PERSONAL PROTECTIVE EQUIPMENT AND METHODS

Abstract

Improved personal protective equipment facial wear including, in one embodiment, an at least partly adhesive mask, and one or more adhesive eye shields. In one implementation, the mask avoids significant contact with the delicate periorbital skin of the wearer, yet provides a substantially airtight seal so as to preclude moisture vapor transfer and “fogging” of eyeware or instruments. In another implementation, adherence of the eye shield is at least partially overlapping with the mask and creates an at least partial seal around a perimeter of the eye shield. Further, an at least partial seal is formed around a perimeter of the mask. The mask and eye shield additionally prevent nasal air flow obstruction, and address the problem of skin irritation and attachment during normal facial expression and movement of the wearer.

Claims

1. A re-usable mask comprising: an air-permeable portion configured to be placed over a mouth and nose of a wearer, and having at least a top, uppermost edge; a securing feature attached to a lower portion of the mask and which is configured to secure said mask via a neck of the wearer; a first adhesive portion coupled, via a bottom edge of the first adhesive portion, to said top edge of said air-permeable portion; and a second adhesive portion coupled to the first adhesive portion, without contacting any portion of said air-permeable portion, via the top edge of the first adhesive portion; wherein each of said first adhesive portion and second adhesive portion of said mask comprises a shape configured to adhere to malar and nasal skin of said wearer.

2. The mask of claim 1, wherein the first adhesive portion comprises a thin-film portion that is configured to, when the mask is donned and adhered to the wearer's face using the thin-film portion, utilize no backing material.

3. The mask of claim 2, wherein said first adhesive portion comprises an adhesive configured to release from any of said periorbital skin contacted thereby without trauma to any periorbital skin when said mask is removed.

4. The mask of claim 1, wherein said shape of at least one of said first adhesive portion or said second adhesive portion comprises: (i) two lateral strip elements; and (ii) a nasal bridge feature, the nasal bridge feature having at least a portion thereof which is of lesser height than a height of each of the lateral strip elements, the nasal bridge feature and at least portion thereof to accommodate a bridge of a nose of the wearer while maintaining said two lateral strip elements at respective elevations which avoid contact thereof with periorbital skin of said wearer when said mask is worn.

5. The mask of claim 1, wherein at least one of said first adhesive portion or second adhesive portion comprises a flexible film dressing having a coefficient of friction and pliability comparable to at least one of said malar or nasal skin, and a thickness of said flexible film dressing is selected so as to permit distortion thereof during normal facial movements of said wearer without causing loss of adhesion.

6. The mask of claim 1, wherein: the first adhesive portion extends above the top uppermost edge of the air permeable portion; and the first adhesive portion is configured to act as a moisture vapor barrier against the wearer's breath so as to avoid fogging of optical apparatus used by the wearer while wearing the mask.

7. The mask of claim 1, further comprising: a first removable backing covering a first side of said second adhesive portion; and a second removable backing covering a first side of said first adhesive portion.

8. The mask of claim 1, wherein said first adhesive portion comprises separate left side and right removable backing portions configured to enable contouring of said first adhesive backing around one or more facial features of said wearer by the wearer.

9. A mask comprising: an air-permeable portion configured to be placed over a mouth and nose of a wearer; a securing feature consisting of a single strap, the single strap attached to a bottom portion of the mask and configured to secure said mask to said wearer via the wearer's neck; and a first adhesive portion disposed above a top edge of said mask, said first adhesive portion configured to adhere to malar and nasal skin of a wearer, the malar and nasal skin disposed above said top edge when the mask is donned; wherein said first adhesive portion is configured to form a moisture vapor seal between a first side of said first adhesive portion and skin of said wearer so as to limit fogging of optical apparatus used by said wearer while wearing said mask.

10. The mask of claim 9, wherein: the mask comprises no ear loops; and the single strap and mask cooperate to enable the mask to be worn lower on the wearer's face than a corresponding mask with ear loops.

11. The mask of claim 9, wherein: the single strap is configured to assert at least a downward bias on the mask during use so as to place at least some tension on the first adhesive portion; and the first adhesive portion is configured to resist the downward bias when the first adhesive portion is adhered to the malar and nasal skin of the wearer.

12. The mask of claim 9, wherein the first adhesive portion comprises a nanostructure-based reusable adhesive.

13. The mask of claim 9, further comprising at least a second adhesive portion coupled directly or indirectly to the air-permeable portion; and wherein the first adhesive portion is configured for removal by the wearer after use thereby, so that the second adhesive portion can be utilized for re-donning the mask.

14.-24. (canceled)

25. An enhanced-comfort mask, comprising: an air-permeable portion configured to be placed over a mouth and nose of a wearer and extend below a chin of the user, and having at least a top edge; a neck securing feature attached to only a lower portion of the mask at respective attachments points disposed on left and right sides of the mask; and at least one first adhesive-carrying portion coupled to and extending above said top edge of said air-permeable portion and configured to adhere to malar and nasal skin of said wearer yet below periorbital skin of the wearer; wherein said mask is configured such that when donned, said mask is securable in place on said wearer using only: (i) said neck securing feature and (ii) said at least one first adhesive-carrying portion.

26. The mask of claim 25, wherein said neck securing feature and said attachment to only a lower portion of the mask at respective attachments points on left and right sides of the mask cooperate to create at least some downward and rearward bias on the mask when donned such that at least a portion of said mask is in tension against the at least one first adhesive-carrying portion.

27.-29. (canceled)

30. The mask of claim 25, further comprising at least a second adhesive-carrying portion coupled directly or indirectly to the air-permeable portion; and wherein the first adhesive-carrying portion is configured for removal by the wearer after use thereby, so that the at least a second adhesive-carrying portion can be utilized for re-donning the mask to the malar skin disposed above the top edge of the mask when the mask is donned.

31. The mask of claim 25, wherein: the at least one first adhesive portion is configured to act as a moisture vapor barrier against the wearer's breath propagating into one or more orbital regions of the wearer's face; and the at least one adhesive portion is configured to allow a distance between at least a portion of the top edge of the mask and a face of the wearer to vary while still maintaining the moisture vapor barrier.

32.-35. (canceled)

36. The mask of claim 1, wherein: the air-permeable portion comprises a bottom edge; the securing feature is attached to a lower portion of the mask proximate the bottom edge; and the securing feature is configured to secure said mask via a neck of the wearer such that the bottom edge contacts a front portion of the neck of the wearer when the mask is donned.

37. The mask of claim 1, wherein: at least the second adhesive portion is configured to be separable by the wearer from the mask; and said separation of the second adhesive portion from the mask does not change a size of the air permeable portion of the mask.

38. The mask of claim 1, wherein: at least the second adhesive portion is configured to be separable by the wearer from the mask; and said separation of the second adhesive portion from the mask does not change a width of the mask.

39. The mask of claim 1, wherein both the first adhesive portion and the second adhesive portion extend above the top edge of the air-permeable portion of the mask.

40. The mask of claim 38, wherein both the first adhesive portion and the second adhesive portion may, when used, enable formation of a gap of varying distance between the top edge of the air-permeable portion and facial skin of the wearer while still maintaining a sealed moisture vapor barrier against moisture vapor propagating to one or more orbital regions of the wearer's face.

41. The mask of claim 1, wherein: the air-permeable portion comprises a bottom edge; and the air-permeable portion comprises a unitary sheet of air-permeable material extending from the top edge to the bottom edge.

42. The mask of claim 41, wherein the unitary sheet of air-permeable material comprises a substantially rectangular shape.

43. The mask of claim 1, wherein the first adhesive portion and the second adhesive portion are (i) formed from a material different than a material of the air-permeable portion; and (ii) are not disposed upon any portion of the air-permeable portion.

44. A mask comprising: an air-permeable portion configured to be placed over a mouth and nose of a wearer, said air-permeable portion comprising at least a top edge and an opposing bottom edge; a single strap attached proximate the bottom edge of said air-permeable portion, the single strap configured to at least partly secure said mask to said wearer via a neck thereof, the single strap configured to create an at least partly downward bias on at least a portion of said mask when said single strap is engaged around said neck; and a first strip mated to the top edge of the air-permeable portion and having a first adhesive-carrying portion disposed above said top edge of said air-permeable portion, said first adhesive-carrying portion configured to adhere to at least a portion of a malar skin of a wearer that is disposed above said top edge when said mask is donned, the first strip further comprising a first removable backing strip, the first removable backing strip disposed on a rear side of the mask and covering at least a portion of the first adhesive-carrying portion; wherein said mask is configured such that it may be secured over the mouth and nose of the wearer via only (i) the single strap disposed at the bottom edge, and (ii) the first adhesive-carrying portion of the first strip disposed at the top edge; and wherein said mask is configured to be donned via: removal of the first removable backing strip, the removal exposing the at least portion of the first adhesive-carrying portion; placement of the mask over at least the mouth and nose of the wearer while the wearer presses on at least one second removable backing strip disposed on a front side of at least the first adhesive-carrying portion so as to cause adherence of the first adhesive-carrying portion to the at least portion of the malar skin above the tope edge, the adherence configured to form a moisture vapor seal of varying distance between said top edge and at least malar skin above the top edge so as to limit fogging of optical apparatus used by said wearer while wearing said mask, yet allowing a non-zero distance to exist between at least some portions of the top edge and the at least malar skin; removal of the at least one second removable backing strip disposed on the front side; and engagement of the single strap around the neck of the wearer.

45. The mask of claim 44, wherein: the at least one second removable backing strip comprises first and second backing strips collectively forming a central arched region configured to accommodate at least a portion of the nose of the wearer at least during said pressing; and the removal of the at least one second removable backing strip comprises removal of both the first and second backing strips by peeling away at least one respective edge of each of the first and second backing strips.

46. The mask of claim 44, wherein: the first strip comprises a film dressing configured to accommodate distortion of at least a portion thereof during said pressing so as to enable formation of said moisture vapor seal.

47. The mask of claim 44, wherein: the at least one second removable backing strip comprises first and second backing strips that collectively form a central region having (i) a lesser width than respective peripheral regions of the first and second backing strips, and (ii) a seam between the first and second backing strips, the lesser width and seam enabling accommodation of at least a portion of the nose of the wearer at least during said pressing; and the first and second backing strips are configured such that the wearer can press on both the first and second backing strips independent of one another.

48. An enhanced-comfort mask, comprising: an air-permeable portion configured to be placed over a mouth and nose of a wearer, and having at least a top edge and an outside surface opposing an inside surface, at least part of the inside surface configured to contact one or more portions of a face of the wearer; a neck securing feature attached to a lower portion of the mask at respective attachments points disposed on left and right sides of the mask; and at least one adhesive element coupled to said outside surface proximate said top edge of said air-permeable portion, a portion of the at least one adhesive element extending above said top edge and having adhesive properties so as to permit adhesion of the portion of the at least one adhesive element to facial skin of the wearer while also allowing varying distances between the top edge and the facial skin while still maintaining a moisture vapor barrier against vapor passing between the top edge and the facial skin to the orbital region of the wearer's face; wherein said mask is unsealed on left and right edges of the air-permeable portion; and wherein said mask is configured such that when donned, said mask is securable in place on said wearer using only: (i) said neck securing feature and (ii) said at least one adhesive element.

49. The mask of claim 48, wherein the air-permeable portion comprises a lower edge, the mask configured such that the lower edge wraps at least partly under the user's chin when the mask is donned.

