Hygienic mask with seal-forming structure

Abstract

A mask for use at an operating pressure substantially equal to atmospheric pressure includes a main body having a three-dimensional shaped chamber configured to receive a user's mouth and nares and to operate at the operating pressure. The mask further includes a nose seal portion having an uppermost portion that contacts a user's nose along a user's sagittal plane and around at least a portion of the user's nares on a lower side of the user's nose below a user's nasal ridge. The mask can include a positioning and stabilizing structure to provide a force to hold the seal-forming structure in place against the user. In use, a portion of the positioning and stabilizing structure directly contacts the user's face between the user's lip inferior and mental protuberance.

Description

[0001] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights.

[0002] 1. Cross-references to related applications

[0003] This application claims the benefit of U.S. Application No. 17 / 161,846, filed January 29, 2021, which claims the benefit of Australian Provisional Application No. 2020903106, filed August 31, 2020, the entire contents of which are incorporated herein by reference. 2 Background Technology 2.1 Technical Field

[0006] This technology relates to face shields or user interfaces, and more particularly, but not exclusively, to sanitary face shields.

[0007] 2.2 Description of relevant technologies

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

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

[0010] When we inhale, airborne particles enter our airways. These particles can include dirt, bacteria, viruses, or other debris that can harm a person. Similarly, people exhale particles (e.g., droplets, aerosols, etc.). These particles may contain bacteria, viruses, or other debris that can harm others who eventually inhale (or otherwise come into contact with) the particles.

[0011] People can wear masks to prevent particles from entering and / or leaving their airways. These masks are called sanitary masks.

[0012] Hygienic face masks, such as those worn by practicing physicians (e.g., during surgery), can have several drawbacks. Known hygienic face masks typically have a perimeter extending over the user's nose (e.g., sometimes on the ridge and / or bridge of the nose), over the cheeks (e.g., near or across the cheekbones), and under the chin. Often, such masks do not conform well to the contours of the user's face around the nose and cheek areas, creating one or more spaces between the perimeter of the mask and the surface of the user's face. This can be more noticeable when the user is moving parts of their face (e.g., when speaking). When the user exhales, some of the exhaled air escapes through this space. This can lead to dry eyes in the user. Furthermore, if the user is wearing glasses (e.g., prescription glasses, sunglasses, safety glasses, etc.), the exhaled air being directed towards the user's eyes is particularly inconvenient, as the exhaled air can cause fogging of their glasses.

[0013] Some existing hygiene masks attempt to minimize this problem by providing a flexible metal component in the upper part of the mask (e.g., the portion configured to contact the ridge of the user's nose). This flexible metal component can be deformed by the user to conform to the shape of their nasal ridge. However, this solution is often only partially successful, and the aforementioned spaces or gaps will still exist to some extent. In other words, while the amount of exhaled air directed towards the user's eyes may be reduced, the user may still experience dry eyes and / or fogging of their glasses.

[0014] Users can wear their glasses at different angles on their noses in an attempt to reduce fogging. However, changing the angle and / or position of the glasses may impair a user's vision because the user is no longer seeing directly through the glasses.

[0015] Similarly, users may wear glasses at different positions along their nasal ridge. For example, a user may wear their glasses below their nasal ridge (e.g., closer to the nasal tip). In some cases, users may wear their glasses on top of a hygienic mask in an attempt to reduce fogging (e.g., making the edge of the mask further away from the nasal tip than where the glasses contact the user's nose). However, this may be uncomfortable for the user and / or may prevent the glasses from sitting snugly on the user's nose.

[0016] Hygiene masks that extend across the user's nasal ridge may have other limitations. Many such masks can be bulky and may reduce the user's field of vision below the horizontal plane. Some potential users may also be limited by the size of traditional masks and therefore avoid using them. In some other cases, masks with a large coverage area on the face result in a large amount of warm air being trapped between the mask and the user's face due to the temperature and humidity of exhaled air.

[0017] One aspect of this technology is to provide a face mask that overcomes or improves upon at least one problem of existing face masks.

[0018] Alternatively, one aspect of this technology is to at least provide the public with useful options. 3. Summary of the Invention

[0020] This technology aims to provide a medical device for limiting airborne particles, which has one or more improvements in comfort, cost, efficacy, ease of use and manufacturability.

[0021] A first aspect of this technology relates to a device for limiting the diffusion of airborne particles by limiting particles inhaled into a user's airway and by limiting particles exhaled into the environment.

[0022] Another aspect of this technology relates to a method for limiting the diffusion of airborne particles by limiting particles inhaled into a user's airway and by limiting particles exhaled into the environment.

[0023] One form of this technology includes forming a sealed mask (e.g., a sanitary mask) around the user's nostrils.

[0024] One form of this technology includes a face mask (e.g., a sanitary face mask) that forms a seal with the front and sides of the periphery of the wing base of the user's nose.

[0025] Another form of this technology includes a face mask comprising a foam or fabric body and a sealing structure made of foam.

[0026] Another form of this technology includes a hygienic mask that does not touch the user's nose above the larger pterygoid cartilage and does not extend below the user's chin.

[0027] One form of this technology includes a face mask comprising:

[0028] The main body, configured to surround the user's nostrils and mouth; and

[0029] Positioning and stabilizing the structure to provide force that holds the main body in the proper position under the user's head;

[0030] Another form of this technology includes a face mask (e.g., a sanitary face mask) that includes a body forming a cavity configured to receive the user's mouth and nostrils at substantially atmospheric pressure.

[0031] Another form of this technology includes a face mask (e.g., a sanitary face mask) configured to filter inhaled and exhaled air and direct exhaled air away from the user's eyes.

[0032] Another form of this technology includes a face mask (e.g., a sanitary face mask) configured to seal the user's face and limit airflow leakage from the mask's chamber.

[0033] Another form of this technology includes a face mask configured to seal the user's face and prevent airflow between the outer periphery of the mask and the user's skin, the face mask including a permeable body configured to allow inhaled and exhaled air to pass through.

[0034] Another form of this technology includes a face mask comprising:

[0035] The main body; and

[0036] A sealing structure is attached to the body and is configured to form a seal around the inlet of the airway of the household.

[0037] In some forms: a) the body is configured to filter out particulate contaminants during use; b) the mask is configured for use in a hygienic environment; and / or c) the sealing structure is configured to form a seal around the user's mouth and around the user's nostrils.

[0038] Another form of this technology includes a face mask comprising:

[0039] main body;

[0040] A sealing structure, attached to the body, configured to form a seal around the user's mouth and around the user's nostrils; and

[0041] Positioning and stabilizing the structure to provide force that holds the sealing structure in the proper position on the user's head.

[0042] Another form of this technology includes a face mask comprising:

[0043] The main body, which defines the chamber; and

[0044] The sealing structure includes a cantilever structure that extends from the body toward the user's face during use. The cantilever structure is configured to form a seal around the lower periphery of the user's nose, and the sealing structure is further configured to form a seal around the user's mouth.

[0045] At least a portion of the main body is configured to allow air to enter and exit the chamber.

[0046] The mask further includes positioning and stabilizing structures to provide forces that hold the sealing structure in place on the user's head;

[0047] In the example:

[0048] a) The main body includes ports through which air can enter and exit the chamber;

[0049] b) At least a portion of the body is porous, allowing air to enter and exit the chamber;

[0050] c) The sealing structure includes a portion configured to at least partially seal the user's face between the chin and under the lips;

[0051] d) The cantilever structure seals the alar ridge directly under the user's face;

[0052] e) The cantilever structure is sealed to the user's face via the lip;

[0053] f) The sealing structure does not form a seal above the lips, directly below the user's nasal septum and nostrils;

[0054] g) A portion of the cantilever structure extends approximately 20 mm from the main body;

[0055] h) The main body is formed of spacer fabric;

[0056] i) The main body forms a cup shape;

[0057] j) The main body is formed of at least one flat sheet;

[0058] k) The main body includes at least one fold.

[0059] h) The main body is formed of thermoforming material;

[0060] m) The upper center of the periphery of the main body is equipped with plastically deformable elements;

[0061] n) The mask is provided with at least one replaceable filter element;

[0062] o) At least one filter element is provided into the interior of the chamber;

[0063] p) At least one filter element substantially covers the entire inner surface of the body;

[0064] q) The positioning and stabilizing structure includes two elastic rings, each configured to engage one of the user's ears;

[0065] r) An elastic ring is connected to the body along at least most of its circumference;

[0066] s) An elastic ring is attached to the body around substantially the entire periphery; and / or

[0067] The positioning and stabilizing structure includes at least one strap that passes around the back of the user's head.

[0068] Another form of the technology includes a mask used at an operating pressure substantially equal to atmospheric pressure, the mask comprising:

[0069] The body defines a chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils; and

[0070] A sealing structure configured to form a seal against the user's face during use, the sealing structure comprising:

[0071] A nasal seal, comprising a cantilever structure extending from the body toward the user's face during use, the cantilever structure being configured to form a seal around the front and sides of the periphery of the wing base of the user's nose, and

[0072] A mouth seal portion configured to at least partially form a seal around the user's mouth.

[0073] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0074] Positioning and stabilizing the structure to provide force that holds the sealing structure in place on the user's head.

[0075] At least a portion of the main body is configured to allow air to enter and exit the chamber.

[0076] In some examples: a) the body includes a port through which air can enter and exit the chamber; b) the body is substantially impermeable and air can only enter and exit the chamber through the port during use; c) at least a portion of the body is permeable, such that air can enter and exit the chamber through the surface of the body; and / or d) the mouth seal is configured to seal on the user's face between the chin and under the lips.

[0077] In some examples: a) the cantilever structure seals directly below the user's nasal ridge; b) the cantilever structure seals to the user's face above the lips; c) the sealing structure forms a seal not above the user's lips, but directly below the user's nasal septum and nostrils; and / or d) a portion of the cantilever structure extends approximately 20 mm from the body.

[0078] In some examples: a) the body is formed of spacer fabric, foam, and / or thermoformed material; b) the body is cup-shaped, wherein the inner surface of the body has a substantially dome shape relative to the user during use; c) the body is formed of rigid or semi-rigid material; d) the body maintains its cup shape regardless of whether the user is wearing a mask; e) the body is formed of a flat sheet and includes at least one pleat; f) the cantilever structure is attached to the body using adhesives, stitching, and / or ultrasonic welding; g) the upper center of the periphery of the body is equipped with a malleable element; and / or h) the malleable element is made of metal.

[0079] In some examples: a) at least one filter element configured to filter air before it enters and / or exits the chamber; b) the at least one filter element is provided to an inner surface of the chamber; c) the at least one filter element substantially covers the entire inner surface of the body; d) the inner surface includes at least one fastener; e) the filter element is configured to be removably connected to the at least one fastener; f) the at least one fastener is formed of a hook-and-loop material; g) a rigid member coupled to at least a portion of the outer periphery of the filter element; and / or h) the rigid member is resilient and configured to return to an intermediate position after the compressive force is removed.

[0080] In some examples: a) the positioning and stabilizing structure includes two elastic rings, each configured to engage one of the user's ears; b) the elastic rings are connected to the body around at least a majority of its circumference; and / or c) the elastic rings are connected to the body around substantially its entire perimeter.

[0081] In some examples: a) the nasal seal is configured not to extend into the user's nostrils; b) the nasal seal and the mouth seal are configured to cooperate in use to form a single, continuous seal against the user's face; c) the nasal seal is made of a single piece of material; d) the nasal seal is symmetrical about a central portion configured to contact the user's nose near the nasal protuberance in use; e) the cantilever structure includes at least a partially linear front edge; and / or f) the positioning and stabilizing structure is connected to the body in an orientation parallel to the front edge.

[0082] In some examples: a) the body includes an outer surface and an inner surface, and an edge between the outer surface and the inner surface; b) the positioning and stabilizing structure is attached to the edge; c) the positioning and stabilizing structure is attached to the edge with an adhesive; d) the positioning and stabilizing structure includes an upper arm and a lower arm, each attached to the edge; and / or e) the upper arm and lower arm are oriented substantially tangentially from the center of the nose seal.

[0083] In some examples: a) the nasal seal includes a front edge and a rear edge configured to contact the user's face; b) the maximum width between the front edge and the rear edge is configured to contact the user near the wing base; c) the lateral edge of the nasal seal includes a minimum width between the front edge and the rear edge, the lateral edge being connected to the mouth seal; d) the rear edge closest to the maximum width is arcuate; and / or e) the minimum width between the front edge and the rear edge is substantially equal to the thickness of the mouth seal.

[0084] Another form of this technology includes a sanitary mask configured to filter the air inhaled by a user, the sanitary mask comprising:

[0085] The main body has a three-dimensional shape to form a cavity;

[0086] A sealing structure configured to seal against the user's face during use; and

[0087] A positioning and stabilizing structure is attached to the body, configured to provide a force that holds the sealing structure in the proper position on the user's head.

[0088] In some examples: a) the sealing structure is configured to guide air through the body and away from the user's eyes; b) the sealing structure forms a single seal around the user's mouth and nostrils; c) the sealing structure includes a nasal seal made of a first material sheet and a mouth seal made of a second material sheet; d) the nasal seal is configured not to extend into the user's nostrils; e) the nasal seal includes a front edge connected to the body, a rear edge opposite to the front edge, and an upper surface extending between the rear edge and the front edge; f) the user's face is configured to contact the rear edge and the upper surface. g) The rear edge comprises a substantially circular shape at its maximum width between the front edge and the rear edge; h) The upper surface near the maximum width is configured to contact the user's face at or near the wing base; i) The nose seal is curved about two axes; j) The width between the front edge and the rear edge gradually decreases toward the lateral end of the nose seal, and the width at the lateral end is configured to be equal to the thickness of the mouth seal; k) The sealing structure is connected to the body near the outer periphery of the body; and / or l) The sealing structure is made of fabric material and / or foam material.

[0089] In some examples: a) the body is constructed of a rigid or semi-rigid material and configured to maintain its three-dimensional shape; b) the body has a substantially cup-shaped form and forms a dome shape relative to the user in use; c) a deformable element is attached to the inner surface of the body adjacent to the outer periphery of the body; d) the deformable element is plastically deformable and configured to maintain its shape; e) the deformable element is metallic; f) the inner surface of the body is configured to be spaced apart from the user's mouth in use; g) the inner surface of the body includes fasteners configured to be detachably attached to a filter element; h) the body is configured to have pleats such that there are substantially no folds along the surface of the body; and / or i) the chamber of the body is substantially maintained at the operating pressure in use.

[0090] In some examples: a) the material used to construct the body is permeable and configured to allow airflow through the body into and out of the chamber; b) the material used to construct the body may be cellulose acetate, cellulose nitrate (e.g., collodion), polyamide (e.g., nylon), polycarbonate, polypropylene, and / or polytetrafluoroethylene (e.g., polytetrafluoroethylene); c) the body is made of fabric and / or foam material; and / or d) the body is constructed of spacer fabric.

[0091] In some examples: a) the body includes a port through which air enters and exits the chamber; b) the body is made of and / or coated with an impermeable material; c) a filter is located within the port and configured to filter particles from inhaled and / or exhaled air; and / or d) the filter is removable from the port.

[0092] In some examples: a) the positioning and stabilizing structure is configured to extend around the user's ears; b) the positioning and stabilizing structure includes a pair of rings, each configured to engage one of the user's ears; c) each ring of the pair is constructed of an elastic material and configured to stretch to fit users of different sizes; and / or d) the rings form a continuous periphery.

[0093] In some examples: a) the positioning stabilizing structure includes a pair of upper straps and a pair of lower straps; b) the upper left strap is configured to connect to the upper right strap in use; c) the upper left strap is configured to connect to the lower left strap in use; d) the lower left strap is configured to connect to the lower right strap in use; e) the lower right strap is configured to connect to the upper right strap in use; f) these straps are joined together using magnets, knots, snaps, hook and loop materials, adhesives, buckles and / or any other similar fasteners; and / or g) the upper and lower straps are flexible and substantially non-stretchable.

[0094] In some examples: a) a filter element is attached to the body to filter air flowing into and out of the chamber; b) the filter is removably coupled to the body; c) the filter element is coupled to an inner surface of the body; d) the filter element is configured to engage fasteners on the inner surface of the body; e) the filter element substantially covers the entire inner surface; f) the filter element is cleanable and reusable; and / or g) the filter element is replaceable.

[0095] Another example of this technology includes a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0096] A body forming a three-dimensional forming chamber configured for operation under operating pressure and for receiving a user's mouth and nostrils, wherein the inner surface of the body has a substantially dome shape relative to the user during use throughout the user's respiratory cycle; and

[0097] A sealing structure configured to form a seal against the user's face during use, the sealing structure comprising:

[0098] A nasal seal, comprising a cantilever structure extending from the body toward the user's face during use, the cantilever structure being configured to form a seal around the front and sides of a wing base portion of the user's nose, the cantilever structure including...

[0099] The central portion, configured to contact the lower region of the user's nose adjacent to the user's nasal protuberance,

[0100] A pair of lateral ends configured to contact the user near the nasolabial fold, and

[0101] A pair of intermediate portions, each of which is located between the central portion and one of the pair of lateral ends, each intermediate portion being configured to contact the user's face near the wing base, and

[0102] A mouth seal, configured to at least partially surround the user's mouth and form a seal between the chin and under the lip, is attached to the pair of lateral ends to form a single, continuous seal.

[0103] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0104] Positioning and stabilizing the structure to provide force that holds the sealing structure in place on the user's head;

[0105] At least a portion of the main body is configured to allow air to enter and exit the chamber.

[0106] Another example of this technology includes a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0107] A body forming a three-dimensional forming chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils, wherein the inner surface of the body is spaced apart from the user during use throughout the user's respiratory cycle; and

[0108] A sealing structure configured to form a seal against the user's face during use, the sealing structure comprising:

[0109] A nasal seal portion, configured to extend, at least a portion thereof, around the user's nostril on the underside of the user's nose below the nasal ridge, and

[0110] A mouth seal, configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, is connected to the nose seal to form a single, continuous seal.

[0111] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0112] Positioning and stabilizing the structure to provide force that holds the sealing structure in place on the user's head;

[0113] At least a portion of the body is configured to allow air to enter and exit the three-dimensional forming chamber.

[0114] Another example of this technology includes a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0115] A body forming a three-dimensional forming chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils, wherein the inner surface of the body is spaced apart from the user during use throughout the user's respiratory cycle; and

[0116] A sealing structure configured to form a seal against a user's face during use, the sealing structure being configured and sized to avoid contact with the user's nasal ridge, the sealing structure comprising:

[0117] A nasal seal having an uppermost portion configured to contact at least a portion of the user's nose along the user's sagittal plane and surrounding the user's nostrils, the uppermost portion being located on the lower side of the user's nose below the nasal ridge, and

[0118] A mouth seal, configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, is connected to the nose seal to form a single, continuous seal.

[0119] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0120] Positioning and stabilizing the structure to provide force that holds the sealing structure in place on the user's head;

[0121] At least a portion of the body is configured to allow air to enter and exit the three-dimensional forming chamber.

[0122] In some forms: a) the three-dimensional forming chamber includes a cup-shaped chamber; b) the body includes a two-dimensional rigidification pattern to help maintain the three-dimensional forming chamber; c) the two-dimensional rigidification pattern radiates outward from the center of the body; d) the body includes a three-dimensional rigid member to help maintain the three-dimensional forming chamber; and / or e) the three-dimensional rigid member and the body are made of the same material.

[0123] In some forms: a) the body includes a port through which air can enter and exit the three-dimensional forming chamber; b) the body is substantially impermeable and air can only enter and exit the three-dimensional forming chamber through the port during use; and / or c) at least a portion of the body is permeable, such that air can enter and exit the three-dimensional forming chamber through the surface of the body.

[0124] In some forms: a) the nasal seal includes a cantilever structure extending from the body toward the user's face during use; b) the cantilever structure is configured to form a seal around the front and sides of the periphery of the user's nasal wing base; c) the cantilever structure of the nasal seal is constructed using a one-piece construction; d) the cantilever structure is attached to the body using adhesives, sutures, and / or ultrasonic welding; e) the cantilever structure includes at least a partially linear front edge; f) the positioning and stabilizing structure is attached to the body in an orientation parallel to the front edge; g) a central portion configured to be close to (e.g., completely below along the user's sagittal plane) the user's nasal protuberance. h) a pair of lateral ends configured to contact the user near the nasolabial fold; i) a pair of intermediate portions; j) each of the pair of intermediate portions is located between the central portion and one of the lateral ends of the pair of lateral ends; k) each intermediate portion is configured to contact the user's face near the wing base; l) the central portion of the cantilever structure seals to the user's face on the lips; m) the central portion of the cantilever structure does not form a seal directly below the user's nasal septum and nostrils, but rather on the user's lips; n) the intermediate portion of the cantilever structure forms the maximum width of the cantilever structure; and / or o) the intermediate portion extends approximately 20 mm from the body.

