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Title:
AUTOMATICALLY ADJUSTABLE CUSHION OF RESPIRATORY MASK FOR BETTER FIT
Document Type and Number:
WIPO Patent Application WO/2013/056389
Kind Code:
A1
Abstract:
Disclosed embodiments may relate to a respirator mask (10) with an automatically adjustable cushion (20) about its periphery (18). In some embodiments, the cushion (20) is fluid-filled so that it conforms readily to the user's face. The conformability of the cushion (20) tends to allow the cushion (20) to fill in the gaps between the mask body (10) and the user's face, providing s snug fit for the specific facial contours of particular user and allowing the mask (10) to be used across a wide demographic of users.

Inventors:
XIONG JACK (CA)
JIN ZHAOXIA (CN)
ZHANG EDWIN YAJUN (CN)
ZHENG JIMMY (CN)
Application Number:
PCT/CN2011/001731
Publication Date:
April 25, 2013
Filing Date:
October 18, 2011
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
HONEYWELL INT INC (US)
XIONG JACK (CA)
JIN ZHAOXIA (CN)
ZHANG EDWIN YAJUN (CN)
ZHENG JIMMY (CN)
International Classes:
A61M16/06; A62B9/06; A62B18/02
Domestic Patent References:
WO2009143586A12009-12-03
WO2006099603A22006-09-21
Foreign References:
CN101378810A2009-03-04
CN101400409A2009-04-01
CN2712394Y2005-07-27
CN2605879Y2004-03-10
US7743768B22010-06-29
Attorney, Agent or Firm:
CHINA PATENT AGENT (H.K.) LTD. (Great Eagle Centre23 Harbour Road,Wanchai, Hong Kong, CN)
Download PDF:
Claims:
CLAIMS

What is claimed is:

1. A respirator mask comprising:

a mask body (10) having a periphery (18) operable to enclose a user's mouth and nose; a conformable cushion (20) attached to the mask body (10) about the periphery (18); and

one or more straps (15) operable to secure the mask body (10) to the user's face.

2. The mask of claim 1 wherein the cushion (20) is operable to conform to the user's facial contours based on the force applied by the one or more straps (15) in securing the mask body (10) to the user's face.

3. The mask of claim 1 wherein the cushion (20) is sufficiently conformable so that snug fit may be accomplished based on nothing more than the force provided by the one or more straps (15) securing the mask body (10) to the user's face.

4. The mask of claim 3 wherein the cushion (20) automatically adjusts to the user's facial contours.

5. The mask of claim 4 wherein the cushion (20) is filled with fluid.

6. The mask of claim 5 wherein the fluid consists of one of the following: air, gas, liquid, or gel.

7. The mask of claim 5 wherein the cushion (20) comprises a single, unified tube with approximately uniform conformability along its length, allowing fluid to flow to one or more portions of the cushion (20) that experience less pressure in use when the one or more straps (15) secure the mask body (10) in place on the user's face.

8. The mask of claim 1 wherein the cushion (20) comprises a single, unified tube that has conformability varying by location along its length.

9. The mask of claim 8 wherein portions of the cushion (20) are more conformable based on one or more of the following: larger diameter of the cushion portion, thinner material forming the tube of the cushion portion, and more elastic material forming the tube of the cushion portion.

10. The mask of claim 8 wherein the cushion (20) is more conformable for concave portions of user's face and less conformable for convex portions of the user's face.

1 1. The mask of claim 1 wherein the cushion (20) comprises a plurality of sealed segments (27) of varying conformability.

12. The mask of claim 1 1 wherein the amount of conformability for each segment (27) depends upon the portion of the user face that will be contacted.

13. The mask of claim 12 wherein the segment (27) associated with the nose bridge (22) is less conformable, and the segments (27) associated with the nose wings (23) are more conformable.

14. The mask of claim 1 1 wherein the plurality of cushion segments (27) are more

conformable based on one or more of the following: larger diameter cushion segment, higher inflation pressure, thinner material forming the cushion segment, and more elastic material forming the cushion segment.