50. The mask of claim 49, wherein: the air-permeable portion comprises a substantially rectangular form factor; the attachment points disposed on left and right sides of the mask comprise attachment points disposed at the lower edge of the substantially rectangular air permeable portion.

51. The mask of claim 50, wherein the mask is configured such that attachment points disposed at the lower edge of the air permeable portion reside at or below a jaw line of the wearer when the mask is donned by the wearer.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0058] FIG. 1A is a front perspective view of a prior art adhesive PPE mask.

[0059] FIG. 1B is a plain view of a prior art PPE mask having a compression metal strip.

[0060] FIG. 1C is a face side perspective view of a prior art PPE mask having a foam strip.

[0061] FIG. 1D is a side perspective view of a wearer of a prior art PPE mask with a compression metal strip having applied supplemental adhesive tape to secure the prior art mask.

[0062] FIG. 1E is a side perspective view of a prior art PPE mask which utilizes elastic compression.

[0063] FIG. 2A is an illustrated representation of typical skin surface layers at areas of increased thickness FIG. 2B is an illustrated representation of typical skin surface layers at areas of decreased thickness.

[0064] FIG. 2C is an illustrated representation of a typical nasal passage demonstrating the internal and external physiologic “valves”.

[0065] FIG. 2D is an illustrated representation of a typical facial muscle configuration that underlies PPE articles worn on or otherwise attached to a user's face.

[0066] FIG. 3A is a representative model of a front view of an exemplary improved adhesive PPE mask according to the present disclosure.

[0067] FIG. 3B is a representative model of an exemplary improved adhesive PPE mask according to the present disclosure.

[0068] FIG. 4A is a front view of an exemplary improved adhesive PPE mask according to the present disclosure.

[0069] FIG. 4B is a back view of an exemplary improved adhesive PPE mask according to the present disclosure.

[0070] FIG. 4C is a front view of a wearer of an exemplary improved adhesive PPE mask according to the present disclosure.

[0071] FIG. 4D is a front perspective view of a wearer of another exemplary embodiment of a mask apparatus according to the present disclosure.

[0072] FIG. 4E is a rear (wearer-side) perspective view of the mask apparatus of FIG. 4D.

[0073] FIG. 5A is a front perspective view of a wearer of a prior art PPE mask, hood, and face shield.

[0074] FIG. 5B is a side perspective view of a wearer of a prior art PPE mask, hood, face shield, and goggles.

[0075] FIG. 5C is a front perspective view of a prior art PPE eye shield.

[0076] FIG. 5D is a bottom perspective view of a prior art PPE eye shield.

[0077] FIG. 6A illustrates a front perspective view of an exemplary improved adhesive PPE mask according to the present disclosure.

[0078] FIG. 6B is a front perspective partial cutaway view of an exemplary improved adhesive PPE mask according to the present disclosure, showing one or elements internal thereto.

[0079] FIG. 6C is a front perspective view of exemplary improved adhesive PPE facial wear according to the present disclosure, including an exemplary mask and eye shields.

[0080] FIGS. 6D-6E are front and side perspective views, respectively, of an exemplary improved adhesive PPE eye shield according to the present disclosure.

[0081] FIG. 7A is front perspective view of exemplary improved adhesive PPE right and left eye shields according to the present disclosure.

[0082] FIG. 7B is front perspective view of a wearer of an exemplary improved adhesive PPE facial wear article according to the present disclosure, showing the disposition thereof during normal use.

[0083] FIG. 8A is a front perspective view of a wearer of another exemplary embodiment of a mask apparatus according to the present disclosure, wherein a single retention mechanism is used.

[0084] FIG. 8B is a rear (wearer-side) perspective view of the mask apparatus of FIG. 8A.

[0085] FIG. 8C is a front elevation view of one embodiment of the sealing strip apparatus used with the mask of FIGS. 8A and 8B (with backing strips attached).

[0086] FIG. 8D is a rear elevation view of the sealing strip of FIG. 8C (with top backing strip attached and mask adhesive exposed).

[0087] FIG. 8E is an image illustrating an exemplary positioning and use of the mask and sealing strip of FIGS. 8A-8D.

[0088] FIG. 9 is a logical flow diagram illustrating one embodiment of the method of donning the mask apparatus of FIGS. 8A-8D.

[0089] FIGS. 10A and 10B are graphical representations illustrating various design features of another embodiment of the mask sealing strip according to the present disclosure.

[0090] FIG. 11 is a logical flow diagram illustrating one embodiment of the method of using the sealing strip of FIGS. 10A-10B to assemble a mask apparatus, according to the disclosure.

[0091] FIG. 12A is a side elevation view of another embodiment of the mask sealing apparatus of the disclosure, supporting multiple uses.

[0092] FIG. 12B is a front elevation view of the mask sealing apparatus of FIG. 12A (shown unattached to mask, and with front backing strips installed).

[0093] FIG. 12C is a rear elevation view of the mask sealing apparatus of FIG. 12A (shown unattached to mask, and with rear backing strips installed).

[0094] FIG. 12D is a rear elevation view of the mask sealing apparatus of FIG. 12A (shown attached to mask, and with rear facial backing strip installed).

[0095] FIG. 12E is a rear elevation view of the mask sealing apparatus of FIG. 12A (shown attached to mask, and with rear backing strips removed).

[0096] FIG. 12F is a rear elevation view of a used facial adhesive portion of the mask sealing apparatus of FIG. 12A (shown detached from sealing apparatus).

[0097] FIG. 13A is a side elevation view of another embodiment of the mask sealing apparatus of the disclosure, also supporting multiple uses.

[0098] FIG. 13B is a front elevation view of the mask sealing apparatus of FIG. 13A (shown unattached to mask, and with front backing strips installed and second use strip flipped down).

[0099] FIG. 13C is a rear elevation view of the mask sealing apparatus of FIG. 13A (shown unattached to mask, and with rear backing strips installed).

[0100] FIG. 13D is a rear elevation view of the mask sealing apparatus of FIG. 13A (shown attached to mask, and with rear facial backing strip of first use strip installed).

[0101] FIG. 13E is a rear elevation view of the mask sealing apparatus of FIG. 13A (shown attached to mask, and with rear backing strips of first use strip removed, but front backing strips thereof installed).

[0102] FIG. 13F is a rear elevation view of the mask sealing apparatus of FIG. 13A (shown attached to mask, and with second use strip flipped up after first use strip has been detached, and backing strip thereof attached).

[0103] FIG. 14 is a logical flow diagram illustrating one embodiment of the method of using a mask having the sealing strip of FIGS. 13A-13F for multiple successive donnings, according to the disclosure.

[0104] FIG. 15A is a side elevation view of yet another embodiment of the mask sealing apparatus of the disclosure, also supporting multiple uses.

[0105] FIG. 15B is a front elevation view of the mask sealing apparatus of FIG. 15A (shown unattached to mask, and with front backing strips installed).

[0106] FIG. 15C is a rear elevation view of the mask sealing apparatus of FIG. 15A (shown attached to mask, and with rear backing strips installed and second use strip flipped down).

[0107] FIG. 15D is a rear elevation view of the mask sealing apparatus of FIG. 15A (shown attached to mask, and with rear facial backing strip of first use strip removed, and second use strip still flipped down).

[0108] FIG. 15E is a rear elevation view of the mask sealing apparatus of FIG. 15A (shown attached to mask, and with second use strip flipped up after first use strip has been detached, and backing strip thereof attached).

[0109] FIGS. 16A and 16B are rear and front elevation views, respectively, of yet another embodiment of the sealing apparatus of the disclosure, supporting multiple successive uses.

[0110] FIGS. 17 and 18 are rear perspective views of yet other embodiments of the mask apparatus of the disclosure, supporting thermal measurement of one or more regions of the wearer's face, and storage/transmission of data relating thereto to another device such as a passive RFID reader/interrogator.

[0111] FIG. 19 is a rear perspective view of yet a further embodiment of the mask apparatus of the disclosure, supporting pathogen sampling and/or diagnosis via one or more activated regions of the mask filter.

[0112] Figures © Copyright 2015-2020 MD Idea Factory™. All rights reserved.

DESCRIPTION OF THE DISCLOSURE

[0113] Reference is now made to the drawings listed above, wherein like numerals refer to like parts throughout.

[0114] As used herein, the term “adhesive” refers generally and without limitation to any substance used for sticking or bonding objects or materials together, such as a substance which is applied to one or more objects and which, once placed in physical contact, at least temporarily resists a separation of the objects or materials. Adhesives generally include without limitation, glues, epoxies, tapes, synthetic or chemical products, and natural binding agents.

[0115] As used herein, the terms “fastener” and “strap” refer generally and without limitation to any means for buckling, fastening, binding, and/or securing objects. As used herein, fasteners and/or straps may be made of any number of materials including, without limitation, cloth, paper, ribbon, string, malleable plastic or thin metals, etc. In addition, straps or fasteners may be secured via any number of securing means such as via tying, ratcheting, pin and hole (such as is found on a belt), glue or other adhesive, Velcro®, “nanotape,” etc.

[0116] As used herein, the terms “mask” and “surgical mask” refer generally and without limitation to any facial covering whether transparent or opaque intended to cover any portion of a wearer's face, neck, throat, ears, eyes, and/or head, despite an intended use or purpose thereof.

[0117] As used herein, the term “film dressing” refers generally and without limitation to thin adhesive patches or strips which are generally known as being sterile, transparent and highly flexible. However, it is appreciated that opaque film dressing, whether sterile or not, or yet other configurations, may be used with equal success consistent with the present disclosure as applicable. Exemplary implementations of such film dressings provide a moist, healing environment; promote autolytic debridement; protect against mechanical trauma and bacterial invasion (such as e.g., when used on a wound); and act as a blister roof or “second skin.” Although exemplary types of film dressings cannot absorb any significant amounts of fluid, they may be permeable to moisture-allowing one-way passage of carbon dioxide and excess moisture vapor away from e.g., a subject's skin.

[0118] As used herein, the term “eye shield” refers generally and without limitation to any eye covering intended to cover and protect one or more eyes of a wearer.

Overview

[0119] The present disclosure provides, inter alia, improved adhesive PPE facial wear. In one embodiment, an improved adhesive PPE mask provides one or more of the following features: (i) particular utility for surgical applications, toxic or infectious environmental applications, and/or clean room applications; (ii) comfort for the wearer; (iii) ability to perform as a germ and disease guard for extended periods; (iv), prevention of escape of air toward a wearer's eyes (which can cause, inter alia, condensation or fogging of instruments or the user's glasses, as well as microbial release through atomization or aerosolization of the user's breath); (v) facilitation of air flow in through the nose by expanding the internal nasal valves; and (vi) a design contoured to the appropriately durable facial skin regions while avoiding the thinnest, most delicate infero-periorbital regions and thereby reducing the skin irritation and advanced aging caused by other masks.

[0120] Exemplary adhesive PPE eye shields may be used alone or in conjunction with the foregoing mask, and provide one or more of the following features: (i) particular utility for surgical applications, toxic or infectious environmental applications, and/or clean room applications; (ii) comfort for the wearer; (iii) ability to perform as a germ and disease guard for extended periods; (iv), enhanced sealing at the lower edge of the eye shield overlapping with or proximal to an upper edge of the PPE mask; and (v) enhanced sealing at the periphery of the eye shield, and resistance to seal failure due to facial movements of the wearer. In some exemplary implementations, the eye shield(s) disclosed herein may further be configured (e.g., by virtue of density, material of construction, and/or other factors) to function as a barrier to e.g., fluids, as well as microbes or other agents of the type previously referenced. For instance, such eye shield(s) can function to protect the eyes of the user from liquid intrusion, such as use for watersports, or being splashed during e.g., chemical handling or mixing operations, surgical procedures, or any number of different activities.

