Two-compartment face mask

Abstract

A filtering face mask is disclosed. The face mask includes a mask body having an upper portion configured to cover a user's nostrils of a first material, a lower portion configured to cover a user's mouth of a second material, and a partition configured to separate the upper and lower portions. The first material, the second material, or both, include a filtering material. The face mask may also include a sample collection material. The sample collection material may be provided as an insert.

Description

Related Applications

[0001]

[0001] This application claims priority to U.S. Provisional Patent Application No. 63 / 245,021, filed September 16, 2021, the contents of which are incorporated herein in their entirety. [Background technology]

[0002]

[0002] Respirators are commonly worn in a person's respiratory tract for at least two general purposes: (1) to prevent impurities and contaminants from entering the user's respiratory system, and (2) to prevent exposure of other people or objects to pathogens and other contaminants exhaled by the user. In the first situation, respirators are worn in environments where the air contains particles (e.g., pathogens) that are harmful to the user. In the second situation, respirators are worn in environments where there is a risk of contamination of other people or objects, for example to protect others from pathogens present in the user's body.

[0003] There are a variety of respirators designed to meet either (or both) of these objectives. Some respirators are classified as "filtering facepiece" because the mask body itself functions as the filtering mechanism. Unlike respirators that use a rubber or elastomeric mask body combined with an attachable filter cartridge (such as that described in U.S. Reissue Patent No. 39,493 to Yuschak et al.) or an insert-molded filter element (such as that described in U.S. Patent No. 4,790,306 to Braun), filtering facepiece respirators are designed so that the filter media covers most of the mask body, eliminating the need for filter cartridge installation or replacement. These filtering facepiece respirators generally come in two configurations: molded respirators and flat-fold respirators.

[0004]

[0004] Molded filtering facepiece respirators typically use thermally bonded nonwoven fibers or meshed plastic mesh to provide a cup-shaped configuration to the mask body. Molded respirators tend to maintain the same shape during use and storage. Therefore, these respirators cannot be folded flat for storage or shipping. Examples of patents disclosing molded filtering facepiece respirators include U.S. Patent No. 7,131,442 to Kronzer et al., U.S. Patent No. 6,923,182 to Angadjivand et al., U.S. Patent No. 6,041,782 to Dyrud et al., U.S. Patent No. 4,807,619 to Dyrud et al., and U.S. Patent No. 4,536,440 to Berg.

[0005]

[0005] A flat-fold respirator, as the name suggests, can be folded flat for shipping or storage, and can be opened into a cup-shaped configuration for use. Examples of flat-fold respirators are shown in U.S. Patent Nos. 6,568,392 and 6,484,722 by Bostock et al., and U.S. Patent No. 6,394,090 by Chen. Summary of the Invention

[0006]

[0006] The present disclosure relates generally to medicine and overall personal, industrial, and environmental hygiene. More specifically, the present disclosure relates to a filtering face mask. The filtering face mask may be used to protect a user from airborne pathogens and other airborne contaminants. The filtering face mask may be used to protect others from pathogens that may be present in the user's body and become airborne through exhalation.

[0007] In one aspect, the present disclosure relates to a face mask including an upper portion of a first material configured to cover a user's nostrils, a lower portion of a second material configured to cover a user's mouth, and a divider configured to separate the upper and lower portions. The first material, the second material, or both, include a filter material. The face mask may include a sample collection material. The sample collection material may be provided as an insert.

[0008]

[0008] Studies have shown that respiratory pathogens are primarily spread by exhaled air exhaled through the nostrils. However, the breathability of face masks is a major concern for users and a major factor in compliance. People who want to protect themselves and protect others will want a mask that is easy to breathe through while filtering out the most contaminants. The airflow, temperature, and humidity through which an individual breathes affect the user's experience while wearing a mask.

[0009]

[0009] Pathogens such as COVID can attack the body through the ACE2 receptors present in the nasal cavity, and the nasal cavity needs to be specifically protected from pathogens entering in this way.

[0010]

[0010] Therefore, there is a continuing need to develop face masks that can reduce or prevent the spread of pathogens and improve breathability, thereby increasing the use of the mask. [Brief description of the drawings]

[0011] [Figure 1A] FIG. 1 is a perspective view of a filtering face mask in one embodiment. [Figure 1B] FIG. 1B is a side cross-sectional view of the filtering face mask of FIG. [Figure 1C] FIG. 1B is a top cross-sectional view of the filtering face mask of FIG. [Diagram 2] FIG. 1B is a plan view of a divider for the filtering face mask of FIG. [Diagram 3]FIG. 1B is a plan view of a divider including an insert for the filtering face mask of FIG. definition

[0012]

[0016] All scientific and technical terms used herein have meanings commonly used in the industry unless otherwise specified. The definitions provided herein are intended to facilitate understanding of certain terms used frequently herein and are not intended to limit the scope of the present disclosure.

[0013]

[0017] All headings provided herein are for the convenience of the reader and should not be used to limit the meaning of the text that follows the heading, unless specifically so specified.

[0014]

[0018] As used here, "ie" is an abbreviation of the Latin phrase id est, which means "that is," while "eg" is an abbreviation of the Latin phrase exempli gratia, which means "for example."

[0015]

[0019] The term "about" is used herein with numerical values ​​that include normal variations in measurement expected by an artisan and is understood to have the same meaning as "approximately" and to cover a typical range of error (e.g., a range of ±5%). Furthermore, unless otherwise indicated, all numbers expressing quantities and all terms expressing directions / orientations (e.g., vertical, horizontal, parallel, perpendicular, etc.) in the specifications and claims are understood to be modified in all instances by the term "about."

[0016]

[0020] The terms "a," "an," and "the" are intended to refer not only to a singular entity, but to include the general class for which a specific example is being used for illustration.

