CA2134764C

CA2134764C - Unidirectional fluid valve

Info

Publication number: CA2134764C
Application number: CA 2134764
Authority: CA
Inventors: Daniel A. Japuntich; Vaughn B. Grannis; Harold J. Seppala; Anthony B. Ferguson
Original assignee: Minnesota Mining and Manufacturing Co
Current assignee: 3M Co
Priority date: 1992-05-29
Filing date: 1993-04-21
Publication date: 1999-04-27
Anticipated expiration: 2013-04-21
Also published as: JPH07506751A; EP0674535A1; US6854463B2; US6843248B2; JP3359033B2; AU4112093A; AU665082B2; DE69312509D1; BR9306447A; CA2134764A1; EP0674535B1; US20020170563A1; JP3907500B2; MX9302879A; JP2002253689A; US20020185133A1; US20030084902A1; WO1993024181A1; US5509436A; DE69312509T2

Abstract

An exhalation valve (14) for a filtering face mask (10) has a flexible flap (24) that makes contact with a curved seal ridge (30) of a valve seat (26) when the valve (14) is in the closed position. The cur vature of the seal ridge (30) corresponds to a deformation curve exhibited by the flexible flap (24) when secured as a cantilev er at one end and exposed at its free portion to a uniform force and/or a force of at least the weight of the free portion of the f lexible flap. A seal ridge curvature corresponding to a flexible flap exposed to uniform force allows the flexible flap (24) to exert a generally uniform pressure on the seal ridge to provide a good seal. A seal ridge curvature corresponding to a flexible flap exp osed to a force of at least the weight of the flap's free portion allows the flexible flap (24) to be held in an abutting relationship to the seal ridge (30) under any static orientation by a minimum amount of force, thereby providing a face mask (10) with an extraordinar y low pressure drop during an exhalation.

Description

TECHNICAL FIELD
This invention pertains to (i) a unidirectional fluid valve that can be used as an exhalation valve for a filtering face mask, (ii) a filtering face mask that employs an exhalation valve, and (iii) a method of making a unidirectional fluid valve.
BACKGROUND OF THE INVENTION
Exhalation valves have been used on filtering face masks for many years and have been disclosed in, for example, U. S. Patents 4,981,134, 4,974,586, 4,958,633, 4,934,362, 4,838,262, 4,630,604, 4,414,973, and 2,999,498. U. S. Patent 4,934,362 (the '362 patent), in particular, discloses a uni-directional exhalation valve that has a flexible flap secured to a valve seat, where the valve seat has a rounded seal ridge with a parabolic profile. The flexible flap is secured to the valve seat at the apex of the parabolic curve, and rests on the rounded seal ridge when the valve is in a closed position.
When a wearer of a face mask exhales, the exhaled air lifts the free end of the flexible flap off the seal ridge, thereby allowing the exhaled air to be displaced from the interior of the face mask. The '362 patent discloses that an exhalation valve of this construction provides a significantly lower pressure drop for a filtering face mask.
SUMMARY OF THE INVENTION
In a first aspect, the present invention provides a unidirectional fluid valve that comprises: a flexible flap having a first portion and a second portion, the first portion being attached to a valve seat, the valve seat having an orifice and a seal ridge that has a concave curvature when viewed from a side elevation, the flexible flap making contact with the concave curvature of the seal ridge when a fluid is not passing through the orifice, the second portion of the flexible flap being free to be lifted from the seal ridge when a fluid is passing through the orifice, the unidirectional fluid valve being characterized by having a concave curvature corresponding to a deformation curve exhibited by the second portion of the flexible flap when exposed to (i) a uniform force that acts along the length of the deformation curve normal thereto, (ii) a force acting in the direction of gravity having a magnitude equal to a mass of the second portion of the flexible flap multiplied by at least one gravitational unit of acceleration, or a combination of (i) and (ii).
In a second aspect, the present invention provides a filtering face mask that comprises:

