WO2021195208A1

WO2021195208A1 - Face mask sealing device

Info

Publication number: WO2021195208A1
Application number: PCT/US2021/023879
Authority: WO
Inventors: Anthony G. Visco
Original assignee: Visco Anthony G
Priority date: 2020-03-24
Filing date: 2021-03-24
Publication date: 2021-09-30

Abstract

The present disclosure describes a reusable face mask sealing device that improves the comfort and effectiveness of the mask. The device disclosed herein is sterializable, and reusable to improve the fit and comfort of earloop masks including KN95 masks used by medical personnel and the general public. The sealing device is configured to be placed adjacent to a user's mask and comprises: a lower portion, the lower portion having a bottom configured for placement between a user's chin and mouth; and an upper portion, the upper portion including a nose-bridging section and a pair of notches, the notches disposed on opposite sides of the nose-bridging portion.

Description

FACE MASK SEALING DEVICE

CROSS REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit under 35 USC 119 of priority to U.S.

Provisional Application No. 62/993,814 filed March 24, 2020 and U.S. Provisional Application No. 63/002,633 filed March 31, 2020, the entire contents of each are hereby incorporated by reference.

FIELD OF THE INVENTION

[0002] The present disclosure relates to reusable face mask devices and face mask sealing devices thereof.

BACKGROUND

[0003] Recent health emergencies have revealed that protective masks for healthcare providers can become scarce or unavailable during periods of high demand. In some cases, providers may be forced to use masks in a manner that conflicts with established guidelines or to administer care with no mask. Either scenario can increase risk of exposure and spread of illness.

[0004] Further, even when masks are readily available, current masks do not fit properly. Some providers, despite being fit tested with a variety of established, typically disposable masks, have facial structure or size that precludes adequate fitting. In these cases, the masks may be less effective and/or uncomfortable. Skin irritation and breakdown are common occurrences, particularly when masks must be worn for extended time periods. [0005] Thus, there is an ongoing need for well-fitting masks that conserve mask material.

SUMMARY OF THE DISCLOSED SUBJECT MATTER

[0006] The purpose and advantages of the disclosed subject matter will be set forth in and apparent from the description that follows, as well as will be learned by practice of the disclosed subject matter. Additional advantages of the disclosed subject matter will be realized and attained by the methods and systems particularly pointed out in the written description and claims hereof, as well as from the appended drawings.

[0007] To achieve these and other advantages and in accordance with the purpose of the disclosed subject matter, as embodied and broadly described, the disclosed subject matter includes a sealing device, the sealing device configured to be placed adjacent to a user’s mask and comprises: a lower portion, the lower portion having a bottom configured for placement between a user’s chin and mouth; and an upper portion, the upper portion including a nose-bridging section and a pair of notches, the notches disposed on opposite sides of the nose-bridging portion.

[0008] In some embodiments, a cross-section of the device has a curvilinear shape.

[0009] In some embodiments, the lower portion includes a first radius of curvature, and the upper portion includes a second radius of curvature, with a point of inflection defined between first and second radii of curvatures.

[0010] In some embodiments, the lower portion defines a first width, and the upper portion defines a second width.

[0011] In some embodiments, at least one retention feature projects normal to the exterior surface of the device.

[0012] In some embodiments, a first pair of retention features are disposed on the lower portion, and a second pair of retention features are disposed on the upper portion.

[0013] In some embodiments, the retention feature includes an elongated stem and arcuate head portion.

[0014] In some embodiments, a fastening strap is fixedly secured to the retention feature(s) on one side of the device.

[0015] In some embodiments, the device is configured as a single integrally formed component.

[0016] In some embodiments, the device is symmetrical about a central axis extending through the nose-bridging section.

[0017] In some embodiments, the nose-bridging section is formed from a different material than the remainder of the device.

[0018] In some embodiments, the notches are formed as recesses which project inwardly and downwardly from the sides of the upper portion. [0019] In some embodiments, the notches are formed as a reduced thickness section of the upper portion.

[0020] In some embodiments, the device is configured for placement on the anterior side of a user’s mask.

[0021] In some embodiments, the external form is made of a flexible material.

[0022] In some embodiments, the device is serializable.

[0023] In some embodiments, the thickness of the device is non-uniform.

[0024] It is to be understood that both the foregoing general description and the following detailed description are exemplary and are intended to provide further explanation of the disclosed subject matter claimed.