15. A respirator mask comprising:

a mask body (10) having a periphery (18) operable to enclose a user's mouth and nose; a conformable cushion (20) attached to the mask body (10) about the periphery (18); and

one or more straps (15) operable to secure the mask body(10) to the user's face;

wherein the cushion (20) is fluid-filled;

wherein the cushion (20) automatically adjusts to the user's facial contours during usage based on the force applied to the mask body (10) by the straps (15);

wherein the cushion (20) comprises a single, unified tube that has conformability varying by location along its length;

wherein portions of the cushion (20) are more conformable based on one or more of the following: larger diameter of the cushion portion, thinner material forming the tube of the cushion portion, and more elastic material forming the tube of the cushion portion; and wherein the cushion (20) is more conformable for concave portions of the user's face and less conformable for convex portions of the user's face.

Description:
TITLE

Automatically Adjustable Cushion of Respiratory Mask for Better Fit

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] Embodiments relate generally to respirator masks, and more specifically to a cushion around the periphery of the body of a respirator mask in order to provide a snug fit.

BACKGROUND

[0005] Respiratory masks are often designed to enclose a portion of a user's face, for example, the user's mouth, the user's nose, or both. It may be difficult for a general purpose mask to properly fit a specific user, however, since there can be a wide range of facial anthropometrics (such as face size and facial contours) from one user to another (across the broad population/demographics of potential users). After all, fit depends on a good match between the facial anthropometrics and the respiratory mask dimensions (size and shape of the mask). Thus, Applicants have developed a cushion that fits onto the mask body (such that the cushion will typically lie between the periphery of the mask body and the user's face during usage of the mask) and that may assist in providing a snug fit. SUMMARY

[0006] Embodiments may include a respirator mask comprising: a mask body having a periphery operable to enclose a user's mouth and nose; a conformable cushion attached to the mask body about the periphery; and straps operable to secure the mask body to the user's face. In some embodiments, the cushion may be operable to conform to the user's facial topography/contours based on force applied by the straps in securing the mask to the user's face (i.e. sufficiently conformable so that a snug fit may be accomplished based on nothing more than the force provided by the straps (that is, no nose clip would be needed for a snug fit)). In some embodiments, the cushion may be sufficiently conformable to fill concave portions of user's facial contours. In some embodiments, the cushion may automatically adjust to the user's facial contours. In some embodiments, the cushion may be filled with fluid (and optionally the fluid may be air, other gas, liquid, or gel). In embodiments, the cushion may be formed of a material sufficiently elastic/pliable so that it distorts when less than about 5 bar of pressure/force is applied to it. In some embodiments, the cushion may be formed of rubber or nylon coated to be impermeable to fluid filling cushion. Embodiments may have a cushion diameter ranging from about 1mm to about 30 mm. In some embodiments, the cushion may be formed of elastic material having a thickness of about 0.3mm to about 0.8mm.

[0007] In some embodiments, the cushion may comprise a single, unified tube (ring-like) with approximately uniform conformability, allowing fluid to flow to the portion of the cushion that experiences less pressure in use (when the straps secure the mask in place on a user's face). Embodiments may have a cushion that is sufficiently conformable so that the cushion expands to seal any gaps between user's face and mask body when mask is secured to user's face. [0008] In some embodiments, the cushion may not have uniform conformabihty, but instead may have conformabihty variation for different portions of the cushion at different locations along the periphery of the mask. Embodiments may have a cushion comprising a single, unified tube that has conformabihty varying by location along its length. In some embodiments, portions of cushion may be more conformable based on one or more of the following: larger diameter of cushion portion, thinner material forming the tube of the cushion portion, and more elastic material forming the tube of the cushion portion. In some embodiments, the cushion may be more conformable for concave portions of user's face (the nose wing portion of cushion, for example) and less conformable for convex portions (the nose bridge and perhaps jaw-line, for example).

[0009] In some embodiments, the cushion may comprise a plurality of sealed segments, with each segment being contoured (having conformabihty) depending upon the part of user's face it will interact with. Embodiments may have a cushion that is segmented along its length so that the overall cushion is formed of a (linear) series of the individual cushion segments of varying contour (conformabihty). In some embodiments, the amount of contour/conformability for each segment depends upon the portion of the user face that will be contacted/sealed. Embodiments may have the segment(s) associated with the nose bridge be less conformable, the segments associated with the nose wings be more conformable, and perhaps the segments associated with the jaw-line be more conformable. In some embodiments, the cushion segment(s) may be more conformable based on one or more of the following: larger diameter cushion segment, higher inflation pressure, thinner material forming the tube of the cushion segment, and more elastic material forming the tube of the cushion segment. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] 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:

