|Publication number||CA1183652 A|
|Application number||CA 403751|
|Publication date||12 Mar 1985|
|Filing date||26 May 1982|
|Priority date||29 May 1981|
|Also published as||CA1183652A1, EP0080505A1, US4424054, WO1982004185A1|
|Publication number||CA 1183652 A, CA 1183652A, CA 403751, CA-A-1183652, CA1183652 A, CA1183652A|
|Inventors||Shepard Conn, Arnold Kushner|
|Applicant||Shepard Conn, Arnold Kushner, Kcdp Corporation|
|Export Citation||BiBTeX, EndNote, RefMan|
|Classifications (6), Legal Events (2)|
|External Links: CIPO, Espacenet|
FLUID-EXPANSIBLE CONTR~CEPTIVE TA:MPON AND ~PPLICATOR
B~C~GROUND OF TH~ IN~ENTION
This invention relates to an apparatus for moistening and dispensing a tampon. More particularly, this invention relates to an applicator which houses a tampon made from, preferably, a hydrophilic, fluid~expansible material in a quiescent, compressed, unactivated state in a first chamber separate from a second chamber, which acts as a reservoir for a spermicide, bacterlcide, virucide or other substance, usually in fluid form. The applicator includes means for bringing the fluid into contact with the tampon upon command prior to use, as well as means for delivering the moistened tampon to a vagina and positioning it therein. Still more particularly, this invention relates to a combination of an applicator of the type described with a tampon made from a body of purposefully-compressed, memory-retentive, hydrophilic, fluid-expansible material with a high coefficient of expansion, which is resilient when moistened or activated prior to insertion into a vagina.
Mankind has long sought an effective me-thod and apparatus for contraception for purposes of population control, for family planning, and for preventing unwanted pregnancies. While a number of contracepti~e techniques have been propo$ed, many of whic~ ha~e been clinically effective~ each has suffered from ~arious types of shortcomings for a numbex of reasons. Fox example, the use of oral contraceptives has been found to be associated with a number of adve~se side e~fects, some of which axe fatal. ~so, intrauterine devices have been known to cause le~ions, and even to perforate the uterus. Furthermore, IUD's are spontaneously rejected from the~uterus in a significant number of women.
The so-called barriex -type of contraceptive has long been included among such con~raceptive proposals. Many barrier contraceptives are efficient and benign. However, they often require spec~al moti~ation for their use by reason of the fact that the~ may initially, especially if xigid or semi-rigid, ha~e to be fitted precisely by a physician.
Even more importantly, in actual use, they are unesthetic and therefore unacceptable to many women. Furthermore, many barrier contraceptives re~uire application just prior to coitus and may be said to be coitally-related, a factor which discourages their use.
By way of background, the human vagina may be considered to be a closed-end collapsed cylinder. The uterine cervix, which varies from l to 4 cm in length, protrudes into the closed end. The uterine cervix may point directly into the axis of the cylinder, or backward (which is the most common orientation) or forward. The spaces around the cervix are called fornices and include an anterior, a left, a right, and a posterior foxnix. A contraceptive barrier, to be ef~ecti~e, must be in contact with the cervix to block the os uteri~ and ideally should fill all of the forn~ces to pxe~en-t the inadyextent migration of semen into the cervical ~ucus.
~n intra~a~inal antišonception tampon wa~ referred s~
to in the Papyros Ebers, circa 1550 BoC~ ~ and has been in use in one form or another for more than 3500 yeaxs. ~owever, there have been no reliable scientific reports of its efficacy.
Such tampons ha~e included sponges moistened with fluid having spermicidal qualities. ~t least as eaxly as the ti~e of the ancient Egyptians, a tampon of lin~ impregna~ed with drugs and honey was said to be capable of contraceptive qualities when placed in the vagina of the user. Later, but at least as early as the nineteenth šentury, a suitable soft sponge tied by a ribbon and properly placed high in the vagina, w~s said to possess contraceptive qualities. Thus, historically, it is known that a suitable sponge properly placed in contact with all vaginal fornices and well moistened with an effective spermicidal solution should act as an effective contraceptive by virtue of (1) its barrier action,
(2) its absorption and reten-tion of ejaculate, and (3) its prolonged spermicidal action.
