CA1139171A - Disposable female contraceptive - Google Patents

Abstract

ABSTRACT OF THE DISCLOSURE

Disclosed is a disposable contraceptive in which a first member engages the vaginal vault and a second member, secured to the first member, engages and closes the cervical open-ing. The first and second members are substantially discoid, with the second member smaller in discoid area than the first.
The second member is a generally impermeable sponge-like material which is lubricated to aid in adhesion and closure of the cervix.
The first member is generally resiliently closable so that the overall dimension of the contraceptive may be reduced in size for insertion into the vaginal vault. The first member is defined at least by opposed anterior and posterior portions which engage the respective anterior and posterior portions of the vaginal vault.
The second member is coupled or joined to the first member at the posterior portion.
In one embodiment, the second member is a sponge joined to a film. The film is held in position to define the first discoid member surface by a rim.
In other embodiments, the first and second members are resiliently joined at the posterior portion so as to urge the second member into positive engagement with the cervix. Thus, a finite resilient nylon filament is bent into a figure 8 and covered with a soft, yieldable, foam plastic covering. By folding at the intersection of the upper and lower loops, the contraceptive is formed. In another example, a liner of resilient plastic in the shape of conjoined circles in covered by a soft, flexible, plastic envelope. In yet another example, an annular discontinuous rim is covered by a foam plastic. The rim has an integrally formed tongue extending therein and about, to which may be secured (by any well known means) a sponge-like impermeable plastic second member.

Description

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DISPOS~BI.E FEM~E CONTR~CEPTIVE

BACXGROUND OF THE INVENTION
_ ,_ This invention relates to contraceptiVes and, more par~icularly~ to a emale contraceptiVe~
The most colNmon type o ~emal ~e contraceptive is the ~ diaphragm. A diaphra~n is a device usually made o thin, flexible `10 material which is placed in the vaginal vault ~or blocking the entrance to the cervix in order to prevent impregnation during sexual intercourse. Generally, such diaphragms comprise a loose hanging pouch made o~ an elastomeric material such as rubber ormed with-an inteyral,heavy, resilient rim intended to engage the walls of the vaginal vault. Xn order to prevent the intrusion of spermatozoa ox disease-carr~ing organisms into the cervix, ~
diaphragm is most usually used in combination wi~h a spermicidal cream. The combination o the two - diaphragm and the spermicidal cream -- usually makes a cumbersome and inconvenient contraceptive . , ,' :' . ' ~.

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Over the years, a number of improvements in contracep-tives have been suggested. Thus, for example, 3. T. Clark, in United States Patent Nos. 2,463,356; 2,540,~32; and ?,638,896;
as well as Ballard et al., in United States Patent No. 2,5~9,363;
Snell, in United States Patent Nos. 2,538,478; and 3,117,573;
Young, in United States Patent No. 2,625,1~4; Kunnasv Jr., in United States Patent No. 2,823,669; Milgrom et al., in United States Patent No. 3,036~570; Lay, in United States Patent No.

2,249,316; and Duncan, in United States Patent No 3,545,~39 all suggest spring-loaded diaphragm rims for resiliently collapsing the diaphragm or ease of insertion and the suhsequent ~irm enyagement of the walls of the vaginal vault.
The disadvantage of these devices is that the prophylac-tic effect is achieved by sealing the diaphragm at the vaginal al}. Pressure can, in some instances, result in discomfort.
Insufficient pressure can result in either impregnation and/or disease entering the cervix.
Another approach was suggestea by Harris in United States Patent No. 2,522!822, in which a disposable vaginal diaphragm or ; 20 pessary is suggested. Essentially, Harris suggests the use of a soft and pliable contraceptive. However, it is believed that such a device cannot be held securely in place within the vaginal vault, thereby causing great di~ficulty and possible misplacement during sexual intercourse.

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Sponges or sponge-like devices have been suggested in the form of pessaries, as disclosed by Steiger et al., in Uniked Sta~es Patent No. 3,216,422; Young, in UJ~ited States Patent No.

3,128,762; and Cruickshan~, in United States Patent No. 2,020,107.
In the device disclosed by Steiger et al., the sponge hangs loosely from an impervious film. The other sponge-like devices are either intended to en~age the cervix in a glove-like arrange-ment or in a cup-like arrangement, similar in shape to prior art diaphragms. The spacing from the cervix opening o cup-like devices increases the possibility of impregnation or in~ection.
The glove-like devices are believed to be dificult to insert and must be specially fitted to each individual user~ Thus, these devices have the same disadvantages as other rim-securing diaphragm devices.
The above-referenced devices are representative of the wide variety of constructions, each having in common the fact that either the rim of the diaphragm is spring-loaded to form a specific contact and that the sealing characteristics are being provided by the rim, or a sponge-like material, which is loosely fo ded as such, the latter having the difficulty of being easily misplaced or mislocated in insertion.

