WO2013053082A1

WO2013053082A1 - Improved nose clip for respiratory mask

Info

Publication number: WO2013053082A1
Application number: PCT/CN2011/001718
Authority: WO
Inventors: Yajun Edwin Zhang; Jack XIONG; Jimmy ZHENG; Zhaoxia Jin
Original assignee: Honeywell International Inc
Priority date: 2011-10-14
Filing date: 2011-10-14
Publication date: 2013-04-18
Also published as: CN103874528B; CN103874528A

Abstract

A respiratory mask with a nose clip (20) is provided. The respiratory mask comprises a mask body (10) comprising a nose bridge portion (12) and a filtration element, a nose clip (20) attached to the mask body (10) to aid in snug fit; wherein the nose clip (20) is free-form deformable and spans the nose bridge portion (12); and the nose clip (20) may comprise a mesh grid or be a solid bar-shape but varies in material along its width (22). The respiratory mask with the nose clip (20) presents the advantages of sufficient malleability to conform to the complex three-dimensional facial contours of a user's nose region and sufficient shape-retaining to hold effective seal once so conformed.

Description

TITLE

Improved Nose Clip for Respiratory Mask

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] Not applicable.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

[0002] Not applicable.

REFERENCE TO A MICROFICHE APPENDIX

[0003] Not applicable.

FIELD

[0004] Disclosed embodiments relate generally to a nose clip for a respirator mask, more specifically to improved nose clips designed to provide better free-form fit.

BACKGROUND

[0005] Respirator masks preferably would fit snuggly against a user's face, in order to provide an effective seal. Achieving an effective seal on the user's face may be difficult, however. There can be a great deal of variance in the facial contours across a wide demographic of users, with the nose bridge of different users varying significantly, for example. And the nose bridge area of a user's face is a complex three-dimensional surface, further complicating attempts to obtain a snug fit. A solid bar nose clip design would not seem to address these concerns effectively, since if a solid bar nose clip would be made of stiff material, it would be difficult to shape and deform; but if it would be made of soft material, it would not retain its deformed shape very well. Additionally, a solid bar nose clip would not be effective in twisting, making it difficult to fit the complex geometry of a user's face. Applicants seek to provide an adjustable nose clip for use on respirator mask(s) that can be easily conformed to the user's face (having good shapeability to provide a snug fit) and that can effectively retain its shape (so that the mask will conform to facial contours during use to provide an effective seal).

SUMMARY

[0006] In one aspect, the disclosure may include a respirator mask comprising: a mask body comprising a nose bridge portion; a nose clip having a height dimension and a width dimension and attached to the mask body; wherein the mask body comprises a filtration element; wherein the mask body is operable to encompass a user's mouth and nose; wherein the nose clip spans the nose bridge portion of the mask body; and wherein the nose clip is free-form deformable. In some embodiments, the nose clip might comprise a high-density mesh grid. The high density mesh grid might comprise a plurality of strands of a soft material (malleable, for example) with sufficient shape-retaining capabilities (stiffness, for example) to form an effective seal (for example, at least retaining its deformed or conformed shape against its own weight and self-restoring tendencies). Each strand might have a thickness of about 0.5 mm and the grid might comprise a pattern of holes having 4 or more holes along the nose clip height dimension and 18 or more holes along the nose clip width dimension. The nose clip height dimension might be at least about 10mm and the nose clip width dimension might be at least about 60 mm. In some embodiment, the plurality of strands might comprise aluminum or mild steel. And in some embodiments, the plurality of strands may be formed of only a single material. In other embodiments, the plurality of strands might comprise more than one material (for example, with each strand being comprised of only a single material, or each strand being comprised of two or more materials, possibly wound together). In some embodiments, the mesh grid may be formed by one or more of the following: weaving strands to form a mesh grid; welding strands into a mesh grid; photo-chemically etching material to form the strands of the mesh grid; electroforming the mesh grid; or expanding material to form a mesh grid. An in some embodiments, the mesh grid may be attached to the mask by one or more of the following: adhering the mesh grid nose clip to the body of the mask using an adhesive; embedding the mesh grid nose clip in the body of the mask; sewing the mesh grid nose clip onto the body of the mask; or inserting the mesh grid nose clip into a slot in the body of the mask. In some embodiments the nose clip may comprise a solid bar having a middle portion and two outer wing portions, and wherein the middle portion of the bar has stiffer (for example, shape retaining) characteristics and the outer wing portions of the bar have softer (for example, more malleable) characteristics. The nose clip may be formed of two different materials, wherein the middle portion comprises a stiffer (shape retaining, for example) material and the outer wing portions comprise a softer (malleable, for example) material, and wherein the stiffer material comprises hardened metal and the softer material comprises non-hardened metal. The stiffer material may make up about half or less of the width of the bar in some embodiments. In some embodiments, the bar may be formed by injection molding, so that the bar is a single, unified element made of two or more materials varying across the width of the bar.

