equal tension; (jj) each of the at least two rear strips can be tensioned by substantially equal forces when worn by the patient; (kk) wherein each of the at least two rear strips is symmetrical and non-independently adjustable such that the at least two rear strips are naturally centered on the respective sides of the top of the patient's head. (ll) The patient interface system may include a slit region defined between the at least two rear strips and said slit region being approximately 200 mm long; and / or (mm) the patient interface may include any of the following: a nasal cannula, a nasal plug, and a breathing mask covering the wearer's nose and / or mouth to the patient's face.

[0069] Another aspect of this technology relates to a positioning and stabilizing structure comprising: at least one strip; and at least one reinforcing arm; wherein the positioning and stabilizing structure is arranged to position the at least one strip and the at least one reinforcing arm relative to each other such that the at least one reinforcing arm imparts a desired shape to the at least one strip at a reinforced portion, and wherein the at least one reinforcing arm is adapted to be connected to a patient interface via a flexible joint such that the patient interface can be moved to engage with a patient's nose.

[0070] In the example, (a) at least one reinforcing arm can be secured to at least one strip within a defined area of ​​at least one strip; (b) the defined area can be adjacent to the opening of the pouch or cannula; (c) the positioning and stabilizing structure can include a headband for the patient interface device to deliver a supply of pressurized air or breathable gas to the inlet of the patient's airway; (d) the at least one reinforcing arm can be crescent-shaped; (e) the at least one strip can be made of an elastic fabric material and the positioning and stabilizing structure can be arranged such that the at least one strip can move substantially freely relative to the at least one reinforcing arm by elastically expanding and / or contracting, and along the at least one strip and / or reinforcing arm; (f) in the absence of at least one reinforcing arm (g) The stretchable length of at least one strip can remain substantially constant relative to at least one strip; (h) The elastic fabric material can be any one of the group consisting of elastic fibers, TPE, nylon, and silicone; (i) The positioning and stabilizing structure can be stretched along substantially its entire length; (j) At least one strip is stretchable and can be arranged in the form of a bushing to slide over the at least one reinforcing arm, the arrangement such that the at least one strip maintains its substantially fully stretchable length and can be stretched substantially freely over the at least one reinforcing arm; (e) At least one strip can include a hollow bushing for receiving the at least one reinforcing arm in place and for holding the at least one... (k) A reinforcing arm receives at least one opening in the bushing; (l) the bushing and the at least one reinforcing arm may be arranged to allow the at least one reinforcing arm to move substantially axially within the bushing; (m) the end portion of the at least one reinforcing arm may be secured to at least one strip; (n) the at least one reinforcing arm may be secured to the at least one strip by stitching, welding, bonding, heat fusion, clamping, fastening, fastening a cover over the end, and / or fastening to the outer portion; (n) if the at least one reinforcing arm is secured to the at least one strip by engaging with the outer portion, the at least one reinforcing arm may be received by aligning the at least one strip with the at least one reinforcing arm and pushing the at least one reinforcing arm within the bushing. At least one reinforcing arm, and securing the bushing and reinforcing arm to the external portion to achieve engagement on the external portion; (o) the external portion may be an external clamp holding the bushing and the respective ends of the at least one reinforcing arm, the clamp being adapted to attach the ends of the positioning and stabilizing structure to the respective ends of the mask frame, and the clamp may be part of the mask frame itself; (p) the given desired shape may direct the pressure of the positioning and stabilizing structure to a predetermined portion of the wearer's face; (q) a plurality of attachment points may be provided such that at least one fixed position can be selected and changed to allow adjustment of the elastic length of at least one strip; (r) at least one reinforcing arm may not extend and may be relatively more rigid than at least one strip;(s) At least one strip may include an elastic wall, said elastic wall being from any of the group consisting of: textile, knitting, weaving, molding, and extrusion; (t) The positioning and stabilizing structure may include two or more reinforcing arms symmetrically arranged on opposite sides of the patient's face; (u) At least one reinforcing arm is completely removable from at least one strip; (v) The positioning and stabilizing structure can maintain its full operating length and is free to extend along at least one reinforcing arm; (w) At least one strip may include two side strip portions arranged to extend from the patient interface along the side of the patient's head, and two rear strip portions arranged to extend along the back of the patient's head; (x) The two rear strip portions may be non-adjustable except by means of the elasticity of said rear strip portions or by means of increasing the tension of said rear strip portions, equivalently by shortening said longitudinal length of said positioning and stabilizing structure. (y) The positioning and stabilizing structure may include three, four, or more individual strips connected by two or more joints; (z) At least one strip may include two pouches, each pouch receiving a reinforcing arm to releasably secure at least one strip to the reinforcing arm; (aa) The positioning and stabilizing structure may include at least one retaining device comprising a ring, a sleeve, and / or a pouch to receive at least one reinforcing arm and hold at least one reinforcing arm in place; (bb) At least one retaining device may be formed on or in at least one strip; (cc) At least one reinforcing arm may be secured to a guide element disposed on at least one strip; (dd) At least one reinforcing arm may be secured to at least one strip only at a local point or area; (ee) The guide element may be an annular or sleeve-like portion, channel, or pouch into which at least one reinforcing arm extends or through; (ff) The guiding element may allow at least one strip to expand or retract relative to at least one reinforcing arm and / or may allow at least one reinforcing arm to move or float substantially freely relative to at least one strip; (gg) at least one strip may include a rear portion split into at least two rear strips; (hh) at least two rear strips may include a first rear strip adapted to engage with the patient at the top adjacent to the head and a second rear strip adapted to engage with the patient at the rear adjacent to the head; (ii) each of the at least two rear strips is adapted to hold the patient interface against the patient's nose with substantially equal tension; (jj) each of the at least two rear strips can be tensioned by substantially equal forces when worn by the patient; (kk) wherein each of the at least two rear strips is symmetrical and non-independently adjustable such that the at least two rear strips are naturally centered on the corresponding side of the top of the patient's head; (ll) a split region may be defined between the at least two rear strips and this split region is about 200 mm long, and / or (mm) the patient interface system may include: a positioning and stabilizing structure according to any of the above examples;And a patient interface, comprising any one of the following groups: a nasal cannula, a nasal plug, and a breathing mask covering the wearer's nose and / or mouth to the patient's face.

[0071] Another aspect of this technology relates to a positioning and stabilizing structure. The positioning and stabilizing structure may include at least one strip comprising at least two posterior strips, each of which is symmetrical and non-independently adjustable such that the at least two posterior strips are naturally centered on corresponding sides of the top of the patient's head.

[0072] In the examples, (a) the positioning and stabilizing structure may include at least one reinforcing arm; (b) the at least one reinforcing arm may be secured to at least one strip within a defined area of ​​at least one strip; (c) the defined area may be adjacent to the pocket or cannula opening; (d) the positioning and stabilizing structure may include a headband for a patient interface device to deliver a supply of pressurized air or breathable gas to the inlet of the patient's airway; (e) the at least one reinforcing arm may be crescent-shaped; (f) the at least one strip may be made of an elastic fabric material and the positioning and stabilizing structure may be arranged such that the at least one strip expands and / or contracts elastically relative to the at least one reinforcing arm, and along the at least one strip and / or reinforced... (g) The fixed arm moves substantially freely; (h) the stretchable length of at least one strip can remain substantially constant relative to at least one strip in the absence of at least one fixed arm; (h) the elastic fabric material can be from any of the group consisting of elastic fibers, TPE, nylon, and silicone, and the positioning and stabilizing structure can be stretched along its substantially full length; (i) at least one strip can be stretchable and can be arranged in the form of a bushing to slide over the at least one fixed arm, the arrangement such that the at least one strip maintains its substantially fully stretchable length and can be stretched substantially freely over the at least one fixed arm; (j) at least one strip can include a means for attaching the fixed arm to the fixed arm. The at least one reinforcing arm receives a hollow bushing in place and at least one opening in the bushing for receiving the at least one reinforcing arm; (k) the bushing and the at least one reinforcing arm may be arranged to allow the at least one reinforcing arm to move substantially axially within the bushing; (l) the end portion of the at least one reinforcing arm may be secured to at least one strip; (m) the at least one reinforcing arm may be secured to at least one strip by stitching, welding, bonding, heat fusion, clamping, fastening, fastening a cover over the end, and / or fastening to the outer portion; (n) if the at least one reinforcing arm is secured to the at least one strip by engaging it to the outer portion, it may be secured by aligning the at least one... The strip and the at least one reinforcing arm are pushed inside the bushing to receive the at least one reinforcing arm, and the bushing and the reinforcing arm are secured to the outside to achieve engagement on the outer portion; (o) the outer portion may be an external clamp holding the corresponding ends of the bushing and the at least one reinforcing arm, the clamp being adapted to attach the end of the positioning and stabilizing structure to the corresponding end of the mask frame, and the clamp may be part of the mask frame itself; (p) a plurality of attachment points may be provided for attachment such that at least one fixed position can be selected and changed to allow adjustment of the elastic length of at least one strip; (q) at least one reinforcing arm may not extend and is relatively more rigid than at least one strip;(s) At least one strip includes an elastic wall, said elastic wall being from any of the group consisting of: textile, knitting, weaving, molding, and extrusion, including two or more reinforcing arms symmetrically arranged on opposite sides of the patient's face; (s) at least one reinforcing arm is completely removable from at least one strip; (t) the positioning and stabilizing structure is able to maintain its full operating length and is able to extend freely along at least one reinforcing arm; (u) at least one strip may include two side strip portions arranged to extend from the patient interface along the side of the patient's head, and two rear strip portions arranged to extend along the back of said patient's head; (v) in addition to the rear strip portions The elasticity, or the increase in tension of the rear strip portion, can be equivalent to shortening the longitudinal length of the positioning and stabilizing structure, except that the two rear strip portions may be non-adjustable; (w) the positioning and stabilizing structure may include three, four, or more individual strips connected by two or more joints; (x) at least one strip may include two pouches, each pouch receiving a reinforcing arm to releasably secure at least one strip to the reinforcing arm; (y) the positioning and stabilizing structure may include at least one retaining device comprising a ring, a sleeve, and / or a pouch to receive at least one reinforcing arm and hold at least one reinforcing arm in place; (z) in at least one strip At least one retaining device is formed in the upper or middle part; (aa) at least one reinforcing arm can be secured to a guide element disposed on at least one strip; (bb) at least one reinforcing arm can be secured to at least one strip only at a local point or area; (cc) the guide element can be an annular or sheath-like portion, channel, or pouch through which at least one reinforcing arm extends; (dd) the guide element can allow at least one strip to expand or retract relative to at least one reinforcing arm and / or can allow at least one reinforcing arm to move substantially freely or float relative to at least one strip; (ee) at least two posterior strips can include a first posterior strip adapted to engage with the patient at the top adjacent to the head and a second posterior strip adapted to engage with the patient at the top adjacent to the head. A second rear strip that engages with the patient near the back of the head; (ff) each of at least two rear strips is adapted to hold the patient interface against the patient's nose with substantially equal tension; (gg) each of the at least two rear strips can be tensioned with substantially equal force when worn by the patient; (hh) a split region may be defined between the at least two rear strips and this split region is about 200 mm long; and / or (ii) the patient interface system may include: a positioning and stabilizing structure according to any of the above examples; and a patient interface comprising any of the following: a nasal cannula, a nasal plug, and a breathing mask covering the wearer's nose and / or mouth to the patient's face.

[0073] Another aspect of this technology relates to a positioning and stabilizing structure. The positioning and stabilizing structure may include: at least one strip comprising a pair of side strips and a pair of rear strips positioned between each of the pair of side strips, wherein the pair of side strips and the pair of rear strips are integral.

[0074] In the examples, (a) the positioning and stabilizing structure may include a crack region defined between the rear strip pairs; (b) the crack region begins at the distal end of each of the rear strip pairs; (c) each distal end may include a reinforcing portion adjacent to the crack region; (d) at least one strip may be more extensible along its longitudinal axis than its transverse axis; (e) at least one strip may include a hole at the proximal end of each of the side strip pairs, the hole being shaped and sized to accommodate the insertion of a reinforcing arm; (f) at least one strip may include a warp-knitted or braided material; and / or (g) at least one strip may be tubular.

[0075] Another aspect of this technology relates to a method for using a patient interface worn by a patient, the patient interface including a positioning and stabilizing structure. This method may include: extending the positioning and stabilizing structure away from the patient interface; arranging a sealing formation structure of the patient interface toward the patient's airway; releasing a portion of the tension of the positioning and stabilizing structure by positioning the rear portion of the positioning and stabilizing structure against the rear of the patient's head; and adjusting the tension of the positioning and stabilizing structure by pulling open a rear stripe of the rear portion of the positioning and stabilizing structure.

[0076] Another aspect of this technology relates to a patient interface system. The patient interface system may include: at least one strip including at least two rear strips having a slit region therebetween; a patient interface including a sealing formation and connectable to the at least one strip; wherein the at least two rear strips are adjustable and separable such that when the sealing formation is arranged against the patient's airway, the tension sealing force generated by the at least one strip against the patient interface is maximized when the angle between the at least two rear strips is zero.

[0077] In the examples, (a) the tension seal force can decrease as the angle between at least two posterior strips increases; (b) the initial angle between at least two posterior strips can be zero to allow the patient to adjust the tension seal force by increasing the angle between the at least two posterior strips; (c) the angle between at least two posterior strips can be less than or equal to 180°; and / or (d) the tension seal force can be approximately less than 40% of the tension seal force when the angle between the at least two posterior strips is approximately 180°.

[0078] Another aspect of this technology relates to a method for repeatedly engaging a positioning and stabilizing structure to a patient interface device. This method may include: inserting an extendable reinforcing arm into a portion of a hollow, stretchable fabric strip; and releasably securing an end portion of the strip to the reinforcing arm; wherein the positioning and stabilizing structure is arranged to position the strip and the reinforcing arm relative to each other such that the reinforcing arm imparts a desired shape to the strip at the reinforced portion while allowing the reinforced portion of the strip to move freely relative to the reinforcing arm.

[0079] In the example, (a) the reinforcing arm may be permanently attached to the face mask frame of the patient interface device; (b) the end portion of the strip may be a pocket end attached to the corresponding capture of the reinforcing arm; and / or (c) the pocket end surrounds the upper part of the corresponding capture of the reinforcing arm;

[0080] In another aspect, a method for manufacturing a patient interface for treating respiratory disorders is provided. This method includes cutting an air vent portion from a fabric formed of interlaced fibers. The fabric has a predetermined number of porosities.

[0081] This method involves keeping the vent portion within the mold.

[0082] This method involves permanently attaching a portion of the ventilation port to a mask frame made of plastic material to form a ventilation port for flushing out exhaled air (including exhaled carbon dioxide) into the patient interface.

[0083] Alternatively, this method includes overmolding the vent portion to the mask frame using a mechanical interlock between the vent portion and the mask frame to form a vent for flushing exhaled air (including exhaled carbon dioxide) into a patient interface. The mechanical interlock provides a permanent connection between the vent portion and the mask frame, preventing removal of the vent from the mask frame. Possible mechanical interlocks are provided by one or more mushroom-shaped mechanical interlock elements. Pretreatment can be applied to the desired mating surfaces of the vent portion and the mask frame to create a micro-roughness profile, improving the mating strength.

[0084] This method may further include permanently attaching a first vent portion having a first airflow velocity to the mask frame. This method may further include permanently attaching a second vent portion having a second airflow velocity different from the first airflow velocity to the mask frame. The first vent portion and the second vent portion are selected if the combined first airflow velocity and the second velocity are within a predetermined range.

[0085] The interwoven fibers can be made of thermoplastic polymers. Thermoplastic polymers can be any of the following groups: polypropylene, polycarbonate, nylon, and polyethylene. The thermoplastic polymer can be SEFAR material TetexMono05-1010-k080 woven polypropylene material.

[0086] Permanent connections can be achieved through molecular adhesion using any of the following groups: overmolding, co-injection molding, and two-emission (2K) injection molding.

[0087] The patient interface for this method can be any of the following: a nasal mask, a full-face mask, and a nasal pillow. Preferably, the patient interface is a nasal pillow or a nasal pad.

[0088] Cutting can be performed from any of the following groups: laser cutting, ultrasonic cutting, and mechanical cutting.

[0089] The vent can be basically semi-circular or D-shaped.

[0090] The fabric can be provided in rolls or strips before the vent portion is cut.

[0091] The vent may have a maximum width of about 16 mm to about 21 mm, preferably about 18.2 mm to 18.6 mm, a maximum height of about 19 mm to about 24 mm, preferably 21.6 mm to 22 mm, and a thickness of about 0.36 mm to about 0.495 mm, preferably 0.40 mm to 0.45 mm.

[0092] The mask frame may have two vents. The first vent is located on the upper left side of the mask frame. The second vent is located on the upper right side of the mask frame. The first and second vents are separated by perforations to receive the air delivery tube.

[0093] This method also includes selectively reducing the amount of porosity in the vent portion if the airflow velocity through the vent portion exceeds a predetermined range.

[0094] The predetermined range can be about 42 to about 59 liters per minute at a pressure of 20 cmH2O, preferably about 47 to about 53 liters per minute at a pressure of 20 cmH2O.

[0095] The airflow velocity of the polypropylene material woven with SEFAR material TetexMono05-1010-k080 can be about 37 to about 64 liters at a pressure of 20 cmH2O, preferably about 42 to about 58 liters at a pressure of 20 cmH2O.

[0096] The porosity of the vent portion can be reduced by any of the following methods: hot melting, deformation of the plastic by compression, ultrasonic welding, application of sealant, and application of a thin film. The sealant can be a hot melt adhesive.

[0097] The porosity of the vent portion can be reduced by partially or completely blocking the holes in the vent portion.

[0098] The porosity of the continuous peripheral edge region of the vent can be reduced.

[0099] In a second aspect, a method is provided for creating a vent for flushing exhaled air (including exhaled carbon dioxide) from a patient interface.

[0100] This method involves cutting an vent portion from a semi-permeable material, having a predetermined number of porosities to diffuse airflow.

[0101] This method involves permanently attaching the ventilation port portion to the mask frame of the patient interface to form the ventilation port. A predetermined amount of porosity is used to achieve an airflow rate of approximately 42 to 59 liters per minute at a pressure of 20 cmH2O for the breathing gas from the patient interface, with an A-weighted sound energy level less than or equal to 25 dBA, having an uncertainty of 3 dBA, and an A-weighted sound pressure at a distance of 1 meter greater than or equal to 17 dBA, also having an uncertainty of 3 dBA. Preferably, the A-weighted sound energy level is approximately 22 dBA and the A-weighted sound pressure is approximately 13 dBA.

[0102] At a pressure of 20 cmH2O for breathing gases, the airflow velocity can be 47 to 53 liters per minute.

[0103] In another aspect, a patient interface for treating respiratory distress is provided. The patient interface includes an airway to flush exhaled air (including exhaled carbon dioxide). The airway is connected to an airway cover made of a plastic material. The airway cover is removably engaged with the mask frame at an airway perforation defined in the mask frame. The airway is made of a fabric formed by interlaced fibers. The fabric has a predetermined number of porosities.

[0104] This allows a portion of the vent to be thermally blocked to achieve a predetermined amount of porosity.

[0105] The vent can have a surface area of ​​approximately 201.6 mm² to approximately 278.6 mm².

[0106] The surface area of ​​the vent can be approximately 1% to 10% of the total open area.

[0107] Another aspect of this technology relates to a gas delivery tube that can be used to deliver breathable gas from a breathing device to a patient. The gas delivery tube may include: a helical coil comprising a plurality of adjacent coils, each coil being separated by a width and having an outer surface defining a coil diameter; and a material mesh coaxial with the helical coils attached between adjacent coils, and having at least one crease extending radially outward between adjacent coils, the at least one crease being defined by a predetermined crease line, wherein the apex of the at least one crease defines a crease diameter, wherein the coil diameter is substantially equal to the crease diameter when the gas delivery tube is in an intermediate state.

[0108] In the examples, (a) the material mesh may include at least one crease extending radially outward along at least one longitudinal portion of the gas delivery tube; (b) when the gas delivery tube is in an intermediate state, the tilt angle of the material mesh may increase from the helical coil to the apex of at least one crease; (c) the material mesh may have an asymmetrical cross-sectional profile around a predetermined crease; (d) the predetermined crease may be uniformly spaced between adjacent adjacent coils; (e) when the gas delivery tube is in an intermediate state, the width separating adjacent coils may be equal to the width of the helical coil; (f) the helical coil may include an outer surface area that is a larger proportion of the outer surface area than at least one crease of the material mesh; (g) the outer portion of the helical coil may have a circular profile; (h) when draped over a cylinder having a diameter of 13 mm, the outer surface of the helical coil may have a radius of curvature of 44 mm under its own weight; (i) the outer portion of the helical coil may have an elliptical profile; (j) the helical coil may have a thickness greater than that of the material mesh. (k) The material mesh may have a substantially uniform thickness; (l) The helical coil may include a thermoplastic elastomer; (m) The material mesh may include a thermoplastic elastomer; (n) The material mesh and the helical coil may be combined to form a uniform and continuous inner surface of the gas delivery tube; (o) At least one crease may extend radially outward between alternating adjacent coils; (p) The helical coil may have a pitch of about 3.2 mm to about 4.7 mm; (q) The helical coil may have a pitch of about 4.5 mm to about 4.7 mm; (r) The helical coil may have an elastic stiffness of about 0.03 N / mm; (s) When in the intermediate state, the inner diameter of the tube may be about 18 mm; and / or (t) The gas delivery tube may include one of three different states: an intermediate state in which the gas delivery tube includes an intermediate length, an extended state in which the gas delivery tube extends to an extension length greater than the intermediate length, and a compressed state in which the gas delivery tube is compressed to a compressed length less than the intermediate length.

[0109] Another aspect of this technology relates to a respiratory therapy system for supplying breathable gas to a patient. The respiratory therapy system may include: a breathing mask assembly worn by a user during treatment; a gas delivery tube according to at least one of the examples described in the preceding paragraphs, the gas delivery tube being fixedly attached at a first end to the breathing mask assembly and having a rotatable adapter fixedly attached at a second end; a separate gas delivery tube, rotatably attached at a third end to the gas delivery tube via the rotatable adapter; and / or a breathing device for generating a flow of breathable gas, which is connected at a fourth end to the separate gas delivery tube.

[0110] Another aspect of this technology relates to a gas delivery tube for supplying breathable gas from a breathing device to a patient. The gas delivery tube may include a helical coil comprising a plurality of adjacent coils, each coil being separated by a width; and a material mesh coaxial with the helical coils attached between adjacent coils, wherein when the gas delivery tube is in an intermediate state, the width separating adjacent coils is substantially equal to the width of the helical coil.

[0111] In the examples, (a) the material mesh may include at least one crease extending radially outward between adjacent coils, the crease being defined by a predetermined crease line and having a apex; (b) the material mesh may include at least one crease extending radially outward along at least one longitudinal portion of the gas delivery tube; (c) the at least one crease may be uniformly spaced between adjacent coils; (d) the helical coil may include an outer surface area larger than at least one crease of the material mesh; (e) the outer surface of the helical coil may define a coil diameter, the apex of the at least one crease may define a crease diameter, and the coil diameter may be equal to the crease diameter when the gas delivery tube is in an intermediate state. (f) When the gas delivery tube is in the intermediate state, the tilt angle of the material mesh can be increased from the helical coil to the apex of at least one crease; (g) The material mesh can have an asymmetrical cross-sectional profile around a predetermined crease; (h) The outer portion of the helical coil can have a circular profile; (i) When draped over a cylinder with a diameter of 13 mm, the outer portion of the helical coil can have a radius of curvature of 44 mm under its own weight; (j) The outer portion of the helical coil can have an elliptical profile; (k) The helical coil can have a greater thickness than the material mesh; (l) The material mesh can have a substantially uniform thickness; (m) The helical coil can include a thermoplastic elastomer; (n) The material mesh can include a thermoplastic elastomer; (o) The material mesh and the helical coil can be combined to form a uniform and (p) The material mesh may include at least one crease extending radially outward between alternating adjacent coils; (q) The helical coil may have a pitch of about 3.2 mm to about 4.7 mm; (r) The helical coil may have a pitch of about 4.5 mm to about 4.7 mm; (s) The helical coil may have an elastic stiffness of about 0.03 N / mm; (t) The inner diameter of the tube may be about 18 mm when in the intermediate state; and / or (u) The gas delivery tube may include one of three different states: an intermediate state in which the gas delivery tube includes an intermediate length, an extended state in which the gas delivery tube extends to an extension length greater than the intermediate length, and a compressed state in which the gas delivery tube is compressed to a compressed length less than the intermediate length.

[0112] Another aspect of this technology relates to a respiratory therapy system for supplying breathable gas to a patient. The respiratory therapy system may include: a breathing mask assembly worn by a user during treatment; a gas delivery tube according to at least one of the examples described in the preceding paragraphs, the gas delivery tube being fixedly attached at a first end to the breathing mask assembly and having a rotatable adapter fixedly attached at a second end; a separate gas delivery tube, rotatably attached at a third end to the gas delivery tube via the rotatable adapter; and / or a breathing device for generating a flow of breathable gas, which is connected at a fourth end to the separate gas delivery tube.

[0113] Another aspect of this technology relates to a gas delivery tube that can be used to deliver breathable gas from a breathing device to a patient. The gas delivery tube may include a helical coil comprising a plurality of adjacent coils, each coil being separated by a width; and a material mesh coaxial with the helical coils attached between adjacent coils, and having at least one crease extending radially outward between adjacent coils, the at least one crease being defined by a predetermined crease line, wherein the apex of the at least one crease defines a crease diameter, and wherein the tilt angle of the material mesh increases from the helical coil to the apex of the at least one crease when the gas delivery tube is in an intermediate state.

[0114] In the examples, (a) at least one crease may extend radially outward along at least one longitudinal portion of the gas delivery tube; (b) at least one crease may be uniformly spaced between adjacent ones of a plurality of adjacent coils; (c) the outer surface of the helical coil may define the coil diameter, the apex of at least one crease may define the crease diameter, and the coil diameter may be equal to the crease diameter when the gas delivery tube is in an intermediate state; (d) the helical coil may include a larger proportion of the outer surface area than the apex of at least one crease; (e) the outer portion of the helical coil may have a circular profile; (f) when draped over a cylinder having a diameter of 13 mm, the outer portion of the helical coil may have a radius of curvature of 44 mm under its own weight; (g) the outer portion of the helical coil may have an elliptical profile; (h) the helical coil may have a thickness greater than that of the material mesh; (i) the material mesh may have a substantially uniform thickness; (j) the helical coil may The gas delivery tube includes: (k) a thermoplastic elastomer; (l) a material mesh that may include a thermoplastic elastomer; (m) a material mesh that may be combined with a helical coil to form a uniform and continuous inner surface of the gas delivery tube; (n) a material mesh that may include at least one crease extending radially outward between alternating adjacent coils; (o) a helical coil that may have a pitch of about 4.5 mm to about 4.7 mm; (p) a helical coil that may have an elastic stiffness of about 0.03 N / mm; (q) an inner diameter of the tube that may be about 18 mm when in an intermediate state; and / or (r) a gas delivery tube that may include one of three different states: an intermediate state in which the gas delivery tube includes an intermediate length, an extended state in which the gas delivery tube extends to an extension length greater than the intermediate length, and a compressed state in which the gas delivery tube is compressed to a compressed length less than the intermediate length.

