Title of Invention


Abstract An absorheni interiabial device worn by female wearers for cauwncnial purposes. incontinence proteedon, or botli, is disclosed. The absorhrnt interlabird device of the present iuvenhiofl includes a liquid pen-ions iupsbeel. a liquid impervious baekslscet, and an tibsorbent core positioned between the two. The length of the device is between about 60 mm and about 130 mm. The with in between about 25 mm and 50 mm. The device has an axii of preteired bending along us Icriginidinal centerline, When folded along the opus and inserted into tile wearer"s intcrl&hial space, the tupshect maintains contact wit the wails of time wearets laths. A method of using a system of feminine hygiene products is also disclosed. The system includes the use of an absorbed inserlabial dovice in combination with a sanitary napkin. The absorbent inlerlabial device of the prescar invention may also be used in combination with an absorbent tampon. The absorbent interlabial device may be packaged in a earnaica package with a SnnitAr-y napkin or a tampon as a feminine hygiene kit.
This invention relates to absorbent devices. and more particularly to an improved absorbent device that is vvorn imerlabially by female vvearers for catamenial purposes, incontinence protection, or both.
All manner and variety of absorbent articles configured for the absorpiion of body fluids such as menses, urine and feces are well known. With respect to feminine protection devices, the art has offered two basic types; sanitary napkins have been developed for external wear about the pudendal region while tampons have been developed for interna! wear within the vaginal cavity for imerruption of menstrual flow therefrom. such tampon devices are disclosed in U.S. Patent No. 4,412,833, entitled "Tampon Applicator", issued to Weigner, et al. on November l, 1983, and U.S. Patent No. 4,413,986, entitled "Tampon Assembly With Means For Sterile Insertion", issued to Jacobs on November 8,1983.
Hybrid devices which attempt to merge the structural features of the sanitary napkins and the tampons into a single device have also been proposed. such hybrid devices are disclosed in U.S, Patent No. 2,092,346, entitled "Catamenial Pad", issued to Arone on September 7, 1937, and U.S. Paient No. 3,905,372, entitkd "Feminine Hygiene Protective Shield", issued to Denkinger on September 16,1975. Other less intrusive hybrid devices are known as labial or interlabial sanitary napkins and are characterized by having a portion vvhich at least partially resides within the vveareťs vestibule and a portion which at least partially resides external of the wearer's vestibule. such devices are disclosed in U,S. Patent No. 2,662,527, entitled "Sanitary Pad", issued to Jacks on December 15, 1953, and U.S. Patent No. 4,631,062, entitled "Labial Sanitary Pad", issued to Lassen, et al. on December 23, 1986.
Interlabial pads have the potential to provide even greater freedom irom inconvenience because of their small size and reduced risk of leakage. Numerous
attempts have 'been made in the past to produce an interlabial pad which would combine the best features of tampons and sanitary napkins while avoiding at least some of the disadvantages associated with each of ihese types of devices. Examples of such devices are described in U.S. Patent 2,917,049 issued to Delaney on December 15, 1959, U.S. Patent 3,420,235 issued to Harmon on January 7, 1969. U.S. Patent 4,595,392 issued to Johnson, et al. on June 17, 1986, and U.S. Patents 5,074,855 and 5336,208 issued to Rosenbluth, et al. on December 24, 1991 and August 9, 1994 respectively, and U.S. Patent 5,484,429 issued to Vukos, et al. on January 16, 1996. A commercially available interlabial device is the "FRESH 'N FIT PADETTE" (also knovvn as "INSYNC" or "INSYNC MiNIFORM") interlabial pad vvhich is marketed by Athena Medical Corp. (now known as-A-Fem) of Poriland, OR and 'described in U.S. Patents 3,983,873 and 4,175,561 issued to Hirschman on October 5, 1976 and November 27, 1979, respectively.
Many of these devices have not niet with great commercial success, howevei. There are drawbacks associated with ail of the above products. For example, the device described in the Delaney patent does not appear to be capable of an easy and comfortable insertion, due to the possibility of the layers of absorbent material opening up during insertion. The commercially available "PADETTE" ( or "INSYNC") interlabial device suffers from the disadvantage that many consumers fmd ii difficult to insert properly and may cause some consumers discomfort especially if not properly inserted. Even when such a device is properly inserted, it may tend to allow by-pass flovv around its edges. such fiow can cause body soiling or panty soiling which many consumers fmd unacceptable. Additionally, previously knovm interlabiai devices such as the "PADETTE" interlabial pad may not reliably cover the urethra and/or the vaginal introitus during alľbody movements (e.g. when tne wearer is squatting). such products may also not be reliably expelled when the wearer urinates.
Therefore, a need exists for an improved interlabial device which will reduce the incidence of body and panty soiling when used. such a device should be easy to insert and be comfortable during vvear. A need exists for an interlabial device which also covers the walls of the weareťs labia throughout a range of body motions and reliably covers the vaginal introitus and preferably also the urethra during such motions. A need also exists for an improved absorbent interlabial device which may be used as part of a system of feminine hygiene protection or with a feminine hygiene kit.
This invention relates to absorbent devices, and more particularly to an improved absorbcni device that is insertable into the interlabial space of a female wearer for catamenial purposes, incontinence protection, or both.
The absorbent interlabial device of the present invention comprises a liquid penious topsheet. a tiquid impervious backsheet which is joined to the topsheet, and an absorbent core positioned between the topsheet and backsheet. The length of the absorbent interlabial device is greater than about 60 mm and less than about 130 mm. The width of the device is betvveen about 25 and about 50 mm. The width and length of the device each exceed its thickness. Additionally, the device comprises an axis of preferred bending, preferably located generally along the longitudinal centerline of the device. When the device is folded along ihis axis and inserted into the weareťs interlabial space, the Topsheet mainiams contact with the walls of the wearer's labia.
In a preferred embodiment, the length o f the device may be between about 90 and about 105 mm. Preferably, the liquid pervious topsheet may be constructed of rayon or needle punched rayon. The absorbent core may also be constructed of rayon, cotton, or a blend of rayon and cotton. The backsheet of the absorbent interlabial device is preferably water dispersible. Preferably, the device comprises biodegradable materials. A tab may be attached to the backsheet of the device to facilitate insertion and optional removai of the device with the fingers.
The present invention also relates to a method of using an absorbent interlabial device, such as the absorbent interlabial device described above, as part of a system of feminine hygiene products. The method comprises the sieps of inserting an interlabial device into the interlabial space of the vvearer, placing a sanitary napkin in the crotch portion of a panty-type undergarment, then pulling the undergarment mto its usual wearing position without removing the sanitary napkin from the undergarment or the interlabial device from the vveareťs interlabial space such that the sanitary napkin rests adjacent the pudendal region of the wearer and the interlabial device and the sanitary napkin are worn simultaneously. In preferred methods of the present invention, the method may ŕurther include the steps of removing ihe interlabial device prior to urination then, subsequent to urination, inserting a new interlabial device which is wom simulianeously with the sanitary napkin. Optionally, the interlabial device may be expelled by urination, then a
second interlabial device may be inserted into the wearer's interlabial space and worn simultaneously with the sanitary napkin.
In another aspect of the present invention, the invention comprises a feminine hygiene kit. The kit is comprised of a sanitary napkin and an absorbent interlabial device packaged in a common package. such a kit facilitates use of a system of feminine hygiene products such as in the method described above. The sanitary napkin and interlabial device are each adapted such that they may be worn simultaneously. Preferably, the absorbent interlabial device included in the kit has all of the preferred features of the absorbent interlabial device described above.
The absorbent interlabial device of the present invention may also be used as part of a system of feminine hygiene products in conjunction with an absorbent tampon. such a method comprises the steps of inserting a tampon into the vaginal cavity of the wearer, inserting an absorbent interlabial device into the interlabial space of the wearer, and wearing the tampon and the absorbent interlabial device simultaneously for a period of time. The absorbent interlabial device used in such a method comprises a liquid pervious topsheet, and liquid impervious backsheet joined to said topsheet, and an absorbent core positioned between the two.
Another feminine hygiene kit comprises the absorbent interlabial device of the present invention packaged in a common package with an absorbent vaginal tampon. The absorbent interlabial device comprises a liquid pervious topsheet, a liquid impervious backsheet joined to the topsheet, and an absorbent core positioned between the topsheet and the backsheet. The absorbent interlabial device is adapted to be worn within the interlabial space of the wearer wherein at least half of the device resides within such interlabial space. Each of the absorbent vaginal tampon and the absorbent interlabial device are adapted such that both may be worn simultaneously.

According to the present invention there is provided an absorbent device comprising a liquid pervious topsheet, a liquid impervious backsheet joined to said topsheet, and an absorbent core positioned between said topsheet and said backsheet, characterized in that:
said length of said absorbent device is between 60 mm and 127 mm, preferably between 85 mm and 127 mm,
said width of said absorbent device is between 25 mm and 40 mm,
said width and said length of said absorbent device each exceed said thickness of said absorbent device,
said absorbent device comprises an axis of preferred bending. RRTEF DESCR1PTION OF THR ACCOMPANYING DRAWINGS
While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter which is regarded as forming the present invention, it is believed that the invention will be better understood from the following description taken in conjunction with the accompanying drawings, in which:
FiG. l Is a top pian view of the absorbent interlabial device of the present invention.
FiG. 2 is a cross sectional view of the absorbent interlabial device of the present invention. taken along line 2-2 of FiG. 1.