[0007] In other aspects, the disclosure might comprise a nose clip having a height dimension and a width dimension comprising: a high-density mesh grid; wherein the high density mesh grid comprises a plurality of strands of a soft material (malleable) and has sufficient shape-retaining capability (stiffness) to form an effective seal; and wherein the grid comprises a pattern of holes (between the strands of the grid) having about 4 holes along the nose clip height dimension and about 18 holes along the nose clip width dimension.

[0008] In other aspects, the disclosure might comprise a nose clip having a height dimension and a width dimension comprising: a solid bar formed of two different materials, wherein the material of the nose clip varies along its width dimension. The bar may be rectangular in shape and/or may comprise a middle portion and two outer wing portions, with the middle portion of the bar comprising a stiffer (shape retaining, for example) material and the outer wing portions of the bar comprising a softer (malleable, for example) material. In some embodiments, the stiffer material may make up half or less of the width of the bar.

[0009] Still other aspects of the disclosure might include a method of making a mask comprising: providing or forming a high-density mesh grid nose clip (as described above); providing or forming a mask; and attaching the nose clip to the mask. In some embodiments, forming a high-density mesh grid comprises one or more of the following: weaving strands to form a mesh grid; welding strands into a mesh grid; photo-chemically etching material to form the strands of the mesh grid; electroforming the mesh grid; or expanding material to form a mesh grid; and/or attaching the nose clip to the mask comprises one or more of the following: adhering the mesh grid nose clip to the body of the mask using an adhesive; embedding the mesh grid nose clip in the body of the mask; sewing the mesh grid nose clip onto the body of the mask; or inserting the mesh grid nose clip into a slot in the body of the mask. The high-density mesh grid may comprise a plurality of strands of a soft material (malleable) with sufficient shape-retaining capabilities to form an effective seal; and/or the grid may comprise a pattern of holes having about 4 holes along the nose clip height dimension and about 18 or more holes along the nose clip width dimension. In some embodiments, each strand is about 0.5 mm in thickness, and/or the height dimension of the nose clip is about 10 mm and the width dimension of the nose clip is about 60 mm or more.

[0010] Another aspect of the disclosure might include a method of making a mask comprising: providing or forming a nose clip having a stiffer middle portion and a softer outer wing portion (as described above); providing or forming a mask; and attaching the nose clip to the mask. In some embodiments, forming a nose clip may comprise one or more of the following: injection molding, punching, cutting, or thermo-form molding; and wherein attaching the nose clip to the mask comprises one or more of the following: adhering the nose clip to the body of the mask using an adhesive; embedding the nose clip in the body of the mask; sewing the nose clip onto the body of the mask; or inserting the nose clip into a slot in the body of the mask. The nose clip may comprise a solid bar, with the middle portion of the bar being less than half the total width of the bar.

[0011] In yet another aspect, the disclosure might include a respirator mask comprising: a mask body comprising a nose bridge portion; a nose clip having a height dimension and a width dimension and attached to the mask body; wherein the mask comprises a filtration element and a perimeter operable to seal to a user's face to encompass the user's mouth and nose; wherein the nose clip spans the nose bridge portion of the mask body; and wherein the nose clip is free-form deformable; wherein the nose clip comprises a high-density mesh grid; wherein the high density mesh grid comprises a plurality of strands of a soft material (malleable) and has sufficient shape-retaining capabilities to form an effective seal. In some embodiments, the strands may be malleable and dead soft. In some embodiments, the high density manner that the strands are formed into a grid may provide effective shape retaining capability (even if the strands themselves are malleable). In some embodiments, each strand may have a thickness of about 0.5 mm and/or the grid may comprise a pattern of holes having 4 holes along the nose clip height dimension and at least 18 holes along the nose clip width dimension; and/or the nose clip height dimension may be about 10mm and the nose clip width dimension may be about 60 mm. In some embodiments, the holes may each be about 2.5 mm by about 3.3 mm (such that the strands are each spaced about 2-4 mm apart).