[0115] Another aspect of this technology relates to a gas delivery tube for delivering breathable gas from a breathing device to a patient. The gas delivery tube may include: a plurality of coils, each separated by a width; and a material mesh coaxial with the coils attached between adjacent coils of the plurality of coils, and having at least one crease extending radially outward between adjacent coils, the at least one crease being defined by a peak; wherein the material mesh includes a raised portion near a first side of the coil and a sloping portion near a second side of the coil, the second side opposite to the first side; and wherein, when the gas delivery tube is in the intermediate state, the slope of the material mesh from the sloping portion to the adjacent peak is steeper than the slope from the raised portion to the adjacent peak.

[0116] In the examples, (a) at least one crease may extend radially outward along at least one longitudinal portion of the gas delivery tube; (b) at least one crease may be uniformly spaced between adjacent coils; (c) the outer surface of the coil may define the coil diameter, the peak of at least one crease may define the crease diameter, and the coil diameter may be equal to the crease diameter when the gas delivery tube is in an intermediate state; (d) the coil may include a larger proportion of the outer surface area than the peak of at least one crease; (e) the outer portion of the coil may have a circular profile; (f) when draped over a cylinder having a diameter of 13 mm, the outer portion of the coil may have a radius of curvature of 44 mm under its own weight; and (g) the outer portion of the helical coil may have an elliptical profile.

[0117] (h) The coil can have a greater thickness than the material mesh; (i) The material mesh can have a substantially uniform thickness;

[0118] (j) The coil may include a thermoplastic elastomer; (k) The material mesh may include a thermoplastic elastomer; (l) The material mesh and the coil may be combined to form a uniform and continuous inner surface of the gas delivery tube; (m) The material mesh may include at least one crease extending radially outward between alternations of a plurality of adjacent coils; (n) The coil may have a pitch of about 3.2 mm to about 4.7 mm; (o) The coil may have a pitch of about 4.5 mm to about 4.7 mm; (p) The coil may have an elastic stiffness of about 0.03 N / mm; (q) When in the intermediate state, the inner diameter of the tube may be about 18 mm; and / or (r) The gas delivery tube may include one of three different states: wherein the gas delivery tube includes an intermediate state of intermediate length, wherein the gas delivery tube extends to an extension length greater than the intermediate length, and wherein the gas delivery tube is compressed to a compression length less than the intermediate length.

[0119] Another aspect of this technology relates to a respiratory therapy system for supplying breathable gas to a patient. The respiratory therapy system may include: a breathing mask assembly worn by a user during treatment; a gas delivery tube according to at least one of the examples described in the preceding paragraphs, the gas delivery tube being fixedly attached at a first end to the breathing mask assembly and having a rotatable adapter fixedly attached at a second end; a separate gas delivery tube, rotatably attached at a third end to the gas delivery tube via the rotatable adapter; and / or a breathing device for generating a flow of breathable gas, which is connected at a fourth end to the separate gas delivery tube.

[0120] According to another aspect of the present technology, a patient interface for treating respiratory disorders is provided. The patient interface may include a reinforcing arm made of a first material. The patient interface system may also include a flexible joint permanently connected to the reinforcing arm, the flexible joint being made of a second material not integrally bonded to the first material; the patient interface system may also include a mask frame permanently connected to the flexible joint, the mask frame being made of a third material integrally bonded to the second material. The reinforcing arm and the flexible joint may be permanently connected by a mechanical interlocking element. The first material, the second material, and the third material may be different materials.

[0121] The bond can be a cobonded bond or a hydrogen bond.

[0122] The first material can be a thermoplastic polymer elastomer. Thermoplastic polymer elastomers can be made from... Manufactured 5556.

[0123] The second material can be a thermoplastic elastomer (TPE). The TPE can be Dynaflex. TM TPE compounds or MD-115.

[0124] The third material can be a thermoplastic polymer. A thermoplastic polymer can be polypropylene (PP).

[0125] Flexible joints can be overmolded onto the mask frame.

[0126] The mechanical interlock may include a protrusion extending from a reinforcing arm that is overmolded with material through a flexible joint. The protrusion may be T-shaped with a gap in a central region, the gap extending from the top surface of the protrusion to the bottom surface so that material of the flexible joint can pass through there.

[0127] The mechanical interlock may include two protrusions that extend laterally from the distal end of the reinforcing arm.

[0128] Near each protrusion, there may be gaps extending through the reinforcing arm so that material from the flexible joint can pass through there.

[0129] The patient interface can be a nasal pillow or a nasal pad.

[0130] According to another aspect of the present technology, a patient interface for treating respiratory disorders is provided. The patient interface may include a reinforcing arm made of a first material. The patient interface may also include a mask frame permanently attached to the reinforcing arm. The mask frame may be made of a second material that is not integrally bonded to the first material. The first material may be relatively more flexible than the second material. The reinforcing arm and the mask frame may be permanently connected by a mechanical interlocking mechanism.

[0131] The mask frame can be overmolded to the reinforcing arm.

[0132] Mechanical interlocking components may include encapsulated portions extending from a reinforcing arm that is overmolded through a material overlay formed by the mask frame.

[0133] The encapsulated portion may have a portion of a bend and a portion of a hook.

[0134] According to another aspect of the present technology, a patient interface for treating respiratory disorders is provided. The patient interface may include a reinforced arm made of a first material. The patient interface may also include a mask frame made of a second material and integrally integrated into the reinforced arm. The first material may be relatively more flexible and elastic than the second material. The first material may be a fiber-reinforced synthetic polypropylene material and the second material may be polypropylene.

[0135] Fiber-reinforced synthetic polypropylene materials can be

[0136] According to another aspect of the present technology, a patient interface for treating respiratory disorders is provided. The patient interface may include a reinforcing arm. The patient interface may also include a mask frame releasably engageable with the reinforcing arm. A first material may be more flexible than the mask frame. The reinforcing arm may include a protruding end of a strap configured to maintain a positioning and stabilizing structure. The protruding end may be adjacent to the mask frame.

[0137] The patient interface may also include a flexible joint that is releasably engageable with the reinforcement arm. The flexible joint may also be releasably engageable with the mask frame. The flexible joint may be more flexible than the reinforcement arm.

[0138] A releasable engagement between the reinforcing arm and the mask frame can be provided via a mechanical clamping assembly.

[0139] Releasable engagements can be provided between the flexible joint and the reinforcing arm, and between the flexible joint and the mask frame, through mechanical clamping assemblies.

[0140] Another aspect of this technology relates to a patient interface for treating respiratory disorders. The patient interface may include a reinforcing arm that may be made of a first material that is possibly inextensible; a mask frame may be permanently attached to the reinforcing arm, the mask frame being made of a second material that may not be integrally bonded to the first material; the first material may be more flexible than the second material, and the reinforcing arm and the mask frame may be permanently connected together by a mechanical interlocking element. The fact that the reinforcing arm is made of the first material and can be permanently attached to the mask frame such that, when worn by a patient, the reinforcing arm can be configured to be flexible only in a plane substantially parallel to the patient's Frankfurt horizontal plane.

[0141] In the example, (a) the mask frame may be overmolded to the reinforcing arm; (b) the mechanical interlock may include a resealable portion extending from the reinforcing arm overmolded through the material of the mask frame; and / or (c) the resealable portion may have a portion of a bend and a hook.

[0142] Another aspect of this technology relates to a rigid arm for operatively attaching a resilient fabric strip of positioning and stabilizing structure to a mask frame. The rigid arm may include a body having a curvature substantially conforming to the shape of a patient's cheek; a protruding end configured to hold a pouch end of the strip, the protruding end being positioned at a distal end of the reinforcing arm; and a connecting portion configured to connect to a flexible joint or mask frame, the connecting portion being positioned at the distal end of the reinforcing arm.

[0143] In examples, (a) the connecting portion may include at least one protrusion and at least one gap configured to overmold for connection to a flexible joint or mask frame; (b) the reinforcing arm may include a thermoplastic polymer elastomer; (c) the reinforcing arm may include a material in which the reinforcing arm is flexible only in one plane; and / or (d) the reinforcing arm may include a non-extending material. Another aspect of the technology relates to a patient interface for delivering a supply of pressurized air or breathable gas to an inlet of a patient's airway. The patient interface may include: a liner member comprising a retaining structure and a nasal pillow pair, the nasal pillow pair being pneumatically connected to a pressurization chamber via handles permanently connected to the retaining structure; and a frame member wherein the retaining structure and the frame member are repeatedly engageable and disengageable from each other; and wherein opposite sides of each handle have unequal material rigidity to provide increased resistance to deformation of the handle along a direction opposite to a predetermined direction.

[0144] Another aspect of this technology relates to a patient interface for delivering a supply of pressurized air or breathable gas to an inlet of a patient's airway. The patient interface may include a padding member comprising a retaining structure and a sealing forming structure permanently connected to the retaining structure; and a frame member wherein the retaining structure and the frame member are repeatedly engageable and disengageable from each other; wherein the sealing forming structure has a greater length than the retaining structure along a direction parallel to engagement and disengagement between the retaining structure and the frame member; and wherein the padding member has a first thickness adjacent to the retaining structure and a second thickness less than the first thickness adjacent to the sealing forming structure, and the thickness of the padding member gradually decreases from the first thickness to the second thickness.

[0145] Another aspect of this technology relates to a patient interface system for delivering breathable gas to a patient. The patient interface may include: a sealed formation structure providing a pneumatic connection to a patient's airway; and a positioning and stabilizing structure including at least one strip and at least one reinforcing arm and configured to releasably hold the patient structure on the patient, wherein the at least one reinforcing arm has a bend to guide the longitudinal axis of the at least one reinforcing arm from a first plane substantially parallel to the sagittal plane to a second plane substantially parallel to the coronal plane.

[0146] Another aspect of this technology relates to a patient interface for treating respiratory disorders. The patient interface may include: a flushable and reusable ventilator for flushing exhaled air having a thickness of no more than 0.45 mm and a weight of no more than 234 grams per square meter; wherein the ventilator has a porous region defining a curved airflow path for the exhaled air and the porous region has a predetermined level of rigidity to substantially maintain its shape during the patient's respiratory cycle.

[0147] Another aspect of this technology relates to a padding member for a patient interface, used to deliver a supply of pressurized air or breathable gas to the inlet of a patient's airway. The padding member may include: a retaining structure for repeatedly engaging and disengaging with a frame member; and a sealing forming structure permanently connected to the retaining structure; wherein the sealing forming structure is made of a first material and the retaining structure is made of a second material with different mechanical properties than the first material, and the second material is more rigid than the first material; and wherein an increase in air pressure within the padding member causes an increase in the sealing force between the sealing forming structure and the frame member.

[0148] Another aspect of this technology relates to a gas delivery tube for delivering a supply of pressurized air or breathable gas to an inlet of a patient's airway via a patient interface. The gas delivery tube may include: a helical coil comprising a plurality of adjacent coils, each coil being separated by a width; a material mesh coaxial with the helical coils attached between adjacent coils and having at least one crease extending radially outward between adjacent coils, the at least one crease being defined by a predetermined crease line; a first end cap for permanently and non-rotatably connecting the tube to a frame of the patient interface; and a second end cap for releasably and rotatably connecting to a tube adapter; wherein the gas delivery tube comprises one of three distinct states: an intermediate state comprising an intermediate length, an extended state comprising an extension length along its longitudinal axis greater than the intermediate length, and a compressed state comprising a compressed length along its longitudinal axis less than the intermediate length.

[0149] Another aspect of this technology relates to a padding member for a patient interface, used to deliver a supply of pressurized air or breathable gas to the inlet of a patient's airway. The padding member may include: a retaining structure for repeatedly engaging and disengaging with a frame member; and a sealing forming structure permanently connected to the retaining structure; wherein the sealing forming structure is made of a first material and the retaining structure is made of a second material that is different from and more rigid than the first material; and wherein the first material allows the sealing forming structure to readily conform to finger pressure and the second material prevents the retaining structure from readily conforming to finger pressure.

[0150] Another aspect of this technology relates to a padding member for a patient interface, used to deliver a supply of pressurized air or breathable gas to the inlet of a patient's airway. The padding member may include: a retaining structure for repeatedly engaging and disengaging with a frame member; and a sealing forming structure connected to the retaining structure; wherein the sealing forming structure is made of a first material and the retaining structure is made of a second material that is different from and more rigid than the first material; and wherein the retaining structure has a continuous peripheral edge on its front side in contact with the frame member.

[0151] Another aspect of this technology relates to a reinforcing arm for attaching a strip of positioning and stabilizing structure to a mask frame. The reinforcing arm may include a body having a curvature along more than one axis substantially following the shape of the patient's cheek; wherein the reinforcing arm extends from the mask frame to a location adjacent to the patient's cheekbone.

[0152] Another aspect of this technology relates to a patient interface for delivering a supply of pressurized air or breathable gas to an inlet of a patient's airway. The patient interface may include: a mask frame having ventilation holes defined within the mask frame; a vent cap made of a plastic material removably engageable with the mask frame at the ventilation holes; and a vent permanently connected to the vent cap, the vent having a porous region for flushing exhaled air; wherein the vent is made of a fabric formed from interlaced plastic fibers and the spaces between the interlaced plastic fibers define a curved air path for the exhaled air; and wherein the fabric is constructed such that the shape, geometry, and profile of the vent remain substantially unchanged during the patient's respiratory cycle and the porous region maintains a substantially constant flushing velocity for the exhaled air.

[0153] Another aspect of this technology relates to a vent cover for a patient interface, used to deliver a supply of pressurized air or breathable gas to the inlet of a patient's airway. The vent cover may include: a vent frame removably engaged with a ventilation opening of a mask frame of the patient interface; and a vent permanently connected to the vent frame, the vent having a porous region for flushing exhaled air; wherein the vent is made of a fabric formed from interlaced plastic fibers and the spaces between the interlaced plastic fibers define a curved air path for the exhaled air; and wherein the fabric is constructed such that the shape, geometry, and profile of the vent remain substantially unchanged during the patient's respiratory cycle and the porous region maintains a substantially constant flushing velocity for the exhaled air.

[0154] Another aspect of this technology relates to a ventilation port for a patient interface, used to deliver a supply of pressurized air or breathable gas to an inlet in the patient's airway. The ventilation port may include: an interlaced structure of fibers having a curved air path for exhaled air defined by the space between the interlaced fibers; wherein the interlaced structure of fibers is configured to substantially maintain its shape, geometry, and profile during the patient's respiratory cycle and the space maintains a substantially constant scouring rate for the exhaled air.

[0155] Another aspect of this technology relates to a patient interface for providing breathable gas to a patient, the patient interface comprising: a connection port; at least two ventilation ports; a first ventilation port of the at least two ventilation ports on a first side of the connection port; and a second ventilation port of the at least two ventilation ports on a second side of the connection port; wherein the ventilation ports are porous ventilation ports or staggered structures.

[0156] Another aspect of this technology relates to a liner member for a patient interface used to deliver a supply of pressurized air or breathable gas to the inlet of a patient's airway, said patient interface including a frame connectable to the liner member. The liner member may include a visual indicator for preventing misalignment of the liner member when it is connected to the frame.

[0157] Another aspect of this technology relates to a gas delivery tube for providing a pressurized flow of breathable gas from a breathing device to a patient. The gas delivery tube may include: a helical coil comprising a plurality of adjacent coils, each coil being separated by width and having an outer surface defining a coil diameter; and a material mesh coaxial with the helical coils attached between adjacent ones of the plurality of adjacent coils, and having at least one crease extending radially outward between adjacent ones of the plurality of adjacent coils, the at least one crease being defined by a predetermined crease line, wherein the apex of the at least one crease defining a crease diameter; wherein when the gas delivery tube is in an intermediate state, the coil diameter is substantially equal to the crease diameter and the adjacent coils are separated from each other in the intermediate state; and the helical coil and the material mesh are made of a thermoplastic material; wherein the helical coil and the material mesh are configured to prevent obstruction of the gas delivery tube during the supply of the pressurized breathable gas flow from the breathing device, and wherein the gas delivery tube has sufficiently low flexural stiffness such that when the distal end of the gas delivery tube is elongated by thirty millimeters in a direction perpendicular to the orientation of the proximal end of the gas delivery tube, there is substantially no torsional tube drag at the proximal end.

[0158] Another aspect of this technology relates to a padding member for a nasal pillow, nasal bridge, or nasal mask, used to deliver a supply of pressurized air or breathable gas to the inlet of a patient's airway. The padding member may include: a retaining structure for repeatedly engaging and disengaging with a frame member; and a sealing forming structure permanently connected to the retaining structure; wherein an increase in air pressure within the padding member causes an increase in the sealing force between the sealing forming structure and the frame member; and wherein the retaining force between the retaining structure and the frame member is greater than the disengagement force causing the retaining structure to disengage from the frame member.

[0159] Another aspect of this technology relates to a patient interface for delivering a supply of pressurized air or breathable gas to an inlet of a patient's airway. The patient interface includes: a liner member comprising a retaining structure and a sealing formation permanently connected to the retaining structure; and a frame member wherein the retaining structure and the frame member are repeatedly engageable and disengageable from each other; and wherein the retaining structure has a main shaft with a length of approximately 50 to 60 mm and a secondary shaft with a length of approximately 25 mm to approximately 35 mm.

[0160] Another aspect of this technology is a patient interface, which is molded or otherwise constructed with a clearly defined peripheral shape intended to match the target wearer (i.e., the patient) in use and closely and consistently with the target wearer's face.

[0161] One aspect of this technology is a method for creating a patient interface.

[0162] Of course, a portion of this aspect can form a sub-aspect of this technology. Furthermore, multiple sub-aspects and / or aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0163] Other features of the art will become apparent from the information contained in the following detailed description, abstract, description of the drawings and claims. Attached Figure Description

[0164] The invention is illustrated by way of example rather than limitation, and in the accompanying drawings, similar reference numerals refer to similar elements, including:

[0165] 5.1 Treatment System

[0166] Figure 1a A system according to the technology of the present invention is shown in which air from PAP device 4000 is humidified in humidifier 5000 and delivered to patient 1000 along air circuit 4170;

[0167] Figure 1b A PAP device 4000 with a nasal mask is shown for use on 1000 patients;

[0168] Figure 1c A PAP device 4000 with a full face mask for use on a patient 1000 is shown.

[0169] 5.2 Therapy

[0170] 5.2.1 Respiratory System

[0171] Figure 2a It shows an overview of the human respiratory system, including the nasal cavity and oral cavity, larynx, vocal folds, esophagus, trachea, bronchi, lungs, alveolar sacs, heart, and diaphragm.

[0172] Figure 2b The diagram shows a view of the human upper airway, including the nasal cavity, nasal bones, lateral nasal cartilage, greater alar cartilage, nostrils, supralabial and sublabial folds, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal folds, esophagus, and trachea.

[0173] 5.2.2 Facial Anatomy

[0174] Figure 2c It is a frontal view of a face with multiple identified surface anatomical features, including the upper lip, lower lip, lower lip, mouth width, inner canthus of the eye, nasal alae, nasolabial groove, and corner of the mouth.

[0175] Figure 2dIt is a side view of the head with several identified surface anatomical features, including the glabella, root of the nose, nasal protuberance, nasal base, supralipal and sublipal points, supramental point, bridge of the nose, supraauricular and subauricular points. The orientation (front-back, up-down) is also indicated.

[0176] Figure 2e This is a further side view of the head. It shows the approximate positions of the Frankfurt level and the nasolabial angle.

[0177] Figure 2f The image shows a top view of the nose.

[0178] Figure 2g A side view showing the surface features of the nose.

[0179] Figure 2h The subcutaneous structures of the nose are shown, including the lateral cartilages, septal cartilages, greater alar cartilages, lesser alar cartilages, and fibroadipose tissue.

[0180] Figure 2i The mid-anatomy of the nose is shown, approximately a few millimeters in the sagittal plane, used to show the nasal septum cartilage, medial angle, and others of the greater alar cartilage;

[0181] Figure 2j A frontal view of the skull is shown, including the frontal bone, temporal bone, nasal bone, and zygomatic bone. The nasal concha is shown as the maxilla, mandible, and mental protuberance;

[0182] Figure 2k A side view of the skull is shown using the contours of the head's surface and several muscles. The following bones are shown: frontal bone, sphenoid bone, nasal bone, zygomatic bone, maxilla, mandible, parietal bone, temporal bone, and occipital lobe. The mental protuberance is shown. The following muscles are shown: digastric muscle, masseter muscle, sternocleidomastoid muscle, and trapezius muscle.

[0183] Figure 2l The frontal lateral view of the nose is shown.

[0184] 5.3 Pap equipment and humidifiers

[0185] Figure 3a An exploded view of a PAP device according to an example of the present technology is shown;

[0186] Figure 3b A perspective view of one form of humidifier according to the present technology is shown;

[0187] Figure 3c A schematic diagram of the pneumatic circuit of one form of PAP device according to the present technology is shown; the upstream and downstream directions are indicated.

[0188] 5.4 Patient Interface

[0189] Figure 4This is another view of a pressurization chamber according to one form of this technology;

[0190] Figure 5 It is along Figure 4 The cross-section of line 5-5;

[0191] Figure 6 From Figure 5 The enlarged detail image taken;

[0192] Figure 7 From Figure 4 A perspective view of the top of the pressurization chamber shown in the image;

[0193] Figure 8 It is along Figure 7 The cross-section of line 8-8;

[0194] Figure 9 From Figure 8 The enlarged detail image taken;

[0195] Figure 10 This is a perspective view of the front side of the pressurization chamber according to an example of this technology;

[0196] Figure 11 yes Figure 4 The view of the pressurization chamber shown in the image;

[0197] Figure 12 It is along Figure 11 The cross section taken from line 12-12;

[0198] Figure 13 From Figure 12 The enlarged detail image taken;

[0199] Figure 14 This is an enlarged cross-sectional view of the pressurized connection area;

[0200] Figure 15 yes Figure 11 The patient interface is shown in the side view.

[0201] Figure 16 It is along Figure 15 The cross section taken from line 16-16;

[0202] Figure 17 From Figure 16 The enlarged detail image taken;

[0203] Figure 18 It is a side view of the patient interface at the appropriate position on the head of the model patient, without any positioning and stabilizing structures shown.

[0204] Figure 19This is a lower view of a portion of the patient interface at an appropriate position on the head of a model patient, according to one form of the present technology. It should be noted that, for clarity, only a portion of the positioning and stabilizing structure connected to the frame is shown.

[0205] Figure 20 This is a side view of the pressurization connection area of ​​a pressurization chamber according to one form of the present technology;

[0206] Figure 21 This is a view of its upper part;

[0207] Figure 22 This is its front view;

[0208] Figure 23 This is its rear view;

[0209] Figure 24 It is its three-dimensional image;

[0210] Figure 25 It is a cross-sectional view of the area where the connecting part is connected to the frame, where the pressurization chamber is not joined to the frame.

[0211] Figure 26 It is a cross-sectional view of the area where the connecting part is connected to the frame, in which the pressurization chamber is in contact with the frame but not fully engaged.

[0212] Figure 27 It is a cross-sectional view of the area where the connecting part is connected to the frame, where the pressurization chamber and the frame are almost completely joined together, causing the retaining feature to be deflected.

[0213] Figure 28 It is a cross-sectional view of the area where the connecting part is connected to the frame, wherein the pressurization chamber is engaged with the frame but separated, such that the retaining feature is deflected.

[0214] Figure 29 It is a cross-sectional view of the area where the connecting part is connected to the frame, in which the pressurization chamber is fully engaged with the frame.

[0215] Figure 30 This is a rear-view perspective view of the patient interface according to an example of this technology, showing the removal of the pressurization chamber and the sealing structure.

[0216] Figure 31 This is a frontal perspective view of the patient interface according to an example of this technology, showing the removal of the pressurization chamber and the sealing structure.

[0217] Figure 32 This is a rear view of the patient interface according to an example of this technology, after the pressure chamber and sealing structure have been removed;

[0218] Figure 33 This is a side view of the patient interface according to an example of the present technology, showing the removal of the pressurization chamber and the sealing structure.

[0219] Figure 34 A perspective view of a patient interface according to another embodiment of the present technology is shown, illustrating the attachment of an exemplary sealing formation structure to a frame from a pressurization chamber to the patient interface;

[0220] Figure 35 A cross-sectional view of a patient interface including a mask frame, a flexible connector, and a rigid arm, according to an example of the present technology, is shown.

[0221] Figure 36 A perspective view of a patient interface including a mask frame, a flexible connector, and a rigid arm, according to an example of the present technology, is shown.

[0222] Figure 37 An exploded view of a patient interface according to an example of the present technology is shown, including a mask frame, a flexible connector, and a rigid arm.

[0223] Figure 38 A detailed view of the end of a rigid member arm according to an example of the present technology is shown;

[0224] Figure 39 A perspective view of a patient interface including a mask frame, a flexible connector, and a rigid arm, according to an example of the present technology, is shown.

[0225] Figure 40 A cross-sectional view of a patient interface including a mask frame, a flexible connector, and a rigid arm, according to an example of the present technology, is shown.

[0226] Figure 41 A perspective view of a rigid member arm according to an example of the present technology is shown;

[0227] Figure 42 A cross-sectional view of a patient interface including a mask frame, a flexible connector, and a rigid arm, according to an example of the present technology, is shown.

[0228] Figure 43 A perspective view of a patient interface including a mask frame, a flexible connector, and a rigid arm, according to an example of the present technology, is shown.

[0229] Figure 44 An exploded view of a patient interface according to an example of the present technology is shown, including a mask frame, a flexible connector, and a rigid arm.

[0230] Figure 45 A detailed view of the end of a rigid member arm according to an example of the present technology is shown;

[0231] Figure 46 A detailed view of the end of a rigid arm and a flexible joint according to an example of the present technology is shown;

[0232] Figure 47 A cross-sectional view of a rigid member arm and a mask frame according to an example of the present technology is shown;

[0233] Figure 48 A detailed cross-sectional view of a rigid member arm and mask frame according to an example of the present technology is shown;

[0234] Figure 49 A cross-sectional view of a rigid member arm and a mask frame according to an example of the present technology is shown;

[0235] Figure 50 A perspective view of a rigid arm and mask frame according to an example of the present technology is shown;

[0236] Figure 51 A detailed perspective view shows the connection between the rigid member and the mask frame according to an example of the present technology;

[0237] Figure 52 A top view of a rigid arm and mask frame according to an example of the present technology is shown, and the bending of the rigid arm in the lateral outward direction in the coronal plane is shown in dashed lines.