[0017]

[0021] The terms "a," "an," and "the" are used interchangeably with the term "at least one." The phrases "at least one" and "including at least one" following a list refer to any one of the items in the list, as well as any combination of two or more items in the list.

[0018]

[0022] As used herein, "or" is generally used in its ordinary sense including "and / or" unless the context clearly dictates otherwise. The term "and / or" refers to one or all of the listed elements or a combination of any two or more of the listed elements.

[0019]

[0023] The recitation of numerical ranges herein by endpoints includes all numbers subsumed within that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4, 5, etc., and 10 or less includes 10, 9.4, 7.6, 5, 4.3, 2.9, 1.62, 0.3, etc.). When a range up to or at least a particular value is stated, then that value is included within the range.

[0020]

[0024] As used herein, the terms "have," "having," "include," "including," "comprise," "comprising," and the like are used in their open sense and generally mean "including, but not limited to." As used herein, the terms "consisting essentially of," "consisting of," and the like are understood to be included in the terms "comprising," and the like. As used herein, "consisting essentially of," in relation to compositions, products, methods, and the like, means that the components of the composition, product, method, and the like are limited to the recited components, and do not include other components that do not substantially affect the basic and novel characteristics of the composition, product, method, and the like.

[0021]

[0025] The words "preferred" and "preferably" refer to embodiments that may provide certain advantages, under particular circumstances, but that other embodiments may also be preferred, under the same or other circumstances. Furthermore, the recitation of one or more preferred embodiments does not imply that other embodiments are not useful, and is not intended to exclude other embodiments from the scope of the disclosure.

[0022]

[0026] Any directions or orientations referenced herein, such as "front", "back", "top", "bottom", "left", "right", "upper", "lower", etc., are described herein for clarity of reference to the figures and are not intended to be limiting to the actual device or system or use of the device or system. The devices and systems described herein may be used in many orientations and orientations.

[0023]

[0027] Any directions or orientations referenced herein, such as "top", "bottom", "left", "right", "upper", "lower", etc., are described herein for clarity of reference to the figures and are not intended to be limiting to the actual device or system or the use of the device or system. The devices and systems described herein may be used in many directions and orientations.

[0024]

[0028] The terms "downstream" and "upstream" refer to relative locations based on the direction of exhaled air flow through the device, e.g., the most upstream element of the device is the air inlet element and the most downstream element is the exhaled air outlet element. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0025]

[0029] Disclosed herein is a filtering face mask (i.e., a respiratory protection device). The disclosed filtering face mask can effectively filter pathogens, such as viruses, from inhaled or exhaled air. The disclosed filtering face mask can further capture a sample taken from exhaled air, which may be used for testing.

[0026]

[0030] Research shows that some respiratory pathogens are spread primarily by exhaled air through the nostrils. Pathogens like the COVID virus can attack the body through the ACE2 receptors present in the nasal cavity. Therefore, it is necessary to protect the nasal cavity from foreign pathogens entering, while at the same time protecting others from possible pathogens exiting the nasal cavity of an infected person.

[0027]

[0031] Filter materials commonly used in face masks, such as electrets, work best when the airflow is slow, and the electrical charge of the electret material works better to attract and trap pathogens. The reduced momentum of the exhaled air improves the electret's trapping ability.

[0028]

[0032] Breathability of face masks is a major concern for users and a major driver of compliance. People are more likely to wear face masks that allow them to breathe comfortably. People who want to protect themselves and protect others will want a mask that is easy to breathe through while filtering out the most pollutants.

[0029]

[0033] According to one embodiment, the filtering face mask disclosed herein provides a close fit to the face and efficient filtration of airborne particles. The face mask includes an upper portion (forming an upper compartment), a lower portion (forming a lower compartment), and a partition separating the upper portion and the lower portion. The upper portion is made of a first material and the lower portion is made of a second material. In some embodiments, the second material is different from the first material. The partition may be made of the first material, the second material, or a third material different from the first and second materials. In some embodiments, the filtering face mask also includes a sample collection material. In some embodiments, the face mask is constructed as a flat-fold mask. In some embodiments, the face mask is constructed as a molded mask.

[0030]

[0034] In one embodiment, the top portion provides a tight fit against the user's nostrils. The top portion may be designed to seal against the user's skin surface to reduce or prevent air from flowing through gaps or openings between the user's skin surface and the mask. Forming a tight fit against the user's skin may help direct airflow through the mask material.

[0031]

[0035] According to one embodiment, the upper portion is made of a first material and the lower portion is made of a second material. The first and second materials may be the same or different materials. In some embodiments, the second material is different from the first material. The first material may be less porous or less dense than the second material. The first material may have a higher pressure drop than the second material. The partition may be made of the first material, the second material, or a third material different from the first and second materials. In some embodiments, the partition is made of the second material or a third material that has a lower pressure drop than the first material.

[0032]

[0036] References to pressure drop herein are intended to mean pressure drop measured in accordance with NIOSH-42CFR84 at a flow rate of 85 L / min. It should be noted that the pressure drop through a filter material will naturally be higher at higher flow rates and lower at lower flow rates. Where a material has different inhalation and exhalation pressure drops, references are made here to the exhalation pressure drop. Filter materials suitable for filtering face masks such as those described herein typically have pressure drops in the range of 10 Pa to 400 Pa at a flow rate of 85 L / min. For example, N95 materials according to NIOSH standards have a maximum exhalation pressure drop of 245 Pa or less and a maximum inhalation pressure drop of 343 Pa or less at a flow rate of 85 L / min.

