Note: Descriptions are shown in the official language in which they were submitted.
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WO 91/08779 PCl'/US90/07159
lNlN15 HYGIENE DEVICE
BACKGROUND
The present invention relates generally to feminine
hygiene devices and more particularly to a vaginal --
~ischArge collection device.
From the time after World War I when bandages were
marketed as sanitary napkins, to the present, there have
been substantially only two types of menstrual collection
products, both absorbent, sold in the market. Currently, -
t~ ,on~ and napkins dominate the market. Improved versions ~; -
of the original sanitary napkins have become the newer pads
and shields, but they still have the disadvantages of bulk,
odor, leakage and ~icpos~l problems. The external ;~
absorbent nature also can create problems of contamination -
and infection. When the t ~ was intro~uce~ into the
market it too was an absorbent collector but was worn
internally. The t~ ,~ solved some of the inconvenience of
the external products but present similar problems while
creating new ones. The basic design of the tampon did not
stop leakage and the externally worn string could lead to
contamination. Infections caused by irritation of the
fibers to the vaginal mucosa and more severe types of
infections caused by the internally worn absorptive materi-
als have caused problems with tampon use.
Accordingly, there is a need in the art for a ~ -
vaginal ~icch~rge collector for collecting menstrual fluid
and other types of vaginal discharge, that avoids the
problems associated with nArk; nC and tampons.
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SUMMARY ,. - .,
The present invention alleviates to a great extent
the disadvantages of the known devices by providing a
vaginal discharge collector including a body for providing
a space for the collection of vaginal discharge and having
an opening for the passage of vaginal discharge into the
collection space, and a rim for providing resilient outward
holding force sufficient for holding the collector in posi- ~ -
tion during use, the rim being affixed to the body
proximate the top of the body. In one aspect of the inven-
tion, the body and the rim are flexible so that the body
may be rolled up on the rim between a rolled-up position
and a rolled-down position so that the collection space is
larger in the rolled-down position. The body may include a
reservoir for providing a reservoir space having an es-
sentially constant size in either the rolled-down position ;~
or the rolled-up position. An absorbent pad may be
inserted into the collection space to absorb liquid and to
inhibit liquid from leaving the collector.
In another aspect of the invention, the collector
includes a closure structure for at least partially cover-
ing the opening for inhibiting the exit of vaginal
~icrh~rge from the collection space. One embo~i ~nt of the
closure structure includes a membrane extPn~;ng over the
area within the rim. The membrane is slit or divided into
two approximately equal parts approximately along a line
exten~ing across the diameter of the rim and approximately
through the radial center of the rim. The two parts of the
membrane may each have an area larger than half of the
circular area defined by the rim so as to overlap along the
slit and/or extend loosely and not stretched tightly across
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the area defined by the rim. This loose and~or overlapping
structure is to allow collection of fluid into the device
through the slit but to inhibit exit of the fluid from the
device. Forces on the device during removal will tend to
close together the overlapping parts of the slit membrane
to prevent the exit of fluid.
Although some alternative non-tampon type
internally used collector devices are known which are ~ -
inserted into the vaginal canal, these have not been
marketed or gained acceptance. Because a substantially
looser fit is needed to inhibit the passage of menstrual
fluid than to inhibit the passage of sperm, the structure
of the present invention may be smaller than the contracep- '
tive diaphragm type devices to increase comfort during
wearing while still being held in position by compression
of the vaginal wall on the rim. The comfort is achieve by
a rim that will conform to the individual and that will be
more flexible and less rigid than that of the diaphragm
type devices. Thus, a single size of the collector accord-
ing to the present invention will be adequate for use for a
range of sizes of vaginal canals, unlike the diaphragm type
devices which must be individually fit by a medical doctor
or specially trained nurse and which are available only by
prescription. Moreover, the diaphragm type devices must
last for long periods of time and must be constructed of
heavyweight materials. Therefore, the invention may be
less expensive than the diaphragm type devices and may be
disposable.
Another advantage of the present invention is that,
because it may be made of an elastomeric material that is
chemically inert and non-toxic, the present invention
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wo91/o877s PCT/US90/0715g
should not be prone to health problems that the current
products seem to cause. Moreover, this soft material will
allow for adjustment to individual shapes and afford excel-
lent comfort while maintaining its original form. The
present invention seals off the blood environment to
inhibit the growth of bacteria 'and entry of air and thus
hinders the odor which results from the oxidation and
decomposition of the menstrual flow.
In another aspect of the invention, the collector
may effect intra-vaginal drug delivery of time release and
non-time release medicants for all diseases of the vagina
and other reproductive organs and any and all diseases of
the entire female anatomy wherein vaginal absorption can be
utilized for both menstruating and non-menstruating
females. For eYA le, for the treatment of yeast and
fungal infection, medication can be delivered without
interruption due to menstruation.
Moreover, for providing a safe sex barrier the
device may be used as a barrier during sexual contact to
aid in the prevention of the tr~r- ission of diseases. The
effectiveness of the device in this regard may be enhanced
by using the device with, or for the delivery of, non-
oxynol 9 or other specific medicants.