[0238] Figure 53 A detailed top view shows the connection between the rigid member and the mask frame according to an example of the present technology;

[0239] Figure 54 A cross-sectional perspective view of a rigid member arm and a mask frame according to an example of the present technology is shown;

[0240] Figure 55 A side view of a rigid member and mask frame according to an example of the present technology is shown, and the bending of the rigid member arm in the vertically downward direction in the sagittal plane is shown in dashed lines.

[0241] Figure 56 A front view of a rigid member arm and mask frame according to an example of the present technology is shown;

[0242] Figure 57 A perspective view of a rigid arm and mask frame according to an example of the present technology is shown;

[0243] Figure 58 A partial exploded perspective view of the rigid member arm and mask frame according to an example of the present technology is shown;

[0244] Figure 59 Detailed and partially exploded perspective views of the rigid member and mask frame according to an example of the present technology are shown;

[0245] Figure 60 A perspective view of a rigid member according to an example of the present technology is shown;

[0246] Figure 61 A view of a rigid member arm according to an example of the present technology, plotted on a grid in the XY plane, is shown;

[0247] Figure 62 A view of a rigid member arm according to an example of the present technology, plotted on a grid in the XZ plane, is shown;

[0248] Figure 63 A view of a rigid member arm according to an example of the present technology, plotted on a grid in the YZ plane, is shown;

[0249] Figure 64 A view of a rigid member arm according to an example of the present technology, plotted in three dimensions, is shown;

[0250] Figure 65 A schematic perspective view of the positioning and stabilization structure according to an example of the present technology is shown;

[0251] Figure 66 It shows along Figure 65 The cross-sectional view of the positioning and stabilizing structure taken by line 66-66;

[0252] Figure 67 A schematic side view of an exemplary rigid member arm for positioning and stabilizing a structure according to the present technology is shown;

[0253] Figure 68 A schematic perspective view of an exemplary positioning and stabilizing structure containing a rigid arm according to the present technology in a first state is shown;

[0254] Figure 69 A schematic perspective view of an exemplary positioning and stabilizing structure containing a rigid arm according to the present technology in a second state is shown;

[0255] Figure 70 A schematic perspective view of an exemplary positioning and stabilizing structure containing a rigid arm according to the present technology in a third state is shown;

[0256] Figure 71 A perspective view of an exemplary positioning and stabilization structure according to the present technology worn on a patient is shown;

[0257] Figure 72 A front view of an exemplary positioning and stabilizing structure according to the present technology is shown on a patient;

[0258] Figure 73 A side view of an exemplary positioning and stabilizing structure according to the present technology is shown on a patient;

[0259] Figure 74A perspective view of an exemplary positioning and stabilization structure according to the present technology worn on a patient is shown;

[0260] Figure 75 A front view of an exemplary positioning and stabilizing structure according to the present technology is shown on a patient;

[0261] Figure 76 A side view of an exemplary positioning and stabilizing structure according to the present technology is shown on a patient;

[0262] Figure 77 A downward perspective view of an exemplary positioning and stabilizing structure according to the present technology worn on a patient is shown;

[0263] Figure 78 A diagram showing the extension (in millimeters) of a strip of a positioning and stabilizing structure according to the present technology subjected to a certain load range (in Newtons);

[0264] Figure 79 A top view of the positioning and stabilizing structure strip of an example according to the present technology is shown at an intermediate stage of production;

[0265] Figure 80 An example of the present technology according to this technology is shown in the intermediate stage of production, along the strips of the positioning and stabilizing structure. Figure 79 The cross-sectional view taken by line 80-80;

[0266] Figure 81 A top view of the strip of the positioning and stabilizing structure according to an example of the present technology is shown;

[0267] Figure 82 A top view detail of the positioning and stabilization structure strip according to an example of this technology is shown;

[0268] Figure 83 An example of the present technology is shown along the strip of the positioning and stabilizing structure. Figure 81 The cross-sectional view taken from line 83-83;

[0269] Figures 84 to 88 A series of perspective views of the patient wear positioning and stabilization structure according to an example of the present technology are shown;

[0270] Figures 89 to 93 A series of side views of a patient-wearable positioning and stabilization structure according to an example of this technology are shown;

[0271] Figures 94 to 98 A series of front views of a patient-wearable positioning and stabilization structure according to an example of this technology are shown;

[0272] Figures 99 to 104A series of side views of a patient-wearable positioning and stabilization structure according to an example of this technology are shown;

[0273] Figures 105 to 107 A series of perspective views of an adjustable wearable patient interface according to an example of the present technology are shown;

[0274] Figures 108 to 112 A series of front views of patient adjustment positioning and stabilization structures according to an example of this technology are shown;

[0275] Figure 113 A detailed diagram shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology.

[0276] Figure 114 Another detailed view shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology;

[0277] Figure 115 Another detailed view shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology;

[0278] Figure 116 Another detailed view shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology;

[0279] Figure 117 Another detailed view shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology;

[0280] Figure 118 Another detailed view shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology;

[0281] Figure 119 A detailed diagram shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology.

[0282] Figure 120 Another detailed view shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology;

[0283] Figure 121 Another detailed view shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology;

[0284] Figure 122Another detailed view shows the connection between the strip and the rigid arm of the positioning and stabilizing structure according to an example of the present technology;

[0285] Figure 123 A detailed diagram of the crack region of the strip in the positioning and stabilization structure according to an example of this technology is shown;

[0286] Figure 124 Another detailed view of the crack region of the strip in the positioning and stabilization structure according to an example of this technology is shown;

[0287] Figure 125 Another detailed view of the crack region of the strip in the positioning and stabilization structure according to an example of this technology is shown;

[0288] Figure 126 A detailed diagram of the branching of the strip in the positioning and stabilizing structure according to an example of this technology is shown;

[0289] Figure 127 Another detailed diagram of the branching of the strips in the positioning and stabilizing structure according to an example of this technology is shown;

[0290] Figure 128 Another detailed diagram of the branching of the strips in the positioning and stabilizing structure according to an example of this technology is shown;

[0291] Figure 129 Another detailed diagram of the branching of the strips in the positioning and stabilizing structure according to an example of this technology is shown;

[0292] Figure 130 Another detailed diagram of the branching of the strips in the positioning and stabilizing structure according to an example of this technology is shown;

[0293] Figure 131 Another detailed diagram of the branching of the strips in the positioning and stabilizing structure according to an example of this technology is shown;

[0294] Figure 132 A perspective view of a positioning and stabilizing structure manufactured according to an example of this technology is shown;

[0295] Figure 133 The process of forming a positioning and stabilizing structural strip from a continuous roller according to an example of the present technology is shown;

[0296] Figure 134 A conventional example of a knitting process described according to the present technology is shown;

[0297] Figure 135 A conventional example of a knitting process described according to the present technology is shown;

[0298] Figure 136The basic warp-knitted fabric shown is an example of this technology;

[0299] Figure 137 yes Figure 136 A schematic diagram of warp-knitted fabrics;

[0300] Figure 138 The basic warp-knitted fabric shown is an example of this technology;

[0301] Figure 139 A basic weft-knitted fabric according to an example of this technology is shown;

[0302] Figure 140 This is a side view of the positioning and stabilizing structure on the patient's head, based on an example of this technique;

[0303] Figure 141 Examples of this technology are shown. Figure 140 The direction of change in the positioning and stabilizing structure's texture or grain;

[0304] Figure 142 An example of this technique is shown showing increased stretching along the direction of the weave of the knitted positioning and stabilizing structure;

[0305] Figure 143 An example of a 3D printing link for forming a positioning and stabilizing structure according to the present technology is shown;

[0306] Figure 144 Examples of 3D printing of structural components, including rigid parts and stabilizing structures, are shown according to the present technology.

[0307] Figure 145 The 3D printing of positioning and stabilizing structural strips and fixtures according to an example of this technology is shown;

[0308] Figure 146 A rear perspective view of a ventilation port for a patient interface according to the present technology is shown;

[0309] Figure 147 A rear-view perspective view of a ventilation port for a patient interface according to the present technology is shown;

[0310] Figure 148 A rear perspective view of a ventilation port for a patient interface according to the present technology is shown;

[0311] Figure 149 A side perspective view of a ventilation port for a patient interface according to the present technology is shown;

[0312] Figure 150 A side perspective view of a ventilation port for a patient interface according to the present technology is shown;

[0313] Figure 151 A side perspective view of a ventilation port for a patient interface according to the present technology is shown;

[0314] Figure 152 A top perspective view of a ventilation port for a patient interface according to the present technology is shown;

[0315] Figure 153 This is a process flow diagram describing a method for manufacturing a patient interface for treating respiratory diseases, based on an example of this technology;

[0316] Figure 154 It is a general description of what is used for execution Figure 153 A system diagram of the apparatus for the method;

[0317] Figure 155 This is a top view of the fabric at the vent portion after heat fusion, as described in the example of this technology.

[0318] Figure 156 This is an enlarged top view of the peripheral edge of the vent portion before heat fusion, based on an example of this technology;

[0319] Figure 157 This is an enlarged top view of the periphery of the vent portion after heat fusion, based on an example of this technology;

[0320] Figure 158 This is an enlarged cross-sectional side view of the peripheral edge of the vent portion before heat fusion, according to an example of this technology;

[0321] Figure 159 This is an enlarged cross-sectional side view of the peripheral edge of the vent portion after heat fusion, based on an example of this technology;

[0322] Figure 160 A short tube in an intermediate state is shown as an example according to the present technology;

[0323] Figure 161 A side view of a short tube in a compressed state according to an example of the present technology is shown;

[0324] Figure 162 A side view of a short tube in an extended state according to an example of the present technology is shown;

[0325] Figure 163 A side view of a short tube in a bent state according to an example of the present technology is shown;

[0326] Figure 164 Examples of this technology are shown, such as Figure 163 The cross-sectional view of the short tube taken along line 163-163 is shown in the figure;

[0327] Figure 165 A perspective view of a short tube in a bent and extended state according to an example of the present technology is shown;

[0328] Figure 166 This is a perspective view showing a patient interface system used on a patient in one form according to the present technology;

[0329] Figure 167 SWIFTFX described in m / s is from ResMedLimited. TM The air velocity in the vertical plane along the x and z axes of the vent of the manufactured nasal pillow mask;

[0330] Figure 168 SWIFTFX described in m / s is from ResMedLimited. TM The air velocity along the horizontal plane of the x-axis and z-axis at the vents of the manufactured nasal pillow mask;

[0331] Figure 169 This description comes from ResMedLimited's SWIFTFX. TM The vertical plane signals along the x and z axes of the ventilation holes of the manufactured nasal pillow mask;

[0332] Figure 170 This description comes from ResMedLimited's SWIFTFX. TM The horizontal plane signals along the x and z axes of the ventilation holes of the manufactured nasal pillow mask;

[0333] Figure 171 It is a graph, in one form according to this technology, describing the vertical plane air velocity from the ventilation port of the patient interface system in m / s along the x and z axes;

[0334] Figure 172 It is a graph, according to one form of this technology, describing the horizontal plane air velocity from the ventilation port of the patient interface system in m / s along the x and y axes;

[0335] Figure 173 It is a graph, according to one form of this technology, describing the vertical plane signal from the ventilation port of the patient interface system along the x and y axes;

[0336] Figure 174 It is a graph, according to one form of this technology, describing the horizontal plane signal from the ventilation port of the patient interface system along the x and y axes;

[0337] Figure 175 The comparison is based on SWIFTFX manufactured by ResMed Ltd. TMA graph showing the distance (in m / s) between the air vent of the nasal pillow mask and the air vent of a patient interface system according to the present technology at a rate (in m / s) along the air vent axis.

[0338] Figure 176 This is a bottom perspective view of a reinforcing portion folded above the end of a strip in a positioning and stabilizing structure, according to one form of this technology.

[0339] Figure 177 This is a top plan view of a reinforcing portion folded above the end of a strip in a positioning and stabilizing structure, according to one form of this technology.

[0340] Figure 178 This is a side perspective view of a reinforcing portion folded above the end of a strip in a positioning and stabilizing structure, according to one embodiment of this technology.

[0341] Figure 179 This is a plan view of a reinforcing portion folded above the end of a strip in a positioning and stabilizing structure, according to one form of this technology;

[0342] Figure 180 yes Figure 179 A magnified view;

[0343] Figure 181 yes Figure 177 A magnified view;

[0344] Figures 182 to 184 The present invention illustrates a series of steps for removing a strip from a rigid arm of a positioning and stabilizing structure according to one form of the present technology;

[0345] Figures 185 to 186 The present invention illustrates a series of steps for attaching a strip to a rigid arm of a positioning and stabilizing structure according to one form of the present technology;

[0346] Figure 187 This is a side plan view of a rigid arm of a positioning and stabilizing structure according to the present technology, showing a form of visual indicator;

[0347] Figure 188 This is a side plan view of a rigid arm of a positioning and stabilizing structure according to the present technology, showing a form of visual indicator;

[0348] Figure 189 This is a front view of a frame and rigid arm of a form according to the present technology, showing a visual and tactile indicator;

[0349] Figure 190 This is a top plan view showing a form of sealed structure for a visual indicator according to the present technology;

[0350] Figure 191This is a rear view plan showing a form of sealed formation structure of a visual indicator according to the present technology;

[0351] Figure 192 This is a top perspective view showing a form of sealed structure for a visual indicator according to the present technology;

[0352] Figure 193 Through Figure 192 The cross-sectional view taken from line 193-193;

[0353] Figure 194 Through Figure 192 The cross-sectional view taken from line 194-194;

[0354] Figure 195 This is a rear view plan of a frame according to one form of this technology;

[0355] Figure 196 This is a top plan view of a frame according to one form of this technology;

[0356] Figure 197 This is a rear-view perspective view of a frame according to one form of this technology;

[0357] Figure 198 This is a side view of a frame according to one form of the present technology;

[0358] Figure 199 This is a rear view plan of the retaining structure of the pressurized connection area according to one form of the present technology;

[0359] Figure 200 This is a bottom plan view of the retaining structure of the pressurized connection area according to one form of this technology;

[0360] Figure 201 This is a rear perspective view of the retaining structure of the pressurized connection area according to one form of the present technology;

[0361] Figure 202 This is a side plan view of the retaining structure of the pressurized connection area according to one form of the present technology;

[0362] Figures 203 to 207 The illustration shows a form of tube extended by 30 mm, 60 mm, 90 mm, and 120 mm according to the present technology, with the lower end of the tube held in a fixed position and its longitudinal axis perpendicular to the direction of extension before the extension begins;

[0363] Figures 208 to 212 ResMed was shown TM SwiftFX TMThe nasal pillow mask tube extends by 30mm, 60mm, 90mm, and 120mm, with the lower end of the tube held in a fixed position, and its longitudinal axis perpendicular to the direction of extension before extension begins.

[0364] Figures 213 to 217 Philips was shown TM Respironics TM GoLife TM The nasal pillow mask tube extends by 30mm, 60mm, 90mm, and 120mm, with the lower end of the tube held in a fixed position, and its longitudinal axis perpendicular to the direction of extension before extension begins.

[0365] Figures 218 to 222 Philips was shown TM Respironics TM Wisp TM The nasal mask tube extends by 30mm, 60mm, 90mm, and 120mm, with the lower end of the tube held in a fixed position, its longitudinal axis perpendicular to the direction of extension before extension begins. Detailed Implementation

[0366] Before describing the technology of the present invention in more detail, it should be understood that the technology can vary and is not limited to the specific examples described herein. It should also be understood that the terminology used in this disclosure is for illustrative purposes only and is not intended to be limiting.

[0367] 6.1 Treatment System

[0368] In one form, the technology of the present invention includes a device for treating respiratory disorders. For example... Figure 1a As shown, the device may include an airflow generator or blower for supplying pressurized breathing gas, such as air, to the patient 1000 via an air circuit 4170 leading to the patient interface 3000.

[0369] 6.2 Therapy

[0370] In one form, the technology of the present invention includes a method for treating respiratory disorders, the method comprising the step of applying positive pressure to the inlet of the airway of a patient 1000.

[0371] 6.2.1 Nasal CPAP for OSA

[0372] In one form, the technology of the present invention includes a method for treating obstructive sleep apnea in a patient by applying continuous positive airway pressure through the nose.

[0373] 6.3 Patient Interface 3000

[0374] Reference Figure 166 According to one embodiment of the technology of the present invention, a non-invasive patient interface 3000 includes the following functional features: a sealing formation structure 3100 (see...) Figure 4 The system includes a pressurization chamber 3200, a positioning and stabilizing structure 3300, and a connection port 3600 for connecting to the air circuit 4170 via a short conduit 4180. In some forms, the functional aspect may be provided by one or more physical components. In some forms, a single physical component may provide one or more functional aspects. In use, the sealing forming structure 3100 is arranged around the inlet to the patient's airway 1000 to facilitate the supply of air to the airway at positive pressure.

[0375] 6.3.1 Sealing Formation Structure 3100

[0376] In one form of the technology of the present invention, the sealing forming structure 3100 provides a sealing forming surface and may additionally provide a gasket function.

[0377] The seal-forming structure 3100 according to this disclosure can be made of a soft, flexible, elastic material such as silicone. The seal-forming structure 3100 can form part of a sealed path for air from the PAP device to be delivered to the patient's nostrils.

[0378] Reference Figure 9 In one form of the invention, the sealing structure 3100 may include a sealing flange 3110 and a support flange 3120. The sealing flange 3110 may include a relatively thin member having a thickness of less than about 1 mm, for example, from about 0.25 mm to about 0.45 mm. The support flange 3120 may be relatively thicker than the sealing flange 3110. The support flange 3120 is or includes a spring-like element and is used to support the sealing flange 3110 from bending during use. In use, the sealing flange 3110 can readily respond to system pressure acting on the bottom surface of the pressure chamber 3200 to advance the sealing flange 3110 into a tight seal with, for example, the face of a patient's nose. The pressure chamber 3200 is made of a soft material, for example, silicone.

[0379] 6.3.1.1 Nasal pillow

[0380] In one form of the technology of the present invention, the sealing structure 3100 of the non-invasive patient interface 3000 includes a pair of nasal sprays or nasal pillows 3130, each nasal spray or nasal pillow being constructed and arranged to form a seal with the corresponding nostril of the patient's nose, for example, forming a seal against the periphery of the patient's nostril.

[0381] According to one aspect of the invention, a nose pillow 3130 ( Figure 9 The device includes: a truncated cone 3140, at least a portion of which forms a seal on the underside of the patient's nose, such as the truncated cone portion; and a handle 3150, an upper flexible region 3142 on the underside of the truncated cone 3140 and connecting the truncated cone to the handle 3150. Furthermore, the structure to which the nasal pillow 3130 of this technology is connected includes a lower flexible region 3152 adjacent to the base of the handle 3150. The upper flexible region 3142 and the lower flexible region 3152 can act together to facilitate a universal joint structure for adjusting the relative movement of both the displacement and angle of the truncated cone 3140 and the structure to which the nasal pillow 3130 is connected. In one example, the truncated cone 3140 may be coaxial with the handle 3140 to which it is connected. In another example, the truncated cone 3140 and the handle 3150 may not be coaxial (e.g., offset). The nasal pillow 3130 can be adjusted and / or shaped such that the nasal pillow extends laterally beyond the wall of the pressurization chamber 3200 discussed below.

[0382] In one form of this technology, each handle 3150 may include variable stiffness to prevent the nasal pillow 3130 from vibrating forward during use due to compression and / or bending of the handle 3150. For example, the side of the handle away from the patient's face during use may be stiffer than the area of ​​the handle 3150 closer to the patient's face. In other words, if the compression or bending of the handle 3150 is not in a predetermined direction, the different material stiffness on the opposite side of the handle 3150 presents greater resistance. This allows the pillow 3130 to be compressed more evenly onto the nostrils by preventing the pillow 3130 from vibrating forward. This arrangement may help prevent bending of the handle 3150 that would cause the nasal pillow 3130 to vibrate forward. Variable stiffness can also be used to provide a weakness that promotes vibration, allowing the handle 3150 to bend in a desired direction. In other words, uniform compression of the nasal pillow 3130 can be achieved. This arrangement may also allow for a sealing force positioned at the top of the nasal pillow 3130. Furthermore, this arrangement may also allow for any deformation of the nasal pillow 3130 during use. When required to rest against the patient's face, the nasal pillow 3130 can also be formed to compress against the pressure chamber, and because the nasal pillow 3130 may be wider laterally than the pressure chamber 3200, no portion of the pressure chamber 3200 extends beyond the pillow 3130. In another example, when compressed, the pillow 3130 can be shaped and / or designed such that the edge of the nasal pillow 3130 is generally flush with the edge of the pressure chamber 3200. In another example of this technology, the handle 3150 may be thinnest at the base of the truncated cone 3140.

[0383] In one example, to engage the pillow 3130 with the entrance to the patient's airway, the pillow 3130 is positioned at the entrance to the nostril. When the positioning and stabilizing structure 3300 is adjusted, tension begins to push the pillow 3130 into the nostril. Continued insertion of the pillow 3130 into the nostril causes the base of the pillow 3130, via the handle 3150, to collapse via a trampoline 3131 moving towards the upper surface of the pressurization chamber 3200. The handle 3150 of the nasal pillow 3130 may be connected to the pressurization chamber and include a thinned or reduced-thickness portion. The thinned portion allows the pillow 3130 to easily break or collapse, and thus adjusts the wing angle to better suit the patient 1000. The trampoline 3131 may be formed with an angle away from the bottom of the pillow 3130 or the patient 1000's diaphragm and / or upper lip. This improves the comfort and stability of the patient interface device 3000.

[0384] It is also envisioned that various sizes of nasal pillows 3130 can be used with pressure chambers having common-sized connection areas and pressure-boosting connection areas. This facilitates allowing patients to conform to the pressure chamber 3200 and pillow 3130, the sizes of which are designed to optimally match the patient's specific skeletal structure, such as the size and orientation of the nostrils.

[0385] In one form of this technology, the sealing structure 3100 at least partially forms a seal on the columellar region of the patient's nose.

[0386] 6.3.1.2 Nasal Liner

[0387] Although a small portion of the nasal pillow 3130 can enter the nose during use, the replaceable form of the sealing structure 3100 is essentially external to the nose during use. Figure 34 In one form of the present technology shown, the sealing formation structure 3100 of the non-invasive patient interface 3000 is constructed and arranged to form a seal against the patient's airway surrounding the two nostrils without being partially located inside the nose. The sealing formation structure 3100 can act on both nostrils using a single throttling orifice, such as a nasal pad or nasal support. Figure 34 In the example, the sealing forming structure 3100 includes a nose flange 3101 arranged around its edge. The view also indicates the attachment of the pressurization chamber 3200 and the sealing forming structure 3100 to the frame 3310.

[0388] 6.3.2 Pressure chamber 3200

[0389] In one embodiment of the invention, the pressurization chamber 3200 serves to allow airflow between the two nostrils and the air supply from the PAP device 4000 via a short conduit 4180. The short conduit 4180 is typically a portion of the air circuit 4170 connected to the frame 3310 via a connection port 3600, and a longer conduit (an additional gas delivery conduit) 4178 is connected to the PAP device 4000. In this approach, the pressurization chamber 3200 may alternatively serve as an inlet manifold during the inspiratory portion of the respiratory cycle and / or an outlet manifold during the expiratory portion of the respiratory cycle.

[0390] The pressurization chamber 3200 can be constructed from elastic materials.

[0391] According to another embodiment of the invention, the pressurization chamber 3200 provides a liner function between the sealing forming structure 3100 and the positioning and stabilizing structure 3300.

[0392] However, in one form of the pressurization chamber 3200, the inlet / outlet manifold and gasket functions are performed by the same physical components, while in alternative forms of the present invention, they are formed by two or more components.

[0393] The sealing structure 3100 and the pressurization chamber 3200 can be formed, for example, by molding into a single, uniform component.

[0394] The pressurization chamber 3200 includes a forearm 3210 and a rear wall 3220.

[0395] The rear wall 3220 includes the rear surface 3222 (see Figure 8 In one form of this technology, the sealing structure 3100 is constructed and arranged relative to the posterior wall 3220 such that the posterior surface 3222 is separated from the patient's septum and / or upper lip during use, as... Figure 18 and Figure 19 As can be seen. In one form, for example, when the sealing structure 3100 includes a nasal pillow 3130, this is achieved by arranging a posterior wall 3220 such that a posterior surface 3222 precedes the last portion 3130.1 of the nasal pillow 3130, as shown in the figure. This arrangement can also focus the sealing force on the nostrils of the patient 1000 by releasing the septum and / or upper lip from contact with the patient interface 3000.

[0396] The pressurization chamber 3200 also includes a contraction zone 3230. Figure 9This forms a connection with the sealing structure 3100. The contraction region 3230 can be a region different from the forearm 3210 and / or the posterior wall 3220. Alternatively, some or all of the corresponding forearm 3210 and posterior wall 3220 can form part of the contraction region 3230. In one form of the present art in which the sealing structure 3100 includes corresponding left and right nasal occipitals 3130, there are corresponding left contraction regions 3232 and right contraction regions 3234 respectively. Figure 4 The contraction regions 3230, 3232, and 3234 are constructed and arranged to bend and / or contract in response to forces encountered during use of the patient interface 3000, such as tube resistance or movement of the patient's head, such as pushing against a bed pillow against the patient interface 3000. The contraction region 3230, the left contraction region 3232, and / or the right contraction region 3234 can be formed, for example, of silicone rubber having an A-type indentation hardness in the range of approximately 35 to approximately 45. However, a wider range is possible if the thickness of these walls 3210 and 3220 is adjusted accordingly to obtain a similar force level.

[0397] According to what can be Figure 4 , Figure 7 , Figure 8 , Figure 10 and Figure 11 Another aspect of this technology, as seen in the diagram, is that the pressurization chamber 3200 has a saddle-shaped region or decoupling region 3236. For example, it can be seen that... Figure 4As seen in the diagram, the contraction region 3230 may include a decoupling region 3236 that may be located between the left contraction region 3232 and the right contraction region 3234. The decoupling region 3236 may be concave and may extend from the forearm 3210 to the posterior wall 3220. By forming a pressure chamber 3200 with said decoupling region 3236, the left contraction region 3232 and the right contraction region 3234 can be decoupled such that movement of one of the contraction regions substantially does not affect the other contraction regions. In other words, deformation and / or bending of the left contraction region 3232 may not result in damage to the right contraction region and vice versa. Advantageously, this may also allow the nasal pillow 3130 associated with the undamaged contraction region to remain in situ on the corresponding nostril of the patient, despite resulting in damage to the other contraction regions. Contact with the septum can be avoided by the decoupling region 3236 recessed between the stems 3150. Furthermore, the decoupling region 3236 may be the thinnest region of the pressure chamber 3200 to allow for a desired amount of flexibility in that region. Alternatively, the decoupling region 3236 can be the final region of the pressurization chamber 3200. By providing a deep curve in the saddle region 3236, septum and / or upper lip contact can be minimized or avoided to improve patient comfort. The saddle region 3236 can be U-shaped or V-shaped and has a nasolabial angle of approximately 70° to approximately 120° at its apex. The saddle region 3236 can have a depth of approximately 0.5 mm to approximately 2.5 mm to provide clearance around the patient's septum.