WO 93/24181 ~ 4 PCr/US93/03797 (a) a mask body adapted to fit over the nose and mouth of a percon;
and (b) an e~h-q~ iorl valve ~t~h~d to the mask body, which e~hq1vq~ion valve comprises:
(l) a valve seat having (i) an orifice through which a fluid can pass, and (ii) a seal ridge circumscribing the orifice and having a concave curvature when viewed from a side elevation, the apex of the concave curvature of the seal ridge being located upstream to fluid flow through the orifice relative to outer eAL~ ."ilies of the concave curvature; and (2) a fle~cible flap having a first and second portions, the first portion being -q~ chcd to the valve seat outside a region encon-p-csed by the orifice, and the second portion ~qcsuming the concave curvature of the seal ridge when the valve is in a closed position and being free to be lifted from the seal ridge when a fluid is passing through the orifice.
In a third aspect, the present invention provides a filtering face mask that comprises:
(a) a mack body that has a shape adapted to fit over the nose and mouth of a person, the mask body having a filter media for removing contaminants from a fluid that passes through the mask body, there being an opening in the mask body that permits a fluid to exit the mask body without passing through the filter media, the opening being positioned on the mask body such that the opening is subs~;n~iq11y directly in front of a wearer's mouth when the filtering face mask is placed on a wearer's face over the nose and mouth; and (b) an eYhql-qtion valve attached to the mask body at the location of the opening, the exhalation valve having a flexible flap and a valve seat that includes an orifice and a seal ridge, the flexible flap being vqttach~ to the valve seat at a first end and resting upon the seal ridge when the elchqhqtion valve is in a closed position, the flexible flap having a second free-end that is lifted from the seal ridge when a fluid is passing through the ~l~hqlqtion valve;
wherein, the fluid-pe~,neable face mask can demonstrate a negative pressure drop when air is passed into the filtering face mask with a velocity of at least 8 m/s under a normal e~rh~1~tion test.
In a fourth aspect, the present invention provides a rnetho~l of m~king a unidirectional fluid valve, which comprises:
(a) providing a valve seat that has an orifice circumscribed by a seal ridge, the seal ridge having a concave curvature when viewe,d from a side elevation, the concave curvature col~c~yol-ding to a deformation curve ~ '~
, ,~, ~ ~ 60557-4876 WO 93/24181 2 1 3 4 7 6 4 Pcr/us93/03797 demon~tr.qt~d by a flexible flap that has a first portion secured to a surface at as a cantilever and has a s~nd~ non sacu~ed portion ~ os~ to a uniform force, a force having a m~nitl)de equal to the mas~ of the second portion of the flexible flap multipli~d by at least one gravitatlonal unit of acceleration,S or a combination ~ ~î; and (b) ~qttaching a first portion of the flexible flap to the valve seat such that (i) the flexible flap makes contact with the se. l ridge when a fluid is not passing through the orifice, and (ii) the second portion of the Lq-tP-ch~ flexible flap is free to be lifted from the seal ridge when a fluid is passing through the lO orifice.
Filtering face masks should be safe and comfortable to we. r. To be safe, the face mask should not allow con~A~ n~nls to enter the interior of the face mask through the exhq1-q-tion valve, and to be comfortable, the face mask should tlicplqce as large a pl_rcenLage of eYh-q-l~d air as possible through thelS eYh-q1q-tion valve with minimq1 effort. The present invention provides a safeexh~1~tion valve by having a flexible flap that makes a subst~ntiq-11y uniform seal to the valve seat under any orientqtion of the eYhq1q-tion valve. The present invention helps relieve discomfort to the wearer by (l) minimi7ing eYhqlqtiQn pre,S:~ul'G inside a fi1tPrir~ face mask, (2) purging a greater 20 p~ .cenL~ge of eY~hq1~ air through the eYhq1qtion valve (as op~sed to having the eYhq1~d air pass through the filter media), and under some circ~lmstqnces (3) providing a negative p.~ s~urG inside a fi1tering face mask during e~hql~qtion to create a net flow of cool, an.bient air into the face mask.
In the first and fourth aspects of the present invention, a unidirectional 25 fluid valve is provided that enables a flexible flap to exert a subst~ntiq11yuniform force on a seal ridge of the valve seat. The subs~ t;q11y uniform force is obLailled by qttq~hing a first portion of a flexible flap to a surface and suspending a second or free portion of t-h-e flexible flap as a cantilever beam.The second or free portion of the flexible flap is then deformed under 30 co."puLer ~imll1qtion by applying a plurality of force vectors of the same m~nitude to the flexible flap at directions normal to the curvature of the flexible flap. The second portion of the flexible flap talces on a particular curvature, ref~n~d to as the defol~naLion curve. llle derollllaLion curve is traced, and that tracing is used to define the curvature of the seal ridge of the 35 valve seat. A valve seat of this WlValUlG prevents the flexible flap from buclding and from making slight or no contact with the seal ridge at certain locations and making too strong a contact at other locations. This uniform c~nt~ting relationship allows the valve to be safe by precluding the influx of cont~ l.L~, 213~76~
W O 93/24181 PC~r/US93/03797 In the first and fourth aspects of the present invention, a unidire -tionar--fluid valve is also provided which minimi7~s eYhql-q-tion p ~ssule. This advantage is acco...~ hPd by achieving the minimllm force l-F~s~ ~ to keep the flexible flap in the closed positiQn under any oripnt~tinn The minimum 5 flap closure force is ob~ined by providing an eYh-ql-qtinn valve with a valve seat that has a seal ridge with a concave curvature that colles~)onds to a de~...~;on curve exhibited by the fleYible flap when it is secured as a cantilever at one end and bends under its own weight. A seal ridge co,les~nding to this deformation curve allows the eY~h-q-l-q-tiQn valve to remain 10 closed when completely inverted but also permits it to be opened with ,.,ini",u", force to thereby lower the pres;.ure drop across the face mask.
In the second aspect of the present invention, a fil~ering face mask is provided with an eYh-ql-q-tion valve that can demonstrate a lowa airflow -resistance force, which enables the eYhql-qtion valve to open easier. This 15 advantage has been accomplished in the present invention by securing the flexible flap to the valve seat outside the region encompassed by the valve orifice. An PYhqlqtion valve of this construction allows the flexible flap to belifted more easily from the curved seal ridge beea~-se a greater moment arm is obtained when the flexible flap is mounted to the valve seat outside the 20 region enco...~ d by the oAfice. A further advantage of an eY~hql-qtion valve of this construction is that it can allow the whole orifice to be open to airflow during an e~h-ql-q~ti~n.
In addition to the above advantages, this invention allows a greater cenlage of eYh~l~ air to be purged through the eY~h-ql~tion valve, and, after 25 an initial positive p~ss~ to open the valve, allows the plcs~u~ inside the filt~ring face mask to decre.,se and in some cases become negative during eYhq-l-q-tion. These two attributes have been achieved by (i) positioning the eYhqlqtion valve of this invention on a filtPring face mask subst-q-ntiqlly directly opposi~e to where the wearer's mouth would be when the face mask is being 30 worn, and (ii) definin~ a p~.led cross-sectional area for the orifice of the eYh-qlqtion valve. When an eYh-ql~tion valve of this invention has an orifice with a cross-s~ctiQn-q-l area greater than about 2 square centimpters (cm2) whenviewed from a plane perpon-liculqr to the direction of fluid flow and the eshql-q-tion valve is located on the filtPring face mask ~u~st~ q~lly directly in 35 front of the wearer's mouth, lower and negalive pl~SSUl~ s can be developed inside of the filtering face mask during normal eYhqlqtion.
In this invention, at least 40 percent of the eYh-qlP~ air can eYit the face mask lhruugh the PYhqlqtion valve at a positive ~ressu~ drop of less than 24.5 pascals at low eY~hqlqtion air velocities and volume airflows greater than 40 40 liters per minute (~/min). At higher eYh-ql~tion air velocities (such as with the Wo 93/24181 213 4 7 6 4 PCI /US93/03797 ", .~r~.'s lips pursed), a ne~,~livc l,r~,~ may be developed inside of the fi1t~ring face mask. In the third aspect of the present invention, a fi1t~ring face mask is provided that de~ nst~s a negative prtSS~ . The negative pi~,S5~UlC allows a volume of air greater than one hundred ~f~nt of the S e~h~ l air to pass out through the e~h~l~tion valve, and further enables ambient air to pass inwardly through the filterin~ media when a person is eYh~1in~. This creates a s;tu~ n where upon the next inh~l~tit)n the wearer breathes in cooler, fresher, ambient air of lower humidity than the wearer's breath and of higher oxygen content. The influx of ambient air is lGÇGllGd to as ~ tir)n, and it provides the wearer of the face mask with improved co,.lfo.l. The aspiration effect also reduces the fogging of eyewea~ be~nse less eYh~1~d air exits the face mask through the filter media. The discovery of the aspiration effect was very surprising.
The above novel fealul~s and advantages of the present invention are more fully shown and described in the drawings and the following detailed desclip~ion, where like reference numerals are used to repl~ ~nl similar parts.
It is to be understood, however, that the drawings and det~i1~ desc.i~lion are for the pul~oses of illustration only and should not be read in a ."~mer that would unduly limit the scope of this invention.
BRlEF DESCRlmON OF THE DRAWINGS
FIG. lis a front view of a fi1tering face mask 10 in accol~ance with the present invention.
FIG. 2 is a partial cross-section of the face mask body 12 of FIG. 1.
FIG.3is a cross-sectional view of an exh~1~tion valve 14 taken along lines 3-3 of FIG. 1.
FIG.4is a front view of a valve seat 18 in accordatlce with the present invention.
FIG. 5 is a side view of a flexible flap 24 suspe~ded as a cantilever and being e~ d to a ~lnifoll-, force.
FIG.6is a side view of a flexible flap 24 suspended as a cantilever as being eAposed to gravitational acceleration, g.
FIG. 7 is a p~lsp~ e view of a valve cover 50 in accordance with the present invention.
DETAnED DESCRlmON OF PREFER:REI) EUBODIMENTS
In describing p,ef~ d emb~~ t~ of this invention, sper-ific terminology will be used for the sake of clarity. The invention, however, is not intPnded to be limited to the sI~ecific terms so s~1~ted, and it is to be 2 1 3 ~ 7 6 L~
Wo 93/24181 ~ Pcr/uss3/o3797 und~od that each term so s~k.ted inrlu-les all the ~hni~l equivalents that_ operate similqrly.
FIG. 1 illll~tratPs a filtering face mask 10 accolding to the present invention. Filtering face mask 10 has a cup shaped mask body 12 to which an eYhqlqtion valve 14 is qttLq~hPd Mask body 12 is provided with an opening (not shown) through which eY~haled air can eYit without having to pass through the filt~tion layer. The ~efell~ loc-q-tiorl of the opening on the mask body 12 is d~eclly in front of where the wearer's mouth would be when the mask is being worn. FYhql?tion valve 14 is Lqtt~~hed to mask body 12 at the location of that opening. With the exception of the location of the eyhqlqtion valve 14, e~scn~;~l1y the entire eAposed surface of mask body 12 is fluid permeable to inhaled air.
Mask body 12 can be of a curved, hemispherical shape or may take on other shapes as so desired. For eAample, the mask body can be a cup-shaped mask having a construction like the face mask disclosed in U.S. Patent 4,827,924 to Japuntich. Mask body 12 may comprise an inner shaping layer 16 and an outer filtrtq-tis)n layer 18 (FIG. 2). Shq-ring layer 16 provides structure to the mask 10 and support for filtration layer 18. Shaping layer 16 may be located on the inside and/or outside of filtration layer 18 and can be made, for example, from a nonwoven web of thermally-bondable fibers molded into a cup-shaped configuration. The shaping layer can be molded in accoldance with known procedures. Although a shaping layer 16 is d~Psign~Pd with the primary pul~ose of providing structure to the mask and support for a filtration laya, shaping laya 16 also may provide for filtr.qtion, typically for filtration of larger particles. To hold the face mask snugly upon the wearer's face, mask body can have straps 20, tie strings, a mask harness, etc. ~qtt~l ed thereto. A pliable dead soft band 22 of metal such as aluminum can be provided on mask body 12 to allow it to be shaped to hold the face mask in a desired fitting relqtion~hip on the nose of the wearer.
When a wearer of a filtPring face mask 10 eY~hql~Ps~ eYhqlP~ air passes through the mask body 12 and eYhql-q-tion valve 14. Comfort is best obtained when a high pelcentdge of the exhql~d air passes through eYh~l-q-tion valve 14, as o~l)Gscd to the filter media of mask body 12. FYhqlP~I air is expelled through valve 14 by having the eYhq-led air lift flexible flap 24 from valve seat 26. Flexible flap 24 is qtt-q-~hP~l to valve seat 26 at a first portion 28 of flap 24, and the lc;...qinhlg cil~;u-,-rerential edge of flexible flap 24 is free to be lifted from valve seat 26 during eYhalqtion. As the term is used herein, nflexible" means the flap can deform or bend in the form of a self-su~polLi-lg arc when secured at one end as a cantilever and viewed from a side elevation (see e.g., FIG. 5). A flap that is not self-supporting will tend to drape towards the ground at about 90 degrees from the horizontal.
As shown in FIGs. 3 and 4, valve seat 26 has a seal ridge 30 that has a seal surface 31 to which the flexible flap 24 makes contact when a fluid is not passing through the valve 14. An orifice 32 is located radially inward to seal ridge 30 and is circumscribed thereby. Orifice 32 can have cross-members 34 that stabilize seal ridge 30 and ultimately valve 14. The cross-members 34 also can prevent flexible flap 24 from inverting into orifice 32 under reverse air flow, for example, during inhalation. When viewed from a side elevation, the surface of the cross-members 34 is slightly recessed beneath (but may be aligned with) seal surface 31 to ensure that the cross members do not lift the flexible flap 24 offseal surface 31 (see FIG. 3).
Seal ridge 30 and orifice 32 can take on any shape when viewed from a plane perpendicular to the direction of fluid flow (FIG. 4). For example, seal ridge 30 and orifice 32 may be square, rectangular, circular, elliptical, etc.
The shape of seal ridge 30 does not have to correspond to the shape of orifice 32. For example, the orifice 32 may be circular and the seal ridge may be rectangular. lt is only necessary that the seal ridge 30 circumscribe the orifice 32 to prevent the undesired influx of cont~min~tes through orifice 32.
The seal ridge 30 and orifice 32, however, preferably have a circular cross-section when viewed against the direction of fluid flow. The opening in the mask body 12 preferably has a cross-sectional area at least the size of orifice 32. The flexible flap 24, of course, covers an area larger than orifice 32 and is at least the size of the area circumscribed by seal ridge 30. Orifice 32 preferably has a cross-sectional area of 2 to 6 cm2, and more preferably 3 to 4 cm2. An orifice of this size provides the face mask with an aspiration effect toassist in purging warm, humid exhaled air. An upper limit on orifice size can be important when aspiration occurs because a large orifice provides a possibility that ambient air may enter the face mask through the orifice of the exhalation valve, rather than through the filter media, thereby creating unsafe breathing conditions FIG. 3 shows flexible flap 24 in a closed position resting on seal ridge 30 and in an open position by the dotted lines 24a. Seal ridge 30 has a concave curvature when viewed in the direction of FIG. 3. This concave 3 5 curvature, as indicated above, corresponds to the deformation curve displayed by the flexible flap when it is secured as a cantilever beam. The concave curvature shown in FIG. 3 is inflection free, and preferably extends along a generally straight line in the side-elevational direction of FIG. 3. A fluid passes through valve 14 in the direction indicated by arrow 36. The apex of the concave curvature is located upstream to fluid flow through the annular '~