[0125] In some forms: a) the nasal seal includes a front edge and a rear edge configured to contact the user's face; b) each intermediate portion includes a maximum width between the front edge and the rear edge; c) a lateral edge at each lateral end of the nasal seal includes a minimum width between the front edge and the rear edge; d) the lateral edges are connected to the mouth seal; e) the rear edge is arcuate near the intermediate portion; f) the minimum width between the front edge and the rear edge is substantially equal to the thickness of the mouth seal; g) a bridging member is connected to the seal-forming structure; h) the bridging member extends between the maximum widths of each intermediate portion; i) the bridging member is made of an elastic material and is connected to the seal-forming structure under tension before use; j) the bridging member is connected to an upper surface of the nasal seal configured to contact the user in use; k) the bridging member does not contact the nasal seal between the maximum widths of each intermediate portion; l) the cantilever structure of the nasal seal includes a first component and a second component joined at a central portion; and / or m) the first component and the second component are constructed of the same material and are symmetrical to each other.

[0126] In some forms: a) the body is formed of spacer fabric, foam, and / or thermoformed material; b) the body is formed of rigid or semi-rigid material; c) the body maintains its three-dimensional shape to space the inner surface of the body from the user's lips during use; d) the body is formed of a flat sheet and includes at least one pleat; e) the cantilever structure is attached to the body using adhesives, stitching, and / or ultrasonic welding; f) the upper center of the periphery of the body is equipped with a malleable element configured to bend and change the shape of the body; and / or g) the malleable element is constructed of metal.

[0127] In some forms: a) at least one filter element configured to filter air before it enters and / or exits the chamber; b) the at least one filter element is provided to an inner surface of the chamber; c) the at least one filter element substantially covers the entire inner surface of the body; d) the inner surface includes at least one fastener, and the filter element is configured to be removably attached to the at least one fastener; e) the at least one fastener is formed of a hook-and-loop material; f) a rigid member is coupled to at least a portion of the outer periphery of the filter element; g) the rigid member is resilient and configured to return to an intermediate position after the compressive force is removed; h) the inner surface of the body includes a recess, and the filter element is removably positioned within the recess; i) the inner surface of the chamber includes at least one fastener; and / or j) the filter element is configured to be removably attached to the at least one fastener.

[0128] In some forms: a) the positioning and stabilizing structure includes two elastic rings, each configured to engage one of the user's ears; b) the elastic rings are connected to the body around at least a majority of its periphery; c) the elastic rings are connected to the body around substantially the entire periphery; d) each of the two elastic rings forms a complete, unbroken periphery; and / or e) the elastic rings are thicker near the body and taper towards a free end away from the body.

[0129] In some forms: a) the nasal seal is configured not to extend into the user's nostrils; b) the nasal seal is made of a single piece of material; c) the nasal seal is symmetrical about a central portion configured to contact the user's nose in use near the nasal protuberance (e.g., along a sagittal plane completely below the nasal protuberance); d) the cantilever structure includes at least a partially linear front edge; and / or e) the positioning and stabilizing structure is connected to the body in an orientation parallel to the front edge.

[0130] In some forms: a) the body includes an outer surface and an edge between the outer surface and the inner surface; b) a positioning and stabilizing structure connected to the edge; c) the positioning and stabilizing structure is attached to the edge with an adhesive; d) the positioning and stabilizing structure includes an upper arm and a lower arm, each connected to the edge; e) the upper arm and the lower arm are oriented substantially tangentially from the center of the nasal seal; and / or f) the center is configured to contact a lower region of the user's nose close to (e.g., along the sagittal plane completely below) the user's nasal protuberance.

[0131] In some forms: a) the nasal seal includes a front edge and a rear edge configured to contact the user's face; b) the middle portion includes a maximum width between the front edge and the rear edge; c) the lateral edges at each lateral end of the nasal seal include a minimum width between the front edge and the rear edge; d) each lateral edge connects to the mouth seal; e) the rear edge near the middle portion is arcuate; and / or f) the minimum width between the front edge and the rear edge is substantially equal to the thickness of the mouth seal.

[0132] In some forms: a) a one-piece construction is used to construct the cantilever structure of the nose seal; b) the cantilever structure of the nose seal includes a first component and a second component joined at the center; and / or c) the first component and the second component are made of the same material and are symmetrical to each other.

[0133] In some forms: a) ports or channels are uniformly distributed on the surface of the body and allow airflow into and / or out of the chamber; b) these ports or channels may be positioned to direct airflow away from the user's eyes to avoid irritation or fogging when wearing glasses; c) the channels or ports may be positioned toward the bottom of the body to direct airflow in the front, lower and / or lateral directions; d) valves or flaps may be included on at least some of the ports or channels; e) the valves or flaps may be one-way valves and may allow airflow to be drawn into the chamber, but may block airflow exhaled from the chamber; and / or f) the ports or channels may include a tensile material (or other adaptable material) to adjust (e.g., reduce) the diameter of the ports or channels during use to change the volumetric flow rate through a particular port or channel.

[0134] Another form of this technology includes a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0135] The body defines a chamber configured for operation under operating pressure and for receiving a user's mouth and nostrils; and

[0136] A deformable member is attached to the upper part of the body, wherein the deformable member is configured to be positioned in use adjacent to the user's nose, below the user's nasal protuberance.

[0137] A sealing structure configured to form a seal against the user's face during use, the sealing structure comprising:

[0138] A nasal seal, configured to extend on the underside of the user's nose, with at least a portion surrounding the user's nostrils.

[0139] A mouth seal portion configured to at least partially form a seal around the user's mouth.

[0140] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0141] Positioning and stabilizing the structure to provide force that holds the sealing structure in place on the user's head;

[0142] At least a portion of the main body is configured to allow air to enter and exit the chamber; and

[0143] The main body and / or the nasal seal are selectively movable to conform to the user's face, and the deformable member is plastically deformable and configured to maintain a selected shape.

[0144] Another example of this technology includes a face mask used at an operating pressure equal to atmospheric pressure, the face mask comprising:

[0145] The main body, which forms a chamber configured to operate at the operating pressure throughout the user's entire respiratory cycle and configured to receive the user's mouth and nostrils; and

[0146] A sealing structure configured to form a seal against the user's face during use, the sealing structure comprising:

[0147] A nasal seal, comprising a cantilever structure extending from the body toward the user's face during use, the cantilever structure being configured to form a seal around the front and sides of a wing base portion of the user's nose, the cantilever structure including...

[0148] The front edge, which connects to the body,

[0149] The rear edge, which is opposite to the front edge, is configured to contact the user.

[0150] A central portion, comprising a first width between a front edge and a rear edge, is configured to contact a lower region of the user's nose near the user's nasal protuberance.

[0151] A pair of lateral ends configured to contact the user near the nasolabial fold, each lateral end of the pair of lateral ends including a second width between the front edge and the rear edge, the second width being smaller than the first width, and

[0152] A pair of intermediate portions, each of which is located between the central portion and one of the pair of lateral ends, each intermediate portion including a third width between the front edge and the rear edge, the third width being greater than the first width, each intermediate portion being configured to contact the face of a user near the wing base, and

[0153] A mouth seal, configured to at least partially surround the user's mouth and form a seal between the chin and under the lip, the mouth seal being attached to the pair of lateral ends to form a single, continuous seal.

[0154] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0155] Positioning and stabilizing the structure to provide force that holds the sealing structure in place on the user's head;

[0156] At least a portion of the main body is configured to allow air to enter and exit the chamber.

[0157] Another form of this technology includes a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0158] A body defining a chamber configured for operation under operating pressure and configured to receive a user's mouth and nostrils, the body including at least one fastening member;

[0159] A filter, which is removably positioned within a chamber and can be flipped onto at least one fastening member;

[0160] A sealing structure configured to form a seal against the user's face during use, the sealing structure comprising:

[0161] A nasal seal, configured to extend on the underside of the user's nose, with at least a portion surrounding the user's nostrils.

[0162] A mouth seal portion configured to at least partially form a seal around the user's mouth.

[0163] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0164] Positioning and stabilizing the structure to provide force that holds the sealing structure in place on the user's head;

[0165] At least a portion of the main body is configured to allow air to enter and exit the chamber; and

[0166] The filter is configured to substantially cover the inner surface of the body, allowing inhaled and exhaled air to pass through it.

[0167] Another form of this technology includes a method for constructing a sanitary face mask, the method comprising:

[0168] Provides substantially flat sheets;

[0169] Pleats are formed in the material sheet and the material sheet is folded to form a substantially cup-shaped body, wherein the surface of the folded material sheet is substantially wrinkle-free;

[0170] A nasal seal is attached to the cup-shaped body, the nasal seal extending from the body in the cantilever portion, and the nasal seal being more impermeable than the material sheet;

[0171] The mouth seal is attached to the cup-shaped body and to the nose seal, and the combination of the nose seal and the mouth seal forms a complete sealing perimeter;

[0172] The positioning and stabilizing structure is attached to the surface of the body, which is substantially perpendicular to the surface attached to the nose seal, and the positioning and stabilizing structure extends substantially around the entire periphery of the body.

[0173] Another form of this technology includes a method of using a sanitary face mask, the method comprising:

[0174] A sanitary face mask is provided, the sanitary face mask comprising a chamber, a sealing forming structure, and a positioning and stabilizing structure;

[0175] The sanitary mask is positioned in an operating position against the user's face, wherein the user's nostrils and mouth are accommodated within the cavity;

[0176] The positioning and stabilizing structure is fixed to the user's head;

[0177] The sanitary mask is sealed to the user's face using the force provided by the fixation; and

[0178] Subsequently, atmospheric pressure is maintained within the chamber throughout the user's entire respiratory cycle.

[0179] Another form of this technology includes a method of using a sanitary face mask, the method comprising:

[0180] Provide sanitary face masks with chambers;

[0181] Wear a sanitary mask below the user's nose;

[0182] The sanitary mask is sealed to the user's face and guides inhaled and exhaled air through the body of the mask; and

[0183] After sealing, the chamber is maintained at essentially atmospheric pressure throughout the user's entire breathing cycle.

[0184] Another form of this technology includes a method of using a sanitary face mask, the method comprising:

[0185] Wearing the sanitary mask, which includes a body forming a three-dimensional shaped chamber;

[0186] A sealing structure is formed against the user's face to guide inhaled and exhaled air through the body; and

[0187] After sealing, atmospheric pressure is maintained essentially within the three-dimensional chamber throughout the user's entire breathing cycle.

[0188] In some forms: a) the method further includes positioning the sealing structure against the user's face to contact a periphery formed by the area of ​​the user's nose adjacent to the user's nasal protuberance, the central area adjacent to the wing base, the lateral area adjacent to the nasolabial groove, and the area between the user's chin and lower lip; b) the body is formed of a permeable or semi-permeable material; c) the method further includes receiving the user's nostrils and mouth such that substantially all inhaled and exhaled air passes through the body; and / or d) the method further includes adjusting the width of the body by bending a deformable member, the deformable member retaining its position after the force is removed.

[0189] Another form of this technology is a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0190] A body forming a three-dimensional forming chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils, wherein the inner surface of the body is spaced apart from the user during use throughout the user's respiratory cycle; and

[0191] A sealing structure configured to form a seal against the user's face during use, the sealing structure comprising:

[0192] A nasal seal portion, configured to extend, at least a portion thereof, around the user's nostrils on the underside of the user's nose below the nasal ridge, and

[0193] A mouth seal, configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, is connected to the nose seal to form a single, continuous seal.

[0194] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0195] Positioning and stabilizing the structure to provide force that holds the sealing structure in the proper position on the user's head;

[0196] At least a portion of the said main body is configured to allow air to enter and exit the three-dimensionally shaped cavity;

[0197] The body includes a port through which air can enter and exit the three-dimensional forming chamber, and the body is substantially impermeable, and in use, air can only enter and exit the three-dimensional forming chamber through the port; and

[0198] The nasal seal includes a cantilever structure that extends from the body toward the user's face during use, the cantilever structure being configured to form a seal around the front and sides of the periphery of the wing base of the user's nose.

[0199] In some forms: a) the body is composed of at least one of cellulose acetate, cellulose nitrate, polyamide, polycarbonate, polypropylene, and polytetrafluoroethylene; b) the body is at least partially composed of a fabric material, and wherein the fabric material is at least partially coated with an impermeable layer; c) the impermeable layer comprises at least one of rubber, polyvinyl chloride (PVC), polyurethane (PU), silicone elastomer, fluoropolymer, and wax; and / or d) the impermeable layer is applied to an inner surface and / or an outer surface of the body, the outer surface being opposite the inner surface.

[0200] In some forms: a) the port includes at least one micropore through which air can enter and exit the three-dimensional forming chamber; b) the port includes at least one visible orifice through which air can enter and exit the three-dimensional forming chamber; c) the body is composed of at least a first material and a second material; and / or d) the first material is substantially impermeable and the second material is more permeable than the first material, wherein the second material forms the port.

[0201] In some forms: a) the port is positioned adjacent to a lower region of the body, which is adjacent to the mouth seal; b) the port is positioned along a central axis of the body extending between the nose seal and the mouth seal; c) the central axis is configured to be positioned parallel to the user's sagittal plane in use; d) the port is located near a side of the body; and / or e) the side is near the ends of the nose seal and the mouth seal.

[0202] In some forms: a) the port is a first port and the body further includes a second port spaced apart from the first port; b) the second port is a one-way valve configured to allow air into the three-dimensional forming chamber and configured to prevent air from leaving the three-dimensional forming chamber; c) the mask is provided with at least one replaceable filter element; d) the filter element is provided to the inner surface of the body; e) the filter element substantially covers the entire inner surface of the body; and / or f) the filter element is disposed within the port.

[0203] In some forms: a) the body is formed of a rigid or semi-rigid material; b) the body maintains its three-dimensional shape to space the inner surface of the body from the user's lips during use; c) the nasal seal includes a cantilever structure extending from the body toward the user's face during use; d) the cantilever structure is configured to form a seal around the front and side portions of the periphery of the user's nasal wing base; e) a central portion configured to contact the lower region of the user's nose along the user's sagittal plane completely below the user's nasal protuberance; f) a pair of lateral ends configured to contact the user near the nasolabial fold; g) a pair of intermediate portions; h) each of the pair of intermediate portions is located between the central portion and one of the lateral ends of the pair of lateral ends; i) each intermediate portion is configured to contact the user's face near the wing base; and / or j) the central portion of the cantilever structure does not form a seal directly below the user's nasal septum and nostrils on the user's lips.

[0204] In some forms: a) the positioning and stabilizing structure includes two elastic rings; b) each ring is configured to engage one of the user's ears; c) the positioning and stabilizing structure includes an upper arm and a lower arm, each connected to the body; d) the upper arm and the lower arm are oriented substantially tangentially from the center of the nasal seal; and / or e) the center is configured to contact the lower region of the user's nose along the sagittal plane, which is completely below the user's nasal protuberance.

[0205] Another form of this technology is a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0206] A body forming a three-dimensional forming chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils, wherein the inner surface of the body is spaced apart from the user during use throughout the user's respiratory cycle; and

[0207] A sealing structure configured to form a seal against the user's face during use, the sealing structure comprising:

[0208] A nasal seal portion, configured to extend, at least a portion thereof, around the user's nostrils on the underside of the user's nose below the nasal ridge, and

[0209] A mouth seal, configured to at least partially surround the user's mouth and form a seal between the chin and under the lips, is connected to the nose seal to form a single, continuous seal.

[0210] The end of the nasal seal is directly connected to the end of the mouth seal; and

[0211] Positioning and stabilizing the structure to provide force that holds the sealing structure in place at the user's head; and

[0212] At least one filter element configured to filter air before it enters and / or exits the three-dimensional forming chamber, and wherein the at least one filter element is provided to the inner surface of the body;

[0213] At least a portion of the said main body is configured to allow air to enter and exit the three-dimensionally shaped cavity;

[0214] At least a portion of the body is permeable, allowing air to enter and exit the chamber through the surface of the body; and

[0215] The rigid member is connected to at least a portion of the outer periphery of the filter element, and the rigid member is elastic and configured to return to an intermediate position after the compressive force is removed.

[0216] In some forms: a) at least a portion of the body is configured to allow air to enter and exit the three-dimensionally shaped chamber, including a first permeability; b) the filter element includes a second permeability less than the first permeability; c) the filter contains a charge; d) the inner surface of the body includes at least one fastener; e) the filter element is configured to be removably connected to at least one fastener; f) at least one fastener is formed of a hook-and-loop material; and / or g) when connected to the at least one fastener, the filter element is substantially flush with the inner surface.

[0217] In some forms: a) the inner surface of the body includes a recess, and the filter element is removably positioned within the recess; b) the filter element substantially covers the entire inner surface of the body; and / or c) the filter element is made of a rigid or semi-rigid material and is configured to serve as a rigid member that maintains the three-dimensional shape of the chamber.

[0218] In some forms: a) the nasal seal includes a cantilever structure extending from the body toward the user's face during use; b) the cantilever structure is configured to form a seal around the front and sides of the periphery of the wing base of the user's nose; c) the rigid member of the filter element is selectively deformable to fit around the cantilever structure; d) a central portion configured to contact the lower region of the user's nose completely below the user's nasal protuberance along the user's sagittal plane; e) a pair of lateral ends configured to contact the user near the nasolabial folds; f) a pair of intermediate portions; g) each of the pair of intermediate portions is located between the central portion and one of the lateral ends of the pair; and / or h) each intermediate portion is configured to contact the user's face near the wing base.

[0219] In some forms: a) a malleable element is provided at the upper center of the periphery of the body, the malleable element being configured to bend and change the shape of the body; b) the rigid member is more elastic than the malleable element; c) the positioning and stabilizing structure includes two elastic rings, each configured to engage one of the user's ears; d) the elastic rings are connected to the body around at least a majority of the periphery of the body; e) each of the two elastic rings forms a complete, undamaged periphery; and / or f) the nasal seal is symmetrical about a central portion, the central portion being configured to contact the user's nose in use along a sagittal plane completely below the nasal protuberance.

[0220] Another form of this technology is a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0221] A body forming a three-dimensional forming chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils, wherein the inner surface of the body is spaced apart from the user during use throughout the user's respiratory cycle; and

[0222] A nasal seal having an uppermost portion configured and sized to avoid contact with the user's nasal ridge and to contact the user's nose along the user's sagittal plane and on the underside of the user's nose, below the user's nasal ridge, at least a portion of which surrounds the user's nostrils. The nasal seal is constructed of at least partially impermeable material and configured to restrict airflow toward the user's eyes during use.

[0223] Positioning and stabilizing structure to provide force to hold the nasal seal in the proper position on the user's head;

[0224] At least a portion of the body is configured to allow air to enter and exit the three-dimensional forming chamber.

[0225] Another form of this technology is a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0226] A body forming a three-dimensional forming chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils, wherein the inner surface of the body is spaced apart from the user during use throughout the user's respiratory cycle; and

[0227] A nasal seal having an uppermost portion configured and sized to avoid contact with the user's nasal ridge and to contact the user's nose along the user's sagittal plane and on the underside of the user's nose, below the user's nasal ridge, at least a portion of which surrounds the user's nostrils. The nasal seal is constructed of at least partially impermeable material and configured to restrict airflow toward the user's eyes during use.

[0228] A positioning and stabilizing structure that provides force to hold the nasal seal in place on the user's head, a portion of which is configured to make direct contact with the user's face between the sublipal ridge and chin ridge during use;

[0229] At least a portion of the body is configured to allow air to enter and exit the three-dimensional forming chamber.

[0230] In some forms: a) at least a portion of the body is permeable, allowing air to pass through the surface of the body into and out of the three-dimensionally shaped chamber; b) the nasal seal includes a cantilever structure extending from the body toward the user's face during use; c) the cantilever structure is configured to form a seal around the front and sides of the periphery of the wing base of the user's nose; d) a central portion configured to contact the lower region of the user's nose along the user's sagittal plane completely below the user's nasal protuberance; e) a pair of lateral ends configured to contact the user near the nasolabial folds; f) a pair of intermediate portions; g) each intermediate portion of the pair of intermediate portions is between the central portion and a lateral end of the pair of lateral ends; h) Each intermediate portion is configured to contact the user's face near the wing base; i) the central portion of the cantilever structure forms a seal not on the user's lips but directly below the user's nasal septum and nostrils; j) the intermediate portions of the cantilever structure form the maximum width of the cantilever structure; k) the nasal seal includes a front edge and a rear edge configured to contact the user's face; l) each intermediate portion includes a maximum width between the front edge and the rear edge; m) a lateral edge at each lateral end of the nasal seal includes a minimum width between the front edge and the rear edge, the lateral edge connecting to the mouth seal; n) a bridging member connects to the nasal seal; and / or o) the bridging member extends between the maximum widths of each intermediate portion.