FiG. 3 is a side view of the absorbent interlabial device of the present invemion.
FiG. 4 shows the absorbent interlabial device of the present invention folded along the axis of preferred bending and being grasped for insertion by the wearers fingers.
FiG. 5 is a cross-sectional saggitai view of a human female wearer showing the placement of the absorbent interlabial device in the wearer's interlabial space.
FiG. 6 is a typical prior art sanitary napkin which may be used in a method of using a system of feminine hygiene products or as part of a feminine protection kit of the present invention.
FiG. 7 is a typical prior an tampon which may be used in a method of using a system of feminine hygiene products or as part of an additional feminine protection kit of the present invention.
FiG. 8 is front view of an individual package for the interlabial device in an unopened condition.
FiG. 9 is front view of the individual package in an opened condition with the folded interlabial device inside.
FiG, 10 is a pian view of an apparatus suitable for flushability determination according to the method described in the TEST METHODS section, below.
FiG. 11 is a cross-seciion of the flushability apparatus of FiG. 10 taken along line 11-11 thereof.
The present invention is directed to an absorbent interlabial device. FIGS. i-3 shows one embodiment of an absorbent interlabial device, interlabial device 20. The present invention, however, is not limited to a structure having the particular configuration shown in the drawings.
As used herein the term "absorbent interlabial device" refers to a structure which has at least some absorbent components, and which is specifically configured to reside within the interlabial space of a female wearer during use. When the absorbent interlabial device 20 is properly sized for an individua! wearer, more than half of the entire absorbent interlabial device 20 of the present invention resides within such interlabial space. Preferably substantially the entire absorbent interlabial device 20 resides within such interlabial space, and more preferably the entire absorbent interlabial device 20 resides uithin such interlabial space of a female wearei during usc.
As used herein, the term "interlabial space" refers to that space in the pudendai region of the female anatomy which is located between the inside surfaces of the labia majora extending into the vestibule. Located within tni s interlabial space are the labia minor, the vestibule and the principal urogenital members including the clitoris, the orifice of the urethra, and the oriilce of the vagina. Standard medical authorities teach that the vestibule refers to the space bounded laterally by the inside surfaces of the labia minora and extending interiorly to the floor between the clitoris and the orifice of the vagina. Therefore, it will be recognized that the interlabial space as defmed above may refer to the space between the inside surfaces of the labia majora, including the space between the inside surfaces of the labia minora also known as the vestibule. The interlabial space for purposes of the present description does not extend substantially beyond the orifice of the vagina into the vagina! interior.
The term "labia" as used herein refers generally to both the labia majora and labia minora. The labia terminate anteriorly and posteriorly at the anterior commissure and the posterior commissure, respectively. It will be recognized by those skilled in the art that there is a wide range of variation among women with respect to the relative size and shape of labia majora and labia minora. For purposes of the present description, however, such differences need not be specifically addressed. It will be recognized that the disposition of the absorbent interlabial

device into the'iuterlabial spacc ot'a wcaier JUÄ defined abovŕ wilj require placcment betwecn the inside surtaces ofihe labia majora withoui reftard to thc ptfrcise lucatkm of ihe boundary belween the Jabia m ajmira and the labia minum for a particular wcarer. For a more detaileO description of tri i s portiun of the fcmalc iumtomy, iiuemion is divcciei.l to Gray's Anatomy, Riuuung Press 1901 F,d, (1974), at 1025-1027.
The absorbcni interlabial device 20 shown in FiG. l has a longitudinal ccnterline L which rum along tltr. "x" axis. The tcrm "loiigiludinal", as uscd hcrŕijj, refers to & linc, axis or direction in the plane yf the interlabial devici- 20 that is gcnerally aligued with (c.g., appio\imately porallcl to) a verlical plane which hi.cts a standing wcnrer iutu left and right body hiilves when tho intcrlahizil device 20 is wora. The terms "transversc," "lateral," or "y direction" as used herci n. aic interchangcable, and refer to a Hne axis or direr.tion ilial is generally perpcnditular to ihe long,Uudmal direction, ľhe latcial direciion is shovm in FIG. l as the "y" direction. The ab.sofbc.nt uilcrlabial device 20 shown in FIG, l aleo has a transvctse ccntcrli.nc T. The "2" dircction shown in FiG, 2, is D direr.tion paiallel 10 thc vertical plono described ubove. The term "upper" rcfei-s to an orientation in the /-directinn toward the wfiarer'3 hcad. "Lcwcr" or downwardly is towiird the veareťs feet.
A.s shown in FIGS, 1-2, the imeddbiai device compriscs at leasi a liquid ptľviuus topsheet 42, a liquid iaipervious backshect 38 joined to the topsheet 42, and axi obsorbent core. 44 positioned betwccn thc topsheet 42 and thc backsheet 38. Tlie inteildbial device 20 must be of a suitable size and shape ihat allows at least the majority oťthe device 20 to fit comfortably within the wearerfs intcrlahil spav« and to covcr the w$arer'3 vaginal orifice, and preferably al.so the wrcar«ťs ureihra. The interlabial device 7,0 al least partially blocks, and more preferably complctftly blocks and intereepts the flow of mcnses, vuliie, and other bodily cxiidates ŕrom the weorer'a vaginal orificc and uretlua.
Tlie size of the intcrlahial device 20 Is importartt tn iu comfort and eŕfectiveness. Ihc lengtli yf ihe absorbcni interlabial device 20 is measured aloug thc longirudiiiai centerlinc L in the lungitudinal direction (or V-dirtiĽtion), Thc 4bsorb«m intcrlahiAl dtvive 20 preferobly has a leugih L, which i5 greatcr than abuui. 60 mm and kss than about 130 mm. More preferobly, the Icngth L, is betwccn alout 90 mm and about 105 mm. The width oťthf. intedabial device 20 is mcasured along the tran.svťrse centerline ľ in tbc. traiivtirse direction (or "y"-direction). The
absorbent inlertabial device 20 ptv.fcrably has a width W, wluch is beuveen about 25 mm and about 50 mm. Tlie tihickness (or caliper) is the "z" dircction dimeasion of the device 70. Caliper mcasuremcnt.s iven herein wcre mcasurtd using an AMES gage with a 0,25 psi (1.7 kPa) (gauge) ioad and a 0.96 inch (2.44 cm) diameter foot. Tho3C skiilcd in the art will recognire that if a 0.96 inch (2.44 vra) diameter ibot i* not appropriate for a particulju sample aizc, the tool size may be vari c d -while the Ioad on thc gange is accordingly vaned to maintain a coniining pressurs of 0.25 p:\ (l .7 kPa) (tiauge). Tlie caiipei T, of The absorbcni intcrlabial device 20 is äess than the width w[ and thu length L, of tbc device 20. Preferahiy thc Ľyliper T, of the absurbent interlabial device 20 is Jess ihan or cqual to about 8 mm, more prcťťrably ihc calipcr T, is less ihan about 6 mm, and cven more prcferahly Ir.ss than about 4
Constnii:(jon gf ;he absorbent inierlabial device 20 according tn ihp particuiax ptuameters given abovc. rtiulih in a product with increased ccmtbri and effectivenesa coropared lo previous interlabial dŕviĽes. For examplc, rnany woajen Htid interlabial pads which are sboiler than ihe absorbent interlabial device 20 of thc present invention (such as previous intcrlabial pads) to be difficult tn posili on properly within ihe interlabial spaoe. Even if such pads arc positloned properly they have an increoscd tcndeucy to allow by-pass ilow rď budy exudates aiouiid the rdgev oťthe pad. AdditionoJly, prcvious pads were not equipped svith a iiquid impen'ious backsheei. Thcac pads, thcrcfore could oJlow body aud panty ioiling as o rcsnlt of contact with iltc bottom surfacc oť tiic pad
Tlie interlabial devicp 20 is preferably providcd wiih sufTicient absorbency to absorb artd rctaui the exudftteg discharged &um the weaier's body Thc eapacity of tlie product, howcvcr, is depcudent at least pariinlly upon the physicai volumc o ť the obsorbent interlabial device 20, Thc absorberil interlabia! device jMcferably has a cŕipaciry of at least about t g of 0.9% by weight saline solulion, and may have a capaoity oťup fo aboui 30 R by using absorbeu( gels or foams that cxpanH when vet. Tapacitics may iypically range. from about 2 to ahout 10 yrams, for salinc. Preferably, the cqificily of the device 2U is gtcater than about 6 g for salinc. Those skilled in the art wil] recognis-e diat ihe capacity for ahsorption of body exxidatcs such as mcnses will typically DO smallcr rhnn the capacitier, givcn abovs for ahsfnptjon of saline. A mcthod fcu measuring absorbent cňpŕtĽ'Uy is dejcribed in thc Test Methods ser-tion, bclow, Since thc mtcvlabmi ypace can expond, lai-grr volumes can bf. stoied in the Interlabial spai.r, if the iluid is storcd as a gel, which adjusta lo Uje body pressurcs. Adrliliunally, if the Qbsorhŕ.nt itucrlabial device 20 doc.s uol
residc complctsly wUhin the Nvcairr's imerlabiai spar, some of ťnc exudates may bc stored externally to the w-carcr's inierlabial spocc,
The: individual component.s which may bc suitabte for the vannus cmbodiments of thc sanitary napkin 20 of thc proseni invenuon will now ] iooked at in grcatcr deixil with referen.cc to FIC3. 1-3,
The topheet 42 Compiises a firsi liquici pcrvious Cumponeut, Thc 42 should be coinpliant, soft feeling, and nou-ariiating to thc weircĽ5, skin. Fuither, tlie lupsheet 42 is liquid priviuus pennitting liquids (e.g., rnenses ond/or vjrinŕ) to readily pcnerratc through its thicknc.ss. A suitable topshect 42 may . manufaciured fixjcn a wide range oť matciials suĽh as wovt;n and nnwoven materials; polymcric itittteriat.s .such as tpnured fonticd thcnDoplatstic fUms, aperturcd pkstic illms, and hydi-ulornied thermoplatotic fdrns; porous foama; reticulatcJ foamň; rcticulatcd thermoplastic tilujs; and thermoplastic so.rj.nis. Suitable wovcn and nľnnvoven materirtls can be compriacd ot'n.atm-iil fibers (o.g.„ wood or cotiuci fibers), synthetic fibers (e. g., polymerk fibers such as polycsler, rayon, polyprnpylcne, ur e fibers) or from a comlnnation of naturai and syntlictic fibers.