213~76~
Wo 93/24181 ! PCr/US93/03797 ~ . _ -- orifice 32 relative to the outer ~ Al~ ies of the concave curvature. Fluid 36 passing tllluugh annul. r orifice 32 exerts a force on flexible flap 24 c llsingfree end 38 of flap 24 to be lifted from seal ridge 30 of valve seat 26 making valve 14 open. Valve 14 is prere~lably ~;. ;f ~.~ on face mask 10 such that the 5 free end 38 of flexible flap 24 is loc. ted below secured end 28 when the mask10 is position~ upright as shown in FIG. 1. This enables eYhqlPd air to be deflected dow~wal~s so as to p,~enl moisture from condP-nQ-ing on the wearer's t;y~;wear.
As shown in FIGs. 3 . nd 4, valve seat 26 has a flap-r~;nil-g surface 10 40 located outside the region enco.-l~c~d by orifice 32 beyond an outer e;Allenlily of seal ridge 30. Flap-re~inillg surface 40 p~efe.ably traverses valve 14 over a ~iiQt~llce at least as great as the width of orifice 32. Flap-in-ng surface 40 may extend in a straight line in the direction to which surface 40 traverses the valve seat 26. Flap-~c!~inil-g surface 40 can have pins 41 for holr~ing flexible flap 24 in place. When pins 41 are employed as part of a means for se~llring flexible flap 24 to valve seat 26, flexible flap 24 would be provided with co"~nding openings so that flexible flap 24 can be positio~ed over pins 41 and preferably can be held in an abutting relationship to flap-,e~inin~ surface 40. Flexible flap 24 also can be ~tt~rh~
to the flap-,e~ining surface by sonic welding, an adhesive, m~}~nir~l C1~mI)ing~ or other suit~ le means.
Flap-~e! in;ng surface 40 preferably is position~ on valve seat 40 to allow flexible flap 24 to be pressed in an abutting r~l~tionQhip to seal ridge 30 when a fluid is not passing through orifice 32. Plap-~ining surface 40 can be positioned on valve seat 26 as a tangent to the curvature of the seal ridge 30 when viewed from a side elevation (FIG. 3). The flap-~ ;ning surface 40 is spaced from orifice 32 and seal ridge 30 to provide a moment arm that assists in the defl~tir)n of the flap during an eYh~l~tion. The greater the sp~ing be~ween the flap-~ ing surface 40 and the orifice 32, the greater the moment arm and the lower the torque of the flexible flap 24 and thus the easier it is for flexible flap 24 to open when a force from eYh~led air is applied to the same. The ~i~t~nce bel~n surface 40 and orifice 32, however, should not be so great as to cause the flexible flap to dangle freely.
Rather, the flexible flap 24 is pressed tow~ds seal ridge 30 so that there is a ~ubst~ lly unifolm seal when the valve is in the closed position. The ~ist~nce belween the flap-~ ining surface and nearest portion of orifice 32, prt;f~ldbly, is about 1 to 3.5 mm, more preferably 1.5 to 2.5 mm.
The space be~n orifice 32 and the flap-~ ;n;ng surface 40 also provides the flexible flap 24 with a tr~n~ition~l region that aUows the flexibleflap 24 to more easily assume the curve of the seal ridge 30. Flexible flap 24 Wo 93/24181 213 4 7 6 ~I Pcr/us93/o3797 is preferably s~ffi~iPntly supple to account for tol~-r~q-n~ v-q~riqtiol~c Flap-.np surface 40 can be a planar surface or it c n be a cQ~tinl1Qus c- ~ ..c;r~n of curved seal ridge 30; that is, it c. n be a curved eytp-nci~n of the defol".ation curve displayed by the fleY~ible flap. As such, however, it is S plGf~lGd that flPYihle flap 24 have a trancitil~nql region between the point of s~iu,eMent and the point of contact with seal ridge 30.
Valve seat 26 preferably is made from a relatively light-weight plastic ~ that is molded into an inte~rql one-piece body. The valve seat can be made by injection moldin~ techniques. The surface of the seal ridge 30 that makes 10 contact with the flexible flap 24 (the contact surface) is plef~.ably fq~hinn~d to be s.~l,s~nt;~lly unirollllly smooth to ensure that a good seal occurs. The contact surface preferably has a width great enough to form a seal with the flexible flap 24 but is not so wide as to allow adhesive forces caused by con~lçn~ed moisture to cignific~qntly make the flexible flap 24 more difficult to 15 open. The width of the contact surface, preferably, is at least 0.2 mm, and preferably is in the range of about 0.25 mm to 0.5 mm.
Flexible flap 24 preferably is made from a m~t~riql that is capable of displaying a bias toward seal ridge 30 when the flexible flap 24 is secured to the valve seat 26 at surface 40. The flexible flap preferably q-cs~mes a flat 20 configuration where no forces are applied and is ela~stomeric and is resistant to ~l,-lancnt set and creep. The flexible flap can be made from an elastomeric mqteriql such as a cro-cclinl~ natural rubber (for example, cros~clin~ed polyisoplclle) or a synthetic elastu---er such as ~leoprel e, butylrubber, nitrile rubber, or silicone rubber. FYqmpl~s of rubbers that may be used as flexible flaps incl~lde: co.. poùnd nuln~ 40R149 available from West Am.oriGqn Rubber Company, Orange, California; co--,pounds 402A and 330A
available from Aritz-Optibelt-KG, Hoxter, G~ y; and RTV-630 available from General Fl~tric Company, WatelrGrd, New York. A ~,lcfe,led flexible flap has a stress relqY-q-tion sufficient to keep the flexible flap in an abutting 30 relationship to the seal ridge under any static Ol ;~nt;.~iQn for twenty-four hours at 70 ~C; see Eur~pedn Standard for the Eur~p~l C~....nill~ for S~ndar~ ;Qn (CEN) Europaishe Norm (EN) 140 part 5.3 and 149 parts 5.2.2 for a test that measures stress relqY-qtio~ under these co~litiQns. The flexible flap preferably provides a leak-free seal accolding to the standards set forth in 30 C.F.R. ~ 11.183-2 auly 1, 1991). A crosclinl~ polyisopl~ is plefelled becau~ it exhibits a lesser degree of stress relqY-q~ n. The flexible flap typically will have a Shore A h~ness of about 30 to 50.
Flexible flap 24 may be cut from a flat sheet of mqtPriql having a generally wlirOllll thiclrnecc In general, the sheet has a thi~l~n~ss of about 0.2 to 0.8 mm; more typically 0.3 to 0.6 mm, and preferably 0.35 to 0.45 mm.