[0011] FIG. 1 shows a perspective view of an exemplary embodiment of a respirator mask having a fluid-filled cushion;

[0012] FIG. 2 shows a front view of the cushion of Fig. 1 ;

[0013] FIG. 3 shows a cross-section of the cushion of Fig. 2, illustrating that the cushion may comprise a hollow tube that may be filled with some fluid to provide inflation for the cushion;

[0014] FIGS. 4A and 4B show the manner in which the cushion of Fig. 2 may operate to expand to fill-in gaps during usage of the mask, with Fig. 4A showing an exemplary embodiment of a respirator mask with cushion before the straps apply force to the cushion to secure the mask in place, and Fig. 4B showing the exemplary embodiment of the mask in place on the user's face so that the straps secure the mask to the user's face and apply force to the cushion that acts to force fluid in the cushion to areas where there are gaps between the mask periphery and the user's face (and thereby less pressure on the cushion) so that the cushion can expand to fill the gaps and provide a snug fit;

[0015] FIG. 5 shows a perspective view of an exemplary embodiment of a respirator mask and a cushion for use along the periphery of the mask, in which the cushion has uniform conformability characteristics along its length/circumference;

[0016] FIGS. 6A and 6B show a perspective view of an exemplary embodiment of a respirator mask in which the cushion has different conformability characteristics for different portions, such that the portion of the cushion associated with the nose bridge portion of the mask may be less conformable (thinner in diameter or less inflated, for example) and the portion of the cushion associated with the nose wing portion of the mask may be more conformable (thicker in diameter or more inflated, for example); Fig. 6A shows the cushion before it is applied to the user's face, while Fig. 6B shows how the cushion might respond when the straps apply force to secure the mask to the user's face; and

[0017] FIGS. 7 A and 7B show a perspective view of an exemplary embodiment of a respirator mask and a cushion for use around the periphery of the mask in which the cushion is comprised of contoured segments that may vary in conformability, with Fig. 7A showing the cushion before it is applied to the user's face, and Fig. 7B showing how the cushion might respond when the straps apply force to secure the mask to the user's face.

DETAILED DESCRIPTION

[0018] The following brief definition of terms shall apply throughout the application:

[0019] 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;

[0020] The term "comprising" means including but not limited to, and should be interpreted in the manner it is typically used in the patent context;

[0021] 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);

[0022] If the specification describes something as "exemplary" or an "example," it should be understood that refers to a non-exclusive example; [0023] 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

[0024] 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.

[0025] Disclosed embodiments may relate to a respirator mask with a cushion located around its periphery. The mask body may enclose the user's mouth, nose, or both, and the mask body is typically designed to filter incoming air. The material of the mask body itself might perform this filtering function, or if the mask is impermeable, a filtering valve (possibly a two-way valve that filters inhalation air and allows exhalation air to be expelled, for example) might be used. In some embodiments, a one-way exhalation valve might be used even when the mask body provides filtration of incoming inhalation air, in order to improve exhalation. The cushion typically operates to improve the seal between the user's face and the mask body (periphery), providing a snug fit. In embodiments where the cushion alone provides a snug fit (when the mask is secured to the user's face by straps, for example), the mask may not include a nose clip (since a nose clip would be unnecessary to provide a snug fit). In other embodiments, however, the mask might include both a nose clip and a cushion, in order to provide a better fit. In some embodiments, the cushion may be an automatically adjustable cushion that automatically conforms to the user's facial contours (topography/anthropometries, for example). In some embodiments, the cushion is fluid-filled so that it conforms readily to the user's face. The conformability of the cushion tends to allow the cushion to fill in the gaps between the mask body and the user's face (during usage of the mask), providing a snug fit for the specific facial contours of a particular user and allowing the mask to be used across a wide demographic of users. In some embodiments, the conformability of the mask may be uniform, and the pressure applied when the straps secure the mask to the user's face may allow fluid in the cushion to flow towards areas where there might be gaps between the mask and the face (since these gaps would be areas where less pressure/force would be applied to the cushion), expanding in those areas to fill the gaps. In other embodiments, the conformability of the cushion might vary based on location, with portions of the cushion that are likely to encounter gaps (for example, concave portions of the user's face) during usage tending to be more conformable, and portions of the cushion that are likely to encounter projecting portions of the user's face during usage tending to be less conformable. In some embodiments, the cushion may be a single, unified (hollow) tube (typically joined in a ring-like manner to encircle the periphery of the mask body). In other embodiments, the cushion might comprise a linear series of individual segments, with each sealed segment acting as an individual cushion for a portion of the periphery of the mask (such that all the segments together might provide cushioning around the entire periphery of the mask).

