Patent Grant
8381727
The present invention relates to a face mask, particularly to a face mask having a seal about its periphery, and specifically to a face mask with an outer seal and an inner seal and an optional bridging seal connecting the outer and inner seals.
Golf courses undulate. That is, even relatively easy and relatively flat golf courses have ups and downs, peaks and valleys, sand dunes, raised tee off areas, and raised greens. Further, even if a fairway happens to be like a pancake, the fairway may dogleg to the left or dogleg to the right to provide an undulation from another perspective.
Each and every golf course is a unique piece of property. The unique features of a golf course are many. A few of these unique features are natural features found prior to development such as lakes, ponds and streams. Other unique features are manmade: the layout, the total yardage, the width of the fairways, and the size of the greens.
Faces, like golf courses, are unique and undulating. The application to a face of a face mask having a single seal is like a game of golf with no Mulligans, but infinitely more serious.
A feature of the present invention is the provision in a face mask having a covering for the nostrils and mouth, with the covering having a periphery, with the covering having an inside confronting the face, and with the covering having an exterior opposing the inside and facing away from the face, of a first endless skin adhesive seal on the inside of the covering, and of a second endless skin adhesive seal on the inside of the covering, with the second endless skin adhesive seal spaced from the first endless skin adhesive seal, and with the second endless skin adhesive seal confronting the first endless adhesive seal.
Another feature of the present invention is the provision in such a face mask, of at least one of said first and second endless skin adhesive seals comprising a bead, with the bead having an at least partially generally curved form such that the bead digs into the face.
Another feature of the present invention is the provision in such a face mask, of at least one of said first and second endless skin adhesive seals comprising a bead, with the bead having a cross-section, with the cross-section having a circumference, with a portion of the circumference engaging the inside of the covering, with another portion of the circumference extending obliquely relative to the portion of the circumference engaging the inside of the covering such that the bead digs into the face.
Another feature of the present invention is the provision in such a face mask, of a connection between the first and second endless skin adhesive seals, with the connection being formed of the same material of the first and second endless skin adhesive seals.
Another feature of the present invention is the provision in such a face mask, of a connection between the first and second endless skin adhesive seals, with the connection being integral and one-piece with at least one of the first and second endless skin adhesive seals.
Another feature of the present invention is the provision in such a face mask, of a third endless skin adhesive seal on the inside of the covering, with the third endless skin adhesive seal spaced from the second endless skin adhesive seal, with the third endless skin adhesive seal confronting the second endless skin adhesive seal, and with the second endless skin adhesive seal being between the first and third endless skin adhesive seals.
Another feature of the present invention is the provision in such a face mask, of a fourth endless skin adhesive seal on the inside of the covering, with the fourth endless skin adhesive seal spaced from the third endless skin adhesive seal, with the fourth endless skin adhesive seal confronting the third endless skin adhesive seal, and with the third endless skin adhesive seal being between the second and fourth endless skin adhesive seals.
Another feature of the present invention is the provision in such a face mask, of the first endless adhesive seal confronting the periphery of the covering.
Another feature of the present invention is the provision in such a face mask, of the face mask being disposed in generally a plane prior to the face mask being applied to the face.
Another feature of the present invention is the provision in such a face mask, of the multiple seal being disposed in a plane prior to application to the face mask.
Another feature of the present invention is the provision in a ready to apply seal apparatus having a front sheet of release paper and a rear sheet of release paper, of a first endless skin adhesive seal sandwiched between the front and rear sheets of release paper, and a second endless skin adhesive seal sandwiched between the front and rear sheets of release paper, with the second endless skin adhesive seal spaced from the first endless skin adhesive seal, with the second endless skin adhesive seal confronting the first endless adhesive seal, and with the second endless skin adhesive seal being disposed inwardly of the first endless adhesive seal.
Another feature of the present invention is the provision in such a ready to apply seal apparatus, of the combination of the apparatus with a face mask, with the face mask comprising a covering for the nostrils and mouth, with the covering having a periphery, with the covering having an inside confronting the face, and with the covering having an exterior opposing the inside and facing away from the face, with the first and second endless skin adhesive seals to be applied to the inside of the covering where the first endless skin adhesive seal confronts the periphery of the covering.