~13427~
Wo 93/ 1 1 Pcr/uss3/o3797 The flexible flap is preferably cut in the shape of a rect~ngle, and has a free--end 38 that is cut to coll~s~nd to the shape of the seal ridge 30 where the free end 38 makes contact llle,~ .,.il]~. For e~mple, as shown in FIG. 1, free end 38 has a curved edge 42 coll~s~onding to the circular seal ridge 30. By 5 having the free end 38 cut in such a ,llannel, the free end 38 weighs less andth~ror~ can be lifted more easily from the seal ridge 30 during eYh~l~tion and closes more easily when the face mask is inverted. The flexible flap 24 preferably is greater than about 1 cm wide, more preferably in the range of about 1.2 to 3 cm wide, and is about 1 to 4 cm long. The secured end of the 10 flexible flap typically will be about 10 to 25 pe~nt of the total cil.;ulllfc.~nlial edge of the flexible flap, with the le~ ing 75 to 90 percent being free to be lifted from the valve seat 26. A prer~led flexible flap of thisinvention is about 2.4 cm wide and about 2.6 cm long and has a rounded free end 38 with a radius of about 1.2 cm.
As best shown in FIGs. 1 and 4, a flange 43 extends laterally from the valve seat 26 to provide a surface onto which the exh~l~tinn valve 14 can be secured to the mask body 12. Flange 43 preferably eYtends around the whole perimeter of valve seat 26. When the mask body 12 is a fibrous filtration face mask, the exh~l~tiQn valve 14 can be secured to the mask body 12 at flange 20 43 by sonic welds, ~lh~cion bonding, m~h~nit~l cl~mping, or the like. It is preferred that the eYhql~tion valve 14 be sonically welded to the mask body 12 of the filtPring face mask 10.
A pr~r~llc;d unidirectional fluid valve of this invention is advantageous in that it has a single flexible flap 24 with one free end 38, rather than having 25 two flaps each with a free end. By having a single flexible flap 24 with one free end 38, the flexible flap 24 can have a longer moment arm, which allows the flexible flap 24 to be more easily lifted from the seal ridge 30 by the dynamic pr~ s~ule of a wearer's eYh~l~d air. A further advantage of using a single flexible flap with one free end is that the exhaled air can be deflected 30 do-vnv ~d to prevent fogging of a wearer's eyewear or face shield (e.g. a welder's helmet).
FIG. 5 illustrates a flexible flap 24 deformed by applying a ullifo~
force to the flexible flap. Flexible flap 24 is secured at a first portion 28 toa hold-down surface 46 and has for a second or free portion suc~-ndffl 35 th~rer~"~ as a cantilever beam. Surface 46 desirably is planar, and the flexible flap 24 is p~ef~ably secured to that planar surface along the whole width of portion 28. The uniform force includes a plurality of force vectors 47 of the same m~nih~de, each applied at a direction normal to the curvature of the flexible flap. The res--lting defol",alion curve can be used to define the WO 93/24181 21 3 4 7 ~ ~ PCr/USs3/037s7 ._ cul~alul~ of a valve seat's seal ridge 30 to provide a flexible flap that eYertsa s~Jbs~ l t;~lly unirl~n~ force upon the seal ridge.
D~t~, ...;ning the curvature of a seal ridge 30 that provides a s~s~nl;qlly uniro,lll seal force is not easily done empiric~qlly. It can, 5 ho~c~, be d~t~""lined n~lmPricqlly using finite elemPnt analysis. The approach taken is to model a flpyihle flap secured at one end with a unifo~
force applied to the free end of the fleYible flap. The applied force vectors ~ are kept normal to the curvature of flexible flap 24 bec,q~ e the seal force ex~P~ut~ by flexible flap 24 to the se~ ridge 30 will act normal thereto. The 10 deformed shape of flexible flap 24 when subjected to this u~ro,.,l, normal force is then used to fashion the concave curvature of se l ridge 30.
Using finite ele~-.r~ l analysis, the flexible flap can be mod~Pll~P~ in a two-~imPncionql finite el~--..r-nt model as a bending beam fixed at one end, where the free end of the flexible flap is divided into numerous conn~te~
15 subregions or elPmPntc within which approA~ ate functiQnc are used to replcscnt beam defo",.alion. The total beam deformation is derived from linear combinations of the individual el~PmPnt behavior. The mqteriql ~,o~llies of the flexible flap are used in the model. If the stress-strain behavior of the flexible flap mqt~riql is non-linear, as in elasl,--,eric m2~riq.1~, 20 the Mooney-Rivlin model can be used (see, R.S. Rivlin and D.W. S-q--)nders (1951), Phil. Trans. R. Soc. A243, 251-298 "L~rge Elastic Dero,-"ation of Isotropic M~qt~riql$ VII T;~1Y ;"-~ nlc on the Defo~ t;on of Rubber~). To use the Mooney-Rivlin model, a set of mlmPricql C4n~ that r~t~r~sent the stress/strain behavior of the flexible flap need to be de~-"ined from 25 experim~Pnt-q-l test data. These co~ct~n~c are placed into the Mooney-Rivlin model which is then used in the two~limension~l finite elemP-nt model. The analysis is a large deflP~tion, non-linear analysis. The mlme~ l solution typically is an iterative one, because the force vectors are kept normal to the surface. A solution is c~lcul~t~ based upon the previous force vector. The 30 direction of the force vector is then up~led and a new solution c~lc~ t A converged solution is ob~ained when the deflected shape is not ch~tlgin from one ite~tion to the next by more than a preset minimum tole~nce.
Most finite ele .l~ ~ analysis co"~ tel pr~gnd,.-s will allow a uniform force tobe input as an elf ,~en~l pr~s;~.l~ which is Illtim-q-tP~y trq-nclqted to nodal forces 35 or input dil~;lly as nodal forces. The total n.~..;tude of the nodal forces may be equal to the mass of the free portion of the flexible flap multipli~P~ by the~~~Pl~r~qtion of gravity acting on the mass of the flexible flap or any factor of gravity as so desired. ~,f~l~l gravitqtionql factors are ~iscussed below.
The final X, Y position of the defle~t~Pd nodes r~ 3rr.l;ng the flexible flap 213~7~4 WO 93/~4181 ~ ~ Pcr/uss3/o3797 can be curve fit to a pol~l.o---ial equation to define the shape of the concav~
seal ridge.
FIG. 6 illu~ t~s a fleYih1P flap 24 being deforrned by gravity, g. The flexible flap 24 is secured as a cantilever bearn at end 28 to surface 46 of a 5 solid body 48. Being secured in this fashion, flexible flap 24 displays a defol.l.~ion curve caused by the ac~1e-~ n of gravity, g. As in~ic~tP~
above, the side-elevational curvature of a valve seat's seal ridge can be fashioned to coll~spond to the dcÇ~,l..-ation curve of the flexible flap 24 whenexposed to a force in the direction of gravity which is equal to the mass of the10 free portion of the flexible flap 24 multiplied by at least one unit of gravitational aCcelcldlion~ B-A gravitatiQn~1 unit of acceleration, g, has been dc~ ed to be equalto a 9.807 meters per second per second (m/s2). Although a seal ridge having a curvature that co,l~sponds to a deformation curve exhibited by a flexible 15 flap exposed to one B can be sufficient to hold the flexible flap in a closedposition, it is plcfcll~ that the seal ridge have a curvature that col~s~nds to a deformation curve exhibited by a flexible flap that is exposed to a force caused by more than one g of acccl~.alion, preferably l.l to 2 g. More ~fe,dbly, the seal ridge has a curvature that coll~,s~nds to the flexible flap's20 derol--ldlion curve at from 1.2 to 1.5 g of acceleration. A most p~ercllcd seal ridge has a side-elevational curvature that coi~s~nds to a defol...ation curve exhibited by a flexible flap eAposed to a force caused by 1.3 B of acceleration.The additional gravitational acceleration is used to provide a safety factor to ensure a good seal to the valve seat at any face mask oriPnt~tion~ and to 25 accommodate flap thic1rnp-s~ t;o~s and additional flap weight caused by conden~ moisture.
In actual practice, it is difficult to apply a preload eYce~Aing 1 B (e.g., 1.1, 1.2, 1.3 g etc.) to a flexible flap. The de~l"lation curve collesponding to such amounts of gravitational acceleration, however, can be delel-"ined 30 through finite e~ Pnt analysis.
To m~thPm~ti~11y describe a flexible flap be-nding due to gravity, the two-~limencional finite elPmPnt model is defined to be constrained at one end in all degrees of freedom. A set of algebraic equations are solved, yielding the beam deÇul.nalion at the e4n~ent nodes of interest, which, when 35 co.nbined, form the entire d~Çu~ alion curve. A curve-fit to these points gives an equation for the curve, and this equation can be used to generate the seal ridge curvature of the valve seat.
The vers~tility of finite e1emPnt analysis is that the ~nit~lde of the gravitational cons~nt's acceleration and direction can be varied to create the 40 desired pre-load on a flexible flap. For instance, if a pre-load of lO percent Wo 93/24181 21 ~ 4 7 G ~ Pcr/uss3lo3797 ,., ~_ of the weight of the flPYi~'~ flap is n~deA~ the def~ "alion curve ~en~
