Note: Descriptions are shown in the official language in which they were submitted.
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VAGINAL SPERMICID~ DISTRIBUTING MEMBRANE
BACKGROUND OF THE INVENTION
Field of the Invention
The present invention relates to a vaginal
contraceptive that is capable of providing both a
physical and a chemical barrier to sperm access to the
cervix. me device of the present invention i~ also
suitable for use in the intra-va~inal application or
distribution of other medisines, such as anti-bacterial
and anti-fungal agents.
Description of the Prior Art
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One type of contxaceptive device that func-
tions to shield the opening to the cervix as well as
optimally locate and distribute spermicide within the
vagina is disclosed in U,S. Patent NoO 4,286,S93.
Basically, the shield disclosed in that patent com-
prises a relatively thick flexible supporting rib
structure bonded to a relati~ely thin flexible film.
The rib structure includes a circumferential rib and a
series of internal ribs connected to the ~ircumferen-
tial rib. The spaces between the various ribs, in com-
bination with the thin film, provide reservoirs for a
spermicidal composition. The shield can be bent into a
U shape to facilitate insertion into the vaginal
cavity~ and the rib structure provides suicient
rigidity to cause the shield to return to a generally
planar configuration to keep the film and coated
spermicide in contact with the vaginal wallq
~ ne s'nield disclosed in the above-described
patent is sound in both structure and function, and it
is desirable to improve upon certain aspects thereof.
In particular, it is the object of the present inven-
tion to provide a novel contraceptive device that
incorporates some of the basic principles of that ~',a
shield but that does not require the bonding of a film
~o a separate rib s~ructure, and therefore is easier to
manufacture. Specifically, it is an object of the
invention to provide a novel one-piece conception
barrier that can be fabricated using injection molding
or compression molding techniques. It is also an
object of the invention to provide a conception barrier
with improved spermicide receptacles that func ion as
progressive impediments to inactivate sperm. A furth~r
object of the invention i~ the provision of an intra-
vaginal conception barrier that can be easily inserted
and removed, as well as a device for assisting the
insertion and removal thereof.
SU~ARY ~F THE INVENTION
In furtherance of these objects, a vaginal
spermicide distributing membrane in accordance with the
present invention comprises a relatively thin membrane
of flexible material having a plurality of integral
rings of thicker dimension~ ~he rings are provided on
one or both sides of the membrane and can be
concentric~ In additiont ribs which interconnect the
various rings can also be provided to enhance the
rigidity of the structure. One or more of the rings
and optional ribs can have a groove or a series of
wells disposed on an exterior surface to function as
additional recepticles for spermicide. m e rings
provide sufficient resistance to deformation so that
when the device is flexed for insertion in the vagina,
the potential energy stored therein will cause it to
return to a planar shape, maintaining the surface of
the shield in close contact with the vaginal mucosa~
The device thus functions as a physical
barrier to the cervical opening, as well as a suitable
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vehicle for the deposit and distribution of spermicide
within the vagina. The rings not only function to keep
the device properly positioned, but any depressions
therein also act as successive impedirnents to the
travel of sperm to the outer periphery of the device
and the vaqinal wall~.
To facilitate insertion and removal of the
barrier, it can be provided with one or more loops on
its outer periphery to enable an inserter to guide the
leading end of the barrier past the cervix to the
posterior fornix of the vagina. In a further aspect of
the i~vention, a specific inserter can be affixed to
the opposite ends of the barrier to direct it into a
position to cover the cervix. Once the ba r rier is
properly positione~, the engagement between the
inserter and the barrier can be easily released through
a quarter rotation of the inserter to facilitate its
removal.
Further features of the invention, and the
advantages provided thereby, are explained in detail
hereinafter with reference to preferred embodiments of
the invention illustrated in the accompanyinq drawings.