[0033]

[0037] According to one embodiment, the first material and the second material have a pressure drop in the range of 10 Pa to 300 Pa, 10 Pa to 200 Pa, 10 Pa to 100 Pa, 10 Pa to 50 Pa, 10 Pa to 40 Pa, 12 Pa to 25 Pa, 10 Pa to 20 Pa, or 12 Pa to 20 Pa. Within the overall range, the first material used to construct the upper portion may have a higher pressure drop than the second material used to construct the lower portion. For example, in some embodiments, the first material has a pressure drop of 10 Pa to 300 Pa, 10 Pa to 200 Pa, 12 Pa to 100 Pa, 12 Pa to 50 Pa, 12 Pa to 40 Pa, 12 Pa to 25 Pa, or 12 Pa to 20 Pa. The second material may have a lower pressure drop than the first material. The second material can have a pressure drop of 10 Pa to 300 Pa, 10 Pa to 200 Pa, 10 Pa to 100 Pa, 10 Pa to 50 Pa, 10 Pa to 40 Pa, 10 Pa to 25 Pa, or 10 Pa to 20 Pa. In some embodiments, the first material used to construct the upper portion is an N95-like material (including N95 material). The pressure drop of the various materials can be selected to direct the air flow in a desired pattern and improve sample collection at the sample collection material. For example, the sample collection material insert in the lower portion and partition has a lower pressure drop than the rest of the upper portion and partition, making it easier for air to pass through the sample collection material and lower portion. Making the lower portion out of a lighter, more breathable material can improve user comfort by facilitating mouth breathing and introducing cooler filtered air to the upper compartment. Making the upper portion out of a heavier, higher pressure drop material slows the air flow from nose breathing and allows more air to pass through the partition and sample collection material, improving capture by the sample collection material. Air drawn in through the partition and bottom passes through at least two layers of material, so is doubly filtered.

[0034]

[0038] Either the first material, the second material, or the first and second materials may be layered materials. In some embodiments, the first and second materials include at least one filtration layer. The filtration layer is typically selected to achieve a desired filtration effect. The filtration layer generally removes a high percentage of particles and other contaminants from the gas stream passing therethrough. In the case of a fibrous filter layer, the fibers selected depend on the type of material to be filtered and are typically selected so as not to bond together during the forming operation. As shown, the filtration layer may be in a variety of shapes and forms, typically having a thickness of about 0.2 millimeters (mm) to 1 centimeter (cm), more typically about 0.3 mm to 0.5 cm, and may be a generally flat web or corrugated to provide an extended surface area. See, for example, U.S. Patent Nos. 5,804,295 and 5,656,368 to Braun et al. The filtration layer may also include multiple filtration layers bonded together by adhesive or other means. Essentially any suitable material known (or later developed) for forming a filtration layer may be used as the filtration material. Webs of melt-blown fibers, especially those in the permanently electrically charged (electret) form, as taught in Wente, Van A., "Superfine Thermoplastic Fibers," 48 Indus. Engn. Chem., 1342 et seq. (1956), are particularly useful (see, for example, U.S. Pat. No. 4,215,682, Kubik et al.). These melt-blown fibers can be microfibers with effective fiber diameters of less than about 20 micrometers (μm) (referred to as "blown microfibers" (BMF)), typically about 1 to 12 μm. Effective fiber diameters can be determined according to Davies, CN, "The Separation Of Airborne Dust Particles," Institution Of Mechanical Engineers, London, Proceedings 1B, 1952. Particularly preferred are BMF webs containing fibers formed from polypropylene, poly(4-methyl-1-pentene), and combinations thereof.Electrically charged fibrillated film fibers, such as those taught in U.S. Reissue Patent No. 31,285 to van Turnhout, may also be suitable, as may rosin wool fiber webs and webs of glass fibers or solution- or electrostatically sprayed fibers, especially in microfilm form. An electrical charge may be imparted to the fibers by contacting them with water, as disclosed in U.S. Patent No. 6,824,718 to Eitzman et al., U.S. Patent No. 6,783,574 to Angadjivand et al., U.S. Patent No. 6,743,464 to Insley et al., U.S. Patent Nos. 6,454,986 and 6,406,657 to Eitzman et al., and U.S. Patent Nos. 6,375,886 and 5,496,507 to Angadjivand et al. Electrical charges can also be imparted to the fibers by corona charging, as disclosed in US Patent 4,588,537 by Klasse et al., or by tribocharging, as disclosed in US Patent 4,798,850 by Brown. Also, additives can be included in the fibers to improve the filtration performance of the web produced through a hydrocharging process, as seen in US Patent 5,908,598 by Rousseau et al. In particular, fluorine atoms can be placed on the surface of the fibers of the filter layer to improve filtration performance in an oily mist environment. See, for example, US Patents 6,398,847, 6,397,458, and 6,409,806 by Jones et al. Typical basis weights of electret BMF filtration layers are about 10 to 100 grams per square meter. For example, when electrically charged according to the techniques described in the '507 Angadjivand et al. patent and containing fluorine atoms as described in the Jones et al. patent, the basis weight is about 20-40 g / m. 2 and about 10 to 30 g / m 2 It can be.

[0035]

[0039] Either the first material or the second material, or both, may further include a pre-filter layer. The pre-filter layer is a layer disposed adjacent to the filtration layer and may provide additional filtration functionality. In some embodiments, the pre-filter layer is disposed between the face of the user and the filtration layer. In some embodiments, the pre-filter layer is disposed on the outside of the filtration layer from the user's perspective. Additionally, an adsorbent material, such as activated carbon, may be disposed between the fibers and various layers that make up the filtration structure. Additionally, a separate particulate filtration layer may be used in combination with the adsorbent layer to provide both particulate and vapor filtration. The filtration structure may include one or more stiffening layers that help provide a cup-shaped configuration.