Another feature of the present invention is the provision in a face mask or respirator, of a multiple seal arrangement disposed between the face mask and the skin of the face, where at least two of the seals are endless seals and where these at least two endless seals are independent of each other, like the independent suspension of an automobile, where the chances are minimized that a force applied to one of the endless seals is transferred or translated to the other seal, such that each of the endless seals works independently of the other endless seal.
Another feature of the present invention is the provision in a face mask or respirator, of a seal having a pair of endless protrusions extending from an adhesive endless base or strip, where the base or connection between the endless protrusions is engaged to the face mask and where the endless protrusions engage the skin of the face.
An advantage of the present invention is that the present face mask is greatly more effective than a face mask having a single seal.
Another advantage of the present invention is that the present face mask may fit, with great effectiveness, the face of an adult or the face of a child.
Another advantage of the present invention is that the present face mask is greatly more effective than a face mask having a single relatively wide seal.
Another advantage of the present invention is that the present face mask is inexpensive to manufacture.
A harness or a pair of rubber or elastomeric bands 22 engages a peripheral portion of the mask 10. One band 22 engages and draws to the face 12 an upper portion of the mask 10. The other band 22 engages and draws to the face 12 a lower portion of the mask 10. Each of the ends of the bands 22 is engaged to the mask 10 via a staple 24 that extends from the exterior 20 to the inside 18.
Mask 10 further includes a bridge strip 26 of bendable material, preferably metal, that engages the outside 20 of the mask 10. Bendable material is little, if at all, resilient. Once bent, material of the bridge strip 26 stays bent. The qualities of the material of bridge strip 26 for a springing back or rebounding to the shape it had prior to being bent are minimized. Bridge strip 26 is malleable. The qualities of the material of bridge strip 26 for retaining its shape after being bent are maximized. Bridge strip 26 is pliable. When bridge strip 26 is bent over the nose, bridge strip 26 stays in such uniquely bent shape. As shown in
The periphery 16 of the covering 14 completely surrounds the nostrils and mouth. The periphery 14 is structured to extend from a first position on the bridge of the nose above the nostrils to the right side of the nose, from said right side of the nose to a position on the front of the face beyond the right side of the mouth, from said position beyond the right side of the mouth to one of a first position on the chin and a second position under the chin, from one of said first and second positions to a position on the front of the face beyond the left side of the mouth, from said position beyond the left side of the mouth to the left side of the nose, from said left side of the nose back to said first position on the bridge of the nose such that the nostrils and mouth are completely surrounded.
As shown in
As shown in
As shown in
As shown in
As shown in
As shown in
Covering or filter 14 and covering or filter 14A are structured to permit air into and out of the coverings 14 and 14A. Coverings 14 and 14A are structured to minimize a flow of substances into and out of the coverings 14 and 14A.
As shown in
It should be noted that the set of seals chosen for apparatus 54 may have connections 38 that are contained between the outer and inner seals. In other words, each of the sealing configurations shown in
As to a process for making the seal configurations of the present invention, the endless seals 30, 32, 40 and 42 and the connections 38 may be formed from a pressure sensitive hot melt adhesive and applied in a manufacturing facility. The adhesive may be applied in a fluid viscous form from an apparatus such as a tube or hot glue gun. Then the adhesive is permitted to cool and set to a rubber or rubber like state. Then the release paper or liner 44 is applied over the pressure sensitive hot melt adhesive. Then the face mask 10 is packaged for sale.
The skin adhesive seals may be skin friendly adhesive seals or skin unfriendly adhesive seals. As to skin friendly and skin unfriendly adhesive seals and other seals and adhesives, the Matich U.S. Pat. No. 7,017,577 B2 is hereby incorporated by reference in its entirety.
The adhesive or seal or bead used herein, such as the double, triple, or quadruple seal arrangement or configuration with or without bridges used herein, may include a styrene-olefin-styrene block copolymer.
One adhesive for the multiple seal arrangement of the present invention that may be used is the pressure sensitive hot melt adhesive HM-650 available from The Glue Factory, An Ellsworth Adhesives Company, of Appleton, Wis. Such adhesive may be used for the double seal with or without bridges, the triple seal with or without bridges and the quadruple seal with or without bridges.