[0025] The accompanying drawings, which are incorporated in and constitute part of this specification, are included to illustrate and provide a further understanding of the method and system of the disclosed subject matter. Together with the description, the drawings serve to explain the principles of the disclosed subject matter.

BRIEF DESCRIPTION OF THE DRAWINGS

[0026] A detailed description of various aspects, features, and embodiments of the subject matter described herein is provided with reference to the accompanying drawings, which are briefly described below. The drawings are illustrative and are not necessarily drawn to scale, with some components and features being exaggerated for clarity. The drawings illustrate various aspects and features of the present subject matter and may illustrate one or more embodiment(s) or example(s) of the present subject matter in whole or in part.

[0027] FIGS. 1-6 are photographs of a reusable face mask in accordance with one embodiment of the present disclosure.

[0028] FIG. 7 is a schematic diagram of a mask retention feature of the reusable face mask in accordance with one embodiment of the present disclosure.

[0029] FIGS. 8-15 are photographs of a reusable face mask in accordance with another embodiment of the present disclosure.

[0030] FIGS. 16-24 are photographs of a face mask sealing device in accordance with an embodiment of the present disclosure.

[0031] FIGS.25-26 are photographs of an external form of a face mask sealing device in accordance with an embodiment of the present disclosure. [0032] FIGS. 27-32 are schematic representations of an external form of a face mask sealing device in accordance with an embodiment of the present disclosure.

[0033] FIGS. 33-37 are photographs of an external form of a face mask sealing device in accordance with an embodiment of the present disclosure.

[0034] FIG. 38 is an image of a customized external form of a face mask sealing device in accordance with an embodiment of the present disclosure.

[0035] FIG. 39 is a schematic illustration of a retention feature in accordance with an embodiment of the present disclosure.

[0036] FIG. 40 is a schematic representation of the face mask sealing device in accordance with an embodiment of the present disclosure.

[0037] FIG. 41 is an image of a person using the face mask sealing device in accordance with an embodiment of the present disclosure.

[0038] FIG. 42 is an exemplary diagram of a sizing chart in accordance with the present disclosure.

[0039] FIG. 43 is an exemplary view of the mask sealing device with protruding retention features, in accordance with the present disclosure.

[0040] FIG. 44 is an exemplary view of the mask sealing device with an elastic strap fixedly attached to one side of the device, in accordance with the present disclosure.

DETAILED DESCRIPTION

[0041] For the purposes of promoting an understanding of the principles of the present disclosure, reference will now be made to preferred embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure is thereby intended, such alteration and further modifications of the disclosure as illustrated herein, being contemplated as would normally occur to one skilled in the art to which the disclosure relates.

[0042] Articles “a” and “an” are used herein to refer to one or to more than one (i.e. at least one) of the grammatical object of the article. By way of example, “an element” means at least one element and can include more than one element.

[0043] Unless otherwise defined, all technical terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. [0044] In some aspects, the present disclosure provides personal protective equipment (PPE) in the form of a reusable face mask. The face mask sealing device can be used in conjunction with a variety of types of existing facemasks. It can also be provided as an assembly or a kit of parts including a mask. The reusable mask and the face mask sealing device are both particularly useful for protecting the user, and/or those in proximity to the user, against airborne illnesses, pathogens, viruses, prions or gases depending on the filter used.

[0045] FIGS. 1-6 are photographs of an example embodiment of a reusable face mask 100 according to one aspect of the present disclosure. In general, the reusable mask 100 includes three components: a body 200, a flexible seal 300, and a filter element 400.

The body 200 has a proximal side 210 (i.e., adjacent to a user’s face) where the seal is located, and the body 200 has an opposite, distal side 220 where the filter element 400 is located. The filter element 400, show in FIGS. 8-11, is disposed over the opening in the distal side.

[0046] In FIG. 1, the reusable mask 100 can be seen with a body 200 in the middle and the flexible seal 300 connected at one end and the filter element 400 at the other end. FIG. 2 shows a different perspective of the reusable mask 100 and the shape of the flexible seal 300 is clearer. Here, the shape of the flexible seal 300 can conform to the user’s face. [0047] In the example embodiment, the proximal end of the body 200 has a generally triangular or teardrop shaped opening. This triangular shape is best seen in FIG.