[0036]

[0040] Either the first material or the second material, or both, may further include a support layer (e.g., a cover web). For example, an inner cover web may be used to provide a smooth surface that contacts the user's face, and an outer cover web may be used to contain loose fibers of the mask body or for aesthetic reasons. The cover web typically does not provide a significant filtration benefit to the filtering structure, but may function as a pre-filter if placed outside (or upstream) of the filtration layer. To obtain adequate comfort, it is preferred that the inner cover web has a relatively low basis weight and is formed from relatively fine fibers. More specifically, the cover web is about 5 to 50 g / m 2 (Usually 10-30g / m 2 ), and the fibers can be less than 3.5 denier (usually less than 2 denier, more typically less than 1 denier but greater than or equal to 0.1). The fibers used in the cover web often have an average fiber diameter of about 5 to 24 micrometers, usually about 7 to 18 micrometers, more typically about 8 to 12 micrometers. The cover web material can be elastic (usually, but not necessarily, 100 to 200% at break) and may be plastically deformable.

[0037]

[0041] Suitable materials for the cover web can be polyolefin BMF materials, such as polypropylene BMF materials, including blends of polypropylene and blends of polypropylene and polyethylene. A suitable process for producing BMF materials for the cover web is described in U.S. Patent No. 4,013,816 by Sabee et al. The web can be formed by collecting the fibers, usually on a smooth-surfaced drum or rotating collector. See U.S. Patent No. 6,492,286 by Berrigan et al. Spunbond fibers can also be used.

[0038]

[0042] A typical cover web can be made from polypropylene or a polypropylene / polyolefin blend containing 50% or more by weight polypropylene. These materials have been found to provide high softness and comfort to the user and, when the filter material is a polypropylene BMF material, are secured to the filter material without the need for an adhesive between the layers. Suitable polyolefin materials for the cover web may include, for example, a single polypropylene, a blend of two polypropylenes, a blend of polypropylene and polyethylene, a blend of polypropylene and poly(4-methyl-1-pentene), and / or a blend of polypropylene and polybutylene. One example of a fiber for the cover web is polypropylene BMF made from Exxon Corporation's polypropylene resin "Escorene 3505G", which has a density of about 25 g / m 2 and has a fiber denier ranging from 0.2 to 3.1 (average of about 0.8 measured over 100 fibers). Another suitable fiber is polypropylene / polyethylene BMF made from a blend of 85 percent Exxon Corporation resin "Escorene 3505G" and 15 percent ethylene / alpha-olefin copolymer "Exact 4023" and has a fiber density of about 25 g / m 2and has an average fiber denier of about 0.8. Suitable spunbond materials are available from Corovin GmbH, Peine, Germany under the trade names "Corosoft Plus 20", "Corosoft Classic 20" and "Corovin PP S 14", and from JW Suominen OY, Nakkila, Finland under the trade name "370 / 15".

[0039]

[0043] The cover web used in the face mask can have a smooth outer surface because very few fibers protrude from the web surface after processing. Examples of cover webs used in the current invention are disclosed, for example, in U.S. Patent No. 6,041,782 by Angadjivand, U.S. Patent No. 6,123,077 by Bostock et al., and International Publication No. WO 96 / 28216 by Bostock et al.

[0040]

[0044] The lower portion of the mask covers the mouth of the user. The lower portion of the mask is made of a second material that is more porous than the first material used to make the upper portion of the mask. This arrangement makes the lower portion more breathable for the user. It can also provide improved temperature control, a supply of fresh air, and improved hearing while speaking.

[0041]

[0045] The face mask also includes a partition that forms a barrier between the nostrils and the mouth, thereby defining an upper (compartment) and a lower (compartment) of the mask. The partition may be made of the same material as the upper or lower portion, or may be made of a different material than the upper or lower portion. The partition may be made of a permeable or non-permeable material. In some embodiments, the partition is made of a material with a heavier pressure drop than the lower portion. The partition may include an insert that includes a sample collection material. The sample collection material may have a smaller pressure drop so that air passes through the sample collection material to facilitate pathogen collection. The insert may be removable for pathogen testing.

[0042]

[0046] The divider can be positioned on the mask body so that it is located under the nose when the mask is worn. The divider may be located above the mouth. In some embodiments, the divider is located below the mouth. The mask body has a height, and the divider may be located at a position measured as a percentage of the height measured from the top of the mask body. For example, the divider may be located at a height of at least 20%, at least 25%, at least 30%, or at least 40% from the top of the mask. The divider may be located at a height of 20% to 50%, or at a height of 25% to 40%. The divider may be located at a height of about 30%, about 35%, or about 40%. In some embodiments, if the divider is intended to be located below the mouth, the divider may be located at a height of about 50%.

[0043]

[0047] The divider can extend from one side of the mask to the other. The divider can span only a portion of the width of the mask. For example, the divider can extend across the central 50% or more, 75% or more, or 90% or more of the width of the mask.

[0044]

[0048] The divider may have a depth (front to back) that accommodates most face shapes and sizes. The divider depth extends from the mask body, which is located in front of the user's face, to the user's face.

[0045]

[0049] In some embodiments, the face mask is constructed as a flat-fold mask. The flat-fold mask can be folded with a divider in place. The flat-fold mask can be folded with an insert in place. Alternatively, the flat-fold mask can be folded without an insert and the insert can be inserted before use. The flat-fold mask can be provided as a kit including the insert and instructions for unfolding the mask and inserting the insert.