As to the adhesive for the double, triple, or quadruple seal arrangements with or without bridges used herein, the following U.S. patents are incorporated by reference in their entireties: 1) the Fujisawa et al. U.S. Pat. No. 6,262,330 issued Jul. 17, 2001, 2) the Kitazaki et al. U.S. Pat. No. 6,297,421 issued Oct. 2, 2001, 3) the Takahashi et al. U.S. Pat. No. 6,323,275 issued Nov. 27, 2001, 4) the Hechenberger et al. U.S. Pat. No. 4,997,861 issued Mar. 5, 1991, 5) the Hickey et al. U.S. Pat. No. 6,310,166 issued Oct. 30, 2001, 6) the Satterfield U.S. Pat. No. 6,179,804 issued Jan. 30, 2001, 7) the Poulsen et al. U.S. Pat. No. 4,367,732 issued Jan. 11, 1983, and 8) the Matich U.S. Pat. No. 7,017,577 B2.
As shown in
Connections or bridges 18 have the advantage of making the seal configurations easier to separate from the release paper 44.
The seal configurations, i.e., one or more of the endless seals 30, 32, 40, 42 and connections 38, may be applied in a hot or cold form to the mask 10 itself and in a hot or cold form to apparatus 54.
The seal configurations provide a uniform fit. That is, a seal configuration with at least one inner seal maximizes the chances that such a seal configuration will fit each of an adult and child's face because, with the multiple seal arrangement, the innermost endless seal or bead has a first relatively small diameter, the subsequent endless seal or bead has a second diameter greater than the first diameter, the subsequent endless seal or bead has a third diameter greater than the second diameter, and the subsequent endless seal or bead has a fourth diameter greater than the third diameter.
The provision of at least one inner seal 32 provides a tortuous path for entry of toxic substances. That is, a toxic substance must confront and find its way through the outer seal 30 and then, if successful, wind its way about the space between the outer and inner seal until it finds an opening in an inner seal 32. The provision of a connection or bridge 38 even further guards against the entry of a toxic substance by blocking such a tortuous path that the toxic substance must take.
The provision of an inner seal 32 provides protection for a maximum number of unique undulating faces. One portion of the outer seal 30 may not perfectly fit a portion of a face. One portion of the inner seal 32 may not perfectly fit a portion of a face. However, in combination, especially with bridges 38, a tortuous path to a maximum degree is provided.
Seals 30, 32, 40 and 42 may not run parallel to each other. In fact, it may be beneficial to provide nonparallel seals 30, 32, 40 and 42.
A face mask or respirator, such as face mask 10, includes a periphery, such as periphery 16, where the face mask filter or covering, such as filter or covering 20 terminates, and where the skin is exposed. The outermost seal of the multiple seal arrangement here, such as the double seal with or without bridges, such as the triple seal with or without bridges, such as the quadruple seal with or without bridges, is preferably placed as close to the absolute periphery as possible without going beyond the periphery. Peripheries of face mask often include flat areas and the beads of adhesive may be placed upon such flat areas.
The peripheral portion of a face mask or respirator may be described as the part of the filter or covering that runs from an absolute periphery to an inner portion spaced from the absolute periphery. This peripheral portion may have elevation differences, or structural differences, or uneven or undulating surfaces, or material or composition differences. These differences may be found as one runs his or her finger endlessly around the peripheral portion. These differences may be found as one runs his or finger radially or in a direction transverse to the endless direction. A multiple seal arrangement of the present invention, where at least two endless beads are independent of each other, or where at least two endless beads are independent of each other except for a few bridges or connections interconnecting the endless beads, maximizes the chances of at least one of the endless beads making a 360 degree connection with the skin of the face. The provision of bridges or connections close off areas where one of the endless seals has not made a 360 degree connection with the skin of the face. Also, it should be noted that the undulating, or the other differences pointed out above, of the peripheral portion of the face mask is compounded by the unique face of an individual, even if the face mask manufacturer has shaped its mask for the shape of a face.
Where connections or bridges 18 are utilized, there may number anywhere from one to about six bridges. There are competing considerations. On the one hand, it may be beneficial to block, one or more times, the tortuous path referred to above. On the other hand, it may be beneficial to keep as much of the seal configuration digging into the skin of the face 12 as possible and, where a great number of connections 38 are present, the amount of digging by distinct beads is reduced.