It has remained a problem of convenience and esthetics for the user of a resilien-t barrier-type contra-ceptive to prepare and insert it into a vagina prior to intercourse. In addition to the actual or perceived non-esthetic qualities of such a preparatory act, such preparations may be inconvenient, susceptible to miscalculation such as by insufficient or excess moistening with spermicide, the premature or tardy application of spermicide, and the like.
Accordingly, it is an overall object of this invention to provide a suitable contraceptiVe ta~pon of barrier design and function made from absoxbent material WhiCh can be impxegnated with a preci~ely metexed amount of spermicide in an applicator and conveniently inserted into the Vagina by using the applicator in such a ~ay th~t the ~oistened tampon
3~jt,j~fl2 material acts as an effective contraceptive. The applicator, after having served to moisten the tampon and to insert it into the Vagina, is disposed of. The tampon i~ intended to remain in place, once positloned i~ the yagina, fox as long as 24 hours, during ~hich time CQitUS may take place one ox more times. Thereafter',~it is removed and disposed of by the user.
While the prlor art has focused its attention on compressible sponge-'like members, such as those made from sea sponges, ox viscose'and cellulose materials whose shape in the quiescent state is approximately the same as its shape in the acti~e'implanted state, it is another purpose of this invention to utlliŠe a compressed (~ithout having to by physically re~txicted to enforce compression), dry tampon material which can be moistened with an effective spermicidal solution immediate:Ly prior to vaginal insertion. When moistened, the compressed material expands markedly either prior to or after lntroduction into the vagina. By using such an expansible material, the contraceptive tampon, in the dry, unactivated state, can be stored in a small, handy compartment in an applicator, and can expand to a clinically effective size after moistening to serve as a barrier to the os uteri and, at the same time, also fill the fornices.
In order to improve the convenience and the esthetic character of the contraceptive act, it is a significant aspect of this inv~ntion to provide an applicator for the expansible hydrophilic tampon in.~hich the tampon is retained in a ch~mb~x sepaxate fxQm a xese~yoix fox'spermicidal solution. It is:the aim of this inY~ntion to bring the spex~icide,. upon com~and, in~o.contajct wlth the ta~pon to expand it to its active si~e and shape, and to use the 2 j~
applicator as an insertion device fox insexting the tampon into its intended position.
It is another objec'~ of this invention ~o provide a disposable, compact applicator-tampon syste~ Which can be conveniently use~ to wet the tampon with a sper:micide stored in the applicator and to insert it into the va~ina with a minimum of manipulations and mo~ing parts.
It is a further object of this invention to provide a new use as a barrier'contxaceptive for a purposefully-compressed, memory-retentive, hydrophilic material which in its unactivated s-tate is compac~, but whic~ becomes resilient and absorbent as it expands to a clinically effective size and shape upon moistenin~ wlth a spermicide or medicament.
In addition to the need for contraception, there exists the need for treating and preventing the spread of sexually transmiss:;ble diseases. It is known that some spermicides act as medicaments as well, and that such bactericides as chloramine, benzethonium chloride and chinosol are used in current contraceptive technology. Furthermore, some spermicides are anti viral agents. Therefore, it is another object of the present invention to use a bacterici~e, virucide or a combined agent for disease prophylaxis and contraception in an applicator for dispensing a moistened tampon.
A problem associated with the use of tampons which has been widely publicized is the occasional adverse effect on the health of tampon usexs, kno~n as toxic shock syndrome.
The pxoblem is caused by toxins produced by an organism known as Staphlococcus ~ureus. Consequently, it iS yet another obje~t of -the pxesent invent.ion to pro~ide~ an appaxatus containin~ a bacter'icide,' for dispensing a ta~pon moistened with the bactericide'for combatting Staphlococcus aureus.
These and other objects of the invention will become apparent from the following description of preerred embodiments of the pxesent inVention taken in conjunction ~ith the accompanying drawing$.
~RI~F SU~R,Y OF T~E INV:E~NTI
-Directed to achleving the aforestated objects and overcoming the problems associated ~ith priox art barrier-type contraceptive devices and prior art tampons, the invention, in one aspect, relates to a compact, disposable applicator which comprises at least a pair of telescoping, generally cylindrical members made from a pliant plastic material.