[0231] In some forms: a) the body is formed of spacer fabric, foam and / or thermoforming material; b) the upper center of the periphery of the body is provided with a malleable element configured to bend and change the shape of the body; c) the malleable element is at least partially enclosed in a sleeve; and / or d) the sleeve is made of fabric material.

[0232] In some forms: a) at least one filter element configured to filter air before it enters and / or exits the three-dimensional forming chamber; b) the at least one filter element is provided to the inner surface of the three-dimensional forming chamber; c) the at least one filter element substantially covers the entire inner surface of the body; d) the inner surface of the three-dimensional forming chamber includes at least one fastener; e) the filter element is configured to be removably connected to the at least one fastener; f) the at least one fastener is formed of a hook-and-loop material; g) the at least one fastener is a plurality of fasteners arranged in a substantially X-shaped configuration; h) each of the plurality of fasteners extends substantially between the outer periphery and the center of the body; i) a rigid member coupled to at least a portion of the outer periphery of the filter element; and / or j) the rigid member is elastic and configured to return to an intermediate position after the compressive force is removed.

[0233] In some forms, a) the positioning and stabilizing structure includes two elastic rings; b) each ring is configured to engage one of the user's ears; c) the elastic rings are connected to the body around at least a majority of its periphery; d) the elastic rings are connected to the body around substantially the entire periphery; e) each of the two elastic rings forms a complete, unbroken periphery; f) the elastic rings are thicker near the body and taper towards a free end away from the body; g) the elastic rings are configured to at least partially surround the user's mouth and contact the user between the chin and under the lip; h) the elastic rings are made of at least partially impermeable material. The elastic rings are constructed of a fabric material and configured to restrict airflow into and / or out of a three-dimensional chamber between the positioning and stabilizing structure and the user's face; i) the elastic rings are made of a fabric material and coated with an impermeable material to restrict airflow; j) each elastic ring is configured to stretch to engage one of the user's ears and provide a tensile force configured to pull the body toward the user's face; k) the elastic rings are configured to at least partially surround the user's mouth in the sealing arrangement and contact the user between the chin and under the lips; l) two elastic rings and a nasal seal form a single continuous seal; and / or m) the elastic rings are formed of a single piece of material and joined together along their unbroken length.

[0234] In some forms, a) the nasal seal is configured not to extend into the user's nostrils; b) the nasal seal is made of a single piece of material; c) the nasal seal is symmetrical about a central portion, which is configured to contact the user's nose in use along a sagittal plane completely below the nasal protrusion; d) a band that connects to the outer periphery of the body on the front surface of the body outside the three-dimensional cavity; and / or e) the band is configured to increase the rigidity of the body.

[0235] Another form of this technology is a face mask used at an operating pressure substantially equal to atmospheric pressure, the face mask comprising:

[0236] A body forming a three-dimensional forming chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils, wherein the inner surface of the body is spaced apart from the user during use throughout the user's respiratory cycle; and

[0237] A nasal portion having a superior portion configured and sized to avoid contact with the user's nasal ridge and to contact the user's nose along the user's sagittal plane and on the underside of the user's nose, below the user's nasal ridge, at least a portion of which surrounds the user's nostrils. The nasal portion is constructed of at least partially impermeable material and configured to restrict airflow toward the user's eyes during use.

[0238] Positioning and stabilizing structure to provide force to hold the nasal seal in the proper position on the user's head.

[0239] At least a portion of the body is configured to allow air to enter and exit the three-dimensional forming chamber.

[0240] In some forms, the mask may not include a mouth seal. The positioning and stabilizing structure may contact the user's face during use without providing a sealing contact, such that the body does not seal the user's face. Alternatively, the positioning and stabilizing structure may contact the user's face in a sealing arrangement, such that the nose and the positioning and stabilizing structure can at least partially seal the body against the user's face.

[0241] Of course, some of these aspects can form sub-aspects of this technology. Sub-aspects and / or aspects of the aspects can be combined in various ways and also constitute other aspects or sub-aspects of this technology.

[0242] Other features of the present technology will become apparent from the information contained in the following detailed description, abstract, drawings and claims. 4. Attached Figure Descriptions

[0244] This technology is illustrated by way of example and not limitation in the various figures of the accompanying drawings, and similar reference numerals in the drawings refer to similar elements, including:

[0245] 4.1 Respiratory Therapy System

[0246] Figure 1 This diagram shows a view of the human upper airway, including the nasal chambers, nasal bones, external nasal cartilages, greater alar cartilages, nostrils, upper lip, lower lip, larynx, hard palate, soft palate, oropharynx, tongue, epiglottis, vocal cords, esophagus, and trachea.

[0247] Figure 2 It is a front view of the face with several marked surface anatomical features, including the upper lip, upper lip vermilion border, lower lip vermilion border, lower lip, mouth width, inner canthus, nasal alae, nasolabial folds, and corners of the mouth. Up, down, radially inward, and radially outward directions are also indicated.

[0248] Figure 2-1 It is a frontal view of the face showing the outer periphery of the sealed contact area along the user's face.

[0249] Figure 3 A bottom view of the nose with several identified features is shown, including the nasolabial folds, lower lip, vermilion border of the upper lip, nostrils, lower point of the nasal septum, columella, nasal protuberance, long axis of the nostrils, and central sagittal plane.

[0250] Figure 3-1 A bottom view of the nose is shown, illustrating the contact area where the seal abuts against the nose.

[0251] 4.2 Drawings of embodiments of this technology

[0252] Figure 4 This is a rear view of a form of sanitary face mask according to this technology.

[0253] Figure 4-1 This is a rear view of another form of alternative sanitary face mask according to the present technology, which includes a two-dimensional rigidified pattern.

[0254] Figure 4-2 This is a rear view of an alternative sanitary face mask according to the present technology, which includes a three-dimensional rigid member.

[0255] Figure 5 yes Figure 4 Front view of the mask.

[0256] Figure 5-1 This is a front view of another example of a face mask, which includes ports for allowing airflow into and out of the chamber.

[0257] Figure 5-2 This is a front view of another example of a face mask, which includes V-shaped folds in the material to improve the mask's aesthetics.

[0258] Figure 6 yes Figure 4 A side view of the mask, with the headband loops held at the back.

[0259] Figure 7 From Figure 4 A perspective view of the back and top of the mask.

[0260] Figure 8 From Figure 4 A perspective view of the back and bottom of the mask.

[0261] Figure 8-1 This is a rear and lower perspective view of another example of a face mask, showing a recess on the inner surface of the face mask body.

[0262] Figure 9 yes Figure 4 The mask shown is a top view from the user's position.

[0263] Figure 9-1 yes Figure 4 The mask is shown from above in the user's position.

[0264] Figure 10 yes Figure 4 The mask shown is a front perspective view from the user's position.

[0265] Figure 10-1 It is used on users who wear glasses. Figure 4 Front perspective view of the mask.

[0266] Figure 11A yes Figure 4 A top view of a face mask designed for use by a user with a relatively wide nose.

[0267] Figure 11B yes Figure 4 A top view of a face mask designed for use by a user with a narrow nose.

[0268] Figure 12 yes Figure 4 The mask shown is a side view from the user's position.

[0269] Figure 12-1 It is used on users who wear glasses. Figure 4 A side view of the mask.

[0270] Figure 13 yes Figure 4 Rear perspective view of the mask, showing the filter element separated from the body.

[0271] Figure 13-1 This is a rear perspective view of another example of a mask with a filter element separate from the main body.

[0272] Figure 13-2 This is a rear perspective view of another example of a mask with a filter element separate from the main body.

[0273] Figure 14-1 yes Figure 13 The filter element shown is in a front view at the compression position.

[0274] Figure 14-2 yes Figure 13 The middle filter element returns to the front view in the relaxed position.

[0275] Figure 15 This is a rear view of another form of sanitary face mask, which includes a bridging element extending through the sealing structure.

[0276] Figure 16 From Figure 15 A perspective view of the back and bottom of the sanitary face mask.

[0277] Figure 17 This is a front view of another form of sanitary face mask according to this technology.

[0278] Figure 18 yes Figure 17 A top view of a sanitary face mask.

[0279] Figure 19 yes Figure 17 Rear perspective view of a sanitary face mask.

[0280] Figure 20 yes Figure 17 Bottom perspective view of the inside of a Chinese-made face mask.

[0281] Figure 21 yes Figure 17 Rear view of the sanitary face mask.

[0282] Figure 22 It is used for Figure 17 A perspective view of the seal of a sanitary face mask. 5. Detailed Implementation

[0284] Before describing this technology in further detail, it should be understood that this technology is not limited to the specific instances described herein, and the specific instances described herein may be modified. It should also be understood that the terminology used in this disclosure is for the purpose of describing the specific examples described herein only and is not intended to be limiting.

[0285] The following description is provided in relation to various instances that may share one or more common features and / or characteristics. It should be understood that one or more features of any one instance may be combined with one or more features of another instance or other instances. In addition, in any instance, any single feature or combination of features may constitute another instance.

[0286] In the example shown herein, the mask 3000 is in the form of a sanitary mask, although the mask shown can also be used to filter non-biological particles or contaminants (e.g., the example mask could be used in a non-medical setting). However, in another form, the mask 3000 of this technology can be used to connect a respiratory device to its wearer, for example, by providing an airflow to the airway inlet. Depending on the treatment to be applied, the patient interface can form a seal with, for example, an area of ​​the patient's face, thereby facilitating the delivery of gas at a pressure sufficiently different from ambient pressure (e.g., a positive pressure between approximately 6 cmH2O and 20 cmH2O, such as approximately 10 cmH2O, relative to ambient pressure) to achieve the treatment. In the example configured as a sanitary mask, this seal is sufficient to seal at normal pressures associated with unassisted inhalation and exhalation. In the example, the mask can be configured to allow minimal leakage around the user's mouth and can form a seal only around the user's nose.

[0287] When referring to the position of the mask 3000 relative to the user's face, the following description may use terms such as down or up and / or front or back. These orientations may specifically refer to the orientation of the mask 3000 when the user wearing the mask 3000 is in an upright position (e.g., standing or sitting with the user's head at its highest point). However, the user may move his / her body (e.g., the user may lie supine) and the mask 3000 will remain positioned (although the orientation terms will change).

[0288] 5.1 Main body of the mask

[0289] First, refer to the appendix. Figures 4 to 8 Some forms of the face mask 3000 include a body 3010. The body 3010 may also be referred to as a shell. The body 3010 may include an outer periphery 3012, the shape of which may substantially correspond to a portion of the user's face. For example, the outer periphery 3012 may have a substantially regular triangular shape (see example...). Figure 5 The outer periphery 3012 of the body 3010 can extend radially outward from below the user's lips, at the corner of the user's mouth, to the user's nasal protuberance. The body 3010 may extend upward but beyond the user's nasal protuberance, such that the user's nasal protuberance is not covered by the body 3010 (e.g., when the user wears the mask 3000 and stands upright, the body 3010 is completely below the nasal protuberance). When the body 3010 is positioned against the user's face in this orientation, the user's mouth and nostrils are radially positioned within the outer periphery 3012. In other forms, the outer periphery 3012 can have different shapes (e.g., circular, elliptical, triangular, rectangular, etc.) and still capture the user's nostrils and mouth within the outer periphery 3012. The size and shape of the body 3010 can contribute to forming a relatively small area of ​​the mask 3000 to minimize obstruction of the user's field of vision.

[0290] In some forms, the body 3010 may include a three-dimensional shape such that the surface of the body 3010 does not come into contact with the user's face during use. For example, the central portion of the body 3010 may not lie in a plane relative to the outer periphery 3012 of the body 3010. The body 3010 may include an arcuate or generally cup-shaped (or dome-shaped) form such that the outer periphery 3012 of the body 3010 lies on an imaginary hyperbolic paraboloid surface, such as... Figure 10 As shown. The inner surface of the body 3010 (e.g., the surface facing the user in use) may include a substantially positive curvature relative to the user wearing the mask 3000. For example, the inner surface of the body 3010 may form a dome shape relative to the user's face in use.

[0291] The cup shape of the main body 3010 can at least partially form a chamber 3014 into which the user breathes, such as in... Figure 7The best view is that the curved shape of the body 3010 separates at least a portion of the body 3010 from the user's face to form a volume of the chamber. In use, the user's nose (e.g., the user's nostrils) and the user's mouth can extend at least partially into the chamber 3014. However, the cup-shaped body 3010 restricts contact between the user's nostrils and / or mouth and the material of the body 3010. This can help reduce the user's claustrophobia because the material of the body 3010 does not directly contact and / or obstruct the user's nostrils and / or mouth, and impede the user's breathing. The material of the body 3010 may only contact the user's face outside the corner of the user's mouth. In some forms, the material of the body 3010 may only contact the user's face at the nasolabial fold or outside on either side of the user's face. In the example where the mask 3000 is a sanitary mask, in use, the internal pressure (e.g., operating pressure) of the chamber 3014 can be substantially equal to atmospheric pressure. In an example where the mask is a patient interface for respiratory pressure therapy (not shown), the chamber may be an inflatable chamber that can receive pressurized air to help alleviate the user's breathing difficulties (e.g., sleep apnea).

[0292] In some forms, the body 3010 may be constructed of a semi-rigid or rigid material. The rigidity of the body 3010 allows the chamber 3014 to maintain its shape (e.g., cup-shaped) regardless of whether the mask 3000 is in use. The material used to construct the body 3010 helps maintain a constant volume of the chamber 3014 when the user wears the mask 3000. For example, when the user inhales, the semi-rigid or rigid material will not be drawn towards the user's mouth and / or nostrils. This can limit airway obstruction caused by the body 3010 and / or limit user discomfort while wearing the mask 3000 (e.g., thereby promoting increased use of the mask 3000). This can limit interruptions when the user speaks (e.g., can reduce muting of the user's speech).

[0293] In some forms, a single piece of material (e.g., a semi-rigid or rigid material) can be used to construct the cup-shaped body 3010. Thermoforming processes can be used to maintain the shape of the material in a cup shape (e.g., regardless of whether a mask 3000 is used).

[0294] In some forms, the cup-shaped body 3010 may be constructed using two or more pieces of material (e.g., semi-rigid or rigid materials). This material may be a spacer material (e.g., a spacer material approximately 2-3 mm thick), although any material with similar properties may be used (e.g., For example, the material can typically be soft and compressible to provide a comfortable fit for the user. Two or more components can be ultrasonically welded together to form the cup shape of the body 3010.

[0295] In one configuration, two pieces of material are welded together using a curved weld to form the curved cup shape of the body 3010. After welding is completed at the location where the weld is made, a ridge 3034 is formed between the two pieces of material. The ridge 3034 increases the stiffness and / or rigidity of the body 3010. This increased rigidity helps maintain the cup shape of the body 3010 (e.g., when the mask 3000 is fastened to the user's face).

[0296] The radius of curvature of the spine 3034 can be inversely proportional to the stiffness of the body 3010. For example, as the radius of curvature increases (e.g., forming a flatter curve and approaching a flat surface), the stiffness of the body 3010 decreases. Therefore, it is desirable to form a welded spine 3034 with a smaller radius of curvature in order to increase the stiffness of the body 3010.

[0297] However, forming the spine 3034 with too small a radius of curvature would result in a body 3010 that does not provide sufficient space for the user's face. Therefore, the body 3010 has an ideal depth-to-height ratio range. The two pieces of material can be welded together with a height that is both small enough to provide sufficient rigidity and large enough to fit the user's facial features. Similarly, the depth is both large enough to fit the user's facial features and small enough to avoid unnecessarily obstructing the user's vision.

[0298] In some forms, an additional sheet of material with a V-shaped fold 3035 can be attached to the body 3010 (e.g., the outer surface and / or inner surface of the body 3010). The V-shaped fold material 3035 can be similar to the material used to construct the body 3010, as it is permeable (or porous) and does not impede the user's breathing. The V-shaped fold material 3035 can be added to cover the spine 3034 and improve the aesthetics of the mask 3000.

[0299] In some forms (see, for example) Figure 6 and Figure 10The material of the body 3010 (e.g., a single piece of material, or two or more pieces of material) may include at least one pleat 3022 (e.g., one pleat 3022 on the left side and one pleat 3022 on the right side of the body 3010). The pleats 3022 allow the material of the body 3010 to maintain a cup-shaped or arched form without wrinkles or other bends in the material. In other words, the pleats 3022 can provide a substantially smooth surface (e.g., without folds or creases), particularly along the outer perimeter 3012. This helps minimize leakage between the outer perimeter 3012 and the user's face (e.g., minimizing the flow of inhaled and exhaled air around the mask 3000 instead of through the body 3010). In some forms, the pleats 3022 may not be necessary when the body 3010 is thermoformed (e.g., when the body 3010 is constructed from a single piece of material). In some forms, the pleats 3022 may be covered by a V-shaped folded material 3035.

[0300] In some forms, at least a portion of the body 3010 is configured to allow air to enter and exit the chamber 3014. In an example where the mask 3000 is configured as a patient interface (e.g., for treating respiratory distress), the body 3010 may be equipped with one or more ports for connection to an air circuit (e.g., which can provide a pressurized, breathable airflow to the chamber 3014). The body 3010 may optionally be equipped with one or more vents through which air can enter and / or exit the chamber 3014.

[0301] In an example configured for use as a sanitary face mask, the body 3010 may include a permeable portion through which air can pass. In other words, a user can inhale breathable air from the environment outside the chamber 3014 and exhale air back into the external environment. The material of the body 3010 allows air to flow between the external environment and the chamber 3014. This helps reduce the likelihood that the user will continue to inhale previously exhaled air. The body 3010 may be made of a permeable material. Due to material properties (e.g., nylon, cotton, or polyester), the body 3010 can be permeable.

[0302] The permeability of the material allows for a uniform airflow across the surface of the body 3010. In some forms, the body 3010 may be shaped (e.g., having a dome shape) such that the airflow through the permeable material is not directed toward the user's eyes. In other examples, the body 3010 may be modified so that the permeable material does not direct airflow into the user's eyes. For example, the body 3010 may be coated to alter (e.g., reduce) the permeability of certain portions (e.g., near the upper part of the body 3010). In this way, more airflow (e.g., particularly exhaled air) passes through the body 3010 away from the user's eyes.

[0303] In some forms, the entire body 3010 may be made of an air-permeable material (e.g., open-cell foam, fabric, etc.). For example, the body 3010 may be made of a fabric similar to a spacer fabric. Suitable fabrics are described in PCT Publication WO2013026091, the entire contents of which are incorporated herein by reference. The permeable material of the body 3010 may also be rigid or semi-rigid to maintain the cup shape. Figure 4-1 As shown, permeable materials can also be stiffened (e.g., by chemical or mechanical methods) to increase the rigidity of the permeable material so that it can maintain a substantially cup-shaped form. The material can be stiffened from the center of the mask 3000 outwards (e.g., from the spine 3034). For example, the body 3010 can be stiffened along a direction radiating outwards from the center of the mask 3000 (e.g., in a spiderweb shape). A two-dimensional stiffening pattern 3038 can help maintain the three-dimensional contour of the mask 3000 (e.g., cup-shaped). However, the stiffening pattern 3038 may not prevent the user from manually manipulating the body 3010. The stiffening pattern 3038 will be flexible enough to allow the user to stretch or compress the body 3010 when putting on or taking off the mask 3000, and to return the body 3010 to its original shape (i.e., cup-shaped) after the user removes the external force. The body 3010 can be selectively stiffened using processes described in PCT / SG2020 / 050792 (e.g., electric current, chemical reaction, applied force), the entirety of which is incorporated into its form. At least one of the procedures described in PCT / SG2020 / 050792 may be selectively applied to predetermined locations of the body 3010 to stiffen the selected locations. The locations may be selected to help maintain the three-dimensional shape of the body 3010 (e.g., cup-shaped). Alternatively or additionally, stitching may be added to the body 3010 in a predetermined pattern to selectively stiffen the body 3010.

[0304] Alternatively, the body 3010 may be permeable due to modifications made during manufacturing. For example, the body 3010 may be made of a material with non-permeable material properties. The body 3010 of the mask 3000 (e.g., a sanitary mask) may be provided with one or more ports, channels, holes, and / or vents 3030, such as... Figure 5-1 As shown. Port 3030 (e.g., microscopic or visible) can be added to the material to provide selective permeability. Port 3030 may have greater permeability than the rest of the body 3010. The body 3010 may also be substantially impermeable and only allow fluid flow between the external environment and the chamber 3014 through port 3030. Such modified impermeable materials may include, but are not limited to, cellulose acetate, cellulose nitrate (e.g., collodion), polyamide (nylon), polycarbonate, polypropylene, and / or polytetrafluoroethylene (Teflon).