[0012] In still another aspect, the disclosure may include a respirator mask comprising: a mask body comprising a nose bridge portion; a nose clip having a height dimension and a width dimension and attached to the mask body; wherein the mask comprises a filtration element; wherein the nose clip spans the nose bridge portion of the mask; and wherein the nose clip is free-form deformable; wherein the nose clip comprises a solid bar having a middle portion and two outer wing portions, wherein the middle portion of the bar is stiffer (shape retaining, for example) and the outer wing portions of the bar are softer (malleable, for example). In some embodiments, the middle portion comprises a stiffer material and the outer wing portions comprise a softer material. In other embodiments, the middle portion and wing portions are formed of the same material, but the middle section is heat treated to be hardened (stiffer, for example). In some embodiments, the middle portion and the outer wing portions may be formed of the same material, but have different heat treatments. And in some embodiments, the middle portion and wing portions may be formed of the same material, but the middle portion may have more material (thicker and/or wider than the wing portions, for example) so that it acts stiffer.

[0013] Persons of ordinary skill will better understand and more fully appreciate embodiments based on the drawings and detailed description.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] For a more complete understanding of the present disclosure, and for further details and advantages thereof, reference is now made to the accompanying drawings, in which:

[0015] FIG. 1 shows an illustrative embodiment of an exemplary respirator mask with a free-form deformable nose clip being worn by a user;

[0016] FIG. 2 shows an illustrative embodiment of an exemplary respirator mask with a nose clip embodiment formed of a mesh grid;

[0017] FIG. 3 shows in more detailed an illustrative embodiment of a nose clip formed of a mesh grid;

[0018] FIG. 4 shows an illustrative embodiment of an exemplary respirator mask with a nose clip formed having material variation along its width; and

[0019] FIG. 5 shows in more detail an illustrative embodiment of a nose clip having material variation along its width. DETAILED DESCRIPTION

[0020] The following brief definition of terms shall apply throughout the application:

[0021] The term "malleable" means that the nose clip may be conformed by mere finger pressure applied by a user;

[0022] The term "dead soft" means that the nose clip retains it shape when conformed or deformed until readjusted or altered by the user;

[0023] The terms "snug fit" or "fit snuggly" and the like means that an essentially air tight fit is provided between the respirator mask and the user's face;

[0024] The term "comprising" means including but not limited to, and should be interpreted in the manner it is typically used in the patent context;

[0025] The phrases "in one embodiment," "according to one embodiment," and the like generally mean that the particular feature, structure, or characteristic following the phrase may be included in at least one embodiment of the present invention, and may be included in more than one embodiment of the present invention (importantly, such phrases do not necessarily refer to the same embodiment);

[0026] If the specification describes something as "exemplary" or an "example," it should be understood that refers to a non-exclusive example;

[0027] The terms "about" or approximately" or the like, when used with a number, may mean that specific number, or alternatively, a range in proximity to the specific number, as understood by persons of skill in the art field; and

[0028] If the specification states a component or feature "may," "can," "could," "should," "preferably," "possibly," "typically," "optionally," "for example," or "might" (or other such language) be included or have a characteristic, that particular component or feature is not required to be included or to have the characteristic. Such component or feature may be optionally included in some embodiments, or it may be excluded. [0029] Disclosed embodiments may relate to a nose clip for use on a respirator mask with free-form shapeability/malleability and effective shape-retaining capabilities. In particular, embodiments may relate to nose clips that provide free-form deformation, with sufficient malleability to conform to the complex three-dimensional facial contours of a user's nose region and sufficient shape-retaining ability to hold an effective seal once so conformed. Stated another way, disclosed embodiments may relate to a nose clip that has three- dimensional deformation capabilities (such that it is capable of being deformed in a wide variety of forms, including bending and twisting by way of non-exclusive example) and shape-retaining capabilities (of retaining its deformed shape at least against its own weight and self-restoring forces).