A suitahlf topsliccL 42 for uac in thc pi.rsc.nt invention is a nnnwoveu matenial fornitid of rayon fibtrs with a basis weight oť ahmit 18 g/m and is available from Veratec uf Walpole, MA sold uuder ihe deaignatjon grade 93 13709070. This raaieriol ts particularly suitable for use as a topshect 42 bacause U b n bicdegradablc material.
As used Lierein. the tcrm "bindegradable maTerials" rctcrs to' a material having Rreater than or cqual lo Hbout 70% biodcgradation (pcrĽentage of thcoretical carbon dioxide cvolution) after 2S day wheti uieasured according tn the Stunn Test whiĽh has been dcsignstcd Mclhod 301B by thc Ocgunization for Economic Cooperatinn tnd Devslopment. Prcferahly, ihe materials comprisinf the prcsant invention hav a biodcgradation. of greater than about 80% and, more preferably, biodegradation is greater than or equal to ahnut 90%,
Tlie topsheet 42 may al.so uomprise an aperturcd fonned film, Apetturcd formed films am pcrvious to body cxudatcs and, if properly apetiurcd, have a reduced lendency to allow liquids lo pass back through and iewcl the xvearer'a skin. Thus, the gurfacc of ihe formed film which is in conUct witii thc body dry, thereby body soiling and cieating a more comtortable. ľccl for the wearer. Suitable formed ťilms flve dcscribed in U, S- ľatcnt 1,929,135, entitJed "
Strugturcs liaving Tapered Capillorics", whicli issued to Thompsou un December 3U, 1975; U.S. Patent 4,324,246 euiitled "Disposabte Ahsurbem Ariicie Having A Stain Resistant Topsheei". which issucd to Mullane, et al. on Apnl 13, 1982; U, S, Patent 4,142,314 emitled "Kesilicm Plaslic Web Exhibitiug Fibar-Like Propertics".. whicb issued to Itadel, d al. on August 3, 1982, U.S. Patent 4,463,04i emhlad "Macroscopicdlly Expanded Ihrcc-Dimeusional Plastic Weh Fxliibitmg Non-Glosay Visible Surface and CInth-Like Tactile Imprcssion", which issued to Alv, ci a!, on July 31, 1 984; auj U.S. 5,006.394 "Ninliilayer Polymeric Film" Uutod 10 Buird nn April 9, 1991. A prefcrred ľbrmed film topshftel for the present invŕntiou is the formcd tilm desĽribed in one or more uf the above patente and maiketed on sanitaiy napkins by The Procter &. Gamble Company of Cincinnati, Ohio as i ke "DRI-WEAVE" tnpsheet.
Auuther suitoblc topsl'iect 42 for the prescnt inveatiun is rnade m with U.S. Patents 4,609,518 and 4,62'A64T botU issued to Curro ct si un September 2, 19Hf irid December 16, 1986, i?ipctively. such a ťnnned film is manuťactured by Tredegar (.'orporation of Terre Haute, Indiaim.
in H preferred erabodimcnt of the present inventina, Lhe body surfacc nf the ibnned film topiheit is bydrophilic to hcJp liqnids transfer ihrough rht topsheet 42 fastcr th?in if ibe 'jody surfacc was noi hydrophilic so as to dimiuisb the liJiclihood that mensirual fluid v-ill iluw off the topghcet 47. .tather than fiowing inro and beinfi absorbcd hy tlie absorbem corc 44. Tlie body suďace of the tnpshtxt 42 oan be rnade hydťophiUc by trcating ii with a surfactant sur.h as is described in U.S. Patent 4,950,254 is.sucd to Osborn, III. In t prefrred cmbodiniťni, surfactŕmt ia .incorporaied intc the pfilymeik materials of the farmed film topsheet.
The inner .surface of topshcct 42 may be securcd in contŕiciing relatioo with an \iuderiying absorbcni layer, This contacting relationship resuhs in liquid penetrating topiheet 42 faster, The toplic;t 42 may be kcpf in y Ľontacting rclationsliip with an luadcrlying, Inyer by bonding the topsheet. 42 to \hc underlying layer. Howcver, it is cot absolutely ncccssry ty bund tlie face oťthe tupvheet 42 to the face uf the underlying layer. The topsheet 42 can be tuaintained contact with an underlying absorbcni vomponent, by cntauglinps the flbers oťthf luidcrlyinc; Jaycr with the topsheei, by fuaing the lupsheet 42 to an uiulerlyinfi absorbent iayŕr b) plurality of discretc iudividual fuoion bond.s, ur by any means loiown m the urt.
It is not-nccessary ihat the lopshect 47 comprise a layer or maimal which is separate or d ISŤ met ftom the absorhent core 44. The topsheet 42 and absorbcnt roi-e 44 may consist of onc unitaiy slructure in w'hich tlie body-contocting siirfacx of ihe absorbent core 44 wul serve os tht liquid pervious topsheet 42. In such an cmbodiuient, the liquid pcrvious body contacting surface may be hydiophniĽ or treated ao aa to render u hydrophuic such that fluids readily pcneiiiuť ihrough the surfaee and into the intcrior of the absorbent core 44. Additionally, the umtary topsheet 42 and absorbent core 44 may be pruvided with a pore sizc, capillary, or hydrophiliciiy gradicnt to assisl in the absorption am.l retention of fluids in the interior nťthe absorbant core 44.
Th& absotbent cors 44, wluĽh is best sccn in l'lfi. 2, i positioned bctween tha topshcct 47. and ihe backsheet 38r Ihc ahsorbent core 4-1 providc.s the meariK for ahiorbiug e.xudates such as mcn.ses and other body fluids. The absorbent corc 44 preferably is gencially corapressible( conthrmablc, and non-irritating to the user' skin.
The absorbei.u Ľure 44 may compnac any suitable material that is capahle uf absnrMug and/or retaining liquids (t.g, menses anďor unnc). Preierably, the absorbent corc 44 has the same general shapc as tlie uverall absorbent inicrlahial device 70. Tlie absorbent corc 44 (and ihe uberali absorbent intcrlabi! deviucr 20) iuwy be manufacturcd in a widc variety of shapcs. Non ľuuiiing examples of shapcs for the ahsorbeiu core 44 when vicwed ťroui ihe top as Ln FiG. l indude o.rjid, elupuĽal, trapezoidal, rcctangular, triangular, diomond-shpcd or any combination of ihc abovc. A.s shown in FiG. l, the prctericd slvapc for the absorbcni core 7.2 and ihe uvetall absorbent intcrlabil devk-e 20 is fienerally ovoid or ellipiical.
The ah.sorbťut core 4-1 be manuťctiued from a wide variety of liquid-absorbem materials commonly nsed Ln absorbent articles SUC!A a s Ľomminuted wood pulp which is gencrally wferred to aa airfcJt. F.xauiples of other suitablc ahsoibem matŕ.rials include cotton fibers viť eolton lintels, crcpcd r.rllnloit: waddtng; meltbtown polymcr.s Jncluding coforra; chcmically siilyned, modificd or cross-linfced cellulosic fibers; synthctic fibeu such as crimpcd polyester fibtirs; peat moss; tissue includmg tissuti sviaps and tissue lamiiMtcs; absorbent fooms; abiorbeitl spongcs; ;uprabsorbent potyracis (in fibrous and particuinte ibrrn); absorbent gelling roatcriaJ.s; or miy equivalent material 01 Ľombinations of materials, or of uiese, Preferrcd ab.-sorbei.il maierials compriac ťoldr.d tiiiucs, cotton s, woven luGtcrials, nni)wuven webs, rayon mcluding necdle punched rayon,

tliln layers oť foarn. The absorbent corc 44 may comprise a smgle materia!. Alternativcly, ih absorbent corc 44 may comprise a combinatiun uf materials.
A particularly prcťcned material for thc absorbcni core 44 ia bart oť my on or a rayon/cotton hlend A tri-lobed rayoa kuown as GALAXY rayon available irom C\i uliati l d y Fibers. Inc. oť A.XIS, Alabama has becn found to work well for thc material comprismg the absorbent corc 44.
