Vaginal device

A three layered disposable vaginal device comprised of two resilient compressible polymeric foam layers separated by a non-permeable layer, the outermost layer being designed to include a receptacle. The device is also designed to include a removal tape that will permit the user to easily remove the same after use. The construction is intended for use as a barrier contraceptive with or without spermicide, as a delivery system for medicaments and also as a barrier to the transmission of sexually transmitted diseases.

This invention relates to a vaginal device and more particularly relates to 
a vaginal sponge used as a barrier contraceptive, as a barrier to disease 
transmission, as a carrier for a contraceptive or as a carrier and 
dispenser of medicaments, such as anti-infectives, anti-virals, 
anti-inflammatories, anti-fungals, hormones, enzymes, psychotropic drugs 
and the like. 
More particularly, the invention relates to a disposable female 
contraceptive and/or a vaginal medication device adapted for insertion and 
placement in the human vaginal canal and subsequent removal therefrom for 
the local administration of a spermicide or one or more of a variety of 
medicaments. 
The invention also relates to a barrier contraceptive device which is 
relatively inexpensive, affords a very high degree of protection from 
pregnancy and disease transmission and overcomes some of the problems and 
disadvantages associated with other contraceptive devices and methods 
which will be described below. 
It is abundantly clear that one of the most crucial problems of man is the 
expanding population. Already the large cities are experiencing a 
disconcerting modern symptom of being "people trapped." What is more, the 
Malthusian nightmare of population exceeding the food supply has become a 
reality. Major efforts have been directed to thwart this crisis. The 
development of the oral contraceptive--i.e., the "pill" has been hailed as 
one of the major discoveries of our age and more significant to the human 
race than the release of atomic energy or space flights. 
Unfortunately, there are side effects and certain risks involved in the 
taking of oral contraceptives. From 15 to 35% of the women using the oral 
contraceptives experience undesirable side effects. Nausea, vomiting, 
breast fullness, mastalgia, headache, dizziness, depression, apathy, 
fatigue, pelvic pain and chloasma are the most frequent. Fluid retention 
and weight gain are also observed. Thrombophlebitis has been the cause of 
greatest concern to the profession, the FDA and the public. Instances of 
jaundice have been reported. There has been some indication that 
contraceptive therapy may increase the blood pressure in a segment of the 
patients. Concerns have been raised about a possible relationship with 
cervical cancer, breast cancer and liver cancer. 
There are other contraceptive products available. They vary in mode of 
application, time of application, nature of device, cost, adverse affects 
and reliability. For the purpose of this disclosure, there may be 
mentioned the diaphragm, IUD's, the cervical cap, foams, jellies, 
suppositories and the vaginal sponge as described in U.S. Pat. No. 
4,393,871. 
The diaphragm and cervical cap involve the intervention of a physician and 
are expensive and in the case of the cervical cap may produce discomfort, 
infection and other problems. They are also difficult to sterilize and 
messy to clean. 
Recently increasing attention has been given to the adverse reactions 
caused by intrauterine devices (IUD's). Both the scientific and the lay 
presses have reported the occurrence of serious side effects associated 
with their use, including pelvic inflammatory disease, ectopic pregnancy, 
and impaired fertility after discontinuing use. The foams, jellies and 
suppositories do not require a physician, are inexpensive and have the 
disadvantages that they are unpleasant and/or messy to use, frequently 
cause irritation to the user and/or her partner, and have reliabilities of 
85% or less. 
It has already been proposed (U.S. Pat. No. 3,262,450) to use as a birth 
control method foam producing spermicidal compositions which are topically 
applied with a cellular sponge of polyurethane plastic in which the 
average pore size does not exceed 1.5 mm. A foam producing material is 
introduced into the device which is termed "a topical application." Just 
prior to use the foam is produced by compressing and expanding the sponge 
and then this foam filled application is introduced into the vaginal 
cavity. Such structure possesses several deficiencies, including the 
already mentioned messiness of foams and more important that the 
applicator can not retain the spermicide containing foam any great length 
of time and thus has limited long term applicability. 
