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Patent 1171603 Summary

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(12) Patent: (11) CA 1171603
(21) Application Number: 379294
(54) English Title: FLUID EXPANSIBLE CONTRACEPTIVE TAMPON AND APPLICATOR
(54) French Title: TAMPON CONTRACEPTIF EXPANSIBLE EN MILIEU LIQUIDE ET APPLICATEUR
Status: Expired
Bibliographic Data
(52) Canadian Patent Classification (CPC):
  • 2/115
(51) International Patent Classification (IPC):
  • A61F 13/20 (2006.01)
(72) Inventors :
  • CONN, SHEPARD (United States of America)
  • KUSHNER, ARNOLD (United States of America)
(73) Owners :
  • KCDP CORPORATION (Not Available)
(71) Applicants :
(74) Agent: RIDOUT & MAYBEE LLP
(74) Associate agent:
(45) Issued: 1984-07-31
(22) Filed Date: 1981-06-08
Availability of licence: N/A
(25) Language of filing: English

Patent Cooperation Treaty (PCT): No

(30) Application Priority Data: None

Abstracts

English Abstract






ABSTRACT OF THE DISCLOSURE
A method and apparatus for contraception wherein
an applicator houses a fluid-expansible, hydrophilic, tam-
pon material in its unactivated, compressed state separate
from a reservoir of spermicide or medicament. The appli-
cator preferably includes a manually frangible portion of
the spermicide reservoir or a fluid communication passage
to bring the spermicide into contact with the fluid-expan-
sible tampon material upon command prior to use. After
activating by moistening, the spermicide-impregnated, ex-
panded tampon can be readily inserted into a vagina by use
of the applicator. Preferably, the tampon is made from a
body of purposefully-compressed, memory-retentive, hydro-
philic material having a resilience and a high coefficient
of expansion when moistened to act as a barrier to the os
uteri, to fill the vaginal fornices and absorb ejaculate.
Various shapes of the tampon are disclosed, as are methods
of making and using the invention.


Claims

Note: Claims are shown in the official language in which they were submitted.



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

1. An apparatus for intravaginally expelling an
activated tampon member from said apparatus comprising:
a first member defining a receptacle receiving and
storing therein said tampon member in a quiescent unactivated
state, said tampon member being activated by a fluid;
a second member defining a reservoir storing said fluid
therein separate from and out of contact with said tampon
member;
manually-activatable means for releasing said fluid
upon command from the reservoir in said second member to
activate the tampon member with said fluid while the tampon
member is retained in said first member prior to intravaginal
insertion; and
means,including the structural cooperation of said
first member and said second member, for intravaginally
expelling said tampon member in its activated state from said
applicator into a vagina.


2. The apparatus as set forth in claim 1, wherein
said fluid is a medicament.


3. The apparatus as set forth in claim 1, wherein
said fluid is a spermicide.


4. The apparatus as set forth in claim 1, wherein
said releasing means includes a compressed gas in said
reservoir to act as a propellant for said fluid.


-page one of claims-

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5. The apparatus as set forth in claim 1, wherein
said fluid in the reservoir in said second member is a
liquid and said tampon member is activated by moistening.


6. The apparatus as set forth in claim 5, wherein
said first member and said second member are telescoped one
within the other in such a manner that the telescoping action
of the second member relative to the first member serves to
expel the tampon therefrom intravaginally.


7. The apparatus as set forth in claim 5, wherein
each of the first member and the second member is a
cylinder, said first member defining a first open end for
expelling said tampon therefrom and a second open end for
receiving said second member, said second member being
structurally adapted to telescope within said first member.


8. The apparatus as set forth in claim 6, wherein
each of the first member and the second member is a
cylinder, said first member defining a first open end for
expelling said tampon therefrom and a second open end for
receiving said second member, said second member being
structurally adapted to telescope within said first member.


9. The apparatus as set forth in claim 7, wherein
the second member defines a closed end made from a material
which is readily fracturable upon the manual application of
a moderate force upon said applicator to release said fluid
from the reservoir defined by the second member to moisten
said tampon material in said first member.

- page two of claims -

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10. The apparatus as set forth in claim 8, wherein
the second member defines a closed end made from a material
which is readily fracturable upon the manual application of
a moderate force upon said applicator to release said fluid
from the reservoir defined by the second member to moisten
said tampon material in said first member.


11. The apparatus as set forth in claim 9 or claim
10, wherein said second member defines a filler and vent
opening at the end opposite its fracturable end and includes
a removable tab member over said vent opening for retaining
said fluid within said reservoir and releasing said fluid
upon removal of said tab member.


12. The apparatus as set forth in claim 9 or claim
10, wherein the first member includes a plurality of
annular rings to provide a gripping surface thereon, one of
said rings being of appropriate dimension to mate with a
detent on the second member to provide an interlock between
the first member and the second member which interlock is
releasable upon the application of a moderate amount of
force axially to the second member.


13. The apparatus as defined in claim 7, wherein
said second member defines a fluid passageway which is
closed against the escape of fluid in a first position and
which is open to the escape of fluid in a second position
for releasing said fluid from said reservoir.
- page three of claims -


-24-


14. The apparatus as defined in claim 8, wherein
said second member defines a fluid passageway which is
closed against the escape of fluid in a first position and
which is open to the escape of fluid in a second position
for releasing said fluid from said reservoir.