[0030] FIGURE 1 illustrates an embodiment of an exemplary respiratory mask body 10 with a nose clip 20. The respiratory mask 10 might be any sort of device worn on a user's face for filtering air. In some embodiments, the respirator mask 10 may be a dust mask. In some embodiments, the respirator mask 10 may be a limited use mask or a disposable mask (which is designed to be used one or more times, for example 1-10 times, before it is discarded and replaced with a new mask). While the respirator mask shown in Fig. 1 is cup- shaped and covers both the user's mouth and nose, in some embodiments that mask might instead cover only the mouth or only the nose. Other shapes of mask bodies operable to enclose the user's mouth and/or nose may also be included in the disclosure. Typically, the respirator mask body 10 of Fig. 1 would have a filtration element (which might be the mask material itself or, if the mask is impermeable, a filtering valve) and one or more straps 15 for securing the respirator mask body 10 to the user's face. In some embodiments, the mask body material itself may be filtering, but a one-way valve may still be used to improve exhalation. Typically, the straps 15 are adjustable to allow the mask to be secured to a wide range of users having different sized heads. And typically, the mask body 10 could be secured to the user's face in a way that forms an effective seal (so that unfiltered air would not leak into the mask). This sealing effect might occur by simply tightening the mask strap(s) 15 sufficiently to form a seal between the mask body 10 and the user's face (such that the entire perimeter of the mask body generally conforms to the user's face), or in other embodiments, the respirator mask 10 might also include a sealing element along some or all of the periphery or perimeter of the mask so that a more effective seal can be formed without the need for tight fitting strap(s). Typically, a snug fit is desired for the respirator mask. - [0031] The respiratory mask body 10 of Fig. 1 covers both the user's mouth and nose. It includes a nose bridge portion 12 designed to fit over the user's nose, which typically may need to be shaped effectively to conform to each specific user's facial contours. Thus, the nose bridge portion 12 of Fig. 1 is sufficiently flexible to allow for the nose bridge portion 12 of the mask to be shaped according to the user (typically with the nose clip being used to retain the shape in approximate conformance to the user's face). In Fig. 1, the respirator mask 10 extends from the nose bridge portion 12 (typically worn at some point on the bridge of the user's nose above the user's nostrils), down across some portion of the user's cheeks, and then down under the user's chin (in order to form a seal around the user's mouth and nose).

[0032] The nose clip 20 of Fig. 1 is designed to be free-form deformable so that it can be shaped to approximately match the complex three-dimensional shape of a wide variety of users' noses. Since the nose clip 20 is free-form deformable, it is able to effectively deform three-dimensionally, and in the embodiment of Fig. 1 to at least effectively bend and twist. The free-form nature of the nose clip 20 of Fig. 1 may also allow the deformation to have high-fidelity or high-resolution, with each small portion of the nose clip operable to be deformed in its own specific way to fit the corresponding portion of the user's face, for example. So specific portions of the nose clip might be shaped into a concavity (around the nose wing area of the user's face, for example) to deform more precisely to the concave areas of the user's face. This ability for small portions of the nose clip to be shaped may allow the nose clip to conform effectively to the various shape changes associated with a user's nose. The nose clip 20 is designed to be sufficiently soft and malleable to allow for effective shaping to conform to a user's face merely by applying pressure using the fingers, but also has sufficient shape retaining capabilities and characteristics so that it will effectively hold its shape during ordinary usage as the mask is being worn, in order to maintain an effective seal. The nose clip 20 of Fig. 1 has sufficient shape retaining capabilities so that it may at least retain its deformed shape against its own weight and self-restoring tendencies. So in practice, the nose clip 20 may help to provide a snug fit of the mask body 10 to the user's face. In Figure 1 , the nose clip 20 spans the nose bridge portion 12 of the respirator mask 10. In the embodiment of Fig. 1, the nose clip 20 is attached to the respirator mask body 10 across the nose bridge portion 12, so that the nose clip can be used to shape the nose bridge portion 12 of the mask body so that it conforms more closely to the user's facial contours (especially to the complex three-dimensional shape of the user's nose region), and to retain the deformed shape of the mask in order to provide an effective seal. In this way, the nose clip 20 can make the respirator mask 10 more effective. In some embodiments, the nose clip 20 allows for effective fitting/sealing of a less-expensive generalized mask, even if the mask itself does not have a shape that conforms particularly well to a specific user's facial contours. The nose clip 20 of Fig. 1 might also allow for effective use of a specific respirator mask across a wider demographic of users (with a wide array of facial contours).

[0033] FIGURE 2 illustrates an embodiment of an exemplary respirator mask 10 having a nose clip 20 formed of a mesh grid. The mesh grid of nose clip 20 of Fig. 2 provides good free-form deformability, allowing the nose clip to more closely match a specific user's facial contours (particularly the complex three-dimensional geometry of the user's nose region). Also, the mesh grid allows the nose clip 20 of Fig. 2 to be sufficiently malleable for shapeability, while also having sufficient shape-retaining characteristics to hold its deformed shape against a user's face (for example the bridge of the user's nose) to form an effective seal. The mesh grid of the nose clip 20 of Fig. 2 allows for high-fidelity or high-resolution deformation. For example, each small portion of the mesh grid nose clip may be shaped to have a specific concavity (to match the corresponding concavity of the user's nose, for example). Each portion of the mesh grid may be independently deformed (by bending and twisting, for example), and typically the higher the density of the grid (with more strands per unit area and/or smaller gaps or holes in the mesh grid, for example), the higher the resolution of deformation allowed. Thus, the mesh grid nose clip may provide high-resolution deformation allowing it to better match the complex and changing shape of a user's nose area for a more accurate fit. So the mesh grid nose clip 20 of Fig. 2 may provide a true three- dimensional deformation, with easy bending and twisting to better conform to complex and diversified facial contours.