[0026] The human face has a complex topography. For example, the human face may include projecting (or convex) portions such as the nose bridge and possibly the jaw line. The human face may also include concave portions, such as the transition from the nose wings to the cheek area (and possibly portions of the cheek as well). The nose region of the face in particular presents complex three-dimensional geometry, with the transition from nose wing to cheek being particularly difficult to effectively seal. Given the complex three- dimensional nature of each human face, along with the broad variance in facial contours across the entire population of users (i.e. the demographic variance), it can be difficult to provide an effective seal for a respiratory mask. Embodiments attempt to use a cushion (typically fluid-filled) with sufficient conformability to allow for a snug fit between the mask body and the user's face. Embodiments may be automatically adjusting, with the cushion conforming to fit the user's facial contours for a snug fit (typically based entirely on the force/pressure exerted by the straps securing the mask in place on the user's face).

[0027] FIGURE 1 illustrates an embodiment of a respirator mask, having a mask body 10 (or face piece) that filters inhalation air during breathing and encompasses the user's nose and mouth, a cushion 20 located around the periphery of the mask body 10 (so that the cushion encircles the periphery), and one or more straps 15 for securing the mask body 10 to a user's face. In some embodiments, the mask body 10 also includes an exhalation valve 11. The mask body 10 in some embodiments may be flexible (non-rigid), allowing the mask body 10 to better conform to the user's facial contours. For example, in the embodiment of Fig. 1, the mask body 10 might be made of filtering fabric (as used in dust mask and/or surgical masks, for example). The cushion 20 of Fig. 1 is fluid-filled, making it conformable. In some embodiments the fluid might be air or some other gas. In some embodiments, the fluid might be a liquid, preferably a liquid that is safe if it makes contact with human skin and/or if it is ingested by a human being. In some embodiments, the fluid might be a gel (for example, a fairly viscous fluid). In some embodiments, the entire cushion is filled with a single fluid, while in other embodiments, different sections of the cushion might be filled with different fluids (depending for example, on the conformability requirements for each section of the cushion). The cushion 20 of Fig. 1 is attached to the periphery of the mask body 10, so that when the respirator mask is used (secured to the face of a user by the straps 15, for example), the cushion 20 can help provide a snug fit. In the embodiment of Fig. 1, the cushion 20 may be attached to the mask body 10 by one or more of several possible attachment means, for example ultra-sound welding, adhesive, insert molding, and/or hook and loop material (such as Velcro.TM). [0028] FIGURE 2 illustrates an embodiment of the cushion of Fig. 1. The cushion 20 of Fig. 2 is a tube that forms a closed, ring-like shape that approximates the periphery of the mask body 10. FIGURE 3 shows a cross-section of the cushion 20 of Fig. 2 taken as shown. As Fig. 3 shows, the cushion 20 is a hollow tube or shell of flexible material. Typically, fluid fills the interior of the cushion 20, inflating the cushion 20 to provide conformability and/or cushioning. The cushion 20 may have a diameter that ranges from about 1mm to about 30 mm. For example, a cushion for a disposable mask might have a diameter of about lmm- 5mm, while a reusable mask might have a larger cushion, with a diameter up to about 30mm for example. The cushion might be formed of rubber, polypropylene, PVC, or nylon, for example, and the thickness of the material forming the cushion might range from about 0.3- 0.8 mm. The cushion 20 of Fig. 2 may be made of elastic material, such as rubber or nylon fabric by way of example. In embodiments, the material of the cushion is sufficiently pliable (for example, flexible and/or elastic) that it may distort or deform (for example, bulging) when pressure is applied to it (typically by the straps when the mask is secured to the user's face). Typically, the straps apply a positive pressure to secure the mask in place and provide an effective cushion seal, with the straps typically applying less than about 5 bar of pressure (to comfortably hold the mask in place on the user's face). One or more of the surface of the cushion 20 may also be coated with a coating material. For example, if nylon fabric or other non-air-tight material is used for the cushion, the inner surface of the cushion 20 might be coated with a sealant (such as rubber, for example) to seal the cushion and render the cushion air-tight (or tight against seepage or leakage of the specific fluid used to fill the cushion). In other words, if the material of the cushion 20 is not sufficiently impermeable, then a coating of sufficiently impermeable material might be applied to one or more surfaces of the cushion 20. In the embodiment of Fig. 1 , the cushion 20 might be inflated with fluid to a pressure to about 1 bar or more, typically in the range of about 1-5 bar (prior to applying the mask to the user's face). FIGURES 4A and 4B illustrate how the cushion 20 might bulge in some areas to fill gaps between the mask body 10 and the user's face during usage of the mask. Fig. 4A shows the mask before it is applied to the user's face, illustrating that the cushion 20 is in an un-deformed state. Fig. 4B shows that the cushion 20 might deform when the mask is secured to the user's face (by straps 15, for example), bulging out in some areas to fill gaps between the user's face and the mask body 10. In other words, Fig. 4B illustrates how the conformability of the cushion may act to provide a snug fit when the mask is applied to the user's face during usage. In Fig. 4B, the cushion is bulging to conform to the nose wing portion of the user's face, for example.