¦ SUMMARY OF THE INVENTION

¦ In view of the foregoing, it is an object of this inven-~L~3.~
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tion to provide a diaphragm which does not depend on the scaling characteristics of ~he rim for prophylaxiS.
It is a further object of this invention to provide a female contraceptive which may be disposable.
S It is still ano~her object of this inventiOn to provide a means for placing a discoid-shaped member over, and thereby closing, the entrance of the cervix.
It is yet a further object of this device to provid~ a contraceptive which is simple in construction, economical in manufacture, and convenienk to use.
In accordance with the teachings of this invention, there is provided a barrier contraceptive of the type intended to be inserted within the vaginal vault. The contraceptive comprises a first member. This first member is characterized by opposed anterior an~ posterior portions or engaging the respective anterior and posterior portions of the vaginal vault. A second member is coupled to the first mel~er substantially at the poster-; ior portion so as to engage and close the opening of the cervix upon insertion into the vaginal vaultO The second member is ¦Idisposed between the first membex and the cervix upon insertion.
In a urther aspect of this invention, there is provided a barrier contraceptive of the type intended to be inserted in a vaginal vault. This contraceptive includes a cervlx engaging means. Resilient and flexible means are provided for positioning and retaining the cervix engaging means within ~he vault and holding the cervix engaging means in con~act with the entrance to the cervix to thereby form an impermeable barrier to the cervix.
In still another aspect of this invention, there is ormed a contraceptive by the process of providing a member so dimensioned as to engage the wall of a vaginal vault. The first member is defined at least ~y a posterior and aiametrically opposed anterior portion. The process urther includes the pro-viding of a second member. The process further includes po~ition-~10 ing the second member at the posterior portion o the fixstmember and coupling the seco~d membex to the ~irst member, at least subs-kantially along the posterior poxtion such that, upon insertion of the contraceptlve into the vaginal ca~ity, the second member comes into intimate contact with, and closes, the cervical portal and the first member engages the vaginal vault wall to hold the contraceptive in place.

A BRIEF DESCRIPTION OF THE DRAWING

FIG. 1 is a top plan view of a disposable vaginal contra-; ceptive constructed in accordance with the teachings of the invention;
~- FIG. 2 is a top plan view of the vaginal contraceptive of FIG. 1 with the ends of the ring closed;

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I ( ( FIG. 3 is a side view of the contr~ceptive o~ F~G. l;
~IG. 4 is a top plan view of anotller embodiment o~ the .
vaginal contraceptive constructed in accc)rdance with the teach-ings of this invention;
S FIC. 5 is a sectional view of a female anatomy showing the vaginal vault with the contraception of FIG. 1 inserted therein;
FIG. 6 is a top plan view o a filament used in anotller embodiment of a vacJinal contraceptive constructed in accordance with the teachi~ s o~ this invent.ion;
FIG. 7 is a s.ide view of an assembled contraceptive using the filament of FIG. ~;
FIG. 8 is a top plan view of a vaginal contraceptive shown in side view in FIG. ~;
15 . FIG. 9 is a top plan view of a rim used in still another embo~iment of a vaginal contraceptive constxucted in accordance with the teachings of the invention;
FIG. 10 is a sectional Yiew of the rim of FIG. 9, taken along the lines 10-10;
~0 FIG. 11 is a top plan view of a vaginal contraceptive employing the rim of FIG. 9; .
FIG. 12 is a side view of the contraceptive of FIG. 11;
: FIG. 13 is a sectional view of the vaginal contraceptive of FIG. 11, taken along line 13;

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FIG. 14 is a top view o a member used in the construc-tion of yet another embodiment o~ a ~agin~l contraceptive construc ted in accor~ance with the teachings of this invention;
FIG. 15 is a top view of a contraceptive using the member of FIG 14;
~ IG. 16 is a side view o an assembled contraceptive of the device of FIG. 15; and ~ 'IG. 17 is a sec~ional view of the vaginal contraceptive o FIG. 16, taken along line 17.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The contraceptive 10 (FIG5. 1-3) generally comprises an annular flexible and resilient member or rim 12. The ri~ 12 may have a generall~ circular shape. It will be noced, however, that the circle is discontinuous Preferably, this rim 12 may be made of any convenien~ material such as plastic, which may be, for example, a polyethylene, polypropylene, polyvinylchloride, or the like. In order to encourage the 1exibility and resil-iency, the posterior portion 14 of the rim 12 may be ~hickened.
This thickened posterior portion 14 may be opposite the anterior rim opening 16. Preferably, the anterior opening 16 should be no more than ten to twenty-ive per cent of the circumference of the rim 12. In one example, the plastic rim may have a thickness ` ~ 3~ L , in the ranqe of 1 to 2 mm. at the posterior portion 14, as compared to a thickness of .5 to 1 mm. at the anterior portioll 16.
A film 18 of a flexible material, such as a plastic sheet, may be secured to the rim 12 and lie substantially in a plane. The film 18 is, preferably, made of the same plastic material as the rim 12. By using such a common material, the ilm 18 may be secured to the rim 12 by heat sealing methods which are well known in the art. In the alternative, the film 18 may be secured by an adhesive. It is not essen~ial that the film 18 be connected at every point along the rim 12. This is a signiEicant depar~ure from prior art contraceptiv~s, which reyard as essential the integrLty of the rim as attached to the remainder of the diaphragm. The film 18 may have an overall thickness of rom .125 to 1.25 mm. ana, preferably, from .38 to .76 mm. The thickness of the ilm 18 depends upon the nature f the material and its ability to be flexible. The rim 12 may ave a height above the film 18 of, for example, from 1 to 2.5 mm.
Attached to the film membrane 18 is a closed network of aterial in the form of a sponge 20, preferably made of a plastic aterial such as polyethylene, polyurethane foam, or the like.
he sponge 20 may be secured to the film 18 by heat or any other well known means of joining. The sponge 20 should be resilient and compliant. It may have, preferably, a circular outline and , ~39~