at 1.1 g would be used as the sidc elc~alional curvature of the seal ridge. The direction may be cl~ng~ by ~la~iilg the gra~ ;ol-ql ~~re1erqtion vector with respect to a horizontal hold-down surface or by rotating the hold-down surface 5 with respect to the gravitational vector. Although a suitable defn~ ;on curve can be det~ ined by having hold-down surface 46 pl,qr~qll~l to the ho. ;7~ , it was found in the l~cll leading to this design that the gledtei.
~ defo.-. Al;on of the flexible flap 24 does not occur when the flexible flap 24 is ;,.-p~ d at the ho.;~nl;l, but when the flexible flap 24 is held elevated 10 above the h- . ;7~nl~l as shown in FIG. 5 and the hold-down surface 46 is at an angle e in the range of 25 to 65 degloes. It was disc4vered that by rotating the hold-down surface at an angle to the hon74nt-l, a de~oll--dtion curve can be genc.dted that closely app~u~imqtes a deformallon curve having been subjected to uniÇul..- forces normal to the curved flap. For a fixed 15 flexible flap length, the best rotational angle e is dependent upon the mq.~nihlde of the gravitational CQI;~ t and the thickness of the flexible flap.
In general, however, a p,~f~,~d defo"--alion curve can be displayed by having hold-down surface 46 at an angle e of about 45 deg~s.
The .~ hP ~ ;C-1 e~pres~ion that defines the dcÇo,-nalion curve of a 20 flexible flap ~-.pos~ to either a uniÇol--- force and/or a force of a factor of at least one unit of gravit-q-tionql accele~alion is a poly..o...ial ~ .e~ l;rql e~ ssion, typically a poly..o.. ial mqthemqtic-l c ,.pl~s~ion of at least the third order. The particular poly..o...ial m~themqtir-l c~,~ ssion that defines the deÇu,l..alion curve can vary with respect to p~qvr~q-m~ten such as flexible flap25 thirkTess, length, co.--~s;l;on, and the applied force(s) and direction of those force(s).
E~h-q-lqtirn valve 14 can be provided with a valve cover to protect the flexible flap 24, and to help prevent the passage of cont~q,..;n~ through the e~hqlqtion valve. In FIG. 6, a valve cover 50 is shown which can be secured to eYhqlq-tion valve 14 by a friction fit to wall 44. Valve cover 50 also can be secured to the eYhq-l-q-tion valve 14 by ul~nic welding, an adhesive, or other suihble means. Valve cover 50 has an opening 52 for the p~C~c~ge of a fluid. Opening 52 pref~,dbly is at least the size of orifice 32, and p,~î~.dbly is larger than orifice 32. The op~ning 52 is placed, ~l~r~dbly, on the valve cover 50 dil~ctly in the path of fluid flow 36 so that eddy l;u~ are minimi7~d In this regard, opening 52 is ap~r~ ly p-r~qll~l to the path traced by the free end 38 of fleYible flap 24 during its opening and closing.
As with the flexible flap 24, the valve cover opening 52 preferably directs fluid flow dowçlw~ds so as to pr~ nt the fogging of a weal~r's ~_~ ~ar. All of the eYhql~d air can be dilGc~d dowllw~ds by providing the valve cover ~1347G ~
Wo 93/~4181 Pcr/us93/o37g7 with fluid-i...~....~hle side walls 54. Opening 52 can have cross-mf .,ber 56 to provide structural support and ~~nhetil s to valve cover 50. A set of ribs S8 can be provided on valve cover 50 for further structural support and ~P-sthetirs. Valve cover S0 can have its interior fq~hionP~ such that there are S female n.f...be.~ (not shown) that mate with pins 41 of valve seat 14. Valve cover 50 also can have a surface (not shown) that holds flexible flap 24 against flap-~ surface 40. Valve cover 50 preferably has fluid i,..pe,l..edble ceiling 60 that inc,~s in height in the direction of the flexible flap from the fixed end to the free end. The interior of the ceiling 60 can be provided with a ribbed or coarse pattern or a release surface to prevent the free end of the flexible flap from l~hPring to the ceiling 60 when moisture is present on the ceiling or the flexible flap. The valve cover design 50 is fully shown in U.S. Design Patent Application 29/000,382. Another valve cover that also may be suitable for use on a face mask of this invention is shown in Design Patent Appli~qtion 29/000,384.
Although the unidirectionql fluid valve of this invention has been described for use as an eYhq-l~qtion valve, it also c~n be possible to use the valve in other applic~tionc~ for eYqmrl~ as an inh~J~qtir~n valve for a r~spildlor or as a purge valve for ~ ntS or positive l~reSi~un, h.olmPt~.
Advantages and other ~ealur~s of this invention are further illustrated in the following ~ pl~s It is to be eA~r~ssly und~,~lood, however, that while the eY~mples serve this ~u,~se, the m~tçri~ ÇCt~ and amounts used, as well as other conditions and details, are not to be construed in a manner that would unduly limit the scope of this invention.
Example l (Finite Flemçnt Analysis: Flexible Flap Exposed to 1.3 ~) In this FY~ml)le, finite elem~-nt analysis was used to define the curvature of a valve seat's seal ridge. The curvature collesponded to the defor",ation curve exhibited by the free portion of a flexible flap after being e ~posed to 1.3 g of accel~ ,~lion. The flexible flap was co",posed of a naturalrubber cclllpound cor.~ 80 weight percent polyisoprcne, 13 weight percent zinc oxide, 5 weight percent of a long-chain fatty acid ester as a plqstici7pr~ stearic acid, and an ~ntioxitlq~nt The flexible flap had a mvteriqldensity of 1.08 grams per cubic cent;l.~et~ (g/cm3), an u1tim-qt~ elongation of 670 ~r~ent, an Illtimqt.o tensile sllclglh of 19.1 .~egPr-~-wl~ns per square meter, and a Shore A harness of 35. The flexible flap had a free-swinging length of 2.4 cm, a width of 2.4 cm, a thit~ness of 0.43 mm, and a rounded free end with a radius of 1.2 cm. The total length of the flexible flap was 2.8 cm. The flexible flap was sllbje~t~d to a tensile test, a pure she. r test, and a biaxial tension test to give three data sets of actual behavior. This data was 213~76~
Wo 93/24181 Pcr/uss3/o3797 ,~ .
ed to Png;n~;ne stress and eng;nP--.;~ strain. The Mooney-Nvlin conC~ were then ga~ ~ using the finite rlpmpnt ABAQUS co""~uler P1~Z51~UII (av ilable from Hibbitt, ~rqrlcsQn and Sorensen, Inc., Pawtucket, RI).
After ch~L;,~e col,lpu~r cim~ q-tions of the stress/strain tests against the S empiricql data, the two Mooney-Nvlin concl; nl~ were det~,l,~led to be 24.09 , nd 3.398. These col-~t~n~c gave the closest numçril sl results to the actual data from the tests on the flexible flap mqteriql.
Input p~"~t~ describing the grid points, boundary çon~iitions, and load were cho~Pn, and those ~.,~ t. . ~ and the Mooney-Nvlin constants were 10 then in~,~d into the ABAQUS finite cle~ nt CO1JI1)Ul~ p~ ull. The shape function of the individual cl~-----nl~ w. s sPlP~ted to be qll~ir~qhic with mid-side nodes. The gravitqhonq-l co~ct-qnt was chosen to be 1.3 g. The angle of rotation e from the hori7Ontq-l for a maximum deformation curvature was de~l",~ed to be 34 degrees by rotating the gravitational vector. A Ç~l~ ssion 15 of the data gave a curve for the valve seat defined by the following equation:
y = + '0.052559x - 2.44S429x2 + 5.785336x3 - 16.625961x4 + 13 787755xS
where x and y are the abscissa and the ordinate, respectively. The coll~ldlion coPfficiPnt squal~d was equal to 0.99, in-ii~ting an eYcPll-Pnt cGllelalion of this equation to the finite.~lc...~nt analysis data.
A valve seat was m~çhine~l from alu",ihlu,l, and was provided with a seal ridge that had a side-elevational curvature which collei,~,onded to the above derollllation curve. A circular orifice of 3.3 cm2 was provided in the valve seat. The flexible flap was rl~m~ to a flat flap-~ ;ning sllrf~c~. The flap-l~!~;n;ng surface was spaced 1.3 mm from the nearest portion of the orifice tangential to the curved seal ridge. The flap-re:~inin~ surface was 6 mm long, and traversed the valve seat for a tlict~nce of 25 mm. The curved seal ridge had a width of .51 mm. The flexible flap rem~ined in an abutting rel~tionchip to the seal ridge no matter how the valve was oriPntPd. The seal between the flexible flap and the valve seat was found to be leak-free.
The ,.,,n.,"~ . force f~uiled to open this valve was then detel"lined.
This was acco",plished by ~t~hing the valve to a fluid-permeable mask body, taping the valve shut, and "loniloling the pres~ule drop as a function of airflow volume. After a plot of ~lessulc; drop vasus airflow was obtained for a fil~rin~ face mask with the valve taped shut, the same was done for the filtPring face mask with the valve open The two sets of data were co",palod.
The point where the two sets of data diverged l~pl~nled the initial opening of the valve. After many repetitions, the average opening pl~S~Ul~, drop was de~.lllined to be 1.03 mmH20. This pl~s;,ule was converted to the force to levitate the flexible flap by dividing the press~ needed to open the valve by the area of flexible flap within the orifice. The area of the flexible flap within 213~7~
Wo 93/24181 Pcr/uss3/o3797 the orifice was 3.49 cm2. This gave an open~ g force of 0.00352 Newtons.
The weight of the free-swinging part of the flexible flap was 0.00251 Nt_~. lons, and the ratio of the opening force to the weight gave an operationalpreload of 1.40 g. This ~luantily is close to the chosen gravitqtiQnql conshl t 5 1.3 g, and the extra force may be taken to be the force needed to bend the flexible flap during op~ning.