One of the cylindrical members acts as a reservoir or a precisely metered amount of spermlcide, bact~ricide, virucide or other fluid medicament and is thus closed. The reservoir member includes a closed end adjacent to a tampon stored in its dry unactivated state in a chamber defined by the other cylindrical tampon storing member. The end of the reservoir member opposite the closed end defines a vent and filler opening to permit the reservoir rnember to be filled and the vent to be sealed. Preferably, the closed end of the reservoir member is openable by the user to release at least a small amount of spermicide, bactericide, virucide or other fluid medicament from the reservoir member to the fluid-expansible tampon~
Upon contact with the small amount of released fluid, the adjacent poxtion of the fluid-expansible tampon ex~nds ~ithin the tampon stoXing membe~r. There~f~ex, the ~emaining fluid is released to ~et and expand -the entire tampon to the de~ired degxee. ~fter the tampon is moistened ~
within the tampon storing membex ~y the fluid, the reservoir member is caused to telescope within the tampon storing member while the tampon storing mem~er is positioned within the vagina to insert the tampon into posi-tion in ~he vagin~.
Release from the applicator permi~S thc t~pon to e~pand further and, ~here the tampon is a cont~aceptive tampon, to act as a clinically effecti~e baxrier to the os uteri, to fill the fornices, and to further act as an absorbent for ejaculate, particularly in cases of repeated intercourse.
It is a second feature of this invention to provide a new use as a barrier contxašeptive for a compressed, memory-retenti~e, hydrophilic, fluid-expanslble material which can be stored in an unactivated state in a compact manner and yet can become resilient and expand into a desired size and shape for insertion and upon insertion into the vagina of the user~ Such materials are well known in other arts and have a hiyh degree of expansibility when wetted.
For purposes of this specification, the "quiescent state" of the tampon refers to its unactivated, compressed state prior to impr~gnation with a fluid and prior to insertion into the body of the user. Similarly, the "dry" state of the compressed hydrophilic material, for example, one made of cellulose, refers to the state of the material prior to impregnation with a spermicide, bactericide, virucide or other medicament, while including a normal moisture level inherent in such material or in the normal en~ironment for the material within the applicator. Such m~terials are memory-retentive.
That is, the matexials c~n be purposefully hea~ed to e~pel moistuxe and compxessed to a dšsixed cQmpact size, thereby compressing and collapsing the cellular structure of the matexial. Such materials thus retain the collapsed or compressed state in the absence of the application of moisture ~ , I I ~J U L. i ~ ~ U i i .L 11 y ~ i ~ L ~_ L. i L) 1~ ~ (-> r ~ r c~ U C i l materials are`commerciall~ aYailable. Examples of suitable materials-are those`known in the trade as "Supe~cel" and "Normandy"* available from the ~erican Sponge & Cha~ois Co.
of Long Is~and City, New York.
In the applicator according to the present in~ention, the cylindrical member of the applicator acting as the reservoix includes a closed end openable to release the fluid and an opposite end defining a vent and ~iller opening.
In several of the preferred embodiments, an elongated element in the reservoir member is movable with respect to the ends of the reservoir member to produce a dispensing opening in one end and a vent opening in the opposite end. A portion of the elongated element extends outside the reservoir member and defines a gripping surface so that the elongated element can be moved by hand with respect to the reservoir member. In two of the preferred embodimentsl the elongated element defines valve elements forming seals with the ends of the reservoir member, the elongated element being movable with respect to the ends to define openings. In another preferred embodiment, the elongated elernent d~fin~s a valve element at one end and a punct:uring element ~or rupturing an opening in the other end. In stil~ another Úmbodiment of the invention, the elongated element is eliminated and the closed end of the reservoir member is provided with score lines or other weaknesses, so that it is readily frangible upon the application of radially directed pressure. The opposi~e end o~ the reservoir member defines a frangible 3~ element provided with a gripping tab, so that the user can make a vent opening in the reservoir member.
* Trade Mark 65'~
These and other features of the invention are described hereinafter in the detailed descxiption of the inVention ta~en in conjunction with the drawings.