15. The apparatus as set forth in claim 13, wherein
said passageway includes a wall opening in the wall of said
second member and mating protruding tab member on the
interior wall of said first member in register with said
wall opening so that upon movement of the second member
relative to the first member, said protruding tab member
disengages from said opening thereby to release fluid
therefrom.


16. The apparatus as set forth in claim 14, wherein
said passageway includes a wall opening in the wall of said
second member and mating protruding tab member on the
interior wall of said first member in register with said
wall opening so that upon movement of the second member
relative to the first member, said protruding tab member
disengages from said opening thereby to release fluid
therefrom.


17. The apparatus as set forth in claim 15 or claim
16, wherein an end of said second member adjacent said tab
member has an upraised flange to provide a gripping surface
for the user and to act as a retaining member when said
second member is completely telescoped within the first
- page four of claims -


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member.


18. The apparatus as set forth in claim 5, wherein
said tampon material is a body of precompressed, hydrophilic
fluid-expansible material which becomes resilient and has
absorbent capabilities upon being moistened by a certain
amount of fluid.


19. The apparatus as set forth in claim 18, wherein
said fluid is a spermicide and said body of said tampon
member is shaped to act as a barrier to the os uteri and to
fill the fornices when expelled within the vagina.


20. The apparatus as set forth in claim 19, wherein
said second member defines an opening and includes a
releasable tab over said opening, and the first member and
the second member structurally coact in such a way that a
small amount of spermicide is released from said reservoir
initially to wet an end portion of said body of said tampon
material whereupon said body expands to approximately the
inner diameter of said first member to act therewith as a
seal against loss of the remainder of fluid released from
said reservoir by release of a tab over an opening in the
second member.


21. The apparatus as set forth in claim 1, wherein
said first member and said second member are made from a
flexible elastomeric material and said releasing means is

defined by a fracturable partition member separating said
receptacle from said reservoir, said fracturable partition

- page five of claims -

-26-


being readily frangible by the manual application of a
moderate amount of force on said applicator in the vicinity
of said partition.


22. The apparatus as set forth in claim 5, wherein
said first member and said second member are made from a
flexible elastomeric material and said releasing means is
defined by a fracturable partition member separating said
receptacle from said reservoir, said fracturable partition
being readily frangible by the manual application of a
moderate amount of force on said applicator in the vicinity
of said partition.


23. The apparatus as set forth in claim 21, wherein
said second member includes a depressable valve to permit
an ingress of air into said reservoir to release the material
therefrom.


24. The apparatus as set forth in claim 22, wherein
said second member includes a depressable valve to permit
an ingress of air into said reservoir to release the material
therefrom.


25. The apparatus as set forth in claim 23 or claim
24, wherein the applicator is structurally adapted to expel,
in cooperation with said valve, the tampon member after
insertion of an end of the applicator into a vagina, by the
repeated pressing and releasing of the body of said applica-

tor in a pumping action.



- page six of claims -


-27-

26. An apparatus for intravaginally expelling a tampon
member comprising:
a first member defining a receptacle for receiving and
storing therein said tampon member in a quiescent state,
said tampon member being activated by moistening; a
second member defining a reservoir for storing a fluid
material selected from the group consisting of medicaments
and spermicides therein separate from said tampon member,
for activating said tampon member by moistening, said
first member and said second member being telescoped
one within the other in such a manner that the telescoping
action of the second member relative to the first member
serves to expel the tampon therefrom intravaginally,
said first member defining a first open end for expelling
said tampon therefrom and a second open end for receiving
said second member, said second member defining a closed
end made from a material which is readily fracturable
upon the manual application of a moderate force upon
said applicator to release said fluid from the reservoir
defined by the second member to moisten said tampon
material in said first member, said second member further
defining a filler and vent opening at the end opposite
its fracturable end and includes a removable tab member
over said vent opening for retaining said fluid within
said reservoir and releasing said fluid upon removal
of said tab member.


- page seven of claims -


-28-



27. An apparatus for intravaginally expelling an
activated tampon member from said apparatus comprising:
a first member defining a receptacle receiving and
storing therein said tampon member in a quiescent
unactivated state, said tampon member being activated
by moistening;
a second member defining a reservoir storing a fluid
material therein separate from said tampon member,
for activating said tampon member by moistening, said
first member and said second member being telescoped
one within the other in such a manner that the tele-
scoping action of the second member relative to the
first member serves to expel the moistened tampon
therefrom intravaginally, said first member defining
a first open end for expelling said tampon therefrom
and a second open end for receiving said second
member, said second member defining a closed end made
from a material which is readily fracturable upon the
manual application of a moderate force upon said
applicator to release said fluid from the reservoir
defined by the second member to moisten said tampon
material in said first member, said first member
including a plurality of annular rings to provide a
gripping surface thereon, one of said rings being of
appropriate dimension to mate with a detent on the
second member to provide an interlock between the
first member and the second member which interlock

is releasable upon the application of a moderate

- page eight of claims -

-29-


amount of force axially to the second member.

28. The apparatus as set forth in claim 27, wherein
said second member defines a fluid passageway which is
closed against the escape of fluid in a first portion and
which is open to the escape of fluid in a second portion for
releasing said fluid from said reservoir, and said passage-
way includes a wall opening in the wall of said second member
and a mating protruding tab member on the interior wall of
said first member in register with said wall opening so that
upon movement of the second member relative to the first
member, said protruding tab member disengages from said
opening thereby to release fluid therefrom.