r:x~lllyle 2 (Finite FlemPnt Analysis:
Flexible F!3~ Exposed to a Uniform Force) In this Ex ul1plc, finite e~ n~ analysis was employed to define a valve seat where the flexible flap would exert a umifo~ force on the seal ridge of the valve seat. The flexible flap that was used in this Example was the same as the flexible flap of FY~mpl~ 1. The ABAQUS co---pu~r program of Example 1 was used in the finite elen e~t analysis. The analysis was a large 15 deflection, non-linear analysis. The force factors that were used in the analysis were kept normal to the surface of the flexible flap. An iterative c~lcul~tion was employed: a curve was calculated based on the previous force vectors, and that curve was Up~tPcl and a new curve was then obtained. The converged numeric~l equation for the curve was obtained when the 20 derol-..alion curve did not change signific~ntly from one iteration to the next.
The final curvature was tr~nCl~tp~ into the following fifth order, poly,.o...ial equation:
y = 0.01744x- 1.26190x2 + 0.04768x3- 1.83595x4 + 2.33781x5 where x and y are the abscissa and o~inate, le~ ely.
Example 3 ~Finite Element Analysis: Flexible Flap Exposed to 1.3 g) In this Example, as in Example 1, finite element analysis was used to define the curvature of a valve seat's seal ridge which co1lesl,onds to the curvature of a free portion of a flexible flap which was eA~sed to 1.3 g of acceleration. This F~mple differs from Example 1 in that the flexible flap was made from co---poui-d 330A, available from Aritz-Optibelt KG. The flexible flap had a m~ten~l density of 1.07 grams per cubic centimeter (g/cm3), an l)ltim~tP el~ ng~ti~n greater than 600%, an llltim~t~p tensile sllc;nglll of 17 me~a.~wlons per square meter, and a Shore A h~dness of 47.5. The geometry of the flap was the same as for the flap in Example 1. When the rubber was subjected to the same testing as in Example 1, the Mooney-Rivlin constants were del~l---ined to be 53.47 and -0.9354. The first col.sl~ t shows this m~tPri~l to be stiffer than that of FY~mple 1, also shown in greater Shore A harrlness.
When a 0.43 mm thick flap made from this m~tPri~l was in~t~llP~ on the valve seat of Example 1, the rubber sealed uniformly across the entire Wo 93/24181 2 1 ~ ~ 7 6 4 Pcr/US93/03797 ;"~
-valve seat curve. However, becaus~ of the greater s~;rrl~ps~ of this mqtPriql, the oppning pl~ul~ drop was slightly higher than the mqtPriql in F~
When a thinner flap of 0.38 mm was in~qll~ to lower this p~s.~e drop, this lower thic1~n~ss did not lie ul~if~ ly across the valve seat, lifting up slightly 5 in the middle of the curve. However, the flap could be made to lie u~iÇo~ ly and le. k-free across the valve seat by either moving the flap-~h~ surface closer or by slightly qlt~-ring the curve of Exa-m--ple 1 to make it shallower.
The ABAQUS p~ l was used in Ex. mple 1 to obtain defo....-~;on curves for this mqt~riql The gravit-qtion-q-l co~ct-q-nt was chosen to be 1.3 g to 10 yield a defollllalion curve having a pre-load of 30 ~r~nt of the weight of the flexible flap. In this case, the angles of rotation e from the hori7Ont-q-l for a ~umu~ defo....~l;on curvature were de~l.,-ined to be 40 de~;,l~s and 32 degrees for the flap thic~ o-c~s of 0.38 mm and 0.43 mm, lespe~ ely.
Regression of the data gave curves for the valve seat having the following fourth order polynomial equations, for 0.38 mm thick flap:
y = -0.03878x - 0.91868x2 - 1.13096x3 + 1.21551x4 and for a 0.43 mm thick flap:
y = 0.00287x- 1.03890x2 + 0.19674x3 + 0.20014x4 where x and y are the abscissa and csldinale, le~ ely.
These curves are shallower than the curve obtained for the rubber of Example 1, showing that the pre-load of the rubber of this Example when applied to the valve seat curve of F~ plc 1 will be greater than 30 percent.