[0398] The posterior wall 3220 can be positioned adjacent to the upper or upper lip of the patient during the use of the patient interface 3000, such as... Figure 18 and Figure 19 As shown.

[0399] In one configuration, the pressure chamber 3200 may further include a sealing lip 3250. Figure 6 The sealing lip 3250 may be constructed from a flexible, elastic material, such as silicone rubber having a type A hardness in the range of about 30 to about 50, to form a relatively soft component. The sealing lip 3250 may be located on the inner surface or inner periphery of the pressure chamber 3200, or on the entire inner peripheral region of the pressure chamber 3200, or formed as part of the inner surface or inner periphery of the pressure chamber 3200, or formed as part of the entire inner peripheral region of the pressure chamber 3200, such as... Figure 5 , Figure 6 as well as Figure 8As shown. However, it should be anticipated that the sealing lip 3250 may be disposed around the outer surface or outer periphery of the pressure chamber 3200, or around the entire outer periphery of the pressure chamber 3200. The sealing lip 3250 may form a pneumatic seal between the pressure chamber 3200 and the frame 3310, as will be described in more detail below. The sealing lip 3250 and the pressure chamber 3200 may also comprise an integral part. Other patient interface devices form a pneumatic seal between the pressure chamber and the frame using a compression seal to compress the pressure chamber, made of an elastically deformable material such as silicone, thereby engaging the pressure chamber to the frame and simultaneously forming a pneumatic seal. In contrast, in one embodiment of the technology of the present invention, a pneumatic seal is formed when the pressure chamber 3200 is initially secured to the frame 3310 by preventing the sealing lip 3250 from deflecting against the frame 3310. When the pressure within the pressurization chamber 3200 increases above air pressure for treating respiratory distress, the pneumatic seal is enhanced and the sealing force increases because a greater force is used relative to the frame 3310 to advance the sealing lip 3250. The air pressure within the liner assembly / pressurization chamber of these other patient interface devices does not affect the sealing force between the liner assembly and the frame. Furthermore, these other patient interface devices have soft liner with sidewalls for engaging with the frame and sealing lip because they are soft, non-rigid, and can be stretched or bent elastically with minimal effort, readily adapting to finger pressure. Specifically, the relatively large size and aspect ratio of the nasal liner contribute to its softness. The sidewalls for frame engagement are so soft that opposite sides of the liner can contract together and contact each other with minimal finger force. This easy sidewall deformation for frame engagement can be a significant advantage for patients with hand arthritis, where the liner could be difficult to quickly attach to the frame in other patient interfaces. It should be understood that by forming the pressure chamber 3200 with sufficient rigidity as described above, the stability of the seal produced by the sealing structure can be improved. Furthermore, the thickness of the pressure chamber 3200 can be varied so that the thickness becomes thinner from the pressure-connecting region 3240 to the sealing structure 3100. In one example of the present invention, the pressure chamber 3200 is approximately 2 mm to 3 mm thick near or at the pressure-connecting region 3240, 1 mm thick at the point between the pressure-connecting region 3240 and the sealing structure 3100, and 0.75 mm thick near or at the sealing structure 3100. The pressure chamber 3200 with these features can be manufactured by injection molding. The gradual reduction in the thickness of the pressure chamber 3200 results in greater deformation of the silicone material closer to the handle 3150 and the patient's nose, thereby enhancing comfort and reducing the possibility of seal interference. The sealing lip 3250 can be constructed from a flexible, elastic material, such as silicone rubber having a type A hardness in the range of about 30 to about 50, to form a relatively soft component.

[0400] Some nasal pillow patient interfaces have the following assembly sequence: (i) a pressure chamber, (ii) a headband connection, and (iii) a sealing structure. In contrast, one example of the patient interface 3000 of the present invention has the following assembly sequence: (i) a headband connection, (ii) a pressure chamber, and (iii) a sealing structure. This difference in arrangement means that headband tension will not cause deformation of the pressure chamber 3200 and the sealing structure 3100, which could potentially disrupt the sealing force.

[0401] 6.3.3 Framework 3310

[0402] like Figure 4 , Figure 10 , Figure 75 , Figure 76 and Figure 166 As shown, frame 3310 serves as a central hub, and short conduit 4180, pressurization chamber 3200, and positioning and stabilization structure 3300 are connected to the central hub in a removable or more permanent manner.

[0403] also, Figures 31 to 33 Various views of a frame 3310 connected via a flexible joint 3305 to a positioning and stabilizing structure 3300 having a strip 3301 are also shown. These views show the frame 3310 without the pressurization chamber 3200 and the sealing formation structure 3100. The connection port 3600 and the vent 3400, both of which can be arranged on the frame 3310, are described in more detail below.

[0404] In one example of this technology, frame 3310 may be formed of polypropylene.

[0405] In another example of this technology, as described herein, the frame 3310 may be made in one size, but the common-sized connection features that can be attached to the pressurization chamber 3200 and the sealing forming structure 3100 of the single frame may be made in multiple sizes.

[0406] In this example of the technique, frame 3310 can be molded without any undercut, so that it can be molded and then removed from the molding tool without bending.

[0407] 6.3.4 Connection between the pressurization chamber and the frame

[0408] In one embodiment of this technology, the pressure chamber 3200 is removably attached to the frame 3310, for example, to facilitate cleaning or to allow for modification of the seal-forming structure 3100 to different sizes. This allows the pressure chamber 3200 to be cleaned and cleaned more frequently than the frame 3310 and the short conduit 4180. Furthermore, it allows the pressure chamber 3200 to be cleaned and cleaned independently of the strip 3301. In an alternative embodiment, the pressure chamber 3200 is not easily removed from the frame 3310.

[0409] The pressurization chamber 3200 may include a pressurization connection area 3240 (see Figure 6 The shape and / or construction of the retaining structure 3242 of the pressurized connection region 3240 is complementary to the shape and / or construction of the corresponding frame connection region 3312 (see...). Figure 10 The retaining structure 3242 of the pressurization chamber 3200 is more rigid than other parts of the pressurization chamber 3200 and can be made of the same material as the frame 3310, for example, polypropylene or polyamide. In other examples, the pressurized connection area 3240 may be made of nylon, and the frame 3310 may be made of polypropylene. Nylon, polyamide, and polypropylene are not soft materials and do not readily adapt to finger pressure. Therefore, when they are joined together, there is an audible clicking sound and a hard-to-hard connection. Figures 20 to 24 The shape of the retaining structure 3242 is depicted in the form of a parabolic or hyperbolic cylinder. The retaining structure 3242 is neither elongated nor stretched so as to maintain its approximate shape when engaged with and separated from the frame 3310. The shape of the retaining structure 3242 allows for a slight degree of bending, but not enough to cause the two opposite sides of the retaining structure 3242 to come into contact with each other when pinched together with finger pressure. In other words, the two opposite sides of the retaining structure 3242 can only come into contact with each other under significant contractile force applied by the patient 1000, which would not occur under normal treatment conditions. In the example shown, using the same amount of contractile force, the bottom and top edges of the retaining structure 3242 can come closer together / are more easily contracted together than the side edges of the retaining structure 3243. (See...) Figure 18As seen in the diagram, the curvature of the frame 3310 and the retaining structure 3242 is designed to follow the natural curvature of the patient's upper lip and prevent contact pressure from accumulating at any particular point on the patient's upper lip, ensuring that the contact pressure from the headband tension is evenly distributed across the patient's upper lip. This minimizes or eliminates skin deterioration caused by prolonged accumulation of contact pressure. Another advantage of the curvature is that the pressure chamber 3200 requires less material compared to a flat frame. A flat frame would require more material at the side edges of the pressure chamber 3200 to conform to the patient's upper lip. Less material results in a reduction in the overall weight of the patient interface 3000. Furthermore, the curvature also reduces any protrusion of the patient interface 3000 from the patient's face in the anterior direction, improving the invisibility of the patient interface 3000. Additionally, according to one example of the present technology, after molding, the retaining structure 3242 can be bonded (e.g., using an adhesive) to the pressure chamber 3200. In another example, intact chemical bonds (molecular attachment) can be used between retaining structure 3242 and pressurization chamber 3200.

[0410] In one example of this technology, the retaining structure 3242 can be molded without any undercut, allowing it to be molded without deflection and then removed from the mold. The retaining structure 3242 has a continuous peripheral edge on its front side that contacts the frame 3310. This continuous peripheral edge is exposed so that it contacts the frame 3310 in a hard-to-hard engagement manner. This contrasts with most soft-to-hard connections, where, in some existing face masks, a front lip portion of the seal-forming structure covers and overlaps most of the detachable rigid retaining structure. The front lip portion is formed by LSR and wraps around the retaining structure to hold it together. However, in such existing face masks, it is difficult and troublesome to wrap the front lip portion with a detachable clip, and the clip may misalign, subsequently causing the seal-forming structure to fail to attach to the frame.

[0411] One purpose of retaining structure 3242 is to align pressurization chamber 3200 when it engages with frame 3310, because the shape of retaining structure 3242 of pressurization chamber 3200 (possibly at different depths) is held within the space defined between obstruction portion 3314 of frame 3310 and frame connection area 3312. Figure 29 ).

[0412] Another objective of retaining structure 3242 is to retain pressurizing chamber 3200 to frame 3310 by preventing relative lateral and relative longitudinal movement between pressurizing chamber 3200 and frame 3310. Pressurizing connection region 3240 may include at least one retaining feature 3244, and at least one complementary frame connection region 3312 may be present. Pressurizing connection region 3240 may include one or more retaining features 3244 (…). Figure 10 In addition to preventing relative lateral and longitudinal movement between the pressurization chamber 3200 and the frame 3310, another purpose of retaining feature 3244 is to prevent relative longitudinal movement between the two components. The remainder of the pressurization chamber 3200 may include a material that is more flexible than the retaining structure 3242 and the pressurization connection area 3240.

[0413] In one form, the pressurization connection region 3240 is constructed of a rigid or semi-rigid material (e.g., high-hardness silicone or TPE, plastic, nylon, high-temperature resistant materials, polypropylene, and / or polycarbonate). The pressurization connection region 3240 may be constructed of a material different from other parts of the pressurization chamber 3200. For example, the pressurization connection region 3240 may be the connection portion 3202 of the pressurization chamber 3200. Figure 10 (Permanently connected, integrally integrated, or mechanically interlocked independent components.) Go to Figure 6 The connecting portion 3202 of the pressurization chamber 3200 may have approximately the same thickness as the retaining structure 3242 of the pressurization connection region 3240. The pressurization connection region 3240 may include a tongue 3211, which is constructed and arranged to be received by a channel portion 3211.1 (e.g., a channel portion of the frame 3310). In this way, the channel portion 3211.1 may form a mating feature for the tongue 3211, and vice versa. In addition, the tongue 3211 and the channel portion 3211.1 may be dimensioned to maximize the sealing surface area in this region.

[0414] 6.3.4.1.1 Attachment of the pressurization chamber to the frame and removal from the frame

[0415] The pressurization chamber 3200 can be fixedly attached to the frame 3310, but it can also be removably attached to the frame 3310. Figure 12 A pressurized chamber 3200 is shown in its connection position relative to frame 3310. In this example, the pressurized connection region 3240 includes only two retaining features 3244 located on opposite sides of the connection region 3240, such as the rear and front sides. Figure 12 and Figure 13 The cross-section through the two hook-shaped portions 3246 is shown, while Figure 17Another cross-section is shown where the hook portion 3246 is absent, forming, for example, a channel or groove 3211.1. The resilient hook portion 3246 is a type of snap-fit ​​member that provides high holding force (to prevent accidental separation) and also allows for relatively easy intentional removal. Figure 17 In this configuration, the pressurized connection region 3240 and the frame 3310 are simply assembled together using a tongue-and-groove method. The frame 3310 and the retaining structure 3242 can be shaped such that the tongue 3211 engages with the channel portion 3211.1 before the retaining features 3244, 3245 engage with the frame 3310. This facilitates the alignment of the retaining features 3244, 3245 for connection.

[0416] Each retained feature 3244 may take the form of a hook-shaped portion 3246 having a front surface 3246.1 and a rear surface 3246.2. Figure 6 and Figure 13 The front surface 3246.1 is adapted to engage with the introduction surface 3312.1 of the frame connection region 3312 of the frame 3310 when the pressurization chamber 3200 and the frame 3310 are moved to engagement. The retaining feature 3244 deforms when pushed into place. Additionally, the upper and lower regions of the frame connection region 3312 of the frame 3310 and the obstruction portion 3314 may also deform slightly. Furthermore, the retaining structure 3242 may also deform slightly, particularly near the retaining feature 3244 (e.g., see...). Figure 27 and Figure 28 (The dotted line in the middle). Go to Figures 195 to 198 The deformation of the frame connection region 3312 and the obstruction portion 3314 of the frame 3310 is controlled by using ribs 3294, based on the allowable amount of deformation and the area where deformation occurs. In one example of this technology, four ribs 3294 are spaced apart around and adjacent to the obstruction portion 3314, but more or fewer ribs are also possible. The ribs 3294 limit the area of ​​deformation of the obstruction portion 3314 to only the area close to the reserved features 3244, 3245. The ribs 3294 can also abut against the inner surface of the pressurization connection region 3240 and resist its deformation to provide a stronger engagement between the pressurization connection region 3240 and the frame connection region 3312 at these contact points when the pressurization chamber 3200 engages with the frame 3310. (Go to...) Figures 199 to 202 The pressurization connection area 3240 of the pressurization chamber 3200 may have a notch 3295 to correspond to the rib 3294. The notch 3295 is a bevel to minimize friction between the pressurization connection area 3240 and the rib 3294 during assembly of the pressurization chamber 3200 and the frame 3310. Once the hook 3246 is pushed a sufficient amount, the hook 3246 snaps outward in a radial direction, so that the hook 3246 presents... Figure 13The held position is shown. This locking action results in an audible sound (e.g., a reassuring click) to provide feedback to the user or patient that a correct connection has been established. In the held position, the rear surface 3246.2 of the hook portion 3246 engages with the holding surface 3312.2 of the frame connection area 3312, as shown. Figure 13 As shown. In one example of this technology, the reassuring click is achieved by forming a sufficiently rigid pressurized connection region 3240 (the rigidity being greatest in the vicinity of the pressurized connection region 3240). This rigidity can be achieved through overmolding manufacturing.

[0417] If available Figure 13 As seen in the diagram, the surfaces of the frame connection region 3312 and the hook portion 3246 are angled in a certain way to facilitate a sliding connection between the pressurization chamber 3200 and the frame 3310. For example, as described above, the front surface 3246.1 and the introduction surface 3312.1 can be formed at corresponding angles to each other, such that these angles toward the surfaces can be relatively easily slidably engaged with each other. Similarly, the rear surface 3246.2 and the retaining surface 3312.2 can be angled relative to each other to facilitate a one-time connection between the frame 3310 and the pressurization chamber 3200. The angle between the rear surface 3246.2 and the retaining surface 3312.2 is chosen such that a tensile force, for example, applied approximately along the axis of the sealing forming structure 3100, is sufficient to cause the hook portion 3246 to bend inward, thereby releasing the pressurization chamber 3200 from the frame 3310. This tensile force does not require the patient 1000 to first deflect the hook portion 3246 radially inward, for example, by squeezing the pressurization chamber 3200 in the anterior-posterior direction. Conversely, due to the angle involved, the radial deflection of the hook portion 3246 occurs only as a result of the applied axial tensile force. In one example of this technology, the deflection of the pressurization connection region 3240 and the disengagement of the pressurization chamber 3200 from the frame 3310 are both performed by contracting the pressurization chamber 3200 (e.g., squeezing the pressurization chamber 3200 in its lateral dimensions (left and right)) and pulling the pressurization chamber 3200 away from the frame 3310.

[0418] If available Figure 13As seen in the view, the pressure chamber 3200 is attached to the frame 3310 via the pressure connection region 3240 and the retaining feature 3244 engages the frame connection region 3312 via the hook portion 3246. Also shown in this view, the retaining surface 3312.2 of the frame connection region 3312 and the rear surface 3246.2 of the hook portion 3246 engage with each other and are flush. For a patient to separate the pressure chamber 3200 from the frame 3310, the patient 1000 must pull the pressure chamber 3200 with sufficient force relative to the frame 3310 to overcome the resistance of the retaining surface 3312.2 relative to the rear surface 3246.2. In one example of this technology, contraction of the pressure chamber 3200 reduces the axial pulling force required to separate the pressure chamber 3200 from the frame 3310. This resistance can be “tuned” or selectively adjusted to a desired level by changing the angle at which these surfaces 3312.2, 3246.2 engage with each other. The closer the direction of the force applied by the patient 1000 to separate the pressurization chamber 3200 from the frame 3310 is to the perpendicularity of these surfaces 3312.2, 3246.2, the greater the force required to achieve separation. Figure 14 This angle is shown as β, where the rear surface 3246.2 is angled relative to the nominal vertical axis 3246.4 (corresponding to the axial pulling direction from the pressurization chamber 3200 to the frame 3310). As β increases, the force required to separate the pressurization chamber 3200 from the frame 3310 increases. Furthermore, as β increases, separation will feel more abrupt to the patient 1000. In one example, an angle β of approximately 75 degrees has been found to produce a comfortable feeling of separation for the patient. In further examples, β can vary from 30 degrees to 110 degrees, or from 40 degrees to 90 degrees, or from 65 degrees to 85 degrees to produce an ideal level of resistance for separation. This has been chosen to minimize the possibility of accidental separation and to allow only intentional separation by the patient 1000.

[0419] The angle α between the nominal longitudinal axis 3246.4 and the front surface 3246.1 can also be “tuned” or selectively adjusted to meet a specific level of force when the patient 1000 attaches the pressure chamber 3200 to the frame 3310. As angle α increases, the force required to engage the retaining feature 3244 with the frame connection region 3312 increases, and the attachment sensation for the patient engaging these components 3244, 3312 becomes more abrupt. In other words, as the front surface 3246.1 of the retaining feature 3244 slides along the introduction surface 3312.1 of the frame connection region 3312, the patient 1000 may experience a smoother engagement sensation as angle α decreases. In one example, an angle α of approximately 30 degrees has been found to produce a comfortable attachment sensation for the patient 1000. In further examples, angle α can vary from 50 degrees to 70 degrees or from 15 degrees to 60 degrees to produce an ideal level of resistance for attachment.

[0420] Furthermore, since the sensation and force of engagement and disengagement between the pressure chamber 3200 and the frame connection area 3312 can be tuned or selectively adjusted independently of each other, angles α and β can be selected to make the patient feel a different level of resistance to engagement than to disengagement. In one example of this technique, angles α and β can be selected such that angle β is greater than angle α, so that the patient feels less resistance to the attachment of the pressure chamber 3200 and the frame 3310 than to the resistance to disengagement. In other words, the patient 1000 may find it more difficult to disconnect the frame 3310 from the pressure chamber 3200 than to connect them.

[0421] If available Figure 4 As seen in the view, one example of this technology includes a pair of retaining features 3244, 3245. Also shown in this view, the exemplary retaining features 3244, 3245 are of different dimensions. In particular, this view shows that the retaining feature 3245 disposed on the lower portion of the pressurization connection region 3240 is narrower than the retaining feature 3244 disposed on the upper portion of the pressurization connection region 3240. By forming the retaining features 3244, 3245 with different dimensions, the patient 1000 is able to attach the pressurization chamber 3240 to the frame 3310 in only one orientation and prevent misalignment. This arrangement is shown in Figure 10 This avoids patient frustration during attachment, minimizes potential damage to the patient interface 3000 from incorrect attachment, ensures the seal-forming structure 3100 is correctly oriented to provide an appropriate seal relative to the patient's airway, and provides comfort by reducing or avoiding concentration of contact forces, especially at the upper lip of the patient 1000.

[0422] exist Figure 10In the diagram, two frame connection regions 3312 and 3313 are shown engaging with corresponding retention features 3244 and 3245. In the example shown here, the narrower front retention feature 3245 is sized to correspond to the narrower front frame connection region 3313. Furthermore, the wider rear retention feature 3244 engages with the correspondingly sized rear frame connection region 3312. This arrangement has the advantage that, where the size of a retention feature is uniquely designed to engage with a correspondingly uniquely sized frame connection region, the patient will only be able to attach the pressurization chamber 3240 to the frame 3310 in one orientation. By limiting the orientation of attachment, improper assembly of the patient interface 3000 by the patient 1000 and receiving suboptimal treatment due to improperly assembled patient interface 3000 are prevented. The arrangement described relative to this particular example of the technology is advantageous to the patient 1000 in order to address the situation where, due to vision problems or the patient 1000 may have difficulty seeing how to properly engage the components while assembling the patient interface 3000 in a dark room (e.g., in the bedroom before going to sleep), the patient 1000 cannot fully assemble the patient interface 3000 if the components are not properly aligned.

[0423] As described above, the angles of the front surface 3246.1 and the rear surface 3246.2 on the hook portion 3246 are important to provide the optimal amount of resistance for assembly and disassembly of the patient interface 3000. The benefits of sizing the retention features 3244, 3245 and the corresponding frame connection regions 3312, 3313 have also been described above, ensuring proper orientation of the components during assembly. Appropriately sizing the retention features 3244, 3245 and the frame connection regions 3312, 3313 helps guide the pressurization chamber 3200 onto the frame 3310. In other words, the frame connection regions 3312, 3313 and the retention features 3244, 3245 can be sized to closely match each other, such that the peripheries of the frame connection regions 3312, 3313 and the peripheries of the retention features 3244, 3245 help guide and align the retention features 3244, 3245 into the corresponding frame connection regions 3312, 3313. This can be beneficial for patients with limited mobility due to illness (such as arthritis) to assemble the patient interface 3000 in a dark room before sleeping or in situations where vision is impaired due to limited visual acuity. Furthermore, by forming the retaining features 3244, 3245 and the frame connection areas 3312, 3313 to be dimensionally closely aligned with each other, this ensures that the seal between the pressurization chamber 3200 and the frame 3310 is maintained by facilitating a secure connection between these two components. Additionally, the close alignment between the retaining features 3244, 3245 and the frame connection areas 3312, 3313 can facilitate equal alignment of the pressurization chamber 3200 on the frame 3310. In one example of this technology, a difference of 0.3 mm to 2 mm can be incorporated between the retaining features 3244, 3245 and the frame connection areas 3312, 3313.

[0424] It should also be understood that the connection between the frame 3310 and the pressure chamber 3200 described above and below can be used with other types of face masks. Such features can also be applied to nasal bone or full-face face masks. Face masks that seal under the patient's nasal bridge (e.g., compact nasal masks or compact full-face face masks) can also incorporate the connection features described herein. Furthermore, face masks lacking forehead support can also include these connection features. It is also contemplated that examples of this technology including face masks that seal under the nasal tip (e.g., those with a nasal pillow 3130 or a nasal support / nasal flange 3101) can also use these connection features.

[0425] 6.3.4.1.2 Sequence of attachment and detachment of pressurization chamber and frame

[0426] Figures 25 to 29The diagram shows a sequence of cross-sectional views of the connection portion 3202 of the pressurization chamber 3200 and the frame connection region 3312 of the frame 3310. This sequence of views illustrates the attachment process of the pressurization chamber 3200 to the frame 3310. Although these views show only one retaining feature 3244 attached to a frame connection region 3312, it should be understood that multiple retaining features 3244 and multiple frame connection regions 3312 may exist, as in... Figure 10 As can be seen and discussed above, there are therefore multiple examples of attachment sequences that complete the full attachment of the pressurization chamber 3200 and the frame 3310 during the attachment sequence process.

[0427] 6.3.5.2 Sequence of Adding and Removing the Pressure Chamber and Frame

[0428] Figure 25 A cross-sectional view is shown of the connection portion 3202 of the pressurization chamber 3200 and the frame connection region 3312 of the frame 3310, wherein the connection portion 3202 and the frame connection region 3312 are close to each other but not in contact. Arrows indicate that the connection portion 3202 and the frame connection region 3312 are brought together. It should be understood that, for simplicity, these views do not include additional portions of the pressurization chamber 3200 and the frame 3310. Therefore, it should also be understood that the frame connection region 3312 and the obstruction portion 3314 of the frame connection region 3312 are two parts of the frame 3310, for example, in... Figure 13 As can be seen from the diagram. Furthermore, it should be understood that the frame connection portion 3312 and the obstructing portion 3314 of the frame connection portion 3312 will move relative to each other through the attachment sequence. Return to Figure 93 This view shows that when both the sealing lip 3250 and the retaining feature 3244 are not in contact with the frame 3310, the sealing lip 3250 does not deform and the retaining feature 3244 does not deform.

[0429] Figure 26The hook-shaped portion 3246 of the retaining member 3244, which begins to contact the frame connection region 3312 of the frame 3310, is shown. Specifically, this view shows the front surface 3246.1 of the hook-shaped portion 3246 in contact with the introduction surface 3312.1 of the frame connection region 3312. In this view, the retaining feature 3244 and the frame connection region 3312 are only just in contact with each other, such that the retaining feature 3244 is not deflected. In addition, the sealing lip 3250 is not deflected because it has not yet contacted the obstructing portion 3314 of the frame connection region 3312. As described above, the angle α of the front surface 3246.1 will begin to affect the resistance felt by the user in the engagement of the pressurization chamber 3200 and the frame connection region 3312, because the front surface 3246.1 will begin to engage in frictional contact with the introduction surface 3312.1.

[0430] Figure 27 Further along the attachment sequence, the pressurization chamber 3200 and frame 3310 are shown, such that the retention feature 3244 is deflected by contact with the frame connection region 3312. As can be seen in this view, the frame connection region 3312 and the obstructing portion 3314 of the frame connection region 3312 are closer to the connection portion 3202. Also shown in this view, the front surface 3246.1 of the hook portion 3246 contacts a portion of the closer retaining surface 3312.2 of the introduction surface 3312.1. In other words, it can be seen that the hook portion 3246 has moved toward attachment to the frame connection region 3312 and relative to... Figure 26 The position shown is shifted. As previously described, the pressurized connection area 3240 of the connection portion 3202 and the pressurized chamber 3200 can also be deflected from the contractile force generated by the patient 1000. Figure 27 It is also shown that the retained feature 3244 has been deflected by contact with the frame connection area 3312 and the outline of the retained feature 3244 in the undeformed state is shown by the dashed line. Figure 27 It is also shown that the sealing lip 3250 has not yet come into contact with the obstructing portion 3314 of the frame connection area 3312, and therefore, the sealing lip 3250 is not deformed. Although not shown in this view, it should also be understood that the frame connection area 3312 can deflect away from the retaining feature 3244 due to the force that presses the frame connection area 3312 and the retaining feature 3244 together.