BRIEF DESCRIPTION OF T}~E DRAWINGS
Figure 1 is a top view of one embodiment of a
vaginal spermicide distributing membrane according to
the present invention;
Figure 2 is a cross-sectional side view of
the embodiment of Figure l;
Figure 3 is a top view of another embodiment
of a conception barrier implementing the principles of
the present invention.
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Figure 4 is a cross-sectional side view of
another embodiment of the invention;
Figure 5 is a top view of a further
embodiment of the invention
Figure 6 is a top view of an embodiment of
the invention having loops for ease of insertion and
withdrawal of the barrier;
Figure 7 is a top view of a variation of the
embodiment of Figure 6;
Figures 8 and 9 are side view of a device for
assisting the insertion and removal of ~he barrierO
Fig~re 10 is a top view of a third embodiment
of the inYention with loops that are incorporated
within the body proper of the barrier;
Figure 11 is a cross-sectional side view of
the embodiment of Figure 10
Figuee 12 is a side view of a second
embodiment of an insertion assistor; and
Figure 13 is a cross-sectional side view
similar to Figure 11 with the assistor engaged with the
barrier.
DETAILE~)_DESCRIPTION
Referring to Figures 1 and 2 of the drawings~
the illustrated embodiment of the invention comprises a
flexible membrane 10 with one side thereof having a
plurality of elevated integral rings 12, 14 and 16 of
greater thickness than the remainder of the membrane.
~ne o~termost ring 12 is at the peripheral margin of
the membrane and is generally semicircular in cross
section, preferably with a smooth, i e., curved,
juncture wh~re it meets the thinner portion of the
membrane at its inner edge. The inner rings 14 and 16
are configured similar to the outer ring, except that
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each is provided with an indentation or depression 18
at its upper surface. These depressions prefer~bly
extend around the circumference of each riny, although
they can be disposed along only portions thereof, if so
desired. mey serve as receptacles that retain some of
the spermicide coated on the shield, and xelease it
during coitusq
The membrane 10 at its thinnest portion can
have a nominal thickness in the range of 0.1-2 mm, Eor
example, to provide sufficient flexibility, depending
on the material that is used. Preferably, the membrane
is as thin a one as can be reasonably attained while
still ass~ring that a solid layer is formed, i.e., one
that can be molded without small holes or other
imperfections. Not only does this feature reduce the
weight and bulk of the device, but it also results in
fragility. In one preferred form, it is desirable that
the conception barrier of the present invention be used
only once and then disposed, since it typically will be
coated with an amount of spermicide that is effective
for only one time. ~lus, if the membrane is made
s~fficiently fragile that it will have a tendency to
rupture or tear upon removal, there is less probability
of re-use.
In contrast to the thinner areas, the rings
have sufficient thickness to provide a measure of
rigidity to the device. Their thickness can be in the
range of 1-10 mm, for example/ and preferably is in the
range of 4-6 mm. As shown in Figure 1, the rings are
concentric. ~owever, they can also have different
arrangements. For example, they can be offset relative
to one another, or can comprise a spiral that extends
from the ~argin of the membrane towards its center.
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The device can be bowed along its longer axis
to facilitate insertion into the vagina. Once
inserted, the potential energy against deformation that
is stored in the rings causes the device to tend toward
maintaining a generally planar configuration. Thus,
the periphery of the device will be held in intimate
contact with the vaginal walls, assuring a good
physical barrier to the cervical os. In a~dition, the
flexibility of the membrane combined with the rigidity
of the rings allows the device to adapt to different
configurations, thus enabling a single size to
comfortably fit most women. By way of example, a
conception barrier having an oval configuration such aS
that shown in Figure 1 might have a width of 60 mm and
a length of 80 mm.