be discoid in shape. Its thickness may be determined by the spongy network. The minimum thic~ness mus~ be such as to prevent an open passa~eway from the disc 20 top to bottom. Pref-erably, the sponge 20 may ~e from 2 to 5 mm. thick and have a diameter of 40 mm. The sponge 20 may be attached to the membrane very close to the posterior portion 14 of the rim 12, for reasons that will be more fully set out below.
I~ use, the rim 12 of the diaphragm 10 is clos~d ~FIG. 2), thereby reducing the overall diame-ter and circumfererlce. As a c~nse~uence, the film 18 and sponge 20 may be expected to buckl~
or be~el slightly (not visible). The diaphxagm 10 may then be conveniently inserted through the vagina 2~ and into the vaginal vault 24 of a female 26 ~FIG. 5). Upon insertion, the diaphragm 10 may be positioned with the posterior portion 14 seated in the posterior cul-de-sac 28 of the vaginal vauLt 24, and the anterior op~n portlon 16 o~ the diaphragm 10 may be positioned anterially toward the symphesis pubis 30. By being so positionedp the sponge 20 is disposed over and against the entrance to the cervix 32.
Thus, it is the sponge 20, and not the remainder of the device 10, which acts as a barrier contraceptive. For this reason, an imper~ection in the film 18 or rim 12, which admits such foreign elements as a virus, bacterium, or spermatozoon, is not critical.
This enables ~he contraceptive to be made inexpensively and simply ¦¦compar to prior ~rt devices.

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The sponge 20 may be saturated with any lubricant,such as a water-washable cream,which acts to seal the sponge 20 to the entrance of the cervix 32. The ream may be bu~ered to a desirecl pH and may carry active ingredients such as spermicides, virucides, antibiotics, or germicides.
Insertion is aided because the natural tendency of the user would be to insert the posterior portion 1~ of the diaphragm 10 first. If this was not done, the anterior portion 16 migh~
tend to open.
The overall size o~ the diaphragm 10 is determined b~
e respec~ive si~e of the vaginal vault o~ a particular user.
In the overall configuration o.f ~he rim 18 o~ the dia-phragm 10, the anterior opening 16 is, preerably, no more than 10 to 35 per cent o~ the circum~erence. The chord at its opening lS may be, preferably, 86.39 mm. It is important that the open edges 34 and 36 of the rim 12 be rounded so as not to be abrasive to the vaginal lining.
After it has been used, the contraceptive 10 may b~
removed in a manner similar to other contraceptives. By virtue of its construction of inexpensiVe materials, the contraceptive 10 can be disposed of and a new contraceptive used on the next occasion.
An alternate rim design may be used. Thus, the rim 38 (FIG. 4) may have a helical arrangement with the ènds 40 and 42 ..

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overlapping. In addition, it may prove desixable to have a flap o~ the film 18 ormed so as to extend beyond the rim 12 at the anterior portion 16 and wrapped about the ends 34 and 36 of the first ~or second) embodiment to further shield the anterior portion 16 and aid in preventing abrasion.
Still another alternative may be to dispose the sponge to extend through a convenient aperture in the film so as to easily engage the cervix, no matt~r which side o th~ devic~ is oriented toward the cervix.
This contraceptive may be mass procluced for use by most ~emales where the location of the cervix in the vaginal vault is predictable. Thus, the appropriate size is a determination which should, pxeferably, be made by the individual's physician, as with any other diaphragm. The diaphragm 10 may be sized to fit. For example, a large diaphragm might have an outer diameter o 110 mm. and a circumference of approximately 345.58 mm. In its closed position, with the anterior ends 34 and 36 of the rim 12 brought togethex, it may ha~e an approximate diameter of 82.5 mm. and a circumference of approximately 260 mm. In a medium size, it may have an open outer diameter of 90 mm. and a circumference of 282.74 mm., and a closed diameter of 72 mm. and a circumference of 226.91 mm. In a small size, the diaphragm 10 may have an open outex dïameter of 75 mm. and a circumference of 235.62 mm. and, when closed, a diameter of 63.18 mm. and a ~11-~1 ~ 113!3i'~

circumerence of 198.5 mm. Clearly, the choice of sizes is discretionary and o~her sizes may bc established and axe intended ~or use in the range of normal vaginal vaults and cervical open-ings. ~bnormally shaped and sized vaginal vaults could be acco~llodated by appropriate dimensional changes in the contra-ceptive.
Turning to another embodiment, there is disclosed, in FIGS. 7 and 8, another contxaceptive 50 which is similar in many .
respects to the devices disclosed in FIGS~ l and ~. Thel.e are 0 provided two gcnerally discoid-shaped members 52 and 54~ ~he larger of the two disco.id mernbers 5~ may have tlle ~ame general disc edge dimensions as that defined by the rim 12. This ~narginal edge of this first discoid member 5~ is de~ined by posterior and anterior portions 56 and 58, respectively. The second substan-~5 tially discoid member 54 is coupled to the first discoid member 52 substantially at the posterior portion 56 and has substantially the same overall dimensions as the second discoid member 20 or sponge 20 of the devices disclosed in FIGS. l and 4.
This contraceptive 50 has, however, certain features ~o which distinguish it from the previously discussed contraceptives (FI~S. l and 4). The present contraceptive 50 comprises a fila-ment 60, which may be made of any resilient material such as, for example, nylon thread. It will be notea that the filament 60 (FIG. 6) is t~isted into a figure 8 configuration, with the upper -12- .~