[0029] FIGURE 5 illustrates an embodiment of a respirator mask with a cushion (shown separately, although in use the cushion would typically be applied to the periphery of the mask body). The mask body 10 has a periphery 18 designed to enclose a user's mouth and nose. The mask of Fig. 5 also has a valve 12 (which may be an exhalation valve), and one or more straps 15 operable to secure the mask body 10 to a user's face (and to provide sufficient force or pressure to form an effective seal). The cushion 20 is operable to be attached to the periphery 18 of the mask body (such that in usage, the cushion 20 would lie between the user's face and the periphery 18 of the mask body to form a snug fit). In the embodiment of Fig. 5, the cushion 20 is formed of a single, unified tube that has uniform conformability characteristics throughout (along its length/circumference). For example, the cushion 20 of Fig. 5 might have uniform (cross-sectional) diameter, uniform material or elasticity, uniform thickness of material (in the walls of the cushion tube), and/or uniform inflation (for example, fluid pressure within the cushion tube). This configuration allows the fluid in the cushion 20 to flow freely throughout the cushion 20 in response to force/pressure acting on the cushion. And the cushion 20 is formed of a material that is sufficiently pliable (flexible/elastic, for example) so that it can deform under pressure to bulge out sufficiently to close any gaps between the user's face and the mask body 10 (such that the cushion 20 is sufficiently conformable to provide a snug fit between the mask body 10 and the user's face, despite the mask body 10 not being customized to a specific user's facial contours (but being a generalized mask designed to fit a wide range of faces)). In usage, the mask body 10 would be secured to the user's face by the straps 15. The straps 15 would thereby apply force/pressure onto the mask body and/or the cushion. The amount of force or pressure exerted by the straps 1 on the cushion 20 would vary by location, primarily based on the user's facial contours, with portions of the cushion contacting projecting (convex, for example) portions of the user's face experiencing more force/pressure and portions of the cushion located in the gaps between the user's face and the mask (typically in the convex regions of the user's face) experiencing less force/pressure. The high force/pressure regions of the cushion 20 would be compressed, forcing fluid flow from those regions into the low force/pressure regions of the cushion 20, thereby swelling or bulging those portions to fill the gaps between the user's face and the mask body to provide a snugger fit. In this manner, the cushion 20 of Fig. 1 might provide an automatically adjusting cushion seal, operable to optimize fit.