Tlie backshaet 38, which ii best shown in I;1GS, 2 and 3, prcvcnts (he exudatcs absorhŕd wd contained in thf: absvrbtint core 44 from wťtiing anicies anfl/'or body pans which may coalact ihe abaorbent inrerlabial device 20 such as pants, pajamas, \mderyaniienTS, pubic hair, the wearer's thijhs, ctc- The backsheet 38 shouM ba flexible ond impcrvit.ius to liquids (e, g,, mcnsss aiid/'or uiine),
The bftcksh?et 38 is impen'ious to liquids (tr.g., menies and/or urint) and is prcľerably flexible. As uscd hercin, tlie. terna "flexible" reťcr? to materials which orc Ľympliant and WiM re?fi.!Jly conform iO the general shape and comours of thc Iniiuan body. Tuc backsheet 38 Qlao providej protecuon for thc wcaveľ's frngers as the iibsorbent interlahia! device 20 is inserteti, or as ihft device is opiiooally rcmovcd
The backshect 3 S may cumprise a wovcn or non wn v en material, polymcrie films such as ihermoplastic filma nť polyetiiykne or polypropylcnc, composite nwierials such as a ftim-coated uunwoven material, or oigaiiic material such aa a collagen tilm. The backsheet may be made irom a polyethylcnc film having a thickiicss of from about u. 017 mm (0,5 raill to about 0.051 nim (2,0 mila). An exemplary polyethyiene film is mantiťacturcci by Clopay Corporation ot CiuĽinnatt, Ohlo, under the designation PI 8-0401, The backshcct may permit vapors to escapc from the device 7.0 (J.c., bs bieathablc) whilc st.ill preventing exudatcs imm pasiiny thrmigh tlie backsheet.
Preferabiy, thc backsheet 38 is dispersihle iind/or dissolvable in water, Polyvinyl ak uhol iincluding co-polymers of poly'inyl atcoliol) has beea found to bc suitable as a material fur a dissolvable backahw.t 38. The poly'inyi alcoho! may be coatcri with a tissue, with a wa or otlicr hydrophobic coating to rcduce ihe rate at which it dissolves in whter. This allows thc backslieel 38 to mointain its integrity dunng iisr, while retaining thc ability tu dissolve in watcr during dii-posal of the device 20.
'Fhe kmi "dispersible" ai appliťd herein to an absorbcni interlabml device or f\ component thcrcof refers to an articlc or mŕiierial which will di.sprrse into at least tWO frflgmcnts in mildly agitated wier. such a device will break imo piccc.s !n a couvencional toilet am:l/or domestic piumhing system, and will uhlmately be eficctivdy piucessed though a sewage trcatment systcm. The im ''dissolvablc1' a /ipplied herein to fln absorbcni interlabial device 01 a component thercot'rcfei lo m aniclc or mtcnal which will at least psrtiblly dissolve and cssentially assumc liquid focm ur otheoviac be indisiinguishable to thc naked eye Trom the liquid medium in which it is dissulved.
The components of Lhe absorbcni intcrlabial device 20 deäcrihŕ.i-1 abuv (topshf.ct 42, bacKsheei 38,, absorhcuf Ľore 44) can be aascmblcd in nny suitablc uianner. In thc preferrcd embodimenl shovs-n in FIGS. 1-3, the componcnts oťthr main body purtion are assemblcd ia & "sandwich" configuratiou with the iiomponems sized so that thc edät of the topsbcet 42 and backsheet 38 extcnd outwcrd heyoud thc ndgss of the absorbcni corc 44, The iopsheei 42 ancl backsheet 38 aie preferably at least partially peripherally joincd uiing kinown lechjiiques. As showTi in I-'ICIS. l and 2, the topsheet 42 is prcfeiably secured to backsheet 18 along a seam, such as seam 60. Seam 00 is preferably liquid impcrvious. The seam 60 can be formcd by ?my menni} comrnonly used in ihe ttrt for this purpose such as by glning, crimping, or heot-scaling. The- ieam 60 and The arca oťthť-. mteiubial device 20 in the vicmity of the seam 60 should bc soft, compressible, and conformahk If thc seam 00 and surrountiing area are tou stiif or non-comprcasihle, tlie wearer may tixperience discomtort. wlicn wearing the interlahifll device 20.
The lerm "joined," as used hereiii, encompasses coniigurations iu which aii element is dircctly sccuted lo another element by aťfixing ll;c elemem dircctly to the other clemeul; Ľonfijgurattons in whir.h the element in indircctly sccureil u the other element by affixing the ť leme m to intetmediotc membcľ(s) which in turn are aiiixed to the other element; and configurations in which one element ia integral with the anotlier element, i.c.. one clcmem ia essemially part ot the other
ľhc c.ompoueni of the absorbcni inteiliibi device 20 can bc jninfd together by adhesives, atitching, hcar tuid/or pressure bonds, dynamit; mechanical bondi, ultroaonic bondv, interraingling or entanlcmenl of the fibers or othci structural clemenis comprisirtg the compunenis of the absorbcnt intcrlabial device 20, aucn as by meltblowing tlie fibers comprising onr cornponem onto another cnirqx'nent, extruďmg, one component ontn ariothei, ur by any other means km.iwn in xhe art, Thc
ť.uraponents of thc absorbcni interlabial device 20 may be joined wuh wai;r soluble adhesivcs in order to increasc thc teadency of the device 20 iu disperso into a plurality of fragmcnts in miully agitated watcr (sneh as iu a coileť).
Prcibrably, ihs inierlabial absorbťul device 20 of thc prestiu invention is toilŕt-disjpysable. Thc tcrm "tnilei-disposable" QS user! herein includea the ťollowing characteristics of au absorbent interlabial device: flushabilif, dispersibtlity, aettlcaľulily, disintegrateability, and biodegtadability. As used herein the. tcrjn "flushablc" and "flushability" refer to A produĽťs abiiity to pas iliuujh typicalJy commerci'dJly available hoMArholil Loileis and plumhiug drainage systcms witl)uut causing ctogging or similar problcms that can be direciiy swciaicd with ihc physical stiuclure of the prodlict. il is recognized, howcver, ihat thero can bc irmny differences bctween thc various types of toibu avaiiablc. 'ľhcrŕfore, for the purposes ofthe appended cloims, a test u determinc the flushabiliiy of a catamcmaJ product, such as on absorbeut interlabial device, is stft out in the JKST METhODS section oť.this specillcation.
"Senleability-" refcrs to Lhe tendency of an ŕibuorbem imerlabial device, such as absorbcni iotcrlabi-al device 20 to cvealually settle to the botiom of a septic tank or other iewage treatmcnt system rather ihan to tlnat on ihe surface of such tiiuks or
y, the abaorhent inierlabiaJ device 20 of ihe presant invention is toilet-disposablc and wi.ll dispetse bito at leasi two fragmento within twy hours of exposure to tnildly agimtcd rormi iemperature water as described in thc Wa(ec Dispersipn Test in tl\e TEST METh(jn,S sectiun, below. More preferably, the interlabial absorbem device 20 will bc dispersed into a plurality of fragments with'm ŕbout tio minutca or, cveu more prefcrably within about 30 minntcs itnd most prefersbly, witiiin about 15 minutes as measured by thŕ Waier Difiperaion 'ľcsr. Prefejrably, tho product will break into firagtncnh whlth are smallcr tlwn nlM( 6 in-, more prcferabiy smaJler ihan about 2 in, uiosl preferobly smaller ihan about l .ä iri-2.
In panlcularly preferred embodiments of the present invcntion, ftiich of the componcnts nť il K; interlabial absorbcnt device 20 wiil di.sperit- into a plurolitj' rif tragnitrnu when immcrseť? in uiitdly agitatcd svätci. Auernatively, thc components of the absorbent interlabial dcvio.ŕ. 20 mny separate f r nm each Oiher withni:i-thcmselves breaking into n pluialiijf of fragment s (c. g. ihe topsheet 42, harkslifei 38. and core 44 may hrcaX a.part from cach other while each othcnvisr remiiinjnp. intact).
frefetably. tlie. absorbcni imerlabial device 20 compriscs matcrials. While biodegradablc material 'are preferred for the absurbent inter!abil devicr 20, it iS not nccrssary lliat eacil and cvcry material used be hnrlcgradable. For example, the device 20 may comprise superabsorbent particle-s which do not Modegiadä, and thi3 Wiil not nffect ihe abtlity oť ŕhc overall device 20 to remaui toiiet-disposablc tid io be effectively professed ia a sewngc trcatmc-nt s
The absorbent intcrlahiiil device 20 of thc presenc invention in its ťully assetnhlcd r.onťjgumtion compriscs at leasl one axis of preferrcri bcadiag A, The axii uf preferred bcnding A is preferably locatcd ginrraJly along The longitudinnl centcrline 1. rf uic absorbent interjabial ricvice 20. .Tho axis of preicrred bending A is a hne or axis along whic.h the absuibent interlabial device 20 will lend tc bcnd nr fold whcn subjcctej co compressivc forccs F dixected imvardly in the trmisverise dircx-tiyn at iho sides 32 of thc device 20. The axis oť preferred bendin# A may result naturaily ťroľu ihe product coiďigtiration, or t]; device 20 may be impacled with a weakened axis or region in ajiy or all of the topsheet A?., baeksheet 38 and core 14 to crcatŕ; th axis of preferred bcnding A, such a weakened o\is my be creŕitcd Ľy uny variety of knovm tcclniiques such as scoring, pre-foldmjj, alining, or the like. Thc absorheui interlabial device 20 may comprist: a region of preferred bending uiade up of a plurality oťflvcs of preferred bending. Any number of such may comprisc such a regiuu of preferred bcnding up to ui infinice number.