[0034] FIGURE 3 illustrates an embodiment of the mesh grid nose clip 20 of Fig. 2. In the embodiment of Fig. 3, the mesh grid is a high-density grid of a plurality of strands 25 of soft or malleable material, with the plurality of strands typically connected to form a grid-like structure. In some embodiments, the strands 25 are formed of soft or mild steel or aluminum or an alloy. For example, the strands 25 might be made from linear dead-soft aluminum that can easily be conformed by applying hand pressure. In one embodiment, an alloy of aluminum might be used for the strands, for example aluminum alloy 3003. In some embodiments, the strands 25 may be made from one or more materials that are malleable and dead soft. The strands 25 of Fig. 3 are approximately 0.5 mm thick. The nose clip 20 of Fig. 3 has a width 22 and a height 24, and the mesh grid of Fig. 3 forms a grid of strands 25 with 4 holes/spaces/openings 27 along the height dimension 24 of the nose clip and about 18 holes/spaces/openings 27 along the width dimension 22 of the nose clip. The strands 25 may typically be spaced between about 1mm and about 5mm apart in the high density mesh grid. In the embodiment of Fig. 3, the holes 27 are typically about 2.5mm by about 3.3mm (such that the strands 25 are typically spaced about 2-5 mm apart), and the high density manner in which the strands form a grid provides good shape retaining capabilities (even if the material of each strand is malleable and/or soft). In Fig. 3, the nose clip 20 has a width 22 of about 60 mm and a height 24 of about 10 mm (although in some embodiments the nose clip 20 might have a width greater than 60 mm and or a height greater than 10 mm). In the embodiment of Fig. 3, the mesh grid is only a single layer of grid strands, such that the thickness of the nose clip 20 would be about the thickness of the strands 25 (typically about 0.5 mm, by way of example). In alternate embodiments, however, more than one layer of grid strands might be used (with the layers overlapping to form a thicker nose clip).

[0035] The high-density mesh grid of Fig. 3 may be quite flexible so that it can be expanded in either height, width, or both dimensions to extend onto the cheek portion of the mask (to provide better or snugger fit for more of the upper part of the mask) or extended further down height-wise the mask to provide a better seal (by providing a larger area of contact between the mask body and the user's face, for example). In some embodiments, the mesh grid nose clip 20 might extend across the cheek portion of the mask for approximately all of the width of the respirator mask. In the embodiment of Fig. 2, however, the nose clip 20 spans the nose bridge portion of the mask and only extends out over the portion of the mask typically associated with a standard range of user noses (such that it will typically extend slightly past the location where the nose meets the user's cheek when worn). The high-density mesh grid may help to deform better, so that the contact area between the face and the nose clip may be increased. The mesh grid nose clip may be easier to shape than a bar-shaped nose clip of the same thickness. So even with a big surface, the mesh nose clip may still be easy to deform, allowing more contact area between the nose clip and the user's face. Thus, the mesh grid height could be much greater to provide more secure contact and a better seal, while still allowing for easy shapeability. And due to the higher shapeability of the mesh grid, embodiments might extend the nose clip over a larger portion of the mask body, extending the nose clip contact from the nose bridge, to the nose wing to the cheek to increase the sealing surface area further. Also, the high-density mesh grid may provide better contact comfort by better conforming to facial contours and evenly distributing pressure. And while the shape of the mesh grid 20 shown in Fig. 3 is approximately rectangular, other shapes could also be used (for example, with the mesh grid being shaped to conform to the upper perimeter of the mask, and/or with the height varying according to facial contours to provide more sealing potential in areas of greater need).