[0121] In one specific embodiment, the PPE mask comprises an air-permeable filter portion configured to be placed over the mouth and nose of a wearer, a securing feature which is configured to secure the mask to the head of the wearer, and an adhesive portion. The adhesive portion of the mask advantageously comprises a contoured shape which adheres to the malar and nasal skin of the wearer, and which avoids contact with the thinnest and thus more sensitive infero-periorbital skin.

[0122] In another specific embodiment, each PPE eye shield comprises a window portion configured to be placed of one or more eyes of a wearer, a lip edge of on a perimeter of the window portion, and an adhesive portion attached at the lip edge. In one exemplary application, the eye shield is used alone or worn underneath a mask, and an adhesive portion of the eye shield(s) advantageously comprises a contoured shape which may adhere to the forehead, malar, and nasal skin of the wearer, and which avoids contact with the thinnest and thus more sensitive infero-periorbital skin. In another exemplary application, the eye shield is used in combination with a mask (such as that previously referenced), and the adhesive portion may adhere to the filter portion and/or the adhesive portion of the mask.

[0123] Additionally, for the adhesive portion of both the exemplary mask and eye shield, the contoured adhesive portion further advantageously comprises a substantially flexible material which is configured to maintain an airtight seal for extended periods throughout normal facial expression and movement of the wearer, and which is highly resistive to slippage or degradation due to user perspiration. Depending on the particular adhesive chosen, the exemplary embodiments of the mask also provide for enhanced tactile dexterity (i.e., the adhesive, while effective, is not overly “sticky” or difficult to handle, and hence easier to manipulate when donning or removing the mask), and leaves effectively no residual adhesive on the user's facial skin, reducing adhesive irritation and obviating the need for scrubbing or scraping of the delicate facial skin to remove residuals.

DESCRIPTION OF EXEMPLARY EMBODIMENTS

[0124] It is noted that while the apparatus of the disclosure described herein are discussed primarily with respect to use by a physician or other medical personnel during medical treatment, certain aspects of the disclosure may be useful in other applications, including, without limitation, non-medical uses, such as painting buildings (interior and exterior), salon and nail care uses, construction, and/or during every day wear to prevent the spread of disease or the ingestions of antigens, chemicals or pollutants. Further, the apparatus may be used in environments where there is potential exposure to toxic and/or infectious materials, or in work places such as those requiring a maintenance of a “clean room” environment.

Current Technology—

[0125] In order to provide a better understanding of the improved mask disclosed herein, various ones of the current technologies previously referenced (and the attendant limitations of each) are now discussed in greater detail.

[0126] Current mechanisms by which a superior aspect of a mask are “sealed” commonly employ adhesives, plastic or foam strips and/or elastic/compressive components.

[0127] FIG. 1A is an image of a prior art surgical mask 100 having an adhesive. As illustrated in FIG. 1A, the superior or top aspect of the mask 100 comprises a removable backing 102 which protects the adhesive disposed underneath. To wear the mask 100, the backing 102 is removed and the two elastic loops 104 are stretched to encircle the wearer's right and left ear, respectively; and the adhesive portion 101 is pressed against the users face below the eyes and across the bridge of the nose. As will be discussed in further detail below, adhesive masks such as that of FIG. 1 are often too sticky, and therefore hurt or damage skin when removed, and/or leave adhesive residue on the skin when removed. In addition, current adhesive masks loosen over time due to the significant coefficient of friction between the thick mask and the wearer's skin. This differential is exacerbated by perspiration which is common in, e.g., long surgical procedures under intense operating room (“OR”) lights). Such loosening disrupts the seal between the mask and the wearer. Loosening may lead to the escape of exhaled air upwards toward the wearer's eyes, and thereby occlude vision and/or create “fog” in a lens of the wearer's glasses or other ocular device due to moisture present in the exhaled volume. Loosening may further lead to discomfort, annoyance and/or full failure of the mask during operation, which wastes both money and time by requiring replacement mid-operation. Finally, due to the rectangular shape of the mask 100, adhesion occurs indiscriminately including both the thick malar and nasal skin as well as the thin infero-periorbital skin.

[0128] FIG. 1B is an image of a prior art surgical mask 110 having a plastic strip 112. FIG. 1C is an image of a prior art surgical mask 120 having a foam strip 122. To wear the surgical mask 110 having the plastic strip 112 or the surgical mask 120 having the foam strip 122, a user places the plastic strip 112 or foam strip 122 across the bridge of his/her nose, and then secures the mask 110 or 120. In the illustrated embodiment, the foam strip mask 120 further comprises four straps 124 which are intended to be joined behind the wearer's head. In this example, two top or superior straps 124 are pulled above a wearer's ears and joined to one another such as by tying; and two lower or inferior straps 124 are pulled below or across a wearer's ears and joined to one another, such as by tying. Although the view of the surgical mask 110 having a plastic strip 112 does not provide straps or fasteners, it is appreciated that any of those disclosed above with respect to FIGS. 1A and 1C may be utilized with the design of FIG. 1B to secure the mask to the wearer's head. A common problem with the masks of FIGS. 1B and 1C is that they are completely insufficient to form a seal between the mask and its wearer, especially at the superior aspect (i.e., under the eyes and across the nose). The insufficient seal causes loosening which may lead to the escape of moist air upwards toward the wearer's eyes, and may further lead to discomfort, annoyance and/or full failure of the mask during operation.

[0129] In a further embodiment, as illustrated in FIG. 1D, any of the foregoing masks (i.e., those of FIGS. 1A-1C) may be further provided with a compression strip 130 made of plastic or other bendable material. The compression strip 130 is intended to increase the seal between the mask and its wearer, thereby avoiding problems discussed above. However, in order to obtain an adequate seal with compression strips 130, they must be compressed to a point which obstructs nasal valve patency. Accordingly, a wearer suffers discomfort and/or difficulty breathing through the nose.

[0130] FIG. 1D further illustrates the use of supplemental adhesives 132 (in this case, tape) to secure the mask to the wearer's face. As shown, subsequent to normal facial movement and/or perspiration, the adhesives 132 lose their effectiveness and pull away from the skin of the wearer. Therefore, these supplemental solutions do not resolve the insufficient seal of the other approaches. Such adhesives leave a residue on the skin which can be irritating and difficult to completely remove.

[0131] FIG. 1E is an image of a prior art surgical mask which utilizes elastic compression. The tensions required to decrease airflow become uncomfortable on even short durations and remain insufficient in blocking air escape, resulting in subsequent ocular fogging and vision obstruction.

[0132] Current mechanisms by which one or more eyes of a user are shielded commonly employ face shields, goggles, or eye masks. These may include adhesives, plastic or foam strips and/or elastic/compressive components at the periphery of the device.

[0133] FIG. 5A is an image of a prior art face shield 500 worn in combination with a mask and hood. As depicted in FIG. 5A, the face shield 100 includes a user-tightened and/or elastic band (not specifically shown) that encompasses a user's head proximal to or at the region of the parietal ridge. The band is attached at opposing superior corners 502 of a face shielding window 504. A foam cushion 506 is attached to a superior edge 508 of the window 504, and is configured to cushion pressure against and conform to the wearer's sinciput. Although the eyes shielded from the front and top, as shown in FIG. 5A, lateral edges 510 and an inferior edge 512 of the window 504 are substantially open and permit passage of liquids, gases, microbes, and particulate matter. Therefore, the face shield 500 worn alone clearly provides insufficient eye protection.

[0134] FIG. 5B shows a prior art pair of goggles 514 worn in combination with a mask, hood, and face shield (substantially similar to face shield 500 shown in FIG. 5A). The goggles 514 include a user-tightened and/or elastic band 516 that encompasses a user's head proximal to or at the region of the temple. In the present example, the band 516 is worn below a band of the face shield. The band 516 is attached to opposing sides of a substantially rigid frame 518, which is configured to accommodate a bridge of the user's nose at an indentation 520. A perimeter of the frame 518 includes a substantially flexible perimeter wall or blade 522 that overlaps or at least partially overlaps with the mask and hood. In this example, the flexible wall 522 is intended to provide an impermeable seal with the skin of the wearer. At the locations where the wall contacts the mask or the hood rather than the user's skin, however, the wall may be unsealed and thus permit passage of liquids, gases, microbes, and particulate matter.

[0135] FIGS. 5C and 5D show an alternative prior art eye shield 524. The foam portion of the eye shield is used to cushion the rigid portion of the eye shield from the wearer's delicate face and cheek, thus improving the comfort of the device. In addition, the foam allows the eye shield to be applied with some pressure, which may be necessary for establishing a tight seal. Furthermore, the foam and adhesive create a barrier against microbe penetration and transmission

Anatomical Considerations—

[0136] The human facial anatomy presents various challenges with which a PPE mask and/or eye shield must coordinate to provide coverage while maintaining comfort and usability. Specifically, there are changes in shape and contour, texture and/or thickness of the skin in different regions, regions which perspire greater than others, muscular movements in varying regions (such as during facial expressions and communication made by the wearer), areas of different sensitivity, etc.

[0137] Accordingly, in one exemplary aspect, the present disclosure provides an improved mask which is configured to maintain a seal between the superior aspect of the mask and the wearer's skin in such a way that does not damage the sensitive infero-periorbital skin. Further, the present disclosure provides improved eye shields which may be used alone or in combination with the improved mask. When used in combination with the improved mask, the exemplary eye shields are configured to maintain both a seal between the superior aspect of the mask and an inferior aspect of the eye shield and a seal with the wearer's skin at regions of the eye shield that do not overlap with the mask. When used alone, the eye shield is configured to maintain a seal between the periphery of the eye shield window and the user's skin.

[0138] As noted above, adhesive masks and/or eye shields are often too sticky and therefore require excessive pulling on the skin to remove. These adhesive masks and eye shields do not take into account the physiological differences between thick, durable (>3 mm) skin as shown in FIG. 2A, and the immediately adjacent thin, ultra-delicate skin (0.5 mm) as shown in FIG. 2B, on a user's face. Specifically, the portion of the skin which includes the top of a human's cheeks and nose is referred to as the malar-lateral nasal skin, and is of the type illustrated in FIG. 2A. The portion of the skin just below the human's eyes, referred to as the infero-periorbital skin, which is among the thinnest, most delicate skin of the body, and is illustrated in FIG. 2B.

[0139] As can be seen in FIGS. 2A and 2B, there is a large difference in the thickness of the epidermal layers of each skin type. Hence, harsh scrubbing, scratching, traction and pulling or otherwise manipulating this skin is not desirable. Moreover, such treatment of this delicate tissue leads to advanced infero-periorbital skin “aging” such as e.g., “Crow's Feet” and festoon development. The repetitive trauma of peeling off current adhesive masks (such as the mask 100 of FIG. 1A) and/or of scrubbing off adhesive residue (as occurs with the masks 100 of FIG. 1A described above) renders the extant prior art technology unable to meet the needs of current consumers.

[0140] FIG. 2C is an illustrated representation of a typical nasal passage. As noted previously, certain ones of the currently available masks, such as are illustrated in FIG. 1D, utilize compression strips 130 to create a firm seal between the mask and the wearer's face. Also noted previously, conventional goggles, such as those shown in FIG. 5B, include a substantially rigid frame having an indentation for accommodating a bridge of the wearer's nose. However, as illustrated in FIG. 2C, the nasal passage comprises both an internal and an external nasal valve. Severe compression of the compressions strips 130 and/or compression of the rigid goggle frame against the user's nasal bridge results in at least partial obstruction of the internal nasal valve. This results in discomfort and inability of the wearer to breathe comfortably.