[0030] FIGURES 6A and 6B illustrate an alternative exemplary embodiment of a respiratory mask. In this variant, the cushion 20 forms a single, unified (fluid-filled) tube about the periphery of the mask body 10, allowing fluid flow throughout the cushion (i.e. throughout its length/circumference). But the cushion 20 of the embodiment of Fig. 6A may have varying conformability characteristics along its length (depending, for example, on the facial contours associated with a generalized user face profile). For example, in some embodiments the more conformable portions of the cushion might correspond to the cheekbone, nose bridge, and/or menton portions of the mask (or user's face), while the less conformable portions might correspond to the side face portion of the mask (or user's face). In some embodiments, the cushion 20 might be pre-contoured, so that its shape might initially be geared towards filling in concave areas where gaps are likely to occur. And the pre- contoured cushion might also vary in conformability, so that in usage the fluid flow will further bulge or deform portions related to concave areas of the user's face. For example, the cushion 20 may be less conformable for portions of the cushion that are expected to contact projecting portions of the user's face, and portions of the cushion 20 may be more conformable for portions of the cushion expected to fill gaps between the user's face and the mask body 10 (for example, portions associated with concave portions of the user's face). The cushion 20 (or portion thereof) may be made more conformable using one or more of the following techniques, by way of example: larger diameter of the cushion, thinner material forming the cushion, and/or more elastic or pliable material used for the cushion. Similarly, the cushion 20 (or portion thereof) may be made less conformable using one or more of the following techniques, for example: smaller diameter of the cushion (perhaps based on the amount of coating applied to the portion of the cushion, for example), thicker material forming the cushion, and/or less elastic or pliable material used for the cushion. In Fig. 6A, for example, the cushion 20 is designed to be more conformable for the portions located along the nose wing portion 23 of the mask body (i.e. the portion that is expected to contact the nose wing of the user during usage), and less conformable for the portions located along the nose bridge portion 22 of the mask body. In some embodiments, the portion of the cushion located along the jaw-line portion 25 of the mask body might have intermediate to low conformability. And in some embodiments, the portions of the cushion located along the cheek portion 24 of the mask body might have an intermediate to high conformability. Fig. 6A illustrates the initial shape or deformation of the cushion 20 (due to the different conformability characteristics at different portions or locations along the mask body), while Fig. 6B illustrates the manner in which the cushion 20 might further deform when the mask is secured to the user's face (typically by straps) to provide a snugger fit (by filling in gaps between the user's face and the mask body, for example at the concave nose wing portions). As Fig. 6B shows, when the straps 15 exert force/pressure on the cushion 20, the fluid in the cushion flows away from high force/pressure portions (such as the nose bridge portion, for example) and towards low force/pressure portions (such as the nose wing portions, for example). In this way, the cushion 20 may automatically adapt itself to provide a snugger fit for a specific user, based on the user's own facial contours.

[0031] FIGURES 7A and 7B illustrate another embodiment of a respirator mask. The mask of Figs. 7A and 7B has a mask body 10 and a cushion 20 attached to the periphery 18 of the mask body. The cushion 20 of Fig. 7A comprises a series of fluid-filled segments 27 connected in series around the periphery of the mask body. Each segment 27 is a sealed, fluid-filled hollow tube (typically of flexible material), and the segments 27 are connected end to end to form the ring-like shape of the entire cushion 20 about the periphery 18 of the mask body. This approach does not allow fluid flow between segments 27 of the cushion 20 (i.e. fluid from one segment will not move or flow into another segment), but the segments 27 may still influence one another somewhat by exerting force/pressure laterally (for example, the fluid in high pressure segments might push on the sidewall and thereby exert some pressure on the fluid within neighboring low pressure segments, which might cause the low pressure segments to deform or bulge to fill gaps between the user's face and the mask body. Each segment 27 of the cushion 20 may have its own conformability characteristic, depending for example on its location and the portion of the mask/user's face that each segment is associated with. The conformability may be adjusted using one or more of the following techniques, for example: altering the diameter of the segment, altering the amount of fluid inflating the segment, altering the thickness of the material forming the cushion segment, and/or altering the elasticity or pliability of the material forming the cushion segment. Thus, a segment may be made more conformable using one or more of the following techniques, by way of example: larger diameter and/or volume of the segment, increasing the fluid (pressure) inflating the segment, using thinner material to form the segment, and/or using more elastic or pliable material for the segment. Similarly, the segment may be made less conformable using one or more of the following techniques, for example: smaller diameter and/or volume of the segment (perhaps based on the amount of coating applied to the portion of the segment, for example), decreasing the amount of fluid (pressure) inflating the segment, thicker material forming the segment, and/or less elastic or pliable material used for the segment. So by way of example, embodiments of the cushion segments might have a diameter ranging from about 3-10 mm, a fluid pressure ranging from about 1.1-5 bar, cushion material thickness ranging from about 0.3-0.8 mm, and/or use material with elasticity ranging from about 0.5-5 kilogram force. In Fig. 7 A, for example, the cushion 20 is designed to be more conformable for the segment(s) located along the nose wing portion 23 of the mask body (i.e. the segment(s) that is expected to contact the nose wing of the user during usage), and less conformable for the segment(s) located along the nose bridge portion(s) 22 of the mask body. Fig. 7 A illustrates the initial (pre-contoured) shape or deformation of the cushion 20 (due to the different conformability characteristics at different section locations along the mask body, for example), while Fig. 7B illustrates the manner in which the cushion 20 might further deform when the mask is secured to the user's face (typically by straps) to provide a snugger fit (by filling in gaps between the user's face and the mask body, for example at the concave nose wing portions).