[0431] exist Figure 28In this view, the pressurization chamber 3200 and the frame 3310 are almost attached, and the retaining feature 3244 is almost completely engaged with the frame connection region 3312. In this view, the retaining feature 3244 is still deformed, but the hook-shaped portion 3246 contacts different parts of the frame connection region 3312. Specifically, the rear surface 3246.2 of the hook-shaped portion 3246 now contacts the retaining surface 3312.2 of the frame connection region 3312. Furthermore, due to the angle between the rear surface 3246.2 and the retaining surface 3312.2 in contact with each other, the retaining feature 3244 and the frame connection region 3312 can be advanced into engagement by the inherent tendency of the deflected retaining feature 3244 to return to its undeformed state, effectively pulling these parts together after a certain insertion distance. Figure 28 The outline of feature 3244, retained in its undeformed state, is also shown in dashed lines. Furthermore, in this view, it can be seen that the sealing lip 3250 contacts the obstruction portion 3314 of the frame connection region 3312. At this point, in the attachment sequence, a seal can begin to form through the contact between the sealing lip 3250 and the obstruction portion 3314 of the frame connection region 3312. The sealing lip 3250 can also be slightly deflected by contact with the obstruction portion 3314 of the frame connection region 3312.

[0432] Figure 29 The pressurization chamber 3200 and frame 3310 are shown fully attached via the engagement of the hook-shaped portion 3246 of the retaining feature 3244 with the frame connection region 3312. In this view, the retaining surface 3312.2 may be flush with the rear surface 3246.2. The retaining feature 3244 may also deflect without contact with the frame connection region 3312. The retaining feature 3244 returns from its deflected or deformed state to its undeformed state, as... Figure 28 As shown, when the hook-shaped portion 3246 and the retained feature 3244 are from Figure 28 The position shown is moved to Figure 29 An audible clicking sound can be produced at the position shown. This reassuring audible clicking sound can be advantageous because it provides the patient 1000 with feedback that the pressure chamber 3200 and frame 3310 are fully engaged. By providing this feedback to the patient 1000 upon completion of engagement, the patient 1000 can use the patient interface 3000 with confidence that the pressure chamber 3200 and frame 3310 are securely attached and will not detach when the patient 1000 is asleep and receiving treatment.

[0433] Furthermore, the required level of sealing contact can be achieved in the pressure chamber 3200 and the frame 3310, such as... Figure 29This is achieved when attached as shown. It can be seen that the sealing lip 3250 deflects against the obstruction portion 3314 of the frame connection region 3312. Through this deflection, the sealing lip 3250, due to its tendency to return to its undeformed state, pushes itself with sufficient force against the obstruction portion 3314 of the frame connection region 3312, thus creating the desired seal between these components. Furthermore, during treatment, the sealing lip 3250 is forced to deflect towards portion 3314 of the frame connection region 3312 due to the increased air pressure in the pressurization chamber 3200, thereby increasing the sealing force in this area. When the pressurization chamber 3200 and frame 3310 are engaged, even though a compression seal is formed between the retaining structure 3242 and the frame connection region 3312, a pressure-activated seal is also formed between the sealing lip 3250 and portion 3314 of the frame connection region 3312 as the engagement strengthens with increasing internal air pressure. In some examples, the compression seal may not be airtight, leading to undesirable leakage.

[0434] Furthermore, if a very large amount of component compression is required to form a compression seal, this could hinder the easy attachment and disengagement of the pressure chamber 3200 from the frame 3310, potentially requiring more than one hand to perform the operation or a significant amount of effort. Therefore, in one example of this technology, the compression seal is primarily used for retention rather than sealing purposes, while the pressure-activated seal is primarily used for creating and maintaining an airtight seal. However, it should be understood that such a sealing effect can occur around the edges of the joint between the pressure chamber 3200 and the frame 3310. For example, Figure 17 A sealing lip 3250 in a similar offset state relative to the frame connection region 3312 is shown at the area separated from the retention feature 3244. Furthermore, in Figure 5 As can be seen, for example, the sealing lip 3250 extends around the periphery of the pressurization chamber 3200. By extending the sealing lip 3250 inward around the periphery of the engagement between the pressurization chamber 3200 and the frame 3310, the required level of sealing can be achieved throughout this area, thereby preventing unwanted leakage of pressurized gas.

[0435] Furthermore, it should be understood that the sealing lip 3250 can press against the obstructing portion 3314 of the frame connection 3312 with a force that pushes these components apart. However, the frictional force caused by the structural engagement between the rear surface 3246.2 of the hook portion 3246 and the retaining surface 3312.2 of the frame connection area 3312 should be sufficient to resist the force that would cause the sealing lip 3250 to return to its undeformed state and separate the pressurization chamber 3200 from the frame 3310.

[0436] Regarding the separation of the pressure chamber 3200 and the frame 3310, it should be understood that this process is essentially the reverse order of the above-described process. In other words, the user can separate the pressure chamber 3200 from the frame 3310 by pulling these components in opposite directions, and Figure 29 The view can be the start of the separation process, while Figure 25 This can represent a view where the pressure chamber 3200 and frame 3310 are completely separated. Contraction or retraction of the pressure chamber 3200 near the pressure connection area 3240 and pulling away from the frame 3310 can assist in removing the pressure chamber 3200 from the frame 3310. It is also conceivable that the patient 1000 can contract the pressure chamber 3200 at any location (e.g., the nasal pillow 3130 or the stem 3150) for clamping purposes and simply pull away from the frame 3310. A twisting motion while pulling can also assist in detaching the pressure chamber 3200 from the frame 3310.

[0437] 6.3.4 Hardware-to-hardware connections

[0438] The pressurized connection area 3240 and the frame 3310 can be assembled and attached, such as Figures 25 to 29As shown. As described above, the pressurized connection region 3240 and / or retaining structure 3242 may comprise semi-rigid materials, such as high-hardness silicon (higher hardness than the pressurized chamber 3200) / TPE, plastics, nylon, polypropylene, polyamide, and / or polycarbonate. The pressurized connection region 3240 may be constructed in the form of a continuous ring or ellipse, two C-shaped clips, a single C-shaped clip, or a single continuous piece, but only surrounds a portion of the pressurized chamber 3200. The clips may serve as spring clips and be formed in a C-shaped or double C-shaped cross section. The spring force of the spring clips may be provided by the elasticity of the pressurized connection region 3240 abutting the frame connection regions 3312, 3313 or the tensioning portion 3314 of the frame 3310. In another example, the clip form may be unnecessary, and without a pressurized connection area 3240 for engagement with connection areas 3312, 3313 and / or a retaining structure 3242, only supporting features 3244, 3245 are permanently and directly connected to the pressurized chamber 3200. It is also conceivable that an example of this technology may include a frame 3310 comprising the same or similar semi-rigid material as the pressurized connection area 3240. By fabricating the pressurized connection area 3240 and the pressurized chamber 3310 of semi-rigid material, a "hard-to-hard" connection or bonding mating can be created. This "hard-to-hard" connection, combined with the structural features of the pressurized connection area 3240 and the frame connection area 3312, can provide the patient 1000 with a confident sense of connection between the pressurized chamber 3200 and the frame 3310 when assembling the patient interface 3000 (e.g., by providing an audible snap-fit ​​or a reassuring audible click). Since a robust fit between the pressure chamber 3200 and the frame 3310 helps ensure that the patient 1000 receives optimal treatment through the patient interface 3000, the ease of use and the confidence in the achieved robust fit provided to the patient 1000 are beneficial. A hard-to-soft connection, as described herein, can also be advantageous because it increases the stability of the seal created by the sealing structure 3100. This contrasts with a hard-to-soft or soft-to-soft connection (in which one or both of the pressure chamber and the frame are made of soft material, making it difficult for arthritic hands to easily and correctly engage the pressure chamber and the frame, especially in a dark room).

[0439] Although the retained features 3244 and 3245 are described as being disposed on the pressurization chamber 3200 and the connecting regions 3312 and 3313 are disposed on the frame 3310, this position can be changed to the retained features on the frame and the connecting regions on the pressurization chamber. Furthermore, a portion of the retained features and connecting regions can be combined to correspond to other portions of the retained features and connecting regions.

[0440] 6.3.5 Method for constructing a pressurization chamber

[0441] The process of manufacturing the pressurization chamber 3200 may include the following steps: molding a pressurization connection region 3240 in a first tool; removing the molded pressurization connection region 3240 from the first tool; inserting the pressurization connection region 3240 into a second tool; and molding a portion of the pressurization chamber 3200, including a connection portion 3202, in the second tool. The pressurization connection region 3240 may be chemically bonded and / or mechanically interlocked with the connection portion 3202.

[0442] In one embodiment, the sealing lip 3250 is constructed and arranged to interfere with the obstruction portion 3314 of the frame connection region 3312 when the pressurization chamber 3200 is assembled with the frame 3310. Figure 13 During use, this causes the sealing lip 3250 to move away from its resting position when assembled with the obstructing portion 3314 of the connection area 3213 to the frame. Figure 6 ) elastic bending, and as a result of the elastic material, at least part of it abuts the hindering portion 3314 ( Figure 12 The sealing lip 3250 is used to resist or prevent air leakage between the sealing lip 3250 and the obstruction portion 3314. Although the sealing lip 3250 has been described as being provided with the pressurization chamber 3200, the sealing lip edge 3250 may also be provided on the frame 3310. Although one sealing lip has been described, two or more sealing lips may be provided, with at least one sealing lip provided with the pressurization chamber 3200 and at least one sealing lip provided with the frame 3310.

[0443] 6.3.6 Positioning and Stabilizing Structure

[0444] Note that in one form of this technology, multiple structural features form part of the positioning and stabilizing structure 3300, such as a headband assembly (which may be simply referred to as the headband). In alternative forms of this technology, one or more of these features are located on the frame 3310. For example, the flexible joint 3305 may be located wholly or partially on the headband or on the frame 3310. Furthermore, the tensioning portion 3350, in addition to being integrally formed with the reinforcing arm 3302, may perform the same function as the flexible joint 3305.

[0445] The sealing structure 3100 of the patient interface 3000 of this technology can be held in a sealed position during use by the positioning and stabilizing structure 3300. Figure 75 , Figure 76 and Figure 166 In one form, the positioning and stabilizing structure 3300 includes a headband. It should be understood that, in one form of the present technology, the positioning and stabilizing structure 3300 may be referred to as a headband.

[0446] The headband can be detachably connected to a part of the patient interface 3000, such as the positioning and stabilization structure 3300, via a headband connector.

[0447] 6.3.6.1 Stripes

[0448] The positioning and stabilizing structure 3300 may include at least one strip 3301 (see example). Figure 65 ) and at least one reinforcing arm 3302 (see Figure 67 Strip 3301 may be made of a plastic material and may have elastic properties. In other words, strip 3301 may be elastically stretched, for example, by a tensile force applied by patient 1000, and return to or shorten to its original length when the tensile force is relaxed. Strip 3301 may be made of or include any elastic material such as spandex, TPE, silicone, etc. The material of strip 3301 may also represent any combination of the above materials with other materials. Strip 3100 may be a single-layer or multi-layer strip. Strip 3301, particularly the side strip portions 3315, 3316 that come into contact with patient 1000 during use, may be woven, knitted, braided, molded, extruded, or otherwise formed. Strip 3301 may include or may be made of textile materials, such as woven materials. Such materials may include synthetic or natural fibers, and on the other hand, provide desired and beneficial surface properties such as tactile characteristics and skin comfort. On the other hand, the material of strip 3301 may include elastomeric materials to provide the desired elastic properties. The entire strap 3301, including the side strap portions 3315 and 3316 and the rear strap portion 3317, can be entirely stretchable. This allows the entire length of the strap 3301 to be stretched, resulting in a comfortable force displacement profile. To allow the strap 3301 to be stretched in use, its length can be smaller than the average small head circumference of the patient. For example, in one example, the different lengths of the strap 3301 could be less than 590 mm and in another example, less than 500 mm. However, straps 3301 of varying lengths can be provided to patients depending on the gender specificity of their head circumference. For example, the length of the smaller strap could be 490 mm, while the length of the larger strap could be 540 mm. In some cases, this means that the length of the strap 3301 does not require a large stretch (i.e., a smaller strap for a larger head circumference), for which a high headband tension and therefore a small, smooth force displacement profile are not necessary, because stretching the smaller strap 3301 results in a longer stretch.

[0449] The strip 3301 is reinforced in some sections, for example, by means of an inserted reinforcing arm 3302 extending from the frame 3301 to a position adjacent to the patient's cheekbone. The strip 3301 may be in the form of a hollow strip. When the strip slides onto the reinforcing arm 3302, it is conceivable that the strip 3301 is threaded onto the reinforcing arm 3302 and is fixed to one end of the reinforcing arm 3302 adjacent to the frame 3301.

[0450] In one example, the strip 3301, including side strip portions 3315, 3316 and back strip portion 3317, is made of a yarn-knitted fabric material. The strip 3301 is a computer-controlled three-dimensional knitted fabric as a single integral piece. Variations in the threads and stitching can occur at different locations along the strip 3301 to adjust the elasticity, strength, and durability of the strip 3301 at certain locations. For example, additional threads can be woven at the locations of openings, insertion points, or buttonholes 3303, 3304, and at the bifurcation point 3324 for the back strip portions 3317a, 3317b, to provide reinforcement to the strip 3301 to prevent it from failing or breaking down at these locations subjected to high stress when stretched during repeated and prolonged use. After the strip 3301 is washed and dried, the weaving method (i.e., warp knitting) and the elastic textile material (e.g., elastic fibers) of the strip 3301 help restore its elasticity. In other words, the elasticity of the strip 3301 can be maintained for a long time by periodically washing the strip 3301, thus extending its working life.

[0451] exist Figures 65 to 73 In the diagram, strip 3301 is shown as a single continuous strip with two pouch-like ends 3311, 3313, attached directly or via flexible connector 3305 to frame 3310. However, it is understood that strip 3301 may comprise, or may be directly connected to each other, for example by stitching or ultrasonic welding. Figure 65 In this diagram, the strip 3301 and the positioning and stabilizing structure 3300 are shown without any adjustment or variation mechanism. However, such adjustment can be provided by changing the way the strip 3301 is fixed to the patient interface 3000 or by using other connecting elements that are stiffer than the strip 3301 (such as a flexible connector 3305). [Go to...] Figure 72 Alternatively, adjustment can be achieved by adding a mechanism, such as sliding on the ladder locking clamp 3305.1 on the back 3317 or side strip portions 3315, 3316 (e.g. Figures 71 to 73 (As shown), or separately adjust the elastic lengths of the strip 3301 and the positioning and stabilizing structure 3300. Figure 65 In the example shown, strip 3301 has a tubular structure, as can be drawn from... Figures 68 to 70As illustrated in the diagrams, corresponding markings 3321a-d, 3323a-e indicate the oval or circular or circular (visible) outer surface facing the observer, as well as the oval or circular markings 3321a-d, 3323a-e, and the markings according to the diagrams. Figure 66 A cross-sectional view. However, it will be understood that the positioning and stabilizing structure 3300 can take any other shape, such as planar or sheet-like, single, multi-layered, or stacked structures. The strip 3301 can have a longitudinal axis, which can be understood as the axis being substantially parallel to the plane of the paper and extending along the strip 3301 (see, for example...). Figure 65 (The dashed line in the middle).

[0452] Strip 3301 may have reinforced seams to improve durability and minimize or prevent points of failure. For example, strip 3301 is subjected to high stress under tension in the areas of the buttonholes 3303, 3304 and the two subsequent strip portions 3317a, 3317b, at the bifurcation point 3324. The material tends to split away from each other at the dividing areas 3326, so reinforced seams are a way to address this problem in these respects. In one example, the central seam runs along the central longitudinal axis of strip 3301 and serves as a reinforcing seam. Also, the distal edge of strip 3301 and the openings at buttonholes 3303, 3304 can be ultrasonically welded to melt any stray fibers and reinforce strip 3301 in these areas. Advantageously, this also prevents fiber abrasion of strip 3301 after repeated washing and extended use. Other techniques are envisioned for reinforcing and strengthening the pouch end 3311, the distal edge, and the buttonhole 3303, which may include additional materials such as adhesive tape. The tape can also include brand and logo information.

[0453] Figures 123 to 125 The views show increasingly detailed views of the segmented region 3326 between the upper rear strip portion 3317a and the lower rear strip portion 3317b. The edges of the upper rear strip portion 3317a and the lower rear strip portion 3317b should be understood as being imperfectly smooth as a result of the weaving process, and it should be further understood that these views show such edges magnified significantly, making the defects obvious. The undulations at the edges of the upper rear strip portion 3317a and the lower rear strip portion 3317b are not easily visible to the naked eye and are generally imperceptible to the patient by touch. Furthermore, stippling is used in these views to show the texture of the rear strip portions 3317a, 3317b, while the segmented region 3326 is shown as empty because it represents the absence of material in that segmented region.

[0454] Figures 126 to 131Detailed views show the presence of bifurcation point 3324, where the upper rear strip portion 3317a and the lower rear strip portion 3317b separate from the side strip portions 3315 and 3316. Reinforcing portion 3325, which may include additional stitching or welding near bifurcation point 3324, is also visible in these views. Reinforcing portion 3325 helps prevent the side strip portions 3315 and 3316 from splitting and / or tearing due to stress from repeated separation of the upper rear strip portion 3317a and the lower rear strip portion 3317b. In other words, reinforcing portion 3325 provides additional strength at locations of stress concentration near bifurcation point 3324. The views also show the upper rear strip portion 3317a and the lower rear strip portion 3317b separating at various angles θ. These views can be interpreted as showing that the reinforcing portion 3325 provides additional strength at the bifurcation point 3324 when the upper rear strip portion 3317a and the lower rear strip portion 3317b extend towards each other at a large angle θ.

[0455] See Figures 176 to 181 In one example of this technology, the end of strip 3301 has a reinforcing portion 3327 having a material overlaid on the end of strip 3301. This is in addition to the welded ends 3311.1 and 3313.3 (see also...). Figure 81 In addition to this, it provides further reinforcement in this area. The material of the reinforcing portion 3327 may be different from that of the strip 3301. The reinforcing portion 3327 can prevent or reduce the possibility that the patient 1000 will tear or rip the strip 3301 along its longitudinal axis starting in this area. The reinforcing portion 3327 helps to provide visual and tactile instructions to the patient 1000 about how to slide up or remove the strip 3301 from the reinforcing arm 3302, as it may help to determine the location of the buckle holes 3303, 3304. The corner 3328 of the reinforcing portion 3327 has been cut off and is rounded so that the corner 3328 at its distal free end 3302.1 roughly matches the rounded corner of the reinforcing arm 3302 (see...). Figure 50 (52, 55, 57, 58, 60). This provides a close fit with the aesthetically pleasing rigid arm 3302. The rounded corners 3328 provide soft edges to avoid facial scratches that might occur if they were replaced with sharp corners.

[0456] 6.3.6.2 Reinforced Arm

[0457] Figure 67An example of the reinforcing arm 3302 is shown, which can be crescent-shaped or semi-circular. The reinforcing arm 3302 can have a generally extended and flattened structure. In other words, its thickness (in the direction of the paper plane) is not large, but it is relatively long and wide (from top to bottom of the paper plane). The reinforcing arm 3302 is a three-dimensional shape with curvature along all three axes (X, Y, and Z). Although the thickness of the reinforcing arm 3302 is generally uniform, its height varies throughout its length. The shape and size of the reinforcing arm 3302 are designed to better conform to the curvature of the patient's face, thus more realistically framing the patient's face. Compared to other parts of the reinforcing arm 3302, its two ends 3319a and 3319b are rounded and / or slightly curved. Figure 67 As shown in the paper plane, the reinforcing arm 3302 may be flat, but note that the desired spatial configuration of the reinforcing arm 3302 can be oriented towards the paper plane (e.g., ...). Figure 67 ), particularly effective in improving facial features such as cheek shape and forehead area (see Figure 71 and 72 Alignment. The longitudinal axis of the reinforcing arm 3302 can be understood as an axis approximately parallel to the plane of the paper, along which the reinforcing arm 3302 extends (e.g., Figure 67 (As shown by the dashed line).

[0458] The reinforcing arm 3302 is stronger than the strip 3301, and the mask frame 3310 is stronger than the reinforcing arm 3302. Especially when the reinforcing arm 3302 and / or the strip 3301 are combined, stiffness is increased at least in one orientation of the strip 3301 or around one of its axes. Furthermore, the reinforcing arm 3302 guides and determines the orientation and trajectory of the strip 3301's stretching, that is, the patient stretches the strip 3301 in a direction generally parallel to the longitudinal axis of the reinforcing arm 3302. Stretching the strip 3301 in other directions would cause the reinforcing arm 3302 to rotate relative to the mask frame 3310, which is undesirable. The stiffness of the reinforcing arm 3302 makes it inclined to its natural, unrotated, untwisted, and undeformed state. To some extent, this makes the positioning and stabilizing structure 3300 a self-adjusting headband. The self-adjusting function avoids the need for manual shortening or lengthening of the headband strip material and can remember the adjusted length. This has always been a tricky process because the headband strips on both sides of the face must be shortened or lengthened sequentially. This may prevent the patient from tightening the strips when a greater strength is not required to secure the headband properly. In the example shown, strip 3301 has a tubular, or sleeve-like structure. In other words, strip 3301 is hollow, so that reinforcing arm 3302 can enter strip 3301 through fastening hole 3303. In another example, reinforcing arm 3302 may be permanently, at least in one location, connected to strip 3301, for example, at an anchor point, where it may be overmolded or glued to form a complete chemical bond (molecular adhesion) between reinforcing arm 3302 and strip 3301.

[0459] The band 3301 consists of side band portions 3315 and 3316 and a rear band portion 3317 located between the side band portions 3315 and 3316. When worn, the side band portions 3315 and 3316 extend along the sides of the patient's head, while the rear band portion 3317 extends along the back of the patient's head, as shown below. Figures 4 to 8 and Figure 166As shown. The back strip portion 3317 may consist of 2, 3 or more parallel strips, specifically to ensure stability. Although the smaller back strip portions 3317a and 3317b are of equal length in the illustration, they are envisioned to be of different lengths. The more smaller back strip portions 3317a and 3317b there are in the back strip portion 3317, the greater the elasticity it provides. In other words, the more the number of smaller back strip portions 3317a and 3317b increases when manufacturing strip 3301, the more tension the side strip portions 3315 and 3316 will experience from the back strip portions 3317a and 3317b, resulting in a more compact side strip portion. In the example shown, the side strip portions 3315 and 3316 of strip 3301 enter the back strip portions 3317a and 3317b, respectively. In one example, compared to each side strip portion 3315 and 3316 of strip 3301, each rear strip portion 3317a and 3317b is made of a semi-elastic material. In another example, positioning and stabilizing structure 3300 is connected to mask frame 3310 via snap holes 3303 and 3304 by a detachable connector located between strip 3301 and reinforcing arm 3302, while reinforcing arm 3302 is mechanically interlocked to mask frame 3310. In yet another example, flexible joint 3305 made of TPE is permanently connected to reinforcing arm 3302 and mask frame. Flexible joint 3305 is overmolded to mask frame 3310 for permanent connection, and flexible joint 3305 is permanently connected to reinforcing arm 3302 via mechanical interlock. In another example, flexible joint 3305 may be made of the same material as reinforcing arm, for example, It is integrated with the reinforcing arm 3302, and the flexible joint 3305 is permanently connected to the mask frame 3310 via mechanical interlocking. The strip 3301 is detachably connected to the reinforcing arm 3302 via buckles 3303 and 3304.

[0460] The strip 3301 and the reinforcing arm 3302 may engage near the mask frame 3310, allowing maximum stretching of the strip 3301. This engagement can be disengaged, completely separating the strip 3301 from the reinforcing arm 3302, and subsequently, the mask frame 3310 facilitates the washing of the strip 3301. The engagement function acts as an anchor point for the strip 3301, so that when the strip 3301 is stretched, the direction of the tension deviates outward from the anchor point. Figures 48 to 60 As shown, the end of the strip 3301 at the anchor point is held by at least one distal end of the reinforcing arm 3302 and / or a protruding end 3306 extending from the reinforcing arm 3302.

[0461] It should be noted that the stiffness of the reinforcing arm 3302 mentioned in this article is greater than that of the strip 3301, thus allowing the reinforcing arm 3302 to be molded into the strip 3301. Compared to the strip 3301, which can extend along at least one axis, the reinforcing arm 3302 can have greater stiffness in at least one axis or around it, and is not stretchable. In another example, the reinforcing arm 3302 can extend / stretch in a direction parallel to its longitudinal axis. While elastomers are characterized by stretchability, some thermoplastic polyester elastomers are not stretchable, but they are flexible, such as... Production 5556. For example, the reinforcing arm 3302 may have a scissor-connection mechanism or a telescopic structure, allowing the reinforcing arm 3302 to move between a compressed position and a maximum extended position. An extendable reinforcing arm 3302 may be more suitable for a patient 1000 with a long face, allowing the length of the reinforcing arm 3302 to be adjusted appropriately according to the patient's face shape. Alternatively, the reinforcing arm 3302 can be considered as a link and / or reinforcement. A link can be understood as a rigid element of the strip 3301 that supports the positioning and stabilizing structure 3300. The reinforcing arm 3302 can be understood as a rigid element of the strip 3302 that forms the positioning and stabilizing structure 3300 when worn on the face.