A vaginal sponge contraceptive has been disclosed in U.S. Pat. No. 
3,762,414 issued in 1973 to the inventor named herein. This sponge is a 
compressible, smooth surfaced, plastic sponge in the form of a solid 
rectangle, cylinder, sphere or the like and as disclosed is divided into 
two or more sections by a plastic, latex or other rubber sheet or film. 
The dividing sheet or film prevents the flow of fluid from one section of 
the sponge to the other. The sponge is used for controlling the flow of 
seminal fluid (contraception) and for dispensing medicaments. 
The use of the aforesaid sponge as a contraceptive is enhanced by 
incorporating into the sponge a spermicidal agent as, for example, a 
copper salt. Still further, the sponge as described in the patent may be 
used as a carrier and dispenser for medicaments, for example, as are used 
to treat infections. 
As disclosed in U.S. Pat. No. 3,762,414, the vaginal sponge is produced 
from polyurethane foam or other smooth surfaced plastic foam and is 
divided into at least two sections separated by a plastic latex or other 
non-porous fluid impervious film. The contraceptive action is provided by 
sponge-like absorption of sperm by the foam material and blockage of the 
passage of such sperm by the film used to separate the sponge sections. 
Contraception is enhanced by the use of a chemical contraceptive which is 
absorbed and released in a sponge-like controlled manner. 
Recently a non-prescription sponge contraceptive has been disclosed (V.L.I. 
Corporation of Costa Mesa, Calif. U.S. Pat. No. 4,393,871) which is round 
in shape and which is adapted to release a chemical, NONOXYNOL-9, 
generically known as nonylphenoxy poly(ethyleneoxy)ethanol that 
inactivates sperm. The V.L.I. sponge contraceptive is formed by foaming a 
contraceptive surfactant and a foam forming polymeric material or a 
monomer or prepolymer thereof. According to V.L.I. the polymerized foam 
substantially encapsulates the contraceptive surfactant so that the same 
will be slowly released for use only in those cases where the surfactant 
is present in large enough amounts i.e., greater than 10% of the dry 
weight of the sponge. If present in an amount less than 10% of the dry 
weight of the sponge, an organic fibril such as collagen must be added to 
help encapsulate the contraceptive agent. 
This sponge, as in the case of the device disclosed in U.S. Pat. No. 
3,762,414, also blocks the cervix and also acts to trap and absorb semen. 
As described by the press, "in clinical trials, the sponge was found to be 
about 85% effective in preventing pregnancy." 
In addition to causing some discomfort to the user, the shape and location 
in the vaginal canal have given rise to removal problems. 
In U.S. Pat. Nos. 4,564,362 and 4,601,714 barrier contraceptives have been 
disclosed which comprise an outermost layer of a resilient compressible 
open-celled polymeric foam, a non-porous barrier film layer affixed to the 
outermost foam layer and a second layer of open-celled polymeric foam 
affixed to the opposite surface of the non-porous film layer. The 
outermost and innermost foam layers differ in density and/or number of 
pores per inch with the more dense or smaller pored foam layer 
constituting the outermost layer, the outermost layer being adapted to lie 
against the cervix of the uterus. 
The device itself constitutes a barrier contraceptive, the contraceptive 
action being provided by sponge-like absorption of sperm by the foam and 
blockage of the passage of such sperm by suitable selection of the foam 
and by the film used to separate the outermost and innermost sponge 
layers. The effectiveness of the device is enhanced by the introduction of 
a chemical contraceptive into at least one of the sponge layers, 
preferably during the manufacturing process for retention therein and from 
which it is absorbed and released in a sponge-like controlled manner. The 
presence of the spermicide serves to improve the device's effectiveness as 
a contraceptive. 
When the device is used as an article for controllably dispensing drugs, 
the same or different drugs can be introduced into at least one of the 
sponge layers. These drugs may be adapted for rapid release or for release 
over a prolonged period of time. The device permits the retention and 
therewith timed release application of medicaments or drugs. 