29. The apparatus as set forth in claim 28, wherein
an end of said second member adjacent said tab member has
an upraised flange to provide a gripping surface for the user
and to act as a retaining member when said second member is
completely telescoped within the first member.


30. The apparatus as set forth in claim 29, wherein
said fluid is a medicament.


31. The apparatus as set forth in claim 30, wherein
said fluid is a spermicide.
- page nine of claims -
-30-


Description

Note: Descriptions are shown in the official language in which they were submitted.


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FLUID EXPANSIBLE CONTRACEPT~VE TAMPON AND APPLICATOR
BACKGROUND OF THE INVENTION
This invention relates to a method and apparatus
for contraception. More particularly, this invention
relates to an applicator which housesj preferably, a hydr-
ophilic, fluid-expansible, material in a quiescent, com-
pressed, unactivated state, in a first chamber separate
from a second chamber which acts as a reservoir for a
spermicide or medicament. The applicator includes means
for bringing the spermicide into contact with the tampon
upon command prior to use, as well as means for delivering
the spermicide-moistening tampon to a vagina and posi-
tioning it therein. Still more particularly, this inven-
tion relates to a combination of an applicator of the type
described with a tampon made from a body of purposefully-
compressed, memory-retentive, hydrophilic, fluid-expans-
ible material with a high coefficient of expansion and
which is resilient when moistened or activated prior to
insertion into a vagina. Still more particularly, this
invention relates to a method of making and using the
apparatus and the tampon according to the invention, as
well as to various shapes for the contraceptive tampon.
Mankind has long sought an effective method and
; apparatus for contraception for purposes of population
control, for family planning, and to prevent unwanted
pregnancies. While a number of contraceptive techniques
j have been proposed, many of which have been clinically
effective, each has suffered from various types of short-
comings for a number of reasons. For example, the use of
oral contraceptives has been found to be associated with a



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11716~
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number of adverse side effects, some of which are fatal.
Alsot intrauterine devices have been known to cause le-
sions, and even to perforate the uterus. Further, IUD's are
spontaneously rejected from the uterus in a significank
number of women.
The so-called barrier type of contraception has
long been-included among such contraceptive proposals.
Many barrier contraceptives are efficient and benignD
However, they oten require special motivation for their
use by reason of the fact that they may, especially if rigid
or semi-rigid, in the first place have to be fitted pre-
cisely by a physician. Even more importantly, in actual
use, they are unesthetic and therefore unacceptable to many
women. Futher, many barrier contraceptives require appli-
`15 cation just prior to coitus and maybe said to be coitally-
related, a factor which discourages their use.
By way of background, the human vagina may be
considered a closed-end collapsed cylinder. The uterine
cervix, which varies from 1 to 4 cm in length, protrudes
into the-closed end. The-uterine cervix may point directly
into the axis of the cylind~r, or backward (which is the
most common orientation) or forward. The potential spaces
around the cervix are called fornices and include an
anterior, a left, a right, and a posterior fornix. A
contraceptive barrier, to be effective, must be in contact
with the cervix to block the os uteri, and ideally should
fill all of the fornices to prevent the inadvertent migra-
tion of semen into the cervical mucus.
An intravaginal anticonception tampon was re-
ferred to in the Papyros Ebers, circa 1550 B.C., and has
.been in use in one form or another for more than 3500 years.
However, there have been no reliable scientific reports of
its efficacy. Such tampons have included sponges moistened
with fluid having spermicidal qualities. At least as early
as the time of the ancient Egyptians, a tampon of lint
~-~' impregnated with drugs and honey was said to be capable of

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contraceptive qualities when placed in the vagina of the
user. Later, bu~ at least as early as the nineteenth
century, a suitable soft sponge tied by a ribbon and
properly placed high in the vagina, was said to possess
contraceptive qualities. Thus, historically, it is known
that a suitable sponge properly placed in contact with all
vaginal fornices and well moistened with an effective
spermicidal solution should act as an effective cor,tra-
ceptive by virtue of (1) its barrier action, ~2) its
10 absorption and retention of ejaculate, and (3) prolonged -
spermicidal action.
It has remained a problem of convenience and
esthetics for the user of a resilient barrier-type con-
traceptive to prepare and insert it into a vagina prior to
intercourse. In addition to actual or perceived nonesthetic
qualities of such a preparatory actl such preparations
may be inconvenient, susceptible to miscalculation such
as by insufficient or excess moistening with spermicide,
the premature or tardy application of spermicide, and
the like. Accordingly, it is an overall object of this
invention to provide a suitable contraceptive tampon of 1-
barrier design and function made from absorbent material
which can be impregnated with a precisely metered amount ~ -
of spermicide in an applicator and conveniently inserted
into the vagina by using the applicator in such a way
that the moistened tampon material acts as an effective
contraceptive. The applicator, after having served to
moisten the tampon and to insert it into the vagina, is
disposed of. The tampon is intended to remain in place,
once positioned in the vagina, for as long as 24 hours,
during which time coitus may take place one or more
times. Thereafter, it is removed and disposed of by the
user.
While the prior art has focused its attention on
35 compressible sponge-like members, such as made from sea
sponges, or viscose and cellulose materials whose shape in