Fxqmplçs 4-6 (Comrqrison of Valve of '362 Patent with Valve of this Invention) In Fxqmpl~s 4-6, the eYhqlqtiQn valve of this invention was cGIl~ Gd to the exh-q-lqtion valve of the '362 patent. In Example 4, the ech-q-l-q-tion v~ve of Example 1 was tested for the valve's airflow resict~nce force by placing the eYhqlqtion valve at the opening of a pipe having a cross-sectional area of 3.2 30 cm2 and ",~c,;i~g the pressure drop with a manometer. An airflow of 85 I/min was passed through the pipe. The measured pres~ul~ drop was multiplied by the flexible flap's surface area over the orifice to obtain the airflow reCict-q-r~c~ force. The data gathered is set forth in Table 1.
Examples S and 6 ccslle~ d to eYqmpl~ 2 and 4 of the '362 patent, ~c;s~i~ely. In examples 2 and 4 of the '362 patent, the length and width of the flaps were ch-q-ng~, and e. ch valve was tested for its ples~lre drop at 85 liters per minute (I/min) through the s. me nozzle of Example 4.

~) 93/24181 ~ Pcr/l)s93/~ 97 _ .

Or~ffcc ~rea ~ ,ei,.,,e ~rop Res~stance Forcc E~ample ~ (cm ) ~ (Pasca.s) ~ Ncw~on~) 4 5.3 26.46 0.0140 5* 5.3 60.76 0.0322 6* 13.5 17.64 0.0238 *Comparative examples corresponding to examples 2 and 4 of the '362 patent, lespec~ ely.
In Table 1, the data demollstrates that the e~h-qlA~ion valve of this invention (E~ample 4) has less airflow resis~qnc~ force than the exh~ ion valve of the '362 patent (Examples 5-6).
Example 7 (Aspiration Effect) In this Example, a normal exh-qlqAtion test was employed to demonstrate how an eYh-ql~ion valve of this invention can create a negative pres5ulc; insidea face mask during eYh~lqAtion.
A "normal eYhql-q.~ion test" is a test that simulates normal eYh~l-qtion of a person. T.he test involves mounting a filtering face mask to a 0.5 centimeter (cm) thick flat metal plate that has a circular opening or nozzle of 1.61 square c~ntime~rs (cm2) (9/16 inch divqmeter) located therein. The filtering face mask is mounted to the flat, metal plate at the mask base such that airflow passing through the nozzle is directed into the interior of the mask body directly towards the exhAlq~ion valve (that is, the airflow is directed along the shortest straight line di~t-q-nce from a point on a plane bisecting the mask base to the exhalation valve). The plate is attached horizontally to a vertically-oriented conduit. Air flow sent through the conduit passes through the nozzle and enters the interior of the &ce mask. The velocity of the air passing through the nozzle can be determined by dividing the rate of airflow (volume/time) by the cross-sectional area of the circular opening. The pl~ss~lre drop can be determined by placing a probe of a manometer within the interior of the filtering face mask.
The e~hql-q-~ion valve of E~ample 1 was mounted to a 3M 8810 filtering face mask such that the e~hA~ on valve was positioned on the mask body directly opposite to where a wearer's mouth would be when the mask is worn.
The airflow through the nozzle was increased to approximqtçly 80 ~/min to provide an airflow velocity of 8.3 meters per second (m/s). At this velocity, zero pr. ssu~e drop was achieved inside the face mask. An ordinary person -~ i 6 0 5 5 7 - 4 8 7 6.~

W(~,~/241~ 4 ~ ~ ~ PCr/US93/03~.

will e~chale at moderate to heavy work rates at an applo~ t~ air velocity of about S to 13 m/s de~ ding on the opening area of the mouth. Negative and relatively low plessulcs can be provided in a face mask of this invention over a large portion of this range of air velocity.