[0305] In other forms, the body 3010 can be made of a variety of materials. At least one of these materials can be impermeable and configured to restrict airflow. At least one material (different from the impermeable material) can be permeable. At least one permeable material can be selectively placed to serve as port 3030.

[0306] In an example with multiple ports 3030, each port 3030 may be spaced apart from adjacent ports 3030 (e.g., approximately uniformly spaced). Ports 3030 may be located on the body 3010 at a location 1050 where eye irritation from fogging of the glasses is unlikely (see example...). Figure 10-1 (and 12-1). For example, ports 3030 may be positioned toward the bottom of body 3010 (e.g., along the bony ridge 3034 and near portion 3132 to be positioned in front of the user's mouth). These ports may be positioned toward the sides of body 3010 (e.g., near the periphery 3012 of body 3010) to guide airflow laterally from the user's face. However, ports 3030 may not be positioned toward the top of body 3010 (e.g., near cantilever portion 3110) to avoid directing air toward the user's eyes. Furthermore, ports 3030 may be located throughout body 3010 (e.g., top, bottom, middle, and / or sides). Ports 3030 may be configured such that inhaled air can be inhaled through all ports 3030 (regardless of location, even if ports 3030 are located in the upper part near the eyes), but only one of ports 3030 is selected to allow exhaled air to pass through, such as a port 3030 that is less likely to cause eye spray / fogging of glasses. For example, a port 3030 located near the upper part of the body 3010 (e.g., near the cantilever structure 3110) can be configured as a one-way valve, allowing only inhaled air to enter the chamber 3014, but preventing exhaled air from leaving the chamber 3014. This can be achieved by one or more flap valves that open during inhalation and close during exhalation. Alternatively, it can be achieved by a tensile material (e.g., a material that expands when tensioned) in certain locations (e.g., near the upper part of the body 3010 of the cantilever structure 3110), which tends to cause the channel to close due to the force generated during exhalation. In other examples, at least some of the ports 3030 can be tapered, such that a smaller diameter opening is inside the chamber 3014, and a larger diameter opening is outside the chamber 3014 on the outer surface of the body 3010. The tapered port 3030 allows air to flow more freely in one direction (e.g., inhaled air travels into chamber 3014) and more difficultly in the opposite direction (e.g., exhaled air leaves chamber 3014). This is useful in limiting airflow into the user's eyes when located near the upper part of the chamber.

[0307] In the example, the mask 3000 is configured such that air passing through ports, holes, or vents 3030 in the body 3010 also passes through the filter element 3024 (described below). In the example, any and all ports, holes, or vents 3030 provided are located within the periphery of the sealing formation 3100. The ports, holes, or vents 3030 may be located near the central region of the body 3010 and substantially aligned with the user's mouth and / or nostrils (e.g., on a common horizontal plane perpendicular to the sagittal plane), such that inhaled and / or exhaled air flows directly through the ports 3030 and into the user's airway. In other forms, the ports, holes, or vents 3030 may be arranged at any location along the body 3010 (e.g., adjacent to the outer periphery 3012).

[0308] In some forms, a deformable object 3028 (e.g., a thin metal strip, wire, etc.) may be coupled to the body 3010. Specifically, the deformable object 3028 may be coupled to the body 3010 near an edge (e.g., near the outer perimeter 3012). The deformable object 3028 can be deformed by the user to change the shape of the upper part 3020 of the body 3010 to better adapt to the shape of a single user's nose and face (see example...). Figure 11A and 11B The deformable object 3028 can be plastically deformable, such that it retains its desired shape after being bent or otherwise manipulated (i.e., inelastically returns to a different position). When attached to the body 3010, the deformable object can act as a rigid member and can increase the stiffness of the body 3010.

[0309] like Figure 20 and 21 As shown, some forms of the mask 3000 may include a sleeve 3029, which can cover a deformable object (e.g., Figure 8 The deformable object 3028 is shown. The sleeve 3029 can be made of a comfortable material (e.g., fabric). The material used in the sleeve 3029 can also be flexible and can not restrict the deformation of the deformable object 3028.

[0310] Sleeve 3029 provides additional support to hold deformable object 3028 in place. Sleeve 3029 also helps limit any unintentional contact between deformable object 3028 and the user's face.

[0311] In an alternative example (not shown), the sleeve 3029 may be deformable and may be used with or in place of the deformable object 3028. For example, the sleeve 3029 may be rigid (e.g., using stitching) or may be formed of a rigid or semi-rigid material that is also comfortable. The sleeve 3029 is capable of elastic deformation to help adjust the shape of the mask 3000.

[0312] In some forms, the deformable object 3028 can be positioned near the center upper portion 3016 of the periphery 3012 of the main body 3010 (see example). Figure 8 Specifically, a user can bend or manipulate the deformable object 3028 to conform to the contours of their nose (e.g., the lateral curvature of the periphery 1100). In this case, the mask 3000 can substantially avoid contact with the user's nasal ridge. (E.g., the nasal seal 3102 can contact the user's nose completely below the nasal ridge). Users with smaller (e.g., narrower) noses can manipulate the deformable member 3028 to include a smaller radius of curvature, while users with larger (e.g., wider) noses can manipulate the deformable member 3028 to include a larger radius of curvature. Users can make various adjustments (e.g., depending on their specific comfort or position on the user's bridging element). Multiple users can also wear a single mask 3000 (e.g., the mask 3000 can be reusable and washable), and each user may need to adjust the deformable member 3028 to their respective face.

[0313] In other forms, the deformable object 3028 may extend around different portions of the outer perimeter 3012 of the body 3010 (e.g., around the sides and / or around the lower center). In other examples, the deformable object 3028 may extend around the entire outer perimeter 3012 of the body 3010. The user is able to adjust different portions of the deformable object 3028 to substantially match various parts of its face.

[0314] In other forms (not shown), the nasal seal 3102 may contact the user's nasal ridge, such that the user's nasal protuberance is included within the chamber 3014 during use. A deformable object 3028 may be used to adjust the shape of the mask 3000 to the shape of the user's nasal ridge (although the deformable object 3028 may not be included).

[0315] like Figure 4-2 As shown, some forms of the body 3010 may include a three-dimensional rigid member 3042. The three-dimensional rigid member 3042 may be made of the same material as the body 3010 (e.g., a permeable material). The three-dimensional rigid member 3042 may be used in addition to, or in place of, the deformable object 3028 and / or the two-dimensional rigid pattern 3038. The three-dimensional rigid member 3042 will be flexible enough to allow the user to stretch or compress the body 3010 when putting on or taking off the mask 3000, and to return the body 3010 to its original shape (i.e., cup shape) after the user removes the external force.

[0316] In some forms, the three-dimensional rigid members 3042 may be arranged in a pattern similar to the two-dimensional rigid member pattern 3038 (e.g., a spiderweb shape). However, the three-dimensional rigid members 3042 may be spaced apart from the spine 3034 (e.g., to avoid contact with the filter element 3024 described below). The three-dimensional rigid members 3042 may extend toward the user's face, although they may be positioned to avoid irritating the user's face. In other forms, the three-dimensional rigid members 3042 may be connected in other patterns (e.g., around at least a portion of the perimeter 3012 of the body 3010). In any mode, the three-dimensional rigid members 3042 help maintain the three-dimensional shape of the body 3010 without interfering with the user's comfort.

[0317] like Figure 17 As shown, some forms of the face mask 3000 may include a band 3044 extending around the periphery 3012 of the body 3010. The band 3044 may cover the edge of the material used to form the body 3010 (e.g., to limit wear and / or increase durability).

[0318] The material used to form the band 3044 may include V-shaped folds. For example, the material may have continuous longitudinal folds along its centerline and be “V”-shaped. The “V” may be positioned on at least one edge (e.g., the top and bottom portions of the original edge) of the fabric component (e.g., body 3010) to which the V-shaped fold is to be added. The band 3044 may be attached (e.g., by stitching, ultrasonic welding, etc.) to the body 3010 to cover and / or mask the unfinished edge. In addition to (or instead of) providing the increased durability described above, the band 3044 may be visually pleasing.

[0319] In some forms, the strip 3044 can be made of a flexible material. For example, the strip 3044 can be constructed of a material similar to the body 3010, such as a fabric. The strip 3044 may not be substantially impermeable (e.g., coated with an impermeable material) because it can cover a portion of the body 3010 that may already be at least partially impermeable (although the strip 3044 may still be impermeable).

[0320] In some forms, the band 3044 can be made of a rigid or semi-rigid material, and can also add stiffness, rigidity, and / or support to the periphery 3012 of the body 3010. This can help the body 3010 maintain a desired shape (e.g., cup-shaped).

[0321] In one form, the band 3044 may be at least partially composed of a deformable object (e.g., an alternative version similar to deformable object 3028 or sleeve 3029). The deformable object may be rigid or semi-rigid. This allows the user to bend or manipulate the band 3044 to adjust the shape of the periphery 3012. The band 3044 retains the desired shape when bent or manipulated.

[0322] In some forms, the material of the body 3010 at the periphery 3012 may be hot-stamped and / or ultrasonically welded to provide rigidity to the periphery and / or increase the durability of the body 3010. The hot-stamped and / or ultrasonically welded body 3010 may not include the band 3044, although some examples may include both.

[0323] In some examples, the body 3010 is made of fabric, wherein the outer surface (i.e., the surface exposed to the external environment) has a degree of water resistance. This can be achieved through the material properties of the fabric or by applying a coating to the outer surface. In some forms, the coating may not substantially affect the permeability of the body 3010. In some forms, the coating may make the body 3010 impermeable, and air may enter and / or exit the chamber 3014 through ports, holes, or vents 3030. In some examples, the coating may also be applied to the inner surface 3032 of the body 3010 (i.e., the surface within the chamber 3014). The water-resistant coating helps limit the saturation of the fabric material by exhaled water vapor. The coating may be rubber, polyvinyl chloride (PVC), polyurethane (PU), silicone elastomers, fluoropolymers, and / or waxes.

[0324] Alternatively, a waterproof material can be detachably attached to the interior of the body 3010. In other examples, the material can be a medium capable of filtering particles of certain sizes (e.g., filter medium 3024 described below). The user can selectively choose whether to use a removable material.

[0325] In some forms, the inner surface 3032 of the body 3010 within the chamber 3014 may include at least one fastener 3026 for attaching removable material to the face shield 3000. In some forms, the body 3010 may include a pair of fasteners 3026, one on the side of the body 3010 (e.g., left and right sides). In some forms, the body 3010 may include a plurality of fasteners 3026 spaced apart around the body 3010 (e.g., three, four, five, etc.). The fasteners 3026 may be arranged symmetrically around the body 3010, although they may also be arranged in an asymmetrical pattern. The fasteners 3026 may be hook-and-loop material, magnets, mechanical snaps, or any other similar fastening element that allows for detachable connection.

[0326] like Figure 8As shown, the inner surface 3032 of the body 3010 may include a pair of fasteners 3026. As previously described, the fasteners 3026 may be positioned on the side of the body 3010. For example, the fasteners 3026 may be close to the nose seal 3102 (described below). In some forms, the fasteners 3026 may not extend completely into the middle of the body 3010. In other words, only discrete portions of the side of the inner surface 3032 include the fasteners 3026. This helps to provide comfort for a user wearing a mask 3000 without a filter element 3024 (e.g., to minimize potential contact between the rough hook-and-loop material and the user's skin).

[0327] like Figure 20 and 21 As shown, the inner surface 3032 of the body 3010 may include four fasteners 3026 (e.g., two pairs of fasteners 3026). The fasteners 3026 may be arranged in a triangular or rhomboid shape (although the fasteners 3026 may be arranged in other shapes, such as X-shapes, at least partially circular shapes (e.g., circles), rectangular shapes, etc.), and may extend from the edges of the inner surface 3032 toward the center of the inner surface 3032 (e.g., diagonally). The fasteners 3026 in each pair may have substantially the same length and extend at similar angles, such that the fasteners form a symmetrical pattern.

[0328] In other examples, the inner surface 3032 of the body 3010 may include any number of fasteners 3026. For example, the inner surface 3032 may include one or more fasteners, such as two, three, or four fasteners, or more than four fasteners (e.g., five, six, seven, eight, etc.) 3026. These fasteners 3026 may have the same characteristics as... Figure 8 and 20 The fasteners 3026 are shown in different shapes. Instead of the strip (as described above), at least some of the fasteners 3026 can be circular, oval, triangular, square, or any other shape. The fasteners 3026 can be arranged in any pattern sufficient to connect to the filter element 3024.

[0329] In some examples, one pair of fasteners 3026 may be longer than another pair of fasteners 3026. In other examples, all fasteners 3026 may be positioned at the same angle and / or have the same length.

[0330] In the form shown, Figure 8 , 20 Fastener 3026 of 21 includes a hook material and is configured to connect to a ring material (e.g., on filter 3024). In some forms, the hook material of fastener 3026 may be hardened along its length and may help maintain the shape of body 3010.

[0331] like Figure 8-1 As shown, some forms of the inner surface 3032 of the body 3010 may include a recess 3046. For example, the recess 3046 may be attached (by stitching, ultrasonic welding, etc.) to the inner surface 3032 around a portion of the periphery of the recess 3046. At least one fastener 3026 may be attached to the inner surface 3032 within and / or near the recess 3046 (see example...). Figure 13-2 The recess 3046 can substantially follow the curvature of the body 3010 to create a substantially small opening leading to the recess 3046 and limit reduced user comfort.

[0332] 5.1.1 Spacer Fabric

[0333] Spacer fabric can be defined as a fabric having an upper grounding structure or layer, a lower grounding structure or layer, and floats or cross yarns woven between the upper and lower grounding structures to form a matrix-like fabric.

[0334] The upper and lower grounding structures can be formed from fabric. The upper grounding structure can have different properties from the lower grounding structure; for example, they can have different tensile strength, stiffness, flexibility, hand feel, or other properties. The upper and lower grounding structures can be substantially parallel to each other. The spacer fabric can be formed by plain knitting. At least one side (i.e., the upper or lower grounding structure) can be formed from a fabric with yarns of, for example, about 30-100 denier, 20-300 denier, or 50-200 denier to obtain a comfortable hand feel. This reduces irritation to the body 3010 when in contact with the user's skin.

[0335] 5.2 Sealing Formation Structure

[0336] like Figure 2-1 As shown in 7 to 8-1, some forms of this technology may include a seal-forming structure 3100 that provides a target seal-forming area and may additionally provide a cushioning function. The target seal-forming area is the area on the seal-forming structure 3100 where a seal may occur and a sufficient seal may be formed. The actual area where a seal occurs—the actual sealing surface—may vary over a given period of use, daily, and between users, depending on a range of factors, including but not limited to the position of the mask on the face, the tension of the positioning and stabilizing structure, and / or the shape of the user's face. The target seal-forming area may be large enough to maintain a substantially identical seal with different actual sealing surfaces. In other words, because the target seal-forming area is large enough to include many actual sealing surfaces, the same user placing the seal-forming structure 3100 in slightly different positions on its surface will experience a substantially identical seal.

[0337] exist Figures 7 to 8-1In the example shown, the sealing structure 3100 may include a lower nasal seal 3102 and / or a mouth seal 3104. The lower nasal seal 3102 may extend in a plane 3106 that is substantially different from the plane 3108 of the mouth seal 3104. The two seals 3102, 3104 may work together to form a seal around substantially the entire outer periphery 3012 of the sealing structure 3100 between the user's face and the mask 3000. For example, the two seals 3102, 3104 may collectively form a single seal on the user's face, which may surround the user's nostrils and the user's mouth.

[0338] like Figure 7 As shown, before use in some forms, plane 3106 may be tilted relative to central axis 3107 (e.g., an axis that is collinear or parallel to the spine 3034 and / or parallel or coplanar with the sagittal plane during use). Forces from the user's nose may cause the angle between plane 3106 and central axis 3107 to increase further. However, the material of nasal seal 3102 may have sufficient rigidity to limit a significant increase in angle. In some forms, the angle 3109 between plane 3106 and central axis 3107 may be between approximately 100° and approximately 170° before use. In some forms, the angle 3109 between plane 3106 and central axis 3107 may be between approximately 110° and approximately 140° before use. In some forms, the angle 3109 between plane 3106 and central axis 3107 may be between approximately 115° and approximately 125° before use. In some forms, the angle 3109 between plane 3106 and central axis 3107 can be approximately 120° before use.

[0339] like Figure 7 As shown, the angle between plane 3106 and central axis 3107 can be designed to accommodate users with a large angle between their post and lip. In some forms, the angle between the post and lip can substantially match the angle between plane 3106 and central axis 3107. Substantially matching the angle between plane 3106 and central axis 3107 to the angle on the user's face promotes an effective seal in users with a large angle between their post and lip. Users with a smaller angle between their post and lip can bend the nasal seal 3102 to bring their nose into contact with the mask 3000 and change the angle between plane 3106 and central axis 3107 to substantially correspond to their face (e.g., and produce a sufficient seal).

[0340] 5.2.1 Lower nose sealing part

[0341] like Figure 4 and Figure 7As shown, the nasal seal portion 3102 of the sealing structure 3100 is configured to surround the periphery 1100 of the user's nose (e.g., as shown). Figure 3 The seal is formed on the side of a portion of the user's nose immediately adjacent to the periphery 1100 (as shown). The periphery 1100 may extend on the underside (e.g., lower portion) of the user's nose, surrounding at least a portion of the user's nostrils (e.g., around the radius of the nasal margin). The underside of the nose may be below the user's nasal tip and the ridge of the user's nose (e.g., adjacent to or near the columella). Specifically, the periphery 1100 may extend from the user's ala adjacent to its lip and back along its nasal ala. The central portion of the seal forming structure 3100 may be positioned along the user's sagittal plane in use and may be positioned completely below the user's nasal tip (e.g., when the user is in an upright position). The periphery 1100 may extend radially outward from the periphery of both nostrils (e.g., and not intersect with and / or extend into either nostril). The periphery 1100 may also extend to the user's nasal tip. For example, the nasal tip of the user's nose may be at the outer edge of the periphery 1100. In summary, the periphery 1100 may be generally C-shaped or generally U-shaped. In other words, the perimeter 1100 may not intersect the user sagittal plane along the user's lip (although some forms may include a completely closed perimeter).

[0342] like Figure 4 As shown, some forms of the nasal seal 3102 include a cantilever structure 3110 extending from the body 3010 toward the center of the mask 3000 (e.g., radially inward from the outer periphery 3012). The cantilever structure 3110 may be fixed near the outer edge of the body 3010. The free end of the cantilever structure 3110 may be positioned toward the center of the mask 3000. The free end of the cantilever structure 3110 is capable of moving into and out of the chamber 3014 according to the direction of the applied force.

[0343] like Figure 4As shown, some forms of the face mask 3000 may include two cantilever portions 3110. For example, the face mask 3000 may include cantilever portions on either side of the face mask 3000 (i.e., the right and left sides). Each cantilever portion 3110 may be symmetrical about the central axis 3107 of the face mask 3000. The cantilever portions 3110 may join together near the central axis 3107 of the face mask 3000 (e.g., at a location near the user's nasal protuberance intended to contact the user's nose). For example, the central portion of the cantilever portion 3110 (e.g., intersecting the central axis 3107) may contact the user's nose along the user's sagittal plane. The cantilever portion 3110 may contact the user's nose along its periphery 1100 such that, along the sagittal plane, the cantilever portion 3110 avoids contact with the user's nasal protuberance (e.g., when the user is in an upright position, the cantilever portion 3110 extends near but below the user's nasal protuberance). The exposed surfaces of the seams between the cantilever portions 3110 can be substantially smooth to reduce irritation to the user's skin. Any protrusions or protrusions may be provided on the opposing surfaces of the cantilever portions 3110 within the chamber 3014 to avoid contact with the user's skin.

[0344] like Figure 8 As shown, certain forms of the cantilever portion 3110 can avoid obstructing the fastener 3026. In other words, the cantilever portion 3110 may not extend over the fastener 3026, making the fastener 3026 visible. This can help the user align the filter element 3024 (described below) with the fastener 3026.