The incredible increase in the incidence of sexually transmitted diseases 
during the last decade has drastically changed the need for devices to be 
used during coitus. The emphasis in the last quarter century has been to 
improve the efficacy, safety and acceptability of contraceptives and has 
resulted as aforenoted, in the development of oral contraceptives, 
intrauterine contraceptive devices, the use of hormonal implants and 
injections and as well of simplified forms of both male and female 
sterilization. The unanticipated and unexpected emergence of virally 
transmitted sex associated diseases such as the group of human papilloma 
viral diseases, herpetic lesions and human immunodeficiency viral disease 
has drastically altered the requirements for safe and efficacious aids to 
protect not only against pregnancy but against sexually transmitted 
disease. These diseases have required that consideration be given not only 
to contraceptive efficacy, but additionally to offer means of protecting 
sexual participants from acquiring diseases that may in many instances be 
incurable, if not fatal. 
It is an object of the present invention to provide a multi-purpose vaginal 
device suitable for use in contraception and medicament application 
improved as compared to the state of the art with respect to consumer 
acceptance, efficacy and production feasibility. 
A further object of the invention is to provide a multi-purpose vaginal 
device that completely prevents fluid flow from one of its ends to the 
other and yet is porous and absorbent. 
Still a further object of the present invention is to provide a vaginal 
contraceptive device having an improved effectiveness in preventing 
pregnancy. 
Yet a further object of the invention is to provide a vaginal device of the 
type described which may be economically mass produced and which may be 
simply packaged to facilitate storage and transportation thereof prior to 
use. 
Another object of the invention is to provide a vaginal device of the type 
described for controllably dispensing drugs. 
Yet another object of the invention is to provide a vaginal device of the 
type described for providing protection from disease transmission. 
Another important object of the invention is to provide a vaginal device 
having an improved effectiveness in preventing pregnancy and additionally 
providing protection against the transmission of any sexually transmitted 
disease. 
Still another object of the invention is to provide a vaginal device of the 
type described in which access is provided to the device for easy removal 
thereof. 
These and further objects and advantages of the invention will be made 
clear or will become apparent during the course of the following 
description. 
In accordance with the present invention, a vaginal device is provided the 
outermost layer of which is a polymeric foam. Affixed to the outermost 
foam layer is a non-porous film layer made of a liquid, virus and bacteria 
proof soft elastomeric material. Affixed to the non-porous film layer is a 
second layer of polymeric foam. The intermediate layer provides a barrier 
between the two foam layers. The outermost layer is formed so as to 
provide a receptacle therein for spermicide and/or medicament. The 
presence of the receptacle also adapts the device for use as a collector 
of menstrual fluid and discharges. The presence of the receptacle in the 
outermost foam layer allows the device to naturally orient itself over the 
cervix increasing the blocking action of the device and also permits 
deeper placement in the vagina decreasing interference during coitus. 
Further the presence of the receptacle makes insertion and removal easier 
than in the case of a uniformly dense continuous outermost layer.

The device as constructed is a three dimensional structure, cylindrical in 
shape and forms a more or less circular unit having a diameter of about 40 
to 75 mm and a depth of about 25 to 75 mm. The invention is not limited to 
the foregoing dimensions, the same being illustrative only. Its diameter 
may decrease somewhat but this aspect is limited as it is critical that 
the device form a barrier across the vaginal canal. The innermost and 
outermost layers should have a thickness of from 10 to 20 and 15 to 55 mm 
respectively. Such thicknesses insure ready impermeability, yet also 
provide flexibility. The receptacle provided in the outermost layer may be 
spherical or globular in shape or may take the form of a truncated cone. 
Its diameter at its topmost aspect should be about 20 to 45 mm and it 
should have a depth of 5 to 50 mm. It is critical that the size of the 
receptacle be regulated so as not to interfere with the dimensional 
stability and/or structural integrity of the device but yet provide ample 
space for spermicide, medicament and/or collected fluid. 