The abiurbtint imerlobiai device ?.0 is folded along the axis of preferred bcnding A, 03 shovm in FTG. 4, prior to insertion within the wearer's i 3pace. Once iuserted, the device 2u will preftuably tend ro unfold slightly the topsheet 42 of thc dcvk-t 20 iu contact with tbc inncr walls of the wearer's labia. The do-ice 70 may b resiliently biased slightly atons the axii of prcťctTŕd beoding A to increase the tcndency nf the device 20 to unfold. This nllows ihe fotded device 20 to act as a "spring" under both wct and dry coudttions and consequcntly, m increaKc. the tendency of thc tnp.hcet 42 of the device to remain iu uunuct with the inner surfaccs of thc labiu when the absorbent ivttfdabial device 20 is in phrc. A device 20 conetructed according tu ihe preferred embodimŕnt de.scnbed above, however, does not uc-i-essarily require ony additional slxuctural feature a to provide thc ability to tnaintain such cnntact. The namrally moisi surfac-e,', uf the labia will have a tcndency to adhere to the material cnmprising ihe topsheet 42 further temjing io kee.i ihtf device 20 in contact with tht: inner surfaces of the lahi.i
.The absorbcni mtertabial device 20 dcscnbed herein is both iiexible and compreasible. Flexibility and compreibilky are important to pioduct comport. Iť the absorbem Interlabial device 20 is too flexiblc, the device is not convcnifcntly w easily placed hetwceu ihe foldg Oi" thc lahla, if it is too stiff, thc device is uncomfcutable and when thfi user Is in a sitting position, the pjuduct can bc forccd forward against the clitoris causing discomihrr
Thc absorbent iotcrlabial device 20 of the prcse-nt invemion is belic vcd to uffer several advntaycs over previous intcrlabial pads. Devices con?truetcd with the size ranes and prcferrcd shapes described above have been found to bc panicuiorly suitcrl for leliable insertion hy a variety of wearers. Additionŕdty, ihe devica 20 descnbed a.bovc have, bceu foiind to be particularly ŕ.ffeťiive at catcbing clots which may hr. fonneil frqm menstrual discharges. This clot catching ahribute ia helicvcd vj b enhanced by the gcnftially fiat topsheet 42 oi'the devica 20 which is fylded along the axis of preferred bending A in use, The foldud configuration oťtiie device 7.0 when properiy sizcd as described above a]Iov,'3 for consisTe.ut coverage of the walls of thc lahia and tlie vaginal introitu3. liuch coveniae substantially rcducei. thc incidence of "by-pasa" aroimd the device 20 by menstrua! or otht-t bodily s which are cxhibhcd by previous imerlabial
Superioi performance in acquiring meustrual dischargef;, ond ciois in particular, is demonatratcd by au absorbent interlabiai device 20 ui ihc nľc.:,',:ni invention as dcscribcd above in w'hich thc topslietil 42 and the absorb.-.ni r OH 44 compristi rayon.
Vhc pre.ferred shape of the abaorbcnt inteilbial device 20 shown in TIOS. 1 3 (i.e. one in wbich thc device is iiipcred ai the ends) diows thft device lu easily and comfonably fit tlie wearer's imertabial spacc. A device- 20 with such a tapered shape, whťn folded along an axis of preferred bending A (as in ľ'IG. 4) will have a profile in which hightst point aJoiiR the oxis of bcnding A (as measured in thc "7"-dircction) is in ihe vicinity of thc center cifthe device 20 rather than at the ends.
The liquid impcrvluus backsheet 38 of thc alisurbĽnt interlabial device 20 is atso rcsponsible for improvcd prodncl performance. As described bove, the backsheet reduces thc likelihood of body or clothing soiling fiom dischaŕgc which oic ahorbed by the device 20, Additiotľrtuy when the device 2i) is folded nlong the a.xis of preferrcd bending A. the backsheet 3S will fnrm a rtttÄs 62 which protects the wcarer's tlngcrs from soiling whcn the device 20 is inserted.
Previous inicrlabiai pads have not combined thc attribule uf the device 20 nť the present invcntioii to obtain the pertormancŕ. and comfort resuhs dcscrihe.d herein. Scvcral (urvious pads consistcd rf a small general [y cylindricki ly shaped absorbcnt material which ia inscrted into the interlabial spaue. These davicca were uoi providcd with a liquid impervious backslicel. Consequently, they are characterized by a less cJeonly insertion and remova] and may bt assuciated with incrcascd pauiy and body soiling in comparison to ťhe pieseul device 20. Othcr previous pads did include an imperviou-s hckslniret, but the pods werc uťh larser than thc device 20 of the prcseui tnvention and included signilicant ponions which re.sided exrernally to llie interlabial spocc. such Jcsitins may also Icari lu increased body soiling as dischorgcd bodily fluids migratc to thc cvtťtmal surfaces of auch paihs. AJditionaily, fhc interlabial device 20 nť tlie present invention is believed to offcr comfnrt advantogcs (e.g. leduced wearing awarcne.ss) as uompared to the abovodescribed iargfir prior arc pads.
It has heen fuund during devciopmcnt of the proent invtntion ibat the absoľbcju interlabial device 20 bctter confomns to thc lahial vault than previously available intcrlahial pads, Addilionolly, the generally ilat and folded configuiation of' ihe absoibent interlabial device 7.0 uf the presant invcntinn is found 10 give Ď licriter visual indication ro users as to how to irscrt and ust: Ihe device. Thcrcihre, thc device 2D uf ihe present inventiotl is assouated with an casier and mure accujato uisenion as compared to pieviyus interlabial pada.
The aburbwu imeriobial device 20 is preferably provided witli ;tn optionai reuiuval tab 52 joined to the backsheet 38. Thc tah 52 may be made of a vanety of matcrials and ucoi not be absorbent. The tab 52 may be formed rrom M nonxvoven nihierial which is beat bonhed to ti ussue laycr, A suitable nonwoven material i? kno\Mi os CX1ROLIND and is avoilable fronv Curovin, Gmbh. Pcine, Cernikuiy, A siiitable airJaid tissuc is availahlc from Merfin hygcm'c Products, Ltd., of Delta, Britiah Coiunibia, Canada, having a basis weight of about 61 g/m and having ihe designaiiun Rrade numbcr 176.
Thc tah 57 may ba of any suilahk size which providcs for a cinvenient finger grip during insertion ?ind, opliunaJly, removal of thc device 20. In thc preferrsd embodiment shmvn in FIGS. 1-1, the lab 52 is about 20 mm lung, and about 13 uim in height (i.c. mcflsnrcd in Lhe "z" dircction aťtcr atlhĽhmenť).
Thr tnb-52 i& prefcr&bly joincd to ihe suriQcc of the backsheet 3 S which face away from the topsheet 42, The iab 52 provides H location for the wcare.T to grasp the device 20 duriny insertiorv. 7ht absojbem interlabini device 20 is desifiDed to be cxpelled by urination. The \b 52, however, may proviue an altamativc meclvuiism for rcmoval oťrhc device 20 (i.e. rcmowil with the fmgera),
As previously discussed, the absorbent interlabial device 20 of the rtresent invention is desiyned to be placed within tlie interlabial space nť a wearer. To usc tlie absorbem intcrlabial device 20 of the prescnt inventioii, ihe wearer grasps the. tnb 52 of the device 20. If ihe device 20 is not ptuvided with a tab 52, uie wearer may hold the folded device 20 i the vides 32 and bcgin inseitjon. The device 20 is thcn fxirther inscrted by pushing with a finger or (Ingers in the recess 62 fomieJ by the tbldedbiichiheeTSS.
As shnwn m FIG 4, the foldcd device 20 forms a reeess 62 within the fulded biickshccl 38 which coveo the lips of the weareť3 ringers diuiny; insertion. This feature provides ťoi a hygienic insertion oťthe absotbcnt interlabial device 20 uf the prcsent iiivention. The wcarcr may asiume a squatting positinn iJuring insertion to assist in apreading the labial surfaces, FiG. 5 show; t preferred embodimcnl of the absorbcni interlabil device 20 o.f the puceni invention insertcd into the mterlabial spuce of a weorcr W. ľhe urugerutal members 3hown in FiG. 5 include the bladder B, the vagina V, the urethra u, the cliioris C, the large inicätine T, tlie anus A, ihe vaginal introitus VI, the hyineneal ring h, the labia minoiaN, and the labia majora J FiG. 5 shfw:ŕ ihe relattonehip oi these anatoniieaj feature3 of the we.arer W to the absorbem interlabial device 20 whn the device is propedy insened for use, Once 'the absorhent interlabisd device 20 is imcrteil, ihe topsheet 12 tends to idhejc to the inside surfaces of tbc labia. Wlien the wearer is standing, the. labial walls close more lightly flround the folded absorbant intcrlabial device 20.