[0032] In some embodiments, rather than pre-fill the cushion with air or some other gas during the manufacturing process, the cushion might instead be filled with chemical materials that can be triggered to react, converting the chemical materials into gas for inflating the cushion. Typically, the chemical materials might be in liquid form prior to being triggered. The chemical reaction might be triggered by compressing, mixing, or shaking the materials, by way of example. In an embodiment for example, one or more of the chemicals might initially be held within a rupturable sack, and the sack might be ruptured by squeezing that section of the cushion to trigger the reaction. In some embodiments, different sections of the cushion might be inflated separately (or left un-reacted and deflated), providing a way to further adapt the cushion to the user's specific facial contours (since the user might trigger only the appropriate sections if further inflation is needed for those sections to form a snug

[0033] In formation, the respirator mask of Fig. 1 might be formed by attaching a cushion 20 to the periphery 18 of the mask body 10. One or more straps 15 might also be attached to either the mask body or the cushion. Mask body 10 might be provided or formed, and the mask body 10 would typically be cup-shaped and designed with a periphery that might enclose a user's mouth and nose. The mask body 10 might be formed of filtering material, or it might be formed of impermeable material but have a filtering valve installed. Alternatively, the mask body might be made of filtering material but also have an exhalation valve installed. In forming the cushion 20, the conformability characteristics of the cushion as a whole or the portions or segments of the cushion might be selected (based for example, on the location of the portion or segment on the mask and/or the area of the user's face expected to be contacted by the segment or portion). The cushion would then be formed with the conformability characteristics selected (which might vary by portion or segment in some embodiments). Formation of the cushion might include one or more of the following: formation of the tube, sealing the surface of the tube (by applying a coating, for example), filling the tube with fluid to a desired or selected pressure, and closing the tube to form the fluid-filled cushion. In some embodiments, formation of the cushion might also or alternatively include forming a plurality of segments of varying conformability, filling each segment with fluid, closing or sealing each segment, and/or joining the plurality of segments into a unified cushion. Once the cushion is formed or provided, it may be attached to the periphery of the mask body. In some embodiments, the attachment means may be permanent, but in other embodiments, the attachment means might be removable (so that the cushion could be attached to a new disposable (or limited-use) respirator mask body when the user changes masks). For example, the cushion might be attached to the mask body by one or more of the following: ultra-sound welding, adhesive, and/or Velcro.TM.

[0034] In usage, the mask body 10 of Fig. 1 , for example, might be fitted onto the user's face to encompass the mouth, nose, or both. Most typically, embodiments encompass both the mouth and nose of the user. The straps 16 may be used to secure the mask body 10 to the user's face. In doing so, the cushion 20 conforms automatically to the specific facial contours of the particular user, deforming (bulging for example) to fill gaps between the periphery of the mask body 10 and the user's face. This provides a snug fit for the respirator mask. In some embodiments, the user might also adjust a nose clip (typically spanning the nose bridge portion of the mask body) on the mask body (for example, a deformable strip of material that is shapeable by hand but which also retains its deformed shape sufficiently to conform to the user's face during usage), but in many embodiments the cushion 20 provides sufficient conformability on its own to provide a snug fit without the need for a nose clip. The pressure exerted on the cushion 20 by the straps 15 during usage may act to automatically shape the cushion 20 (based on conformability) to fit the particular user's specific facial contours. In this way, embodiments may provide improved fit for respiratory masks, and simplify usage (by eliminating the need to manually adjust the mask body, using a nose clip for example). Persons of skill will understand these and other uses of the embodiments. [0035] 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.

[0036] 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.

[0037] 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.