The barrier film should have a thickness of about 0.5 to about 3 mils, 
preferably from 1 to 2 mils. 
As noted hereinabove, the device in use must be positionable to block the 
cervical opening and for making a compression seal against the walls of 
the vaginal canal. 
The foam must of course be biocompatible, non-toxic and non-irritating and 
is preferably a polyurethane foam. In addition the foam must be natural 
and soft in feeling so that the user in the case of medical application 
and in the case of contraceptive use, the latter including barrier use for 
preventing the acquisition of a sexually transmitted disease, neither 
sexual partner is aware of its presence. Any polyurethane foam which can 
be fabricated with the characteristics needed for the intended end use 
(soft, pliable, flexible, porous, may be employed. 
While the polyurethane foams are preferable, there are not presently any 
reasons why the polyester, polyether, polyethylene, crosslinked 
polyethylene and the like combination foams, as for example 
polyester-polyurethane foams may not be used. In addition the alginates, 
polymeric Hypan compounds, have been found to be suitable for use in the 
fabrication of the device of the invention. The criteria for selection of 
course must include in addition to effectiveness, safety for intended use. 
Preferably, the foams are open cell, but it would appear that closed cell 
foams would work as well. It has been found that the closed cell foams are 
especially suitable for fabricating the outermost layer i.e., layer 
provided with the receptacle. The cell structure most preferably is open 
cell, 80-200 pores per inch. The density of the foam will vary as 
hereinafter described but can range from 1.5 to 3.0 lbs. per cu. ft. and 
even higher. 
The tensile strength characteristics are somewhat important and should 
amount to about 30-39 psi. It can be appreciated that the foams involved 
are readily available and that there is no difficulty envisioned should 
there be a need to custom fabricate so as to produce the desired 
characteristics. 
Most important, the sponge must be permeable, must be capable of absorbing, 
retaining and then releasing a spermicide or medicament. At the same time, 
it must be a barrier for the microsized highly motile sperm. In this case, 
the pore size is critical not only for barrier effectiveness but for 
ensuring retention of the spermicide or medicinal agent for any 
appreciable period. 
Foams marketed under the trade names Scott Industrial Foam, Scottfelt Foam, 
Pyrell and the like are particularly suitable for use in producing the 
device of the invention. Two foams are used in constructing the instant 
device with the foams being selected so as to provide layers of differing 
resiliency, stiffness and absorbency. The density and cell structure, 
particularly the pores per inch, determine the characteristics. In some 
applications the more dense or smaller pored foam is preferably selected 
for forming the outermost layer. 
The two layers, however, may be the same or different. In the latter case, 
the foams may have different characteristics of resiliency and absorbency. 
The foam layers are separated one from the other by a barrier film. The 
film barrier can be made of natural rubber, synthetic rubber or latex 
material, or other elastomeric material. It is also possible to use as a 
barrier layer certain of the laminated packaging materials, as for example 
a barrier coextruded layer comprised of a two or three layer combination 
of ethylene methacrylate copolymer and polyester. It is contemplated that 
in place of the barrier film a glue layer may be used. As glue there may 
be used any suitable adhesive i.e., one which is pharmacologically 
acceptable, biologically inert and capable of forming an impervious layer. 
An example of such an adhesive layer is a polyolefin adhesive layer. 
Another adhesive which may be used is ethylene acrylic acid. 
The layers of sponge are so arranged as to provide an outermost layer 
provided with a receptacle and which aids in securing the device, holding 
the device in position, and which furthermore reinforces the barrier 
effect of the film and of the innermost sponge layer. 
The use of a string or thread or woven fabric ribbon is contemplated for 
facilitating removal and/or withdrawal of the device, removal tapes being 
preferred. Alternate removal means may be substituted as for example tab 
means applied with a biocompatible adhesive on the exposed surface and 
capable of being grasped and/or held while the device is being removed. 