The location of the bridges 38 are preferably at about the three o'clock, six o'clock and nine o'clock positions. The bridges 38 can be placed equidistant apart if desired. The bridges 38 are preferably placed about the lower half of the mask 10 since this portion of the mask 10 encounters a relatively great amount of movement or flexing because of the opening and closing of the mouth of the user.
As shown in
As shown in
A PortaCount® Plus mode 8020 Respirator Fit Tester is a machine manufactured by TSI Inc. of Shoreview, Minn. This PortaCount® tester quantitatively measures whether a respirator is donned properly. This PortaCount® tester performs a quantitative respirator fit test.
A PortaCount® Plus mode 8020 Respirator Fit Tester and N95-Companion brochure available from TSI Inc. of Shoreview, Minn., provides in part the following:
Specifications
PORTACOUNT Plus Model 8020 Respirator Fit Tester
Fit Factor Range: 1 to greater than 10,000
Concentration Range: 0.01 to 5×105 particles/cm3
Particle Size Range: 0.02 to greater than 1 micrometer
Typical Fit Factor Accuracy: ±10% of reading
Specifications
Model 8095 N95-Companion Accessory
Fit Factor Range: 1 to 200
Concentration Range: 0.01 to 5×105 particles/cm3
Test Particle Size: 0.04 micrometer (nominal)
Typical Fit Factor Accuracy: ±10% of reading
Using the PORTACOUNT Plus Model 8020 Respirator Fit Tester, applicant utilized the following method for testing a double bead adhesive seal having no bridges, where the double bead adhesive seal had essentially the structure of the beads 30 and 32 of
The respirator used was a 3M 1860 N95 filtering facepiece respirator which is available in two sizes; small and regular. That respirator was selected because it has a very typical design with a pliable metal nose band that must be manually formed by the wearer to conform to the shape of the face and nose bridge. The fit test operator selected the size respirator that was likely to fit each test subject based on visual evaluation of face size and shape. The identical size respirator (with and without adhesive) was used for each pair of fit tests.
The adhesive used for the double bead (independent beads, spaced from each other) was the pressure sensitive hot melt adhesive HM-650 available from The Glue Factory, An Ellsworth Adhesives Company, of Appleton, Wis.
The double bead (independent beads) of adhesive was applied from by a hot melt adhesive hand gun applicator, where the adhesive exits the hand gun applicator as a liquid and then cools to a rubber or rubbery like state. An automated process may be used to apply the adhesive to existing respirators. The adhesive application may or may not be an “after market” adhesive that may be easily applied by respirator users.
The adhesive is a clear non-toxic material with very high adhesion to human skin. The adhesive remains tacky after a few donnings, indicating that the respirator could be used more than once, however this study did not evaluate reusability. All fit tests done on adhesive equipped respirators were first time donnings.
The high adhesion was most obvious when the respirator was doffed. However, there was never any evidence of adhesive residue left on the skin after a respirator was removed.
There were 7 male and 4 female test subjects. Workers with beards were not allowed to participate. However, there was no attempt to eliminate those who had facial stubble, were cigarette smokers, or had previous respirator experience. Test subjects were accepted as is.
Test subject training was minimal, consisting of a verbal explanation of the respirator manufacturer's recommended donning method immediately prior to the fit test. Since the study was not concerned with test subject donning skills, the fit test operator assisted when necessary to make sure the respirator straps were properly positioned. Most test subjects had never worn a respirator before.
Test subjects were directed to perform a positive and negative user seal check in an attempt to make sure the respirator was well seated. Adjustments to the nose band were made as needed. Once the test subject indicated that face seal leakage could not be detected, the fit test began immediately.
The OSHA 8-exercise quantitative fit test protocol (29 CFR 1910.134) was used for all fit tests:
Measurements were taken using a PortaCount® Plus model 8020 Respirator Fit Tester (available from TSI Inc, Shoreview, Minn.) without the use of the N95-Companion™ accessory normally used with N95 respirators. The N95-Companion was not used because it limits the measurable fit factor to a value of 200, which would have biased the fit factor data. Fit factors above 200 were likely to occur; the filtration efficiency of the 3M 1860 respirator easily exceeds the 95% NIOSH minimum under the conditions present during typical fit testing with ambient aerosol.