[0345] like Figure 7 As shown, the cantilever portion 3110 may include a front edge 3120 and a rear edge 3126. The front edge 3120 may be substantially linear and may extend the entire length of the cantilever portion 3110. The rear edge 3126 of the cantilever portion 3110 may be at least partially arched. For example, the cantilever portion 3110 may curve from its center 3122 toward its maximum width 3140. Specifically, the rear edge 3126 may have a positive curvature relative to the user's nose in use. In some forms, the radius of curvature at the maximum width 3140 may be between about 10 mm and about 50 mm. In some forms, the radius of curvature at the maximum width 3140 may be between about 20 mm and about 40 mm. In some forms, the radius of curvature at the maximum width 3140 may be between about 25 mm and about 35 mm. In some forms, the radius of curvature at the maximum width 3140 may be about 30 mm.

[0346] The maximum width 3140 can be the length of a chord extending from the rear edge 3126 and perpendicular to the front edge 3120. In some forms, the measured maximum width 3140 is less than twice the radius of curvature (e.g., a partial diameter) because the front edge 3120 is substantially linear. For example, the measured maximum width 3140 can be between approximately 25% and approximately 95% of twice the radius of curvature. For example, the measured maximum width 3140 can be between approximately 40% and approximately 80% of twice the radius of curvature. For example, the measured maximum width 3140 can be between approximately 50% and approximately 70% of twice the radius of curvature. For example, the measured maximum width 3140 can be approximately 66% of twice the radius of curvature.

[0347] In some forms, the maximum measured width 3140 can be between approximately 1 mm and approximately 50 mm. In some forms, the maximum measured width 3140 can be between approximately 10 mm and approximately 40 mm. In some forms, the maximum measured width 3140 can be between approximately 15 mm and approximately 30 mm. In some forms, the maximum measured width 3140 can be approximately 20 mm.

[0348] like Figures 4 to 4-2 In some forms, the cantilever portion 3110 can be the middle portion between the central portion 3122 and the lateral portion 3124. However, the cantilever portion 3110 can be asymmetrical on either side of the maximum width 3140 between the central portion 3122 and the lateral portion 3124. For example, the maximum width 3140 may not be central; the cantilever portion 3110 may be off-center. In some forms, the maximum width 3140 may be closer to the lateral portion 3124, which can create more space between the two maximum widths 3140 (e.g., on either side of the central portion 3122), providing more space for the user's nose. In other forms, the maximum width 3140 may be evenly spaced between the central portion 3122 and the lateral portion 3124, or the maximum width 3140 may be arranged closer to the central portion 3124.

[0349] In some forms, the shape of the cantilever portion 3110 may be non-uniform on either side of the maximum width 3140. For example, the cantilever portion 3110 may be substantially linear between the maximum width 3140 and the lateral portion 3124 (e.g., its length is tangent to the radius at the maximum width 3140). This distance may be inclined relative to the front edge 3120. In some forms, this length may include a curvature close to the lateral portion 3124. This can provide a substantially smooth transition between the front and rear edges 3120, 3126 to limit irritation to the user's skin. In some forms, the radius of curvature at the maximum width 3140 may be between about 10 mm and about 50 mm. In some forms, the radius of curvature at the maximum width 3140 may be between about 20 mm and about 40 mm. In some forms, the radius of curvature at the maximum width 3140 may be between about 25 mm and about 35 mm. In some forms, the radius of curvature at the maximum width 3140 may be about 30 mm.

[0350] In some forms (see, for example) Figure 4 and Figure 7 The width between the front edge 3120 and the rear edge 3126 at the lateral edge 3124 is essentially negligible. In other words, the curvature near the lateral edge 3124 can incorporate the rear edge 3126 into the front edge 3120, resulting in virtually no thickness between the edges 3120 and 3126.

[0351] Continue to refer to Figure 4 and Figure 7 Some forms of the cantilever portion 3110 can be symmetrical about the central portion 3122, regardless of whether the cantilever portion 3110 is made of a single piece of material or a single material. In a single-piece construction, the central portion 3122 is not an edge, but merely marks the axis of symmetry. In a multi-piece construction, the central portion 3122 is the edge on any cantilever portion 3110 before connecting the cantilever portions 3110.

[0352] In some forms, the length between the center portion 3122 and the side edges can be between approximately 50 mm and approximately 150 mm. In some forms, the length between the center portion 3122 and the side edges can be between approximately 75 mm and approximately 125 mm. In some forms, the length between the center portion 3122 and the side edges can be between approximately 80 mm and approximately 100 mm. In some forms, the length between the center portion 3122 and the side edges can be approximately 89 mm. In some forms, the length can be adjusted on different sizes of the mask 3000 to fit different face sizes. For example, in some forms, the length may not exceed approximately 15 mm (e.g., approximately 74 mm). As described below, this reduced length still provides sufficient facial contact to form a hygienic mask-quality seal.

[0353] In some forms, the cantilever portion 3110 is attached to the body 3010 with an adhesive (e.g., glue). For example, the adhesive may be applied along the front edge 3120 and / or the inner surface 3032 near the outer periphery 3012. The adhesive can form a substantially airtight interface between the cantilever portion 3110 and the body 3010 to limit leakage. The adhesive can also be used to increase the rigidity of the mask 3000 (e.g., the adhesive can serve as a rigid element). In other examples, the cantilever portion 3110 and the body 3010 may be connected to each other using different methods (e.g., ultrasonic welding, mechanical coupling, magnets, etc.). These other connection methods may also serve as rigid elements of the mask 3000. In other examples, the cantilever portion 3110 and the body 3010 may be constructed from the same piece of material in a single piece and / or integrally joined. Once the cantilever portion 3110 is attached to the body 3010, in use, the rear edge 3126 may be positioned closer to the user's face than the front edge 3120 (e.g., positioned further back).

[0354] like Figure 4 and Figure 7 As shown, the front edge 3120 of the cantilever structure 3110 curves out of plane to match the periphery 3012 of the body 3010. In other words, the compliant properties of the material used in the cantilever structure 3110 allow the front edge 3120 to curve along the outer periphery 3012 and match the shape of the body 3010. The cantilever portion 3110 may curve about an axis pointing towards the user's face in use (e.g., about an axis parallel to or coplanar with the sagittal plane, or an axis inclined relative to the sagittal plane). In some forms, due to the curvature, the central portion 3122 of the front edge 3120 of the cantilever structure 3110 is higher than the lateral portion 3124 of the front edge 3120 of the cantilever structure 3110. In some forms, as a result of the curvature, the central portion 3122 may be further forward than the lateral portion 3124 (e.g., because the user's nasal protuberance may be the most forward facial feature). Because the cantilever structure 3110 is curved, a portion of the rear edge 3126 (i.e., the free end) can be configured to move into the chamber 3014 in different directions. For example, Figure 7 The portion of the rear edge 3126 near the center 3122 is shown oriented in a substantially horizontal direction (e.g., in a substantially lateral direction intersecting the user's sagittal plane), and the portion of the rear edge 3126 near the lateral portion 3124 is oriented in a substantially vertical direction (e.g., in a substantially vertical direction in use). In some forms, the cantilever portion 3110 may be curved about the maximum width 3140 on either side of the center portion. In other words, the arcuate portion adjacent to the maximum width 3140 may be a transition between the substantially horizontal and substantially vertical portions.

[0355] The rear edge 3126 near the center portion 3122 can move downward into the chamber 3014, while the rear edge 3126 near the side portion 3124 can move forward into the chamber 3014. The curvature of the cantilever structure 3110 can stiffen the cantilever structure 3110, making it more resistant to bending in the downward direction (e.g., when deflected downward by the lower side or below the user's nose) compared to when the entire cantilever structure 3110 is essentially flat when connected to the body 3010.

[0356] The cantilever structure 3110 is configured to engage the lower periphery 1100 of the user's nose without obstructing the user's nostrils, or at least without significantly or completely obstructing the nostrils (see example). Figure 3-1 In other words, the portion of the cantilever section 3110 between the two maximum widths 3140 may include curvature (e.g., C-shaped or U-shaped) as a result of its connection to the body 3010. This shape may substantially conform to the shape of the periphery 1100 of the user's nose. Specifically, the rear edge 3126 of the cantilever structure 3110 may be shaped to substantially conform to the shape of the outer edge of the lower surface of a typical user's nose (e.g., along the user's wing flange). Additionally, the maximum width 3140 may be configured to contact the user's face near the wing base. The curvature at the maximum width 3140 provides a comfortable interface against the user's skin. The maximum width 3140 may extend along the sealing periphery 1105 across the corner of the user's nose near the wing base. In some forms, the cantilever structure 3110 near the maximum width 3140 may wedge into the corner region of the user's nose near the wing base. A wedge-shaped material may help provide an effective seal and reduce the possibility of leakage in this area. Figure 3-1 As shown, some forms of the cantilever structure 3110 may not extend around the entire perimeter 1100, but may radiate from the user's nose near the corner area in order to bridge the space between the perimeter 1100 and the user's cheek.

[0357] like Figure 2-1 As shown, the nasal seal 3102 can contact the user's face between the nasal ala and the nasolabial fold to bridge the corner of the user's nose. A specific cantilever shape and the maximum width portion 3140 help wedge into the corner area and form an effective seal. As described, the seal can then contact the user's face outside the corners of the mouth and around the mouth, along the total seal circumference 1105.

[0358] As described above, in some examples, the shape of the rear edge 3126 can be changed (e.g., made narrower or wider) by bending the deformable object 3028 in the body 3010. For example, Figure 11A The deformable element 3028 is shown to be configured for a wider and / or shorter nose, and Figure 11BThe diagram illustrates a deformable element configured for narrower and / or longer noses. The deformable element 3028 allows the user to adjust the shape of the nasal seal 3102 to better fit their face.

[0359] like Figure 9 As shown, the cantilever structure 3110 can be configured to seal both sides of the lower periphery 1100 of the user's nose from a point immediately below the tip of the nose to the point where the nose meets the face (directly below the wingtips). The cantilever structure 3110 contacts and / or seals the user's nose slightly below the user's nasal protuberance, such that the nasal protuberance is not located within the cavity during use. However, the cantilever structure 3110 may not extend beyond the user's nasal protuberance (e.g., it may not contact the ridge of the user's nose). In some forms, the cantilever structure 3110 may not extend above the tip of the user's nose. However, other forms (not shown) may include the cantilever structure 3110 that contacts the ridge of the user's nose and / or extends above the user's nasal protuberance.

[0360] In use, the user's nose can be pressed downwards (i.e., in the downward direction) on the upper surface 3128 of the cantilever structure 3110, adjacent to the rear edge 3126 of the cantilever structure 3110, thereby causing the cantilever structure 3110 to bend downwards (i.e., in the downward direction). The cantilever structure 3110 can apply the opposite force to the underside or lower part of the user's nose, thereby sealing the lower periphery of the user's nose. This provides some resistance to the cantilever structure 3110, preventing the user's nose from completely sinking into the cavity 3014 and establishing a good seal between the nose sealing part 3102 and the user's face.

[0361] like Figure 15 and Figure 16 As shown, some forms of the mask 3000 may include a bridge 3152 for providing additional support and resistance to the user's nose, so that the user's nose does not sink completely into the chamber 3014 and a good seal is established between the nose seal 3102 and the user's face.

[0362] like Figure 15 As shown, bridging member 3152 extends through cantilever structure 3110. Bridging member 3152 may be attached to a portion of cantilever structure 3110. For example, bridging member 3152 may cover cantilever structure 3110 and may be bonded (e.g., by adhesive) to cantilever structure 3110. Bridging member 3152 may be substantially thin (e.g., compared to the thickness of cantilever portion 3110). The substantially small thickness of bridging member 3152 can maintain a substantially smooth and / or flush upper surface 3128 of cantilever portion 3110. For example, bridging member 3152 may not protrude significantly from upper surface 3128 to limit the formation of ridges or angles that may cause irritation to the user. This can help provide a comfortable surface for the user (e.g., upper surface 3128).

[0363] In some forms, the bridging member 3152 may extend between locations near the lateral portion 3124. The bridging member 3152 may also intersect with the rear edge 3126 near the maximum width 3140 on either side of the cantilever structure 3110. This can produce a substantially curved path followed by the bridging member 3152. Figure 16 As shown, the central portion of the bridging member 3152 may extend between the rear edges 3126 (or multiple rear edges 3126) between the maximum widths 3140, and may be unsupported (i.e., may not cover the cantilever portion 3110). In some forms, the bridging member 3152 may be connected to the unsupported area in a substantially taut orientation.

[0364] In some forms, the bridging member 3152 is formed from a single piece of material that is about 1 mm to about 15 mm wide (e.g., measured in the front-to-back direction). In some forms, the bridging member 3152 is formed from a single piece of material that is about 5 mm to about 10 mm wide. In some forms, the bridging member 3152 is formed from a single piece of material that is about 7 mm wide.

[0365] In some forms, the bridging element 3152 is formed of a single piece of material with a length of approximately 10 mm to approximately 50 mm (e.g., measured between the maximum width 3140 of the rear edge 3126 (or the rear edge 3126)). In some forms, the bridging element 3152 is formed of a single piece of material with a length of approximately 20 mm to approximately 40 mm. In some forms, the bridging element 3152 is formed of a single piece of material with a length of approximately 35 mm.

[0366] By adding bridging member 3152, the mask 3000 can contact the entire periphery around the user's nose. For example, cantilever structure 3110 contacts periphery 1100, as described in the previous example. Bridging member 3152 forms the complete periphery receiving the user's nostrils. In other words, bridging member 3152 contacts the user's face between the wing bases and across the lips. Bridging member 3152 can contact the user's nasal septum, and the user's nostrils can extend into and partially through the space formed by cantilever structure 3110 and bridging member 3152.

[0367] When in contact with the user's upper lip, the bridging element 3152 is deformable. The bridging element 3152 may be made of a flexible material and is unsupported, allowing bending when force is applied. In some forms, the bridging element 3152 may be made of an elastic material. The elastic material helps the bridging element 3152 stretch, which can help improve user comfort. For example, the elasticity in the bridging element 3152 can provide and limit the stiffness of the material in contact with the upper lip and / or nasal protuberance (e.g., which may be a sensitive area). After each use, the bridging element 3152 can elastically deform and return to its initial taut position.

[0368] In some forms, the position of the cantilever structure 3110 can be moved by bending the deformable member 3028. When the deformable member 3028 moves to a wider orientation, the elastic material of the bridging member 3152 is stretched and held in a taut position. Moving the deformable member 3028 does not move the bridging member 3152 into a region of plastic deformation, which allows the bridging member 3152 to extend further upon contact with the user and to return to its initial taut position when the deformable member 3028 moves to a narrower orientation. When the deformable member moves to a narrower orientation, the elastic material remains in a taut position, allowing users with a narrower nose to retain the benefits of the elastically deformable bridging member 3152.

[0369] In some forms, the bridging element 3152 helps the user correctly orient the mask 3000 on their face. For example, the bridging element 3152 can restrict the user from positioning the cantilever structure 3110 above the nasal protuberance and in contact with the nasal ridge. The material of the bridging element 3152 and the opening 3156 formed by the cantilever structure 3110 and the bridging element 3152 encourages the user to correctly orient their nose within the mask 3000. The size of the opening 3156 approximately corresponds to the size of the user's nose, thus encouraging the user to correctly position their nose within the mask 3000. As described above, the deformable object 3028 can be adjusted to change the size of the opening 3156 and accommodate noses of different sizes while still restricting incorrect positioning of the user's nose.

[0370] In some forms, the bridging member 3152 can limit the user's nose from fully extending into the cavity 3014. Due to contact with the user's nose, the bridging member 3152 provides a reaction force. In other words, the tension in the bridging member 3152 limits its length extension. Therefore, the bridging member 3152 can help the user's nose to be correctly oriented in the vertical direction. The tension in the bridging member 3152 can prevent the user's nose from extending too deeply into the cavity 3014 (e.g., where the bridge of the nose is at least partially within the cavity 3014). The nose can then contact the cantilever portion at the desired location and form a seal.

[0371] The cantilever structure 3110 may be made of foam, such as closed-cell foam (e.g., Belmont foam). The foam may be substantially airtight. In other words, the foam may have considerably low permeability compared to the material of the body 3010, allowing air to pass through the body 3010 but not through the cantilever structure 3110. Alternatively, the foam may be completely impermeable. For example, the foam may be thicker than the material of the body 3010 (e.g., textiles), which can help reduce permeability. In some forms, the foam may be between about 1 mm and about 20 mm thick. In some forms, the foam may be between about 2 mm and about 15 mm thick. In some forms, the foam may be between about 4 mm and about 10 mm thick. In some forms, the foam may be between about 6 mm and about 10 mm thick. In some forms, the foam may be about 8 mm thick.

[0372] In the example, the cantilever structure 3110 may be a semi-permeable foam or may include pores (e.g., similar to port 3030) that may be substantially uniformly spaced. Any pores may be positioned to direct airflow away from the user's face to reduce eye irritation or fogging caused by the glasses 1050 when worn (see example...). Figure 10-1 (and 12-1). For example, the opening in the cantilever structure 3110 may be positioned near the lateral portion 3124 to guide airflow laterally from the user's face and avoid directing air toward the user's eyes. In some examples, the cantilever structure 3110 may be configured such that inhaled air can be drawn in through the material, but only at selected locations (or no locations) is exhaled air allowed to pass through, for example, to avoid causing eye spray / fogging of glasses. For example, the cantilever structure 3110 may be constructed as or include a one-way valve and may allow only inhaled air into the chamber 3014, but may prevent exhaled air from leaving the chamber 3014 (exhaled air may be discharged through the body 3010 as described above). This can be achieved by one or more caps (holes) that open during inhalation and close during exhalation. Another alternative may include a tensile material at certain locations (e.g., near the lateral portion 3124) that tends to cause closure of the channel due to the slightly higher force generated during exhalation. In other examples, at least some of the holes in the cantilever structure 3110 may be tapered, such that the smaller diameter opening is inside the chamber 3014, and the larger diameter is outside the chamber 3014 on the outer surface of the body 3010 (e.g., on the upper surface 3128). The tapered port 3030 can allow air to flow more freely in one direction (e.g., inhaled air travels into the chamber 3014) and more difficultly in the opposite direction (e.g., exhaled air leaves the chamber 3014). This is useful in limiting airflow into the user's eyes when approaching the upper part of the chamber.

[0373] like Figure 10-1As shown in Figure 12-1, the cantilever structure 3110 allows the user to wear the mask 3000 more comfortably. As described above, the cantilever structure 3110 can seal the periphery 1100 of the user's nose (e.g., the radius of the outer nasal edge from the area near the nasal tip to the posterior nasal angle near the wing base) (e.g., below the user's nasal tip when the user is in an upright position) and block or substantially block airflow, or it can be semi-permeable and guide any exhaled air away from the user's eyes. In either case, substantially no exhaled air travels along the nasal ridge towards the user's eyes. Therefore, the user is able to avoid fogging their glasses 1050. Furthermore, because fogging of the glasses 1050 is not a significant issue for the cantilever structure 3110, the user can wear the glasses 1050 in a predetermined position. In other words, the user can wear the glasses 1050 in the intended position (e.g., as...). Figure 12-1 (as shown in the image, near the bridge of the nose) and / or at the desired angle (e.g., as shown in the image). Figure 12-1 The glasses 1050 shown are worn with the arm resting against the user's ear. When using a cantilever structure, the user may not need to distort their vision (e.g., by tilting the lens relative to their eyes) or position the glasses in an uncomfortable position (e.g., overlapping with part of a mask).

[0374] The foam can expand in a direction perpendicular to the applied force, which can cause the foam to partially or completely cover the user's nostrils. To limit this, the foam may not be excessively compressible (e.g., due to material properties and / or due to thickness). This helps limit the occurrence of nostril blockage. Even when substantially incompressible, the foam is comfortable for the user. In some forms, the foam used to construct the cantilever structure 3110 is typically stretchable. However, the thickness of the cantilever structure 3110 typically limits the total length extension (e.g., to limit the occurrence of blockage). The cantilever structure 3110 can still stretch beyond the body 3010, which is used to maintain the cup shape.

[0375] In some forms, the upper surface 3128 of the cantilever structure 3110 may be coated (e.g., with silicone) to increase impermeability. This coating may be substantially smooth and provide a comfortable feel for the user. In other forms, the upper surface 3128 may remain uncoated, which limits the adhesion of the cantilever structure 3110 to the user's face (e.g., preventing creases and folds where leaks may occur).

[0376] Of course, the cantilever structure 3110 can be made of other materials, such as fabric. A cantilever structure 3110 made of another material can have a similar thickness to a cantilever structure 3110 made of foam. For example, the cantilever portion 3110 can be made of substantially impermeable fabric, vinyl, silicone, or thermoplastic polyurethane. These other materials may also have limited compressibility to limit obstruction of the user's nostrils during use. These materials may also have limited adhesiveness or stickiness to prevent them from adhering to the user's face.