Accordingly, it can be appreciated that the use of the urethane-barrier 
film or adhesive layer sponge device per se without the addition of a 
spermicidal agent is contemplated as reliable for contraceptive and 
disease transmission use. 
However, the efficacy is improved when prior to its use as a contraceptive 
the receptacle provided in the outermost layer is filled with a 
spermicide, such as NONOXYNOL-9, generically known as nonylphenoxy 
poly(ethyleneoxy)ethanol which has long been recognized as safe and 
effective for this purpose. Other examples of spermicides which are 
suitable for use herein include, methoxypolyoxyethyleneglycol 500 
laureate, stearic acid, ricinoleic acid, p-diisobutylphenoxyethoxyethanol, 
p-menthanylphenylpolyoxyethylene ether, octylcresolpolyoxyethylene ether, 
polyoxyethylene oxypropylene stearate, polyoxyethylene laureate, glycerol 
ricinolate, triisopropyl phenylpolyoxyethylene ether, mono-iso-octyl 
phenyl ether, polyethylene glycol, polyoxyethylene stearylamine, 
benzalkonium chloride, sodium dodecylsulfate, sodium oleate, zinc 
phenolsulfonate, dodecylbenzene sulfonate, dodecyl diaminoethyl glycine, 
and the like. 
The spermicide is required to be present in an effective amount and the 
size of the receptacle is dimensioned so as to provide at least that 
amount. 
No preservatives or pH reducers should be required but if they are added, 
it is well within the skill of the art to determine in what amounts the 
same may be present and the manner in which they are to be incorporated 
into the various formulations prior to their use. 
Instances of preservatives include benzoic and sorbic acid. 
An example of an agent which may be added to lower the pH is citric acid. 
The pH in the vagina is approximately 4.0 to 5.0. If the vaginal pH is 
increased to any extent above this range, the growth of bacteria is 
encouraged. The citric acid can be added in an amount whereby the pH of 
the solution in the sponge is below that of the vaginal pH and namely 
below 4.0 and preferably at about 3.5. 
In addition to the spermicide or in place thereof, pharmaceuticals such as 
antibiotics, antifungals, antivirals, antibacterials, steroids, etc., 
illustrated hereinafter, can be delivered into the receptacle provided in 
the sponge. 
Thus, and this is most important, the sponge may be used as means for 
dispensing medicaments as for example, anti-infection agents, 
anti-microbials, anti-virals, hormones, enzymes, psychotropic drugs, 
cardiac and blood pressure regulators, etc. This aspect of the invention 
is considered to be a very important one. Further, the medicament itself 
or the medicament and sponge may be modified for controlled or timed 
release during use. 
Illustrative of the suitable medicaments and the categories in which they 
fall are the following: 
______________________________________ 
Name Category 
______________________________________ 
aminophylline smooth muscle relaxant 
aspirin analgesic 
conjugated estrogen 
estrogen 
ethinylestradiol 
prostaglandin labor inducing 
iodochlorhydroxyquin 
local anti-infective 
interferon, acyclovir 
antiviral 
metronidazole anti-trichomonal 
sulfonamides antibacterial 
retin A anti-dysplasia 
miconazole anti-fungal 
prochlorperazine tranquilizer 
ketoconazol anti-yeast and anti-Candida 
nystatin 
______________________________________ 
Other medicaments which can be mentioned are barbiturates, narcotics, 
phenobarbital, procaine, penicillin, tetracycline, ampicillin, 
cephalosporins, nitrofurazone, hydrocortisone, triamcinolone, 
prostaglandine and the like. 
While in one aspect the device of the invention is a vaginal barrier that 
is designed to afford reasonable contraceptive efficacy, most importantly 
it serves to provide protection against the transmission and/or 
acquisition of any sexually transmitted disease. It is now known that the 
passage of sperm through the cervical canal is one of the ways in which 
pathogenic microorganisms gain access to the upper genital tract (uterus, 
fallopian tubes, and ovaries). Several investigators have established, for 
example through use of such means as electron microphotographs, the 
adherences of bacteria to the heads and necks of spermatozoas thereby 
providing for them a piggy back ride to the upper genital tract. 