[0462] 6.3.6.3 Connection between strip and reinforcing arm

[0463] Figure 65 Each of the side strip portions 3315 and 3316 of the strip 3301 shown includes two buckle holes 3303 and 3304, respectively. Buckle holes 3303 and 3304 may be located on the outer surface of the strip 3301, i.e., the surface facing away from the patient 1000 during use. Buckle holes 3303 and 3304 are adapted to receive a reinforcing arm 3302 for insertion into or removal from the tubular or sleeve-shaped strip 3301. Optionally, buckle holes 3303 and 3304 may be located on the inner surface of the strip 3301. Buckle holes 3303 and 3304 may be oriented and / or shaped such that the reinforcing arm 3302 is inserted into and / or removed through the buckle hole 3303 for assembly positioning and stabilization of the structure 3300, while preventing accidental removal or detachment of the reinforcing arm 3302 from the strip 3301 during use. Figure 65As shown, this can be achieved by providing a snap hole 3303 with a slit-like construction, similar to a buttonhole, which can be positioned along or across the strip 3301. Optionally, if desired, the snap hole 3303 can be oriented across the strip 3301. In other words, the elongated extensions of the snap holes 3303 and 3304 can extend substantially coaxially to the longitudinal axis of the strip 3301 and the reinforcing arm 3302. Because the strip 3301 is elastic, this makes it easier for the reinforcing arm 3302 to be inserted into the tubular or sleeve-shaped strip or a portion of the strip 3301, while preventing accidental removal. The end of the strip 3301 located between the end of the strip 3301 and the snap hole 3303 covers the edge of the reinforcing arm 3302 and acts as an anchor point. The edge or anchor point of the reinforcing arm 3302 can be a fastener. The end of the strip 3301 can also be referred to as a pocket end 3311. During the use or disuse of the patient interface 3000, this prevents the strip 3301 from slipping off the inserted reinforcing arm 3302 when stretching and adjusting the strip 3301.

[0464] Reference Figure 185 and 186 The reinforcing arm 3302 can be inserted into the first fastening hole 3303 of the strip 3301. That is, the strip 3301 can slide off the reinforcing arm 3302 through the fastening hole 3303. The free end 3302.1 of the reinforcing arm 3302 is first inserted into the strip 3301 through the fastening hole 3303. The reinforcing arm 3302 is further pushed into the strip 3301 until most or almost all of the reinforcing arm 3302 is inserted into the strip 3301, so that the end of the strip 3301 can be firmly anchored to the edge of the reinforcing arm 3302. Some of the strip 3301 material around the fastening hole 3303 is adjusted so that it is below the outer surface 3319 of the protrusion 3309 (see...). Figure 38 After the reinforcing arm 3302 is inserted into the strip 3301, the reinforcing arm 3302 can be unfixed and unrestricted within the strip 3301, such as... Figures 6 to 8 As shown. Most importantly, the snap-fit ​​hole 3303 should be located above the engagement point because the end of the strip 3301 abuts against the protruding end 3306 of the reinforcing arm 3302 to secure the strip 3301 to the reinforcing arm 3302. When the strip 3301 is stretched, its end is pulled in the opposite direction to the protruding end 3306. Generally, the location of the engagement point between the reinforcing arm 3302 and the strip 3301 is more important than the type of connection; for example, snap-fit ​​holes 3303 and 3304 are used in the strip 3301. See reference. Figures 182 to 184The connection type between the reinforcing arm 3302 and the strip 3301 facilitates the removal of the strip 3001 from the reinforcing arm 3302, allowing for separate rinsing of the strip 3301. In other words, the rinsing and cleaning time for the strip 3301 differs from that of the mask frame 3310. The patient 1000 slightly stretches the strip 3301 around the buckle hole 3303 to loosen the strip 3301 from the reinforcing arm 3302. After the end of the strip 3301 is untied, the strip 3301 can be completely removed from the reinforcing arm 3302 through the buckle hole 3303.

[0465] Alternatively, the reinforcing arm 3302 may be secured to the strip 3301. This securing is achieved by attaching the reinforcing arm 3302...

[0466] The second end of the reinforcing arm (located near the buttonhole 3303 after insertion) is secured to the strip 3301 of the positioning and stabilizing structure 3300. As described in the introductory section of this specification, the fixation can be localized. Here, the connection between the reinforcing arm 3302 and the strip 3301 is not distributed along the strip 3301, but is concentrated in the area adjacent to the buttonhole 3303. Alternatively, the connection can be established in the area adjacent to the buttonhole 3304. Fixation can be achieved by stitching, welding, bonding, heat fusion, clamping, buttoning, adsorption, or by using end caps, or by adsorbing an external component, such as an external clamp holding the ends of the strip and the reinforcing arm 3302, by pushing the reinforcing arm 3302 into the strip 3301 and securing the strip and the reinforcing arm 3302 to an external component. The strip 3301 can also be chemically bonded to the reinforcing arm 3302. Clips can also be used to secure the end of the strip 3301 to a corresponding end of the face mask frame 3310. In this way, the clip becomes part of the mask frame 3310 itself.

[0467] Using this technology, although the strip 3301 is configured to adopt the shape of the reinforcing arm 3302, it can still be significantly stretched along its entire length. Therefore, the reinforcing arm 3302 provides the desired shape, directing the pressure of the positioning and stabilizing structure 3300 towards the desired portion of the face, while the elastic positioning and stabilizing structure 3300 maintains its entire operating length and can extend freely along the reinforcing arm 3302. Furthermore, the reinforcing arm 3302 enables coronal plane decoupling of the sleeve torque. Simultaneously, the small-radius bend 3307 of the reinforcing arm 3302 helps maintain and decouple the sagittal plane of any sleeve torque. Meanwhile, the strip 3301 of the positioning and stabilizing structure 3300 can cover the reinforcing arm 3302, providing a soft feel and enhanced comfort.

[0468] The small-radius bend 3307 improves the stability of the patient interface 3000. When the patient 1000 is in a lateral position, the reinforcing arm 3302 on the face side of the bed pushes inward. The small-radius bend 3307 decouples this movement in the coronal plane to prevent interference with the seal force. The bend on the upper surface of the small-radius bend 3307 (facing away from the patient's face) is sharper than that on the lower surface (facing the patient's face). The radius of the lower surface of the small-radius bend 3307 (outer wash) is larger than that of the upper surface. Because the contact pressure is less concentrated when any contact occurs with the patient's septum and / or upper lip, the small-radius bend 3307 smooths out and avoids or reduces facial markings on the patient 1000 (caused by nasal drooping due to cannula weight or cannula torque). The distance between the two small-radius bends 3307 is approximately 50 mm.

[0469] Despite Figures 65 to 70 The specific examples shown are explored. It should be noted that strip 3301, or each strip side strip portion 3315, 3316, may be equipped with only one fastening hole 3303, 3304. However, it may also be equipped with two or more fastening holes. Alternatively or supplemented, strip 3301 cannot be a tubular or sleeve-shaped strip, but can be a flat single-layer or stacked configuration. Here, by providing a blocking device, including attaching one or more loops, sleeve portions, or sleeves to the outer surface of strip 3301 (e.g., the surface facing away from the patient), the reinforcing arm 3302 can be positioned relative to strip 3301.

[0470] Alternatively or additionally, different combinations of connection mechanisms described herein may be provided. For example, the reinforcing arm 3302 may be fixed at a single point or local area (as described above) near the pocket-shaped ends 3311, 3313 of the adjacent strip 3301, while simultaneously mounting the reinforcing arm 3302 adjacent to the strip 3301 by providing a loop or sleeve-like element on the outer surface of the strip 3301, such as the areas marked 3321b, 3323b. In other words, the reinforcing arm 3302 can be connected to the strip 3301 by fixing it at a local point or local area, while also functioning as an additional guiding element for the strip 3301. This guiding element function can be achieved through a loop or sheath-like portion or channel or pouch, while the reinforcing arm 3302 is based on... Figure 66The strip 3301 shown has a shape that extends into or through the strip 3301. The strip 3301 can be tubular, but not necessarily cylindrical. This allows the strip 3301 to extend to its maximum extent. Alternatively, the reinforcing arm 3302 can be placed independently in one or more pouches (such as a single-ended pouch with a measurable length supporting the reinforcing arm at some point in the middle, or two pouches, each supporting one end of the reinforcing arm), or as multiple loops distributed along the length of the strip 3301, without being connected. The aforementioned guiding element functions, whether or not fixed at one end, to substantially allow the reinforcing arm 3302 to move or float freely relative to the strip 3301. This configuration has the same advantages and benefits as the configuration described above. Furthermore, according to a technical example, the direction of extension or bending of the reinforcing arm 3302 is not the same as that of the strip 3301. Instead, the reinforcing arm 3302 can extend or bend in a plane in a direction substantially perpendicular to its longitudinal axis.

[0471] In the example discussed above, the reinforcing arm 3302 does not extend beyond the end of the strip 3301. However, according to an alternative aspect, the reinforcing arm 3302 may be fixed to the strip 3301 at points or areas adjacent to the respective pocket ends 3311, 3313, while also extending beyond the strip 3301. In this configuration, the reinforcing arm 3302 can shape, geometry, and / or stiffness of the strip 3301, while providing structural means, such as a flexible joint 3305, for connection with the patient interface 3000. This allows the reinforcing arm 3302 to simultaneously function as both a reinforcing arm 3302 and a connector that connects the strip 3301 and the positioning and stabilizing structure 3300 to the frame 3310, the gas collection chamber 3200, or the sealing structure 3100, respectively.

[0472] Figures 113 to 122 A detailed view is shown of the connection between the bag-shaped ends 3311, 3313 and the reinforcing arm 3302. Figure 113 and 114 The pouch-shaped ends 3311, 3313 surrounding the corresponding protruding ends 3306 of the reinforcing arm 3302 are shown. The protruding ends 3306 are not visible in these views because they are covered by the pouch-shaped ends 3311, 3313. The straight portion 3351 on the extension 3350 of the reinforcing arm 3302 (discussed further below) is shown by a mark 3358 on the outer surface 3355 of the extension 3350. The mark 3358 may be an imprint, a raised surface, or an embossing, thereby helping the patient 1000 to determine the position of the device 3000 during use in a dark environment. It can be seen that the straight portion 3303 of the extension 3350 extends outward from the snap holes 3303 of the corresponding pouch-shaped ends 3311, 3313. The straight portion 3351 is part of the reinforcing arm 3302, as... Figures 47 to 60As shown, the reinforcing arm 3302 facilitates the connection between the strip 3301 and the mask frame 3310. Figure 114 It shows the relationship with Figure 113 A similar view, however, the outer surface 3355 of the straight portion 3351 is not marked. It should be understood that... Figure 113 The connection between a reinforcing arm 3302 and a single bag-shaped end 3311 is shown, while Figure 114 The description pertains to the connection between another reinforcing arm 3302 and another bag-shaped end 3313. By placing a marker 3358 on only one outer surface 3355, the patient 1000 can determine the position of the device 3000 by touch, thus facilitating installation in a dark environment. Figure 114 The flange 3359, visible through the buckle hole 3303, is also shown.

[0473] Figure 115 It shows the relationship with Figure 114 Similar features, but Figure 115 More details are provided to better illustrate the relationship between flange 3359 and bag-shaped end 3313. Figure 116 It shows the relationship with Figure 113 Similar features, but Figure 116 More detailed, thus better showing the mark 3358 and the buttonhole 3303 located at the end of the bag 3313.

[0474] Figure 117 It shows Figure 114 Further detailed views are provided to better illustrate the snap hole 3303 at the bag-shaped end 3313. Figure 118 It shows Figure 113 Further detailed views are provided to better illustrate the snap hole 3303 at the bag-shaped end 3313.

[0475] Figures 119 to 122 As shown Figures 113 to 118 Similarly, but in these views, flange 3359 is separated from buckle 3303, thus better showcasing its design. Figure 119 and 122 It is shown that the reinforcing arm 3302, which includes the mark 3358 on the outer surface 3355, extends from the buckle hole 3303 of the bag-shaped end 3311. Figure 122 It should be understood as Figure 119 A more detailed view. Figure 120 and 121 Another reinforcing arm 3302 without markings is shown. Figure 121 It shows Figure 120 A more detailed view.

[0476] 6.3.6.4 Extension of the strip relative to the reinforcing arm

[0477] from Figure 68 As shown in the example, two reinforcing arms 3302 are inserted into the side strip portions 3315 and 3316 of the strip 3301 of the positioning and stabilizing structure 3300. The reinforcing arms 3302 are held in proper position around the strip 3301; at the same time, the sleeve-like construction of the strip 3301 allows at least a portion of the strip 3301 to extend or move relative to the reinforcing arms 3302. Preferably, this extendable portion is a solid portion, because the strip 3301 is only secured to the reinforcing arms 3302 at anchor points. In some examples, the movement of the reinforcing arm 3302 is typically restricted when one of the ends 3319a or 3319b of the reinforcing arm 3302 moves toward and abuts against the corresponding pocket end 3311 of the strip 3301, such as... Figure 69 As shown. For example, when the positioning and stabilizing structure 3300 is not on the patient's head and the strip 3301 is loose; when the inserted reinforcing arm 3302 moves too quickly toward the rear strip portions 3317a and 3317b, its end 3319b can enter the open end of one of the rear strip portions 3317a and 3317b. Since the width of the rear strip portions 3317a and 3317b is smaller than the width of the reinforcing arm 3302, the end 3319b of the reinforcing arm 3302 is close to the corresponding rear strip portion 3317a and 3317b to limit its further movement in this direction.

[0478] The attachment of the strip 3301 and the reinforcing arm 3302 described in the preceding section also affects the size of the head that the positioning and stabilizing structure 3300 can accommodate. In other words, by providing a larger strip 3301 along the reinforcing arm 3302, the total extension length of the positioning and stabilizing structure 3300 can be increased so that a head with a larger circumference can be accommodated without increasing the extension of the strip 3301. Furthermore, the length of the strip 3301 connected to the reinforcing arm 3302 can be varied. This requires a wider range of head sizes and circumferences to accommodate without altering the extension of the strip 3301.

[0479] The length of the band 3301 is between approximately 400 mm and approximately 700 mm. The length of the band 3301 can be approximately 490 mm. The band 3301 can provide a comfortable level of headband tension for most head sizes. Two lengths and sizes of the band 3301 are available, which are gender-specific. The male version is longer than the female version. Preferably, two sizes and lengths of the band 3301 are designed for each gender. The comfort level headband tension is approximately 2 Newtons to 5 Newtons; the comfort level headband tension is approximately 2.2 Newtons to 4.7 Newtons. When the band 3301 is stretched from 490 mm to 526 mm for a patient with a smaller head circumference of 1000 mm, the headband tension measured using an Inström machine is 2 Newtons. When the band 3301 is stretched from 490 mm to 662 mm for a patient with a larger head circumference of 1000 mm, the headband tension measured using an Inström machine is 4.4 Newtons. For the measurement, the buttonholes 3303 and 3304 of strip 3301 are attached to a clamp. Using a tensile testing machine with a force sensor of 100 Newtons, strip 3301 is extended to and held at predetermined extension points (e.g., 90.5 mm, 73 mm, and 108 mm) for one minute, and the force value (in Newtons) at each extension point is recorded. This measurement does not take into account friction between the material of strip 3301 and the patient's face and hair.

[0480] The length of the dividing region 3326, defined between the two posterior strip portions 3317a and 3317b, is approximately 180 mm to 220 mm. The length of the dividing region 3326 can be 200 mm. If the dividing region 3326 is not long enough, the two posterior strip portions 3317a and 3317b will not be able to perform suction cup treatment on the back of the patient's head; therefore, they cannot maintain their position during treatment, and the headgear tension will not remain at the patient's preferred setting. If the dividing region 3326 is too long, when the two posterior strip portions pass through the ears, rather than above or around the ears, the two posterior strip portions 3317a and 3317b will separate in front of the patient's ears, causing discomfort. Simultaneously, it also reduces the maximum angular range of the two posterior strip portions 3317a and 3317b relative to each other.

[0481] With the strip 3301 in a neutral and unstretched state, the two rear strip portions 3317a and 3317b have an angle θ between them, approximately 0° to 10°. After the patient interface 3000 is put on, the two rear strip portions 3317a and 3317b can be separated from each other so that the angle θ can reach approximately 180°. This allows a maximum angle range of 180°, thereby providing a wide range of headgear tension reduction by continuously separating the two rear strip portions 3317a and 3317b. The angle range can be reduced from a default angle of 10° to a maximum angle of 120°. The patient 1000 can use one or both hands to remove the two rear strip portions 3317a and 3317b, which are under tension, individually or together behind their head. By moving the two rear strip portions 3317a and 3317b further apart, the segmented region 3326 expands, resulting in a reduction in hood tension between 2.5 Newtons and 5 Newtons in the unseparated range. When measured with a force sensor, one example indicates a 30% to 50% reduction in hood tension, while another example suggests a reduction of approximately 40%. In other words, for patients with a small head circumference (e.g., 1000), increasing the distance between the two rear strip portions 3317a and 3317b can reduce hood tension from 2 Newtons to 1.2 Newtons. For patients with a large head circumference, increasing the distance between the two rear strip portions 3317a and 3317b can reduce hood tension from 4.4 Newtons to 2.64 Newtons.

[0482] Therefore, the reinforcing arm 3302 can be allowed to move unrestricted along the length of the strip 3301 and be attached to the strip 3301 or may be close to the end of the strip 3301.

[0483] like Figure 70 The configuration shown allows the strip 3301 and the positioning and stabilizing structure 3300 to extend in length. Such extension is not limited by unconnected or non-parallel portions of the strip 3301 and the reinforcing arm 3302, and the extension, particularly the elastic extension, is achieved within the region of the reinforcing arm 3302. This is readily apparent from… Figure 68 The reinforced arm 3302 and Figure 70 (Others are the same, except that strip 3301 is in a stretched state) The length comparison of reinforcing arm 3302 shows that... Figure 70 The reinforcing arm 3302 strip has markings 3321a-d and 3323a-e to indicate the length of strip 3301 relative to the length of the reinforcing arm 3302. By comparison... Figure 68 and Figure 70 The reinforcement arm 3302 extends from marker 3321a to 3321c, and from 3323a to 3323d, while... Figure 68 We can conclude that it remains in an unextended state. Conversely, according to... Figure 70In the extended state, the reinforcing arm 3302 extends only from mark 3321a to mark 3321b and from 3323a to 3323c. Therefore, it is clear that the strip 3301 also extends within or along the area containing the reinforcing arm 3302. However, when the strip 3301 is extended, the reinforcing arm 3302 remains in an unstretched state.

[0484] As will be seen shortly, the positioning and stabilizing structure 3300 may include one or more reinforcing arms 3302. The above discussion has primarily focused on the relationship between the reinforcing arms 3302 and the strips 3301; it should be noted that... Figures 68 to 70 The example shown includes two reinforcing arms 3302, one of which is provided on each corresponding side strip portion 3315 and 3316 of the strip 3301. In the above annotation, although one reinforcing arm 3302 is ultimately referred to, the same applies to two or more reinforcing arms 3302 connected to the mask frame 3310.

[0485] The previously described beneficial property of allowing the strip 3301 to extend relative to the reinforcing arm 3302 allows the patient 1000 to put on and take off the patient interface 3000 together with the positioning and stabilizing structure 3300 without separating any strips or other connectors. This can be helpful for patients 1000 using the device 3000 in a dark bedroom before or after sleep, where the patient does not need to visually connect or disconnect the components to connect or disconnect the patient interface 3000. Instead, the patient 1000 can simply pull open or close the patient interface 3000 and the positioning and stabilizing structure 3300; the sealing formation structure 3100 is also necessary during wear. However, all of this is accomplished through touch, not vision.

[0486] It may be advantageous to separate the gas collection chamber 3200 or the sealing structure 3100 from the positioning and stabilizing structure 3300. For example, it is preferable to be able to clean the gas collection chamber 3200 or the sealing structure 3100 without wetting the positioning and stabilizing structure 3300. For this purpose, it may be necessary to separate these components.

[0487] 6.3.6.5 Reinforce the arm and mask frame

[0488] Figures 47 to 60 The image shows a reinforced arm 3302 and a mask frame 3310, which are further examples of this technology.

[0489] Based on examples of this technology, Figures 47 to 49 as well as Figure 54The figures show a cross-sectional view of the reinforcing arm 3302 and the mask frame 3310, as well as their connection. Near the small-radius bend 3307 of the reinforcing arm 3302, a joint 3356 connects to the extension 3350. Near the small-radius bend 3307, there is also a protruding end 3306 of the reinforcing arm 3302, which holds and stabilizes a pocket-shaped end of a side strip portion 3316 of the structure 3300. In these figures, the mask frame 3310 can be formed around the hook 3353 and a closable portion 3354 of the extension 3350. An opening 3335 can also be formed in the mask frame 3310 near the closable portion 3354. The mask frame 3310 is formed and secured around the closable portion 3354 of the reinforcing arm 3302, and the opening 3335 is formed during the overmolding process. According to this example, the reinforcing arm 3302 can be formed of thermoplastic polyester elastomer, and the mask frame 3310 can be formed of polypropylene. Since thermoplastic polyester elastomer is creep-resistant, it is well-suited for forming the reinforcing arm 3302. Because these materials cannot be integrally bonded, the mask frame 3310 can be overmolded into the reinforcing arm 3302 in this example to form a fixed connection. It should also be noted that in this example, the extension 3350 and the reinforcing arm 3302 can be injection molded as a single unit. The mask frame 3310 and the reinforcing arm 3302 are connected at the corresponding extension 3350 opposite the distal free end 3302.1. The extension 3350 includes a straight section 3351 connected to a bend 3352 and then to a hook 3353. The hook 3353 and a portion of the bend 3352 form a closable portion 3354.

[0490] It should be understood that the engagement point 3356 of the extension 3350 to the reinforcing arm 3302 provides a flexible target point that can be shaped and formed to allow bending in desired directions and angles. Therefore, once the patient interface 3000 is put on, the reinforcing arm 3302 is tensioned by the straps from the positioning and stabilizing structure 3300, and the reinforcing arm 3302 can bend at the engagement point 3356 to maintain a facial contour shape while positioning the mask frame 3310 relative to the desired position of the patient's face.

[0491] Based on examples of this technology, Figure 50 and Figure 51 A perspective view and a detailed perspective view of the reinforcing arm 3302 connected to the mask frame 3310 are shown respectively. Figure 51 The closable portion 3354 is further marked with dashed lines and is covered by the mask frame 3310 to secure the mask frame to the end of the reinforcing arm 3302. Figures 47 to 49The opening 3335 can be seen, forming a channel through which the hook 3353 of the mask frame 3310 and the reinforcing arm 3302 can pass completely.

[0492] Based on examples of this technology, Figure 52 and Figure 53 A top view and a detailed top view of the mask frame 3310 connected to the reinforcing arm 3302 are shown respectively. Figure 52 In the diagram, dimension L represents the length of the reinforcing arm 3302 in the indicated direction. The scale length L of the reinforcing arm 3302 is preferably 114 mm. These views show in detail how the joint 3356 connects the extension 3350 and the reinforcing arm 3302 between the protruding end 3306 and the small radius bend 3307.

[0493] Based on examples of this technology, Figures 55 to 57 The side view, front view, and perspective view of the reinforcing arm 3302 and the mask frame 3310 are shown respectively. Figure 55 In the diagram, dimension H represents the length of the reinforcing arm 3302 in the indicated direction. The scale length H of the reinforcing arm 3302 is 33 mm. The reinforcing arm 3302 and the extension 3350 are formed as a single piece and then connected to the mask frame 3310 by overlaying the closureable portion 3354 of the extension 3350, which is formed relative to the reinforcing arm 3302, onto the mask frame 3310. The extension 3350 adjusts nose droop by rotating relative to or perpendicular to the reinforcing arm 3302. Because the extension 3350 is shorter than the remaining portion of the reinforcing arm 3302, uses less material, and is not hooked to the remaining portion of the reinforcing arm 3302 via a small-radius bend 3307, the bending of the extension 3350 is localized and occurs before the bending of the remaining portion of the reinforcing arm 3302. This reduces the possibility of the seal being compromised.

[0494] Based on examples of this technology, Figure 58 and Figure 59Exploded views and detailed exploded views of the reinforcing arm 3302 and the face mask frame 3310 are shown. The hook 3353 and the closable portion 3354 of the extension 3350 can be separated from the face mask frame 3310. The shape of the hook 3353 and the closable portion 3354 can be seen in these views, and it should be understood that these portions are formed to ensure a stronger mechanical interlock with the face mask frame 3310 when it is overmolded. These views specifically show that the closable portion 3354 is formed by the flare of the hook 3353 to provide a retaining surface for the face mask frame 3310. In another example of the art, the closable portion 3354 includes an opening to confine the reinforcing arm 3302 within the mold during the overmolding process of the face mask frame 3310. The mold can be inserted through this opening to secure the reinforcing arm 3302 when the face mask frame 3310 is overmolded near the reinforcing member. This is highly advantageous because the pressure of the overmolding causes the reinforcing arm to shift during the injection molding process, thus forming a mechanical interlock of the mask frame 3310 that is slightly below the ideal state.

[0495] Based on examples of this technology, Figure 60 A perspective view of the reinforcing arm 3302 is shown. It shows the reinforcing arm 3302 securely connected to the face mask frame 3310 at the front. As mentioned above, the reinforcing arm 3302 includes a hook 3353 and a closable portion 3354 that connects it to the face mask frame 3310 via a mechanical interlock. This permanently connects the reinforcing arm 3302 and the face mask frame 3310. By permanently connecting the reinforcing arm 3302 to the face mask frame 3310, the number of detachable parts is reduced, and the possibility of losing parts when assembling / disassembling the patient interface 3000 for cleaning is reduced.

[0496] 6.3.6.6 Localization and stabilizing structures on the patient

[0497] Figures 71 to 73 An example of this technology is shown. As can be seen, the positioning and stabilizing structure 3300 includes a strip 3301, which is composed of lateral strip portions 3315 and 3316 and a posterior strip portion 3317. The posterior strip portion 3317 further includes two parallel posterior strip portions 3317a and 3317b running along the back of the patient's head. The positioning and stabilizing structure 3300 includes two reinforcing arms (not shown), each contained within the lateral strip portions 3315 and 3316 of the sleeve-like or tubular strip 3301. The reinforcing arms 3302 give the strip 3301 a predetermined or desired shape and / or rigidity, thereby forming the positioning and stabilizing structure 3300. For example, the lateral strip portions 3315 and 3316 of the strip 3301 have a curvature formed to conform to the desired contour of the patient's face (which can be seen from...). Figure 52 ,54 Reference numerals 3323 (reference curvature) for 58 and 60 are formed by reinforcing arms 3302 of various predetermined shapes. In the example above, the positioning and stabilizing structure 3300 is connected to the mask frame 3310, the gas collection chamber 3320, or the sealing structure 3100 that supplies breathable gas (such as air), ultimately pressurizing and supplying pressurized breathable gas into the patient's airway. In the example above, this breathable gas is supplied via a hose or hollow tube 4180 connected to the patient interface 3000. The other end of the vacuum tube 4180 (not shown) is connected to a source of the breathable gas, such as a blower or ventilator that supplies pressurized breathable gas. The patient interface 3000 includes a frame portion or mask frame 3310 to form structural integrity and / or connect to the positioning and stabilizing structure 3300. The positioning and stabilizing structure 3300 is connected to the mask frame 3310, the gas collection chamber 3320, or the sealing formation structure 3100 via a separate connector (not shown) provided by the strip 3301 and / or the reinforcing arm 3302.