[0046]

[0050] The face mask may further include a breath sample collection material. For example, the top, bottom, partition, or a combination thereof may include a breath sample collection material. The sample collection material may be provided as a removable insert. In some embodiments, the top or partition of the face mask includes a material designed to capture and collect analytes in a bioaerosol sample exhaled through the user's nostrils. In one embodiment, the entire top of the mask is capable of capturing and collecting analytes in a bioaerosol sample. In one embodiment, a region of the top of the mask is capable of capturing and collecting analytes in a bioaerosol sample. In one embodiment, another material capable of capturing and collecting analytes in a bioaerosol sample is bonded or attached to the inner surface of the mask (the surface of the mask facing the user's face). The sample collection material may be removably bonded or attached to the mask. In one embodiment, the partition is capable of capturing and collecting analytes in a bioaerosol sample. In one embodiment, a portion of the partition is capable of capturing and collecting analytes in a bioaerosol sample. In one embodiment, the divider may have another material bonded or attached thereto that can capture and collect analytes of interest in a bioaerosol sample, and the second material may be separated from the top of the mask and / or the divider and analyzed.

[0047]

[0051] The sample collection material may have any suitable size. The size of the sample collection material may be sized to facilitate inhalation through the sample collection material. For example, if the pressure drop through the sample collection material is different than other materials used to make the mask, the size of the sample collection material may be sized to facilitate a suitable overall pressure drop through the mask. The size of the sample collection material may be sized to facilitate collection of a sample from an airflow passing through the sample collection material. The size of the sample collection material may be sized to facilitate attachment of the sample collection material to the mask. The sample collection material may be an insert or may form part or parts of the mask, such as a partition, a top, a bottom, or a combination thereof. When the sample collection material is provided as an insert, the size of the sample collection material may be smaller than when it is provided as, for example, a partition. The surface area of ​​the sample collection material is understood as the surface area of ​​a single major surface of the material. The sample collection material may be a material having a major surface area of ​​50 mm 2 Above 100mm 2 Above 200mm 2 or more, or 300mm 2 The surface area of ​​the main surface can be more than 500 mm 2 Below, 400mm 2 Below, 300mm 2 Less than or equal to 250mm 2 The surface area of ​​the main surface can be 50 mm 2 From 500mm 2 , 75mm 2 From 400mm 2 , or 100mm 2 From 300mm 2 The range can be:

[0048]

[0052] The sample collection material can be an insert that covers a window or opening in the mask. For example, the mask can include a window or opening in the partition or bottom, or both. In one embodiment, the mask includes one or more windows or openings in the partition. The one or more windows or openings can be located directly under the nose or nostrils. Or, the one or more windows or openings can be located on the side of the partition. The one or more windows or openings can be covered by the sample collection material. The sample collection material can be removable and used to test for viruses, other pathogens, or other analytes.

[0049]

[0053] In another embodiment, the entire top portion and / or the entire partition of the mask can be made of a material that attracts analytes contained in a bioaerosol sample expelled from the user's nostrils or filtered from outside air by inhalation. The entire top portion of the mask, a portion of the top portion, the entire partition, or a portion of the partition can be analyzed for analytes of interest.

[0050]

[0054] A particularly suitable material for capturing and collecting samples is an electret. In another embodiment, a sample capture and collection electret material can be bonded or attached to the top of the mask and / or to the partition. The sample capture and collection electret material can be removed from the mask or partition and analyzed.

[0051]

[0055] In some embodiments, the sample collection material is an electrostatically charged nonwoven material. The electrostatic charge may aid in capturing pathogens, viruses, or other analytes from the exhaled airstream. In some cases, the sample collection material may be a hydrophobic nonwoven material. In other cases, the sample collection material may be a hydrophilic nonwoven material. The sample collection material may be an electrostatically charged hydrophobic nonwoven material configured to capture pathogens, viruses, or other analytes from the exhaled airstream. The sample collection material may be an electrostatically charged hydrophilic nonwoven material configured to capture pathogens, viruses, or other analytes from the exhaled airstream. The term "hydrophobic" refers to a material having a water contact angle of 90 degrees or greater, or between about 90 degrees and about 170 degrees, or between about 100 degrees and about 150 degrees. The term "hydrophilic" refers to a material having a water contact angle of less than 90 degrees. Water contact angles are measured using ASTM D5727-1997, Standard Test Method for Surface Wettability and Absorbency of Sheet Materials Using an Automated Contact Angle Tester.

[0052]

[0056] The sample collection material can be formed of any suitable material capable of capturing viruses, pathogens, or other analytes from an exhaled air stream and releasing the captured viruses, pathogens, or other analytes upon contact with a solvent (e.g., saline). The sample collection material can be formed of a polymeric material. The sample collection material can be formed of a polyolefin. Examples of suitable polyolefins include polypropylene, polylactic acid, and the like, including combinations thereof. In one embodiment, the sample collection material is formed of polypropylene. In one embodiment, the sample collection material is formed of polylactic acid. One exemplary sample collection material is commercially available under the trademark FILTRETE Smart MPR 1900 Premium Allergen, Bacteria & Virus Air Filter Merv 13 from 3M Company, St. Paul, Minnesota, USA.

[0053]

[0057] The sample collection material can have a thickness perpendicular to the major plane of 200 micrometers (μm) or more, or 250 μm or more. The sample collection material can have a thickness of 750 μm or less, or 1000 μm or less. The sample collection material can have a thickness in the range of 200 μm to 1000 μm, or 250 μm to 750 μm.

[0054]

[0058] A user can exhale through the mask to load a sample of the exhaled airstream onto the sample collection material to form a loaded sample collection material. For example, a user can exhale through the top through the nostrils and have the exhaled airstream pass through the sample collection material. The sample collection material can also be used to test environmental exposure for viruses and other pathogens. A user can inhale air so that the inhaled airstream passes through the sample collection material. The sample collection material is constructed to capture viruses, other pathogens, or other analytes from the exhaled airstream, the inhaled airstream, or both. The user can later remove the portion of the mask containing the loaded sample collection material. The user can use an appropriate assay to test for the presence of pathogens or provide the loaded sample collection material to a laboratory or medical facility. The sample can be eluted from the loaded sample collection material using an appropriate liquid (e.g., a buffer) and further tested using an appropriate assay. In some embodiments, the mask can be used in an environment where a user may be exposed to a pathogen (e.g., a respiratory virus) or multiple such pathogens, and the sample collection material can be removed and submitted for testing after a period of exposure. For example, the mask can be worn in healthcare settings, educational settings, hospitality settings, restaurants, travel settings, etc. In one exemplary embodiment, a healthcare worker can wear the mask during a work shift and test the sample collection insert at the end of the shift.