Thť incerlabial device 20 is preferabiy at leost parfinlly itlained in place by exerting a slight Iŕiierally outwardly-oricnted pressura on Ihe inncr aurtace of the wcflťer's labia minora, labia majora, ur both, Additjonaily, the. product may also bc held by attraction of iiaturally raoist labial surfaĽes to the material comprising iha topsheet 42. Optionally, the topsheet 42 of the device 2i) may be pryvided with a bio-compatiblc adhesive to asBist the adhesion of (lic device 20 to the inside Biirfaveij of the weaier'ii labia. The strength of such an adhesive shoulri be. seleuted to assist vh absorbent interlabiŕil device 20 in staying in -plate, while still allowing fyr rcliablCj am:l cumfonable reraova! nťthc- device from the wcareťs inic-rlabial space,
The absorbcni imerihbial device 20 can be woni os a "staad alonc" prnruiei. Additionally, vuperior performancc in redudng body and clothin voiling over cxttnided periods of wcar fime (such as overnight) can bc obtained by u3ing fhc absorbent intcrlabial device 20 as part oť a usys(em" of feminine hygienu pruducts. dne such system whlch is etrei-.tive in reducing soiling is an absorbem interlabial device, such as ahsurherK interlabial device 20, which is wom aimultaneonsly with a saniirtry napkin, such as aanitary napkin 70 (shown iri hu. (\).
Sucb a system of an interlabial device in combination with a .snniťary uapkin is more effeciive than cither a samiary napkin or an intcrlahial pad wom alonc. The absorbent intcrlabia! device used in the system of thc present invcntion may, and pretcrahly does, hav all oť the prcfeucd anributes of th ahsurbent interlabial device 20 describcd fibove, The sanitary napkin 70 uf the present systcm may be any suitable Ľunventional sanitary rwpkin, The sanitary napkin 70 preferably Ľpmprices at Icast a liqiiid pervious topshect 72, TI liquiu impen'ious backshcct 74 jomed to uul topsheei, and on absorbcni corc 7(5 posilioned bctwtcn The lupsheot 72 and the backshcct 74. Addilionally, the soniiary napkiri 70 preferabli' includc f\ prcssure scnsiliv(r adhesive 80 disposed on ihc garmem facing sidc of thc batksheet 74, The adheaivc 80 allo; ilie sanitary napkin 70 tr hc adhtred to the crotch portion of thc wearer's undergarments. Wben the uaJerearmentG orc wom in (lidr nsiidl wearing position, thc samtary mapkin 70 will rest adjaccnt tlie- pudendal region of thc weareťs body. The sanitar)' napkin 70 may also be providcd with adulidunal ftr.ulures commonly found iri sanitary napkins, including wings" ur "flaps" such as ingg 78, A suitable sanitar)' napkin for usc i a the above-described system is the "ALWAYS" ultra thin Maxi wit1i Winys saniury napkin which is niaiiufactured and packaged by the Procler & Gamble Company oť Cmcijuiali, Ohio undcr one or mm-e oť II.S Patents: 4,312.314; 4,463,045; 4,556,146; BI 4,5h9,fi76; 4,687,478: 4,950,261; 5,uu9,6S3; • 5,267,992; 5,413,568; 5,460,623; 5,462,166; 5,48(J;2R3; 5,569,231; and Re, 32,649. Other sanitaiy napkins are also ooccptahle, such as ihose withoui wing3 78 or tho&e which are not of thc "uirra-tliin" lype.
In 01 der to use an absorbcni mterlabial device and a aanitary napkin as a system Of fcmininc hygiene products, the wcarcr inscits ihe absorbent intcrtabil device into her interlabial spacc and places a sanitary napkin in ihe cratcli portion. of a paiuy-type undcrgannenl. These two Steps may bc peiformed in eithcr order. Somc women ill prefer to place thc sanitaty napkin in u\Q panty crotdi first in oitler to catch and absorb and diops of mensiruttl flow which might be released pnor to the timc thar tbc absorbent interlabial dcvicft t:n be insarted. Other womcu

lu first inscrt thc absorbent interlabial devica Afler the absorbcni device is inserteil and the sanjtary napkin is poshioned in ihe undetgarmem crotch, the umlergarment la pultcd up iuio its usual wcartng jiusiiion. Consequently, the sanitary napkin wiu reste adjacent thc pudendal region of the woarcr's body iuid will bc wom simullaneously with the bsurbent interlabial device.
Preferahly, the absorbent intcriabial device used with thc ahove-Jscribed system is chiinf.ed each time t lis wearer urinates. Triŕ. associaied sanitory napkin may bo worn dimng fyr lonper pcriods oť t'unc (i.e, beyond thc changuiu of ihe absorbcni iuicrlabial device) bccansc Lhe blllk of the bodily fluiJs will ba dcposittd on and absorbcd by thť interlabial device as oppused to thc samtaiy riapkin, Particulaľly if the absorbent interubial device 20 is providcd with a tab 52 for removal, some women wiJl prefer to removc the absorbent interJabia] dcvicft 20 priur to urination, thcn subsequently re-inserl Lhe same device 20 iťii lias nul yet absorbcd ucar its ftill capacity.
The sdiiiiary napkin and thc absorbent intorlabioi dcvirc of ih above-dtstribed system may hc packaged in a common package as a femininc hygiene "kit." such a kii lacilitates use of thc system of the present invcntion. Pirlerably, the [.)tiukaginR associated with such a kit will includc instructiuiis un how to use thc absorbont intcrlabiat device and thc sanitary napkin according tc the above-described intfthod as o ayatcm of feimmne hygiene products.
An altcrnate suitable system ol ťcminine hygiene produds comprises the absnibenL interlabial device 20 of tlie present invemion used siiuultaneously with an absorbont tanapfin= sneh os tampon 86 ahown in FiO. 7. The absorbent tampon uf this system of feminine hygiene pruduct may be ony smtable convenuonal tampon inc.uidiny any of the tampons syld under ihc tradcmaik " and disoibuted by 'lie. Procter & Gamble Company uf Cincinnati. Ohio, The tampon used may bc siiher of thc applicatot irtyjrtion or digiia! in.sprtiou type and any suilable applicator knnwn in Lhe art may be uscd. Thc tampon is first uiserted bito thc vaginal cavity of the weaier. Following iiiierrion of the tampon, tlie absorbent inierlabial device is inscrte-ťl into ih intetlabial space of thŕ v-earer. The inierlabiaj device and thr tanipun are then worn simultontruusly for a period oťtimr, The absorbent interlabial device may be rauovtfd and chongcd each tiiue. the wearer Sj or may be rcmoved tbeu re-inserted subscqucnt to urination.
. Similorly, the alľst.irbent tampon and the ahsm-beut bterlabia] device 20 of thia system may also be packaged in a f.ommou packajje as a fcmmine hygiene kit, Tl\h kii facititatas uac oťthe altcrnine system of thepresent ii
Systems and ayyociaied kits of the pvicnt iuvention may also com.prise the use of cm abanrbent Juierubial device, tampon, and sanitary napkin. Kits compnsmg all tlure types of fciflinine hygiene products may alao he packayed in a comuion package nnd include apprupriaie instructions ťrr use of such systems,
In addition fn llie systems describcd ahovc, tlie absorbent intcrJabial device 20 may be wom simultaneously with a paniJiiner, or incontincnce pad for menstruoi or inoontinence ac. Tbc absorbent interlabiat device 20 described nbovc may be combinf.d and packafied with a pantiliner, an incontinence pad, or a simitary napkin to ibnn a feminine urinary incontinence kit. Sneh aii iacontinence kit preťeutibly includcs apj.irupriate packaging matťriat iuslructing the wcarfcr as tu how 10 us the leminine hygiene products for hght incontittcnce proteviion, The intertabial 20 con bc wom in uunventioncd panties, n u can b used with mcnsinial sl
Numsrous alternative cmbodiments of the absorhcnt interlabial device ol the present invcntion aie possible. For cxample, ihcse products are dcsigncd lu be rcmoved by urinatiotj, although an allcniative extraction string 01 loup may be uscd. These producis may fllso be used with emollients and/or medicLnal tre?ttmeuto. For cxflmple, d suitable emollient ťm ttse on the absorbcnt intcrlabiid device 20 of the presem invcntion is cumprised of obout 50% petrolatum, about 39% CciĽaryl Aicohnl, nnd about 15% Cetcarefh-10. An emollient coatmg nf abuut 0,03 g/pad haa been found to bc s
Ihc sbsorbent interlabial device 20 of the piesent invcntion my be provided with a visual indication on the center of the topsheŕt 42 designating ihc area of greoic3t ahsorbeut uapacity of tbc device: 20. such an indicatioti may Ľunsist of a differtfntly colorcd region such as apink oval. 'ľhe. indicittion may be about M nun vidc and ahoui 20 mm long. The absorbcni interlabial device 7.0 may also be piuvided with a VISUIL! change bidication, In other w:iuls, the device 20 may havr a ring, bonding pattcrn, compre33ion lints, ur other visual indicator provijtsd on the Äurface of ihe topahcct 42 at a predetennined distancft iiiboard firom the scam CO. When abaorhed bodily dischargea rcach the visual chango indicatinn or oulboard of the change indicacion, the usct iuiuws to replace the ahsorbeut interlabial device 20. such a change indivadyn is particularly uviŕul tu users who rcmovc thr device 20
prior to uilntuion and thcn re-inscrt UK same device '20 iťii has not yet reached its absorbenc capacity.
l ť fifsirŕul, the absorbcni imcrhbial device 20 may be packaged in an mdiviuual packagc, sucli a s the package 50 shown in FIOS. 8 and 9, The individual packagc .50 may be comprised ot a nnmbei uf suhable matcrials, inclmJing ťiltns and loilet-disposable matenals. Iu FIGS, 8 and 9, the pat.kage 50 is made oť a film which is franglbly sealed at the cdges. Tlis packafte 50 is providcd with au upening tau 56 which con bc of any iuilable configuration. Suititile meihods for ŕrangihly sealing paf.kage ar descrlbed in u. ti. Paieni 4,556,146 issued to Swanson miu u.S. Patent 5,462,166 iagucd to Miniun, e{ &L Suitable taba fht sxich A paukafie 5,41 3,56ti issucd to Rnach, cL al,
Tha following cxamples are presented to ptovide a more detoilcd undcrstanding uf ihe benefits which arc aťhicvej from the absorbcni inierlabial device, ihe methods ond the. kits of ihe presem invcntion. Tlie EXAMPLES are intendcd to he. rcpi'ey;nlätive, and are not intended \\i specjfically limit the scojv of fhe mveiaion.