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the quiescent state is approximately the same as its shape
in the active implanted state, it is another purpose of this
invention to utilize a compressed (without having to be
physically restricted to enforce compression), dry tampon
material which, immediately prior to vaginal insertion can
be moistened with an effective spermicidal solution. When
moistened, the compressed material expands markedly either
prior to introduction into the vagina or when placed in the
vagina. By using such an expansible material, the con-
traceptive tampon, in the dry, unactivated state, can bestored in a small, handy compartment in an applicator, and
can expand to a clinically effective size after moistening
to serve as a barrier to os uteri and, at the same time, also
fill the fornices.
In order to improve convenience and the esthetic
character of the contraceptive act, it is a significant
aspect of this invention to provide an applicator for the
expansible hydrophilic tampon retained in a chamber separ-
ate from_a reservoir for spermicidal solution. Upon
command, it is the aim of this invention to bring the
spermicide into contact with the tampon to expand it to its
active size and shape and to use the applicator as an
insertion device for the tampon into its intended position.
It is another object of this invention to provide
a disposable r compact applicator-tampon system which can
be conveniently used to wet the tampon with a spermicide
stored in the applicator and insert it into the vagina with
a minimum of manipulations and moving parts.
It is a further object of this invention to
provide a new use as a barrier contraceptive for a pur-
posefully-compressed, memory-retentive, hydrophilic mat-
erial which in its unactivated state is compact, but which
becomes resilient and absorbent as it expands to a clini-
cally effeGtive size and shape upon moistening with a
; 3i spermicide or medicament.



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These and other objects of the invention will -
become apparent from the foregoing descrîption of the .
embodiment taken in conjunction with the accompanying
drawings. .




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BRIEF SUMMARY OF THE INVENTION ;
Directed to achieving the aforestated objects
and overcoming the problems in connection with prior art
barrier-type contraceptive devices, ~he invention, in one
aspect, relates to a compact, disposable applicator which
comprises at least a pair of telescoping, cylindri~l
members made from a pliant plastic material. One of the
cylindrical members acts as a reservoir for a precisely
metered amount of spermicide or medicament and is thus
closea. That member includes a closed end adjacent to a
tampon stored in its dry unactivated state in a chamber :
defined by the other cylindrical member. The end opposite
the closed end of the firs~ cylindér defines a vent and
filler opening to permit the first cylinder to be filled and
the vent to be sealed by a removable tab. Preferably, the
closed end of the first cylinder contains a plurality of
score lines or is otherwise readily frangible by the
application of pressure by the user to release at least a
small amount of spermicide from the spermicide reservoir to
the fluid-expansible tampon.
Upon contact with the small amount of released
~spermicide, the adjacent portion of the fluid-expansible
tampon expands within the second cylinder. Thereafter, the
tab is removed to release the remaining spermicide to wet
and expand the entire tampon to its desired degree. After
moistening within the second cylinder by the spermicide,
the first cylinder is caused to telescope within the second
cylinder within the vagina to insert the spermicidally
effective tampon into position high in the vagina. Release
from the applicator permits the tampon to expand further
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and act as a clinically effective barrier to the os uteri,
to fill the fornices, and to ~ur~her ac~ as an absorbent for
ejaculate, particularly in cases of repeated intercourse.
It is a second fea~ure of ~his invention to
provide a new use as a barr;er contraceptive to a com-
pressed, memory-retentive, hydrophilic, fluid-expansible
material, which can be stored in an unactivated state in a
compact manner and yet become resilient and expand into a
desired size and shape for insertion and upon insertion
into the vagina of the user. Such materials are well known
in other arts and have a high degree of expansibility when
wetted. For purposes of this specification, the "quiescent
state" of the tampon refers to its unactivated, compressed
state prior to impregnation with a spermicide or medica-
ment, and prior to insertion into the body of the user.Similarly, the "dry" state of the compressed hydrophilic
material, for example, one made of cellulose, refers to the
state of the material prior to impregnation with a spermi-
cide or medicament, while including a normal moisture level
20- inherent in such material or in the normal environment for
the material within the applicator. Such materials are
memory-rententive. That is, the materials can be pur-
poseully heated to expel moisture and compressed to a
desired compact size which compresses and collapses the
cellular structure of the material. Such materials thus
retain the collapsed or compressed state in the absence of
the application of moisture and without req~iring physical
restrictions or restraints to retain the compressed state.
Such materials are commercially available. Examples are
the materials available from the American Sponge & Chamois
Co. of Long Island City, New York which are sold under the
names '~Supercèl1' and ;"Normandy~
It is a further object of this invention to
provide a plurality of shapes for the tampon of the type
described, including a cylinderical or oval disc, folded
into a shape resembling a folded umbrella to be inserted
:; * trade mark

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- 8 - 1171~3

into the vagina. A second such member can be joined either
apex-to-apex or at a plurality of points along the cir-
cumference of the disc or at the centers of each disc in
order to form two-layer barrier-type devices. In another
configuration, the tampon material in quiescent state is
folded in such a manner as to be inserted edgewise into the
vagina af~er activation by moistening. In still another
embodiment, a plurality of particulate segments of the
tampon material are contained within a porous fluid-per-
meable membrane to be wetted in the manner described toexpand into an approximately cylindrical or spherical con-
figuration. Other shapes for the tampon are also dis-
closed.
These and other features of the invention are
described hereinafter in the detailed description of the
invention taken in conjunction with the drawings.