3. The proximal opening is designed to fit over the mouth and the nose of the user. The body 200 can be substantially rigid material, and it can optionally have some amount of pliability. It can be formed, for example, of a plastic or silicone material, and it can be produced in any suitable manner, such as in a molding, machining, or additive manufacturing process. The body 200 can be reusable and is preferably made of material that can be sterilized between uses.

[0048] The proximal side of the reusable mask 100 also includes a feature for attaching the flexible seal 300. In some embodiments, the attachment feature is in the form of a channel, groove, or slot. In other embodiments, it can simply be a circumferential area with a wider or narrower lip than the adjacent portion of the body, which acts as a visual and/or physical guide for attaching the seal.

[0049] The flexible seal 300 is attached to the attachment feature in a removable manner. The seal 300 is disposed around the full circumference of the proximal side of the body 200 and provides an airtight barrier between the reusable mask 100 and the skin (see, e.g., FIGS. 3-4). A portion of the seal extends into the body via the attachment feature, and the remaining portion of the sealing material is positioned against the user’s face. This allows a soft interface to the skin and a comfortable fit for a variety of facial structures and sizes. It also helps create a seal in users with facial hair. The width and thickness of the seal can vary. In a non-limiting example, the width of the seal (i.e., the amount of material extending from the edge of the body) can be in the range of approximately 2-35 mm. The thickness of the seal can be approximately 2-35 mm. Multiple seals can be provided with a single body such that a user can select a seal that best fits the user’s face. Further, the seal can also be provided in modular sections in order to further customize the fit. For example, there may be a fully circumferential section that is attached to the body 200, and a selection of shorter strips that can be stacked into one or more layers over the base seal as needed to fill air gaps (such as across the bridge of the nose or around the chin). The reusable mask 100 can be provided in a kit of parts including a variety of seals.

[0050] The flexible seal 300 can be made for a skin-safe polymer material. Having no air bypass between the reusable mask 100 and the skin is important for the effectiveness of the mask. Thus, in some embodiments, the flexible seal 300 is tacky (i.e., mildly adhesive) on at least the inner surface of the seal. Optional tackiness on two sides allows for attachment of the seal to the main body 200 of the reusable face mask 100 and the opposite end of the face. This advantageously encourages better sealing against the skin and can also facilitate sealing over facial hair.

[0051] In FIG. 4, the distal side 220 of the base (i.e., the side away from the user) has an opening 410 for mounting a detachable filter 400, as well as retention features for holding the filter in place. This is best seen in FIGS. 4-6. In the example embodiment, the filter opening 410 is approximately circular in shape. Other shapes are also possible, e.g., square, triangular, etc. The filter can be attached the reusable mask by any suitable method, such as a “mason-jar” style twist ring, snap rings, clips, elastic, adhesive, drawstring, etc.

In some embodiments, the filter material can be formed integrally with retention features. This allows the reusable mask 100 to be customized for different levels of filtering.

[0052] FIG. 5 specifically shows the reusable face mask 100 on a user’s face. The flexible seal 300 is closest to the user’s nose and face. The filter element 400 is on the other end and is more visible in FIG. 6. Here, the filter element 400 is open on the end. [0053] Another advantage of the present disclosure is that the amount of filter material needed is less than that of a traditional mask. The geometry of the opening can be formed such that a single NIOSH-rate (air filtration rating via the U.S. National Institute for Occupational Safety and Health classification of filtering respirators) air filtration mask can be cut into pieces and used for several masks as disclosed herein. It is also envisioned that non-traditional sources of filters, such as HEPA sheet filter medium found in HVAC systems, can also be cut to an appropriate size and used in the reusable mask. Furthermore, the reusable mask can accommodate more rigid filters than conventional face masks.

[0054] Referring now to FIG. 7, the body of the mask also optionally includes fastening features for holding the mask on the user’s face. These features can be located symmetrically apart from one another on the proximal side of the body. They can be of any suitable form, such as hooks, bosses, circular mushroom shaped stems, “T” shapes, etc. In the example embodiment show, the T-shaped retention feature has a through-hole. An elastic band can be looped through the passageway of the T and knotted to prevent the elastic from separating from the body. When the reusable mask is applied to the face, the elastic can be simply wrapped behind the user’s head and hooked over the T on the opposite side. The elastic band or tie can be a disposable/replaceable component. The T or mushroom like stems also allows the use of readily available rubber bands should elastic material be in short supply. Other possible approaches will be evident to a person of skill in the art. It is also noted that the mechanical holding features may not be required if the filter material has an adhesive surface.

