Unit package containing ready-to-use vaginal contraceptive

A premoistened ready-for-use vaginal contraceptive device and method of use thereof are described wherein a porous polyurethane sponge is provided which is impregnated with a bacteria-free sterile spermicide, pectin and pH control and swelling agent aqueous solution enclosed within and readily removable from a sealed packet and wherein the premoistened polyurethane sponge with its absorbed components when removed from the packet is immediately inserted in position and is ready for contraceptive use. After one or more coital episodes the sponge is removed, its effective life being up to about 24 hours. The spermicide is present in a maximum of 8% and the pectin constitutes about 5%, both percentages being based on the weight of the solution.

BACKGROUND OF THE INVENTION 
Oral contraceptives of various types, particularly in "pill" form are well 
known and widely used because they have been found to be generally 
effective in the prevention of conception and it is further known that 
they can and do present risks of hormonal imbalances coupled with 
neurological disorders and other disadvantageous side effects. Spermicidal 
foams, gels and suppositories as well as diaphragms and IUD's are well 
known for preventing contraception. 
Studies to find better and safer intravaginal contraceptives are constantly 
under investigation including a recently available device comprising a 
polyurethane disc having a central recess and containing 1,000 milligrams 
of a spermicide known as nonoxynol-9, chemically definable as 
nonylphenoxypoly (ethyleneoxy) ethanol. While generally comparable in 
effectiveness to a conventional diaphragm, the polyurethane disc device 
has serious drawbacks as set forth in my aforesaid copending application 
as it is capable of causing irritation and allergic reactions of sensitive 
tissue and the relatively large content of nonoxynol-9 has been found to 
be undesirable and even unsafe because it must be combined with water 
before use which may render the device non-sterile and the polyurethane 
disc is not reliably shape-stable in the presence of moisture and/or 
pressure due to its shape and relatively poor absorbent power or retention 
of substances coming into contact therewith. 
NATURE OF THE PRESENT INVENTION 
This invention relates to a sealed foil or plastic package containing a 
ready-to-use vaginal contraceptive comprising a sponge or spongy vaginal 
insert premoistened with a spermicidal composition and which insert, upon 
removal from its package, is positionable in and removable from the vagina 
at will and constitutes a safe, effective and reliable sterile non-toxic 
means for avoiding conception without harmful side effects. 
In addition, the sponge-type intravaginal contraceptive of the present 
invention is designed to eliminate or substantially reduce the 
disadvantages of the polyurethane disc device as my novel contraceptive is 
individually packaged as a sterile, premoistened unit in a sealed, 
bacteria-free, foil packet with its spermicide already activated and 
instantly ready-for-use as the sponge is impregnated with a solution of 
sterile or distilled bacteria-free water so that the sponge is at all 
times sterile and uncontaminated and usable immediately upon removal from 
its packet. Thus, the sponge and its spermicide of the present invention 
is maintained sterile as it is out of contact with contaminants until 
ready for use; its dosage of spermicidal material is reliable, uniform and 
highly effective with a minimal amount of spermicide not greater than 
approximately 100 milligrams of nonoxynol-9, whereby optimal spermicidal 
action is quickly achieved and retained upon insertion of the premoistened 
sponge while minimizing or eliminating the possibility of irritation and 
other adverse or undesirable side effects on the vaginal vault while 
blocking access of semen or seminal fluids which could result in 
conception. 
DESCRIPTION OF THE INVENTION 
The present invention relates to a vaginal ready-for-use intravaginal 
contraceptive comprising, as a unit in an openable foil packet, a 
compressed or uncompressed porous, spongy mass suitable for manual or 
applicator insertion into the vaginal vault while ensuring maintenance of 
sterility. The spongy mass expands upon removal from its packet and is of 
appropriate size and shape and may, if desired, contain a swelling agent 
to achieve sufficient expansion to exert radial pressure against the 
vaginal wall and to block the cervix upon intravaginal insertion. The 
radial pressure maintains the contact established between the spongy mass 
and the vaginal wall and blocks access to the cervix, preventing 
dislodgment or mispositioning and providing an effective barrier against 
sperm penetration beyond the sponge without harmful effect on the female 
reproductive organs or adjacent tissue. 
The spongy mass is preferably comprised of a polyurethane spheroidal sponge 
approximately 1.5 to 2.0 inches in diameter. 
A drawstring or the like is attached to and extends from the sponge and 
provides means for withdrawal after use. The drawstring may be looped 
diametrically through and/or around the sponge and, when tightened, 
compresses an area or portion of the sponge. 
The contraceptive sponge is immediately ready to be used upon removal from 
its sealed packet or container. This results, for example, from utilizing 
a sealed foil packet in which the contraceptive unit has the nonoxynol-9 
spermicide which is already in solution absorbed in and held by the voids 
or pores of the sponge. 