[0498] Figures 74 to 77 The characteristics shown are Figures 71 to 73 Similar to, however Figures 74 to 76 as well as Figure 77 The examples given illustrate different connections between the positioning and stabilizing structure 3300 and the mask frame 3310. Each end of the side strip portions 3315, 3316 has a pouch-shaped end 3311, 3313, as shown... Figure 65 and Figure 81 The bag-shaped ends 3311 and 3313 are retained on the reinforcing arm 3302 via protrusions 3306 on the respective reinforcing arms (not shown in the view because they are within the side strip portions 3315 and 3316), as... Figures 47 to 60 As shown. Although in Figures 74 to 77 It is not shown in the image, but it is still necessary to know that in this example... Figure 81 The described end welds 3311.1 and 3313 are used to close the bag-shaped ends 3311 and 3313, thereby supporting the protruding end 3306. The reinforcing arm 3302 is thus permanently mechanically fixed to the mask frame 3310 by overlapping molding, as... Figures 47 to 60 As shown in the relevant section.

[0499] 6.3.6.7 Separable rear strips for positioning and stabilizing structure

[0500] According to one aspect, the structure of the strip 3301 and the positioning and stabilizing structure 3300 is relatively advantageous. In particular, the two elastic strips or posterior strip portions 3317a and 3317b prepared on the back support the head and adjust the vector by appropriately positioning the tension vector, such as by dispersion. The two posterior strip portions 3317a and 3317b can also provide better support and stability and increase elasticity to prevent damage to particularly sensitive areas on the back of the head. The posterior strip portions 3317a and 3317b are used to support the skullcap to maintain position and contact. In one example, depending on the patient's specific head shape and the splitting amount of the posterior strip portions 3317a and 3317b, the upper half of the posterior strip 3317a is located near the parietal bone, while the lower half of the posterior strip 3317b is located near the occipital bone or trapezius muscle fibers (i.e., near the back of the neck or nape). The lower half of the posterior strip 3317b can be configured to contact a location on or below the external occipital protuberance of the patient's head. Unlike previous face shields that required adjustments to material length (shortening or stretching), the tension provided by the positioning and stabilizing structure 3300 can be easily adjusted by opening or closing the relative angle between the two rear strip sections 3317a and 3317b. When the patient interface 3000 wears down, the two rear strip sections 3317a and 3317b on the back of the head can be further separated to reduce the tension of the face shield. To increase the tension, the relative angle between the two rear strip sections 3317a and 3317b is reduced. This adjustment method is suitable for strips with notches, where the tension can only be adjusted via preset increments. TM (For non-breakable terry cloth) The straps need to be tightened and loosened multiple times until the headgear achieves the desired tension, or the straps can be looped around the strap buckles, which makes it easier to increase the headgear tension because the straps are tightened by stretching them as they pass through the buckles. Additionally, patients may worry about incorrect headgear tension or needing to change the headgear tension.

[0501] The two smaller strips or posterior strip portions 3317a and 3317b on the back of the head may be of equal or non-adjustable length unless adjusted by the elasticity of the material or by increasing the tightness by shortening the total length of the side strip portions 3315 and 3316 of the positioning and stabilizing structure 3300. For example, a sliding mechanism (not shown) can be used to allow the strips 3301 to overlap to varying degrees, thereby changing the overall length of the positioning and stabilizing structure 3300. The shoulder strip length is not independently adjustable, allowing the two posterior strip portions 3317a and 3317b to naturally converge at the top of the head. The two posterior strip portions 3317a and 3317b can be symmetrical or asymmetrical. That is, the upper half of the posterior strip 3317a can be naturally fixed at the top of the head, while the lower half of the posterior strip is naturally fixed at the back of the head near or below the occipital lobe. This avoids the strips being too loose, causing the positioning and stabilizing structure 3300 to become unsuitable, and thus requiring manual over-tightening. This could not only cause physical discomfort but also negatively impact treatment compliance. The combined length of the two portions 3317a and 3317b of the rear strap is likely roughly equal to the width of one side strap portion 3315. This is not only for aesthetic purposes but also to provide the patient with a visual indication of how to adjust the rear strap portions 3317a and 3317b when the patient interface 3000 is put on. While the two portions 3317a and 3317b of the rear strap have been described, it is more likely that they will provide adjustments for different degrees of headgear tension. If the strap 3301 is in a neutral and unstretched state, the two portions 3317a and 3317b of the rear strap are partially separated, creating a gap between them, inviting or instructing the patient to adjust the rear strap portions 3317a and 3317b when the patient interface 3000 is put on. This improves the intuitiveness of adjusting the headgear tension and provides visual guidance on how to adjust the headgear tension when the previous mask is unavailable.

[0502] As described above, two or more connectors can be provided, and a positioning and stabilizing structure 3300 can be constructed using three, four, or more independent strips (but not continuous strips 3301). This may complicate assembly, but it can also simplify the manufacturing process. The connectors can be placed at the bifurcation point 3324 between the side strip portions 3315, 3316 and the two rear strip portions 3317a, 3317b, or at the center of the back. The connectors can be made by stitching, welding, bonding, or molding, and can also be infused with high-friction materials to help reduce head movement. High-friction materials include pad printing and silicone printing, used to increase the relative surface friction between the strips 3301, 3317a, 3317b and the patient's skin or hair, maintaining the position of the strips 3301, 3317a, 3317b on the patient's head. High-friction material may be used only on the patient contact surfaces of the rear strip portions 3317a, 3317b, since the reinforcing arm 3302 can perform the function of partially or mostly maintaining the position of the side strip portions 3315, 3316 relative to the patient's face.

[0503] High-friction material can also be incorporated into the inner surface of the posterior or lateral strip portions 3315, 3316, 3317a, and 3317b to prevent the strip from slipping on the patient's face or hair. For the arm or lateral strip portions 3315 and 3316, incorporating high-friction material helps to position and stabilize structure 3300 in the cheek position, while in the posterior strip portion 3317, it prevents the positioning and stabilization of structure 3300 from slipping on the back of the head. This material can be printed, cast, or molded onto the surface or incorporated into joints, or, as described above, sewn or welded. Additionally, elastic yarns from textile materials can be used to reduce slippage.

[0504] The reinforcing arm 3302 can be inserted freely from the opening 3308 near the bifurcation point 3324 of the positioning and stabilizing structure 3300, but not from the button holes 3303 and 3304 near the mask frame 3310 (e.g., Figure 65 (As shown) Insert. Once the reinforcing arm 3302 is inserted, the elasticity of the material can be used to hook the reinforcing arm 3302 back into the opening of the small rear strip portion 3317a or 3317b (upper or lower half). This prevents the reinforcing arm 3302 from moving, thus ensuring it remains in place. Alternatively, the buttonholes 3303, 3304 can be sewn, molded, or otherwise permanently closed to secure the reinforcing arm 3302 within the strip 3301.

[0505] The split area 3326 on the back can include two, three, or more strips for stabilization. A similar positioning and stabilization structure 3300 can be used simultaneously with a full-face mask (covering the nose and mouth) or a nasal mask. Other positioning and stabilization structures on the back of the mask may have two or more strips (the width may be the same as the side strips), with the lower half of the rear strip typically engaging at or below the occipital protuberance of the patient's head. Such a rear strip is non-stretchable and inelastic, but its length is adjustable. Additionally, the rear strip may tend to return to a preset angle to avoid wrinkling or distortion of the convergence point of a single side strip. For example, the preset angle might be a 45° split angle between the two rear strips to support and contact the patient's head, and the rotation of the rear strips relative to each other is used to put on and take off the patient connection, securing the patient connection in a position and providing tension to the closed-shape structure of the patient's face. The two rear strips tend to return to the 45° angle, thus only supporting the back of the patient's head and stabilizing the patient connection, but not maintaining any angle deviating from 45°.

[0506] By using this technology, the provision and use of the reinforcing arm 3302 may affect the length of the strap 3301. This allows the positioning and stabilization structure 3300 to accommodate a wide range of head sizes. This could effectively be a "one-size-fits-all" positioning and stabilization structure 3300, meaning the external shape of the pocket-shaped positioning and stabilization structure 3300 can be more adaptable to patients, even those who have never tried or used a pocket-shaped positioning and stabilization structure 3300 before. This technology can provide a positioning and stabilization structure 3300 that is easier to put on and take off for the patient interface 3000. In particular, this may mean that, unlike some other positioning and stabilization structures, the tension setting will not change and / or be lost when removing the mask 3000. The reinforcing arm 3302 can be shaped to ensure adequate space around the eyes and ears for both comfort and visibility. The fabric of the strap 3301 allows the skin to breathe and sweat naturally, and is free of materials such as silicone, foam, or plastic that generate and retain surface heat and sweat condensation.

[0507] Two elastic strips 3317a and 3317b prepared on the back of strip 3301 can support the patient's head and distribute the applied force, adjustable by distributing and independently changing their position. The two smaller strips or rear strip portions 3317a and 3317b on the back of the head may be of equal length or non-adjustable unless adjusted by the elasticity of the material, or by increasing the tightness by shortening the total length of the strips in the positioning and stabilizing structure 3300.

[0508] 6.3.6.8 Flexible Joint

[0509] Figure 19 , 71Figures 73, 75, 76, and 166 illustrate the connection between the positioning and stabilizing structure 3300 and the frame 3310 associated with the air collection chamber 3200. Specifically, the joint 3305 at the reinforcing arm 3302 and the frame 3310 can be flexible and / or elastically deformable. Therefore, when the patient 1000 wears the closed-shape structure 3100, the structure can adapt to various nasolabial angles (e.g., ...). Figure 2e (As shown). Therefore, it should be understood that the flexibility of the connector 3305 allows the frame 3310, the air chamber 3200, and other related components to move back and forth along a certain axis within the reinforcing arm 3302. In one embodiment of this technology, the frame 3310 and the air chamber 3200 can be rotated about an axis defined between the ends of the reinforcing arm 3302 via the flexible connector 3305. With this arrangement, the closed-shape structure 3100 can form an angle with the lower part of the patient's nose within a wide range of nasolabial angles.

[0510] Depend on Figure 18 , 19 Examples 75, 76, and 166 show that the closure structure 3100 remains below the patient's nose 1000, aligned with the patient's airway, such as the nostrils. The correct positioning of the closure structure 3100 is a crucial factor in effectively using the truncated cone 3140 to close the patient's nostrils, thus minimizing leakage of pressurized gas with minimal holding force. Since the truncated cone 3140 may extend axially from the handle 3150 of the closure structure 3100, it is advantageous to allow for a degree of flexibility in the orientation of the patient interface 3000 relative to the patient's nose for optimal closure. This flexibility is beneficial because typical patient interfaces need to accommodate various nasolabial angles (see...). Figure 2eThis flexibility can be achieved by providing a flexible connector 3305 to the exemplary patient interface 3000. In one example of this technology, the flexible connector 3305 may be positioned between the frame 3310 and the reinforcing arm 3302. In this exemplary arrangement, the frame 3310 may be made of a material that facilitates the bending of the flexible connector 3305 and the reinforcing arm 3302, which positions and stabilizes the structure 3300. In other arrangements, the reinforcing arm 3302 may be bent via an extension 3350, allowing the appropriate positioning of the closed-form structure 3310 to align with the underside of the patient's nose. Additionally, partial bending of both portions is also contemplated. In any anticipated arrangement, the desired outcome is that the patient interface 3000 can rotate relative to the patient's nose, allowing for adaptation of various nasolabial angles. The flexibility provided by the flexible connector 3305 allows the spring pad 3131 to more effectively apply comfortable force to the patient's nostrils or nose. Without the flexible connector 3305, the spring pad 3131 cannot effectively adapt to various nasal wing angles and remain stable, because when the tension of the positioning and stabilizing structure 3300 keeps the closed-form structure 3100 in a closed position aligned with the patient's airway, the handle 3150 and the air collection chamber 3200 will be in a partially or completely folded state.

[0511] The frame 3310 and / or reinforcing arm 3302 are fabricated within a modulus that provides sufficient elasticity for the joint 3305 to be flexible. This allows for a flexible joint 3305 while maintaining sufficient rigidity to ensure effective closure. Furthermore, the frame 3310 and / or reinforcing arm 3302 can also be formed into a flexible structural shape for this region. That is, the frame 3310 and / or reinforcing arm 3302 can be formed into a shape with a degree of flexibility in the region of the joint 3305. This can be achieved by removing these structural parts, reducing their rigidity, and allowing them to bend.

[0512] Another potential advantage of this technology in this respect is the reduction of bending moments associated with the stiffening arm 3302 and the frame 3310. For example... Figure 19 , 71As shown in Figures 73 and 75, the reinforcing arm 3302 can be shaped to conform to the patient's facial contours. Furthermore, when the closure structure 3100 engages with the patient's nostrils, the frame 3310 may shift due to the limited flexibility between the positioning and stabilizing structure 3300 abutting against the closure structure 3100, the air chamber 3200, and the frame 3100. When the patient 1000 puts on the patient interface 3000, the use of a flexible joint 3305 between the frame 3310 and the reinforcing arm 3302 may reduce the bending moments associated with these structures as some of the relevant forces are dissipated into the bending of the joint 3305. This is advantageous because the patient interface 3000 will subsequently experience less force during use, thus reducing wear. Additionally, distributing these forces into the bending of the flexible joint 3305 reduces the bending of the reinforcing arm 3302 and / or the frame 3310. If the reinforcing arm 3302 is made to conform to the shape of the patient 1000's face, the consistency of the curvature will be reduced, leading to discomfort for the patient 1000. Therefore, this method may be advantageous. The same applies to the curvature of the frame 3310, which may cause the closed-shape structure to shift on the patient's nose.

[0513] It should also be understood that the arrangement discussed above may help increase the stiffness of the reinforcing arm 3302. By using a material with sufficient stiffness to make the reinforcing arm 3302 and / or shaping the reinforcing arm 3302 with sufficient stiffness, it can be ensured that the flexible joint 3305 does not shift the closure structure on the patient's nose. That is, proper installation and effective closure can be achieved by using a reinforcing arm 3302 with sufficient stiffness to maintain conformity to the patient's facial requirements, while allowing sufficient displacement of the closure structure 3100 to engage with the patient's nose and achieve effective closure. The reinforcing arm 3302 can be made of a material with a flexural modulus of 180 MPa and a tensile modulus of 180 MPa at 23°C (26). The materials used in its fabrication. It should also be understood that, in one aspect of this technology, the patient interface 3000 may be configured to be elastically deformable only at the closed-form structure 3100 and at the flexible joint 3305 between the frame 3310 and the reinforcing arm 3302.

[0514] As described in this technical example, without the flexible joint 3305, the extension portion 3350 of the reinforcing arm 3302 performs a function similar to that of the flexible joint 3305 described above.

[0515] 6.3.6.9 Tensioning Vectors for Positioning and Stabilizing Structures

[0516] As described above, the exemplary positioning and stabilizing structure 3300 helps to fix the tension vector of the headband on the patient's head, so that the compression vector associated with the closed-shape structure 3100 can be correctly aligned with the patient's nose or nostrils. Figure 72 , Figure 73 , Figure 75 and Figure 76 As shown, vector V is used to indicate the direction and magnitude of the standard force exerted by the closure structure 3100 on the nose of patient 1000. When the closure structure 3100 is implemented with the illustrative positioning and stabilizing structure 3300, the tension of the positioning and stabilizing structure 3300 applied to patient 1000 is sufficient to generate a force with the same direction and magnitude as vector V to push the patient interface 3000 to compress the nose or nostrils of patient 1000. The concept of vector can be explained as follows: In order to properly and / or effectively form a closure at the nostrils of patient 1000, when using the nasal pillow 3130 described in this technical example, the closure structure 3100 should push and compress the patient's nostrils in a direction substantially coaxial with the longitudinal axis of the closure structure 3100 from the individual stem 3150. The magnitude of the force must also be sufficient to allow the closure structure 3100 to close around the nostrils. However, the force should not be too large, causing discomfort or deformation of the relatively soft closure structure. Therefore, the closure structure 3100 should use a force with the same magnitude and direction as vector V. However, suspending the strip 3301 between the eyes and along the patient's nose or between the ears is also impractical. This would be both uncomfortable and harmful to the patient 1000. Two focused forces and vector controls allow the strip 3301 to gently stabilize the mask 3000 while pulling the nasal pillow 3130 into the proper position, thereby creating an airway seal in the patient's airway.

[0517] In the process of transferring the sealing force from certain areas of the patient's face, to overcome the problem of the sealing force needing to have a certain direction and magnitude, the reinforcing arm 3302 and / or frame 3310, as described above, can be used. The reinforcing arm 3302 and / or frame 3310 can act as an intermediary in the process of transferring tension from the positioning and stabilizing structure 3300 to the sealing structure, while also allowing the strip 3301 to be removed from the patient's eyes. That is, due to being under tension, the positioning and stabilizing structure 3300 can generate a very strong force at the end of the individual reinforcing arm 3302 and / or frame 3310. This individual reinforcing arm 3302 and / or frame 3310 can transmit this force, which has the same direction and magnitude as the sealing structure 3100, to its opposite end, that is, the location of the sealing structure 3100. Therefore, the sealing structure 3100 is forced to compress the patient's nose, thereby forming an effective closure. In other words, the reinforcing arm 3302 and / or frame 3310 help to structurally separate and stabilize the positioning structure 3300 and the closed-form structure 3100, while continuing to maintain the appropriate orientation and magnitude of the closing force.

[0518] As described above, in some examples, the strips 3301 of the positioning and stabilizing structure 3300 may surround the reinforcing arm 3302. To facilitate the forces described above for separating and maintaining the sheath-like arrangement of the strips 3301 and the reinforcing arm 3302, the reinforcing arm 3302 may consist of a smooth surface along at least a portion of it. Providing a smooth surface along the reinforcing arm 3302, the strips 3301 of the positioning and stabilizing structure 3300 may extend or contract along the reinforcing arm 3302 in a relatively free and / or low-friction manner. That is, except at the pouch-shaped ends 3311 fixed to the reinforcing arm 3302, the strips 3301 float above the reinforcing arm 3302. Furthermore, by reducing friction along the positioning and stabilizing structure 3300 of the reinforcing arm 3302, other irrelevant and unwanted forces can also be avoided. These other forces could, in turn, cause wear or damage and / or discomfort to the pneumatic seal of the closed-form structure 3100.

[0519] Some previous face mask positioning and stabilization structures featured multi-layered composite strips. The layers of these strips were made of different materials, permanently laminating together strips of varying elasticity. Other previous face mask positioning and stabilization structures permanently connected multiple layers of strips by stitching or adhesive. In contrast, in another example, the positioning and stabilization structure 3300 of this technology has a strip 3301 that can be detachably coupled to the reinforcing arm 3302 (removable). This allows for separate cleaning of the strip 3301 on the reinforcing arm 3302 and the frame 3310. This detachable coupling can be done in a small, confined area (the edge of the reinforcing arm 3302 is close to the frame 3310) by using the pouch-shaped end 3311 of the strip 3301, allowing the strip 3301 to extend approximately its entire length from the point of contact with the frame 3310. Other previous face mask positioning and stabilization structures can use adjusting buckles or Velcro. TM Adjusting the length of one or more headbands (usually by decreasing the length) adjusts the tension of the headbands on the patient's face at the patient interface 3000. Conversely, in another example, the positioning and stabilizing structure 3300 of this technology does not utilize length adjustment to adjust headband tension, thus being particularly beneficial for patients with arthritis in their hands, as they may lack the proper means to adjust the headband tension using an adjusting buckle or Velcro. TM To develop small muscle movement skills that involve tension and adjustment, especially in a dark room.

[0520] 6.3.6.10 Strip Manufacturing

[0521] The positioning and stabilizing structure 3300 is manufactured in a shape (e.g., formed as a single unit, or, in other words, "thoroughly processed" without the need to reduce a large amount of material), thus generating almost no waste. Alternatively, the positioning and stabilizing structure 3300 can also be divided into clips, each of which can be manufactured individually (e.g., by weaving) and then joined together. Figure 132 The demonstration features a single, unified, seamless structure with at least two regions (e.g., the crown section or rear section 210 and the shoulder strips 220), where at least two regions extend from an intersection (the junction of the shoulder strips 220 and the rear section 210), with the strips 220 extending from different angular orientations to the rear section 210. The rear section 210 and the strips 220 are formed in a continuous process (meaning the materials and shapes of the components are executed individually) – this differs from the process of making a piece of material and then cutting it into shape (which is not so much an individual execution). Figure 132 It also demonstrated that the strip 220 could extend to the rear 210 at different angles or directions without the need for stitching or additional forming steps.

[0522] If a knitted component is constructed as a single knitted element that is largely unaffected by additional stitching or welding processes, then it is defined as forming a “single knitted structure,” such as a positioning and stabilizing structure.

[0523] like Figure 133 As shown, strip 220 can form (e.g., through warp knitting, circular knitting, or three-dimensional knitting) a continuous portion for later cutting, as this step can further improve production efficiency.

[0524] Continuously weaving the various parts of the positioning and stabilizing structure has advantages. This is because there are few or no additional manufacturing steps requiring suturing, fusing, or adhering adjacent parts. Therefore, the manufacturing process can reduce strips. The amount of waste can also be reduced, so in fact, there are no sutures between adjacent parts of the positioning and stabilizing structure 3300, and the positioning and stabilizing structure 3300 made of fabric has no significant connections or sutures. This is more comfortable for the patient. Figure 132 It also shows a band 220 that branches or extends at a different angle or direction from the rear portion 210 without requiring suturing or additional forming steps.

[0525] 6.3.6.10.1 Method

[0526] Under this technology, numerous methods can be used to manufacture positioning and stabilizing structures 3300 with minimal waste material production. This technology can produce a single, uniform, seamless positioning and stabilizing structure. Techniques that can produce a single, uniform, seamless structure include mechanical operations involving the interlacing of yarns (e.g., weaving), interlacing and / or winding (including cross-weaving, knotting, and crochet). Another alternative technique is three-dimensional knitting, which can also produce a single, uniform, seamless structure.

[0527] A manufacturing technique under this technology may have one or more characteristics: (1) producing little or no waste; (2) manufacturing positioning and stabilizing structures that make patients feel comfortable; (3) manufacturing suitable positioning and stabilizing structures; (4) manufacturing breathable positioning and stabilizing structures; (5) manufacturing positioning and stabilizing structures that minimize the size of the mask; (6) manufacturing lightweight positioning and stabilizing structures.

[0528] 6.3.6.10.1.1 Interlocking Operation – Knitting

[0529] Consistent with examples using this technology, the positioning and stabilizing structure 3300 is constructed from interlocking operations such as knitting (e.g., spinning or weaving). The positioning and stabilizing structure 3300 is composed of cross-knitting or circular knitting, although other knitting methods are also feasible. Cross-knitting and circular knitting are advantageous because these two knitting methods can be woven into the positioning and stabilizing structure 3300 in a unified, seamless structure. Cross-knitting or circular knitting machines can be used to knit a weft-knitted or warp-knitted fabric. Various knitting processes, including circular knitting and warp or weft cross-knitting, can be used to produce components of the positioning and stabilizing structure. Cross-knitting has several advantages, including but not limited to: (1) the ability to locate and find floats on a positioning and stabilizing structure strip to provide additional cushioning or bulk and / or (2) the ability to add additional spinning loops to the upper or lower surface of a positioning and stabilizing structure strip to create an effect such as a soft terry fabric or to connect with hook and loop belts to knit a complete terry fabric. And / or (3) the ability to weave a 3D gasket fabric construction in a location close to a double-sided fabric construction within a single, uniform positioning and stabilizing structure.

[0530] The positioning and stabilizing structure 3300 is mainly composed of multiple spinning processes, which are mechanically operated to produce a single structure composed of parts with different physical properties through interconnected rings.

[0531] Figure 134 The image shows the raised stripes of the weft-knitted fabric 64, or the direction in which the coils of one stripe connect to the coils of another stripe. Figure 135 The diagram shows the direction of process 85, or the coil woven from a single weave. Figure 136 and 137 The image shows a basic closed-weave fabric 90. Figure 138 The image shows an example of the structure of a warp-knitted fabric, in which the yarn is woven in a curved form in the vertical direction, while being combined with other curved yarns and running with raised stripes, somewhat similar to this process.

[0532] like Figures 136-139As shown, the wavy fabrics 90 and 90-1 are composed of parallel longitudinal loops and transverse stripes. In the weft fabric 100, however, the longitudinal loops rotate perpendicular to the transverse loops. The positioning and stabilizing structure 3300 utilizing this technology is composed of either the wavy fabric or the weft fabric. A wavy fabric, such as a warp-knitted fabric, a Rachel warp-knitted fabric, or a warp-velvet fabric, is more resistant to snagging and easier to manufacture, and may utilize multiple yarns (allowing the use of multiple colors or types of yarn). The weft fabric 100 is composed of a single yarn; however, the use of multiple yarns is also reasonable. The positioning and stabilizing structure 3300 utilizing this technology may be composed of either the wavy fabric or the weft fabric.

[0533] Compared to woven fabrics, knitted fabrics may have different stretch characteristics. Knitted fabrics are more flexible than woven fabrics, which may only stretch in one direction (depending on the yarn). Therefore, they will provide a more comfortable experience for the patient. Knitted fabrics are constructed in a way that allows the fabric to stretch in both directions—that is, the first yarn oriented in the first direction has less elasticity than a yarn stretched in both directions. This construction along the 3300 strips of the positioning and stabilizing structure is more desirable because it allows the strips to extend only in length and not width, or only in width and not length. In addition, knitted fabrics have four-directional extensibility, meaning that the yarns extending in the first and second directions are elastic, so the strips can extend both longitudinally and laterally.

[0534] Figure 142 The example shown illustrates a strip 1200 with textured or longitudinal loops 1250, and also demonstrates how textured or longitudinal loops affect stretch. Knitted fabrics tend to stretch more longitudinally. Therefore, the positioning and stabilizing structure 3300 can be designed to extend in one direction but not in others. For example, if the strip 1200 extends in the width direction A (from the patient's face to the back of the head), it cannot extend in the length direction. This structure can increase the comfort of the positioning and stabilizing structure 3300 while increasing its stability in the length direction. To enable the strip 1200 to more effectively cover the patient's face with the mask in a way that increases the coverage area, the strip 1200 can be configured to extend in one direction but not in others.

[0535] like Figure 140 and 141As shown, the knitted strip 1105 consists of a top 1102, a back 1104, and a bottom 1106. The bottom 1106 forks at the junction forming the top 1102 and the back 1104. The angle of the top 1102 may differ from that of the back 1104; for example, the top 1102 may extend approximately 30-110 degrees, 90 degrees, or to a position perpendicular to the back 1104. The direction of the knit or the knit weave or longitudinal loops 1150 may be changed to accommodate the shape or stretch of the fabric within a certain range. For example, the weave or longitudinal loops 1150 may be adjusted so that the strip bends across the face to avoid obstructing the patient's vision. Additionally, as... Figure 141 As shown, the texture or longitudinal coil 1150 can be bent to the slit as indicated by arrow B in the figure to form the top 1102 and the back 1104. The top 1102 and the back 1104 are configured in this way so that the strip can be better secured to the patient's head, thereby allowing the knitted strip 1105 to cover the patient's face more concentratedly in a way that increases the coverage area.