The depressions 18 have a size that
accosnmodates a suitable amount of spermicide that
slowly dissolves during coitus and chemically inhibits
migration of the sperm over a prolonged period of
time. They can have a semicircular or oblong cross
section, with a depth of approximately 0.2-3 mm, for
example. As shown in Figures 1 and 2 t the depressions
18 can be yrooves that are provided around the entire
circumference of the rings on which they are
provided. Alternatively, the depressions can be
comprised of a series of wells 19 that are spaced along
the surrace of the rings, as shown in Figure 3. ~.~ese
wells can be oval, circular or any other suitable
shape, or any com~ination thereof. The diameter, or
cross-sectional width, of the wells can be appro-
priately chosen to control the d~ration of the
effectiveness of the spermicide. More particularly, as
the diameter of a well is decreased, the spermicide
that is contained ~:ithin it will be released (i.e.,
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dissolved) at 2 ~lower rate, thus ~ncrea~ing tbe length
of tlme over which i~ sperm killin~ or-inhib~ting
function i~ effective.
The grooves or w~ hat for~ the ~permic~de
receiving depression~ ca~ be loca~d on the ~l~es of
the rings as well ~ on the ~.op margin~ thereof. In
fact, they can be provided by undercutting the rings
~heir intersect~on with the planar ~embrane 10 to
provide ~uitable recesses 20, as best sho~ in Figure
11.
Any suitable spermicide can be coated on he
membrane, preferably on b~th ~ides thereof. Nonoxynol
9, in a gelatinous form, has been found to b~ one
spermicide ~hat f~nctions well in the context o ~he
inve~tionO Other compositions will be apparen~ to
those familiar with this art.
me membrane can be made rom a number of
materials that ar~ physiologically sae. Preferably,
~t is made from a thermoplast~c material~ for example
2-30% ethylene-vinyl acetate, de~ending on the desired
thickness and flexibilityO One ma~er~al ~hat has been
found to be particularly suitable in thi~ context is
*Kraton, distributed by Shell Oal Co~ Since th~
membrane, including the integral thicker portions, i~
made from one piece of materi~ t is particularly
well-suited to be injection or compre~ion molded~
In the embodiment of Figures 1 and 2, ~he
mem~rane is illustrated as having a generally oblong or
oval shape, and rings disposed on only one ~ide
thereof. ~ne oval shape i~ preferred because ~
provides optimal positioning for the straight, l.e.,
longer, margin~ of the device and is most compat;ble
with the long axis of the vagina. However~ other
shapes can also be utilized. For example, it can be
TRADEMARK
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egg-shaped, as shown in Figure 3. Such a shape may
facilitate insertion into the vagina~ More
particularly, it provides the user with the ability to
select whether to insert with the narrow end first (to
orient the device as it is heing inserted) or with the
broad end first (for stabil:ization within the posterior
vagina).
In addition, it is feasible to provide rings
on both sides of the membrane~ In such a case, it may
be desirable to stagger the rings on opposite sides, as
shown in Figure 4, so as to maintain the overall
thinness of the device, as well as assure sufficient
flexibility. In addition, the outermost ring 12 is
provided with a depression 18 on each side thereof in
this embodiment.
If it is found that the membrane tends to
compress too easily in the radial direction, such that
effective contact with the vaginal walls is not
ass~red, additional thickness can be added at strategic
locations, as illustrated in the embodiment of Figure
5. This additional thickness can be in the form of
ribs 21 extending in a generally radial direction
between two rings~ These ribs can have the same
thickness as the rings, but are preferably somewhat
less, e.g., 2-4 mm, to maintain minimal thickness. As
also shown in Figure 5, the membrane can have a
circular shape.
Additional features can be provided to assist
in the insertion and removal of the barrier, as well as
enhance its proper positioning. Referring to Figure 6,
a pair of semi-circ~lar loops 22 are provided on the
external periphery of the outer ring 12 These loops
are located adjacent either end of the barrier,
slightly offset from its longitudinal axis. Alter-
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natively, as shown in Figure 7, the loops can belocated at the outermost extremes of the barrier, along
its long;tudinal axis. The loops preferably lie in, or
parallel to, the plane of the membrane 10, and can have
a thickness equal to or slightly greater than ~hat of
the membrane. m ey need not be as thick as the rings
12, 14, etcO, so that they are sufficiently flexible to
be easily displaced when the barrier is properly
positioned within the va~ina.