Buse Pad l is a commercially availabk "ALWAYS" ulira thm Maxi sanitarj' napkin. Base ľad 1 is a commercially avoilablc "AtAVAVS" ultra thin Maxi with w'ings siiilary napkin, Both arc maniifactitfed by The Procter & tlamhle Cumpany of Cincinnati, Ohin.
Intcrlabial Pad l is tho commercially "IN-SWC MINIFORM" interlabial pwl (also previously knnwn K the "FRESh 'N FIT PADĽITE") manufacrured by A-Fem (prevjously kiiuwn as Athena Mcdjcal Corp.) y f Portland, OR.
Interlabial Pad 2 is ao absorbcni interlabial device nť Iie present invention conatnictcd ?is destribed above. the topihcct is 100% rayon. The corc i? 50% cotiun and 50% Galaxy Rayon. The backsheei is a polycthylene film manufactured by Clopay Corporation of Cincitinati, Dhin, nndcr flie designation P18-04u1. Tlie pad lias a removal tab constnittd of a nonwoven material hcat linuJed to a tissue layer, The nonwovcai iimterlal is COROLlNn availabltf irom Corovjn, (Jmhh, Pcinŕ, Oennany. The tiasuc is an aiiliiid lissue is availablc from Mtrrfin hygenic Products, Ltd., of Delta, British Columbia, (Janada, having the designatton grade numbcr 176. The pad calipcr is ahonl 15 mm, the width abour 40 mm, and the
icngth ahiini 85 mm. Each pad is contcd with about 0,03 g oi cmollŕeni Ľomprised uf abouc 5094 petrolatum, aboui 39% Cetearyl Alcohol, iuid about 15% Cetearcih-30.
"lahlc l below describes fly.stf.ms of pacls which arc used by groups of jnensiruating wornen for one Ľomplete menstrual cyde.' The below dcscribcd systcm.s arft iistd cxclusively during tlie cyde. The participonts arŕ insuucted to clmnge all pads cach time they urinate (about evcry 2-1 liouii), The table rcports incidcnce oťpaiuy suiJinfi associated sv-ith each sysiem or pad.
Base ľad Pad l Pad i Pad l Pad 2 Pad 2 Pad 2
iulerlabial Pad Nonc Pad 1 Pad 2 Nonc Pad l Pad 2
Numbcroť 31 3S Sfi 45 20 (A
Panty 15% 22% 13% 19% 12% 6%
As is demonstraitŕd above, significant pch-nrmaiace improvements are obtained frum the method and kit oťthe presedi invention, and from thc interlubiaJ device of the prescnt invrntioii.
TEMF.ThODS Capacitv
Absorbcni. e?ipacity may be detertnincd ns follow. The test is pcrformed OD es that have been cnnditioned by teaving them in a room at 50% relativo
humidity and nt 73"F for a period of two hours prior (o tbe tesi, The test shoiild bc
pcrfonned under similar condittons
The articlŕ is weiyhed to the neoreat 0.1 grajn. Thc article is then subnacrged in a beaker of sterile 0.9% salinc snh/tion (obtainable firoin thc Biixteľ Travenol Company of Deertieli iL), such that the ortiele is fotally submerged and is not bent or othei wisť ;wisted or folded. Thc article is submerged for 10 minutcs. Thc article is reitioved from the sŕiline and laid horizontal ly on a wire raesh screcn having square opemngs 0.25 inches by 0.7..S inches (0.64 cm by 0.64 cm) tbr flvc minutes to alloiv the salinc to hrin oui ly the article. Both sidcs nf \\K. article are then covcrcri
wŕch absorbcnt-blottera, such as the filter papcr #631 availablc from tlie Fiuration Science Corp., Eaton-Dikcman Divisiori of Mount holly iSpriiigb;, Pa. A uniform 1 pound per squorc inc.h load is placed over the atticltr to squeeze excess fluid oul. The nbaorh"ni blgiters are replaccd evcry 30 seconds until thc amonni o f fluid transfcrred it the absorbcnt blorfŕrs is less than 0,5 grams in a 30 second period. Na, the articlc is wdghed to the ncarcs 0.1 ytam and the dry iwcighi uf the anicle is i The diffcrencc ax grams ifi the Qbsorbent capac-ity of the articlc.
watei Dispersion Test
Junior Orbit Shakŕr nvailable from Lab Line lusirumems of Melrose Park, Illinois,
30 to 120 with l dcgiee divkions
Digital . Jar with Lid
1 6 M. G!assjorwithiid.
C'ondilioned Room Tempcraturc aiid humidity should bc contrnlln'l iu within the following limits:
Tempcraturc: 7330F (23°C±2QC) Ilunudiij'; 50±2% Rclativc huimdity
Tc3t Sŕtun
1.l-'ill llic yloss jar with 300 ml. of 3±3ftF lap water.
Set the spccd on thc Junior Orbit Shaker to 251) rpm to the iiianuŕacmreťs directions.

Procfidiirc 1.
hold a sample (c.g. an absorbcnt interlahiaJ device 20) 3 to 4 inches (7.6 io 10.2 cf.ntime.tvrs) above the aurface nt the water in the jar. Geady drop the sampie ontn the water surface.
Place the lid on thc jar.
3. IMŕir.e thc jai into the Junior Orbii Shaker such that thc jai is
on its sidc.
4. start thŕ Junior Orbit shaker witli the on/off switch, start mg
UK timer whcn the sliaker is rumed on,
5, Record thft time lequired until the vnmple separates imc ai
leail LWQ pieccs. Sftparation does not ineludt; the
diĎossociaiion of a fe-w individual fibc-n; flrom an othcrwise.
intact sampJe. Thc timc is ihe total time thc sample is being
Repei steps l through 5 with an additionat 3 samplcs,
CalcutatiQo anii Reponina
Calculate and xcport tlie mean and standard deviation or the water dispersibility timc for l be four saniplca
As uotej above, thc temvs "flushable or flushability" refer to a produďs capacity to pass througji typical commcrci'iijly available household luilets and plumbing flraiaiage systoms without rausing clogging or similaj problems that can liť rfirealy associated wuh ti, physical charactcriÄtics of the product. i'or tlie nijrpose of The appended claims, catamcnial proJuuts are cvaluatcrf Tur flushability via rclaflve s?ase of toilct howl ajJ Irap evacuation and subsequent transport uxiounh a simulated plumbiny sysiem. The tlu.shrtbility of such a device shuuld be mcasuŕcd hy the fullywing test procedure.
The tcrt proceuure is designcd to simulate two days of normal lotlet usagc for a family of 4 (2 men, 2 wotncn) The test etnploys a flxishhig sequencc to simulaic the fouowinf conditious: male urination visits, fŕmale virination visii.s (including post urinary drying wuh tissuc), disposal of caiomcnial product (that is, ihc interlabiaJ device or other device tu be tesied) with clftťtiiing using ti53uC and bowel movemcnt viaits. Thc amouiit of tisaue to be used for each tissue flush is a normal Inading uf 2 strips of seven shŕrts. The normal loading is based on conaumftr reseurch regording trpical habits and practices. The test is designed to simulate thc conditions a produĽt wlJl cncounter if it ie flushed through a conventionaJ toilei and into a
municipal scwer or inio a septic tank. Samples are evolimted. ťor. 1) tyilet txwl and trap rlearance, 2) dram line blockayti, and 3) disintegration during flushing.
Au apparatus suitablc ťor tlie flushabiuty test is shown in pian view in FIJ, 10. The apparatui
• a 3.5 galJon (13.2 liter) war saver siphon vortcx ttv'lct referred 10 as 210
(additinnal toilcis Ľan also be artacbed m (he piptne layout shown in FiG, 10
tu tjvaluaie thc behavior of Lest samples uaing diťťerent flushiny mechanisms
such a.s ťxuiiinťrcial, pressure toilcts);
• approximately 59 ťeet (l R meiers) of 4 inch (l u cm) insidc djtimeier acrylic
pipe (As in be seen from FiG. l (J, thn pipiuy is assembled in roughly
square configuration having liiiear rune 211, 213. 215, 217, 219, 221
approximately 10 feci (3 meters) long);
a Crtsl iron tee 223 slighdy downstrcam uf ihe toitet 210 that is opcn TO the attnosphcrc for
five ctisi iron nlnety degee clhows 212, 214, 216, 218, and 220;
222 posiŕioncd veriially (FiG, 1 1) approximatel)/ 15 feet frcm the pipc's ttuuinal end and approximatcly 1 iuĽh (2.5 cm) long; and
• a screen (No, 4 Tylcr .SIRVC) to captiire Boiid efflucnt for cvaluniua of
Tlie apparatus used foť this mtthod is set up to be cquivaJent tn ANSI Standard A112.19.2M-1990 foi Vitrt?ous China fixtures. 'ľhe pipmg is plumbed to provihe a hrop of 0.25 inch per foot (2 centimeteni/meter) of pipe length.
iissuc Product used in Test: standard "ChARMIK' toilet tissuc manufaciured by The Procter & Gamble Company of Cincinnati, Ohio.