[0377] like Figures 7 to 8-1 As shown, some forms of foam (or other materials used to construct the cantilever portion 3110) may comprise substantially the same thickness along its entire length (e.g., from side portion 3124 to side portion 3124, or from side portion 3124 to center portion 3122). In other forms, the foam (or other materials) used to construct the cantilever structure 3110 may comprise varying thicknesses. The thickness may vary between the side portion 3124 and the center portion 3122 and / or between the front edge 3120 and the rear edge 3126.

[0378] In some forms, the foam may be thickest between the central portion 3122 and the lateral portions 3124 (e.g., the thickest portion may be close to the maximum width 3140, and the thinnest portion may be close to both the central portion 3122 and the lateral portions 3124). The increased thickness of the foam near the maximum width 3140 helps the foam conform to the sharp corners of the user's face and ensures that the material of the cantilever portion 3110 completely fills the user's wing base area, which can limit leakage. The thinner areas near the central portion 3122 and / or the lateral portions 3124 reduce irritation to more sensitive parts of the user's skin. In other forms, the varying thickness may be reversed (i.e., the maximum width 3140 is thinner than the central portion 3122 and / or the lateral portions 3124).

[0379] In some forms, the foam may be thicker near the front edge 3120 and thinner near the rear edge 3126. The thinner material near the user's nostrils may be more comfortable. However, other forms may have a thicker portion near the rear edge 3126, which can provide a better seal.

[0380] During use, the cantilever portion 3110 contacts the lower surface of the user's nose around the perimeter 1100. For example... Figure 9 and 9-1As shown, the flange of the user's nose can contact the cantilever portion 3110 between the central portion 3122 and the corresponding lateral portion 3124. The user's nose can exert a contact force on the cantilever portion 3110, which can cause the cantilever portion 3110 to bend in a downward direction. For example, the cantilever portion 3110 can bend into the chamber 3014 due to contact with the user's nose. The elastic properties of the material used to construct the cantilever portion 3110 can resist the contact force from the user's nose. This can establish the necessary seal on the user's nose. The seal between the cantilever portion 3110 and the user's face limits the leakage of air in the chamber 3014 around the outer perimeter 3012. The combination of the low permeability of the cantilever portion 3110 and the seal between the user's face and the cantilever portion 3110 can guide airflow through the body 3010. In some forms, approximately 50% to approximately 100% of the inhaled and exhaled airflow passes through the body 3010. In some forms, approximately 75% to approximately 100% of the inhaled and exhaled airflow passes through the body 3010. In some forms, approximately 90% to approximately 100% of the inhaled and exhaled airflow passes through the body 3010. In some forms, approximately 95% of the inhaled and exhaled airflow passes through the body 3010. In some forms, approximately 100% of the inhaled and exhaled airflow passes through the body 3010. In other words, the inhaled and exhaled air can flow along the path of least resistance. Because the body 3010 has low permeability and does not seal the user's face, airflow can enter and exit the chamber in the front-to-back direction and is restricted to travel in the vertical direction (e.g., through the cantilever portion 3110).

[0381] Restricting airflow vertically helps keep it away from the user's eyes. Directing exhaled air forward rather than upward can be particularly helpful in reducing irritation. Exhaled air may be warmer than inhaled air due to heat transfer within the user's airway. This warm exhaled air may condense on solid surfaces at cooler air temperatures (e.g., if the ambient air temperature is lower than the exhaled air temperature). This can be particularly irritating to users wearing glasses 1050 (e.g., exhaled air may condense on the surface of glasses 1050, which may be cooler than the exhaled air temperature). This can limit the user's vision. Even if the user is not wearing glasses, warm exhaled air can dry out their eyes and cause irritation. Directing airflow away from the user's eyes limits this problem.

[0382] Even if some air does pass through the cantilever portion 3110, or between the cantilever portion 3110 and the user's face, the airflow is not directed toward the user's eyes. The central portion 3122 contacts the user's nose near or adjacent to the nasal protuberance. However, the central portion 3122 does not extend beyond the tip of the user's nose, nor does it extend along the bridge of the user's nose. In other words, the central portion 3122 contacts the user's nose along the sagittal plane below the nasal protuberance, although the central portion may contact the user's columella near the nasal protuberance. Therefore, the direction above the cantilever portion 3110 is at least partially in front of the user's eyes (e.g., airflow can pass over it without entering the user's eyes). Additionally, by not extending along the user's nasal ridge (e.g., avoiding any contact with the user's nasal ridge), the cantilever portion 3110 is not used to guide air backward along the user's nasal ridge (e.g., exhaled air). However, in the form extending along the nasal ridge, the cantilever portion 3100 (or other structure) can provide a sliding fit to restrict airflow toward the user's eyes.

[0383] In other forms, the cantilever portion 3110 has the highest impedance, while the rest of the mask 3000 (e.g., the body 3010 and the mouth seal 3104) has lower impedance. These lower impedances can be the same or different (e.g., the impedance of the mouth seal 3104 can be between the impedances of the cantilever portion 3110 and the body 3010). Airflow can travel along the path of least resistance and is more likely to pass through the body 3010 and / or the mouth seal 3104, rather than the cantilever portion 3110. In this way, airflow (e.g., particularly warm exhaled air) is less likely to flow toward the user's eyes and will instead flow in a forward and downward direction away from the user's face.

[0384] In other forms, the cantilever portion 3110 may be at least partially permeable (e.g., less permeable than the inner surface 3032 of the body 3010). Airflow (e.g., exhaled air) can pass through the cantilever portion 3110, but the reduced permeability of the cantilever portion 3110 (e.g., compared to the body 3010) can help diffuse the air. For example, the entire exhaled airflow through the cantilever portion 3110 may not be directed in a common direction (e.g., towards the user's eyes). This can also help improve user comfort (e.g., by limiting stimuli within and / or around the user's eyes).

[0385] 5.2.2 Nose sealing part

[0386] 5.2.2.1 Nose sealing component

[0387] like Figure 4 and Figure 8As shown, some forms of the mask 3000 may include a mouth seal 3104 extending from the nose seal 3102, which surrounds the side of the user's mouth and is below the user's mouth. The nose seal 3102 and the mouth seal 3104 may together form a substantially complete seal around the outer periphery 3012 of the body 3010.

[0388] In some forms, a portion 3130 of the mouth seal 3104 is formed by a cantilever structure 3110 (e.g., formed by the portion of the rear edge 3126 of the cantilever structure 3110 between the maximum width 3140 and the lateral portion 3124). Figure 9 As shown, a portion 3130 of the cantilever structure 3110 sealing the user's mouth can extend from an area directly below the user's nose to the side of the mouth area. For example, the portion 3130 of the cantilever structure 3110 can extend from an area near the base of the wing on the user's face toward the nasolabial fold. In some forms, the portion 3130 may not extend above or below the user's lips during use. In the example, the sealing structure 3100 does not seal the area directly below the user's nasal septum and nostrils above the lips. In this way, the user is not prevented from breathing into the cavity through their nose.

[0389] In some forms, the mouth seal 3104 includes a portion 3132 configured to seal the lower part of the user's face. For example, the portion 3132 may seal between the chin and under the lips and may extend between the lateral portions 3124 of the cantilever structure 3110. This can make the mask 3000 appear less bulky compared to a mask that extends below the user's chin, because the mouth seal 3104 occupies a smaller area on the user's face.

[0390] However, some masks (not shown) may contact the user's chin (e.g., near the user's chin hump) and / or extend below the user's chin (e.g., below the user's chin hump) to provide additional coverage on the user's face.

[0391] In some forms, portion 3132 may be constructed from a single piece of material. Portion 3132 may be attached to the outer periphery 3012 of body 3010 in a manner similar to that of cantilever structure 3110 (e.g., by gluing, ultrasonic welding, mechanical fasteners, magnets, etc.). Once attached to body 3010, portion 3132 may include an arcuate shape (e.g., a semi-elliptical shape) that contacts the user's face from a nasolabial fold, laterally outside the user's mouth to below the lip, and to the opposite nasolabial fold. In other forms, portion 3132 may be constructed from two pieces of material. These two portions may join at approximately the central axis of body 3010 (e.g., substantially in a straight line with center portion 3122 in the bottom-up direction).

[0392] In some forms (see example) Figure 11A and 11B Part 3132 may not extend from the body 3010 in a cantilevered manner. In other words, part 3132 may not extend into the cavity 3014. Alternatively, part 3132 may extend substantially vertically from the body 3010 (e.g., toward the user's face in use). Contact with the user's face may compress part 3132 (e.g., in the anteroposterior direction) into the body 3010.

[0393] like Figure 8 As shown, some forms of portion 3132 may be configured as a flange 3134 extending from the periphery of body 3010. Additionally or alternatively, if body 3010 is made of a suitable material (e.g., a suitable fabric or foam), a portion of nozzle seal 3104 may include the periphery of body 3010.

[0394] In some forms, the thickness of portion 3132 (e.g., measured in a direction substantially perpendicular to the body) can be substantially small, such that the mask 3000 does not extend significantly from the user's face and does not obstruct the user's view. In some forms, the thickness of portion 3132 can be between about 1 mm and about 50 mm. In some forms, the thickness of portion 3132 can be between about 2 mm and about 40 mm. In some forms, the thickness of portion 3132 can be between about 3 mm and about 30 mm. In some forms, the thickness of portion 3132 can be between about 4 mm and about 20 mm. In some forms, the thickness of portion 3132 can be between about 5 mm and about 10 mm.

[0395] like Figure 4 and 8 As shown, some forms of the nasal seal 3102 can be incorporated into or integrated into the mouth seal 3104. In other words, the cantilever structure 3110 can be integrated into the portion 3132, such that the two portions of the seal-forming structures 3110 and 3132 are connected by a substantially smooth transition.

[0396] As described above, the cantilever structure 3110 can be connected to the body 3010 along its front edge 3120. Specifically, the front edge 3120 can be in direct contact with the body 3010 (e.g., near the outer periphery 3012). Figure 8 As shown, the cantilever structure 3110 can extend over the chamber 3014 and can extend in the rearward direction during use.

[0397] like Figure 4 and 8As shown, the cantilever structure 3110 decreases in width near the lateral portion 3124. In other words, the distance between the rear edge 3126 and the front edge 3120 decreases. Therefore, the rear edge 3126 can converge toward the front edge 3120. As the width between the front and rear edges 3120 and 3126 decreases, the width of the cantilever portion 3110 becomes closer to the portion 3132. In other words, the lateral portion 3124 has substantially the same thickness as the portion 3132. The cantilever portion 3110 can transition smoothly into the portion 3132. For example, there is a non-discontinuous transition (e.g., non-stepped) between the lateral portion 3124 and the portion 3132. This can be aided by the curved shape of the lateral portion 3124, which allows for a smooth transition.

[0398] like Figure 8 As shown, some forms of the mask 3000 may include an angle between portion 3132 and cantilever structure 3110. While the interface between portion 3132 and cantilever structure 3110 may be smooth (e.g., with minimal or no sharp corners), the interface may not be perfectly circular. The angle between the proximal end of portion 3132 and cantilever structure 3110 may be an obtuse angle measured between the rear edge 3126 and flange 3134. The angle 3150 between portion 3132 and cantilever structure 3110 may correspond to an angle close to the user's face near the nasolabial fold. In some forms, this angle 3150 may be between approximately 91° and approximately 179°. In some forms, this angle 3150 may be between approximately 110° and approximately 175°. In some forms, this angle 3150 may be between approximately 130° and approximately 170°. In some forms, this angle 3150 may be between approximately 155° and approximately 165°. In some forms, the angle 3150 can be approximately 165°. The angle 3150 can approach 180° because the facial contours near the user's nasolabial folds can be nearly vertical in some users. The mask can be adjusted (e.g., by bending) to provide some degree of fit for different users, allowing a single mask to fit a wide range of users. Alternatively, multiple sizes of masks 3000 can be manufactured, each including different angles within the aforementioned range.

[0399] Section 3132 and cantilever structure 3110 may be connected adjacent to each other to body 3010 such that there is substantially no gap between section 3132 and lateral section 3124. In some forms, lateral section 3124 may be directly coupled to section 3132, which reduces leakage from chamber 3014. Section 3132 and cantilever structure 3110 may be coupled together end-to-end to form a substantially sealed interface (e.g., a sanitary mask quality seal interface). However, such examples may include a small gap (e.g., less than about 5 mm) between the proximal end of section 3132 and cantilever structure 3110. In some forms, a shorter cantilever structure 3110 (e.g., shortened by no more than about 15 mm) may be used with an accompanying longer section 3132 (e.g., longer by no more than about 15 mm). The shorter cantilever structure 3110 can still press against the cheek area for a sanitary mask quality seal.

[0400] In some configurations, cantilever sections 3110 and 3132 may be made of substantially the same material. This can improve user comfort because the user will not perceive any significant differences between sections 3110 and 3132.

[0401] In some forms, cantilever portion 3110 and portion 3132 can be made of the same piece of material, making cantilever portion 3110 and portion 3132 a one-piece structure.

[0402] In some forms, part 3132 may be coupled to body 3010 in a one-piece and / or integral construction. Cantilever part 3110 may be connected to part 3132 and / or body 3010 in a one-piece and / or integral construction.

[0403] In some forms of the mask 3000 used with a patient interface to treat breathing difficulties (e.g., using CPAP therapy to treat sleep-disordered breathing), the mouth seal 3104 may not be included. For example, while some forms of the patient interface may include a full facial seal (i.e., a nasal seal 3102 and a mouth seal 3104), some forms of the patient interface may include only the nasal seal 3102 and may seal only around the user's nostrils. For example, the nasal seal 3102 may abut against the flange and supralipal seal and may not contact the sublipal region. In this form, the user's mouth is not exposed to pressurized air but remains in the ambient environment.

[0404] 5.2.2.2 Main body forming mouth seal

[0405] like Figures 17 to 22 As shown, some forms of the mask 3000 may not include a separate sealing structure (e.g., a foam flange 3134 extending from the body 3010) for at least partially sealing around the user's mouth.

[0406] These types of face shields 3000 may include a cantilever structure 3110 that is substantially the same as described above. For example, a portion 3130 of the mouth seal 3104 may be formed by the cantilever structure 3110 (e.g., by the portion of the rear edge 3126 of the cantilever structure 3110 between the maximum width 3140 and the lateral portion 3124). Figures 20 to 22 As shown, a portion 3130 of the cantilever structure 3110, which partially seals around the user's mouth, extends from the area directly below the user's nose to the side of the mouth area. The nose seal 3102 may have a similar shape to... Figure 9 The nasal seal portion 3102 is approximately the same size as the nasal seal portion 3102, so that it contacts the same area of ​​the user's face. For example, portion 3130 of the cantilever structure 3110 can extend from the area of ​​the user's face near the base of the wing toward the nasolabial fold. In some forms, portion 3130 may not extend above or below the user's lips during use. In the example, the seal-forming structure 3100 does not seal above the lips but directly in the area below the user's nasal septum and nostrils. In this way, the user is not prevented from breathing into the cavities through their nose.

[0407] However, Figures 20 to 22 The mask 3000 shown may not include portion 3132. For example, the mask 3000 may not include foam material extending completely around the periphery of the body 3010. The foam material may stop at the lateral portion 3124 and the material of the body 3010 (e.g., fabric) may be exposed.

[0408] As mentioned above, Figure 8 and 8-1 The portion 3132 of the mask 3000 shown can have a substantially small thickness. For example, the curvature near the lateral edge 3124 can incorporate the rear edge 3126 into the front edge 3120, resulting in substantially no thickness between edges 3120 and 3126. Therefore, when the mask 3000 is worn, removing... Figures 20 to 22 The portion 3132 of the mask 3000 shown may not create a noticeable gap between the main body 3010 at the lateral edge 3124 and the user's face. Furthermore, when the mask 3000 is worn, there may not be a noticeable gap between the main body 3010 and the user's lower lip.

[0409] Specifically, such as Figure 21 and 22 As shown, the thickness of the cantilever structure 3110 can be incorporated into the surface of the ring 3302 of the positioning and stabilizing structure 3300 (described below). As mentioned above... Figure 8As illustrated in the example, the rear edge 3126 may include a smooth curve such that it gradually transitions into the surface of the ring 3302. In some forms, there may be essentially no edge or corner between the rear edge 3126 of the cantilever structure 3110 and the surface of the ring 3302. Since the rear edge 3126 contacts the user's face during use, this allows the user to comfortably wear the mask 3000.

[0410] In some forms, the user's face can directly contact the body 3010 and / or the positioning and stabilizing structure 3300 without the portion 3132. In particular, the user's face can contact the positioning and stabilizing structure 3300. As described in more detail below, the surface of the positioning and stabilizing structure 3300 (e.g., the surface of the ring 3302) can restrict airflow into the chamber 3014 and / or form a seal with the user's face.

[0411] 5.3 Filter Elements

[0412] As described above, some forms of the body 3010 may include a permeable portion through which air can pass. In some forms, the permeable portion may be used to filter air passing through it sufficiently so that no additional filtration (e.g., through a specific filter element) is required. However, in examples where the face mask 3000 is configured as a multi-purpose sanitary face mask and / or where a greater degree of filtration than is provided by the material of the permeable portion alone is required, the face mask 3000 may be provided with an additional filter element 3024 (see, for example...). Figures 13 to 14-2 The filter element 3024 may have lower permeability than the body 3010 of the mask 3000, allowing fewer particles or debris to enter the chamber 3014 and be inhaled by the user, and / or allowing fewer particles to leave the chamber 3014 after the user exhales. Lower permeability may have virtually no impact on airflow into and / or out of the chamber (i.e., the filter element 3024 may not adversely affect the user's breathing).

[0413] In some forms, the filter element 3024 may be configured to attach to a fastener 3026 on an inner surface 3032 within a chamber 3014. As described above, the fastener 3026 may be a hook-and-loop fastener or any other suitable fastener. The filter element 3024 may have a corresponding fastener (not shown) that detachably engages with the fastener 3026. While some forms of the filter element 3024 can be attached to the fastener 3026 without a separate corresponding fastener (e.g., the material of the filter element 3024 includes a ring material capable of engaging with the hook-and-loop material of the fastener 3026), the inner surface 3032 may include varying amounts of fasteners 3026 (e.g., depending on the type of fastener 3026 and / or whether the filter element 3024 includes a corresponding fastener) to provide an appropriate level of engagement with the filter element 3026. For example, with Figure 8 Compared to the inner surface of 3032, Figure 20 and 21 The inner surface 3032 may include a greater number and longer fasteners 3026. In other forms, the filter element 3024 may be coupled to the outer surface of the body 3010 (e.g., positioned outside the chamber 3014). The filter element 3024 may be coupled to the outer surface in substantially the same manner as the filter is coupled to the inner surface 3032 (e.g., using at least one fastener).

[0414] In some forms, Figure 20 and 21 The triangular (or diamond) shape of the fastener 3026 can surround the outer periphery of the filter element 3024. This helps to better secure the filter element 3024 in place during use.

[0415] like Figure 13-1 As shown, in some forms, the filter element 3024 can be positioned within a recess 3046. The recess 3046 is sized to tightly receive the filter element 3024. In some forms, the recess 3046 may include a resilient portion to help retain the filter element. In some forms, a single recess 3046 may be sufficient to retain the filter element 3024 during use. However, as... Figure 13-2 As shown, fastener 3026 can be used with recess 3046 to provide additional retention.

[0416] In either case, the connected filter element 3024 can provide additional rigidity to the mask 3000. In other words, the filter element 3024 can provide additional stiffness to the body and act as an additional rigid member to help maintain the three-dimensional shape (e.g., cup-shaped) of the body 3010. The filter element 3024 can be formed of a rigid or semi-rigid material to serve as a rigid member.

[0417] In some forms, the filter element 3024 may be reusable and may be disconnected from the body 3010 (e.g., after each use) and cleaned before being reattached to the fastener 3026.

[0418] In other forms, the filter element 3024 can be disposable and can be discarded after each use. The user can connect a new, clean filter element 3024 before each use.

[0419] In some forms, the filter element 3024 can be shaped to substantially correspond to the shape of the body 3010 (see example...). Figure 13For example, the shape of filter element 3024 may substantially correspond to the shape of outer periphery 3012. Filter element 3024 may be positioned against the inner surface 3032 of body 3010 such that it is at least partially covered by cantilever element 3110. In other words, a user can position filter element 3024 below cantilever structure 3110 such that filter element 3024 can extend to outer periphery 3012 without interfering with the seal between the user's face and cantilever structure 3110. Filter element 3024 may be made of a substantially flexible material, allowing a user to bend or otherwise reposition filter element 3024 to fit around cantilever structure 3110. The rigidity of body 3010 helps maintain the spacing between filter element 3024 and the user's airway to reduce breathing resistance experienced by the user.