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loop 62 being substan~ially smaller than the lowcr loop 6~. Thc natural tendency of the filameIlt 60 is to form two substantially ellipsoid portions 62 and G4. The upper loop may have, for e~ample, a dimension o 38.~ mm.by 31.8 mm. with the major axis intersecting the intersection 66 of the crossed filament 60. The lower and lar~er ellipsoid may have a dimension of, for example, ¦66.7 mm~by 63.5 mm. with the major axis running perpendi.cularly to the major axis o the upper loop 62. The above dimens:ions are, by way o~ example, of the ratio of sizes o the upper discoid loop 62 to the :Lower discoid loop 64. In actual use~ dimellsions of larger and smaller discoids 6~ and 62, respectivel~, will be as discussed in connec-tion with the devices of FIGS. 1 and ~.
The filament 60 may have a diameter of .25 to 2 mm. and, pre~erably, .5 mm. thick.
To complete the contraceptive 50 J the filament 60 may be covered or enveloped by any well known plastic material such as, for example, a polyethylene film of approximately 1 to 3 mm. in thickness, which is heat sealed at the edges. The double film, which may also be made of a sponge-like construction, provides the discoid surfaces 52 and 54 with a texture approaching that of human sk.in. It will be noted that both ends of the filament 60 terminAte in the ~irst discoid member 52. These open ends 68 and 70 of the filament 60 may be rounded so as to prevent a sharp ¦¦dis rLinuous edge. In assembly, the second discoid eLement 54 i~¦

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' folded over the first ~iscoid el~ment 52. The natural ~'memory'' resiliency of the filamcnt 60 causes or tends to cause the second discoid member 54 to rnove resiliently up~ardLy and away from the first discoid member 52. This "memory" factor of the filament 60 serves to push the upper discoid 54 in the direction of the cervix 32 (FIG. 5). Thus, this embodiment, like all others herein, has in common the separation of the function o;f the contraceptive into two distinct par~s: one, the lower and larger discoid me~er positlons the contraceptive and enyages the vaginal cavity.
Secondly, the upper con-traceptive member closes or seals shut the cervical opening or por~al. The open ends ~8 and 70 o~ ~he fila-ment 60 enable the closing ~hereof so that the larger discoid S2 of the contraceptive 50 may be domed or formed into a concavity for insertion into the vaginal vault.
Turning to yet another embodiment (FIGS. 9 -through 13), there is disclosed a con~raceptive 74 comprised of a larger first iscoid member 76 and a smaller-dimensioned second discoid member 78 (FIG. 11). The contraceptive 74 is formed by means of an nnular rim 80 (FI5. 9). The rim 80 may be made of polymerized lastic and may have a yenerally concave semicircular cross-ection (FIG. 10)~ Thus, the overall rim 80 may be approximately ¦l mm. Ihick and have a substantially semicircular cross-section with ~n ou~er diameter of approximately 2 mm. Integrally formed, ~ 3~ $ ~

¦and also approximately ~ l~n. o~ ~hickness and extend:ing at the ¦upper ed~e 82 o~ -the rim 80 and a-t the posteri.or por~ion 8~, ma~
a tongue 86. The tongue 86 may ex-tend inwardly of the rim 80 for 30 to 50 mm. and have a width of approximately 4 to 6 mm. The tongue 86 may be provided Wi~l a slight cant upward from the plain defined by the upper edge 82 of the rim 80. The func-tion of this cant or upward acute angle i.ll be more ully discussed hereinafter.
In order to construct -the contracepkive 74 of this embodiment, i.t may be preerable to ~lace ~he xim 80 in ~ molcl hav.ing a s~stan~ially clish--].ike cavi-~y (no-t shown). ~ poly-. merizable plastic may then be foarned about ~he rim so as to coverthe rim 80 and leave exposed the tongue 86. This polymerized portion forms the lower or larger ~irst discoid men~er 76 (FIGo 13). As a second step, a shim or other molding device may be : placed between the ~irst member 76 and the tongue 86.... The second discoid member 78 may then be foamed in situ on top of the shim (not shown) to thereby form the second discoid member 78. The . second discoid member 78, as in the prior embodiments, is located substantially at the posterior portion 88 of the ~irst discoid member 76.
. It will be noted that the rim 80 is open at its ends 90 and 92 to permit, as with the other devices herein, the doming of . , . .
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the contraceptive 74 for ease of inser~ion into ~hc vaginal vault ~4. I~ will be noted that the first discoid member 7~ has a somewhat concave cross-sectian ~FIG. 13) so as to encourage the collapse of the contraceptive 74 and aid in the insertion in-to the vayinal vault 24 and to further encourage the lifting o the cervical cover' or second discoid member, 78. This second discoid member 78 may have a thickness of approximately 3 to 4 mm.
Still another embodiment is a contraceptive 96 (FIGS.
14 through 17), in which the "memory" o a plastic material is emplo~ed. A liner 98 (~IG. 14) o~ a "memory" pLas~ic, or lik~
aterial, may be employed. 5uch`a material, for example, may be a polyethylene rigid foam wi~h a closed cellular network having, or example, an approximate thickness of l to 4 mm. In this instance, the liner 98 may havc a "snowman" shape deEined by a discoid first men~er lO0 which is, preferably, substantially ~irsular and sunnounted by an integrally formed circular second discoid 102 portion. The "memory" aspect of this material is such that when the second discoid member 102 is ~olded over ;'he irst discoid member lO0 at the junction of the two circular ~0 portions 104, the liner 98 straightens out, or returns, to a planar position.
The second discoid member 102 may be, for example, 35 to 40 mm., while the lower or first discoid lO0 may have a diameter of 60 to 75 m~.