[0036] While the embodiment of Fig. 3 shows a mesh grid nose clip 20 in which all strands 25 are made of the same material, in other embodiments the mesh grid could be formed of strands 25 of two or more different materials. For example, the strands 25 running along the width dimension of the nose clip could be one material, while the strands 25 running along the height dimension could be a different material. Alternatively, embodiments could employ strands 25 that are formed of two different materials (for example, with two thinner strands of different materials twisted together to form a single strand used to form the mesh grid). Or in another embodiment, the material of each strand in a row of the grid could alternate, and/or the material of each strand in a column of the grid could alternate. Another embodiment might use different strand material for different portions of the mesh grid, based on the needed characteristics for matching the user's facial profile or contours. For example, the portion of the nose clip on the nose bridge portion of the mask might be made of more malleable strands, while the portion of the nose clip interacting with the cheek portion of the mask might be made of a material with better shape- retaining properties (or the reverse). For example, in an embodiment the strands 25 of the columns of the gird (running along the height of the nose clip) spanning the nose bridge portion of the mask might be stiffer or have better shape retaining characteristics, while the strands 25 of columns of the grid further out towards the wing ends might be softer or have better malleability. And while different materials could be used for different portions of the grid in some embodiments, alternatively the same material might be used for all portions of the mesh grid, but the strand thickness might vary by location. For example, the strands spanning the nose bridge portion (typically near the center or middle of the nose clip) might be thicker, while those strands further towards the ends (for example, relating to the cheek portions) might be thinner. In such an embodiment, the thicker strands would tend to be stiffer (more shape-retaining, for example), and the thinner strands would tend to be softer (more easily deformed to conform to complex shapes, for example). In such an embodiment, the thicker strands might have a diameter of about 0.6mm, while the thinner strands might have a thickness of about 0.4 mm, for example. By mixing strands of different materials (and/or different thicknesses), it might be possible to customize the characteristics of the nose clip in a more refined manner, to provide a better fitting/sealing mask.

[0037] In creating a respirator mask (as shown in Fig. 2), a mask body 1 Omay be formed or provided. A nose clip 20 that is free-form deformable but having sufficient shape- retaining capabilities to form an effective seal with the user's face (as described above, for example) may either be formed or provided. If the nose clip comprises a mesh grid, the mesh grid may be formed using one or more of the following techniques: weaving strands to form a mesh grid; welding strands into a mesh grid; photo-chemically etching material to form the strands of the mesh grid; electroforming the mesh grid; or expanding material to form a mesh grid. The mesh grid nose clip 20 may then be attached to the mask body 10, typically so that the mesh grid spans the nose bridge portion 12 of the mask. In an embodiment, the nose clip 20 is attached to the outer surface of the mask (away from the user's face). This attachment may be performed using one or more of the following: adhering the mesh grid nose clip to the body of the mask using an adhesive; embedding the mesh grid nose clip in the body of the mask; sewing the mesh grid nose clip onto the body of the mask; or inserting the mesh grid nose clip into a slot in the body of the mask.

[0038] In other embodiments, the nose clip 20 might be a solid bar that has different characteristics along its length. For instance, the middle portion or section of the nose clip might be stiffer than the outer or wing portions of the nose clip (such that the middle section has better shape retaining capabilities, while the outer wing portions are more malleable and/or have better free-form deformability). FIGURE 4 illustrates another embodiment, showing a respirator mask body 10 with a solid nose clip 20 formed of two different materials. The nose clip 20 of Fig. 4 varies in material along its width, so that the material characteristics at any point along the width of the nose clip can better fit the specific issues raised by the user's facial topography or contours at each point. For example, the nose clip may be stiff in the middle of its width (to more effectively retain its shape across the bridge of the user's nose), but may be softer on its ends away from the middle (to allow for better shaping to conform to the complex three-dimensional shape of the user's nose). Again, in this embodiment the nose clip 20 typically spans the nose bridge portion 12 of the mask body.

[0039] FIGURE 5 illustrates an exemplary embodiment of the nose clip of Fig. 4. In the embodiment of Fig. 5, the nose clip 20 is generally linear, typically rectangular or bar-shaped, with a width that is greater than its height (it should be understood, however, that other shapes are possible and are intended to be included within this disclosure). In Fig. 5, the nose clip 20 is formed of different sections, with the middle portion or section 28 being stiffer (for example, having better shape retaining properties) and the outer wing portions 29 being softer (for example, being more malleable). In one embodiment, the nose clip 20 is formed of two different materials, with the middle section 28 of the nose clip being formed of a stiff er material (that is not as malleable or shapeable, but that will retain its deformed shape better), while the outer or wing portions 29 of the nose clip (at the far ends away from the middle portion 28 of the nose clip) are formed of a softer or more malleable material (and typically each of the wing sections would be formed of the same material). Alternatively, the same material might be used throughout the nose clip, but the stiffer middle (nose bridge portion, for example) section 28 might be thicker, while the softer wing portions might be thinner. In the embodiment of Fig. 5, the entire nose clip 20 may be formed of mild steel, with the nose bridge (middle) section 28 having a thickness of about 0.6 mm. for example, and the wing portion 29 having a thickness of about 0.4 mm, for example. In another embodiment, both the middle section 28 and the wing portions 29 of the nose clip of Fig. 5 might be made of the same material, but with different heat treatment. For example, the middle portion might be hardened by heat treatment so that it has better shape retaining capabilities and is less malleable than the wing portions 29 (which might be untreated, for example). By way of example, induction hardening heat treatment method might be used on aluminum or soft steel to get a different hardness/stiffness for the same material. In an alternative embodiment, both the middle portion.28 and the wing portions 29 might_^be'made of the same material (typ cally with the same heat treatment), but the middle portion 28 might be thicker and/or wider than the wing portions 29 (such that the middle portion would contain more material), so that it exhibits stiffer properties. In the embodiment of Fig. 5, the middle portion 28 (of stiff material) might be about half or less of the entire width of the nose clip 20, with the remaining amount of the width of the nose clip being divided between the wing portions 29 (of malleable or soft material). Thus, in the embodiment of Fig. 5, the two different materials may be formed into a single, unified nose clip. In some embodiments, more than two materials might be used, with the material properties of the nose clip possibly varying along the width of the nose clip in symmetrical mirror-image fashion about the center-line through the width of the nose clip. It should also be noted that embodiments might use a mesh grid that varies in material along the width of the nose clip in a fashion similar to that described above. Typically, the nose clip of Fig. 5 is sized similarly or slightly larger than existing nose clips. For example, the nose clip of Fig. 5 might have a width of about 90mm and a height of about 8mm.