Fl~pnutle 8-13 lPiltenr~ Pace M~Tr of th s Invention -- Measure of ~s~.l,e Dro~ ~n~pcr~n To~tal Flow T-h-rou-~h the - F.hq1~ion V~1ve ~ ~ Puncaon Tot~l Atrflow Thron~ph F~ c~
The efficiency of the e~h~1q~ n valve to purge breath as a percentage of total e~hq1~tior flow at a certain ~ s~ure drop is a major factor affecting wearer comfort. In E1~amples 7-12, the e~h~l~ticn valve of E~cample l was tested on a 3M 8810 filterin~ face mask, which at 80 ~/min flow has a ~,lcssule drop of about 63.7 p~1s. The e~h~1a~iQn valve was positioned on 15 the mask body directly c,p~site to where a wearer's mouth would be when the mask is worn. The ~essule drop th.~lJgh the valve was measured as described in E~cample 7 at different vertical volume flow rates, using airflow noz7l~s of different cross-section~l areas.
The percent total flow was de~. n,ined by the following method. First, 20 the linear equation deselibing the filter media volume flow (Qf) re1~tion~hipwith the piesslle drop (~P) was found with the valve held closed by correlating e~cperimental data from positive and negative pless.ne drop data (note: when the plesaule drop is posidve, Qf is also positive. The plesa~le drop with the valve allowed to open was then measured at a specified 25 e~h~ ion volume flow (QT)- The flow through the valve alone (Qv) is calculated as QV = QT - Qf, with Qf c~1cu1~t~l at that ~esaO~e drop. The percent of the total esh~1~tion flow through the valve is c~lc~l?ted by lOO(QT - Qf)/QT- If the plessure drop on eYh?l~ion is negative, the inward flow of air through the filter media into face mask will also be negative, 30 giving the condition that the flow out through the valve orifice Qv is greater than the xhalation flow QT. The data for pressure drop and percent total flow are set forth in Table 2.

. - 19 -fL~
~ 60557-4876 ~w ~

~p~ Jn~'t~ ~a:~I.U~c~ 0.:~6~ i5~ 4~
8 12 9.02 8.92 8.92 1 2 2 ' O 9 24 15.09 14.21 11.17 19 24 39 48 18.62 14.99 4.31 30 60 87 11 60 20.48 15.09 -1.76 56 68 102 12 72 22.34 14.80 -7.55 61 73 112 13 80 24.01 14.41 -12.94 62 77 119 o 21347~
Wo 93/24l81 Pcr/uss3/o3797 .~
In Table 2, the data shows that for low ~o.~ nl.. airflows an increase in airflow causes an incl~se in p~ssu~ drop (18.1 cm2 nozzle). Low Illo",r~ ", airflows are rare in typical face mask usage. NonçthP~o~s~ the percent total flow is greater than 50 percent at above applo~imatply 30 e/min S (Examples 1~13). A typical person will exhale at about 25 to 90 ~/min ~epen-ling on the person's work rate. On average, a person exhales at about 32 ~/min. Thus, the face mask of this invention provides good co"~roll to a wearer at low mo...Pntu... airflows.
At higher mG..~ntu... airflows (obt~ned using a 2.26 cm2 nozzle), an 10 increase in airflow causes a lower pl~S~lc drop than the 18.1 cm2 nozzle.
As the airflow is increased, the effect of aspiration becomes appa~e"t as the p~ U~ drop reaches a mq~i...u... and then begins to decrease with increasing airflow. The percent total flows through the eYh~1~q~ti~n valve increase with higher airflows to greater than 70 percent, thereby providing better comfort 15 to the wearer.
At the highest mc....cnt~l... airflows (using a 0.95 cm2 nozzle), the pressulc drop increases slightly and then decre. ses to negative qllqntitiPs as airflow incl~ses. This is the aspiration effect and is shown in Table 2 as percent total flow qu-qntitips that are greater than 100 ~.~nt. For inst. nce, in Example 13 the percent total flow at 80 l/min is 119 ~,~n~: where 19 percent of the total volume flow is drawn through the filter media into the interior of the face mask and is e~ p~ out through the eYh-q-l~tiQn valve.
Various motlificqtions and q-ltP~tiQns of this invention may become ap~ ;nt to those skilled in the art without departing from the invention's scope. It thel. forc should be understood that the invention is not to be undulylimited to the illu~l-dted embo~imçnts set forth above but is to be controlled by the limit~tions set forth in the claims and any equivalents thereof.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. A unidirectional fluid valve that comprises a flexible flap having a first portion and a second portion, the first portion being attached to a valve seat, the valve seat having an orifice and a seal surface that has a concave curvature when viewed from a side elevation, the flexible flap making contact with the concave curvature of the seal surface when a fluid is not passing through the orifice, the second portion of the flexible flap being free to be lifted from the seal surface when a fluid is passing through the orifice, the unidirectional fluid valve being characterized by having a concave curvature corresponding to a deformation curve exhibited by the second portion of the flexible flap when exposed to (i) a uniform force that acts alongthe length of the deformation curve normal thereto, (ii) a force acting in the direction of gravity having a magnitude equal to a mass of the second portion of the flexible flap multiplied by at least one gravitational unit of acceleration, or a combination of (i) and (ii).

2. The unidirectional fluid valve of claim 1, wherein the concave curvature corresponds to a deformation curve exhibited by the flexible flap when exposed to a uniform force that is not less than the mass of the second portion of the flexible flap multiplied by at least one gravitational unit of acceleration

3. The unidirectional fluid valve of claims 1-2, wherein the concave curvature corresponds to a deformation curve exhibited by the flexible flap when exposed to a uniform force having a magnitude in the range of the mass of the second portion of the flexible flap multiplied by 1.1 to 1.5 g of acceleration.

4. The unidirectional fluid valve of claims 1-3, wherein the flexible flap has a stress relaxation sufficient to keep the second portion of the flexible flap in leak-free contact to the seal surface under any static orientation for twenty-four hours at 70°C when a fluid is not passing through the orifice.

5. The unidirectional fluid valve of claims 1-4, wherein the orifice is 3 to 4 cm2 in size.

6. The unidirectional fluid valve of claim 1, wherein the concave curvature corresponds to the deformation curve exhibited by the second portion of the flexible flap when exposed to a force acting in the direction of gravity and having a magnitude equal to a mass of the second portion of the flexible flap multiplied by 1.1 to 2 g of acceleration.

7. The unidirectional fluid valve of claim 1, wherein the concave curvature corresponds to the deformation curve exhibited by the second portion of the flexible flap when exposed to a force having a magnitude equal to a mass of the second portion of the flexible flap multiplied by 1.2 to 1.5 g of acceleration.

8. A filtering face mask that comprises:
(a) a mask body adapted to fit over the nose and mouth of a person;
and (b) an exhalation valve attached to the mask body, which exhalation valve comprises:
(1) a valve seat having (i) an orifice through which a fluid can pass, and (ii) a seal surface circumscribing the orifice and having a concave curvature when viewed from a side elevation, the apex of the concave curvature of the seal surface being located upstream to fluid flow through the orifice relative to outer extremities of the concave curvature; and (2) a flexible flap having a first and second portions, the first portion being attached to the valve seat outside a region encompassed by the orifice, and the second portion assuming the concave curvature of the seal surface when the valve is in a closed position and being free to be lifted from the seal surface when a fluid is passing through the orifice.

9. The filtering face mask of claim 8, wherein the concave curvature of the valve seat corresponds to a deformation curve exhibited by the second portion of the flexible flap when the first portion of the flexible flap is secured to a surface and the second portion is not secured and is exposed to a uniform force that acts normal to the deformation curve or a force having a magnitude equal to a mass of the second portion of the flexible flap multiplied by at least one gravitational unit of acceleration.

10. The filtering face mask of claims 8-9, wherein the exhalation valve has a single flexible flap that has a single second portion that is located below the first portion when the filtering face mask is held in an upright position, and wherein the concave curvature is defined by a polynomial mathematical equation of at least the third order.

11. The filtering face mask of claims 8-10, wherein the filtering face mask demonstrates a negative pressure drop when air is passed into the filtering face mask at a velocity of at least 9 m/s under a normal exhalation test, the negative pressure drop allowing ambient fluid to pass into an interior of the mask through the filter media.