[0055]

[0059] The lower portion can be permanently or removably attached to the upper portion. In one embodiment, the lower portion is adjustable and / or removable. In this embodiment, the upper portion and divider stay in place to cover the nose and nostrils, and the user can lower, raise, or remove the lower portion to open the mouth for eating, drinking, or speaking. The mask can include a hinge mechanism to lift the lower portion up, lower it, or remove it. The mask can include hook and loop fasteners, adhesives, or other fasteners to connect the lower portion to the mask to allow oral access.

[0056]

[0060] The face mask may further include additional components to facilitate use of the face mask and fit to the face, for example, the face mask may include straps, nose clips, seals, exhalation valves, or combinations thereof.

[0057]

[0061] The straps used in the face masks can be made of a variety of materials, such as thermoset rubber, thermoplastic elastomers, braided or woven rubber / yarn combinations, and non-elastic woven components. The straps can be made of elastic materials, such as elastic woven materials. The straps can be stretched preferably more than twice their total length and return to a relaxed state. The straps can also be increased to three or four times their relaxed length and return to their original state without damage when the pulling force is removed. Thus, the elastic limit is preferably not less than two, three or four times the length of the strap in the relaxed state. Typically, the straps are about 20 cm to 30 cm long, 3 mm to 10 mm wide, and about 0.9 mm to 1.5 mm thick. The straps can extend as a continuous strap from one side of the mask to the other, or can have multiple parts, such as loops for hanging over the ears. For example, the straps can have a first part and a second part connected by a fastener that can be quickly released when the user removes the mask body from the face. One example of a strap that may be used in connection with the current invention is shown in U.S. Patent No. 6,332,465 to Xue et al. Examples of fasteners or clasp mechanisms that may be used to connect one or more portions of a strap are shown, for example, in U.S. Patent No. 6,062,221 to Brostrom et al., U.S. Patent No. 5,237,986 to Seppala, and European Patent No. 1,495,785 to Chien.

[0058]

[0062] A nose clip can be an optional add-on that helps improve the fit over the user's nose. Because the user's face is prominent in the nasal area, a nose clip can help achieve a proper fit at this location. The nose clip can be constructed of a flexible, dead-soft metal strip, such as aluminum, that can be shaped to hold the mask in the desired fit over the user's nose and where the nose meets the cheeks. An example of a suitable nose clip is shown in U.S. Patent No. 5,558,089 and U.S. Design Patent No. 412,573 to Castiglione. Other nose clips are described in U.S. Patent Nos. 8,066,006 and 8,171,933.

[0059]

[0063] The sealing material can be provided around all or a portion of the mask. The sealing material can be any material or structure that is deformable. The sealing material can include or can include foam, rubber, elastic, gathers, combinations thereof, or any other suitable material or structure that can conform to the contours of the user's face. For example, a seal can be provided around the perimeter where the mask contacts the user's face that is constructed to seal the mask against the user's face. The seal can be provided along the free edge of the divider. The seal can be provided around the top of the mask. The seal can be provided around the bottom of the mask.

[0060]

[0064] The exhalation valve can be attached to the mask body and facilitate the removal of exhaled air from the internal gas space. The use of the exhalation valve can improve the comfort of the user by quickly removing warm, moist exhaled air from the mask interior. In some embodiments, the exhalation valve is included in the lower part of the mask. See, for example, U.S. Pat. Nos. 7,188,622, 7,028,689, 7,013,895 to Martin et al., 7,428,903, 7,311,104, 7,117,868, 6,854,463, 6,843,248, 5,325,892 to Mittelstadt et al., 6,883,518 to Mittelstadt et al., and U.S. Reissue Patent No. 37,974 to Bowers. Any exhalation valve that provides an adequate pressure drop and that can be suitably secured to the mask body can be used in conjunction with the present invention to rapidly deliver exhaled air from the interior gas space to the exterior gas space.

[0061]

[0065] 1A-3 illustrate examples and materials. As shown in FIG. 1A, the face mask 10 includes a mask body 100 and a strap 200. The mask body 100 is composed of an upper portion 110 and a lower portion 120 connected thereto. The upper portion 110 and the lower portion 120 can be separated by a boundary line 130 that runs from side to side across the center of the mask body 100. In the illustrated embodiment, the strap 200 includes a first strap 210 that extends from a first end 211 attached to an upper corner of the mask body 100 to a second end 212 attached to a lower corner of the mask body 100. A second strap 220 is attached to the other side of the mask body 100 in a similar manner.

[0062]

[0066] The mask body 100 has an inner surface 101 and an outer surface 102. The inner surface 101 faces towards the user when the mask 10 is worn. The outer surface 102 faces away from the user. FIG. 1B shows a side cross-sectional view of the mask 10. A divider 140 extends from the inner surface 101 along a boundary line 130. The area above the divider 140 forms an upper portion 110. In some embodiments, the user's entire nose, including the nostrils, fits within the upper portion 110 when the mask 10 is worn. The upper portion 110 can form a seal against the user's face around the bridge of the nose. The area below the divider 140 forms a lower portion 120. In some embodiments, the user's mouth and optionally the chin fit within the lower portion 120 when the mask 10 is worn. The lower portion 120 can form a seal against the user's face around the mouth.