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BRIEF DESCRIPTION OF THE DRAWINGS
In the drawings:
Fig. 1 is a perspective view of the manual-
ly-frangible applicator according to the invention, par-
tially cut away to show a compressed tampon in its quiescentstate;
Fig. 2 is a side cross-sectional view of the
embodiment of ~ig. l;
Fig. 3 is a partial end view of the sperm-
icide-containing cylinder showing the score-lines to fac-
ilitate manual fracturing of the cylinder to release the
spermicide;
; Fig. 4 is a non-detailed view showing the appli-
cator according to the~invention inserted into a vagina for
expelling the impregnated tampon therefrom;
Fig. 5 is a side cross-sectional view of an I ,
alternate embodiment showing a sealed passageway in the
wall of the~reservoir defined by the second applicator
member;
Fiy. 6 is a view similar to Fig. 5 showing the
passageway after unsealing by relative movement between
the first member and the second member;
Fig. 7 is~ a side cross~sectional view of an
alternative embodiment of the applicator according to the
invention
IFig. 8 is a side cross-sectional view of still ¦~
another alternative embodiment of the applicator according
to the invention; ~ l
; Figs. 9 and~9A show aclisc of tampon material and 1-
a folded~umbrella shape for the body of the tampon;

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Fig. 10 shows a pair of folded umbrella body
shapes connected together so that their apexes are axially
pointed in opposite directions;
Fig. 11 shows a pair of folded umbrella body :"
shapes connected together at their peripheries; I-
Fig. 12 shows a pair of ~olded umbrella body
shapes connected together so that the apexes are axially .
pointed in the same direction; .:
Fig. 13 shows a disc of tampon material with
10 folds indicated for edgewise insertion into the applicator ¦~
and therefore into the vagina;
Fig. 14 shows an end view of the disc of Fig. 13
folded therein;
Figs. 15A-15C show alternative blank shapes for
15 the tampon body for folding edgewise as in the case of the ,f
embodiment of Fig. 13; and
Fig. 16 shows a plurality of particulated tampon
bodies of the type described with a porous casing for
expansion into a generally spherical configuration.
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DETAILED DESCRIPTION OF_ THE PREFERRED EMBODIMENTS
In Fig. 1, a perspective of the applicator ac-
cording to the invention, designated generally by the
reference numeral 20, is shown in a partially cut-away
perspective view. The applicator 20 includes a first
member 22 defining an open-ended chamber 23 for receiving
a folded compressed tampon 24 which upon wetting acts as a
contraceptive tampon as will be discussed in greater detail
later in this specification. The tampon 24 has a string or
cord 26 secured thereto to remove the tampon from the vagina
when appropriate to dispose thereof. If desired the
chamber 23 may be closed by a removable cover member secured
to the member 22.
The member 22 is preferably made from a flexible
lS thin-wall plastic material defining an opening at the outer
distal end 28 thereof. The outer end 28 is; preferably
rounded and the exterior wall of the member 22 is preferably
smooth to avoid irritation of the tissues of the vagina when
. the member 22 containing the tampon 24 is inserted therein
to expel the tampon for contraception.
The inner end 30 of the outer telescoping member
22 is structurally adapted to receive a second member 32 in
a telescoping relationship wherein the inner wall of the
member 22 comfortably mates with the outer wall of the
member 32 to permit free ingress and egress of the member
32 into the interior member 22.
As best seen in Fig.~2, the inner end of the
member 32 includes an upraised flange portion 34, the inner
edge 35 of which wil- abut the edge 30 of the member 22 when
the member 32 is completely extended into the interior of
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- ~ ,

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- 12 ~ 3

the member 22. The flange portion 34 also provides a
convenient gripping surace for the hand of the user during
utilization of the device.
As best seen in Fig. Z, the outermost surface of
the member 32 defines an opening 36 which serves as a filler
and vent opening. ~he opening 36 may be covered by an
adhesively secured, removable member 38, such as a plastic
tab, paper liner, or the like. With the tab 38 in place,
the member 32 serves as a closed reservoir for a fluid
spermicide or medicament designated generally by the ref-
erence numeral 40. The fluid 40 may be introduced into the
reservoir defined by the member 32 through the opening 36
which thereafter is sealed by the tab 38 to retain the fluid
therein until the applicator 20 is used. A number of known
effective spermicides and medicaments available in the
fluid state may be used. For example, a 5%-solution of the
commonly-used spermicidal agent nonoxonol-9 may be used.
The surface 42 of the member 32 includes a
plurality_of score lines 44 and 45 sufficient in depth to
permit the fracture of the inner end of the member 32 by the
application of pressure against the flexible assembly of
the members 22 and 32 in the area of the score lines. As
shown in Fig. 3, the score lines may extend along a portion
of the length of the member 32 to permit a more complete
rupture of the end of the member in use. The location and
depth of the score lines are a function of the material
used, its thickness, and its frangibility characteristics.
In the embodiment shown in Fig. 2, a plurality of
annular rings 48 may be provided on the member 22 to provide
a convenient gripping surface for the user. A raised detent
ring 50 on member 22 is in register with the depressed
detent ring 51 on the member 32 to retain the members in the
position shown in Fig. 2. The annular rings 48 act as both
finger grips on the outer surface of the member 22 and as
bearing surfaces for application of pressure on the end of
the member 32 to fracture it when desired. A raised detent