[0141] FIG. 2D depicts an illustrated example of a typical muscular structure that underlies PPE facial wear. There are 43 muscles that are known to contribute to facial expression and communication. Particularly muscles in the sincipital and malar regions of the face are prone to movement during facial expression and communication. During wear of facial PPE, skin of the sincipital region is contacted by an eye shield (e.g., goggles), while skin of the malar region is contacted by a mask and/or eye shield. Thus, normal facial expression and communication can contribute to disruption of mask and/or eye shield seals.

[0142] Moreover, no PPE mask has been developed that specifically addresses the unique facial anatomical transition from the thick, firm, tough malar and nasal skin to the most delicate and mobile infero-periorbital skin. Protecting the patency of the nasal valves has also not been adequately addressed in either of PPE masks or eye shields. The present disclosure provides, inter alia, an improved mask and eye shield which addresses each of the above unique physiological concerns (and others), as described in greater detail below.

Improved Mask—

[0143] Referring now to FIGS. 3A and 3B, representative models showing front views of an exemplary improved adhesive PPE mask 300 according to a first implementation of the present disclosure are given. As shown, the mask 300 generally comprises a paper-based filtration portion 302, one or more fasteners 304, and a superior anatomically shaped film dressing portion 306 configured to engage with skin in nasal and medial malar regions of the wearer's face.

[0144] The paper filtration portion 302 is a semi-permeable paper barrier used to guard against transmission of germs (and other agents or substances) via the mouth. The fasteners 304 of the illustrated embodiment comprise four paper strings which are intended to be secured around the wearer's head, such that the top two strings are pulled above the wearer's ears and joined together, and the bottom two strings are pulled below the wearer's ears and joined together. It is appreciated however, that any number and type of fasteners may be utilized with equal success. For example, the fasteners may comprise Velcro®, bendable or flexible wire, elastics, etc.

[0145] The extremely thin and flexible film dressing portion 306 has a coefficient of friction and pliability similar to the facial skin which eliminates the disruptive shear effect compromising the seal in traditional paper masks. The previously unrecognized advantage of utilizing a film dressing, most notably in the present context, is that this material is configured to adjust comfortably to the skin of the wearer as he/she moves (such as to talk, make facial expressions, etc.). Additionally, film dressing is specifically designed to remain adherent to the skin for extended periods despite perspiration. Other advantageous features of the film dressing 306 will be discussed in greater detail below.

[0146] As illustrated in FIGS. 3A and 3B, in one exemplary embodiment, the film dressing 306 is specifically shaped to accommodate the shape and curvature of a wearer's face. In the illustrated embodiment, the film dressing portion 306 comprises a dip or depression 310 which is intended to conform to the wearer's nasal bridge. In this manner, the two portions of the film dressing 306 on either side of the depression 310 are of sufficient height so as to be affixed just below the infero-periorbital skin of the wearer. Additionally, the depression 310 is of sufficient height to accommodate glasses or other eyewear. In a further embodiment, the film dressing 306 may further comprise a raised section, of any geometric shape (including e.g., a flat strip), which aides in contouring to facial anatomy.

[0147] As also illustrated, the mask 300 comprises one or more simple mask removal tabs 308, the mask removal tabs 308 simplify removal of the mask without irritation to the delicate infero-periorbital skin. The removal tabs 308 assist in the removal of the adhesive dressing from the users malar and nasal skin. They are shaped to allow simplified removal process wherein the user feels for the tabs without the need to look in mirror. In this manner, the wearer is not required to make any abrasions to the delicate infero-periorbital skin (such as by scratch at the interface of the dressing and the skin to pull up an edge or corner).

[0148] It will be appreciated that while human faces are generally somewhat similar in the region of interest (i.e., area of nose, bridge, periorbital regions, etc.), significant variations from individual to individual may exist, including variations in dimensions, angles, textures, and other features which may affect the performance of the mask described herein. Moreover, the transition of skin types may occur at different areas, and other differences may exist.

[0149] Accordingly, while the exemplary embodiments of the mask described herein advantageously can generally adapt to such variations (e.g., through use of the aforementioned film dressing), the present disclosure also contemplates the creation of user-customized masks which are particularly adapted to the wearer. For example, in one implementation, a 3D model of the relevant portions of the user's face (such as via a laser or optical scan of the wearer's face) is created, and this information used to particularly adjust one or more aspects of the mask construction. Hence, user-specific lots of masks, such as for surgeons who routinely wear them, can be fabricated and provided (including e.g., labeling such as a colored dot or printed name on the mask front, which can be used to identify the proper mask for a given individual).

[0150] FIGS. 4A and 4B illustrate front and back views, respectively, of an additional embodiment of an improved adhesive mask 400. According to this embodiment, paper support tabs suspend the adhesive membrane which facilitates application of the mask. These tabs are removed as the adhesive layer is applied to the nasal and malar skin while avoiding adhesion to the delicate infero-periorbital skin. FIG. 4C is an image of a person wearing the exemplary improved adhesive surgical mask 400 according to the present disclosure. This embodiment demonstrates the assembly of mask 400 with film dressing strip 406. Additionally, 400 shows the ability of the film dressing to follow the faces' contours during movement of a typical user.

[0151] As shown, the mask 400 comprises a paper filtration mouth cover 402 having at least two fasteners 404, and a film dressing strip 406 coupled to an upper rim thereof. As discussed above with respect to the embodiment of FIGS. 3A and 3B, the film dressing 306, 406 may be uniquely contoured to the durable malar and lower nasal skin, while avoiding attachment to the delicate adjoining infero-periorbital skin (see e.g., FIG. 4C). Other advantageous features of the film dressing 406 will be discussed in greater detail below.

[0152] As shown, the mask 400 is configured to, when purchased, comprise one or more minimally adherent wax, paper, or other backings 408 which protect the adhesive surface of the film dressing. In this manner, the many masks 400 may be easily packaged and shipped without risk of attaching to one another or to shipping materials. The paper backing 408 is removed then the mask is placed on the face. Unlike any other currently available masks, the exemplary implementation described includes front protective tabs configured to “lift” automatically when applied to the nose, allowing easy removal when donning the mask. The front backing is shaped differently, in one embodiment, in an effort to contour the nose. Additionally, a plastic liner separate from the paper backing 408 may be provided.

[0153] FIGS. 4D and 4E illustrate yet another embodiment of mask of the present disclosure. In this embodiment, the mask 430 (FIG. 4D) comprises a generally planar paper- or fiber-based filtration portion 432, upper and lower ties or straps 440 on each side connected by respective sidebars 442 (which may all be one continuous piece as shown, or discrete components), and an adhesive strip 434 which at least partly overlays an upper portion 438 of the filtration portion 432 (and which is adhered thereto via adhesive on the back side of the strip 434. Two waxed-backing removable tabs 436 cover respective left and right sides of the front, upper portion of the strip 434; these two tabs enable a wearer to, after the adhesive (rear) side of the strip 434 has been exposed as described further infra, press down on the front side of the tabs 436 with their fingers to firmly seat the adhesive of the strip 434 against the user's facial tissue. Once the mask is set and adhered, the two tabs 436 can simply be peeled up and removed, thereby exposing the front side of the strip 434.

[0154] As shown in FIG. 4D, the filtration portion 432 also includes a series of louvers or folds 444 which run laterally across the front of the mask 430 (as well as the back, in inverted configuration 445, as shown in FIG. 4E). The louvers 444, 445 maintain filtration integrity consistent with the rest of the filtration portion 432, yet also provide other benefits, which may include without limitation increased effective filtration surface area, shielding or “hiding” of portions of the portion 432 from direct impingement from external fluids or contaminants, and mechanical flexibility (e.g., the folds can “billow out” to some degree to accommodate features of the wearer's face).

[0155] The back (wearer) side of the mask 430, as shown in FIG. 4E, includes the adhesive side of the strip 432 with adhesive 449 (shown partly exposed as the back-side backing 450 is pulled away before use), as well as a complementary lower adhesive strip 452 and associated backing 456. The two adhesive portions 449, 452, when exposed, adhere to the malar and other facial tissues of the user, again minimizing or even eliminating contact with sensitive periorbital tissue.

[0156] Turning now to FIGS. 6A-6B, front views of an additional embodiment of an exemplary improved adhesive PPE mask 600 and an exemplary improved adhesive PPE eye shield 616 according to a second implementation of the present disclosure are given. As shown, the mask 600, similar to masks 300 and 400, generally comprises a paper-based filtration portion 602, one or more fasteners 604, and a superior anatomically shaped film dressing portion 606 configured to engage with skin in nasal and medial malar regions of the wearer's face. Differently from masks 300 and 400, mask 600 further includes lateral film dressing portions 612 configured to engage with skin in anterior malar and/or facial regions and an inferior film dressing portion 614 configured to engage with skin in and/or proximal to the mental region of the wearer's face. The embodiment of FIG. 6A also includes (as depicted in FIG. 6B) metal tabs 628 disposed within the mask (i.e., below the outer paper layer(s)) and configured to bend, in order to shape the mask to the face of the user.

[0157] As described above in reference to mask 300, 400, the paper filtration portion 602 is a semi-permeable paper barrier used to guard against transmission of germs (and other agents or substances) via the mouth. The fasteners 604 of the illustrated embodiment comprise four paper strings which are intended to be secured around the wearer's head, such that the top two strings are pulled above the wearer's ears and joined together, and the bottom two strings are pulled below the wearer's ears and joined together. It is appreciated however, that any number and type of fasteners may be utilized with equal success. For example, the fasteners may comprise Velcro®, bendable or flexible wire, elastics, etc.

[0158] The extremely thin and flexible film dressing portions 606, 612, and 614 have a coefficient of friction and pliability similar to the facial skin which eliminates the disruptive shear effect compromising the seal in traditional paper masks. The previously unrecognized advantage of utilizing a film dressing, most notably in the present context, is that this material is configured to adjust comfortably to the skin of the wearer as he/she moves (such as to talk, make facial expressions, etc.). Additionally, film dressing is specifically designed to remain adherent to the skin for extended periods despite perspiration. Other advantageous features of film dressings 606, 612, and 614 will be discussed in greater detail below.

[0159] As illustrated in FIGS. 6A-6C, in one exemplary embodiment, the film dressing 606 is specifically shaped to accommodate the shape and curvature of a wearer's face, particularly when coverage of the face and overlap with eye shielding PPE is desired. Differently from film dressing 306, in the illustrated embodiment, the film dressing portion 606 comprises a continuously curved extension or flap 610 which is intended to conform to the wearer's nasal bridge. In this manner, the two portions of the film dressing 606 on either side of the extension 610 are of sufficient height so as to be affixed just below the infero-periorbital skin of the wearer. Additionally, the extension 610 is of sufficient height to accommodate overlap with a PPE eye shield. In a further embodiment, the film dressing 606 may further comprise a raised section and/or extension, of any geometric shape (including e.g., a flat strip, a flat strip having slits, more than one extension, etc.), which aides in contouring to facial anatomy.