Additionally, the invention may be used for intra-
vaginal delivery of hormones for birth control and for
treatment of the female anatomy, such as during menopause.
The invention may also be used for the delivery of
time released and non-time released deodorizing materials
for odor prevention, for the delivery of lubrication and
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for the delivery of steroids, anti-bacterial agents or any
pharmacological agent, chemical, natural, or homeopathic
agents.
Moreover, the invention may be used for intra- -
vaginal delivery of anesthetic for local surgical
procedures and for general surgical procedures and for the
delivery of pain relieving medication for intermittent and
chronic pain, as well as for drug delivery for pregnant
women for any and all prophylaxis and illnesses particular
to the fetus and/or mother-to-be.
The invention may be used for the delivery of drugs
and other substances in veterinary applications including
primates other than humans and other animals.
Moreover, the invention may be employed as an aid
to conception for humans, primates, and other ~n; -1s.
Conception can be aided by either using the collector for
ret~;n;ng sperm in the vaginal vault after intercourse or
by placing sperm in or on the collector and then inserting
it in the vaginal vault. This is different from and not a
substitute for the medical procedures of artificial
insemination that are required for certain circumstances
and that are done by doctors in a clinical/hospital set-
ting.
The invention may also be used as a specimen col-
lector to collect blood and/or vaginal, cervical and/or
uterine ~isch~rge.
It is an object of'the present invention to provide
a vaginal ~is~h~rge collector.
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WO91/08779 PCT/US90/07159
It is another object of the present invention to
provide a vaginal discharge collector which has an adjust-
able discharge collection capacity.
It is yet another object of the present invention
to provide a vaginal discharge collector with the foregoing
advantages and which may be adjusted to a number of
intermediate positions between and including a rolled-up
position and a rolled-down position.
It is a further object of the present invention to
provide a vaginal discharge collector with the foregoing
advantages and which provides a reservoir which has es-
sentially constant capacity in either the rolled-up and
rolled-down positions.
It is another object of the present invention to
provide a vaginal discharge collector with the foregoing
advantages and which provides an absorbent material for
absorbing and holding collected liquid.
It is still another object of the present invention
to provide a vaginal discharge collector with the foregoing
advantages and which provides a closure structure for
inhibiting the exit of collected dischaxge fluid.
It is yet a further object of the present invention
to provide a vaginal discharge collector with the foregoing
advantages and which provides time released and non-timed
released dosages of substances for both menstruating and
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~'O 91/08'79 PC~r/US90/07159
- 7 -
non-menstruating females so that there will be no interrup-
tion of treatment, which substance may be, for example,
medication, lubrication, deodorants, hormones and
analgesics.
It is another object of the present invention to
provide a vaginal discharge collector with the foregoing
advantages and which does not require individual fitting
for each user and which may be produced economically enough
to be used as a disposable product.
It is yet another object of the present invention
to provide a vaginal discharge collector with the foregoing
advantages and which is easy to insert and remove without
scraping delicate tissue.
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It is still another object of the present invention
to provide a vaginal discharge collector with the foregoing -~
advantages and which provides a barrier against the blood
environment. ~ -
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It is a further object of the present invention to
provide a vaginal discharge collector with the foregoing
advan~ages and which is light weight without the bulk as-
sociated with other devices and which once inserted cannot
be felt by the user so that the user is free of the annoy-
ing awareness associated with other devices.
It is yet a further object of the present invention
to provide a vaginal discharge collector with the foregoing
advantages and which during use is undetectable by others.
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WO91/08779 PCT/US90/07159
It is still a further object of the present inven-
tion to provide a vaginal discharge collector with the
foregoing advantages and which is designed to meet the need
for a feminine hygiene product that is neither an internal
absorbent tampon nor an external absorbent pad.
It is another object of the present invention to
provide a vaginal discharge collector with the foregoing
advantages and which is inexpensive and therefore available
to all women.
Other objects and advantages of the present inven- ,~;
tion will become readily apparent from the following
description and drawings which illustrate preferred
embodiments of the present invention.
BRIEF DESCRIPTION OF THE DRAWING
~,~
FIG. l is a top view of a first preferred
embodiment of a vaginal ~j~chArge collector according to
the present invention in a rolled-down position.
FIG. 2 is a partial cut-away side view of the col-
lector of FIG. l.
FIG. 3 is a top view of the collector of FIG. l in
a rolled-up position.
FIG. 4 is a partial cut-away side view of the col-
lector of FIG. 3.
.
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WO91/08779 PCT/US90/07159
FIG. 5 is a top view of a second preferred
embodiment of a vaginal discharge collector accordi~g to
the present invention.
FIG. 6 is a partial cut-away side view of the col-
lector of FIG. 5.
FIG. 7 is a top view of a third preferred
embodiment of a vaginal discharge collector according to
the present invention. -~
FIG. 8 is a partial cut-away side view of the col-
lector of FIG. 7.
FIG. g is a top view of a fourth preferred
embo~i nt of a vaginal discharge collector according to ,
the present invention. ';
FIG. lO is a partial cut-away side view of the col-
lector of FIG. 9.