Contraceptive methods such as the IUD do not protect women against this 
route of transmission. Tubal ligation and oral contraceptives also do not 
appear to provide a reliable means of protecting women against sexually 
transmitted diseases. The vaginal barrier device of the invention provides 
three mechanisms that serve to prevent the transmission of disease. 
first: an innermost or distal sponge layer to absorb spermatozoa. 
second: an impermeable barrier layer to prevent transmission of spermatozoa 
and microorganisms including viruses. 
third: a spermicidal/bactericidal/virucidal agent to immobilize and kill 
spermatozoa and microorganisms that penetrate beyond the first two defense 
layers. 
The provision of the receptacle in the proximal portion of the device 
further enhances the efficacy of the device of the invention. It now 
becomes suitable for the collection of samples of cervical secretions or 
menstrual fluid. Tissue specimens thus collected may then be evaluated 
with respect to infertility, hormonal status, or cancer screening. An even 
more likely use would be for the collection of menstrual fluid to serve as 
a sanitary system for menstrual protection that might be safer and more 
comfortable than those currently in use i.e., tampons and napkins. 
The device of the invention not only allows for the delivery of medicaments 
to the vagina or circulatory system but the presence of the receptacle 
enables it to be used to deliver spermatozoa to the upper vagina and 
cervix. This delivery capability decreases the loss of spermatozoa during 
insemination procedures done in infertile or subfertile patients, and 
increases the amount of contact time of the spermatazoa with the cervix. 
The presence of the receptacle also allows for the placement of monitoring 
devices that can record and transmit information on the temperature, pH, 
glucose content, and other chemical and mineral constituents of upper 
vaginal/cervical/uterine fluids that would be of interest and importance 
in physiological investigations and infertility therapies. These measuring 
devices would be of particular importance to the prediction and monitoring 
of ovulation important both in reducing infertility and in using "natural" 
methods of family planning by enhancing the effectiveness of periodic 
abstinence. 
If the sponge's effectiveness in preventing transmission of disease is to 
be enhanced, the use of an antiviral agent such as idoxiredome, acyclovir, 
interferon and the like is particularly indicated. 
For using the vaginal device of the present invention to deliver spermicide 
or to deliver medication including anti-virals to the vagina or the 
cervix, an effective amount of the spermicide or of the desired drug is 
incorporated into an appropriate pharmaceutical carrier, for example a 
cream, foam, gel or the like and in this form introduced into the 
receptacle portion of the device. 
The amount of drug introduced into the receptacle provided in the vaginal 
device of the present invention varies, depends on the particular drug, 
the desired therapeutic or prophylactic effect, and the time span for 
which the device provides therapy. The upper limit and the lower limit 
will depend on the activity of the drug and the time span of its release 
from the device. Thus, it is not practical to define a range for the 
therapeutically effective amount of drug to be incorporated in or released 
by the vaginal device. 
As noted, the above drugs and other drugs can be present in the vaginal 
device alone or in combination with pharmaceutical carriers to make the 
drugs more easily delivered and retained in the device. The carrier may 
also contain adjuvants for preserving, stabilizing, wetting, emulsifying, 
and the like. 
The vaginal sponge of the invention can be fabricated by any of the 
conventional foam techniques. The incorporation of the film between the 
two foam layers is known, as are the techniques for making the foams. Any 
of the known methods of molding, extrusion, stamping, etc., may be used 
singly or in combination to make the device. 
The method of manufacture of the end product polymer sponge must encompass 
its packaging as it is critical with a product of this type that the 
product be delivered in a sanitary or sterile form. A number of packaging 
methods are contemplated including the use of barrier laminates such as 
are presently used in connection with liquid, food, cosmetic and medical 
products The sponge is placed on a sheet of barrier film which is 
thereafter covered over with a further sheet of the same film and sealed 
on all four sides. If the packaging involves the use of an envelope or bag 
sealed on three sides or even one side, the respective sides not so sealed 
can thereafter be sealed using an adhesive if necessary or by relying on 
the heat seal nature of the barrier film itself. It is contemplated that 
in place of heat, ultrasound, RF or other form of sealing techniques can 
be used. The atmosphere, materials and other precautionary measures are 
observed to provide a sterile packaged sponge. What results is a packet of 
the type known in the art for retaining a product for prolonged periods of 
time having a long shelf life, yet easily opened when needed. 