[0160] Also similar to masks 300 and 400, the mask 600 comprises one or more mask removal tabs 608. As illustrated in FIGS. 6A-6C, the mask 600 includes removal tabs 608 not only at the superior film dressing portion 606, but also at an edge of each of film dressing portions 612 and 614. The exemplary mask removal tabs 608 simplify removal of the mask without irritation to the delicate skin (e.g., infero-periorbital skin). The removal tabs 608 assist in the removal of the adhesive dressing from the users malar, nasal, and mental skin, and are shaped to allow the user to feel for the tabs, without the need to look in a mirror or utilize another person to guide them. In this manner, the wearer is not required to make any abrasions to the skin (such as by scratch at the interface of the dressing and the skin to pull up an edge or corner), and the tabs can be used even if the wearer or other person removing the mask has no exposed nail or otherwise has insufficient dexterity to “peel up” the edge of the adhesive as required in some prior art apparatus.

[0161] FIGS. 6C-6E depict an exemplary embodiment of PPE eye shields 616 which can be used alone or in combination with a mask. Although FIG. 6C shows eye shields 616 in combination with mask 600, it will be appreciated that the eye shields can be used alone, in combination with the mask 300, the mask 400, or another PPE mask and/or equipment (e.g., hood, face shield, etc.). It is also appreciated that while shown as two substantially discrete elements (i.e., one for each of the wearer's eyes), the individual eye shields can be aggregated into a single, common apparatus or assembly if desired, with suitable flexibility and conformability to the user's face substantially maintained thereby.

[0162] The eye shields 616 include a raised window portion 618 having a generally a half ellipsoid shape which is configured to be placed over an eye and later periorbital skin of a wearer. A lip or edge 620 disposed on a perimeter of the window 618 is laterally extended outward from the window perimeter.

[0163] The window 618 in the illustrated embodiment is transparent or semi-transparent to permit viewing through the eye shield, while being at least partly impermeable to liquids, gases, microbes, and/or particulate matter. For example, the degree of permeability of any may be determined by the particular application; the present disclosure contemplates that there may be instances where some degree of inward or outward permeability to, e.g., certain molecular species, may actually be desired. Likewise, not every application may require effectively zero permeability, and hence the cost, thickness, etc. of the windows 618 can be reduced accordingly.

[0164] In some alternative examples, the eye shield may be at least partly opaque and limit the passage of light to the eye, and conceivably may also incorporate e.g., photo- and/or thermally sensitive materials such that opacity varies as a function of exposure to solar radiation, heat. In some implementations, the window may be clear, tinted, dichroic, and/or polarized. Additionally or alternatively, in some examples, the window may include a coating, such as a fog-resistant coating (e.g., on the interior surfaces), a UV-blocking coating, a scratch resistant coating, etc. The window 618 may also optionally be adapted for various degrees of magnification for the user's eye; e.g., with cost-effective inclusion of a “bifocal” or similar portion such that the user, in adjusting their gaze and/or head position, can be provided some degree of magnification through the windows.

[0165] Further, the window 618 and the lip or edge 620 are in one variant comprised of a generally more rigid material in order to, inter alia, retain a protective or invariant eye space or void 622 (e.g., for ballistic protection, to prevent the deformation of the window when wiping their face, and the like). Accordingly, the window and/or the lip or edge may be fabricated from glass, plastic, resin, polycarbonate, and/or any other suitably rigid material known or yet to be discovered.

[0166] Further, the window and the lip or edge can be one co-molded piece (e.g., for cost and ease of manufacturing), or they can be separate adhered or otherwise attached pieces. Thus, in some examples, the lip or edge and the window can be comprised of differing materials and/or materials with differing properties (e.g., opacity, transparency, coatings, etc.).

[0167] As illustrated in FIGS. 6C-6E, each eye shield 616 further includes a film dressing portion 624 adhered to or otherwise attached to lip or edge 620. Akin to that used for the exemplary mask described elsewhere herein, the extremely thin and flexible film dressing portion 624 has a coefficient of friction and pliability similar to the facial skin which eliminates the disruptive shear effect compromising the seal in traditional eye shields (e.g., goggles). The previously unrecognized advantage of utilizing a film dressing, most notably in the present context, is that this material is configured to adjust comfortably to the skin of the wearer as he/she moves (such as to talk, make facial expressions, etc.). Additionally, film dressing is specifically designed to remain adherent to the skin for extended periods despite perspiration. Other advantageous features of the film dressing 624 will be discussed in greater detail below.

[0168] The exemplary film dressing 624 is also specifically shaped to accommodate the shape and curvature of a wearer's face. In the illustrated embodiment, the film dressing portion 624 comprises a generally elliptical shape which is intended to conform to the wearer's skin in the malar and sincipital regions. In this manner, the film dressing 624 is of a sufficient height so as to be affixed to the wearer's skin above the supraorbital region (at a superior region of the film dressing 624), and optionally overlap at least a portion of the film dressing 606 of the mask 600 (at an inferior region of the film dressing 624). Additionally, the film dressing 624 may cover skin in the region of the wearer's nasal bridge (at a medial region of the film dressing 624) and may cover skin in the anterior orbital region (at an anterior region of the film dressing 624). In a further embodiment, the film dressing 624 may further comprise sections of any geometric shape, which aide in contouring to facial anatomy and/or the film dressing 624 may additional include removal tabs, such as the removal tabs 308, 608 described above.

[0169] It will be appreciated that the exemplary film dressing 624 substantially seals around one eye of the user, thereby limiting permeability of liquids, gases, microbes, and/or particulate matter at the perimeter of the eye shield 616. During normal use, two eye shields 616 are used (as depicted in FIG. 6C) for covering each of the left and right eyes of the user. As such, the film dressing 624 preferably overlaps at the anterior regions of the eye shields when worn by the user. In some alternate examples, in order to increase comfort of wear for the user, the window and/or lip edge portions can include one or more one-way “vents” (e.g., perforations within the window 618 or other component which allow air (and moisture) to flow only outward from the interior region), to allow humid air to escape the sealed protective eye space while limiting permeability of liquids, microbes, and/or particulate matter. For instance, the present disclosure contemplates use of an anti-fog coating of the type used on other vision or glass apparatus, such as on the interior surface of the eye shield lens. As another alternative, a one-way valve can be used for such purpose. As yet a further alternative, dry air can be pumped into the void space between the user's face and the shield(s) so as to create a slight positive pressure therein, and force any moisture (e.g., vapor) therein out through the one-way valve. Such air can be pumped in using e.g., a small-diameter flexible tube (e.g., Tygon or the like) routed through a sealed perforation or seam of the shield(s), and supplied by e.g., a miniature air pump with dehumidifier, or even a small fan, with e.g., (ingress) microbe filter.

[0170] Moreover, a miniaturized electronic device such as those operating under the Peltier Effect (i.e., a temperature difference created by applying a voltage between two electrodes connected to a semiconductor material) may be used consistent with the apparatus of the present disclosure for e.g., dehumidification. In one such approach, a miniature Peltier cooler or dehumidifier device is places such that its active surface is at least partly in contact with a humid airspace (e.g., interior of eye shields) such that condensation generated thereby is able to “drip” out a channel or other conduit so as to permit the egress of moisture.

[0171] As yet another alternative, the eye shields may each include one or more “ports” disposed around the periphery thereof which facilitate the egress of moist/humid air within the interior volume of the eye shield to dissipate to the environment (and hence, inter alia, reduced or eliminated “fogging”). In one such implementation, a number of different ports are spaced around the periphery, and the ports are covered each by a portion of the aforementioned film dressing or other at least partly porous material or component, such that the moist air from within the eye shield(s) can permeate outward through the port and overlying film dressing, yet maintain a substantially sealed barrier against ingress of external contaminants. In another implementation, a substantially moisture-absorbent material (e.g., a thin layer of sponge-like material or similar) is used to cover the port(s) so as to permit the absorption of the moisture within the eye shield. Moreover, it will be appreciated that such absorbent material may be used alone (i.e., without the aforementioned ports), such as on or within a peripheral interior surface of the eye shield (e.g., this strips of the sponge-like material) which absorb moisture yet do not appreciably occlude the visibility of the wearer).

[0172] In other alternate examples, the left and right eye shields can be connected via a single film dressing sheet (substantially forming a PPE eye mask).

[0173] It will be appreciated that while human faces are generally somewhat similar in the region of interest (i.e., area of nose, bridge, periorbital regions, malar regions, mental regions, etc.), significant variations from individual to individual may exist, including variations in dimensions, angles, textures, and other features which may affect the performance (and requisite configuration) of the mask described herein. Moreover, the transition of skin types may occur at different areas, and other differences may exist.

[0174] Accordingly, while the exemplary embodiments of the mask and the eye shield described herein advantageously can generally adapt to such variations (e.g., through use of the aforementioned film dressing), the present disclosure also contemplates the creation of user-customized masks and/or eye shields which are particularly adapted to the wearer. For example, in one implementation, a 3D model of the relevant portions of the user's face (such as via a laser or optical scan of the wearer's face) is created, and this information used to particularly adjust one or more aspects of the mask construction. Hence, user-specific lots of masks, such as for surgeons who routinely wear them, can be fabricated and provided (including e.g., labeling such as a colored dot or printed name on the mask front, which can be used to identify the proper mask for a given individual).

[0175] FIGS. 7A and 7B illustrate front views of an additional embodiments of an improved adhesive PPE mask 700 and an improved adhesive PPE eye shield 716. As shown in of FIG. 7A, paper support tabs suspend the adhesive membrane which facilitates application of the eye shields. These tabs are removed as the adhesive layer is applied to the nasal, malar, and sincipital skin while avoiding adhesion to the delicate infero-periorbital skin. FIG. 7B is an image of a person wearing the exemplary improved adhesive PPE mask 700 and PPE eye shield 716 according to the present disclosure. This embodiment demonstrates the assembly of the eye shields 716 with film dressing portions 724 and supportive lips or flanges 722. Additionally, FIG. 7B shows the ability of the film dressing to follow the faces' contours during movement of a typical user. It will be appreciated that, although not specifically shown, mask 700 can additionally include paper or other types of support tabs (such as those shown in FIGS. 4A and 4B).

[0176] As can be seen in FIG. 7B, the mask 700 comprises a paper filtration mouth cover 702 having at least two fasteners 704, and a film dressing strip 706 coupled to an upper rim thereof. As discussed above with respect to the embodiment of FIGS. 6A-6C, the film dressing 606, 706 may be uniquely contoured to the durable malar and upper nasal skin, while avoiding attachment to the delicate adjoining infero-periorbital skin and overlapping with the film dressing 724 (see e.g., FIG. 7B).

[0177] As shown, the eye shields 716 are configured to, when purchased, comprise one or more minimally adherent wax, paper, or other backings 720 which protect the adhesive surface of the film dressing. In this manner, the many eye shields 716 may be easily packaged and shipped without risk of attaching to one another or to shipping materials. The paper backing 724 is removed then the eye shield is placed on the face. Additionally, a plastic liner separate from the paper backing 724 may be provided.

[0178] The masks 300, 400, 600, and 700, as well as eye shields 616 and 716, of each of the foregoing embodiments is applied simply without compromising or augmenting natural nasal valve air flow, and is atraumatically removed without skin residue. The various film dressing strips seals the mask 300, 400, 600, and 700 from respiratory vapor escape, avoiding fogging of any glass devices including microscopes, endoscopes, loupes, personal corrective lenses, glasses, eye shields, and/or goggles. Throughout its use, the mask and the eye shields are comfortable due to the light weight, and remains adherent due to the naturally flexible nature of the film dressing.