( ( ; ~

- 13 - 3~ 6~3

50 on the member 22 is in register with a corresponding
depressed detent of the member 32 to fix the member 32 in
the extended position shown in Figs. 1 and 2. The dimen-
sions of the raised detent ring 50 are such that the members
5 22 and 32 are retained in a position that can easily be
overcome by a moderate force applied axially to the member
32O
When pressure is applied to the applicator 20 by
manually gripping the end 30 of the member 22 in the area
Of the score lines 44 and 45 on the inner end 42 of the
member 32, the inner end of the member 32 is caused to
rupture to release a small amount of spermicide to begin to
moisten the contraceptive tampon 24 in the position shown
in Fig. 1. Subsequent removal of the tab 38 permits the
15 ingress of air through the opening 36 to cause the remaining
fluid in the reservoir defined by the member 32 to be
released to the tampon to complete its wetting and moist-
ening.
Retaining the tab 38 in position covering the
20 opening 36 after fracture of the inner end 42 of the
spermicide reservoir defined by the number 32 has a signi
ficant advantage in connection with the use of the appli-
cator. Because a small amount of spermicide escapes the
reservoir when the scored end of the member 32 is fractured,
25 the inner end of the tampon 24 adjacent to the outer end
of the member 32 is moistened. When moistened, the tampon
end will expand and fill the diameter of the member 22 in
the area adjacent to the fractured end of the member 32,
thereby to prevent léakage of the remaining spermicide
30 between the tampon and the interior wall of the member 22.
Thereafter, when the tab 38 is removed, the remainder of the
spermicide will flow to moisten the remainder of the
tampon. Preferably, this action is caused to occur with the
apparatus 20 located in a vertical alignment or in such
35 alignment so that gravity assists the flow of the fluid 40
.~.~ ; .
and the orientation of the applicator 20 is such as to
.

- 14 - ~ ~7i~3

prevent the loss of spermicide thrugh the opening 36.
Moreover, because the initial escape of spermicide had .
caused the top end of the tampon 24 to expand and fill the
diameter of the member 22, the remainder of the fluid which
flows from the reservoir defined by the member 32 is pre-
vented from escaping between the outer surface of the -
tampon 24'and the inner surface of the member 22 and thus
providing for effective utilization.
As shown in Fig. l, the length of the member 32
lO from end 30 of the member 22 to the end of the member 32 will -
be on the order of 7 cm in order to provide a comparable
- length between the end 42 of the member 32 and the end 28
of the member 22 for receiving the folded tampon 24. Thus,
the overall dimension of the member 22 will be related to
this length and to the volume necessary in the reservoir 32
as determined by the volume of fluid necessary and desir-
able to moisten the tampon 24. Therefore, the area of
overlap of the two cylinders must be sufficient to provide
a constant rigidity for maintaining the two members in
juxtaposition, and sufficient space for the finger grip-
ping as described in connection with Fig. 2. Preferably,
the length of the member 22 is equal to the overall length
of the member 32 so that, in use, the member 32 is com-
pletely telescoped within the member 22 for complete ex-
~5 pulsion and proper positioning of the tampon in the vagina.
Enough fluid is provided from the reservoirdefined by the member 32 to sufficiently moisten the tampon
24. In its contraceptive function, the degree of moist-
ening by spermicide is such as to impart an expansion to the
tampon while leaving the tampon with enough absorbent
capacity remaining in the tampon to accommodate ejaculate
during intercourse. The median ejaculate volume is about
4-8 ml within the normal range of 2 and lO ml. If it is
desired to accommodate two or three consecutive usages, the
size of the tampon and the degree of moistening can be
selected to receive for example, 12 to 15 ml of semen. In



- ~ :
.:
:: .

- 15 ~ L6D3 ~.

any event, it is desirable to retain at least some absorbent
capacity for semen in the tampon to improve its effec-
tiveness and reliability. :
Fig. 4 is a view of the applicator 20 according
to the the invention after insertion into a vagina 49. The -
tampon 24 has been ejected from the applicator to a position
high in the vagina 49 to act as a barrier to the os uteri .-
50. Some degree of expansion of the tampon 24 occurs after
insertion both because prior to the expulsion the expansion --
Of the tampon had been confined by the physical dimensions
of the member 22 and partially because of a further absorp-
tion of vaginal fluid when positioned.
An alternative embodiment for the applicator of
Figs~ 1-4 is shown in Figs. 5 and 6. In Figs. 5 and 6, like
reference numerals on like parts have been used. In the
position shown in Fig. 5, the wall of the member 32 contains
a pair of diametrically opposed openings 50 which are
sealed by virtue of their being positioned against the
inwardly-directed nibs 52 located on the inner surface of
the member 22 in register with the openings 50. Rotation
of the member 32 disengages the opening 50 from the nibs 52
(as shown in Fig. 6) to permit the egress of a small amount
of fluid 40 from the reservoir defined by the member 32 in
the manner similar to that previously described. There- ;
after, removal of the tab 38 and the expulsion of the tampon
into the vagina may proceed as previously described.
Other more complex valving mechanisms may also
be utilized to communicate by a predetermined passageway
the fluid from the reservoir to the tampon location. There-
fore, the embodiments of Figs. 5 and 6 are intended to beillustrative. For example, a centrally located, axial-
ly-extending tube could extend from the member 22 toward
the closed but fracturable or penetratable end of the
member 32~ By telescoping the members 22 and 32 slightly,
the tube could be injected into the reservoir to permit the
passage of spermicide to the tampon.



, . ~. . .