FIG. 11 is a top view of a fifth preferred
embodiment of a vaginal discharge collector according to
the present invention.
FIG. 12 is a partial cut-away side view of the col-
lector of FIG. 11.
FIG. 13 is a top view of a sixth preferred
embod; -nt of a vaginal discharge collector according to
the present invention.
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FIG. 14 is a top view of a seventh preferred
embodiment of a vaginal discharge collector according to
the present invention.
FIG. 15 is a partial cut-away side view of the col-
lector of FIG. 14.
FIG. 16 is a top view of an eighth preferred
embodiment of a vaginal discharge collector according to
the present invention.
FIG. 17 is a top view of a ninth preferred
embo~; -nt of a vaginal discharge collector according to
the present invention.
FIG. 18 is a view of the collector of FIG. 5 in
place in the vaginal canal. ~ -
FIG. 19 is a side view of a tenth preferred
embo~i -nt of a vaginal discharge collector according to
the present invention.
FIG. 20 is a side view of an eleventh preferred
embo~; ~nt of a vaginal ~isch~rge collector according to
the present invention.
.
FIG. 21 is a side view of a twelfth preferred
e hodi -nt of a vaginal discharge collector according to
the present invention.
FIG. 22 is a side view of a thirteenth preferred
embodi ~nt of a vaginal discharge collector according to
the present invention.
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W09t/08779 PCT/~S90/07159
FIG. 23 is a side view of a fourteenth preferred
embodiment of a vaginal discharge collector according to
the present invention.
FIG. 24 is a sch~ -tic view of the rim structure of
the collector of FIG. 7.
FIG. 25 is a schematic view of the rim structure of
the collector of FIG. 9.
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FIG. 26 is a schematic view of the rim structure of
the collector of FIG. 11.
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FIG. 27 is a top view of a fifteenth preferred
embodiment of a vaginal discharge collector according to
the present invention.
FIG. 28 is a partial cut-away side view of the col-
lector of FIG. 27.
DETATT~ DESCRIPTION OF ~K~:~h~k~:~ EMBODIMENTS
Refer now to FIGS. 1-4, there being shown a first
preferred embo~i ent of a vaginal-discharge collector,
generally designated by reference numeral lO, according to
the present invention. The collector 10 includes a
resilient circular rim 11. The body 14 of the collector 10
includes a cup-shaped membrane wall 15 ext~n~ing downward
from the rim and terminating in a reservoir 12 to form a
collection space 19. The membrane wall 15 includes at its
bottom a reservoir 12 that is a bubble-like protrusion
ext~n~ing at edge 18 from the body 14 surface defined by
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W09l/08779 PCT/US90/07159
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the membrane wall 15. As shown in FIGS. 1 and 2, the col-
lector 10 is in a rolled-down position. As shown in FIGS.
3 and 4 the collector 10 is in a rolled-up position with
the body membrane 14 rolled around the rim 11. In the
rolled-up position the collection space 19 has a smaller
volume than it has in the rolled-down position.
In adjusting the collector 10 from the rolled-down - -
position of FIGS. 1 and 2 to the rolled-up position of
FIGS. 3 and 4, the body 14 is rolled onto the rim 11. Ad-
ditionally, the body 14 may be rolled onto the ri~ 11 to a
number of intermediate positions between the rolled-down
position and the rolled-up position. Because the inside of
the rim 11 has a smaller diameter than the outside of the
rim 11, as the rim 11 is twisted inside out to roll around
itself, the inner portion of the rim 11 is stretched.
Because the rim 11 is made from a resilient material, it
will tend to relax to a position where its inside is facing
inwardly and its outside is facing outwardly so that the
rim is in a low state of compression and extension. In
other positions, such as with the inside of the rim 11 fac-
ing outward, the inside of the rim would be stretched and
the outside would be in compression. Therefore, during
rolling of the body 14 onto or off of the rim 11, the rim
11 tends to rest in a number of discreet intermediate posi-
tions. The number of such positions will depend upon the
depth of the body 14, the thickness of the body 14 and the
tightness upon which the body 14 is wound around the rim
11 .
The capacity of the reservoir 12 is essentially the
same in either the rolled-down or rolled-up position. In
the rolled-up position as shown in FIGS. 3 and 4, the
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reservoir 12 has a capacity that is essentially the same as
in the rolled-down position of FIGS. 1 and 2. The capacity
of the reservoir 12 remains essentially unchanged from the
rolled-down through the intermediate positions to the
rolled-up position because it is essentially a bubble-like r
protrusion extending off of the surface of the body 14.
The upper extent of the reservoir 12 is defined by the edge
18 where the reservoir 12 begins to extend from the body
14. When the collector 10 is in the rolled-up position of
FIGS. 3 and 4 and the body 14 extends nearly flatly over
the area within the ring shaped rim 11, the reservoir 12
still extends outward off of the surface of the body 14
Even though the edge 18 of the reservoir 12 may stretch or
expand to some extent, relative to the change in the capac-
ity of the total collector space 19, the capacity of the
reservoir remains essentially constant. Thus, essentially
constant for purposes of the invention means reiatively
less change than the change in the total collection space.