BRIEF DESC~IP~ION OF TH~ DR~W~NGS
_ _ .
Fig. 1 is a perspective View of a ta~pon applicatox according to a preferred embodiment of the present lnvention;
Fig. 2 is a cross seătion along the line 2-2 of the tampon applicator of Fig. l;
Fig. 3 is a cross section of another preEerred embodiment of the applicator;
Fig. 4 1s a croSS section of still another embodiment of the applicator prior to the release of liquid;
Fig. 5 is a cross section of the applicator of Fig. 4 after the release o~ the liquid; and Flg. 6 is a cross section of yet another embodiment of the applicator.
DETAILED DESCRIPTION OF THE PREFERRED E~BODIMENT
As shown in Figs. 1 and 2, the applicator accordlng to the present inVention is designated generally by the reference numeral 10. The applicator 10 includes a first generally cylindrical tampon storing member 12 defining an open-ended chamber 14 for storing a folded compressed tampon 16 which, upon Wetting, can act as a contraceptive, bactericidal and/or Yirucidal tampon, as Will be discussed in greater detail latex in the specification. ~he ta~pon 16 has a ~tring or coxd 18 secured ther:eto ~o allo~ easy removal of t~e ~ampon 16 from -the Vagina when disposal is appropriate.
_ g_ If desired t the chamber 14 may be closed by a removable co~rer member secured to the'member 12.
The tampon storin~ me~ber 12, ~hich is p~eexably made from a flexible thin-wall plastlc material, has a body portion 20 which de~ines an outer end 21, and a neck poxtion 22 which defines an inner end 23. The body portion 20 and the nec'k portion 22 are connected by a shoulder 24, and the neck portion 22 defines a serles of ridges 25 or some other structure to insure that the neck portion 22 can be firmly gripped by the user. The outer end 21 of the body portion 20 is preferahly rounded, and the exterior wall of the tampon storing member 12 is preferably smooth to avoid irritation of the tissues of the ~agina when the tampon storing member 12 is inserted to expel the tampon 16.
The tampon storing member 12 is adapted to receive a reservoir member 26 in a telescoping relationship. The reservoir member 26 includes a piston portion 28 comfortably slidable within the body portion 20, a shaft portion 30 slidable within the neck portion 22 and a shoulder 32, which connects the piston portion 28 and the sha~t portion 30 and engages an internal surface of the shoulder 24 of the tampon storing member 12 to limit the travel of the reservoir member 26 with respect to the tampon storing member 12.
The reservoir member 26 has an outer end 34 closed by a wall 36 secured to the outer end 34, the wall 36 extending radially beyond the shaft poxtion 30 to define flanges 380 The wall 36 also defines a central opening 40 which serves as a fi~ler and Vent opening A la~el 41 having pertinent info'r~ation, such as the conten-ts of the applicato~ 10 and the amount of f:luid in the'xesexyoir member 26, can be affixed to the'outer' surface of the wall 3~. The reserVoir member 26 also has an inner end 42 closed by a wall 44 secured to the inner end 42 whereby the reservoiX men~ex 26 defines a reservoir, the wall 44 forming a flange 46 ex~ending radiall~ beyond the pis~on poxtion 28. The wall 44 defines a central opening 48 for dlspensing its contents into the tampon storing member 12 for moi~tening the tampon 16.
The reservoir membe~ 26 is fllled with a spermicidal fluid, a bactericidal fluid or a virucidal fluid, or with a fluid which acts ~s a combination of these fluids. Among the fluids contemplated for use with the presen-t invention are such bactericides as chloramine, benŠethonium chloride and chinosol, which are currently used in contraceptlve technology. In addition, some fluids which are commonly thought of as spermicides are also anti-viral agents. They and other virucides also are contemplated for use in the present invention~
The flanges 38 abut the inner end 23 of the tampon storing member 12 when the reservoir member 26 is completely telescoped into the interior of the tampon storing member 12. The flanges 38 define a convenient surface engageable by the hand of the user to move the reservoir member 26 into the tampon storing member 12. The flange 46 on the wall ~4 secured to the inner end 42 of the reservoir member 26 has a diameter slightly greater than the inner diameter of the body portion 20 of the tampon storing member 12. To accommodate the flange 46, an annular groove 49 is formed in the interior surface of the body portion 20 and is spaced from the shoulder 24 a distance approximately e~ua~ to the distance between the flange 46 and the shoulder 32 on the xesexVoir membex 26, SQ that the annular ~rooYe 49 xeceiYes the flange 46 when the`xeservoir member 26 is fully retracted wi~h respect to the tampon storing member 12. The flange 46 is flexible, so that the reservoir member 26 is releasably ~eld in the xetracted position and may be` moved by a force suffišie~t to 1ex the flange 46.