[0179] In a further embodiment (not shown), the film dressing may be bonded or fused to a foam pad so as to provide further comfort to the wearer. The foam pad in one embodiment is adhered to the top edge and comfortably rests against the user's malar and nasal skin. The film dressing, on the outside of the mask's top edge then seals the mask from the release of warm air. The pad can also be made to be substantially moisture absorbent, so as to assist in absorption of the user's perspiration and/or exhaled breath moisture.

[0180] The improved mask 300, 400, 600, 700 and/or eye shields 616, 716 of the present disclosure is, in one embodiment, manufactured of materials which are disposable or sufficient for only a single use. Accordingly, in another variant, one or more portions of the mask and/or eye shields can be made to indicate, upon use by the user, that the mask or eye shield has been worn (so as to, e.g., prevent a user from reusing it inadvertently). In one implementation, the mask and/or eye shields includes a small amount of moisture-reactive chemical or dye present in the filter portion such that, when appreciable moisture from the user's breath or perspiration comes in contact therewith, at least a portion of the mask or eye shield turns a different color than its surroundings, so as to be readily noticed by the (prospective subsequent) user. Yet other approaches may be used, including other types of chemical reactions, timed decay or dissolution of a portion of the mask or eye shield (e.g., the adhesive is rendered useless after exposure to a prescribed temperature for a given period of time, a moist/dry cycle, etc.).

[0181] As can be seen given the embodiments and discussion above, the improved mask 300, 400, 600, 700 and eye shields 616, 716 are easily applied and removed without skin trauma or adhesive residue. Specifically, the film dressings 306, 406, 606, 706, film dressing 612 and 614, and film dressing 624, 724 are comprised of a material which is removed easily and which does not leave such residue. Moreover, the film dressing portion 306, 406, 606, 706 of the mask 300, 400, 600, 700 is anatomically designed to adhere only to the malar and nasal skin; and to avoid contact with the delicate infero-periorbital tissue.

[0182] As noted above, the film dressing portion 306, 406, 606, 706 and film dressing 624, 724 advantageously enables an airtight seal to be created while still ensuring that the wearer's nasal valve remains fully open and unobstructed. In certain embodiments, the mask 300, 400, 600, 700 and/or eye shields 616, 716 can further be configured such that an outward bias on the user's outer nasal area skin can be created when wearing the mask or eye shields, thereby in effect further expanding at least the inner nasal valve (and enhancing nasal air flow as compared to a normal static (unbiased or uncompressed) state), somewhat akin to the known Breathe Right® strips currently commercially available. Specifically, in one variant, the film dressing portion itself can be configured with a slightly reduced degree of flexibility in at least the area spanning the sides and bridge of the nose, such that when adhered to the user's skin in those areas, the combination of the reduced flexibility or “springiness” (i.e., tendency to straighten out to a more flat, planar shape when bent) and adhesive will cooperate to bias the outer nasal tissue outward (and hence further open the internal nasal passages/valve). This reduced flexibility can be accomplished by, e.g., making the film dressing significantly thicker in the region proximate the nose, and/or adding a strip or other mechanism to enhance the aforementioned springiness (such as by adhering a thin plastic strip to the outer portion of the film dressing).

[0183] In another variant, a plastic or other material strip, rod or other shape is embedded in or mated to a region of the superior portion of the mask around the user's nose (as in the example shown in FIG. 6B), thereby providing the aforementioned outward bias or “springiness”. This feature can be configured such that the outward bias does not cause any significant stress on or separation of the film dressing from the user's facial tissue in the malar region, under the eyes, etc., thereby fully preserving the full sealing function of the mask described supra, as well as the aforementioned expansion of the nasal valve and accompanying enhanced air flow.

[0184] It is further noted that the film dressings 306, 406, 606, 706, film dressing 612 and 614, and film dressing 624, 724 of the herein described improved mask 300, 400, 600, 700 and eye shields 606, 716 facilitate normal facial expression and perspiration by creating a flexible adhesion thereto which does not loosen or shift during wear, even over extended operative periods lasting many hours. This durability prevents the need for a user to “break sterility” by “scrubbing out” in order to apply a new PPE mask and/or eye shield. Moreover, the described film dressings are resistant to the accumulation of perspiration due to the nature of its integral skin seal. Accordingly, the wearer of the mask 300, 400, 600, 700 and/or eye shields 616, 716 discussed herein do not waste time adjusting or replacing slipping or loosened masks and eye shields.

Exemplary Methods—

[0185] The improved masks 300, 400, 600, 700 and eye shields 616, 716 of the present disclosure are used according to the following methods.

[0186] Specifically, in regards to masks 300, 400, 600, 700, a wearer first removes a protective backing 408 from the film dressing 306, 406, 606, 706. The contoured 310, 610, 710 dressing is placed on the bridge of the wearer's nose and smoothed to lie flat against, and therefore adhere to, the durable malar and lower nasal skin, while avoiding attachment to the delicate adjoining infero-periorbital skin. Thus, the superior edge of the mask is at least partially sealed to the wear's skin. In the example of mask 600, 700, protective backings are removed from lateral film dressings 612 and inferior film dressing 614 and the film dressings are applied to and smoothed to lie flat against, and therefore adhere to, the anterior malar skin and mental skin regions, respectively. In this example, the periphery of the mask is at least partially sealed the lateral edges and inferior edge of the mask in addition to the superior edge of the mask.

[0187] Next, the fasteners are coupled, fastened, placed into contact, or otherwise activated to secure the remaining air-filtration portion around the wearer's head. In some embodiments, where the mask includes a film dressing edging which surrounds the entire mask (such as the configuration of the mask 600 shown in FIGS. 6A-6C), the fasteners may be excluded. Hence, in this embodiment, the mask may be worn by simply removing a protective backing and affixing the mask directly to the skin.

[0188] After the mask is secured, eye shields 616, 716 may be applied. Specifically, the wearer first removes a protective backing 720 from the film dressing 624, 724. Next, the window 618, 718 is aligned with one of the wearer's eye and the surrounding film dressing 616, 716 is applied to and smoothed to lie flat against, and therefore adhere to, the wearer's skin above the supraorbital region (at a superior region of the film dressing 624, 724) and overlap at least a portion of the film dressing 306, 406, 606, 706 of the mask 300, 400, 600, 700 (at an inferior region of the film dressing 624, 724). In the present example, the film dressing 624, 724 additionally covers skin in the region of the wearer's nasal bridge (at a medial region of the film dressing 624, 724) and in the anterior orbital region (at an anterior region of the film dressing 624, 724). It will be appreciated that a second eye shield 616, 716 may be dawned in a substantially similar manner over the wearer's other eye. In some examples, the film dressings 624, 724 of adjacent eye shields will at least partially overlap at the nasal bridge and medial sincipital regions of the user's skin. In examples where the left and right eye shields are attached in a single film dressing sheet, both eye shields may be concurrently applied in a substantially similar manner.

[0189] To remove the mask and/or eye shields, a wearer may first unfasten the one or more fasteners such as by untying, cutting, ripping, pulling apart, or stretching these away from one another and/or away from the head of the user to create a space large enough for the user's head to escape. Next, an edge of one or more of the various film dressings of the mask (the film dressing 306, 406, 606, 706, and/or film dressings 612 and 614) is grasped in order to pull the dressing away from the user's skin. In some examples, the removal tabs 308, 608 are grasped to aid in pulling the dressing away from the user's skin. Further, in some examples, the film dressing 624, 724 is at least partially overlapping with the film dressing 306, 406, 606, 706, the eye shields 616, 716 may be pulled away from the user's face along with the mask. In other examples, an edge of the film dressing 624, 724 may be grasped to facilitate removal of one or more of the eye shields from the wearer's face.

[0190] As noted above, the above described film dressings do not leave a residue and do not adhere so firmly to the skin so that removal is traumatic to the skin. Therefore, the detachment is generally accomplished without causing significant impact to the wearer's skin. As noted above, the mask 300, 400, 600, 700 and eye shields 616, 716 may be comprised primarily of disposable materials, and therefore may be discarded after removal.

Multi-Use/Re-Usable Mask and Sealing Apparatus—

[0191] FIG. 8A is a front perspective view of a wearer of another exemplary embodiment of a mask apparatus 800 according to the present disclosure, wherein a single retention mechanism is used. In this embodiment, the mask apparatus has both enhanced comfort and sealing capability. In one variant, the mask apparatus includes a sealing strip 810 disposed at a top edge of a filter mask portion 845 via an adhesive strip 838, and a single lower retention mechanism 816 (e.g., elastic strap or complementary left/right strap portions 816a, 816b which the user fastens behind their neck when wearing the mask apparatus). The absence of ear-based retention mechanisms (e.g., left and right ear straps or bands) advantageously (i) reduces irritation of the user's sensitive skin around their ears while wearing the mask (e.g., for long durations), and (ii) allows the mask to be worn lower down on the face of the user (see FIG. 8E), such that the sealing strip is well below the sensitive periorbital or other skin proximate the eyes. The sealing strip acts to both block moisture vapor (e.g., breath) from fogging the user's eyewear, optical instruments being used, etc., and support the mask at its upper portion, while the single strap/band 816 retains the mask against the user's face (i.e., in a direction generally normal to a plane of the user's face).

[0192] As shown, the front portion of the strip 810 includes two removable backing elements 836 which attach to the front side of the e.g., Tegaderm or other adhesive strip 849 used to attach to the face. The backing elements allow the user to press on the front side of the Tegaderm strip when the latter is adhered to the face to firmly secure the bond, and also provide a level of pathogenic protection in the backings 836, where the user presses with potentially contaminated fingertips, can be removed and safely discarded, thereby minimizing changes of residual pathogen near the user's eyes. These backings 836 also maintain mechanical stability of the thin Tegaderm strip until it is firmly bonded to the facial skin.

[0193] FIG. 8B is a rear (wearer-side) perspective view of the mask apparatus 800 of FIG. 8A, showing the rear backing strip 850 covering the e.g., Tegaderm strip 849 adhesive.

[0194] FIG. 8C is a front elevation view of one embodiment of the sealing strip apparatus 810 used with the mask of FIGS. 8A and 8B (with front backing strips 836 attached). In this embodiment, a seam 866 is formed between the two backing strips 836 such that when the user dons the mask and presses it against their face (i.e., with adhesive 838 exposed), their nose naturally pushes up the seam 866, which advantageously (i) relieves stress on the strip 810, making it easier to apply to the face and obtain a good seal, and (ii) flips up and outward the two inner edges 867 of the respective backing strips 836 making them easy to grasp by the user for removal.

[0195] FIG. 8D is a rear elevation view of the sealing strip of FIG. 8C (with top backing strip 850 attached and mask adhesive 838 exposed).

[0196] FIG. 8E is an image illustrating an exemplary positioning and use of the mask 800 and sealing strip 810 of FIGS. 8A-8D. As shown, the mask can advantageously be worn at a lower level 856 on the face than the level 854 of other masks since (i) the lower single retention mechanism 816 helps bias or pull the mask in a generally downward and rearward direction, and (ii) there are no ear bands as in the prior art (FIG. 1A) which would, if present, tend to pull the mask up and backward. In effect, the upper edge of the mask 800 is supported by the firm bonding of the e.g., Tegaderm adhesive under the user's eyes (in this case lower than otherwise possible with ear bands), thereby enabling the adhesive to interface with less sensitive skin (but still provide excellent anti-fogging and sealing capabilities). The single mechanism 816 in effect very lightly tugs the mask against the user's face and downward (resisted by the adhesive bond), thereby making it advantageously more taught against the user's face as well.