The collector 10 is composed of a latex rubber and
may be formed by a latex dipping process in which a mandrel
is dipped into a tank of coagulating agent, and then dipped
into a tank of liquid rubber latex which coagulates on the
mandrel. It is then subjected to drying and curing with
heat and the device is removed from the mandrel. The
material of the preferred embodiment is elastomeric, such
as a latex rubber and similar materials. Further informa-
tion regarding the latex dipping process may be obtained
from Faultess Rubber Company, Ashland, Ohio. Materials for
the collector may be chosen which may be impregnated with a
substance to be delivered during use of the device. Such
materials are generally known, such as described in U.S.
.
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WO91/08779 PCT/US90/07159
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Patent No. 4,589,880. Other suitable methods of making the
collector may be used, such as by molding.
The rim ll of the collector lO is formed entirely
of solid latex rubber. However, as discussed below with
reference to other preferred embodiments, alternative rim
constructions may be used. The diameter of the rim is
preferably about two to about four inches (about five to
about ten centimeters). The thickness of the rim is ~ ;
preferably less than about one quarter inch (about six mil-
limeters) to result-in the greatest degree of comfort to
the user. The thickness of the wall, which is
substantially impervious to liquid, of the body 14 and the
reservoir 12 is preferably more than about one ten
thousandth of an inch (about two micrometers). In a
rolled-down position, the depth of the collector lO from
the rim ll to the bottom of the reservoir 12 is preferably
about one to three in~h~s (about two to eight centimeters).
The depth of the reservoir 12 from the edge 18 to the bot-
tom of the reservoir 12 is preferably about one sixteenth
to one half of an inch (about two millimeters to about
thirteen millimeters). The volume of the collection space
l9 is preferably about one to about two ounces (about
fifteen to about thirty milliliters). The thickness and ~-
diameter of the rim will depend upon the stiffness of the
material used as the rim should be resilient and flexible
to be inserted into position and to exert sufficient force
to hold the collector lO in position during use as
~iSC~cs~ further below in reference to FIG. 18. The
thirkn~sc of the body 14 will depend upon the properties of
the material used so that the body 14 will have sufficient
strength and flexibility.
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Refer to FIGS. 5 and 6, there being shown a second
preferred embodiment of a vaginal discharge collector,
generally designated by reference numeral 20, according to
the present invention. The collector 20 includes a
resilient circular rim 21. The body 24 of the collector 20
is a cup-shaped membrane wall extending downward from the
rim to form a collection space 29. As shown in FIGS. 5 and
6 the collector 20 is in a rolled-down position. Like the
collector lO, the collector 20 may be positioned in a
rolled-up position with the body membrane 24 rolled around '~
the rim 21. In the rolled-up position the space 29 has a
smaller volume than it has in the rolled-down position.
The construction of the collector 20 is essentially the
same as the collector 10, but the collector 20 does not
include the reservoir feature.
FIGS. 7 and 8 show a third preferred embodiment of
a vaginal discharge collector, generally designated by
reference numeral 30, according to the present invention.
The collector 30 includes a resilient circular rim 31. The
body 34 of the collector 30 is a cup-shaped membrane wall
ext~n~;ng downward from the rim to form a collection space
39. The membrane wall includes at its bottom a reservoir
32 that is a bubble-like protrusion on the body 34 surface
defined by the membrane. As shown in FIGS. 7 and 8, the
collector 30 is in a rolled-down position. Similar to the
collector 10 as shown in FIGS. 3 and 4, the collector 30
may be positioned in a rolled-up position with the body
membrane 34 rolled around the rim 31. In the rolled-up
position the space 39 has a smaller volume than it has in
the rolled-down position. The collector 30 includes a
closure means in the form of two membranes 33 to inhibit
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WO91/OX779 ~ ~ 7~ PCT/VS90/071S9
menses or other vaginal discharge from exiting the collec-
tion space 39. Membrane 33 extends across the circular
area defined by the rim 31 forming, between their édges 36,
a slit 35 which extends across the diameter of the rim 31.
The edges 36 are curved so that the width of slit 35 is
greatest at the center and the edges 36 come together at
the rim 31. The area of the slit 35 is preferably between
about five percent and about ninety five percent of the
area defined by the rim 31. The sizes of the slit 35 and
the membrane 33 are chosen such that the slit 35 is large
enough for fluid to enter the collector 30 and the
membranes 33 inhibit the exit of fluid to the desired
extent. The thickness of the membranes 33 is preferably
greater that about one ten thousandth of an inch (about two
micrometers). If the membranes are used for drug delivery,
the size and thickness of the membrane may be chosen to
meet the dosage needs. The collector 30 also includes a
L~ -val means in the form of a looped string 38 which is
attached to opposite points on the rim 31 and is long
enough to be grasped by the user for ~ :val of the collec-
tor 30 from its use position in the vaginal canal. The
structure of the rim 31 of the collector 30 includes a coil
spring ext~nAlng within the elastomeric covering material.
The structure of rim 31 is discussed in more detail with
reference to FIG. 24.