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The cord ormed at the juncture 104 of -~he two circular, or discoid, portions 100 and 102, may have a length of lS to 20 mm. in length. Obviously, the greater the ovexlap of the two circular configurations of the upper and lower discoids 100 and 102, the longer the cord and the greater the resiliency in the tendency of -the liner 98 to return to a planar configuration.
It will be noted that there i5 a discon~inuit~, or interruption, 106 in the circumference oE th~ firs~ disco:icl member 100. This discontinuity 106 rnay be in the orm of a sec3m~nt o~
the circle, providing an angul~r opening o betweell 90 and 110~
of which a cord may be de~ined of about 25 to 30 mm. in length.
This discontinuity l06 is to aid in the folding of the contracep-tive 96 and the doming thereo~ for base of insertion into the vaginal vaul-t lS The rigid liner 98 may be covered by a soft, cellular, easily deformable plastic covering 108 (FXGSo lS through 17). The combined soft cellular covering 108 has the same general config-uration as the more resilient and relatively more rigid line~98.
The combination thereby forms the contraceptive 96. The covering 108 may be joined by heat sealing or the like to thereby define the first and second discoid members 112 and 110, respectively.
~ In assembly, the contraceptive 96 is formed by folding the second discoid mem~er 110 ove7- the first discoid member 112 (FXGS. 16 and 17). Upon insertion into the vaginal vault 24, the : ~ t7~ ( discontinuity 106 of the first discoid portion lO0 is closed, causing the contraceptive 96 to dome or form a concavity in the irst member ll~. This has t:he effect of reducing the diameter of the contraceptive 96 to aid insertion into the vaginal vault 24 and to cause or aid the tendency of the second member 110 to : move upwardly and away from the first member 112and in compliance with the "memory" of the liner 980 As with the previously discussed devices h~rein, lO ~F:CG~
1 and ~), 50 ~FIGS. 7 and 8), and 7~ (F~C.S. ll and 12), the contra-cepk.ive 96 has a small~r discoid member llO coupl.ecl s-~s~n~.iall~
at the posterior portion ll~ of the first discoicl l:l2 This posterior portion 114 is coincident with the aforemen~ioned juncture 104 of the liner 98. q'he disposition of the second dis-coid 20 (FIGS. l and 4), 54 (FIGS. 7 and 8), 78 (FIGS. ll and 12), and llO ~FIGS. 16 and 17) is to come into contact with the cervi-cal opening, closing it to yerms, sperma~o~oa, or the ].ike. Xn ~his connection, such a second discoid 20, 5~, 78, and llO may be moistened by any o the.materials mentioned i.n connection with ~ the second discoid 20 of the first two embodiments (FIGS. l and 4).
In addition, it is believed to be desirable to use a material wnich aids the adherence of these second discoids 20, 54, 78, and l~ to the cervix, such as by use of, ~or example, a tenacious gel employing a gum adhesive property. Such adhesives may be, for example, guar, -tragacanth, caragenin, or the like.

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While tlle embodiments h~rein have ccrt~in struc~u-ral cha.racteristics in common, there are some cl.istincJuishing charactex.istics, as well.
The sponge 20 of the embodiments of FIGS. 1 and 4 is disposed against the cervical opening by the first discoid member, .- or film, 18. In the remaining embodiments of FIGS. i, 8, 11, 12, 16t and 17, the second discoid members 54, 78, and ilO are resil lently movable with respect to the first discoid rnemb~rs 52, 7G, and 112, respect.ively. Thus, when cach o~ these lat:te~ devices is inserted into the vagi.nal vault, the resi.l;.ency or tendency o~
the second rnembers 5~, 78, an~ 110 ~Q open .into a co-planar relationship to the respective irst discoi.d members 5~, 76, and 112 is employed to cause grea~er contact pressure o~ the second .-discoid members 54, 78, and 110 with the cervical opening. .
The overall dimensions of each discoid member are, : preferably, in accordance with those set forth in connection withthe first disclosed embodiment (FXG. 1).
It should be noted that the -term "discoid" is used throughout as a matter of convenience, and any desired shape may he employed, such as elliptical or oval/ as long as the closing of the cervical opening by the second member and the holding in position by the fi.rst member is accomplished.