~ n elongated el'ement 50 extend~ axially thxough the reservoir member 26 from the ou~er ~nd 34 to the inner end 42 and includes a gripping portion extending beyond the outer' end 34 to permit manipulation of the elonga-ted element 50 by the hand of the user so that fluid in the reservoir i member 26 can be released. In the embodiment shown in Fig.
1, t~e elongated element 50 is in the foxm of a plunger made of a relatively rigid material, such as a rigid plastic, having a pull tab 52 comprising a gripping portion on the extending portion. The elon~ated element 50 has a pair of sealing elements in the form of bulbous formations 54 and 56, one positioned at each end of the resexVoir member 26, each bulbous formation 54, 56 having an annular groove 58 and 60, respectively. The bulbous formations 54 and 56 are positioned in the vent opening 40 and the dispensing opening 48, respectively, clefined in the walls 36 and 44 at opposite ends of the reservoir member 26. The material of the walls 36 and 44 defining the openings 40 and 48 orms seals with the bulbous formations 54 and 56 in the annular grooves 58 and 60. When the elongated element 50 is partially withdrawn from the reservoir member 26 by pulling on the pull tab 52, the bulbous formations 54 and 56 move out of the vent opening 40 and thš dispensing opening 48, thereby effecting the flow of the fluid contents of the reseryoir member 26 out of the dispen$in~ opening 48 into the tampon ~toxing membe~ 12, whexe they axe ab~o~bed by th~ ta,~pon 16, and t~e flow of ~ir throu~h the'vent opening 40 in the ~es'ervoir member 26.
In assembly and manufacture, befoxe the ~all 44 is secured to the'inner end 42 of the reservoir member' 26, the elongated element 50 is insexted in the reserVoir member 26 until the bulbous ~ormation 54 fills thš vent open~ng 40 to form a fluid-tight sea'l. Then the reser~oir member 26 is inverted and a meter'ed amount of fluid is poured into it.
The wall 44 is forced onto the bulbous formation 56 of the elongated element 50, there~y sealing the dispensing opening 48. The wall 44 is, thus, in po~ition so that it engages the inner end 42 of the reservoir member 26 to which it is secured as by welding or cementing.
Another embodiment of the applicator 10, as is illustrated in Fig. 3, is simila~ to the embodiment shown in Figs. 1 and 2~ but differs in that the wall 44 which closes the inner end 42 of the reservoir member 26 has a frustoconical depression 62 which initially has a bottom defined by a thin, conformable membrane. There is no bulbous formation at the end of the elonga-ted element 50 adjacent the inner end 42 of the reservoir member 26. Instead, the straight rod shape of the elongated element 50 ruptures the conformable membrane during assembly and forms a fluid-tight seal therewith.
In operation, the elongated element 50 is grasped by the pull tab 52 and withdrawn from the reservoir member 26. The elongated element 50 moves away from the dispensing opening 48 it created by rupturing the membrane, thereby allowing a small amount of the contents of the reservoir member 26 to moisten and expand the tampon 16, thus forming a~ tight se~l in the tampon storing member 12. ~imultaneously, the bulbous portion 54 moVes out of the vent opening 40 in the'outer end 34, thereby ~enti~g the reservoir member 26 to allo~ t~e'rem~inder of the contents to flow out of the dispensing opening 48 into the tampon 16.