Notwithstanding the 200 limit, not using the N95-Companion probably caused fit factors to be lower than they would have been if it were used, since the function of the N95 Companion is to eliminate filter penetration and isolate face seal leakage. Thus, the fit factors reported in this study should be thought of as total inward leakage (TIL) measurements. It should also be noted that this testing does not include an analysis of pass vs. fail for the OSHA minimum fit factor of 100. The use of TIL measurements instead of classic fit factors invalidates the application of that pass/fail value. However, it should be noted that since TIL measurements include filter leakage as well as face seal leakage, any TIL measurement above 100 can safely be assumed to indicate a fit factor above 100. In other words, a test subject who achieves a TIL-based fit factor value above 100 would certainly have passed the fit test with an even higher value if a classic fit factor (face seal only) measurement had been made.
Another change was made due to the absence of the N95-Companion which employs a device called the sampling pendant that hangs around the test subject's neck and supports the weight of the 1.5-foot twin sample tube. Unlike most elastomeric respirators, filtering facepiece respirators can be affected by the weight of the sample tube pulling down. When the N95-Companon is not used, the 5-foot PortaCount sample tube (pair of ⅛ inch ID×¼ in OD) represents a significant weight which could bias the measurements. For this study we used 5 feet of light weight tubing (pair of ⅛ inch ID× 3/16 inch OD) tubing which is less than half the weight of the factory tubing. In addition, subjects were instructed to prevent the sample tube from pulling on the respirator during the bending exercise by holding onto it with one hand.
The respirators with adhesive yielded overall fit factors that were an average of 271 percent higher than overall fit factors without adhesive, as shown in Table 1 below.
All subjects except for subject 10 experienced a higher fit factor with adhesive. Subject 10 achieved an overall fit factor of 1170 without adhesive, which was the highest non-adhesive overall fit factor recorded during the study. Keeping in mind that the measurements are technically TIL rather than true fit factors (see previous discussion), a measurement that high on an N95 filtering facepiece indicates near zero face seal leakage. A perfect fit cannot be improved, as suggested by the trivial 3 percent drop in the overall fit factor with adhesive (1170 to 1130).
While the adhesive respirators showed improved overall fit factors in virtually all cases, individual exercise fit factors showed significant variation. It was observed that the exercises following the grimace maneuver were sometimes very low for the non-adhesive respirator. The purpose of the grimace exercise is to intentionally attempt to break the face seal in order to see if the respirator reseats afterwards. There is no measurement made during the 15-second grimace because what is important is the fit factor for the exercise following the grimace; bending. A high fit factor during bending indicates that the face seal either never broke during the grimace or it re-seated immediately. A low fit factor after the grimace indicates that the face seal was broken and failed to re-seat. Subjects 4 and 12 are cases where the non-adhesive respirator was fitting well until after the grimace. The adhesive respirator never exhibited face seal failure due to grimacing for any test subject. It was observed that breaking the aggressive adhesive seal with facial movement is unlikely because once the adhesive area is pressed against the skin the respirator cannot slide on the face. Movement of the face stresses the respirator fabric, but the adhesive seal remains intact.
Subject 4 was tested despite not being clean shaven. A 3 day stubble was obvious and could be the cause of the face seal being broken and not resealed.
Subject 12 had a large nose bridge and commented that he considered respirators generally useless for him because they always leaked. The first respirator tried was a regular and the wearer determined the nose bridge leakage was excessive and the test was terminated. The subject requested the other size (small) and determined the leakage was much less. The test was then completed and comparison made. In this case, we used the size that the wearer said felt like it sealed the best.
The aggressiveness of the adhesive requires a modified donning procedure. The wearer must carefully center the respirator in the proper position on the face on the first try because the adhesive does not permit adjusting the respirator by sliding it on the face. If the respirator is not properly centered on first contact, it can be removed for another attempt, as the adhesive remains tacky for several donnings. The re-use of adhesive respirators was not part of this study and all subjects were cautioned about initial centering of the respirator.
As the above method and results show, face seal adhesive can significantly improve the protection provided by an N95 filtering facepiece respirator.
Events that can degrade the face seal of a respirator such as extreme facial movement or inadvertently shifting the respirator due to physical activity are much less likely to happen with an adhesive seal because the respirator is prevented from moving in relation to the face.