[0040] In formation of the respirator mask of Fig. 4, a mask is formed or provided; a nose clip varying in material along its width (as described above, for example) is formed or provided; and the nose clip is attached to the mask (typically spanning the nose bridge portion of the mask body). The nose clip may be formed by dual injection molding in one embodiment. Other embodiments might use different formation techniques depending upon the material. For example, adhesive could be used to join the different material elements. And the nose clip could be attached to the mask in any number of ways (for example, adhered, embedded, sewn, or slotted).

[0041] In use, the respirator mask would typically be placed on the user's face, with the nose bridge portion over the bridge of the user's nose. The nose clip might then be manually manipulated, pressing the nose clip into conformance with the user's facial profile so that the ,

.4 mask fits snuggly over at least the user's nose. This might require bending or twisting of the nose clip, so that its free-from deformability allows a good match with the user's face. The nose clip should then retain its deformed shape sufficiently so that the mask fits snuggly even as it is worn over time (as the user performs activities, for example). The nose clip may have to be readjusted periodically, especially is the limited use mask is removed and then reused, to ensure a snug fit. Once the nose clip loses its ability to retain its shape (typically after several uses and re-shaping), the mask would typically be discarded and replaced. [0042] While various embodiments in accordance with the principles disclosed herein have been shown and described above, modifications thereof may be made by one skilled in the art without departing from the spirit and the teachings of the disclosure. The embodiments described herein are representative only and are not intended to be limiting. Many variations, combinations, and modifications are possible and are within the scope of the disclosure. Alternative embodiments that result from combining, integrating, and/or omitting features of the embodiment(s) are also within the scope of the disclosure. Accordingly, the scope of protection is not limited by the description set out above, but is defined by the claims which follow, that scope including all equivalents of the subject matter of the claims. Each and every claim is incorporated as further disclosure into the specification and the claims are embodiment(s) of the present invention(s). Furthermore, any advantages and features described above may relate to specific embodiments, but shall not limit the application of such issued claims to processes and structures accomplishing any or all of the above advantages or having any or all of the above features.

[0043] Additionally, the section headings used herein are provided for consistency with the suggestions under 37 C.F.R. 1 .77 or to otherwise provide organizational cues. These headings shall not limit or characterize the invention(s) set out in any claims that may issue from this disclosure. Specifically and by way of example, although the headings might refer to a "Field," the claims should not be limited by the language chosen under this heading to describe the so-called field. Further, a description of a technology in the "Background" is not to be construed as an admission that certain technology is prior art to any invention(s) in this disclosure. Neither is the "Summary" to be considered as a limiting characterization of the invention(s) set forth in issued claims. Furthermore, any reference in this disclosure to "invention" in the singular should not be used to argue that there is only a single point of novelty in this disclosure. Multiple inventions may be set forth according to the limitations of the multiple claims issuing from this disclosure, and such claims accordingly define the invention(s), and their equivalents, that are protected thereby. In all instances, the scope of the claims shall be considered on their own merits in light of this disclosure, but should not be constrained by the headings set forth herein.

[0044] Use of broader terms such as comprises, includes, and having should be understood to provide support for narrower terms such as consisting of, consisting essentially of, and comprised substantially of. Use of the term "optionally," "may," "might," "possibly," and the like with respect to any element of an embodiment means that the element is not required, or alternatively, the element is required, both alternatives being within the scope of the embodiment(s). Also, references to examples are merely provided for illustrative purposes, and are not intended to be exclusive.