[0420] In some forms, the filter element 3024 may be formed of a semi-rigid material (e.g., to act as a rigid body for maintaining the three-dimensional shape of the body 3010), but may be bendable or manipulatorable by the user. This allows the user to position the filter element 3024 around the cantilever structure 3110 while still allowing rigid support for the body 3010 during use.

[0421] In similar Figure 15 In some forms, when connected to fastener 3026, filter element 3024 can sit flush with inner surface 3032. Therefore, filter element 3024 can occupy virtually no volume in chamber 3014, and the user's skin can avoid contact with filter element 3024 during use.

[0422] In some forms, the filter element 3024 can be more rigid around its outer periphery than near the center. For example, Figure 14-1 and 14-2 A rigid member 3025 is shown, which can be attached to the outer periphery of the filter element 3024, helping the filter element 3024 maintain its shape. Although the rigidity is greater than the center of the filter element 3024, the rigid member 3025 can be flexible, allowing the user to adjust the shape of the filter element 3024. For example, the user can adjust the shape of the body 3010 and the cantilever portion 3110, such as... Figure 11A and 11B As shown. The user can also adjust the shape of the filter element 3024 so that it continues to fit flush with the modified shape of the body 3010 and / or the cantilever portion 3110.

[0423] In one embodiment, the rigid member 3025 may be elastic and able to return to its neutral position when no external force is applied. For example, the user can bend the filter member 3024 to fit it within the chamber 3014 (see, for example, [link to relevant documentation]). Figure 14-1 After the filter member 3024 is positioned in the desired orientation, the rigid member 3025 can return to its intermediate position (see example...). Figure 14-2 In other words, the filter member 3024 can expand toward the outer periphery 3012 of the body 3010. The filter member 3024 can substantially or completely cover the inner surface 3032 of the body 3010 and can restrict airflow around the outer edge of the filter member 3024 (e.g., and not be filtered).

[0424] In some forms, the rigid member 3025 of the filter element 3024 may be more flexible than the deformable object 3028 attached to the body 3010.

[0425] The main body 3010 is equipped with a port (for example, see...). Figure 5-1 In the example of ports, holes, or vents 3030, filter element 3024 may be configured to extend only through or within these ports, holes, or vents. Fasteners may be arranged close to the ports, holes, or vents 3030 such that filter element 3024 may be positioned to directly cover the ports, holes, or vents 3030. In other examples, filter element 3024 may be configured to cover the entire inner surface of body 3010.

[0426] In one example, the filter element comprises essentially the same material as that used in surgical masks in the prior art.

[0427] In addition to collecting debris, bacteria, and / or other particles that the user does not want to inhale or that they do not want others to inhale, the filter element 3024 also prevents droplets from contacting the body 3010. The filter element 3024 protects the body 3010 and keeps it relatively clean. This allows the user to replace only the filter element 3024 and continue using the body 3010 multiple times without cleaning.

[0428] In some forms, filter element 3024 may include an electrical charge to help capture debris. For example, debris may have a negative charge. Filter element 3024 may have a positive charge to attract negatively charged debris. Alternatively, filter element 3024 may have a negative charge to attract positively charged debris.

[0429] 5.4 Positioning and Stabilization Structure

[0430] like Figure 7 , 8As shown in Figures 1 and 12, the face mask 3000 is provided with a positioning and stabilizing structure or headband 3300, which helps to maintain the body 3010 and the sealing forming structure 3100 in a position against the user's face. The positioning and stabilizing structure 3300 can provide a force (e.g., a sealing force) oriented at least partially in the rearward direction to provide sufficient contact and sealing force between the sealing forming structure 3100 and the user's skin.

[0431] like Figure 12 As shown, some forms of the headband 3300 are formed as a headband and include loops 3302 that encircle the user's ears and hold the mask 3000 in place. Each loop 3302 can form a complete periphery (i.e., without breaks or interruptions in the material). This helps to prevent the loops 3302 from tangling. The loops 3302 can be made of a fabric or foam of suitable elasticity (e.g., elastic foam). This allows the loops 3302 to expand and stretch as the user puts on and / or takes off the mask 3000 to fit different ear sizes. This also allows the loops 3302 to return to a relaxed state during use of the mask 3000, allowing the loops 3302 to contact the user's ears and provide a seal.

[0432] like Figure 12 As shown, certain forms of the rings 3302 can contact the user's face when engaged with the user's ear. For example, each ring 3302 can rest against the corresponding user's cheek below the user's eyes (e.g., these rings do not protrude significantly from the user's cheek and can be considered substantially flush with the user's face). The material of the rings 3302 can be substantially thin to avoid obstructing the user's vision. Thinner materials offer less resistance to stretching, thus also making the rings 3302 easier to stretch.

[0433] In some forms, ring 3302 can be the most extended portion of mask 3000. In other words, ring 3302 can extend the maximum length of any portion of mask 3000 under tension. This stretchability helps maximize the fit range of mask 3000 (i.e., increasing the number of heads that can wear the same size mask 3000). The thickness of each ring 3302 can be minimized to provide maximum stretchability while providing sufficient strength (e.g., so that ring 3302 does not break when tension is applied).

[0434] In some forms, each ring 3302 may be made of foam material with a thickness between about 0.1 mm and about 10 mm. In some forms, each ring 3302 may be made of foam material with a thickness between about 1 mm and about 5 mm. In some forms, each ring 3302 may be made of foam material with a thickness between about 1.5 mm and about 4 mm. In some forms, each ring 3302 may be made of foam material with a thickness of about 2 mm.

[0435] In some forms, each loop 3302 may be made of a fabric (e.g., a woven fabric) material with a thickness between about 0.1 mm and about 10 mm. In some forms, each loop 3302 may be made of a fabric (e.g., a woven fabric) material with a thickness between about 0.5 mm and about 5 mm. In some forms, each loop 3302 may be made of a fabric (e.g., a woven fabric) material with a thickness between about 0.75 mm and about 4 mm. In some forms, each loop 3302 may be made of a fabric (e.g., a woven fabric) material with a thickness of about 1 mm.

[0436] like Figure 5-6 As shown in Figures 12 and 17, some forms of the ring 3302 may include an elongated and / or substantially elliptical shape. For example, the upper and lower sides of each ring 3302 may be substantially parallel to each other. The distance between the upper edge of the upper side and the lower edge of the lower side is approximately equal to the height of the body 3010. In other words, the coverage area of ​​the ring 3302 in the bottom-top direction may be substantially the same as the coverage area of ​​the body 3010 in the same direction.

[0437] like Figures 5 to 5-2 As shown, some configurations of the ring 3302 are such that it is substantially connected to or engages the entire periphery 3012 of the body 3010, or at least a large portion of the periphery 3012 of the body 3010, rather than being attached to the body 3010 at a narrower or more localized point. The positioning of the ring 3302 can help reduce or eliminate wrinkles in the body 3010, particularly at portions of the body 3010 that form part of the sealing forming structure 3100.

[0438] In some forms, the headband 3300 is attached to the inner periphery 3136 of the lower half of the body 3010, thereby forming at least a portion of the mouth seal 3104 of the sealing structure 3100. In examples, the headband 3300 is attached to the body by an adhesive (e.g., glue, tape, or a combination of glue and tape), ultrasonic welding, sewing, mechanical fasteners, or any similar attachment method. Adhesives can also be used to increase the rigidity of the mask 3000 (e.g., the adhesive can serve as a rigid element). In other forms, the headband 3300 can be attached to the body 3010 by a one-piece and / or integral connection (e.g., constructed from the same sheet of material, thus eliminating the need for attachment devices).

[0439] In some configurations, the headband 3300 may be coupled to the body 3010 near the front edge 3120 and the upper surface 3128. For example... Figure 7 , 12As shown in Figure 19, the headband 3300 may include an upper arm 3306 and a lower arm 3308 located on either side of the face mask 3000. Each upper arm 3306 may be connected to the upper part of the body 3010 (e.g., near the cantilever portion 3110), and each lower arm 3308 may be connected to the lower part of the body 3010 (e.g., near portion 3132). The upper arm 3306 and lower arm 3308 on either side (e.g., the left and right sides) may be formed as a single piece of material and may be joined together to form the aforementioned loop.

[0440] like Figure 9 , 9-1 As shown in Figure 22, some form of upper arm 3306 can be attached to the edge 3036 of the body 3010. The edge 3036 can form the outer boundary of the outer perimeter 3012. The edge 3036 can also be oriented substantially perpendicular to the inner surface 3032. Thus, the upper arm 3306 can be oriented close to the upper surface 3128 of the cantilever portion 3110. Adhesives (e.g., glue, tape, or a combination of glue and tape), ultrasonic welding, sewing, mechanical fasteners, or any similar attachment method can be applied to each upper arm 3306 and / or edge 3036. Any of these attachment methods also serves to increase the rigidity of the mask 3000 (e.g., the adhesive can be used as a rigid element).

[0441] like Figure 22 As shown, the front edge 3120 of the cantilever structure 3110 can be connected to the ring 3302, such that at least a portion of the cantilever structure 3110 can be perpendicular to the positioning and stabilizing structure 3300 (e.g., when the mask 3000 is not in use). Specifically, the upper arm 3306 of each ring 3302 can be connected to the body 3010 as described above. The cantilever structure 3110 can extend substantially perpendicularly relative to the upper arm 3306, such that the cantilever structure 3110 protrudes toward the user's face, which can help provide proper contact when the user wears the mask 3000.

[0442] Continue to refer to Figure 9 and 9-1 In some forms, each upper arm 3306 may extend in a direction substantially parallel to at least a portion of the cantilever portion 3110 (e.g., close to the maximum width 3140). In some forms, each upper arm 3306 may be substantially tangent to a portion of the cantilever portion 3110 (e.g., tangent to the center portion 3122). In some forms, the upper arms 3306 may be spaced apart from each other (e.g., not connected at the center portion 3122).

[0443] In some forms, the upper edge 3310 of each upper arm 3306 can be substantially linear. For example... Figure 7As shown, the width of each upper arm 3306 can decrease towards the center 3122, allowing each upper arm 3306 to be incorporated into the body 3010 (e.g., edge 3036). The upper edge 3310 of each upper arm 3306 can be substantially collinear with the edge 3036. Therefore, the upper arms 3306 do not significantly increase the area occupied by the mask 3000. The linear shape of the upper edge 3310 also helps to guide the sealing force upward and into the user's face.

[0444] In some forms (see) Figure 6 The upper arm 3306 and / or lower arm 3308 may taper gradually along their length. For example, the upper arm 3306 and / or lower arm 3308 may be wider near the body 3010 and narrower further away from the body 3010. The wider portion near the body 3010 may contribute to a better connection (e.g., a larger connection surface area) and / or increase stability between the body 3010 and the arms 3306, 3308. The narrower portions of the arms 3306, 3308 may contribute to increased user comfort. For example, a thinner arm 3306, 3308 results in a smaller surface area in contact with the user, which reduces irritants. Additionally, the narrowest portion of the arms 3306, 3308 may extend around the user's ear during use. This helps to provide forces that are less likely to cause irritation to the back of the user's ear.

[0445] like Figure 7 As shown, the lower arm 3308 can be attached to the body in a similar manner to the upper arm 3306. For example, the lower arm 3308 can also be attached (by adhesive, ultrasonic welding, stitching, mechanical fasteners, or any similar method) to the edge 3036. The lower arm 3308 can be attached to the edge 3036 in an orientation substantially perpendicular to the portion 3132 attached to the inner surface 3032. Any of these attachment devices also serves to increase the rigidity of the faceplate 3000 (e.g., the adhesive can be used as a rigid element).

[0446] like Figure 21 As shown, any seams formed by connecting the lower arm 3308 to the body 3010 are not exposed. In other words, the seam created by the connection method can be between the body 3010 and the lower arm 3308, so that the user will not come into contact with the seam. This can be particularly advantageous when part 3132 is omitted and the user is in direct contact with the lower arm 3308 (e.g., there is a smoother surface that will reduce irritation to the user's skin).

[0447] like Figure 8 As shown, some forms of the lower arm 3308 can be connected to the body 3010 close to each other. For example, the ends of the lower arm 3308 can contact each other.

[0448] Continue to refer to Figure 8 Some forms of the lower arm 3308 may include a slight bend 3312. In other words, the lower edge 3314 of each lower arm 3308 may not be perfectly linear (e.g., but may include two sloping portions). The bend 3312 may be oriented such that it is substantially parallel to the upper edge 3310, and the upper and lower arms 3306, 3308 guide the sealing force in substantially the same direction.

[0449] See attached document Figures 17 to 22 The positioning and stabilizing structure 3300 helps provide sufficient contact between the mask 3000 and the user's face. As mentioned above, this form of mask 3000 does not include structures for sealing the sides or bottom of the user's mouth (e.g., sealing the user's lower lip). Therefore, a seal can be completely omitted at the lower end of the mask 3000. For example, air leaking from the chamber 3014 in a downward direction (e.g., when the user is upright) is less likely to cause user irritation (e.g., the air is not directed into the user's eyes or glasses). The user will also feel more comfortable without a seal under their lips. In some forms, the positioning and stabilizing structure 3300 can hold the body 3010 tightly under the user's lips without creating a seal. The nasal seal 3102 can still prevent fluid from flowing in an upward direction, but the material of the nasal seal 3102 (e.g., foam) may not be effective in sealing the chamber 3014.

[0450] In some configurations, most of the air inhaled by the user can still pass through the filter element 3024 (if used). Any gap between the user's lower lip and the positioning and stabilizing structure 3300 can be small, allowing a limited amount of unfiltered air to enter the chamber 3014 in that direction. Additionally, the user's mouth and nose can be positioned close to the filter element 3024, such that most of the air inhaled into the chamber 3014 is inhaled after first passing through the filter element 3024. This helps reduce the effects of incomplete sealing around the entire sealing perimeter 1105. In other words, the mask 3000 can continue to help the user limit the inhalation of debris and other unwanted particles even without forming a complete seal.

[0451] exist Figures 17 to 22 In other examples, the positioning and stabilizing structure 3300 can provide a sealing force capable of forming a seal around the entire sealing perimeter 1105. Although the lower part of the mask 3000 may not include the portion 3132 for sealing the user's lips, the material of the lower part of the mask 3000 can be sufficiently impermeable to form a seal.

[0452] For example, the positioning and stabilizing structure 3300 (or at least the lower arm 3308 of the ring 3302) can be substantially impermeable (e.g., constructed of or coated with an impermeable material). Figure 8 and 8-1 As shown, portion 3132 overlaps with at least a portion of the lower arm 3308. Therefore, the lower arm 3308 covers the user's sublipal region. For example, the lower arm 3308 can directly contact the user between the sublipal region and the mental protuberance. Return to Figures 18 to 22 For example, when part 3132 is removed, the lower arm 3308 can be positioned adjacent to or in contact with the user's lower lip (because the intermediate structure is no longer present).

[0453] As described above, the lower arm 3308 can be formed of a comfortable material to limit stimulation to the user. Instead of portion 3132, the lower arm 3308 (or all rings 3302) can be made of foam and / or fabric materials to provide cushioning for the user's face. For example, the lower arm 3308 can be thicker than other portions of the rings 3302 to provide cushioning for the user in the absence of portion 3132. Additionally, seams can be concealed to limit stimulation to the patient.

[0454] Sufficient force can be applied using the positioning and stabilizing structure 3300 to pull the lower arm 3308 into contact with the user's lower lip in a manner similar to that used in contact with part 3132. Because the inner arms 3308 are impermeable, they can be finished around the perimeter (e.g., with cantilever structure 3110) to form a complete seal around the sealing perimeter 1105.

[0455] Due to the force from the positioning and stabilizing structure 3300, the material of the lower arm 3308 can press against the user's face to limit discomfort caused by wearing the mask 3000. This provides a cushioning effect upon contact with the user's face, which replicates the sensation of part 3132 and provides a seal with the user's face.

[0456] As described above, the rear edge 3126 of the cantilever structure 3110 can be incorporated into the surface of the ring 3302 without the portion 3132. Figure 22 As shown, the curve of the rear edge 3126 can be substantially smooth. This can limit any gap (i.e., leakage source) between the user's face and the surface of the ring 3302 when the user wears the mask 3000.

[0457] As described above, the lower arm 3308 typically contacts the user's face between the lower lip and chin. However, some masks (not shown) may contact the user's chin (e.g., near the user's mental protuberance) and / or extend below the user's chin (e.g., below the user's mental protuberance) to provide additional coverage on the user's face.

[0458] In another form, ring 3302 may be provided with a sliding adjuster (not shown) to allow adjustment of the effective size of the ring. This allows ring 3302 to be made of a less elastic material. Instead, the user can move the adjuster away from the body 3010 (e.g., toward the free end of each ring 3302) so that the rings are larger than their ears for putting on and / or taking off the rings 3302. The user then moves the adjuster toward the body 3010 (e.g., toward the end attached to the body 3010) to adjust the size of the rings 3302 so that they provide sufficient sealing force and adequate comfort.

[0459] In another form, the headband 3300 may include a pair of upper straps and a pair of lower straps. Both the upper and lower straps are connected to the body 3010. However, each upper strap is not connected to a corresponding lower strap to form a loop. In other words, the corresponding upper and lower straps do not have a complete sheet of material. Instead, the user can tie the straps together to form a loop. The user can form a knot of selected length to change the size of the loop. The upper straps may also be tied together, and the lower straps may also be tied together. In other words, the connected upper straps may contact the back of the user's head covering the parietal bone, and the connected lower straps may contact the back of the user's head covering the occipital bone.

[0460] In other forms of this technology, for example, if the mask 3000 is configured as a CPAP patient interface, alternative forms of positioning and stabilization structures can be used, such as a headband comprising one or more straps extending around the patient's head. A catheter delivering air into the chamber 3014 can also be used as a strap.

[0461] 5.5 Glossary

[0462] 5.5.1 General Rules

[0463] Air: In some forms of this technology, air may be considered to mean atmospheric air, and in other forms of this technology, air may be considered to mean some other combination of breathable gases, such as oxygen-enriched air.

[0464] Leakage: The word "leakage" is considered to refer to undesirable airflow. In one example, leakage may occur due to an incomplete seal between the mask and the user's face. In another example, leakage may occur in a bend in the swivel tube leading to the surrounding environment.

[0465] 5.5.1.1 Materials

[0466] Fiber: A filament (monofilament or multifilament), ply, yarn, thread, or twist that is significantly longer than its width. Fibers can include: animal-based materials such as wool or silk; plant-based materials such as linen and cotton; and synthetic materials such as polyester and rayon. Fiber can specifically refer to a material that can be interwoven and / or interlaced (e.g., in a web) with other fibers of the same or different materials.

[0467] Fabric: A material comprising at least one natural or man-made fiber. In this specification, fabric may refer to any material formed as a network of interwoven and / or interlaced fibers. One type of fabric may include a cloth fabric, which is constructed by interlacing these fibers using specific techniques. These include weaving, knitting, crocheting, knotting, woven, tufting, or braiding. Cloth may be used synonymously with fabric, although it may specifically refer to a processed sheet of fabric. Other types of fabrics may be constructed using bonding (chemical, mechanical, thermal, etc.), felting, or other nonwoven processes. Fabrics produced by one of these methods are cloth fabrics and may be considered synonymous with fabric for the purposes of this application.

[0468] 5.5.1.2 Mechanical Properties

[0469] Resilience: The ability of a material to absorb energy during elastic deformation and release energy during unloading.

[0470] Elasticity: Releases virtually all of the energy upon unloading. Examples include certain siloxanes and thermoplastic elastomers.

[0471] Hardness: The ability of a material to resist deformation (e.g., described by Young's modulus or an indentation hardness scale measured on a standardized sample size).

[0472] • "Soft" materials may include silicone resins or thermoplastic elastomers (TPEs) and may change easily, for example, under finger pressure.

[0473] • "Hard" materials can include polycarbonate, polypropylene, steel or aluminum, and are not easily deformed, for example, under finger pressure.

[0474] Stiffness (or rigidity) of a structure or component: the ability of a structure or component to resist deformation in response to an applied load. The load can be a force or moment, such as compression, tension, bending, or torsion. A structure or component can provide different resistance in different directions. The reciprocal of stiffness is flexibility.

[0475] Flexible structures or components: structures or components that will change shape, such as bending, when subjected to a relatively short period of time, such as 1 second, while supporting their own weight.

[0476] Rigid structures or components: Structures or components that do not substantially change shape when subjected to the loads typically encountered in use. An example of such use could be, for instance, setting and maintaining a sealed relationship between the patient interface and the inlet of the patient's airway at a pressure of approximately 20 to 30 cmH2O.

[0477] As an example, an I-beam may include a different bending stiffness (resistance to bending loads) in the first direction compared to the second orthogonal direction. In another example, the structure or component may be flexible in the first direction and rigid in the second direction.