Refer now to FIGS. 9 and 10, there being shown a
fourth preferred emboAl -nt of a vaginal discharge collec-
tor, generally designated by reference numeral 40, accord-
ing to the present invention. In FIG. 9, a top view of the
collector 40 is shown. The collector 40 includes a
resilient circular rim 41. The body 44 of the collector 40
is a cup-shaped membrane wall extending downward from the
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WO91/08779 PCT/US90/07159
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rim to form a collection space 49. The membrane wall
includes at its bottom a reservoir 42 that is a bubble-like
protrusion on the body 44 surface defined by the membrane.
As shown in FIGS. 9 and 10, the collector 40 is in a
rolled-down position. Like collector 10, as shown in FIGS.
3 and 4, the collector 40 may be positioned in a rolled-up
position with the body membrane 44 rolled around the rim
41. In the rolled-up position the space 49 has a smaller
volume than it has in the rolled-down position. The collec-
tor 40 includes a removal means in the form of a tab 48
which is attached to the rim 41. The tab 48 may be at-
tached to or formed integrally with the rim 41 and has suf- '
ficient length to be grasped by the user for removal of the
collector 40 from its use position in the vaginal canal.
The structure of the rim 41 of the collector 40 includes a
telescoping metal core as discussed in greater detail with
reference to FIG. 25. The collector 40 has ventilating
holes 43 ext~n~ing through the body 44 near the rim 41.
The holes 43 allow air to pass through the body 44 for
equalizing pressure in the vaginal canal during insertion
and removal of the collector 40. The collector 40 also
includes a number of vertically extPn~;ng ribs 47 which are
thickDned portions of the inner and outer surface of body
44. The ribs 47 strengthen the body 44.
Refer now to FIGS. 11 and 12, there being shown a
fifth preferred r ho~; ~nt of a vaginal discharge collec-
tor, generally designated by reference numeral 50, accord-
ing to the present invention. In FIG. 11, a top view of
the collector 50 is shown. The collector 50 includes a
resilient circular rim 51. The body 54 of the collector 50
is a cup-shaped - ~Lane wall ext~n~;ng downward from the
rim to form a collection space 59. The membrane wall
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includes at its bottom a reservoir 52 that is a bubble-like
protrusion on the body 54 surface defined by the membrane.
As shown in FIGS. 11 and 12, the collector 50 is in a
rolled-down position. However, like collector 10 as shown
in FIGS. 3 and 4, the collector 50 may be positioned in a
rolled-up position with the body membrane 54 rolled around
the rim 51. In the rolled-up position the space 59 has a
smaller volume than it has in the rolled-down position.
The collector 50 includes a removal means in the form of a
string 58 which is attached to the rim 51. The string 58
has sufficient length to be grasped by the user for removal
of the collector 50 from its use position in the vaginal
canal. The structure of the rim 51 of the collector 50
includes an internal wire core as discussed in greater
detail with reference to FIG. 26. The collector 50 has
ventilating holes 53 extending through the body 54 near the
- rim 51. The holes 53 allow air to pass through the body 54
for equalizing pressure in the vaginal canal during inser-
tion and removal of the collector 50. The collector 50
also includes a number of horizontally ext~n~ing ribs 57
which are thi~kene~ portions of the inner and outer surface
of body 54. The ribs 57 strengthen the body 54.
Refer now to FIG. 13, there being shown a sixth
preferred embo~; ~nt of a vaginal discharge collector,
generally designated by reference numeral 60, according to
the present invention. The collector 60 includes a
resilient circular rim 61. The body 64 of the collector 60
is a cup-shaped membrane wall extending downward from the
rim to form a collection space 69. The membrane wall
includes at its bottom a reservoir 62 that is a bubble-like
protrusion on the body 64 surface defined by the membrane.
Positioned within the collection space 69 of the body 64 is
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W091/OX779 PCT/US90/07159
an absorbent pad 65 composed of cotton fiber or other
absorbent material. The pad 65 absorbs fluid that enters
the collection space 69. The pad 65 may expand upon
absorbing fluid to increase its capacity, and the volume of
the collector space 69 may be enlarged by any resulting
outward deformation of the elastomeric body 64. As shown
in FIG. 13, the location of the top surface of the pad 65
is shown in phantom by line 66a with the pad 65 in an
initial relatively low absorption state. In this state the
pad 65 could be dry or could have absorbed some fluid
without expanding substantially, depending upon the proper-
ties of the absorbent material of the pad 65.
Alternatively, the pad could be sized for the initial upper ~
surface to be located above or below the line 66a of FIG.
13. The line 66b shows the level of the top of the pad 65 -
at an absorption state relatively higher than the state
defined by line 66a and pad 65 has expanded somewhat. The
pad 65 does not completely fill the collection space 69 and
will inhibit any fluid in the reservoir 62 below the pad 65 -
from exiting the collector 10. Although the embodiment of
FIG. 13 does not include a closure membrane structure, the
pad 65 could also be used with a collector having such a
closure membrane structure as described herein with respect
to various embo~irents of the invention. As shown in FIG.