Synthrtic Fccal Material Prepared atĽurdiiiR to the method dcscribcd lxluw
Tcsylilmhinp. Sťquence
The test ilughing .sŕi.juence simulates 2 days of normal toilet usagc for a of 4 (2 mcn, 2 woroen; based on consumer habits and practicc.1; lo'tarch). The sequence of 3;l toto! fhiihcs cousiits of 14 flushes wirh n ernpiy bowj, ii ŕluihcs with tissuťt only, 6 ilushes with tissue and a Ľatameniäl product and 6 flubes with tissuc and simulatcd fccal matrw (SFM), When it is usedŕ the SFM is placed in the bowl just prior to \\x addition of tissue. The SFM luding of 160 g - 5 g cotmsii of two ] inch (2.5 centimeter) x 4 inch (10 centimeter) piercs and une l inch (2.i centimeter) x ?. iaĽh (5 centimeter) piccc. Foideu lissue stripa (or the caiamenial pruducťj are placed in thc bowl ai 10 second intcrvala. len scrconds after the final strip or catnmcnial pruduct is placcd into thc bowl, the toiiet is ilushed. The flushing sequcncti ie describcd below a.s a series of two routinca combined in Lhe follow'ing order:
R.uutine #1 (To bc pcrfornicri firsi 6 times for a total or 30 tluihes)
1) Fiush with Tissue Only - Take a drain line l.ilutkage reading 2 minutes rtAtir the water reaches the. ilmulated obstruction, waii l minute, and muve to step 2.
Wnh Empty Bowl. ľake a drain line biockage rcading 2 minules aŕter thc wtcr reavhäa the snag point and nicive (u step 3,
J) Fli.ish with Tissue and Catamem! PiouutL - Take a drain line
reading 2 minutes after ihe water reachcs thc snag point, wait [ adch'tioaal minute, and movc to step 4.
4) Flush with bmpty Bo-wl, Take a drain line blockagn jfadins 2 minutes reaches thc snag point and move to step 5.
5) Flush with Jasne nd Siiiiuiated Fecal Matter (SFM) Take a drain line blockagc rcadinR 2 minutes aŕtfir ŕlie waler reaches the snag point, wait l additional minute.
Roitfmc #2 (To be perfurmed l timc)
1) Flush with Ti3sue Oniy - Take a drain hne biockage rcadiny; 2 minutes aner thc vnter reaches the snag point, wait l additional minute, and move to step 2.
2) Flush with Empty Bowl. Take 3. drain Imc uockage rcading 2 minutes after tlie water rcaches the snog point and movc to step 3,
3) Flush with Tissue Oniy - Titke a drain linc hluckage readin 2 minutes
cĽťter tlie water reQChp.s tlie snag poiut, wan l addttional minute, and
muve to step 4
4) Flush Wiŕ1i Empty Bowl. Tke a dram liue blookagc rcading 2 minute
ŕr the water reache ihe snag point,
TolaJ numbcr of flushes per ,sa]uence is .54.
If, aAer thc aecoud flush in the flushing acqucace, ihe product remaias in thŕ. bowl or trap aftcr .Qushing, ihc tisuä and or cafmenial prnduct is plungcd im o the drninagc line manually and tlie flushing scquence v.ill coni'uiue. Aftcr completion oi'eacli Irial loadtng, thc drainagc pipc uill be clearch pi jur w bcgjnľiing subsfequcnt
Tlie above descubŕd fluahing sequence is repcated ihrec times for cach test product,
The dcgieť of drain linc blockagc is deiermined by measuring thc Ictigth of warcr daiumed up bchind the obatniction. Graduatinus are morkcf) every 12 inchťi; (30 ctiniimcters) un the drampipe upstreom of ihe obstructirm. Bach onc iboi length that the waicr is backcd up cortesponds lo 0.25 inch (0.6 centimeter) yr 6,25% of btockage at thc nbstiuction point. Test producf residues which exit The drainpipe are alsocollcctcd.
The foilowmg data are recotded for each evaluation1.
i ) Incidence oť ťailmc (%) of caf?imental product w clear bowl atid trap in one flush

AJ uii-mcuve of iailure (%) of catameijial product to cisar bowl nd trap in
3) Inrjdenca of produĽl on simulatcd snag
4) Maximum Icvet (%) of draui line blockagi
.•5) Cumutative. levei (%) ot diuin line bloclcďge over thr 1 Jay simulated test period.
. the pioducts described hereio wih Ľompletciy clear ihe bowl at Icast about 70% rif tbs time in uvo or fcwer tKishes, mnrŕ prsferably at Icasi about 80% of thc lirue in onc flush, even moie preferably at Icast about 90h of the timt in onc ilush, and most preierably ai least about 05/0 of thc time in onc flin,h. Thc producb drscribed hcrcin will pretcrably have a maxirtiuo; Icvrl of drain liue blockage of less than or equal to about 80%. The producf described hemn wi\\ preferably havt; a. cumutativc levei of draiu line blockŕigt? over thc 1 dav si test pŕriou of less than ur equai to about 50%.
Picgatation of Svrjthetic tcg l jiateriqi I- [vigtcriaSs
svnthŕtic fecal mattct (900 (Availahle from Sllicloue studio, Valley Forgc, l'A HS product RFPS-7 dry concentratc ) Ťap wotcr at 1 00° C (6066 grams)
Mixer (Available frora hobart Corp,, Troy, Oh as Model A200) Extnidti (Availablc from hobart Corp,, Troy, Oh as Model 4812)
Duposable Centrifuge tubes xvhh screw cAps (50 ml) (Avniiable from VWR Reieulifie, Chicago, !L as Catalog No. 21-008-176)
Bath to conirul temperalitre to 37 C. III.
1, Poui' the 100° C water into the. mixing bowi uf the miiccr and add the
dr Feclone conceuiraie.
2, Mŕx oij low for \ minute.
3, Mix on mediiun speed fnr 2 minutcs.
4 Aftcr the material i s well mixed, transfer to thc e.xtruder.
5. uaing an ico pick, pmicb a smaJI hole in the tip nf each centrifuge tube.
K Extnidii tht: Feclonc into Ihe centrifuge: tubes,
7, Cap the centrifuge tubes and 3torc in the refrigcrator.
K. Beforc using, put the tube in ihe watcr bath at 38° C.
This concludes the test.
The fusclosure oťall paiems, patent pplications (and any patent which issue. thcrcoii, as well as any correspondiug publishcd ibreign patent applications), and publicationa meulioned throughout this dcs;ription arc hereby incorporated by reŕercncc herein, u is expressly not admitted, howe,ver, that any of ihe documenis incorporated by i'eference hcrŕin teach or discluue the prc.serit iuvention.
Wlťd particuJar mbodimcnis of ihe prcsent iuvention have bcn illustratcd and dtfscribcd, it would be obvious to thosc ikilied ui thc ari that vaiicnis other uhangcs anil modificfitinns can be madc without dcpartiug from thc spirit and scnpc of the. invention.

We claim:
1. An absorbent device comprising a liquid pervious topsheet, a liquid
impervious backsheet joined to said topsheet, and an absorbent core positioned
between said topsheet and said backsheet, characterized in that:
said length of said absorbent device is between 60 mm and 127 mm, preferably between 85 mm and 127 mm,
said width of said absorbent device is between 25 mm and 40 mm,
said width and said length of said absorbent device each exceed said thickness of said absorbent device,
said absorbent device comprises an axis of preferred bending.
2. The absorbent device as claimed in claim l wherein said liquid pervious
topsheet comprises rayon.
3. The absorbent device as claimed in claim l wherein said absorbent core
comprises rayon, preferably a blend of rayon and cotton.
4. The absorbent device as claimed in claim l wherein the tíme required fór said
absorbent device to disperse into at least two fragments as measured by the Water
Dispersion Test is less than two hours, preferably less than l hour, more preferably
less than 30 minutes.
5. The absorbent device as claimed in claim l wherein said liquid impervious
backsheet comprises polyvinyl alcohol.
6. The absorbent device as claimed in claim l wherein said absorbent device is at
least 70% biodegradable, preferable at least 90% biodegradable.
7. The absorbent device as claimed in claim l further comprising a removal tab
joined to said backsheet.
8. The absorbent device as claimed in claim l wherein said device is resiliently
biased to unfold along said axis of preferred bending.
9. An absorbent device substantially as hereinbefore described with reference to
the accompanying drawings.





1647-DEL-1998-Correspondence Others-(17-06-2011).pdf



1647-del-1998-description (complete).pdf












Patent Number 216253
Indian Patent Application Number 1647/DEL/1998
PG Journal Number 13/2008
Publication Date 28-Mar-2008
Grant Date 11-Mar-2008
Date of Filing 15-Jun-1998
# Inventor's Name Inventor's Address
PCT International Classification Number A61F 13/15
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 08/876,206 1997-06-16 U.S.A.
2 09/071,425 1998-05-01 U.S.A.