[0055] FIGS. 8-15 depict another embodiment of the disclosed reusable face mask

500. Here, the reusable mask 500 is shown assembled with a filter 600 and flexible seal 800. In this example, the filter 600 is attached to the body 700 of the reusable mask 500 with a threaded “mason jar” style retention ring 610. The opening of the body 700 has complementary threads or bosses 620 to receive the ring 610.

[0056] FIG. 9 is a similar embodiment as in FIG. 8, but now shown with rubber band elastic 900. This is to ensure that the mask stays easier on the face of the user.

[0057] FIG. 12 is a view of the reusable face mask 500, but not on the user. Here, the body 700 is sandwiched between the flexible seal 800 and the filter 600. FIG. 13 is a top view of the same reusable face mask 500 and a closer view of the filter 600 is seen. The retention ring 610 circumscribes the filter in this embodiment. [0058] A deconstructed view of the parts of the reusable face mask 500 are seen in

FIGS. 14-15. The flexible seal 800 is partially removed from the body 700 in FIG.14. In FIG. 15, the body 700 is separated from both the filter 600 and the retention ring 610.

[0059] FIGS. 16-24 are photographs of an example embodiment of a facemask sealing device 1000 according to the present disclosure. The sealing device 1000 includes at least a flexible material that can be sandwiched between a user’s face and a mask material 1100. The flexible material is skin safe and can be either inherently tacky or can be coated with a skin-safe, light adhesive. The flexible material be coated with a moderate to strong adhesive on the side that is placed against the mask material. The flexible material can be provided in a continuous loop or in a longitudinal strip. In the strip-style embodiment, the strip can be joined, for example, by a separate adhesive 1200, by abutting or overlapping adhesive end regions of the flexible material, or by any other suitable methods. In a non-limiting example, the flexible material can be approximately 4-18 inches in length, 0.25-1.5 inches in width and 0.03-0.6 inches in thickness. The thickness can vary over the length of the device in order to accommodate varying facial structures. For example, the material can be thicker or thinner across the bridge of the nose, in the cheek region, or along the chin.

[0060] The flexible material can have either a flat (e.g., cookie-cutter) or a three- dimensional (e.g., contoured) profile. The cross-section can be round, square, or have flat and round areas along the circumference. The thickness of the device can be the same throughout or be thicker in certain areas to promote contact with the polymer to help maintain contact with the polymer to help maintain and air seal or otherwise improve the product or the wearer’s comfort. The configuration and orientation of the external form may be uniform throughout or twist, similar to a roller coaster, to maximize comfort and contact between the external form, the mask, the polymer, or the wearer’s face or skin. [0061] To use the sealing device 1000 with a mask 1100, the user wraps or places the adhesive material around the mouth and nose. A mask 1100 (or mask material) is then pressed onto the adhesive material. This forms an assembly that prevents air from passing around or behind the mask, thus increasing the possible effectiveness of the mask. Any suitable mask material can be used, from simple ear-loop masks to NIOSH-rated air filtration masks. It is also envisioned that non-traditional sources of filters, such as HEPA sheet filter medium found in HVAC systems, can also be used as the mask material. Additionally, the flexible material of the device can be of suitable adhesiveness on the outer surface such that a mask or masks can be applied multiple times to the sealing device. Alternately, the flexible material can be pre-applied to a mask for single-mask usage. The sealing device can have differing amounts or types of adhesive on the inner and outer surfaces, and it can potentially be adhered multiple times to a user’s face. The material itself can be tacky enough on either surface that an adhesive is not necessary.

[0062] In some embodiments, the sealing device comprises a flexible material that is inherently tacky (e.g., a sticky polymer). In other embodiments, the flexible material has an externally applied adhesive layer 1200. In yet another embodiment, the flexible material is used in conjunction with an external form, described in further detail herein below.

[0063] FIG. 16 specifically shows the sealing device 1000 around a user’s nose and on the face. FIG. 17 is another view of the user’s sealing device 1000 around the nose.

FIG. 18 is yet another view of the sealing device 1000 on the user’s face with adhesive 1200 applied for further adhesion.