[0536] The knitted strip 1105 provides support to the patient interface 3000 (such as a nasal mask) on the patient's face. A connector 1120 can be used to attach the strip 1105 to the patient interface 3000, while an air circulation system 4170 delivers breathable air through the patient interface 3000 into the patient's airway. In the example shown, the patient interface 3000 is located below the patient's nose, covering the outer surface of the nose.

[0537] Furthermore, the positioning and stabilizing structure 3300 utilizing this technology is composed of grooves, channels, surfaces, and / or ribs. Such a positioning and stabilizing structure 3300 can be knitted using circular or plain knitting. The grooves or channels are reinforced with a material that is stiffer than the knitted fabric, thereby achieving the effect of reinforcing the positioning and stabilizing structure 3300. Reinforcing the positioning and stabilizing structure 3300 makes the mask more secure on the user's face. Materials used to stabilize the positioning and stabilizing structure 3300 include plastics such as polyamide, polypropylene, polycarbonate, or high-stiffness fabrics such as braided cord. The positioning and stabilizing structure 3300 can be fixed to bony areas of the patient's head, such as the face, occipital region, or top of the head. This reinforcing structure is inserted during the knitting process; for example, stiffer, smoother yarns or rigid polymer elements can be added to the knitted structure during or after the knitting process. Ropes or rigid components can serve to withstand tension and pressure; for example, this positioning and stabilizing structure strip can be tightened during treatment or to secure the mask, or it can help to act as a coupling or fixing medium to attach the positioning and stabilizing structure components to the mask connection.

[0538] Alternatively, the grooves or pipes can be padded to increase comfort. For example, the grooves or pipes can be filled with foam, gel, voile, multi-loop yarn, or other cushioning materials.

[0539] The positioning and stabilizing structure 3300 is knitted in plain or circular stitches, and has an edge. That is, the positioning and stabilizing structure 3300 can have a more delicate structure, so the edges of the yarn can have a fine construction, and the ends of the yarn used to construct the positioning and stabilizing structure 3300 have virtually no edge of this positioning and stabilizing structure component. A major advantage of finishing that makes the positioning and stabilizing structure component delicate is that the yarn is not cut, thus preventing fraying and simplifying the process. By forming a delicate edge, the integrity of the positioning and stabilizing structure 3300 can be maintained or enhanced, thus requiring fewer post-processing steps to (1) prevent the positioning and stabilizing structure component from disintegrating and / or (2) create a clear and soft edge (e.g., during the ultrasonic cutting and sealing of “cushions” using a laminated material made of a combination of sponge and fabric) and / or (3) highlight the aesthetic and durability characteristics of the positioning and stabilizing structure 3300.

[0540] The positioning and stabilizing structure 3300 utilizing this technology is made of regularly or irregularly reinforced knitting. The reinforced knitting directs the first yarn to the correct side (i.e., the side not in contact with the patient, visible once the positioning and stabilizing structure 3300 is installed), while directing the second yarn to the incorrect side (i.e., the side in contact with the patient, invisible once the positioning and stabilizing structure 3300 is installed). In other words, the yarn exposed on the correct side may differ from that exposed on the incorrect side. For example, the yarn on the correct side may have a seemingly comfortable appearance, while the yarn on the incorrect side may have a more comfortable feel for the patient's skin. Furthermore, the yarn on the correct side may have better sweat absorption, while the yarn on the incorrect side may have less sweat absorption. For example, the yarn on the correct side contains more of a more absorbent microfiber, while the yarn on the incorrect side contains more of a less absorbent non-microfiber.

[0541] For simplicity, the positioning and stabilizing structure 3300 can be manufactured into a uniform knitted structure with consistent materials and characteristics. However, it can also be manufactured seamlessly into a uniform structure comprising parts with different physical properties. These parts may exhibit, but are not limited to, different levels of strength, abrasion resistance, elasticity, enhanced durability, and better or worse moisture absorption, sweat absorption, water absorption, breathability, liquid permeability, stretchability or stretch resistance, compression, cushioning, support, stiffness, resilience, fit, or form. The construction of each part is designed to exhibit variations in directional stretching, such as four-way or two-way stretching, customized stretch resistance levels, or no stretching. This can be achieved, but is not limited to, by selecting specific yarns or knitting construction types.

[0542] The positioning and stabilizing structure 3300, as a unified seamless structure, can be composed of one component with uniform characteristics or two or more components with different characteristics. The components of these two or more positioning and stabilizing structures may differ due to the use of two or more different yarns with inconsistent twist, fineness, fiber composition, etc., thus giving the positioning and stabilizing structure 3300 different physical properties. The components of two or more positioning and stabilizing structures may differ due to the use of two or more different knitting stitching methods, thus giving these two components unique physical properties.

[0543] Given that one part may use elastic fibers or polybutylene terephthalate (PPT) to enhance elasticity, other parts may use nylon or polyester to enhance durability. Similarly, to meet the needs of customized cushioning and stiffness or mass production, one part of the positioning and stabilizing structure 3300 may contain yarns of a certain fineness, while other parts may be composed of yarns of different fineness, curvature, or texture.

[0544] Two or more components within a positioning and stabilizing structure are joined using a hanging needle or other stitching technique, for example, to seamlessly connect a first part to a second part. This is achieved by first knitting the first part, then using a hanging needle to sew the connection between the first and second parts, and finally knitting the second part. The hanging needle is used to seamlessly connect sections between longitudinal loops, especially when using a narrow-tube circular knitting machine.

[0545] The positioning and stabilizing of structural components are made ingenious by their seamless connections. If woven from undyed yarn, this would be achieved through knitting with yarn containing water-soluble fibers. These water-soluble fibers allow the fabric to shrink during the dyeing process and provide neat, complete edges, reducing the need for additional edge stitching.

[0546] To improve production efficiency, knitting machines can also be used to assemble a series of positioning and stabilizing structural connecting components, such as strips or top parts. That is, a knitting machine can form a single component that contains multiple positioning and stabilizing structural parts. Each positioning and stabilizing structural part may be generally the same in shape and size. Furthermore, the parts arranged sequentially on each positioning and stabilizing structure may differ in shape and size. Moreover, to allow different parts of the positioning and stabilizing structure (such as strips) to be separated without cutting, a knitting release area (which may contain, for example, soluble yarn, loose knitting yarn, fine-grained guard yarn, tearable placeholder yarn, etc.) can be knitted into a series of positioning and stabilizing structural components.

[0547] 6.3.6.10.1.1.1 Variable warp and weft densities of fabrics

[0548] In another example, the warp and weft density of a fabric can vary throughout the fabric to enhance comfort, fit, and / or performance. For instance, the warp and weft density may be higher in areas requiring greater stiffness (e.g., the cheek area and occipital region). However, in areas where stiffness requirements are lower (e.g., along the loops of the strip), the warp and weft density may be lower, making the material more flexible.

[0549] Therefore, the warp and weft density and stiffness of a fabric may be determined by the type of yarn, the type of stitch (e.g., a cross stitch may be stiff), and the distance between the stitches.

[0550] 6.3.6.10.1.1.2 Yarn

[0551] Yarn can be used to create the positioning and stabilizing structure 3300 of this technology. The yarn may be synthetic, twisted, or filled, and may be derived from, but is not limited to, nylon, polyester, acrylic, rayon, or polypropylene. The yarn may be conventional staple fiber yarn, microfiber, or a combination of both. The yarn may contain an elastic fiber or monofilament to provide stretch and recovery properties, such as fibers bearing the Lycra trademark from DuPont. The yarn may be derived from synthetic materials or natural fibers, such as cotton, wool, or bamboo, or natural monofilaments, such as silk.

[0552] The yarn used to construct any component for positioning and stabilizing a structure may be formed from monofilament fibers or a combination of monofilaments; that is, multifilament.

[0553] The yarn may consist of individual filaments made of different materials. The yarn may also consist of filaments each composed of two or more different materials, such as a striped sheath configuration or a bicomponent yarn consisting of two halves of filaments made of different materials. Different degrees of crimping and curling, as well as different fineness, can affect the positioning and stability of the structure 3300.

[0554] The materials used to construct the positioning and stabilizing structural components 2900 may be recyclable or biodegradable, and the yarns may include recyclable or biodegradable fibers or filaments.

[0555] Areas of the positioning and stabilizing structure 3300 with greater abrasion resistance (e.g., but not limited to areas in contact with the patient's pillow), particularly those located at the back of the head or neck, may be manufactured more densely, thus being heavier and less prone to stretching. Conversely, this area may withstand greater accumulation of sweat moisture, and therefore may require a thin, strong, mesh-like structure with custom-designed perforations. In this case, only abrasion resistance of the yarn itself may be necessary.

[0556] 6.3.6.10.1.23D 3D Printing

[0557] In another example, the positioning and stabilizing structure 3300 might be produced using a 3D printer. For example... Figure 143 As shown, a single 3D printer may be used to print several continuous chain strips 2802, thus forming a flexible 3D printed fabric 2804. (See details...) Figure 144 This forms a positioning and stabilizing structure 2900, which includes a reinforcing arm 3302. The reinforcing arm 3302 includes a hole 2922 through which a chain strap can pass when the fabric 2804 is printed and integrated with the reinforcing arm 3302. The reinforcing arm 3302 can be made of any suitable material (e.g., a polymer such as nylon 12, or a sintered solid derived from metal powder, or any other material that can be used in additive manufacturing processes). With advancements in additive manufacturing technology, the material choices for 3D printed fabrics are expected to become more extensive, including the selection of rigid components such as the reinforcing arm 3302. The structure can be contained within the material itself or through its shape, form, or structure.

[0558] In addition, such as Figure 145 As shown, a 3D printed strip may be integrated into the holes 2912(1) and 2914(1) of the convex and concave clamps 2912 and 2914.

[0559] 6.3.6.10.2 Formation and completion of strips

[0560] Figure 79 and Figure 80A view showing strip 3301 at an intermediate step in production. In this example, the exemplary strip 3301 shown is of its original length, without the production braiding material being cut to a certain length using the methods and processes described above. For example, a pair of buttonholes 3303 can be seen at the far left end of strip 3301; however, after completion, only one buttonhole will remain at that end because the original strip will be cut between these buttons to produce the desired braiding. Figure 81 The bands shown in the image. Furthermore, they form as... Figure 79 The weaving process of the original length of strip 3301 shown in the image forms multiple split sections 3326 along the length of the strip. However, as... Figure 81 The completed strip 3301 shown in the image consists of only one cleaved region 3326. This is again because during the finishing process, strip 3301 will be cut into sections such as... Figure 79 Cut between the rightmost buckle hole 3303 shown in the image to... Figure 79 The original length of strip 3301 shown in the image is divided into multiple strips.

[0561] According to one example of the technology, a warp marking machine with multiple bars can be used to form chains in the fabric to create stripe 3301. According to another example, stripe 3301 can be formed using a Comez machine with six bars, which connects the two side stripe portions 3315, 3316 to the two central back stripe portions 3317a, 3317b. Adding more bars to the Comez machine allows for more weaving directions to be accommodated. The weaving process can also include forming stripe 3301 at the bifurcation point 3324 using a different weave. The material of stripe 3301 can include a warp and weft density of 1740. The sequence of pattern types for weaving stripe 3301 can be as follows: regular, then buttonhole, then regular, then split, then regular, then buttonhole, then regular again. Subsequent stripes 3301 are then woven in the same sequence, proceeding again for each produced stripe 3301.

[0562] In one example of this technology, the needle used to braid the strip 3301 can be a double helical winding.

[0563] To further increase strength at potential break points, strips 3301 can be formed at these points using special stitching. Potential break points may include snap holes 3303, snap holes 3304, and bifurcation points 3324. Furthermore, additional threads can be woven along the middle of the strips 3301 for additional reinforcement.

[0564] Figure 80 Displaying the section cut off at 80-80 degrees along the line. Figure 79A cross-sectional view of the side strip portion 3316. The bifurcation point 3324 can be seen to indicate the split region 3326 of the side strip portion 3316 and the division between the upper rear strip portion 2217a and the lower rear strip portion 3317b.

[0565] Figure 79 The dimensions L1 to L6 of various features of the strip 3301 are also indicated. L1 indicates the distance between the buckle hole 3303 of one strip 3301 and the buckle hole 3303 of an adjacent strip. In one embodiment of the present technology, L1 can be approximately 515 mm. L2 indicates the distance between the buckle holes 3303 of the same strip 3301, and according to one embodiment, this value can be approximately 500 mm. L3 indicates the length of the split region 3326, and in one embodiment of the present technology, this length can be approximately 200 mm. L4 can indicate the distance between adjacent buckle holes 3303 of adjacent strips 3301, and in one instance can be approximately 15 mm. L5 can indicate the width of the buckle hole 3303 and in one instance can be approximately 5 mm. L6 can indicate the width of the strip 3301 and in one instance can be approximately 15 mm.

[0566] Figures 81 to 83 This displays a view of the completed strip 3301 according to an example of this technology. (As shown in...) Figure 81 As can be seen, each end of the strip 3301 has only one split region 3326 and only one fastening hole 3303. Therefore, it should be understood that, according to the embodiment of this technology, this strip 3301 is cut from... Figure 79 The strip 3301 shown in the image is cut and completed. Furthermore, in... Figure 81 The image shows a strip identifier 3357 formed on strip 3301 in the form of, for example, a company logo or artwork. Strip identifier 3357 can be formed by pad printing or ultrasonic welding. If strip identifier 3357 is formed by ultrasonic welding, this can help open the rear strip portions 3317a and 3317b at the bifurcation point 3324 so that the patient can unfold the rear strip portions 3317a and 3317b to ensure ideal installation and strip tension.

[0567] Figure 81End weld points 3311.1 and 3313.1 are also shown. As described above, the side strip portion 3316 can be woven into a hollow or tubular shape. Therefore, the end is open unless closed by, for example, welding to prevent breakage along the open end. End weld points 3311.1 and 3313.1 can be formed by ultrasonic welding to seal the loose fibers of strip 3301. Although ultrasonic welding can reduce the elasticity of the fibers including strip 3301, it can be used to reduce wear at the end and increase strength at high pressure points. Because end weld points 3311.1 and 3313.1 are close to the respective bag-shaped ends 3311 and 3313, the end welds provide strength for the strip 3301 to be held to the reinforcing arm 3302 at the respective protruding ends 3306 of the reinforcing arm. It should be understood that, according to one example of the technology, the bag-shaped ends 3311 and 3313, and their corresponding end welds 3311.1 and 3313.1, are the main components of the strip 3301 used to retain and / or anchor to the reinforcing arm 3302. After extended use, the strip 3301 may lose its elasticity; however, it should be understood that by cleaning and drying the strip 3301, at least some or all of this elasticity can be restored.

[0568] The StretchWise™ headband supplied by Fisher & Paykel™ for the Pilaio™ face mask features a rigid, detachable central connection between a rigid, plastic hook-shaped end of the headband strap and a rigid, plastic vertical bar located on the face mask frame. In contrast, a strap 3301 in one embodiment of this technology does not have a rigid, detachable connection between the strap 3301 and the face mask frame 3310, which avoids, for example, creep and breakage of the hook-shaped end after repeated engagement and disengagement of the rigid components. Significant force is required to substantially deform the rigid hook-shaped end of the StretchWise™ headband to engage or disengage it from the rigid bar. In contrast, the reinforcing arm 3302 of this techno...

Claims

1. A patient interface for providing an airflow to a patient at a therapeutic pressure above ambient air pressure throughout the patient's respiratory cycle to treat sleep apnea, said patient interface comprising: A frame made of a first material, the frame having a connection port, and the frame having a first set of vent holes located on a first side of the connection port and a second set of vent holes located on a second side of the connection port opposite to the first side. A sealing structure is removably connected to the frame to at least partially form an air chamber. The sealing structure is configured to contact and seal with the patient's face during use to deliver the airflow to the patient's nostrils. The sealing structure is also configured to expose the patient's mouth during use. The sealing structure is made of a second material that is more flexible than the first material. A tube, which is connected to the frame at the connection port without bending, is configured to guide airflow into the air chamber for the patient to breathe; A pair of reinforcing arms, each made of a third material that is more flexible than the first material but less flexible than the second material, are connected to the frame. and A strip, made of textile material, having a pair of length-adjustable side strip portions, each length-adjustable side strip portion being removably connected to a corresponding reinforcing arm in the reinforcing arm, the strip having a length-adjustable upper strip portion positioned between and connected to each of the length-adjustable side strip portions, the strip having a rear strip portion positioned between and connected to each of the length-adjustable side strip portions, and forming a gap between the length-adjustable upper strip portion and the rear strip portion.

2. The patient interface according to claim 1, wherein a pair of mesh portions are located on the frame on the respective sides of the connection port, and the first set of vents and the second set of vents are formed by the respective mesh portions.

3. The patient interface of claim 1, wherein the tube is permanently connected to the frame at the connection port.

4. The patient interface of claim 1, wherein a sleeve is overmolded onto the tube, and in, The cover is attached to the frame at the connection port by overmolding.

5. The patient interface according to claim 1, wherein the first material and the third material are not integrally bonded.

6. The patient interface of claim 1, wherein the sealing structure includes a nasal pillow configured to contact and seal against the underside of the patient's nose at a corresponding nostril in the patient's nostril.

7. The patient interface of claim 1, wherein the sealing structure includes a nose pad.

8. The patient interface of claim 1, wherein the sealing structure includes a single hole configured to guide the airflow into the patient's two nostrils during use.

9. The patient interface according to claim 1, wherein, The reinforcing arms are individually attached to the frame.

10. The patient interface of claim 1, wherein the frame includes a channel portion and the sealing formation includes a tongue configured to insert into the channel portion when the sealing formation is removably attached to the frame.

11. The patient interface of claim 1, wherein the frame is symmetrical across the first plane. in, Each reinforcing arm includes a first curve such that a first portion of each reinforcing arm extends away from the first plane at the first curve, and Each of the reinforcing arms includes a second portion extending from the first portion, the second portion having a second curve such that the surface of the second portion facing the first plane is concave, and configured to be positioned against a corresponding cheek in the patient's cheek during use.

12. The patient interface of claim 11, wherein the second portion of each reinforcing arm is bent upward such that, in use, a corresponding side strip portion of the length-adjustable side strip portion is oriented between the corresponding patient's eye and ear.

13. The patient interface of claim 1, wherein the textile material is elastically stretchable.

14. The patient interface of claim 1, wherein the length-adjustable side strip portion is sized such that the length-adjustable upper strip portion, the rear strip portion, and the gap are located behind the patient's ear during use.

15. The patient interface of claim 1, wherein the length-adjustable side strip portion, the length-adjustable upper strip portion, and the rear strip portion are sized such that the length-adjustable upper strip portion and the rear strip portion are separated from each other at a position above the patient's ear during use.

16. The patient interface of claim 1, wherein the length-adjustable upper strip portion is configured to engage the patient's head across the parietal bone during use, and the rear strip portion is configured to engage the patient's head near the occipital bone during use.

17. The patient interface of claim 1, wherein each reinforcing arm includes a closable portion, and the frame is overmolded around the closable portion of each reinforcing arm.

18. The patient interface according to claim 1, wherein, The reinforcing arm and the frame are integrally integrated.

19. The patient interface of claim 1, wherein each reinforcing arm includes a main body portion and an extension portion extending from said main body portion and connected to said frame, and in, The extension portion is narrower than the main body portion.

20. The patient interface of claim 1, wherein each length-adjustable side strip portion includes a sleeve portion, and each reinforcing arm extends into the sleeve portion of the corresponding side strip portion of the length-adjustable side strip portion.

21. The patient interface of claim 1, wherein the textile material is flexible, such that the distance between the length-adjustable upper strip portion and the rear strip portion is adjustable during use.

22. The patient interface according to claim 1, wherein the second material is silicone resin.

23. The patient interface of claim 22, wherein the sealing formation further comprises a base removably connected to the frame.

24. The patient interface of claim 23, wherein the base is made of silicone resin with a higher hardness than the silicone resin of the remainder of the sealing structure.

25. The patient interface of claim 24, wherein the base and the frame are configured to be removably connected by an audible snap-fit.

26. The patient interface of claim 23, wherein the frame includes an edge extending away from the frame in a direction opposite to the connection port, the edge forming an opening, and in, The inner periphery of the base is configured to surround and seal the outer periphery of the edge when the base is removably attached to the frame.

27. The patient interface of claim 1, wherein each reinforcing arm is connected to a corresponding side of the frame via an overmolded connection.

28. The patient interface of claim 1, wherein the tube includes a rotary connector located at the end of the tube opposite to the frame.

29. The patient interface of claim 1, wherein a visual indicator is formed on the outer surface of the sealing structure to indicate the orientation of the sealing structure for assembly onto the frame.

30. The patient interface according to claim 1, wherein: The tube is permanently connected to the frame at the connection port; The first material and the third material cannot be integrally bonded; The reinforcing arms are individually connected to each other on the frame. The frame includes a channel portion, and the sealing structure includes a tongue portion configured to insert into the channel portion when the sealing structure is removably attached to the frame. The frame is symmetrical across the first plane. Each reinforcing arm includes a first curve such that a first portion of each reinforcing arm extends away from the first plane at the first curve. Each reinforcing arm includes a second portion extending from the first portion, the second portion having a second curve such that the surface of the second portion facing the first plane is concave, and configured to be positioned against a corresponding cheek in the patient's cheek during use. The second portion of each reinforcing arm bends upward, such that the corresponding side strip portion in the length-adjustable side strip portion is oriented between the corresponding patient's eye and ear during use; The textile material is elastic and stretchable. The adjustable side strip is sized such that the adjustable upper strip, the rear strip, and the gap are located behind the patient's ear during use. The dimensions of the adjustable side strip, the adjustable upper strip, and the rear strip are designed such that the adjustable upper strip and the rear strip are separated from each other above the patient's ear during use. The adjustable upper strip is configured to cross the parietal bone and engage with the patient's head during use, and the posterior strip is configured to engage with the patient's head close to the occipital bone during use. Each reinforcing arm includes a closable portion, and the frame is overmolded around the closable portion of each reinforcing arm. Each reinforcing arm includes a main body portion and an extension portion extending from the main body portion and connected to the frame. The extended portion is narrower than the main body portion. Each length-adjustable side strip section includes a sleeve portion, and each reinforcing arm extends into the sleeve portion of the corresponding side strip section of the length-adjustable side strip section. The textile material is flexible, allowing the distance between the length-adjustable upper strip and the rear strip to be adjusted during use. The second material is silicone resin. The sealing structure also includes a base that is removably connected to the frame. The frame includes an edge extending away from the frame in the opposite direction to the connection port, the edge forming an opening. The inner periphery of the base is configured to surround and seal the outer periphery of the edge when the base is removably attached to the frame, and The tube includes a rotary connector located at the end of the tube opposite to the frame.

31. The patient interface according to claim 30, wherein: A pair of mesh portions are located on the frame on the corresponding sides of the connection port, and form the first set of vent holes and the second set of vent holes through the corresponding mesh portions. The sealing structure includes a nasal pillow configured to contact and seal against the underside of the patient's nose at the corresponding nostril. The base and the frame structure are configured to be removably connected by an audible snap-fit ​​mechanism, and A visual indicator is formed on the outer surface of the sealing structure to indicate the orientation of the sealing structure for assembly onto the frame.

32. The patient interface according to claim 30, wherein: The sealing structure includes a nose pad, and The base is made of silicone resin with a higher hardness than the silicone resin of the rest of the sealing structure.

33. The patient interface according to claim 1, wherein: The tube is permanently connected to the frame at the connection port. The sealing structure includes a nasal pillow configured to contact and seal against the underside of the patient's nose at the corresponding nostril. The reinforcing arms are individually connected to each other on the frame. The frame is symmetrical across the first plane. Each reinforcing arm includes a first curve such that a first portion of each reinforcing arm extends away from the first plane at the first curve, and Each reinforcing arm includes a second portion extending from the first portion, the second portion having a second curve such that the surface of the second portion facing the first plane is concave, and configured to be positioned against a corresponding cheek in the patient's face during use. The second portion of each reinforcing arm bends upward, such that, during use, the corresponding side strip portion of the length-adjustable side strip portion is oriented between the corresponding patient's eye and ear. The dimensions of the length-adjustable side strip, the length-adjustable upper strip, and the rear strip are designed such that the length-adjustable upper strip and the rear strip are separated from each other above the patient's ear during use. The adjustable-length upper strip is configured to cross the parietal bone and engage the patient's head during use, and the posterior strip is configured to engage the patient's head close to the occipital bone during use. Each reinforcing arm includes a main body portion and an extension portion extending from the main body portion and connecting to the frame. The extended portion is narrower than the main body portion. The textile material is flexible, allowing the distance between the length-adjustable upper strip and the rear strip to be adjusted during use. The second material is silicone resin. The tube includes a swivel connector located at the end of the tube opposite to the frame, and A visual indicator is formed on the outer surface of the sealing structure to indicate the orientation of the sealing structure for assembly onto the frame.

34. The patient interface according to claim 1, wherein: The tube is permanently connected to the frame at the connection port. The sealing structure includes a nose pad. The sealing structure includes a single hole configured to guide the airflow into both nostrils of the patient during use. The reinforcing arms are individually connected to each other on the frame. The frame is symmetrical across the first plane. Each reinforcing arm includes a first curve such that a first portion of each reinforcing arm extends away from the first plane at the first curve. Each reinforcing arm includes a second portion extending from the first portion, the second portion having a second curve such that the surface of the second portion facing the first plane is concave, and configured to be positioned against a corresponding cheek in the patient's face during use. The second portion of each reinforcing arm bends upward, such that, during use, the corresponding side strip portion of the length-adjustable side strip portion is oriented between the corresponding patient's eye and ear. The dimensions of the length-adjustable side strip, the length-adjustable upper strip, and the rear strip are designed such that the length-adjustable upper strip and the rear strip are separated from each other above the patient's ear during use. The adjustable-length upper strip is configured to cross the parietal bone and engage the patient's head during use, and the posterior strip is configured to engage the patient's head close to the occipital bone during use. Each reinforcing arm includes a main body portion and an extension portion extending from the main body portion and connecting to the frame. The extended portion is narrower than the main body portion. The textile material is flexible, allowing the distance between the length-adjustable upper strip and the rear strip to be adjusted during use. The second material is silicone resin. The tube includes a swivel connector located at the end of the tube opposite to the frame, and A visual indicator is formed on the outer surface of the sealing structure to indicate the orientation of the sealing structure for assembly onto the frame.

Images