13, the collector 60 is in a rolled-down position.
~owever, like collector 10 as shown in FIGS. 3 and 4, the
collector 60 may be positioned in a rolled-up position with
the body membrane 64 rolled around the rim 61. In the
rolled-up position the space 69 has a smaller volume than
it has in the rolled-down position. If necessary, the pad
65 may be removed, such as to adjust the volume of the
space 69. The collector 60 includes an apron 67 attached
to and exten~in~ downward from the rim 61 along the entire
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WO91tO8779 PCT/US90/07159
- 20 -
periphery of the rim 61. The apron 67 functions to stiffen
the rim 61 and to aid in blocking against the passage of
matter between the rim 61 and the wall of the vaginal canal
and may be useful for delivering substances such as
spermicide or medication. The rim 61 includes an inner
core 63 encased in the outer elastomeric material of the
rim 61 along the entire circumference of the rim 61. The
inner core 63 is composed of a plastic material to give the
rim 61 increased rigidity. Alternative materials for the
core 63 include dense sponge or foam and other polymers.
The tab 68 is attached to and may be integrally formed with
the reservoir 62 of the body 64. The tab 68 may be grasped -
for removal of the collector 60 from the vaginal canal.
Refer now to FIGS. 14 and 15, there being shown a
seventh preferred embodiment of a vaginal discharge collec-
tor, generally designated by reference numeral 70, accord-
ing to the present invention. In FIG. 14, a top view of
the collector 70 is shown. The collector 70 includes a
resilient circular rim 71. The body 74 of the collector 70
is a cup-shAped membrane wall ext~n~;ng downward from the
rim to form a collection space 79. The membrane wall
includes at its bottom a reservoir 72 that is a bubble-like
protrusion on the body 74 surface defined by the membrane.
As shown in FIGS. 14 and 15, the collector 70 is in a
rolled-down position. The collector 70 may be positioned
in a rolled-up position with the body membrane 74 rolled
around the rim 71. In the rolled-up position the space 79
has a smaller volume than it has in the rolled-down posi-
tion. The collector 70 includes a closure means in the
form of a membrane 73 to inhibit the exit of menses or
other vaginal ~is~hArge from exiting the collection space
79. The membrane 73 extends around the periphery of the
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WO9~/08779 PCT/US90/07159
- 21 -
circular area defined by the rim 71 forming with its edge
76 a circular slit 75. The width of the membrane 73
between edges 76 and rim 71 is preferably about five
percent to about ninety five percent of the diameter of the
rim 71. The collector 70 also includes a number of verti-
cally extending ribs 77 which are thickened portions of the
inner and outer surface of body 74. The ribs 77 strengthen ~ -
the body 70 and extend in a U-shaped manner from the rim 71
vertically downward and back upward to rim 71. The various
ribs 27 are positioned substantially parallel to one
another.
Refer now to FIG. 16, there being shown an eighth
preferred embodiment of a vaginal discharge collector, -
generally designated by reference numeral 80, according to -
the present invention. In FIG. 16, a top view of the col-
lector 80 is shown. The collector 80 includes a resilient
circular rim 81. Similar to the collector 70 the body 84
of the collector 80 is a cup-shaped membrane wall extending
downward from the rim to form a collection space 89. The
membrane wall includes at its bottom a reservoir 82 that is
a bubble-like protrusion on the body 84 surface defined by
the membrane. As shown in FIG. 16, the collector 80 is in
a rolled-down position. The collector 80 may be positioned
in a rolled-up position with the body membrane 84 rolled
around the rim 81. In the rolled-up position the space 89
has a smaller volume than it has in the rolled-down posi-
tion. The collector 80 includes a closure means in the
form of two membranes 83 to inhibit the exit of menses or
other vaginal discharge from exiting the collection space
89. The membranes 83 extend across the circular area
defined by the rim 83 forming between their edges 86 a slit
85 which extends across the diameter of the rim 81. The
WOg/ 7 9 ~ 7~
l08 7 PCT/US90/07159
- 22 -
edges 86 are straight and substantially parallel so that
the width of slit 85 is substantially constant and prefer-
ably between about five percent and about ninety five
percent of the diameter of rim 81. A curvilinear rib 87
extends along and strengthens each of the membranes 83. -~
Refer now to FIG. 17, there being shown an ninth
preferred embo~; ent of a vaginal discharge collector,
generally designated by reference numeral 90, according to
the present invention. The collector 90 includes a
resilient circular rim 91. Similar to the collector 70ï
the body 94 of the collector 90 is a cup-shaped membrane
wall extending downward from the rim to form a collection
space 99. The membrane wall includes at its bottom a
reservoir 92 that is a bubble-like protrusion on the body
94 surface defined by the -bLane. As shown in FIG. 17,
the collector 90 is in a rolled-down position. The collec-
tor 90 may be positioned in a rolled-up position with the
body membrane 94 rolled around the rim 91. In the rolled- -
up position the space 99 has a smaller volume than it has
in the rolled-down position. The collector 9O includes a
closure means in the form of a membrane 93 to inhibit the
exit of menses or other vaginal ~;qch~rge from exiting the
collection space 99. The membrane 93 extends around the
periphery of the circular area defined by the rim 91 form-
ing with its edges 96 a rectangular slit 95. A number of
parallel ribs 97 are formed on and strengthen the membrane
93. The area of slit 95 is preferably between about five
percent and about ninety five percent of the area defined
by rim 91. Alternatively, the slit could be diamond
shaped, or have other shapes as desired.