[0064] FIG. 19 is a side view of the user with the sealing device 1000 used in conjunction with a mask 1100. FIG. 20 is the opposite side view of the user’s face with a mask 1100 and the sealing device 1000. Here, the sealing device 1000 and mask 1100 are shown to function together to provide more protection from outside materials. FIG. 21 shows a front view of the user wearing a mask 1100 and the sealing device 1000 underneath (not visible). FIG. 22 shows that the user should firmly press against the mask 1100 with the sealing device underneath (not visible) to ensure that the mask and sealing device work together.

[0065] FIG. 23-24 show yet another embodiment where the sealing device 1000 is shown over the mask 1100. This is another embodiment of the disclosure that shows that the sealing device 1000 can be work under or over the mask 1100.

[0066] FIGS. 25-26 are photographs of an example external form 1000 according to the present disclosure (also shown in FIGS. 23-24). The external form 1000 is made of a substantially rigid material having a generally triangular, oval, or teardrop shape. The narrow side of the form can have an out-of-plane curvature designed to fit the shape of a human face. It can be formed, for example, of a plastic or silicone material, and it can be produced in any suitable manner, such as in molding, machining, or additive manufacturing process. The form can be reusable and can be made of a material that can be sterilized between uses. The form may come in a variety of sizes and shapes to be more universally applicable, or it can be custom-fitted to a particular person’s face and face structure (see, e g., FIG. 38).

[0067] When the form is used, the mask is applied by the following method. First, the flexible material is applied to the face as described herein above. Next, the mask is pressed on to the flexible material. Finally, the form is applied over the mask in the region over the flexible material and attached around the user’s head with a tie or an elastic. This provides an extra measure of retention and sealing, while distributing the retention pressure for a comfortable fit.

[0068] Alternately, the tacky adhesive material can be pre-applied to the mask material. In this case, the mask is lightly positioned over the mouth and nose and then pressed into place. The external form can be optionally positioned over the outer surface of the mask over the flexible material, as described herein above.

[0069] FIGS. 27-32 depict another embodiment of an external form 3000 according to the present disclosure and FIGS. 33-37 depict another embodiment of the external form 3000. The external form 3000 optionally includes a texturized inner surface 3005 (e.g., ribs, bosses, bumps, etc.).

[0070] FIG. 37 illustrates another embodiment of an external form 3000. In this embodiment, the external form can be customized to a user’s face. The design can be based, for example, on a 3D rendering of the user’s facial features (shown as the dark area of FIG. 38). This allows the form to be designed as an individualized geometry for each user, further increasing the comfort and effectiveness of the sealing device.

[0071] The external form 3000 also optionally includes fastening features for engaging with the flexible/elastic material and holding the mask on the user’s face. FIG. 39 is cross-sectional view of an optional retention feature 3200. The retention feature projects in a normal/perpendicular direction from the exterior surface of the device to provide a stem 3202 with sufficient surface area exposed to engage and retain the fastener (e.g. elastic strap). In the exemplary embodiment show, two parallel stems 3202 are provided to increase the frictional force between the stems and the fastening strap to provide a more secure grip and reliable retention of the device on the user’s face. Also, the space between stems 3202 can serve as a pass-through for a fastening strip to be tied or otherwise anchored.

[0072] In some embodiments, these retention features 3200 can be adjustable in size, e.g., the stems can have an adjustable length (such as telescoping struts). This allows the retention feature to be extended outwardly, to facilitate the receiving of the fastening strap, then collapsed to a position closer to the device thereby inhibiting or prohibiting the strap from being accidentally disengaged from the device. These features can be located symmetrically apart from one another on the proximal side of the body. They can be of any suitable form, such as hooks, bosses, circular mushroom shaped stems, “T” shapes, etc. In the example embodiment shown, the t-shaped retention feature has a through-hole. An elastic band can be looped through the passageway of the T and knotted to prevent the elastic form separating from the body. When the mask is applied to the face, the elastic can be simply wrapped behind the user’s head and hooked over the T on the opposite side. The elastic band or tie can be a disposable/replaceable component. The T or mushroom-like stems also allow the use of readily available rubber bands should elastic material be in short supply. Although described as a “T-shape”, in some embodiments the head of the retention feature 3200 can be arcuate so that the edges are curved in the posterior direction (relative to the user) and provide a lip to provide a more secure retention or grip of the elastic fastener. Other possible approaches will be evident to a person of skill in the art.