Referring to FIG. 1, an outermost layer 1 of open cell polyurethane foam 
having about 150 pores per square inch and having a thickness of about 42 
mm is affixed to a latex film 2 having a thickness of about 1.5 mils. The 
innermost layer is an open cell polyurethane foam 3 having about 100 pores 
per square inch and having a thickness of about 13 mm. The device is a 
cylindrical construction having a diameter about 60 mm and a thickness 
just exceeding 55 mm. 
As illustrated in FIGS. 2 and 3, the receptacle 4 occupies less than 3/5ths 
of the device i.e., it has a total depth of about 30 mm, a diameter at its 
topmost portion of about 40 mm tapering down to about 20 mm at its 
lowermost portion which is located approximately 12 mm above the base of 
the outermost layer 1 and the latex film or barrier film layer 2. 
As shown in FIGS. 4 and 5, a removal tape 5 is provided for facilitating 
removal. The tape 5 can be made of a cotton or nylon woven or non-woven 
material. It can also be made of any other non-irritating material as for 
example of a synthetic plastic such as polyester, which is soft, 
non-irritating and biocompatible. In the preferred embodiment, the removal 
tape has a thickness of 7 mm and is introduced in the manufacturing 
process for providing retention in the device under the tension exerted 
thereon in effecting removal. The tape can be continuous or interrupted, 
extends into the uppermost layer but below the terminating portion of the 
receptacle. The tape 5 as provided allows the vaginal device to be easily 
grasped for removal from the vaginal canal. The presence of the receptacle 
4 in the uppermost portion of the device contributes to the ease with 
which the device is inserted and removed. It is readily apparent while the 
barrier across the vaginal canal is readily retained, the device is 
particularly well adapted to lie against the cervix of the uterus and the 
edges 6a and 6b of the outermost layer being adapted to block the vaginal 
fornices. 
While the device constituting my invention has been described as being more 
or less circular in shape, other shapes, i.e., elliptical, pear and the 
like, are contemplated. 
In the same manner, while the device has been disclosed as consisting of 
two (2) layers of sponge separated by a layer of impervious film, it is of 
course possible to have additional layers of sponge. However, at least one 
layer of impervious film must be present and disposed between two layers 
of sponge, i.e., only one layer of impervious film is required, regardless 
of how many foam layers are present. 
While it has been indicated that the spermicide, or medicament is 
introduced into the receptacle for delivery therefrom, it can be 
appreciated that the device is in the main constituted of a polymeric foam 
or sponge material and that the sponge material will absorb and retain 
spermicide or drug so that it too serves as a vehicle for retention and/or 
dispensing of the spermicide or medicament. In fact the sponge serves to 
assure that a reserve of spermicide or medicament i.e., antiviral agent is 
available. 
It is also contemplated that a layer of suitable adhesive 
(pharmacologically acceptable and capable of forming an impervious barrier 
layer) may be substituted for the elastomeric film. 
As noted above, while polymeric foams such as polyurethane are preferred, 
alginate and polymeric hypan compounds can be used to equal advantage. 
It is well within the skill of the artisan and the user as to how the 
device is to be inserted and removed and accordingly, the details thereof 
need not be expressly set forth. 
It is also believed well within the skill of the art to appreciate how to 
introduce the spermicide or medicament into the receptacle. 
It is contemplated that the spermicide and/or medicament can be provided to 
the user in a single packet or that they can be provided separately. 
It is further contemplated that the outermost layer be constructed of a 
non-porous material and that in such circumstances, no barrier film layer 
will be required.