Sterility and freedom from bacteria prior to use are essential and are 
ensured by means of the use of a sealed packet container for the sponge 
and the bacteria-free, distilled water base in which the water-soluble 
spermicide is dissolved and enclosed in the container. The spermicidal 
action is achieved with no or a very minimum possibility of irritation to 
the vaginal vault or adjacent tissue by employing not more than about 100 
milligrams of the nonylphenoxypoly (ethyleneoxy) ethanol in the sponge. 
The spermicidal composition in the sealed packet with the sponge comprises, 
by weight, about 5% to 8% of nonylphenoxypoly (ethyleneoxy) ethanol and 
about 0.5 to 5% of pectin in a bacteria-free aqueous solution. Preferably, 
the composition comprises 8% of the nonylphenoxypoly (ethyleneoxy) ethanol 
and 0.5% of pectin in bacteria-free distilled water. 
One of the major advantages of the invention is the inclusion of pectin in 
the spermicidal composition. Pectin (N.F.) is described in the National 
Formulary and is essentially a partially methoxylated polygalacturonic 
acid which conjugates with and detoxifies many toxins. It enzymatically 
degrades to acidic end products and thus enzymatically degrades in the 
vaginal vault to produce or maintain an acidic environment conducive to 
deodorization and the prevention or suppression of malodors from whatever 
source whether natural or unnatural or due to the presence of 
microorganisms or lactobacillary flora. The composition also contains at 
least one preservative and a pH adjusting agent and may, when necessary or 
desirable for sizing purposes of the sponge at its insertion, contain a 
cellulosic swelling agent such as sodium carboxymethylcellulose.

DETAILED DESCRIPTION OF THE INVENTION AND ITS USE 
This invention is characterized by a unit foil or plastic packet sealing 
therein a spermicidally impregnated sponge which can be quickly or readily 
removed for immediate use. Approximately 100 milligrams of the 
spermicide,which is nonylphenoxypoly (ethyleneoxy) ethanol, is absorbed as 
a bacteria-free aqueous solution containing pectin and a preservative and 
pH control or swelling agent by the sponge and this reduced but effective 
amount of spermicide avoids irritation to the vaginal vault and ensures 
contraceptive protection. 
The sponge, which is preferably a mass of porous polyurethane, is of 
appropriate size for intravaginal insertion and contains in the above 
solution absorbed therein a swelling or softening agent which causes 
expansion of the sponge sufficient to exert mild radial pressure against 
the vaginal wall and to block tbe cervix without adverse side effects. 
This prevents slippage or undesired movement or displacement from the 
intended position and maintains adequate contact between the sponge and 
the cervix of the female during and throughout its use. The sponge is free 
from discomfort to both sex partners and provides reliable spermicidal 
activity for 24 hours and through multiple coital episodes, following 
which it is removed and discarded. 
A significant and highly important feature of the invention is the 
inclusion of pectin in the aqueous formulation absorbed by the sponge 
since it is biodegradable and a detoxicant as well as a deodorant and 
preventative of malodorous properties of vaginal flora. The naturally 
acidic environment which exists is maintained but may be supplemented by 
the addition of a pH adjusting agent. 
The invention is extremely simple to use, is ready for immediate use upon 
removal from its packet and generally avoids any serious systemic side 
effects or physical discomfort. 
Referring now to the drawings, reference numeral 10 denotes generally a 
vaginal contraceptive sponge enclosed in a sealed packet of foil or other 
suitable impervious material such as an aluminum-plastic laminate. The 
sponge 12 is a generally spheroidal open-celled polyurethane mass having 
approximately 80 to 100 cells per lineal inch. A string 14 is looped 
diagonally through the sponge 12 and tied taut in a loop 16 for anchoring 
purposes. The tied loop 16 compresses and gathers a zone of the sponge and 
distorts its original spheroidal configuration as seen in the drawings. 
The looped string 14 forms a convenient means for withdrawing the sponge 
12 from the vaginal vault after the sponge has served its intended 
purpose. A knot may be formed at the ends of the looped string 14 to form 
a second large loop and to assist the user in locating the looped string 
for withdrawing the sponge 12. 
As best seen from FIG. 4, the sponge 12 is packaged in a hermetically 
sealed sterile foil packet 18 comprising two opposing sheets or films heat 
and/or pressure sealed around their periphery to form an enclosure for the 
sponge and to ensure sterility of the packet contents. The sponge 12 
impregnated with a spermicide solution as referred to above is then 
encased in the packet 18 in a class 100 clean room for complete sterility. 
The packet 18 sheets may comprise a foil-thermoplastic film laminate 
sealed together around their periphery. 