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In ~cll in~;~ance, the second m~ml~er o each embodim~nt:
her~in is maae of an .imperm~abl~ spon~e-like sn~crial which h~s heen lubrica~ed with any or all of the subs tances heretofore mentione~.
In cach of the em~odiments herein~ it will be noted that the first disc.oid me~ber is characterized by an interruption or discont;nuity in the circu~ference at the allterior portion, Thls d.iscontinuity ~ay be from 33 1/3 to 15 percent of t:he circulnEcr-ent:ial len~h and preferably 25 percent of the circ:umEercnce of 10 the discoid. ~t is wel:L known that there many diE~crent slzed vaginal vaults. Xn the prlor art~ it ha~ beel~ necessary tO "size"~
a contraceptive to fit a part;cular vaginal vault~ r~he design of tlle circu~lference of the the first member of this invention . lenables the contraceptive to be self-adjusti~g to a great many Idifferently sized Yaginal vaults. Thus~ one c~ntraceptive may fit ~any different di~nensioned vaults. In th;s way~ the design ~, of the first member is applicable to other female contraceptives independent of the other features of this inventio~.
The adjustability of the contraceptive is to be disting-uished fro~ prior art devices in ~hich spring loaded rims are closeable. In each such device, it is believed that the sole purpose is to pro~ote co~pliance of a "sized" contraceptive to irregularities in the vaginal wall.

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Claims (64)

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

1. A barrier contraceptive of the type intended to be inserted within a vaginal vault, said contraceptive comprising:
a) a first member means having opposed anterior and posterior portions for releasably and resiliently engaging the respective anterior and posterior portions of the vaginal vault; and b) a second member means coupled to said first member means substantially at said posterior portion, such that, upon insertion of said contraceptive into the vaginal vault, with said second member means disposed between said first member means and the cervix, and said first member means' posterior and anterior portions engaging, respectively, the posterior and anterior portions of the vault, said second member means being positionable to thereby close the cervical opening.

2. A contraceptive as recited in claim 1 wherein said first and second member means each have substantially discoid configurations and said second member means has a smaller disc surface area than said first member means.

3. A contraceptive as recited in claim 2 wherein said second member means comprises a sponge-like material, said sponge-like material being capable of receiving a lubricant.

4. A contraceptive as recited in claim 3 wherein said first member means comprises a substantially resilient annular member with a flexible film secured thereto and lying substantially in a plane; said second member means being secured to said film and within said annular rim.

5. A barrier contraceptive as recited in claim 4 wherein said annular member comprises a rim having a generally circular configuration and having a discontinuous portion, so that the free ends of said rim may be pressed together, thereby reducing the diameter of said rim.

6. A contraceptive as recited in claim 5, said discontinuous portion of said rim being said anterior portion and said sponge being secured to said film substantially adjacent to said posterior portion of said rim.

7. A contraceptive as recited in claim 6, said rim being thicker at said posterior portion than at said free ends to thereby improve said resiliency.

8. A contraceptive as recited in claim 7 wherein said rim, sponge and film are each made of a plastic.

9. A contraceptive as recited in claim 8 wherein said free ends of said rim are rounded; said sponge extending higher from the plane defined by said film than said rim extends from said plane.

10. A contraceptive as recited in claim 9 wherein said posterior rim has a thickness of from 1 to 2 mm., said anterior free ends of said rim having a thickness of from .5 to 1 mm.; said rim and sponge being secured to said film by heat sealing; said film being co-terminus with the outer circumference of said rim and defining a chord at said anterior portion; said sponge being from 2 to 5 mm. thick, being discoid, and having a diameter of approximately 40 mm.;
said film having a thickness of from .125 to 1.25 mm.

11. A contraceptive as recited in claim 6 wherein said sponge is secured to one side of said film so that said film covers one exposed surface of said sponge.

12. A contraceptive as recited in claim 6 wherein said sponge is secured to said film and has two exposed surfaces on either side of said planar surface of said film.

13. A contraceptive as recited in claim 4 wherein said annular member comprises a rim having a generally circular configuration and further comprises overlapping separate ends along said anterior portion such that, upon pressing radially upon said rim, said free ends move about said circumference of said rim to thereby reduce the diameter of said rim.

14. A contraceptive as recited in claim 6 wherein said film further comprises a flap extending from said anterior portion and without said rim being wrapped about said free ends of said rim and joined to said film within said rim.

15. A contraceptive as recited in claim 3, said second member means being resiliently secured to said first member means for movement away from said first member means so as to yieldably contact and close the cervical opening.

16. A contraceptive as recited in claim 15 further comprising a resilient and flexible filament of finite length and bent into a figure 8 configuration to thereby exhibit a tendency to remain in a plane; said first and second member means' circumferential dimensions being substantially defined by said figure 8 configuration.

17. A contraceptive as recited in claim 16 further comprising a soft, pliable, sponge-like, plastic material enveloping said figure 8 filament and conforming to said shape, said second member means being the upper loop of said figure 8 filament and said first member means being the lower loop of said figure 8 filament, said upper loop being folded over said lower loop at the juncture of said loops, said juncture corresponding to said posterior portion.

18. A contraceptive as recited in claim 17 wherein said filament terminates in said lower loop at said anterior portion so that said ends may be pressed together, thereby reducing the diameter of said rim.