[0197] It will also be recognized that the aforementioned configuration helps maintain the nostrils of the wearer wide open (versus pinching them via a clamp or constricting arrangement), while also maintaining the moisture/vapor barrier; i.e., the flexibility and shape of the adhesive strip 849 allows the distance between the mask and face to vary, including accommodating wide-open nostrils of the user.

[0198] In yet other embodiments of the mask disclosed herein, the facial adhesive region of the strip 849 can utilize a re-usable tape or adhesive, such as so-called “Nanotape” (e.g., that made using carbon nanotubes or other micro-level fibers or similar), which as a class of materials generally has high levels of adhesion, yet which is also easier to remove as compared to traditional adhesives such as those used on Tegaderm products.

[0199] As yet another option, the outer (front) backing strips 836 can be maintained in place while the mask is worn, and when removed, the backings 836 maintain the adhesive strip 849 sufficiently rigid such that it does not fold on to itself. This approach generally will provide the user with 2-3 different uses, so long as the adhesive is sufficiently protected from dirt, etc.

[0200] FIG. 9 is a logical flow diagram illustrating one embodiment of the method of donning the mask apparatus of FIGS. 8A-8D. In this embodiment, the method includes: (i) removing a backing strip from a rear adhesive region of the mask sealing strip to expose adhesive for adhering to the face; (ii) placing and pressing the exposed adhesive against the user's face (i.e., by pressing on the front side removable backing strip(s)) to form a seal at the top edge of the mask; (iii) removing the front side backing strips; and (iv) engaging the single retention mechanism so as to retain the mask against the user's face (e.g., by tying or joining two strap portions behind their neck.

[0201] In an alternative embodiment, the single lower retention mechanism is a one-piece elastic or other band that can fit over a user's head, and method includes placing the band over the user's head such that the mask hangs below the user's face (e.g., against their chest), and then removing the rear backing strip and adhering the sealing strip to the user's face (and removing the front backing strip(s)) as described above.

[0202] FIGS. 10A and 10B are graphical representations illustrating various design features of another embodiment of the mask sealing strip according to the present disclosure. In this embodiment, the rear lower backing strip 851 is made to extend to the edges of the strip apparatus 810 while the facial adhesive 838 does not extend that far, thereby enabling the user to easily peel up the backing strip during donning. Moreover, the slit 866 in the central region (separating the two backing strips 836) allows each interior portion of the backing strips (i.e., those next to the slip) to deflect upward when the adhesive strip apparatus is donned (due to the protrusion of the bridge of the nose), thereby facilitating removal of the backing strips by the user. It will be appreciated, however that other mechanisms for facilitating backing strip removal such as e.g., eccentric or salient tabs extending beyond an edge of the strip apparatus 810 that the user can grasp may be used consistent with the disclosure, whether in place or in combination with the foregoing approach.

[0203] FIG. 11 is a logical flow diagram illustrating one embodiment of the method of using the sealing strip of FIGS. 10A-10B to assemble a mask apparatus, according to the disclosure.

[0204] FIG. 12A is a side elevation view of another embodiment of the mask sealing apparatus 1210 of the disclosure, supporting multiple uses. In this embodiment, the apparatus is configured to leverage a plurality (e.g., 2 or more) sealing strips (e.g., disposed in a front-to-back or other disposition on the mask) such that after removing the mask after first use, the user can remove (e.g., tear off via perforation 1211) the expended sealing strip 1202c, thereby exposing a new/unused sealing strip 1202b for a subsequent application of the mask. In one variant, the plurality of sealing strips are disposed in a generally “stacked” fashion (front-to-back) as shown in FIG. 12A, while in another variant second (and any subsequent) strips are folded downward at the perforation seam, and can be simply folded up after the used strip has been removed (see FIGS. 13A and 15A).

[0205] As shown, each sealing strip “finger” 1202 (i.e., upper region of the apparatus 1210) is separable from that adjacent to it (i.e., they are not bonded together in this region), such that stresses or movement of one adhesive strip 1249 (and its associated interior adhesive layer 1214) is not constrained by the others, thereby allowing for flexible distortion of the strip 1249. In this embodiment, each finger 1202 includes a rear backing strip 1250, but only the front finger 1202a includes front backing strip(s) 1236. This approach allows the user to use the front finger backing strips 1236 to press on the next-in-line adhesive strip 1249 (after it's rear backing 1250 has been removed) to achieve good bonding to the face, while reducing the thickness of the upper portion of the apparatus 1210 as a whole.

[0206] In the lower region of the strip apparatus 1210 (at or below the perforation lines 1211), the individual adhesive strips 1249 are bonded together, with a single backing 1251 covering the rearward-facing mask adhesive region 1238. This allows each facial adhesive strip 149 to be grasped by the user and torn off after use, thereby exposing next strip (and its backing 1250) in line.

[0207] FIG. 12B is a front elevation view of the mask sealing apparatus of FIG. 12A (shown unattached to mask, and with front backing strips installed). As shown, the various backings on the strips (and even the adhesive strips 1249 themselves) may carry instructions (text, images, arrows, etc.) to aid the user in application and re-use.

[0208] FIG. 12C is a rear elevation view of the mask sealing apparatus of FIG. 12A (shown unattached to mask, and with rear backing strips installed).

[0209] FIG. 12D is a rear elevation view of the mask sealing apparatus of FIG. 12A (shown attached to mask, and with rear facial backing strip installed).

[0210] FIG. 12E is a rear elevation view of the mask sealing apparatus of FIG. 12A (shown attached to mask, and with rear backing strips removed).

[0211] FIG. 12F is a rear elevation view of a used facial adhesive portion of the mask sealing apparatus of FIG. 12A (shown detached from sealing apparatus). As shown the adhesive may also contain a moisture- and/or heat-sensitive chemical or compound impregnated into the adhesive which changes transparency, color, etc. when exposed to a threshold level of heat/moisture so as to alert the user that the adhesive has already been used. In another variant, removal of the backing strip 1250 activates the compound such as via exposure to air or electromagnetic radiation (e.g., visible light) such that once the backing is peeled off, the image/text appear.

[0212] FIG. 13A is a side elevation view of another embodiment of the mask sealing apparatus 1310 of the disclosure, also supporting multiple uses. In this embodiment, the second (and any subsequent) strips 1349a are folded down in front of the lower portion of the sealing apparatus 1310, e.g., at the perforation seam 1311. As with the embodiment of FIG. 12A, the second strip 1349a is separate from the first 1349b, and hence the first is free to move, articulate, bend, etc. (including its two front backing strips 1336 and seam 1366, as previously described). The rear backing 1350 of the second strip 1349a points forward when folded down as shown, and rearwards when folded up (see discussion of FIGS. 13B-13F below).

[0213] FIG. 13B is a front elevation view of the mask sealing apparatus 1310 of FIG. 13A (shown unattached to mask, and with front backing strips installed and second use strip flipped down).

[0214] FIG. 13C is a rear elevation view of the mask sealing apparatus 1310 of FIG. 13A (shown unattached to mask, and with rear backing strips installed).

[0215] FIG. 13D is a rear elevation view of the mask sealing apparatus of FIG. 13A (shown attached to mask, and with rear facial backing strip of first use strip installed).

[0216] FIG. 13E is a rear elevation view of the mask sealing apparatus of FIG. 13A (shown attached to mask, and with rear backing strips of first use strip removed, but front backing strips thereof installed).

[0217] FIG. 13F is a rear elevation view of the mask sealing apparatus of FIG. 13A (shown attached to mask, and with second use strip flipped up after first use strip has been detached, and backing strip thereof attached).

[0218] FIG. 14 is a logical flow diagram illustrating one embodiment of the method of using a mask having the sealing strip 1310 of FIGS. 13A-13F for multiple successive donnings, according to the disclosure.

[0219] FIG. 15A is a side elevation view of yet another embodiment of the mask sealing apparatus 1510 of the disclosure, also supporting multiple uses. In this embodiment, rather than being folded down in front of the mask 1545, the second (and subsequent) strips 1549a are folded rearward over the top edge of the mask when not in use. The backing 1550 for the second strip 1549 shows facing the user when putting on the mask. Due to its limited thickness, the presence of the second strip 1549 and backing 1550 advantageously cause no discomfort for the user when folded down due to the mask only being tightly adhered to the user's face at the top (facial adhesive) region of the apparatus 1510.

[0220] FIG. 15B is a front elevation view of the mask sealing apparatus of FIG. 15A (shown unattached to mask, and with front backing strips installed).

[0221] FIG. 15C is a rear elevation view of the mask sealing apparatus 1510 of FIG. 15A (shown attached to mask, and with rear backing strips installed and second use strip flipped down).

[0222] FIG. 15D is a rear elevation view of the mask sealing apparatus 1510 of FIG. 15A (shown attached to mask, and with rear facial backing strip of first use strip removed, and second use strip still flipped down).

[0223] FIG. 15E is a rear elevation view of the mask sealing apparatus 1510 of FIG. 15A (shown attached to mask, and with second use strip flipped up after first use strip has been detached, and backing strip thereof attached).

[0224] It will be appreciated that the various sealing apparatus 1210, 1310, and 1510 may be intermixed if desired, such as where (i) all three variants are combined, in effect giving the user five (5) separate wearings, (ii) the variants of FIGS. 13A and 15A are combined, giving the user three (3) separate wearings, (iii) the variants of FIGS. 12A, 13A and 15A are combined, yet with the variant of FIG. 12A having only one finger (thereby yielding three total wearings), and so forth. Multiple other combinations will be recognized by those of ordinary skill given the present disclosure.

[0225] Moreover, it will be recognized that the adhesive on lower part of apparatus 1210, 1310, 1510 may be adhered to the back/face side of mask (versus the front as shown), for instance by using a forward-facing adhesive surface and backing strip that is bifurcated such that the top (facial) adhesive portion faces rearward, but the lower (mask) portion faces frontward.

[0226] It will also be recognized that the second (and subsequent if any) strips of the embodiments of FIGS. 12A, 13A, and 15A can be (lightly) adhered to front/rear of mask or mask adhesive strip or backing as applicable so as to help retain them in place when not in use. For example, a low-shear force “gum dot” or similar mechanism can be used to hold the folded-down strips in a given orientation prior to use if desired.

[0227] FIGS. 16A and 16B are rear and front elevation views, respectively, of yet another embodiment of the sealing apparatus 1610 of the disclosure, supporting multiple successive uses. In this embodiment, the successive adhesive strips (covered by the backings 1650a, 1650b in FIG. 16A) are stacked vertically, such that a perforation 1611 between each allows each strip to be used, torn off, and then the next lower (or even upper, such as where the user folds the top strip forward until use) strip used. Similarly, front backings 1636 are used on the front of the apparatus 1610 to allow for finger-pressing for adhesion of the relevant strip as previously discussed.

[0228] FIGS. 17 and 18 are rear perspective views of yet other embodiments 1700, 1800 respectively of the mask apparatus of the disclosure, supporting thermal measurement of one or more regions of the wearer's face, and storage/transmission of data relating thereto to another device such as a passive RFID reader/interrogator.