The spermicide absorbed by or impregnated into the sponge comprises a 
formulation, by weight, of about 5% to 8% nonylphenoxypoly (ethyleneoxy) 
ethanol, and about 0.5% to 5% of pectin , both in a sterile bacteria-free 
aqueous solution. Preferably, the solution comprises 8% of the 
nonylphenoxypoly (ethyleneoxy) ethanol and 0.5% of pectin in sterile 
bacteria-free distilled water together with the other additives or 
adjuvants. The pectin in addition to its advantages described above serves 
to control malodors, particularly odors accompanying trichomonas vaginalis 
and non-specific vaginitis. It is especially efficacious as a deodorizer 
for vaginal fluids and male semen and inhibits growth of vaginal flora and 
their odors due to vaginal pH changes. A pH adjusting agent such as 
glycine may also be employed as a constituent of the absorbed solution 
held in the voids or pores of the sponge and the glycine may cause a 
certain amount of gelatin of the pectin to avoid excessive fluidity. 
The following table represents the preferred and best mode solution. 
______________________________________ 
SPERMICIDAL SOLUTION 
Percentage Mg. Per 
Ingredient by weight Sponge 
______________________________________ 
Nonylphenoxypoly 
8.000 100.0000 
(ethyleneoxy) ethanol 
Pectin 0.500 6.2500 
Glycine 0.500 6.2500 
Sodium 0.125 1.5625 
Carboxymethylcellulose 
Methylparaben (q.s.) 
0.050 .6250 
Lactic Acid (q.s.) 
0.050 .6250 
Sodium Benzoate (q.s.) 
0,100 1.2500 
Distilled Water 
90.675 1,133.4375 
TOTAL 100.000% 1,250.0000 mg. 
______________________________________ 
The methylparaben acts as a preservative useful against molds, fungi and 
yeast. It is also useful against gram positive bacteria. 
The sodium benzoate is a preservative which is also useful as a urinary 
antiseptic against bacteria and molds. 
The lactic acid is a bactericide useful in the prevention of leucorrhoea 
and tends to maintain a pH normal for vaginal fluids. 
The pectin is further useful as an emulsifier and stabilizer and aids in 
the formation and maintenance of a uniform solution of suitable 
consistency. 
The sponge 12 is ready for immediate use upon its removal from the packet 
18 since it contains and carries in its pores and voids the active 
spermicidal solution. The sponge has a minimum uncompressed peripheral 
dimension in a transverse diametrical plane of 1.5 to 2.0 inches. 
In use the premoistened, ready-for-use sponge 12 as removed from its 
packet, is gently compressed and is then immediately urged upwardly into 
the vaginal vault 20, as indicated by the arrow 22, beyond the vaginal 
mouth 24 until it abuts the lips 26 of the cervix 28. Such positioning is 
depicted in FIG. 5, and the final position is shown in FIG. 6, in which 
the arrows 30 illustrate an important function of the contraceptive in 
that the sponge 12 is sufficiently wide to fill the void across the 
vaginal wall 32 and exerts mild pressure thereagainst. A minimum 
uncompressed transverse dimension of approximately 1.8 inches is 
compatible with practically all women. The transverse dimension of the 
sponge, wherein the sponge dimension is measured, may typically comprise 
the horizontal plane shown by arrows 30 or any other plane which passes 
through the sponge when in peripheral contact with the vaginal wall 32. 
It is understood that the impregnated sponge 12 may contain a swelling 
agent as a component of the solution. Sodium carboxymethylcellulose or 
other suitable water-soluble cellulose derivative such as methyl cellulose 
are exemplary to assist in creating adequate but gentle radial sponge 
expansion and pressure (schematically illustrated by the arrows 30) 
against the vaginal wall 32. Such pressure assures that the sponge 12 will 
fit snugly within the vaginal vault 20 without causing tissue irritation 
or slippage during and after intercourse. The snug fit provides that the 
sponge 12 will be maintained in its abutting contact with the lips of the 
cervix 28. In this position, the sponge 12 will prevent passage of sperm 
around the vaginal wall 32 and will block entrance of sperm into the womb. 
The sponge 12 may be retained in place and provide contraceptive 
spermicidal activity for 24 hours. It may be removed from the vaginal 
vault 20 by grasping the looped string 14 and pulling downwardly. The 
knot, which may be located adjacent the end of the drawstring, is useful 
in locating and pulling the drawstring. 
The method of utilizing the sponge contraceptive will be clear from the 
foregoing description. 
With respect to the constituents of the spermicidal formulation, the 
nonylphenoxypoly (ethyleneoxy) ethanol may be obtained from Rohm & Haas 
Company under the trademark Triton N-101. All of the constituent 
ingredients of the spermicidal formulation are USP grade and are 
obtainable from conventional sources. With respect to the sponge 12, 
suitable polyurethane sponge spheres are obtainable from the Scott Foam 
Division of the Scott Paper Co. 
Thus, it will be seen that there is provided a premoistened, ready-for-use 
sterile and harmless intravaginal sponge contraceptive capable of 
effective prevention of conception for up to about 24 hours after which it 
is removed and discarded. 
It is understood that the foregoing is typical or exemplary and not 
limitative and that various modificatifons may be made without departing 
from the invention as defined by the subjoined claims.