[0063]

[0067] The mask 10 may include a nose clip 170. The nose clip 170 may be located near the top of the top portion 110 to improve the facial fit of the mask 10.

[0064]

[0068] The upper portion 110 can be made of a first material and the lower portion 120 can be made of a second material. The second material can be different from the first material. For example, the second material can have a lower pressure drop through it than the first material, making it easier for a user to breathe through the lower portion 120. Suitable materials for the upper and lower portions 110, 120 are described above. The divider 140 can be made of the same material as the upper portion 110 or a different material. The inner edge 142 of the divider 140 can further include a seal 148 to improve the fit of the divider 140 against the user's face.

[0065]

[0069] The divider 140 shown in FIG. 2 has a perimeter 141 and an inner edge 142. The divider 140 has a first major side 144 (e.g., upper side) and an opposing second major side (e.g., lower side). The location of the nose 400 and nostrils 410 on the first major side 144 of the divider 140 are shown in phantom lines. The divider 140 is attached to the mask body 100 along its perimeter 141. The perimeter 141 can follow the contour of the inner surface 101 of the mask body 100. The divider 140 can be permanently or removably attached. The inner edge 142 of the divider 140 seals against the user's face when the mask 10 is worn.

[0066]

[0070] In an alternative embodiment of the partition 140' shown in FIG. 3, the partition 140' includes an insert 240. The insert 240 can be attached to a major surface of the partition 140' or inserted into a pocket or hole formed in the partition. The insert 240 can be removably attached to the partition 140'. The insert 240 can include a sample collection material constructed to collect a sample from the exhaled airflow. The insert 240 can be positioned in the partition 140' to be located directly under the user's nostrils when the mask is worn. Although the insert 240 is shown as oval, any suitable shape can be used. The insert 240 can also be the same shape and size as the partition 140', or the same shape as the partition 140' but slightly smaller in size. The insert 240 can be made of a material with a lower pressure drop than the partition 140' and can help direct the airflow through the insert 240.

[0067]

[0071] In another alternative embodiment, the entire divider 140 is made from a sample collection material. The entire divider 140 can be removably attached to the mask body 10 so that it can be removed for testing after use.

[0068] (Embodiment)

[0072] Below is a list of embodiments according to the present disclosure.

[0069]

[0073] Embodiment 1 is a filtering face mask having an upper portion of a first material configured to cover a user's nostrils and a lower portion of a second material coupled to the upper portion and configured to cover the user's mouth, wherein the first material, the second material, or both, comprise a filtering material, and the filtering face mask includes a partition dividing the mask body into an upper portion and a lower portion.

[0070]

[0074] Embodiment 2 is the filtering face mask of embodiment 1, wherein the first material exhibits a higher pressure drop than the pressure drop of the second material, and optionally the partition has a lower pressure drop than the pressure drop of the first material, and optionally the partition is made of the second material.

[0071]

[0075] Embodiment 3 is the filtering face mask of embodiment 2, wherein the first material has a pressure drop of 10 Pa to 300 Pa, 10 Pa to 200 Pa, 12 Pa to 100 Pa, 12 Pa to 50 Pa, 12 Pa to 40 Pa, 12 Pa to 25 Pa, or 12 Pa to 20 Pa, measured at a flow rate of 85 L / min.

[0072]

[0076] Embodiment 4 is the filtering face mask of embodiment 2 or 3, wherein the second material has a pressure drop of 10 Pa to 300 Pa, 10 Pa to 200 Pa, 10 Pa to 100 Pa, 10 Pa to 50 Pa, 10 Pa to 40 Pa, 10 Pa to 25 Pa, or 10 Pa to 20 Pa, measured at a flow rate of 85 L / min.

[0073]

[0077] Embodiment 5 is a filtering face mask according to any one of embodiments 1 to 4, further comprising a sample collection material.

[0074]

[0078] Embodiment 6 is the filtering face mask of embodiment 5, wherein the sample collection material comprises an electrostatically charged nonwoven filtration layer.

[0075]

[0079] Embodiment 7 is the filtering face mask of embodiment 5 or 6, wherein the nonwoven filtration layer is hydrophobic.

[0076]

[0080] Embodiment 8 is the filtering face mask of any of embodiments 5 to 7, wherein the sample collection material forms a removable insert.

[0077]

[0081] Embodiment 9 is the filtering face mask of embodiment 8, wherein a removable insert is disposed within or on the partition.

[0078]

[0082] Embodiment 10 is the filtering face mask of any of embodiments 5 to 9, wherein the sample collection material is 50 mm 2 ~500mm 2 , 75mm 2 ~400mm 2 , or 100mm 2 ~300mm 2 is a filtering face mask having a major surface with a surface area of

[0079]

[0083] Embodiment 11 is the filtering face mask of any of embodiments 5 to 10, wherein the sample collection material forms at least a part of the top, bottom, partition, or a combination thereof.

[0080]

[0084] A twelfth embodiment is the filtering face mask of any one of the first to eleventh embodiments, wherein the filtering face mask is a flat-fold mask.

[0081]

[0085] Embodiment 13 is a filtering face mask including a mask body including an upper and lower portion, where a first portion, a second portion, or both include a filtering material, and an insert including a sample collection material.

[0082]

[0086] Embodiment 14 is a filtering face mask of embodiment 13, wherein the upper portion forms an upper section configured to fit the user's nose.

[0083]

[0087] Embodiment 15 is the filtering face mask of embodiment 13 or 14, wherein the insert is disposed in the upper compartment.

[0084]

[0088] Embodiment 16 is the filtering face mask of embodiment 13 or 14, in which the insert forms a partition dividing the mask body into an upper and lower part.