Claims

CLAIMS What is claimed is:

1. A respirator mask comprising:

a mask body (10) comprising a nose bridge portion (12);

a nose clip (20) having a height dimension (24) and a width dimension (22) and attached to the mask body (10);

wherein the mask body (10) comprises a filtration element;

wherein the nose clip (20) spans the nose bridge portion (12) of the mask body; and wherein the nose clip (20) is free-form deformable.

2. The mask of claim 1 wherein the nose clip (20) comprises a high-density mesh grid.

3. The mask of claim 2 wherein the high density mesh grid comprises a plurality of strands (25) of a soft material with sufficient shape-retaining capabilities to form an effective seal.

4. The mask of claim 3 wherein each strand (25) has a thickness of about 0.5 mm and wherein the grid comprises a pattern of holes (27) having 4 or more holes along the nose clip height dimension (24) and 1 8 or more holes along the nose clip width dimension (22); and wherein the nose clip height dimension (24) is at least about 10mm and the nose clip width dimension (22) is at least about 60 mm.

5. The mask of claim 2 wherein the mesh grid is formed by one or more of the following: weaving strands to form a mesh grid; welding strands into a mesh grid; photo-chemically etching material to form the strands of the mesh grid; electroforming the mesh grid; or expanding material to form a mesh grid.

6. The mask of claim 2 wherein the mesh grid is attached to the mask body (10) by one or more of the following: adhering the mesh grid nose clip (20) to the body of the mask using an adhesive; embedding the mesh grid nose clip in the body of the mask; sewing the mesh grid nose clip onto the body of the mask; or inserting the mesh grid nose clip into a slot in the body of the mask.

7. The mask of claim 1 wherein the nose clip (20) comprises a solid bar having a middle portion (28) and two outer wing portions (29), and wherein the middle portion (28) of the bar has stiffer characteristics and the outer wing portions (29) of the bar have softer characteristics.

8. The mask of claim 7 wherein the nose clip (20) is formed of two different materials, wherein the middle portion (28) comprises a stiffer material and the outer wing portions (29) comprise a softer material, and wherein the stiffer material comprises hardened metal and the softer material comprises non-hardened metal.

9. A method of making a mask comprising:

providing or forming a high-density mesh grid nose clip (20);

providing or forming a mask body (10); and

attaching the nose clip (20) to the mask body (10).

10. The method of claim 9 wherein forming a high-density mesh grid comprises one or more of the following: weaving strands (25)to form a mesh grid; welding strands (25) into a mesh grid; photo-chemically etching material to form the strands (25) of the mesh grid; electroforming the mesh grid; or expanding material to form a mesh grid; and wherein attaching the nose clip (20) to the mask body (10) comprises one or more of the following: adhering the mesh grid nose clip (20) to the body of the mask using an adhesive;

embedding the mesh grid nose clip in the body of the mask; sewing the mesh grid nose clip onto the body of the mask; or inserting the mesh grid nose clip into a slot in the body of the mask.

1 1. The method of claim 9 wherein the high-density mesh grid comprises a plurality of strands (25) of a soft material with sufficient shape-retaining capabilities to form an effective seal; and

wherein the grid comprises a pattern of holes (27) having about 4 holes along the nose clip height dimension and about 18 or more holes along the nose clip width dimension; and wherein each strand is about 0.5 mm in thickness, and wherein the height dimension of the nose clip is about 10 mm and the width dimension of the nose clip is about 60 mm or more.

12. A respirator mask comprising:

a mask body (10) comprising a nose bridge portion (12);

wherein the mask body (10) comprises a filtration element and a perimeter operable to seal to a user's face to encompass the user's mouth and nose;

wherein the nose clip (20) spans the nose bridge portion (12) of the mask body; and wherein the nose clip (20) is free-form deformable;

wherein the nose clip (20) comprises a high-density mesh grid;

wherein the high density mesh grid comprises a plurality of strands (25) of a soft material and has sufficient shape-retaining capabilities to form an effective seal.

13. The mask of claim 12 wherein the strands (25) are malleable and dead soft.

14. The mask of claim 12 wherein each strand (25) has a thickness of about 0.5 mm and wherein the grid comprises a pattern of holes (27) having 4 holes along the nose clip height dimension (24) and at least 18 holes along the nose clip width dimension (22); and wherein the nose clip height dimension (24) is about 10mm and the nose clip width dimension (22) is about 60 mm.

15. The mask of claim 14 wherein the holes (27) are each about 2.5mm by about 3.3mm.