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Refer now to FIG. 18 which shows the collector 20 ~ -
in position for use in the vaginal canal 201 of a women
200. The rim 21 of the collector 20 is resilient and
exerts outward force on the wall of the vaginal canal 201
at the rearward location 203 behind the cervix 202 and at a
forward location 204 h~hin~l the pelvic bone 205. The rim
21 also contacts and exerts a force against the wall of the
vaginal canal 201 at points around the periphery of the rim
21, which force is sufficient to effectively prevent menses ~ -
or other vaginal discharge from passing between the rim 21 -~
and the vaginal canal wall 201. In FIG. 18, collector 20
is shown rolled to an intermediate position between the
rolled-up and rolled-down positions. Also note that collec-
tor 20 is rolled so that the wall 24 extends downward from -
the inside of rim 21. Conversely, as shown in FIG. 4, wall
14 of collector 10 is rolled in an alternative manner such
that the wall 14 extends down from the outside of rim 11. -
Refer now to FIGS. 19 through 23 which show ad- ~ -
ditional preferred embodiments of the present invention.
Each of these embo~ nts is constructed similar to the
collector 10 and as ~licc~lcse~1 below. FIG. 19 shows a tenth
preferred embo~ nt, a collector 100, having a body 104
and two reservoirs 105 which function similar to reservoir
12 of collector 10. The edges 108 of the two reservoirs
105 meet at ridge 109. In FIG. 20, the eleventh preferred
embodiment, collector 110, inaludes a body 114 having a
number of pleated sections 117 of decreasing size to form
an inverted cylindrical pyramid shape. FIG. 21 shows the
twelfth preferred embodiment, collector 120, which has a
cone-shaped body 124 with a rounded point 127. The rim 121
of collector 120 is formed hollow with numerous pleats 122
which extend around the entire rim 121. The pleats 122
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WO91/OX7~9 PCT/US90/07159
- 24 -
allow the rim 121 to be compressed and collapsed to a
smaller diameter for insertion of the collector 120 into
the vaginal canal. Alternatively, the pleats could extend
over only a portion of the rim 121. The thirteenth
preferred embod;r~nt of FIG. 22, collector 130, is similar
to collector 120 but has a body 134 ending in a relatively
sharp point 137. In FIG. 23 the fourteenth preferred
embodiment, collector 140, has a body 144 that includes an
upper generally cylindrical portion 145 extending from the
rim 141 and a lower conical portion 146 extending from the
portion 145 at the edge 148 to a lower point 147. Each of
the embodiments of FIGS. 20 through 23 have lower extents
that tend to form a reservoir space when the collector is
in the rolled-up position which reservoir space functions
similarly to the reservoir 12 of collector 10.
, ~,
Refer now to FIGS. 24-26 which shows schematically
three types of internal rim structures. In each type of
structure elastomeric rim material is formed around and
seals in the structure. In FIG. 24 a coil spring 170 hav-
ing a number of small closely turned coils 171 is formed
into a circle. A circular inner core 172 extends within
the coils 171. The coils 171 are preferably tightly spaced
and wrapper around the core 172. The spring materials and
the diameters of the wire, the core 172 and the coils 171
are chosen to provide the desired resiliency and spring
force for the collector 30. In FIG. 25, a ring 180 has a
hollow large end 181 and a thin small end 182 that
telescopes inside the end 181. The ring 180 can be
c ~essed with the small end pushed into the large end 182
to make the collector 40 smaller for insertion into the
vaginal canal. After insertion, the ring 180 resiliency
expands withdrawing the end 182 from the end 181 to some
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- 25 -
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extent to exert outward holding pressure on the vaginal
wall. The elastomeric rim 21 is formed so that it is
relaxed or slightly stretched with the end 182 fully
inserted into the end 181. FIG. 26 shows a ring shaped wire
l9Q that has overlapping free ends 191 and 192. The ring
may be compressed within the hollow rim 51 to decrease the
size of the rim 51 during insertion into the vaginal canal.
Refer now to FIGS. 27 and 28, there being shown a
fifteenth preferred embodiment of a vaginal discharge col-
lector, generally designated by reference numeral 150, ac~
cording to the present invention. In FIG. 27, a top view
of the collector 150 is shown. The collector 150 includes
a resilient circular rim 151. The body 154 of the collec-
tor 150 is a cup-shaped membrane wall extending downward
from the rim to form a collection space 159. The membrane
wall includes at its bottom a reservoir 152 that is a
bubble-like p~o~usion on the body 154 surface defined by
the membrane. As shown in FIGS. 27 and 28, the collector
150 is in a rolled-down position. However, like collector
10, as shown in FIGS. 3 and 4, the collector 150 may be
positioned in a rolled-up position with the body mem~rane
154 rolled around the rim 151. In the rolled-up position
the-space 159 has a smaller volume than it has in the
rolled-down position.