19. A contraceptive as recited in claim 18, said first and second member means each being substantially ellipsoid, the major axis of said second member means being perpendicular to the major axis or said first member means, said major axis of second member means intersecting said juncture of said loops, and said ends of said filament being rounded.

20. A contraceptive as recited in claim 19 wherein said filament is made of a plastic and has a cross section diameter in the range of .25 to 2 mm.; the covering of said plastic comprising opposed sheets, each of 1 to 3 mm.
in thickness, said upper loop having dimensions of approximately 38.1 mm. by 31.8 mm.

21. A contraceptive as recited in claim 15 wherein said first member means comprises a substantially resilient annular member; said second member means comprises a tongue integrally formed within said annular member at said posterior portion and extending inwardly of said rim.

22. A contraceptive as recited in claim 21 wherein said rim is generally circular and has a discontinuous portion opposed to said tongue so that the free ends of said rim may be pressed together to thereby reduce the diameter of said rim.

23. A contraceptive as recited in claim 22 wherein said first member means further comprises a soft, sponge-like plastic covering about said rim and enclosing the space therewithin; said second member means further comprises a sponge-like plastic covering secured to said tongue.

24. A contraceptive as recited in claim 23 wherein said tongue extends resiliently upwardly from the discoid plane of said first member means at an acute angle.

25. A contraceptive as recited in claim 24, said rim being formed from a resilient plastic of approximately 1 mm. thick and formed to define the circumference of a semicircle with an outer diameter of approximately 2 mm.;
said tongue extending inwardly of said rim for approximately 30 to 50 mm. and being 4 to 6 mm. wide; said second member means having a thickness of 3 to 4 mm. and a diameter of 40 mm.

26. A contraceptive as recited in claim 15 further comprising a continous resilient liner and an envelope of soft, flexible material; said liner tending to return to a plane; said liner and flexible material being folded along said posterior portion to thereby form said first and second member means.

27. A contraceptive as recited in claim 26, said liner having a notch at said anterior portion such that the ends defined by said notch may be drawn together to thereby reduce the circumferential dimension of said second member means.

28. A contraceptive as recited in claim 27 wherein said liner comprises two conjoined circles, said liner and said envelope being folded along a chord defined by the juncture of said circles, said notch being a segment of said first member means circle.

29. A contraceptive as recited in claim 28 wherein said second member means has a diameter of approximately 40 mm.;
said seqment having an angle of 90° to 110°; said chord defined by said juncture of said circles being 15 to 20 mm.
in length; said liner having a thickness of 1 to 4 mm.; said soft envelope being heat-sealed along the circumferential edges and made of a foam, sponge-like plastic 2 mm. in thickness.

30. A contraceptive as recited in claim 3 further comprising a lubricant, said second member means being moistened by said lubricant to thereby aid in closing said cervical opening; said second member means being impermeable.

31. A contraceptive as recited in claim 30, said lubricant further having adhesive properties so as to thereby aid in the adhesion of said second member means upon being disposed against the cervix.

32. A contraceptive as recited in claim 6 further comprising a lubricant; said second member means being moistened by said lubricant to thereby aid in closing said cervix; said second member means being impermeable.

33. A contraceptive as recited in claim 32, said lubricant further having adhesive properties so as to thereby aid in the adhesion of said second member means upon being disposed against the cervix.

34. A contraceptive as recited in claim 10 further comprising a lubricant; said second member means being moistened by said lubricant to thereby aid in closing said cervix; said second member means being impermeable.

35. A contraceptive as recited in claim 34, said lubricant further having adhesive properties so as to thereby aid in the adhesion of said second member means upon being disposed against the cervix.

36. A contraceptive as recited in claim 15 further comprising a lubricant; said second member means being moistened by said lubricant to thereby aid in closing said cervix; said second member means being impermeable.

37. A contraceptive as recited in claim 36, said lubricant further having adhesive properties so as to thereby aid in the adhesion of said second member means upon being disposed against the cervix.

38. A contraceptive as recited in claim 20 further comprising a lubricant; said second member means being moistened by said lubricant to thereby aid in closing said cervix; said second member means being impermeable.

39. A contraceptive as recited in claim 38, said lubricant further having adhesive properties so as to thereby aid in the adhesion of said second member means upon being disposed against the cervix.

40. A contraceptive as recited in claim 25 further comprising a lubricant; said second member means being moistened by said lubricant to thereby aid in closing said cervix; said second member means being impermeable.

41. A contraceptive as recited in claim 40, said lubricant further having adhesive properties so as to thereby aid in the adhesion of said second member means upon being disposed against the cervix.

42. A contraceptive as recited in claim 29 further comprising a lubricant; said second member being moistened by said lubricant to thereby aid in closing said cervix; said second member means being impermeable.

43. A contraceptive as recited in claim 42, said lubricant further having adhesive properties so as to thereby aid in the adhesion of said second member means upon being disposed against the cervix.

44. A contraceptive of the type intended to be inserted within a vaginal vault, said contraceptive comprising:
a) cervix engaging means; and b) resilient and flexible means for positioning and retaining said cervix engaging means within the vault and holding said cervix engaging means in contact with the entrance to the cervix so as to form an impermeable barrier to the cervix.