'

- 16 -
.,
Alternatively, the function of the member 32 (to
act as a fluid reservoir~ and the function of the member 22
(to house the compressed tampon) may be combined into a
single member as shown in Fig. 7, the entire structure
forming a single tube made from a flexible elastomeric
material with a fracturable partition 42 separating the
cavity 43, which serves as a fluid reservoir, from cavity
40a, which serves as a housing for the tampon 24. In this
alternative design, the partition 42, scored to facilitate
fracturing, is caused to fracture by the user's application
of finger pressure on the outer surface of the tube in the
vicinity of the partition 42, thereby releasing a small
amount of fluid to wet and, thus, expand the end of the
tampon 24 adjacent to the partition 42 so that it fills the
entire diameter of the tube. Upon completlon of the
initial, partial, moistening of the tampon, a valve flap 47
is depressed allowing an ingress of air and causing the
remainder of the fluid to flow from the reservoir 43 into
the cavity 40a wherein the tampon 24 is contained and so to
fully moisten the tampon 24 with a precisely metered amount
of fluid. Subsequent to full discharge of fluid into the
tampon 24, the open end of the tube 28 is inserted into a
vagina and the elastomeric tube is alternately and repeat-
edly pressed and released in a pumping action to propel, by
means of air pressure, the tampon 24 out of the chamber 40a,
and into place in the vagina. A flap valve arrangement 47,
located at the end of the reservoir 43 is so fashioned that
alternate finger pressure on and release of the tube on the
outer surface of the cavity 43 will cause a build-up of air
in sufficient pressure in the chamber 43 to cause the volume
of air to push against the end of the tampon 24 adjacent to
the fractured partition 42 and, in so doing, cause the
tampon 24 to be expelled from the open end of the tube into
the vagina.
In still another alternate design, the fractur-
able partition 42 is supplanted by a partition 42a with an


. . .
- , . ~ .
'


' . ~. ' ': ', ' '~:

- 17 ~ 16~3

opening covered by a flap valve 5l as depicted in Fig. 8.
In this case, the outer surface of the kube can be pumped
by finger pressure in the vicinity of the chamber 43 to
expel fluid into the cavity 40a and, when all the fluid is
exhaus~ed, the air that replaces it through the valve
en~rance 48 will eventually force the moistened, expanded
tampon from the end of the tube and into the vagina.
The tampon 24 according to the invention may be
provided in a number of shapes to achieve its intended
purpose as a barrier-type contraceptive device capable of
easy insertion into the vagina by use of the applicator 20
and readily removable therefrom by means of a retrieval
loop 26, while effectively acting as a contraceptive.
While a number of materials may be used, such as ordinary
compressible sponges, viscose, cellulose, collagen spon-
ges, polyurethane, vinyl sponges, rubber sponges, and
other fluid absorbent materials, the material most suit-
able for utilization in a compact applicator is shown as a
compressor, fluid-expansible, hydrophilic cellulose mat-
erial having a memory capability when compressed to itsquiescent state. In this respect, the material is similar
to a commercially available expansible cellular material.
Specific examples of suitable materials are known in the
trade as "Supercel" and "Normandy" and are available from
the American Sponge & Chamois Co. of Long Island City, New
York, among others. The material is characterized in tha~ 1
it has a high coefficient of explansion from its dry or
quiescent state to its moistened state on the order of 5-20
times the original volume or more, may be purposely dried
under compression to occupy a significantly small volume
and thereafter expand upon moistening.
Figs 9 and 9A illustrate one shape of the tampon
for use according to the invention. A compressed, dry,
cellulose, hydrophilic disc is designated generally by the
reference numeral 60. The disc 60 is preferably cut from
a sheet of such material and scored along the lines 60a to




.

(
L7~ 3
- 18 -

facilitate folding into the shape shown in Fig. 9A. The
disc 60 is approximately 6 cm in diameter and is approxi-
mately 1 mm thick. In certain designs, the disc 60 may have
a plurality of notches cut into the perimeter.
- The removal loop 26 is then stitched to a point
at the center of the disc 60. Thereafter, the disc of Fig.
9 is ~olded along the score lines 60a and twisted tightly
on a mandrel to provide a shape shown in Fig. 9A. After
folding, the folded disc 60a is inserted, while tightly
folded, into the applicator as previously described. The
folded disc may be oriented in either direction along its
axis so that, in one configuration, the apex 62 is inserted
first into the vagina while in another, the apex is inserted
last.
A single disc of the type described will unfold
from its umbrella-like shape to take a position in the
vagina adjacent the os uteri. This configuration will seat
comfortably in mos~ individuals in such a way that the
center 62 of the face of the disc lies adjacent the os uteri
while th~e folds 64 therèof will expand to fill the fornices.
Moreover, during intercourse, the head of the penis will
tend to push the tampon contraceptlve well into place
rather than slide between the outer folds of the tampon and
the adjacent vaginal wall. This occurs principally because
of the tendency of the tampon to expand outwardly to occupy
the greatest circumferential area, as well as because the
trailing end 63 presents a receptacle for receiving the
penis. Another advantage of the single disc design of Fig.
9 is that it points inwardly in place toward the os uteri
and is thus easily inserted. The trailing edges 63 will
tend to preserve an orientation toward the entrance to the
vagina and, thus, resist expulsion from the vaginal tract.
Moreover, the loop 26 is not uncomfortable to the male and
is readily available to extract the tampon. Preferably, it
is removed several hours after intercourse to permit its
- spermicide capabilities to act as well as to absorb as much
~ seman as possible after ejaculation.