[0073] FIG. 40 is another embodiment of the external form 3000, also referred to as the mask-sealing device. Here, a fastening feature 3010 of the external form are shown. This allows for elastic band(s) 3020 to be attached, as shown in FIG. 41. The elastic band(s) 3020 then fit more securely around a user’s head while also wearing a mask 3100. This embodiment of the external form 3000 improves the fit and comfort of the user’s mask 3100. The external form 3000 placed on top of (i.e. on the exterior surface) the mask 3100 maximizes filtration by eliminating the air gaps around the edges of the mask 3100. The seal between a user’s face and mask is significantly improved due to the use of the external form 3000 as a sealing device.

[0074] In the exemplary embodiment shown in Fig. 40, the device 3000 includes a lower portion 3030 for surrounding a user’s mouth, and an upper portion 3040 for surrounding (and bridging) a user’s nose. The edges or sides of the device can be formed with a non-linear shape having a plurality of radii of curvature. For example, the lower portion 3030 can have an undulating shape with a point of inflection as the sides transition to the upper section that defines a first width W1 (which coincides with a user’s lips, when in use) and a second width W2 above. The bottom of the device is arcuate, and configured to be positioned under a user’s mouth, but above the user’s chin. In the exemplary embodiment shown, the device 3000 is symmetrical in shape about a central longitudinal (or vertical) axis extending through the device.

[0075] The upper portion 3040 can also include a pair of notches 3042 in the nose bridging section to accommodate a user’s glasses. The notches 3042 are equidistantly spaced from the center of the nose bridging section and are positioned on the user’s cheeks, when in use. These notches 3042 form a seal external to, or underneath, the frames of the glasses so that the user’s breath/ehaling does not fog the lenses). The notches 3042 can be recesses that are curved inward/downward with a radius of curvature greater than all other radii of curvature of the device. In such embodiments, the user’s glasses are able to rest on the user’s face (with a mask disposed therebetween) without resting on top of or engaging the device 3000. In other embodiments, the notches 3042 are “cut-outs” resulting in a reduced thickness of the notch 3042 such that the user’s glasses can rest on top of the device 3000.

[0076] Accordingly, the present disclosure provides an external form to be used with any earloop face mask to improve the fit and comfort of the face mask. These include filtering face mask respirators (KN95) and surgical and non-surgical face masks (e.g. earloop masks).

[0077] KN95 masks/respirators often have adequate filtration but do not create an airtight seal against the users’ face. The apparatus disclosed herein is a contoured external form that fits over earloop masks and improves comfort and fit. If fit testing is required for the degree of protection desired or indicated, individual fit testing can be performed prior to, and/or after, attaching the external form 3000 to the mask disposed on the user’s face.

In operation

[0078] The device 3000 can be placed over the user’s existing mask and attached behind the head using elastic or rubber bands/straps, and adjusted so the nose section is positioned just inferior to (lower than) the malleable nose section of the mask to improve comfort and fit. The straps can be adjustable in length and/or include a locking mechanism (e.g. buckle & latch) to retain the straps at a fixed length once adjusted for proper fit so that the device 3000 is not inadvertently dislodged from the user’s face.

[0079] In an exemplary embodiment, there are two fastening elements 3200 (e.g. hooks) on each side of device 3000, both hooks on either side can be attached to the strap(s) in order to confirm that the upper and lower portions of the mask are pushed gently, but firmly, against the face to maximize contact. This dual hook design avoids only engaging one hook on each side, which can lead to inadequate compression against the face.

[0080] In an exemplary embodiment, the fasting mechanism is an elastic strap configured as a single (continuous) loop 3020, as shown in Fig. 44. The strap 3020 can be fixedly attached to retention features 3200 on one side of the device 3000. To apply the device 3000 to the user’s face, a user places the device over the mask, and covering their nose/mouth, then wraps the elastic strap behind their head to wrap around to the opposite side of their face and securely engage the retention features 3020.

[0081] The device 3000 can be formed by a variety of techniques, including an injection molding and/or 3D printing, and formed from a variety of biocompatible materials (e.g., FHR Polypropylene 13R9A and SantopreneTM 8281-35MED). In some embodiments, the device 3000 is formed having a plurality of hardnesses/rigidity throughout, e.g., the device can have and softer integrated nose-bridge piece using a double injection mold technique. This double-mold method allows the “frame” to be of a sturdy plastic material with the initial mold, while allowing the nose section to have a softer “silicone like” feel to further improve comfort and fit achieved with the second injection mold. Additionally or alternatively, the device 3000 can be formed by only single injection technique, or other manufacturing techniques (e.g. 3D printing). The device 300 can be formed such that the cross-sectional shape of the device, taken at all points around the perimeter of the device, have a non-planar shape. For example, the device can have chamfered or rounded edges, which result in the cross-section of the device having a shape similar to the opening of a USB-C type cable connector.