45. A contraceptive as recited in claim 44, said resilient and flexible means comprising a substantially circular rim and a film of impermeable material secured to said rim; said cervix engaging means comprising a substantially impermeable sponge secured to said film.

46. A contraceptive as recited in claim 45, said rim having posterior and anterior portions corresponding to and for engaging at least the posterior and anterior portions of the vaginal vault; said rim being discontinuous at said anterior portion such that, upon pressing upon said rim, said rim is resiliently reduced in size, said film flexibly yielding to said rim and returning to its original condition upon said rim being released.

47. A contraceptive as recited in claim 44 further comprising a continuous, resilient filament of finite length disposed to form upper and lower loops of a figure 8; and a soft, foam-like plastic material enveloping said figure 8, said upper loop being substantially elliptical and folded over said lower loop at the intersection of said loops, said upper loop thereby defining said cervix engaging means; said lower loop, in combination with said covering, thereby defining said resilient and flexible means.

48. A contraceptive as recited in claim 47, said lower loop having posterior and anterior portions corresponding to and for engaging at least the posterior and anterior portions of the vaginal vault; said fold being at said posterior portion; the ends of said filament being spaced apart at said anterior portion such that, upon pressing said lower loop together, said lower member is resiliently reduced in size, said covering flexibly yielding to said filament;
said filament resiliently urging said cervix engaging member into the plane of said resilient and engaging means.

49. A contraceptive as recited in claim 44, said resilient and flexible means comprising a substantially circular rim and an envelope of soft, flexible sponge-like plastic; said cervix engaging means comprising a tongue-like extension integrally formed in said annular rim and extending inwardly thereof and a discoid-shaped sponge-like plastic member secured to said tongue.

50. A contraceptive as recited in claim 49, said rim having posterior and anterior portions corresponding to and for engaging at least the posterior and anterior portions of the vaginal vault; said rim being discontinuous at said anterior portion such that, upon pressing upon said rim, said rim is resiliently reduced in size, said plastic envelope about said rim yielding to said rim and returning to its original position upon said rim being released.

51. A contraceptive as recited in claim 44 wherein said cervix engaging means, in combination with said resilient and flexible means, comprises a liner of a resilient plastic material and a soft, flexible, sponge-like plastic enveloping said liner; said cervix engaging means and flexible means being further defined by two discoid members intersecting at a common chord and folded therealong; said liner tending to resiliently urge said cervix engaging means away from said resilient and flexible means to thereby positively engage the cervix upon insertion into the vaginal vault.

52. A contraceptive as recited in claim 51, said resilient and engaging means having at least anterior and posterior portions corresponding to and for engaging at least the posterior and anterior portions of the vaginal vault; said liner having a segment like notch at the anterior portion such that, upon pressing said liner segment edges together, said resilient and engaging means is reduced in size, said covering flexibly yielding to said liner and returning to its original position upon said liner being released.

53. A contraceptive as recited in claim 46 wherein said cervix engaging member further comprises a lubricant having adhesive properties and said engaging member being impermeable.

54. A contraceptive as recited in claim 48 wherein said cervix engaging member further comprises a lubricant having adhesive properties and said engaging member being impermeable.

55. A contraceptive as recited in claim 50 wherein said cervix engaging member further comprises a lubricant having adhesive properties and said engaging member being impermeable.

56. A contraceptive as recited in claim 52 wherein said cervix engaging member further comprises a lubricant having adhesive properties and said engaging member being impermeable.

57. A contraceptive as recited in claim 44 wherein said cervix engaging means acts as a barrier for blocking the entry of foreign matter into a cervix; said resilient and flexible means for positioning and retaining said cervix engaging means within the vault further comprising rim means for engaging the wall of the vault and being in cooperative engagement with said cervix engaging means; said rim means being resiliently and flexibly engagable with the vaginal vault for positioning said contraceptive and having a circumferential discontinuity so dimensioned as to permit said rim to be resiliently reduced in size so as to be accommodated by vaginal vaults of varying cross-sectional dimensions.

58. A contraceptive as recited in claim 57 wherein said discontinuity is from 15 to 33 1/3 percent of the circumferential length of said rim.

59. A contraceptive as recited in claim 58, said rim means comprising a substantially annular member defining a substantially circular configuration; said discontinuity being defined by spaced ends of said annular member, said annular member being resilient such that said ends may be pressed together to thereby reduce the diameter of said rim means.

60. A contraceptive as recited in claim 59 wherein said free ends are rounded.

61. A contraceptive as recited in claim 58, said rim means comprising a substantially annular member defining a substantially circular configuration; said discontinuity being defined by overlapping separate ends of said annular member, said annular member being resilient such that said ends are free to move about said circumference of said rim to thereby reduce the diameter of said rim means.

62. A contraceptive as recited in claim 61 wherein said free ends are rounded.

63. A contraceptive as recited in claim 58 wherein said rim means comprises a generally continuous, discoidal, resilient member having a discontinuity in one circumferential part thereof; and an envelope of a flexible member having a discoidal shape for enclosing said discoidal resilient member;
said notched ends being so spaced such that upon pushing said notched ends together the diameter of said rim means is reduced.

64. A contraceptive as recited in claim 63 wherein said discontinuity comprises a segment of a circle.