[0229] In the embodiment of FIG. 17, the mask 1700 includes one or more strap(s) 1716, mask adhesive 1738, backing strip 1750 similar to other configurations, yet with a thermal monitoring “pigtail” 1721 emanating from one (or both if desired) sides of the mask 1700. The pigtail includes an adhesive with its own removable backing strip 1723, and an integrated ASIC 1725 configured for both thermal monitoring and data logging, and RF transmission of the data to an external device such as an RFID or NFC interrogator, smartphone with NFC capability, etc. In use, the wearer, after donning the mask as discussed above, removes the backing 1723 of the pigtail 1721, thereby exposing the adhesive, which the user then simply runs up the side of their temple to a point at one peripheral edge of the forehead. As determined in numerous studies (see e.g., J Dent, 1990 October; 18(5):250-3. doi: 10.1016/0300-5712(90)90022-7. “Measurement of facial skin temperature,”—S Ariyaratnam 1, J P Rood; “A new evaluation of heat distribution on facial skin surface by infrared thermography,” Denise S Haddad, et al, and “Simulation of Temperature Distribution on the Face Skin in Case of Advanced Personalized Ventilation System”—Ferenc Szodrai and Ferenc Kalmir Department of Building Services and Building Engineering, University of Debrecen; Otemeto str. 2-4, 4028 Debrecen, Hungary), the temperature of the “average” person in this region tends to be generally commensurate with that of the middle of the forehead (as contrasted with e.g., the cheeks generally being a colder region on the human anatomy than the forehead). The ASIC is battery-less and includes a passive RFID/NFC device (i.e., that powered by the incident RF energy of the interrogator) configured to record thermal data at the location of the ASIC 1727, roughly akin to extant handheld thermal “guns” as previously described, yet without either (i) the “single data point”, or (ii) serial reading, limitations of the prior art. Numerous wearers of the mask 1700 proceeding through e.g., an airport terminal portal can be rapidly interrogated using an RFID interrogator, and their data logged over the course of the wearing of the mask, without screener (e.g., TSA) interaction, thereby further enhancing social distancing and reducing possible contagion spread.

[0230] In one implementation, the ASIC 1727 comprises an ultra-Miniature, low frequency (134 KHz) RFID Passive Wireless Sensor such as that available from Phase IV Engineering (see https://www.phaseivengr.com/product/pressure-temperature-ultra-miniature-low-frequenev-lf-rfid-sensor/). This ASIC uses the 4th generation of the world's first RFID sensor chip, is ultra-miniature, battery-free, and the use of a low frequency and magnetic radio coupling allows it to read through many materials, including the mask filter. In operation, a unique ID number is transmitted with sensor data (such as logged temperature values over time), and has a typical read range between a few inches to a few feet—depending on the size of the reader antenna. Data logging capability further advantageously provides the data recipient (e.g., airport or healthcare screener) with a profile of data over time, versus a single measurement at one discrete point in time.

[0231] It will be appreciated that for applications where a higher degree of privacy is desired, more limited range NFC frequencies and antennae may be used (akin to commercially available NFC interfaces on smartphones used for wireless payment services and the like).

[0232] In another variant, one or more ASICs 1727 such as those described with respect to FIG. 17 may be used to measure temperature of the impregnated test regions 1945, 1946 and log such data, so as to enable assessment of whether a suitable temperature profile was maintained for a sufficient period to cause the test results yielded by each region of the mask to be validated. For instance, if the user takes the mask off in the middle of a test period, the temperature may fall below a prescribed minimum, and hence the test is invalidated. In one implementation, the logged data is uploaded to a scanner (e.g., smartphone with passive RFID interrogator or NFC interrogation device) with application software to evaluate the thermal profile one or more of the regions for such validation. The application software can be configured for example to validate that a sufficiently complete and continuous set of data is present before a given wearer is “all clear”—those without sufficient data can be submitted to additional screening as flagged by the application.

[0233] It will be further appreciated that while shown integrated with the mask 1700, 1800 of FIGS. 17 and 18 to varying degrees, the temperature sensor and transmitter apparatus may also be implemented as a separate stand-alone device, e.g., as a “dot” or strip or patch with adhesive backing which one can simply adhere to their forehead, temple or other portion of skin to be measured. In this fashion, the mask can be removed and re-donned independent of the temperature sensor/transmitter. In one variant, the temperature sensor/transmitter is configured as a skin-tome matching patch or dot which can be disposed e.g., under the user's hairline so as to minimize visual profile for the wearer.

[0234] FIG. 18 shows an alternative embodiment of the instrumented mask apparatus of the disclosure, wherein a printed antenna 1824 is included within the mask filter and electrically connected to the ASIC 1827 (such as via one or more thin conductors or conductive traces 1822 along the pigtail 1821. As with the other embodiment, the mask 1800 includes one or more straps or retention mechanisms 1816, a pigtail adhesive backing 1823, and facial adhesive 1849 and backing 1850 in the sealing strip apparatus 1810. It will be appreciated that other types of antennae and form factors may be used consistent with the present disclosure, the embodiments of FIGS. 17 and 18 being merely examples.

[0235] FIG. 19 is a rear perspective view of yet a further embodiment of the mask apparatus 1900 of the disclosure, supporting pathogen sampling and/or diagnosis via one or more activated regions 1945, 1946 of the mask filter. In one embodiment, the regions 1945, 1946 are each configured with filter or other material that has been impregnated with compounds which facilitate RNA replication, such as for COVID-19 and related coronavirus pathogens, Ebola, or other. In one implementation, the technology developed by University of Oxford's Engineering Science Department and the Oxford Suzhou Centre for Advanced Research (OSCAR) (Prof. Zhanfeng Cui and Prof. Wei Huang) is used, wherein the change in color of one or more reagents is indicative of a positive result for the target pathogen. See also “A colorimetric RT-LAMP assay and LAMP-sequencing for detecting SARS-CoV-2 RNA in clinical samples” Viet Loan Dao Thi, et al, Science Translational Medicine 12 Aug. 2020: Vol. 12, Issue 556, which is incorporated herein by reference in its entirety.

[0236] As shown in FIG. 19, when an “activated” region 1946 is exposed to the pathogen and sufficient time has passed (and suitable temperature range is maintained), the reagent(s) changes color or transparency to indicate to the user that they should seek medical attention. In contrast to nasal/throat swab approaches, the mask 1900 of FIG. 19 uses a “passive” sampling approach, wherein a user wearing the mask 1900 provides both (i) a constant stream of nasal/mouth water vapor aggregated over each exhalation cycle, and (ii) a generally constant temperature roughly in the range of 100-120 F. As such, a user wearing the mask on say a multi-hour airplane trip with the mask on will exhale perhaps thousands of times, and any pathogen in their nasal and/or respiratory tract will at least in part be captured on the filter paper sample areas 1945, 1946 by virtue of carriage in water droplets which cling to the filter material. In that the Oxford technology only requires a simple heat source which maintains a generally constant temperature for RNA reverse transcription and DNA amplification (e.g., RT-LAMP), the mask serves as a convenient albeit incidental test apparatus. Advantageously, the results can be read by the naked eye using a simple color change to identify the presence of the (e.g., from pink to yellow in one configuration). In one variant, each test region 1945, 1946 is impregnated with e.g., three different primers (one is a negative control; this can form e.g., the outline regions surrounding the text shown in FIG. 19 in region 1946).

[0237] Notably, the masks 1900 equipped with this test technology can advantageously be shipped and maintained at ambient temperature.

[0238] Moreover, the present disclosure contemplates variants wherein (i) the activated or impregnated regions 1945, 1946 can be removed by the user (or a health care provider) to facilitate in-laboratory testing (e.g., where the necessary sufficiently isothermal test regime cannot be maintained for whatever reason), and (ii) variants which include material configured to help maintain the aforementioned isothermal profile, such as an exothermic chemical layer or other configuration (e.g., one which is moisture and/or breath heat activated) which helps maintain the desired temperature range for the reagents during the typical (e.g., 60-90) minute test time based on the temperature necessary to separate the RNA strands.

[0239] In another variant, in order to minimize the size of the reagent impregnated region which must maintain the isothermal condition, the regions 1945, 1946 are (or contain smaller sub-regions which are) very small in size, and which can be maintained more easily in an isothermal condition at the prescribed temperature, such as via the aforementioned exothermic chemical reaction (e.g., small regions of exothermic chemical which have reagent disposed thereon).

Film Dressing—

[0240] In one specific embodiment, the various film dressing portions discussed herein comprises a dressing having properties generally similar to extant wound or other dressings, such as for example the 3M™ Tegaderm™ Dressing; however other types of dressing may be utilized with equal success, given that they provide similar performance in terms of flexibility and resistance to perspiration. Similar dressing products are available from McKesson's Transparent Dressing and Medline's Suresite Window Transparent Film Dressing).

[0241] In one exemplary implementation, the “film dressing” utilized with various embodiments described herein comprises a multi-layer (e.g., two layer) laminate structure, having for instance a substrate and an adhesive. It will be appreciated, however, that various different configurations may be utilized, including without limitation, (i) ones where the adhesive is deposited on or bonded to the host substrate; and (ii) ones where the adhesive itself actually forms the substrate. Moreover, various degrees of permeability to e.g., humidity, air, etc. are contemplated.

[0242] One or more of the various film dressing portions may further comprise an anti-microbial layer and may, in one embodiment, be transparent. Further, the various film dressings comprises a breathable material which is configured to enhance moisture evaporation and adhesiveness of the dressing to the skin. Hence, it remains adhesive despite sweating and natural movement of the skin and muscles of the wearer.

[0243] It will also be appreciated that one or more film dressings, such as those described above, may be used on other regions of the mask/filter component, such as on the sides. For example, in one variant, the sides of the mask filter 302, 402 (and in fact, the whole of the filter) can be shaped so as to optimize bonding to the sides of the user's face via respective film dressings, so as to at least partially “seal” the sides of the mask as well. In one exemplary configuration, the mask filter is performed so as to be “cupped” substantially around the user's face (versus being substantially planar prior to application, as shown with respect to the embodiments of FIGS. 3A-3B, 4A-4B, and 6A-6C above), thereby causing the sides to lay generally flat against the sides of the user's face during use, and permitting attachment thereto directly using e.g., film dressings. Such embodiment may or may not further include additional fasteners as discussed in the embodiments given above.

[0244] Many other approaches and combinations are envisaged consistent with the disclosure, as will be recognized by those of ordinary skill when provided this disclosure.

Results—

[0245] Informal testing of various embodiments of the masks and eye shield(s) disclosed herein by the inventors hereof in situ (i.e., during one or more closed surgical procedures, during extended travel such as on airplane trips, during daily wear including use of eyewear, and similar) indicate markedly improved performance of the disclosed mask and/or eye shielding equipment over the prior art, especially in terms of the above-described aspects of reduced “fogging” of optical equipment, comfort, and reduced/eliminated trauma upon removal, including over extended activities lasting many hours.

[0246] It should be recognized that while the foregoing discussion of the various aspects of the disclosure has described specific sequences of steps necessary to perform the methods of the present disclosure, other sequences of steps may be used depending on the particular application. Specifically, additional steps may be added, and other steps deleted as being optional. Furthermore, the order of performance of certain steps may be permuted, and/or performed in parallel with other steps. Hence, the specific methods disclosed herein are merely exemplary of the broader methods of the disclosure.

[0247] While the above detailed description has shown, described, and pointed out novel features of the disclosure as applied to various embodiments, it will be understood that various omissions, substitutions, and changes in the form and details of the device or process illustrated may be made by those skilled in the art without departing from the disclosure. The described embodiments are to be considered in all respects only illustrative and not restrictive. The scope of the disclosure is, therefore, indicated by the appended claims rather than the foregoing description. All changes that come within the meaning and range of equivalence of the claims are embraced within their scope.