[0082] In accordance with another aspect of the disclosure, the device 3000 can be formed with separate nose piece that can attached (e.g. mechanically coupled, via interference fit, tongue and groove coupling, etc.) to the main portion of the device 300. This separate nosepiece design allows for a greater range of mask sizing and customization where the nosepiece can be universally sized, and interchangeably attached to mask devices of varying sizes (e.g. devices having widths W1 and W2 sized to fit adult vs. child faces). Additionally, the device 3000 disclosed herein can be reusable and serializable between uses, while allowing OSHA approved filtration masks (e.g. KN95) to have air tight seal around the perimeter of the mask, without damaging or modifying the underlying mask. [0083] Any patents or publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. These patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference. In case of conflict, the present specification, including definitions, will control.

[0084] While the disclosed subject matter is described herein in terms of certain preferred embodiments, those skilled in the art will recognize that various modifications and improvements may be made to the disclosed subject matter without departing from the scope thereof. Moreover, although individual features of one embodiment of the disclosed subject matter may be discussed herein or shown in the drawings of the one embodiment and not in other embodiments, it should be apparent that individual features of one embodiment may be combined with one or more features of another embodiment or features from a plurality of embodiments.

[0085] In addition to the specific embodiments claimed below, the disclosed subject matter is also directed to other embodiments having any other possible combination of the dependent features claimed below and those disclosed above. As such, the particular features presented in the dependent claims and disclosed above can be combined with each other in other manners within the scope of the disclosed subject matter such that the disclosed subject matter should be recognized as also specifically directed to other embodiments having any other possible combinations. Thus, the foregoing description of specific embodiments of the disclosed subject matter has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the disclosed subject matter to those embodiments disclosed.

[0086] It will be apparent to those skilled in the art that various modifications and variations can be made in the method and system of the disclosed subject matter without departing from the spirit or scope of the disclosed subject matter. Thus, it is intended that the disclosed subject matter include modifications and variations that are within the scope of the appended claims and their equivalents.

Claims

What is claimed is:

1. A sealing device, the sealing device configured to be placed adjacent to a user’s mask and comprises: a lower portion, the lower portion having a bottom configured for placement between a user’s chin and mouth; an upper portion, the upper portion including a nose-bridging section and a pair of notches, the notches disposed on opposite sides of the nose-bridging portion.

2. The sealing device of claim 1, wherein a cross-section of the device has a curvilinear shape.

3. The sealing device of claim 1, wherein the lower portion includes a first radius of curvature.

4. The sealing device of claim 3, wherein the upper portion includes a second radius of curvature.

5. The sealing device of claim 4, wherein a point of inflection is defined between first and second radii of curvatures.

6. The sealing device of claim 1, wherein the lower portion defines a first width.

7. The sealing device of claim 1, wherein the upper portion defines a second width.

8. The sealing device of claim 1, further comprising at least one retention feature, the retention feature projecting normal to the exterior surface of the device.

9. The sealing device of claim 8, wherein a first pair of retention features are disposed on the lower portion, and a second pair of retention features are disposed on the upper portion.

10. The sealing device of claim 8, wherein the retention feature includes an elongated stem and arcuate head portion.

11. The sealing device of claim 1, further comprising a fastening strap, the fastening strap fixedly secured to the retention feature(s) on one side of the device.

12. The sealing device of claim 1, wherein the device is configured as a single integrally formed component.

13. The sealing device of claim 1, wherein the device is symmetrical about a central axis extending through the nose-bridging section.

14. The sealing device of claim 1, wherein the nose-bridging section is formed from a different material than the remainder of the device.

15. The sealing device of claim 1, wherein the notches are formed as recesses which project inwardly and downwardly from the sides of the upper portion.

16. The sealing device of claim 1, wherein the notches are formed as a reduced thickness section of the upper portion.

17. The sealing device of claim 1, wherein the device is configured for placement on the anterior side of a user’s mask.

18. The sealing device of claim 1, wherein the external form is made of a flexible material.

19. The sealing device of claim 1, wherein the device is sterializable.

20. The sealing device of claim 1, wherein the thickness of the device is non-uniform.