One of the loops can be used for insertion
and the other for removal. Insertion is accomplished
by pulling the barrier with the loop located at its
leading edge, for example by guiding it with a finger
or fingernail. ~is action is much easier than the
pushing that is required when no loops are present.
For removal, the finger can ~e easily hooked onto the
other loop and the barrier pulled out
For social, religious or personal reasons,
some women may not desire to use their finger to insert
and remove the barrier. In these instances, easy and
reliable insertion to the posterior vagina can be
achieved with an assistor 24 of the type shown in
Figure 8. One end ~6 of the assistor is Y-shaped or
otherwise suitably formed to provide a groove or recess
28 which guides one of the loops 22 during insertion.
~ne other end of the assistor can be provided with a
hook 30 for grabbing the other loop to remove the
barrier.
The assistor 24 can be a unitary structure as
depicted in Figure 8. I~owever, because of its length,
it may be preEerable that the assistor be jointed as
shown in Figure 9 to enable it to be easily packaged
with a barrier. In this case, the assistor is made of
two pieces having complementary fittings at their
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respective ends remote from the recess 28 and hook
30. A hinge 32, for example, a flexible strip,
connects these two ends to permit folding of the
assis~or and yet assure that they remain fitted
together during insertion and removal of the barrier.
In the embodiment of Figures 6 and 7, the
loops are provided on the ex~erior periphery of the
barrier. Alternatively, they can be incorporated
within the body of the barrier to eliminate any
external projections. Such an embodiment is
illustrated in Figures 10 and 11. In this embodiment,
the outer margin of the barrier is slightly thicker at
opposite ends thereof, to provide a discernible lip 32
on the underside of the barrier, as best illustrated in
Figure 11. In the region of this lip, the membrane 10
is undercut to provide a small opening 34. Thus, the
loops for inserting and removing the barrier are
actually formed by the outer ring 12.
A different embodiment of an assistor can be
used to facilitate insertion of the barrier illsutrated
in Figures 10 and 11. Referring to Figures 12 and 13,
one end of the assistor 36 is provided with a groove
38, for receiving the lip 32 at one end of the
barrier. A raised portion 40 having a recess 42
therein is provided on the assistor at a distance from
the end groove 38 that is related to the length of the
barrier Accordingly, this recess is disposed to
accomodate the other lip 32 on the opposite end of the
barrier, as illustrated in Figure 13. Ihis assistor
can be comprised of two hinged pieces, as in the
emhodiment of Figure 9.
When the barrier is engaged on the assistor
as shown in Figure 13, it can be inserted in the vagina
and properly positioned to cover the cervix. Once it
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is so positioned, disengagement of the barrier and the
assistor to remove the latter is effected by rotating
the assistor a quarter turn, thus releasing the lips 32
from the grooves or recesses.
me barrier can be easily removed from the
vagina by grasping or catching one of the lips 32, for
example with a fingernail and pulling it.
It will be appreciated by those of ordi~ary
skill in the art tha~ the present invention can be
embodied in other specific forms without departing from
the spirit or essential characteristics thereof. For
example, although the intra-vaginal device of the
present invention has been specifically disclosed in
the context of its use as a contraceptive, it will be
appreciated that it can be similarly used for the dis~
tribution of medicines other than spermicidest such as
anti-bacterial and anti-fungal agents. The presently
disclosed embodiments are therefore considered in all
respects to be illustrative and not restrictive. The
scope of the invention is indicated by the appended
claims rather than the foregoing description, and all
changes that come within the meaning and ran~e of equi-
valents thereof are intended to be embraced therein.