The apparatus and method used to generate the data of Table 1 was also utilized to generate the data of Table 2 and Table 3 below, except that the face mask tested employed a single bead, namely, bead 30 instead of bead 32 of
The multiple seal arrangements shown and described in this application, i.e., the double seals with and without bridges, triple seals with and without bridges, and quadruple seals with and without bridges, may be employed on a number of face masks or respirators. These face masks or respirators include 1) face masks or respirators for occupational use, 2) face masks or respirators for use by the general public, 3) disposable face masks or respirators, 4) woven or nonwoven face masks or respirators, 5) face masks with multiple layers such as a filter layer and a supporting layer, 6) half masks, 7) full masks, 8) air supplied respirators, 9) self-contained respirators, 10) active respirators, 11) filtering face piece respirators, 12) air purifying face masks or respirators, 13) particulate filter face masks or respirators, 14) gas filtering or blocking face masks or respirators, 15) electret face masks or respirators, 16) face masks or respirators designed to protect the wearer of the face mask or respirator, 17) face masks or respirators designed to protect a person or thing other than wearer of the face mask, such as surgical face masks.
The multiple seal arrangements shown and described in this application, i.e., the double seals with and without bridges, triple seals with and without bridges, and quadruple seals with and without bridges, may be employed on a number of face masks or respirators having a number of features, with the features including but not limited to the type of face mask, the shape of the face mask, the valve or valves on the face mask or respirator, the filter or covering of the face mask or respirator, the layer or layers or material or materials making up the filter or covering of the face mask or respirator, the chemical composition of the filter or covering of the face mask or respirator, and, as to such face masks and respirators and such features, the following U.S. patents and U.S. patent application Publications are hereby incorporated by reference in their entireties into this application:
Thus since the invention disclosed herein may be embodied in other specific forms without departing from the spirit or general characteristics thereof, some of which forms have been indicated, the embodiments described herein are to be considered in all respects illustrative and not restrictive. The scope of the invention is to be indicated by the appended claims, rather than by the foregoing description, and all changes which come within the meaning and range of equivalents of the claims are intended to be embraced therein.
This application claims the benefit under 35 U.S.C. 119(e) of U.S. provisional application No. 61/241,861 filed Sep. 11, 2009, which provisional application is hereby incorporated by reference in its entirety into this application.
| Number | Name | Date | Kind |
|---|---|---|---|
| 5676133 | Hickle et al. | Oct 1997 | A |
| 6196223 | Belfer et al. | Mar 2001 | B1 |
| 6341606 | Bordewick et al. | Jan 2002 | B1 |
| 6948499 | Griesbach et al. | Sep 2005 | B2 |
| 7017577 | Matich | Mar 2006 | B2 |
| 7524176 | Yao | Apr 2009 | B2 |
| 20030136410 | Matich | Jul 2003 | A1 |
| 20040089304 | Barakat et al. | May 2004 | A1 |
| 20040231023 | Huang | Nov 2004 | A1 |
| 20070050883 | Matich | Mar 2007 | A1 |
| 20080110469 | Weinberg | May 2008 | A1 |
| 20090211581 | Bansal | Aug 2009 | A1 |
| 20090211582 | Reese et al. | Aug 2009 | A1 |
| Number | Date | Country |
|---|---|---|
| 2005013492 | Jan 2005 | JP |
| 2007215877 | Aug 2007 | JP |
| Entry |
|---|
| International Society for Respiratory Protection, Sixteenth International Conference, schedule of conference, Sep. 23-27, 2012, six pages, International Society for Respiratory Protection, Mona Vale, Australia. |
| Rengasamy et al., Nanoparticle Penetration Through Filter Media and Through Face Seal Leakage of N95 Filtering Facepiece Respirators, power point presentation, Sep. 25, 2012, International Society for Respiratory Protection, Boston, MA, USA. |
| Grinshpun et al., Performance of an N95 Filtering Facepiece Particulate Respirator and a Surgical Mask During Human Breathing: Two Pathways for Particle Penetration, Journal of Occupational and Environmental Hygiene, Oct. 2009, 6: 593-603, Philadelphia, PA, USA. |
| Number | Date | Country | |
|---|---|---|---|
| 20110061656 A1 | Mar 2011 | US |
| Number | Date | Country | |
|---|---|---|---|
| 61241861 | Sep 2009 | US |