[0478] 5.5.2 Anatomy

[0479] 5.5.2.1 Facial Anatomy

[0480] Alar: The outer wall or "wing" of each nostril (plural: alar).

[0481] Alar tip: the outermost point on the ala of the nose.

[0482] Nasal wing curve (or nasal apex) point: the last point on the baseline of each nasal wing curve, found in the crease formed by the junction of the nasal wing and the cheek.

[0483] Auricle: The entire visible external part of the ear.

[0484] (Nasal) skeleton: The nasal skeleton includes the nasal bone, the frontal process of the maxilla, and the nasal part of the frontal bone.

[0485] (Nasal) Cartilage: The nasal cartilage includes the septum, lateral cartilage, and major and minor cartilages.

[0486] Columella: A strip of skin that separates the nostrils and extends from the nasal protuberance to the upper lip.

[0487] Columellar angle: The angle between a line drawn through the midpoint of the nostril and a line drawn perpendicular to the Frankfort plane (the two lines intersect at the lower point of the nasal septum).

[0488] Frankfurt Plane: A line extending from the lowest point of the eye socket margin to the left cochlea. The cochlea is the deepest point in the notch above the tragus of the auricle.

[0489] The glabella is located on soft tissue, at the most prominent point in the sagittal plane at the midpoint of the nasal protuberance.

[0490] The lateral nasal cartilage is a generally triangular cartilaginous plate. Its upper edge attaches to the nasal bone and the frontal process of the maxilla, and its lower edge connects to the greater alar cartilage.

[0491] Lower lip (midpoint of the lower lip): A point on the face between the mouth and the supramental point, located in the midsagittal plane.

[0492] Upper lip (midpoint of the upper lip): A point on the face between the mouth and nose, located in the midsagittal plane.

[0493] Greater alar cartilage: A cartilaginous plate located beneath the external nasal cartilage. It curves around the front of the nostril. Its posterior end connects to the frontal process of the maxilla via a tough fibrous membrane containing three or four smaller cartilages.

[0494] Nostrils (or nasal eyes): Approximately oval-shaped openings that form the entrance to the nasal cavity. The singular form of nostril (nare) is nasal nasal (naris). The nostrils are separated by the nasal septum.

[0495] Nasolabial folds or nasolabial folds: Skin folds or grooves that extend from each side of the nose to the corners of the mouth, separating the cheeks from the upper lip.

[0496] Nasolabial angle: The angle between the columella and the upper lip (which intersects at the lower point of the nasal septum).

[0497] Base point below the ear: the lowest point where the auricle attaches to the facial skin.

[0498] Base point on the ear: the highest point where the auricle attaches to the facial skin.

[0499] Nasal protuberance: The most prominent point or tip of the nose, which can be identified in a side view of the rest of the head.

[0500] The philtrum is the midline groove that extends from the lower border of the nasal septum to the top of the upper lip.

[0501] Prechin point: Located on the soft tissue, at the midpoint of the front part of the chin.

[0502] Nasal ridge: The nasal ridge is the midline protrusion of the nose that extends from the bridge of the nose to the nasal protuberance.

[0503] Sagittal plane: A vertical plane running from front to back. The midsagittal plane is the sagittal plane that divides the main body into the right and left halves.

[0504] Nasal bridge point: Located on the soft tissue, it is the most concave point covering the nasolabial fold area.

[0505] Septal cartilage (nose): The nasal septal cartilage forms part of the septum and separates the anterior part of the nasal cavity.

[0506] Posterosuperior lateral lamina: the point at the lower edge of the base of the nasal ala, where the base of the nasal ala joins the skin of the upper (superior) lip.

[0507] Subnasal point: Located on the soft tissue, at the junction of the columella and the upper lip in the midsagittal plane.

[0508] Mandibular alveolar seat: The point of maximum concavity located on the midline of the lower lip, between the midpoint of the lower lip and the soft tissue anterior mental point.

[0509] 5.5.2.2 Anatomical Structure of the Skull

[0510] Frontal bone: The frontal bone includes a large vertical portion (frontal scale), which corresponds to the area called the forehead.

[0511] Mandible: The mandible forms the lower jaw. The mental protuberance is the bony protuberance of the mandible that forms the chin.

[0512] Maxilla: The maxilla forms the upper jaw and lies above the lower jaw and below the orbit. The frontal process of the maxilla protrudes upward from the side of the nose and forms part of the lateral boundary.

[0513] Nasal bones: The nasal bones are two small, oval-shaped bones whose size and shape vary from individual to individual; they are located side by side in the middle and upper part of the face and form the "bridge" of the nose through their junction.

[0514] Nasal root: The junction of the frontal bone and the two nasal bones, located directly between the eyes and in the upper part of the bridge of the nose.

[0515] Occipital bone: The occipital bone is located at the back and lower part of the skull. It includes an oval-shaped foramen (foramen magnum), through which the cranial cavity communicates with the vertebral canal. The curved plate behind the foramen magnum is the occipital squamus.

[0516] The eye socket is the bony cavity in the skull that houses the eyeball.

[0517] Parietal bone: The parietal bone is the top and sides of the skull when joined together.

[0518] Temporal bone: The temporal bone is located at the base and sides of the skull and supports the part of the face known as the temples.

[0519] Cheekbones: The face consists of two cheekbones, which are located on the upper and side parts of the face and form the protrusions of the cheeks.

[0520] 5.5.2.3 Anatomical Structure of the Respiratory System

[0521] Diaphragm: A muscular plate that extends across the bottom of the ribcage. The diaphragm separates the thoracic cavity, which contains the heart, lungs, and ribs, from the abdominal cavity. As the diaphragm contracts, the volume of the thoracic cavity increases and air is drawn into the lungs.

[0522] The larynx: The larynx or larynx contains the vocal cords and connects the lower part of the pharynx (hypopharynx) to the trachea.

[0523] Lungs: The human respiratory organ. The conduction area of ​​the lungs includes the trachea, bronchi, bronchioles, and terminal bronchioles. The respiratory area includes the respiratory bronchioles, alveolar ducts, and alveoli.

[0524] Nasal chambers: The nasal chambers (or nasal fossae) are large, air-filled spaces located in the middle of the face above and behind the nose. The nasal chambers are divided into two parts by vertical wings called the nasal septum. On the sides of the nasal chambers are three horizontal branches called nasal conchae (singular "concha"). The front of the nasal chambers is the nose, while the back connects to the nasopharynx via the internal nasal openings.

[0525] Pharynx: The part of the throat located below the nasal cavity and above the esophagus and larynx. The pharynx is routinely divided into three segments: the nasopharynx (hyperpharynx), the oropharynx (middle pharynx), and the laryngopharynx (hypopharynx).

[0526] 5.5.3 User Interface

[0527] Frame: The frame is generally considered to refer to the mask structure that bears the tensile load between two or more points of connection with the head strap. The mask frame can be a non-airtight load-bearing structure within the mask. However, some forms of mask frames can also be airtight.

[0528] Headband: A headband is considered to refer to a form of positioning and stabilization structure designed for use on the head. For example, a headband may include an assembly of one or more support bars, straps, and reinforcements configured to position and hold a user interface on the user's face (e.g., for delivering respiratory therapy). Some straps are formed from soft, flexible, resilient materials, such as laminated composites of foam and fabric.

[0529] Membrane: A membrane is to be understood as a typically thin element that is preferably not flexurally resistant but is tensilely resistant.

[0530] Inflation chamber: The mask inflation chamber is considered to refer to the portion of the patient interface having walls that at least partially enclose a volume of space, which, during use, contains air pressurized therein to above atmospheric pressure. A housing may form part of the wall of the mask inflation chamber.

[0531] Sealing: can refer to the noun form of a structure (sealant) or the verb form of the effect (seal). Two elements can be constructed and / or arranged to 'seal' or to achieve 'sealing' between them, without the need for a separate 'sealing' element itself.

[0532] Shell: A shell is considered to mean a curved and relatively thin structure with bendable, stretchable, and compressible stiffness. For example, the curved structural walls of a face mask can be a shell. In some forms, the shell can be multifaceted. In some forms, the shell can be airtight. In some forms, the shell may not be airtight.

[0533] Reinforcing member: A reinforcing member is considered to be a structural component designed to increase the bending resistance of another component in at least one direction.

[0534] Support: The support will be considered as a structural component designed to increase the compressibility of another component in at least one direction.

[0535] Lacing (noun): A structure used to resist tension.

[0536] Ventilation port: (noun): A structure that allows airflow from inside the mask or tubing to ambient air, for example, to effectively flush out exhaled gases. For example, clinically effective flushing can involve a flow rate of approximately 10 liters per minute to approximately 100 liters per minute, depending on the mask design and treatment pressure.

[0537] 5.5.4 Shape of the structure

[0538] Products according to this technology may include one or more three-dimensional mechanical structures, such as mask pads or thrusters. Three-dimensional structures can be combined using two-dimensional surfaces. These surfaces can be distinguished using markings to describe the associated surface orientation, location, function, or some other characteristic. For example, a structure may include one or more of a front surface, a rear surface, an inner surface, and an outer surface. In another example, a seal-forming structure may include a surface that contacts the face (e.g., the exterior) and separate surfaces that do not contact the face (e.g., the underside or interior). In yet another example, a structure may include a first surface and a second surface.

[0539] 5.5.4.1 One-dimensional curvature

[0540] The curvature of a plane curve at P can be described with a sign (e.g., positive, negative) and a quantity (e.g., the reciprocal of the radius of the circle that only touches the curve at P).

[0541] Positive curvature: If a curve turns outward toward the normal, then the curvature at that point will be positive (if you imagine little people leaving the point, they would have to go uphill). Such curves are often called concave.

[0542] Zero curvature: If the curve is a straight line, the curvature will be zero (if you imagine little people leaving point p, they can walk horizontally without going up or down).

[0543] Negative curvature: If a curve deviates from the outward normal, the curvature in that direction at that point will be negative (if you imagine little people leaving that point, they would have to go downhill). Such curves are usually called convex curves.

[0544] 5.5.4.2 Two-dimensional curvature

[0545] A description of the shape at a given point on a two-dimensional surface according to the present invention may include multiple normal sections. These sections may cut through the surface in a plane including an outward normal (“normal plane”), and each section may be cut in a different direction. Each cross section produces a planar curve with a corresponding curvature. The different curvatures at that point may have the same sign or different signs. Each curvature at that point has a quantity, for example, a relatively small quantity.

[0546] Principal curvature and principal direction: The direction of the normal plane where the curvature of the curve reaches its maximum and minimum values ​​is called the principal direction.

[0547] A region of a surface: a connected set of points on the surface. This set of points in a region can have similar characteristics, such as curvature or sign.

[0548] Saddle-shaped region: a region in which the principal curvature has opposite signs at each point, i.e., one sign is positive and the other sign is negative (which may be going up or down depending on the direction the imagined individual is turning).

[0549] Dome region: A region in which the principal curvature has the same sign at each point, such as two positive ("concave dome") or two negative ("convex dome").

[0550] Cylindrical region: A region in which one principal curvature is zero (or, for example, zero within manufacturing tolerances) and the other principal curvature is not zero.

[0551] Planar region: A surface region in which both principal curvatures are zero (or, for example, zero within manufacturing tolerances).

[0552] Surface edge: The boundary or limit of a surface or region.

[0553] Path: In some forms of this technique, 'path' will be considered to mean a path in a mathematical-topological sense, such as a continuous spatial curve from f(0) to f(1) on a surface. In some forms of this technique, 'path' can be described as a route or distance, including, for example, a set of points on a surface. (The path of an imaginary person is the place where they walk on the surface, and is similar to a garden path).

[0554] Path length: In some forms of this technique, 'path length' will be considered as the distance along the surface from f(0) to f(1), i.e., the distance along the path on the surface. There can be more than one path between two points on the surface, and such paths can have different path lengths. (The path length for an imaginary person would be the distance they must walk along the path on the surface.)

[0555] Straight-line distance: Straight-line distance is the distance between two points on a surface, but without considering the surface itself. On a planar region, there will exist paths on the surface with the same length as the straight-line distance between the two points. On a non-planar surface, there may not be paths with the same length as the straight-line distance between the two points. (For the imaginary reader, straight-line distance will correspond to distance "in a straight line".)

[0556] 5.6 Other Remarks

[0557] This patent document contains a portion of copyrighted material. The copyright holder does not object to the reproduction of this patent document or patent disclosure by any person in the form it appears in the patent office documents or records, but otherwise reserves all copyright rights.

[0558] Unless explicitly stated in the context and a numerical range is provided, it should be understood that every intermediate value between the upper and lower limits of the range, up to one-tenth of the lower limit unit, and any other value or intermediate value within the range are broadly included within this technique. The upper and lower limits of these intermediate ranges may be included independently within the intermediate range and within the scope of this technique, but are subject to any explicitly excluded boundaries within the range. Where the range includes one or both of the extreme values, this technique also includes ranges that exclude any one or both of those included extreme values.

[0559] Furthermore, where one or more values ​​described herein are implemented as part of this technique, it should be understood that such values ​​may be approximate unless otherwise stated, and such values ​​may be used to the extent permitted or required by the practical implementation of the technique for any appropriate valid digits.

[0560] In addition, as used herein, “about,” “substantially,” “approximately,” or any similar terms mean + / - 5 to + / - 10% of the stated value.

[0561] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention pertains. While any methods and materials similar to or equivalent to those described herein may also be used in the practice or testing of this technology, a limited number of exemplary methods and materials are described herein.

[0562] When a particular material is determined to be used for constructing a component, obvious alternative materials with similar properties may be used as substitutes. Furthermore, unless otherwise stated, any and all components described herein are to be understood as being capable of being manufactured and therefore can be manufactured together or separately.

[0563] It must be noted that, unless the context clearly specifies otherwise, the singular forms “a,” “an,” and “the” used herein and in the appended claims include their plural equivalents.

[0564] All publications mentioned herein are incorporated herein in their entirety by reference to disclose and describe the methods and / or materials that are the subject of those publications. The publications discussed herein are provided solely for their publication prior to the filing date of this application. Nothing herein should be construed as an admission that the present invention is not entitled to priority of those publications due to prior art. Furthermore, the publication dates provided may differ from the actual publication dates and may require separate verification.

[0565] The terms “comprises” and “comprising” should be understood as referring to each element, component, or step in a non-exclusive manner, indicating the marked element, component, or step that may be present or utilized, or a combination with other unmarked elements, components, or steps.

[0566] The headings used in the detailed description are for the convenience of the reader only and should not be used to limit the subject matter found throughout this disclosure or the claims. These headings should not be used to interpret or limit the scope of the claims.

[0567] Although the present technology has been described herein with reference to specific embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the technology. In some cases, terms and symbols may imply specific details not required by the practical art. For example, although the terms "first" and "second" may be used, unless otherwise stated, they are not intended to indicate any order but rather to distinguish different elements. Furthermore, although process steps in a method may be described or illustrated in sequence, such order is not required. Those skilled in the art will recognize that such order can be modified and / or aspects may be performed simultaneously or even concurrently.

[0568] Therefore, it should be understood that numerous modifications can be made to the exemplary embodiments described herein, and that other arrangements can be designed without departing from the spirit and scope of the present technology.

Claims

1. A face shield for use at an operating pressure equal to atmospheric pressure, the face shield comprising: A body forming a three-dimensional shaped chamber configured to operate at the operating pressure throughout the user's respiratory cycle and configured to receive the user's mouth and nostrils, wherein the inner surface of the body is spaced apart from the user during use throughout the user's respiratory cycle; as well as A nasal seal having a cantilever structure having a front edge, a rear edge, and an upper surface extending from the front edge to the rear edge, the upper surface being configured and sized to avoid contact with the user's nasal ridge and to contact at least a portion of the user's nose along the user's sagittal plane and on the underside of the user's nose, below the user's nasal ridge, surrounding the user's nostrils, the nasal seal being constructed of at least partially impermeable material and configured to restrict airflow toward the user's eyes during use; as well as A positioning and stabilizing structure provides force to hold the nasal seal in place on the user's head, a portion of which is configured to directly contact the user's face between the sublipus and mental protuberance during use. At least a portion of the body is configured to allow air to enter and exit the three-dimensional forming chamber. The cantilever structure is fixed to the main body at the front edge, and the rear edge is the free end of the cantilever structure. At least a portion of the rear edge is configured to engage the user's face.

2. The face mask of claim 1, wherein at least a portion of the body is permeable, allowing air to enter and exit the three-dimensional shaped chamber through the surface of the body.

3. The face mask of claim 1, wherein the cantilever structure is configured to form a seal around the front and sides of the wing base of the user's nose.

4. The face mask according to claim 3, wherein the cantilever structure comprises: The central portion is configured to contact the lower region of the user's nose completely below the user's nasal protuberance along the user's sagittal plane; A pair of lateral ends configured to contact the user near the nasolabial fold; as well as A pair of intermediate portions, each of the pair of intermediate portions being located between the central portion and one of the pair of lateral ends, each intermediate portion being configured to contact the user's face near the wing base.

5. The face mask according to claim 4, wherein the central portion of the cantilever structure forms a seal directly below the user's nasal septum and nostrils, not on the user's lips.

6. The face mask according to claim 4, wherein the middle portion of the cantilever structure forms the maximum width of the cantilever structure.

7. The face mask of claim 4, wherein each intermediate portion includes a maximum width between the front edge and the rear edge, and wherein a lateral edge at each lateral end of the nose seal includes a minimum width between the front edge and the rear edge, the lateral edge being connected to the mouth seal.

8. The face mask of claim 7, further comprising a bridging member connected to the nasal seal, wherein the bridging member extends between the maximum widths of each intermediate portion.

9. The face mask according to claim 1, wherein the body is formed of spacer fabric, foam and / or thermoformed material.

10. The face mask according to claim 1, wherein a malleable deformable element is provided at the upper center of the periphery of the main body, the malleable deformable element being configured to bend and change the shape of the main body.

11. The face mask of claim 10, wherein the malleable element is at least partially enclosed in a sleeve.

12. The face mask of claim 11, wherein the sleeve is made of a fabric material.

13. The face mask of claim 1, further comprising at least one filter element configured to filter air before it enters and / or exits the three-dimensional forming chamber, wherein the at least one filter element is disposed on the inner surface of the three-dimensional forming chamber.

14. The face mask according to claim 13, wherein... The at least one filter element covers the entire inner surface of the body, and the inner surface of the three-dimensional shaped chamber includes at least one fastener; The filter element is configured to be removably connected to the at least one fastener; and The at least one fastener is formed of hook and loop material.

15. The face mask of claim 14, wherein the at least one fastener is a plurality of fasteners arranged in an X-shape, each of the plurality of fasteners extending between the outer periphery and the center of the body.

16. The face mask of claim 13, wherein the rigid member is coupled to at least a portion of the outer periphery of the filter element, the rigid member being elastic and configured to return to an intermediate position after the compressive force is removed.

17. The face mask of claim 1, wherein the positioning and stabilizing structure comprises two elastic rings, each elastic ring configured to engage one of the user's ears.

18. The face mask of claim 17, wherein the elastic ring is connected to the body around the entire periphery of the body.

19. The face mask of claim 17, wherein each of the two elastic rings forms a complete, undamaged periphery.

20. The face mask of claim 17, wherein the elastic ring is thicker near the body and gradually tapers at its free end away from the body.

21. The face mask of claim 17, wherein the elastic ring is formed of a single piece of material and joined together along its unbroken length.

22. The face mask of claim 17, wherein the elastic ring is made of at least partially impermeable material and configured to restrict airflow into and / or out of the three-dimensionally shaped cavity between the positioning and stabilizing structure and the user's face.

23. The face mask of claim 22, wherein the elastic ring is made of a fabric material and coated with an impermeable material to restrict airflow.

24. The face mask of claim 22, wherein each elastic ring is configured to stretch to engage the user's ear and provide tension configured to pull the body toward the user's face, wherein the elastic ring is configured to be arranged in a sealing manner to at least partially surround the user's mouth and contact the user between the chin and under the lips.

25. The face mask of claim 24, wherein the two resilient rings and the nose seal form a single continuous seal.

26. The face mask of claim 1, wherein the nasal seal is configured not to extend into the user's nostrils.

27. The face mask according to claim 1, wherein the nose seal is made of a single piece of material.

28. The face mask of claim 1, wherein the nasal seal is symmetrical about a central portion, the central portion being configured to contact the user's nose in use along a sagittal plane completely below the nasal protrusion.

29. The face mask of claim 1, wherein a strap is attached to the outer periphery of the body on the front surface of the body outside the three-dimensionally shaped cavity, wherein the strap is configured to increase the rigidity of the body.

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