In order to facilitate the rolling down ~or rolling
up) operation, the body means 154 and reservoir means 152
are pl-ch~ through the slit 155 formed between the edge 156
of the membrane 153 and the edge 16~ of the membrane 163.
Then, the rim 21 is twisted so that the inner annular
surface becomes the outer annular surface (which causes the ,~
body means 154 to either roll up or roll down along the
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WO91/08779 PCT/US90/07159
circumference of the rim, dependent upon the direction of
the twisting motion). The membranes 153 and 163 are each
then stretched back over the adjoining portion of rim 21
and allowed to snap back into position on the opposite side
of the rim from their starting position. The rim may stay
in such position or may continue to twist such that the
initial inner annular surface again becomes the inner an-
nular surface, depending upon the elastic properties of the
rim and of the components of the collector attached to the
rim as well as upon other forces acting on the rim. This
results in the collector being turned inside out and the ~
point of attachment of the body to the rim be'ing positioned --
on the top-facing portion rather than the bottom-facing
portion of the rim. In addition, by choosing the membrane
material with the appropriate elastic properties, the rim
can be rolled to a '?r of intermediate positions in -
which the --ane is rolled up in the body wound around
the rim.
Note that the body 154 is deeper, preferably about
three to about four inches (about eight to about ten
centimeters) in depth, and has a larger capacity, prefer- -
ably about two to four ounces (about thirty to sixty mil-
liliters), than the collector 10 of FIGS. 1 through 4.
This embo~; ~nt is particularly useful for over-night use
or when relatively large volumes of discharge are to be
collected. The collector 150 includes a closure means that
includes two membranes 153 and 163. The upper membrane 153
extends over approximately half of the area defined by the
rim 151 and has no or relatively little slack so that it
extends approximately horizontally. The lower membrane 163
extends over more than half of the area defined by the rim
151. The edge 166 of the membrane 163 extends underneath
.
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WO9l/08779 ~ ~ 7 '~ PCT/US90/071~9
- 27 -
the upper membrane 153. The slit 155 formed between the
edge 156 of the membrane 153 and the edge 166 of the
membrane 163 allows discharge to drain into the collection
space 159. However, as collected fluid moves upward
towards exiting the device, force is exerted upward on the
membrane 163 to cause it to contact the underside of -
membrane 153. In this manner, the closure means shuts the
slit 155 to inhibit the exit of fluid from the collection
space 159. The rim 2~ includes a wire ring 161 encased in
the elastomeric rim material. The wire ring 161 is
composed of a material known as a shape memory alloy.
These alloys resist plastic deformation and may be bent
severely and will still return to their original shape.
This property is referred to as superelasticity or
pseudoelasticity. Some shape memory alloys known as
thermoelastic alloys, exhibit superelasticity upon being
heated to a certain temperature. One known type of such
alloy is composed of about fifty percent titanium, about
forty-nine percent nickel and about one percent vanadium.
Such alloys are available from Raychem Corporation of Menlo
Park, California. Other types of shape memory materials
may also be used for the rim construction, whether as cores
or other interior or exterior components of the rim or as
the material for the entire rim, depen~;ng upon the ap-
propriateness of the material properties considering design
and regulatory requirements. ,.
.
The materials and the size and thickness of the
various components of the invention should be chosen for
the considerations discussed with respect to one or more of
the preferred embodiments. These conditions may be ap-
plicable to each of the preferred embodiments described
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W091/OX779 PCT/US90/07159
- 28 -
above, as well as other embodiments of the present inven-
tion, even though not individually stated for each
embodiment in conjunction with its description above.
Although the roll-down and roll-up feature has been ~ ;
described above with respect to a number of embodiments,
collectors similar to the described embodiments and other
embo~i ~nts may be constructed which do not include this
feature.
With respect to use of the collector for the
delivery of drugs and other substances, the substances may
be applied to the collector in a number of ways. The
substance may be applied to the collector by mixing the
substance or its precursors with the material of the
collector's body, rim, reservoir, membrane, and/or other
portion during manufacturing, such as prior to forming the
collector during a molding operation by mixing the
substance with the ingredients, whether dry or liquid, to
be molded. Another way to apply the substance is to
inject, impregnate, or absorb it partially or completely
through the material (or cavities or porous portions
thereof) of the collector's body, rim, reservoir, and/or
other portions after such portions have been formed. Yet ~ ,
another way to apply the substance is to coat portions of
the collector surface with the substance.
For non-human primate and other veterinary uses,
the collector may be adapted by sizing it to fit the dimen- -
sions of the vaginal canal of the animal concerned.
The above description and drawings are only il-
lustrative of preferred embodiments which achieve the
objects, features and advantages of the present invention,
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WO91/08779 PCT/US90/07159
- 29 -
and it is not intended that the present invention be
limited thereto. Any modifications of the present inven- .
tion which come within the spirit and scope of the follow- ~-
ing claims is considered part of the present invention.
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