As is illustrated in Figs. 4 and 5, still another embodiment of applicator 10 accoxdlng to the present invention includes the bul~ous foxmation 54 fo~ sealing the vent opening 40 at one end of the reservoir member 26, ~nd the wall 44 sealing the' inner end 42 Qf the resexvoir membex 26 including the frustoconical depxession 62 having the ruptuxable membrane at its bottom. The elongated element 50 includes a puncturing member'64 having a sh~xp edge, the puncturing member 64 being wider than the rest of the elongated element.
The eY~tending portion of the elong~ted element 50 has a gripping element defined by a push bar 66 rather than a pull tab, so that the elongated element 50 can be pushed farther into the reservoir member 26. As can be seen in Fig. 4~
this movement results in the punc-turing member 64 puncturing the dispensing opening 48 in the membrane at the bottom of the frustoconical depression 62. The vent opening 40 is enlarged to accommodate the insertion of the puncturing member 64, and the bulbous formation is enlarged to correspond to the enlarged Vent opening 40.
A plurality of nibs 68 are defined on the under-side of the push bar 66 to maintai.n the push bar 66 spaced a slight distance from the wall 36 closing the outer end of the reservoir member 26 to cooperate with a thinned neck 69 in the elongated element 50 between the push bar 66 and the bulbous formation 54 in insuring an air passage for venting.
The distance bet~een the nibs 68 and the wall 36 when the bulbous fo~mation 54 is in its sealing position is chosen so th~t,,~hen the push bar 66 is pushed to the poin~,whexe the nibs 6~ en'gage the wall 36, -the puncturing member 64 will pass completel'y thr'ough the'rupturable'membrane, thexeby providing a space between the puncturing memher 64 and the dispensing opening 48 so that fluid may flow out past the puncturing member 64. ~t the same time, the bulbous formation 54 is forced out of the vent opening 40 and into ~he xesexvoir member 26 to enable a smooth 10w of the spermicide, bactericide, virucide or other substance through the dispensing opening 48.
In manufacturing and assembling the embodiment illustrated in Figs~ 4 and 5, -the reservoir member 26 can be rilled by two alternate methods. According to the first method, with the wall 44 secured to the inner end 42 but without the elongated element 50 in place, the fluid is directed through the vent opening 40 until the xeservoir member 26 isfilled to a specified level. Then the elongated element 50 is inserted through the vent opening 40 until the groove 58 in the bulbous formation 54 is seated in the vent opening 40 to form a seal with the wall 36. According to the second method~ the elongated element 50 is in place, with the bulbous formation 54 sealing the vent opening 40, but with the inner end 42 open. The reservoir member 26 is then inverted and filled to a specified level, whereupon the wall 44 is heat sealed or otherwise suitably attached to the inner end 42.
Another embodiment according to the present invention, as illustrated in Fig. 6, operates without the use of an elongated element. Instead, the wall 44 on the inner end 42 of the reservoir member 26 is a frangible member having score lines ox other form of weakening, so that the wall 44 can be ruptured by pressure applied xadially thxough the tampon storin~ membe~ 12. ~s mentioned earliex, the tampon storing member 12 ~s made of a flexible plastic material, 3~
which is deformable unde~r radial foxce, so that radial force ~ rp~ ^-k ~h^ ~ ib~ nd ~lr~ ~
dispensing opening. The annular groove 49 ls defined within an annular ridge 70 which protrudes from the tampon storing member 12 and serves to indicate t~e lošation at which radial pressure should be applied. Such score lines are described in more detail in Cana~ian Application Serial No.
379,294, filed 8 June, 1981 by KCDP Corporation.
A frangible element 72, such as a frangible neck is defined on the wall 36 at the outer end 34 of the reservoir member 26. ~ tear tab 74 is connected to the frangible element 72 so that it can be conveniently grasped and suffi-cient tearing force can be applied to the frangible element 72 to cause its ~ailure and to effect a vent opening in the wall 36.
The invention may be embodied in other specific forms without departing from its spirit or essential charac-teristics. The present embodiments are, therefore, to be considered in all respects as illustrative and not restric-tive, the scope of the invention being indicated by the claims rather than by the foregoing description, and all changes which come within the meaning and ranye of the equivalents of the claims are therefore intended to be embraced therein.
|International Classification||A61F6/12, A61F13/26, A61F13/20|
|Cooperative Classification||A61F6/12, A61F13/2051, A61F13/26|