- ". `

19 - 1 ~7 1~ 3

Fig. 10 is composed of a pair of members folded
as described in connection with~Figs. 9 and 9A. The pair
of members 70 and 71 are sewn together at their peripheries
with an anatomically acceptable thread (e.g~ cotton, poly-
S ester, nylon, surgical thread, or the like) to form a pairof umbrellas having oppositely facing rounded frontal end
portions 72 and 73 respectively.
Fig. 11 shows still another configuration in
which a double disc assembly is joined apex-to-apex and
enfolded in umbrella-like fashion with circumferential
portions facing in opposite directions. In this design,
the trailing edge of the rearmost member has the advantages
of the member of Fig. 9~ for resisting expulsion from the
vagina. Further, by virtue of the firm fastening of the
center of the foremost disc to that of the rearmost disc,
upon expansion of the double-disc assembly, tension will be
created in such a fashion that the centers of each disc will
form concavities. The benefits of such concavities are as
follows: The concavity of the foxemost disc will tend to
"cap" the uterine entr-ance and the concavity of the rear-
most disc will tend to form a natural mode of receiving the
head of the penis whereby said penis will be enabled to push
the entire double-disc assembly more firmly into the upper
reaches of the vagina and thus to seaI more effectively
against the migration of semen into the os uteri and the
fornices.
In another configuration, the members may have
their rounded closed end coaxially pGinting in the same
direction, as shown in Fig. 12. In this embodiment the
trailing edge of the rearmost member has the advantages of
the member of Fig. 9A for resisting expulsion and being
pushed higher in the vagina by the penis. Moreover, the
ease of insertion is retained since the rounded, closed
ends of both members 70 and 71 face in the same direction
toward the os uteri and both members 70 and 71 resist
` ~ expulsion from the vagina.

- 20 - ~ 3 ~-

Fig. 13 shows an alternate way for folding a disc
80 of the type shown in Fig. 9 in the configuration,
resembling the letter "W" in cross section. An end view of
the applicator 20 shown in Fig. 14 depicts the diss in its
folded state and inserted into the tube 22. This embodiment
differs principally from the axially-insertable embodi-
ments of Figs. 9-12 in that it is inserted edgewise into the
vaginal tract after expulsion from the applicatorO The
disc 80 enters the upper vault of the vagina laterally and
is pushed by the plunger member 32 of the applicator to
cover the os uteriO In using this embodiment, the loaded
applicator must be oriented properly by the user so that the
plane of the disc after expansion acts as a barrier. An
advantage of this embodiment, however, resides in the fact
that the material need not be formed as a disc. Rather,
shapes such as those representatively shown by the refer-
ence numerals 82, 84, 86 in Figs. 15A through 15C can also
be used, after folding along the fold lines 83, 85t and 87
respectively. The relative ratios of the folds and the
number of folds are selected within an overall width of
about 6 cm and a length of about 7 or 8 cm. The embodiment
of Fig. 15A is in the shape of an irregular pentagon, that
of Fig. 15B in the shape of an irregular pentagon, that of
Fig. 15B in the shape of a squared circle, while that of
i5 Fig. 15C is a rectangle with rounded corners.
Fig. 16 is an alternate embodiment in which a
plurality of randomly-positioned particulated tampons 90
of the type described are positioned and enclosed in a
porous enclosure 92. Upon wetting, the overall configura-
tion is generally spherical for insertion in the vagina inthe manner described.
As an alternative embodiment of this invention,
the cylindrical member as seen in Fig. 2 which acts as a
reservoir for a spermicide or medicament is sealed after
having been filled through the filler hole 36 with said
spermicide or medicament under pressure from a compressed

l~nt;~3
- 21

gas, such as air, carbon dioxide, vinyl chloride, fluoro-
carbon or the li~e, most especially, however, gases of a
nature that will not react chemically with the spermicide
or medicament or will not, in any manner, be harmful to
human tissue. Such gas, under pressure, will provide
potential energy to act as propellant to the spermicide or
medicament sealed with it in the reservoir member. With the
applicator held in a vertical position so that the com-
pressed gas is above the level of fluid spermicide or
medicament, upon fracturing of or opening the valve at the
end of said member that is adjacent to the fluid-expansible
tampon stored in the second cylindrical member, the gas
will force the entire amount of fluid to flow toward the
expansible tampon and thus to wet said tampon.
The invention may be embodied in other specific
forms without departing from its spirit or essential char-
acteristicsO The present embodiments are, therefore, to be
considered in all respects as illustrate and not restric-
tive, the scope of the invention being indicated by the
claims rather than by the foregoing description and all
changes which come within the meaning and range of the
equivalents of the claims are therefore intended to be
embraced therein.
2S

Representative Drawing

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Administrative Status

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Administrative Status

Title Date
Forecasted Issue Date 1984-07-31
(22) Filed 1981-06-08
(45) Issued 1984-07-31
Expired 2001-07-31

Abandonment History

There is no abandonment history.

Payment History

Fee Type Anniversary Year Due Date Amount Paid Paid Date
Application Fee $0.00 1981-06-08
Owners on Record

Note: Records showing the ownership history in alphabetical order.

Current Owners on Record
KCDP CORPORATION
Past Owners on Record
None
Past Owners that do not appear in the "Owners on Record" listing will appear in other documentation within the application.
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Document
Description 
Date
(yyyy-mm-dd) 
Number of pages   Size of Image (KB) 
Cover Page 1994-04-15 1 19
Drawings 1994-04-15 3 106
Claims 1994-04-15 9 358
Abstract 1994-04-15 1 30
Description 1994-04-15 21 1,030