[0085]

[0089] Embodiment 17 is the filtering face mask of any of embodiments 13 to 16, wherein the insert is removably attached to the mask body.

[0086]

[0090] Embodiment 18 is the filtering face mask of any of embodiments 13 to 17, wherein the sample collection material is 50 mm2 to 500 mm 2 , 75mm 2 ~400mm 2 , or 100mm 2 ~300mm 2 is a filtering face mask having a major surface with a surface area of

[0087]

[0091] Embodiment 19 is the filtering face mask of any of embodiments 13 to 18, wherein the sample collection material comprises an electrostatically charged nonwoven filtration layer.

[0088]

[0092] Embodiment 20 is the filtering face mask of any of embodiments 13 to 19, wherein the nonwoven fabric filtration layer is hydrophobic.

[0089]

[0093] Embodiment 21 is a filtering face mask of any of embodiments 13 to 20, wherein the first part is made of a first material and the second part is made of a second material, and the first material exhibits a higher pressure drop than the pressure drop of the second material.

[0090]

[0094] Embodiment 22 is the filtering face mask of any of embodiments 13 to 21, wherein the first material has a pressure drop of 10 Pa to 300 Pa, 10 Pa to 200 Pa, 12 Pa to 100 Pa, 12 Pa to 50 Pa, 12 Pa to 40 Pa, 12 Pa to 25 Pa, or 12 Pa to 20 Pa, measured at a flow rate of 85 L / min.

[0091]

[0095] Embodiment 23 is the filtering face mask of any of embodiments 13 to 22, wherein the second material has a pressure drop of 10 Pa to 300 Pa, 10 Pa to 200 Pa, 10 Pa to 100 Pa, 10 Pa to 50 Pa, 10 Pa to 40 Pa, 10 Pa to 25 Pa, or 10 Pa to 20 Pa, measured at a flow rate of 85 L / min.

[0092]

[0096] Embodiment 24 is a filtering face mask according to any one of embodiments 13 to 23, further comprising a partition dividing the upper and lower parts.

[0093]

[0097] Embodiment 25 is the filtering face mask of embodiment 24, wherein the partition has a lower pressure drop than the pressure drop of the first material, and optionally the partition is made of a second material.

[0094]

[0098] Embodiment 26 is a filtering face mask of any of embodiments 13 to 25, wherein the filtering face mask is a flat-fold mask.

[0095]

[0099] In view of the above, it will be seen that the several advantages of the present disclosure are achieved and other advantageous results obtained. Although changes may be made in the above method without departing from the scope of the disclosure, all matter contained in the above description and accompanying drawings is to be interpreted in an illustrative and not limiting sense.

[0096]

[0100] While the present disclosure is susceptible to various modifications and alternative forms, exemplary embodiments have been illustrated by way of example in the drawings and are described in detail herein. However, the description of the exemplary embodiments is not intended to limit the present disclosure to the particular forms disclosed, but on the contrary, is intended to cover all modifications, equivalents, and alternatives within the scope of the disclosure as defined by the above embodiments and the following claims. Therefore, to interpret the scope of the present disclosure, reference should be made based on the above embodiments and the following claims.

Claims

1. A filtering face mask comprising a mask body and a partition, the mask body having an upper portion made of a first material and configured to cover a user's nostrils, and a lower portion made of a second material, coupled to the upper portion and configured to cover a user's mouth; the first material, or the second material, or both, comprise a filter material; A filtering face mask, wherein the divider divides the mask body into the upper and lower portions.

2. 10. The filtering face mask of claim 1, wherein the first material exhibits a higher pressure drop than the second material.

3. 10. The filtering face mask of claim 1, further comprising a sample collection material.

4. 4. The filtering face mask of claim 3, wherein the sample collection material comprises a nonwoven filter layer having an electrostatic charge.

5. 5. The filtering face mask of claim 4, wherein the nonwoven filter layer is hydrophobic.

6. 4. The filtering face mask of claim 3, wherein the sample collection material forms a removable insert.

7. 7. The filtering face mask of claim 6, wherein the removable insert is located within or on the partition.

8. The sample collection material is 50 mm ２ ~500mm ２ , 75mm ２ ~400mm ２ , or 100 mm ２ ~300mm ２ 4. The filtering face mask according to claim 3, having a major surface with an area of

9. The filtering face mask of any one of claims 3 to 8, wherein the sample collection material forms at least part of the upper part, the lower part, the divider, or a combination thereof.

10. 10. The filtering face mask of claim 1, which is a flat-fold mask.

11. a mask body including an upper portion and a lower portion, wherein the upper portion, the lower portion, or both, comprise a filter material; an insert containing sample collection material; 1. A filtering face mask comprising:

12. 12. The filtering face mask of claim 11, wherein the upper portion forms an upper compartment configured to fit over the nose of a user.

13. 13. The filtering face mask of claim 12, wherein the insert is disposed within the upper compartment.

14. 12. The filtering face mask of claim 11, wherein the insert forms a divider that divides the mask body into the upper and lower portions.

15. 12. The filtering face mask of claim 11, wherein the insert is removably attached to the mask body.

16. The sample collection material is 50 mm ２ ~500mm ２ , 75mm ２ ~400mm ２ , or 100 mm ２ ~300mm ２ 12. The filtering face mask according to claim 11, having a major surface with an area of

17. A filtering face mask as described in any one of claims 11 to 16, wherein an upper portion is made of a first material and a lower portion is made of a second material, and the first material exhibits a higher pressure drop than the second material.

18. 12. The filtering face mask of claim 11, wherein the sample collection material comprises a nonwoven filter layer having an electrostatic charge.

19. 19. The filtering face mask of claim 18, wherein the nonwoven filter layer is hydrophobic.

20. 12. The filtering face mask of claim 11, which is a flat-fold mask.

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