Note: Descriptions are shown in the official language in which they were submitted.
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Device for Insertion into a Body Cavity
Cross-Reference to Related Applications
This application is related to commonly assigned, co-
pending US Serial No. 09/342,544, filed June 29, 1999.
Field of the Invention
The present invention relates to an intravaginal
device comprising components capable of being distended to
engage vaginal walls during use and then contracted prior
to its removal.
Background of the Invention
Intravaginal devices for managing bodily fluids are
known in the art. Two major uses are known: managing
discharged bodily fluids, such as menses, and support of
the urinary system, such as "pessaries". Devices for
managing bodily fluids generally fall into two main
categories. The first category consists of one or more
absorbing bodies such as tampons containing absorbent
material. An example of a tampon and methods for making
the same, are disclosed in Friese, US Pat. No. 4,816,100.
Tampons are typically manufactured from a web of absorbent
fibers and compressed into a cylindrical form for
inserting into a user's vaginal canal, either digitally or
with the assistance of an applicator.
The second category of intravaginal devices known in
the art consists of collecting devices, such as those
disclosed in Zoller, US Pat. No. 3,845,766 and Contente et
al., US Pat. No. 5,295,984. Collection devices are
designed to assume a normally open, concave configuration,
with an open side facing a user's cervix. The collection
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devices may be folded, or otherwise manipulated, to
facilitate insertion into the vaginal canal.
Three recently published inventions relating to
collection devices, comprise inflatable components for
sealingly engaging the walls of the vaginal canal. They
are Zadini et al., US Pat. No. 5,674,239 and PCT Pub. No.
WO 99/07433, and DEKA Products Limited Partnership, PCT
Pub. No. WO 99/13810. The devices disclosed in these
references incorporate valves that allow pressurized air
to enter the device during inflation, but do not allow the
air to escape for deflating the devices. Due to this
directional limitation, additional design features or
techniques must be included to help in removing the
devices after their useful life.
Zadini et al., US Pat. No. 5,674,239, discloses an
intravaginal balloon for blood leakage prevention, with
two alternative methods for removal after use. The first
method disclosed consists of pulling on an attached
removal means, such as a string, sufficient to decrease a
transverse diameter of the balloon. The second method
employs microporous material for constructing the balloon.
This allows air to escape at a substantially predetermined
time following inflation of the distensible member.
Zadini et al., PCT Pub. No. WO 99/07433, discloses an
intravaginal balloon for blood leakage prevention. A
method of deflating the intravaginal balloon consists of
creating a slit in a chamber wall of the balloon with the
removal string, thereby providing an escape route for
carbon dioxide or suitable inflating gas.
DEKA Products Limited Partnership discloses a
catamenial collector having a receptacle with a flexible
hollow rim capable of inflation. The device employs tear
marks along portions of a handle extending from the
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receptacle, whereby portions of the device can be torn
away, allowing for deflation prior to removal.
In each of these inflatable devices, the gas that
escapes from the inflatable portion is not assuredly
directed outside of the body. Indeed, in one or more of
the Zadini embodiments, the gas may be discharged directly
into the vagina. However, Osborn et al., WO 98/41179
suggests that the presence of excessive amounts of gas,
including oxygen and carbon dioxide, in the vaginal canal
may be undesirable. Therefore, it is desirable to ensure
that discharges of such gases into the vagina is
prevented. In addition, the inflatable devices that are
pumped from the atmosphere may allow the user to over-
inflate the devices with dangerous consequences.
Therefore, what is needed is a distensible
intravaginal device that prevents discharge of potentially
dangerous gases into the user's vagina and that safely
limits the distension of any insertable reservoir.
What is still needed, is an intravaginal catamenial
device comprising an distensible member and a single
valve, the valve capable of repeated two-way fluid
communication providing a means for both inflation and
deflation of the device.
Summary of the Invention
The present invention relates to a device for
insertion into a body cavity having a wall. The device
includes an insertable reservoir that is capable of being
inserted into the body cavity and distending to engage the
wall of the body cavity. An external reservoir is in
fluid communication with the insertable reservoir through
a conduit. There is a valve associated with the conduit
that is capable of alternately preventing and allowing
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fluid to flow, via the conduit, from the external
reservoir to the insertable reservoir and from the
insertable reservoir to the external reservoir, as desired
by a user. Preferably, the device contains a
predetermined quantity of a working fluid. The device may
be used intravaginally as a catamenial device or as a
urinary system support. Additionally, the device may be
useful if dimensioned to fit within a user's urethra to
block unwanted urinary discharge.
The invention also relates to a method for
controlling the passage of bodily discharges from a body
cavity having a wall. The method includes inserting an
insertable reservoir into the body cavity; transferring a
quantity of fluid from an external reservoir into the
insertable reservoir via a conduit; distending the
insertable reservoir to engage the wall of the body
cavity; operating a valve to maintain fluid in the
insertable reservoir; operating a valve to permit transfer
of a quantity of fluid from the insertable reservoir to
the external reservoir via the conduit; and removing the
insertable reservoir from the body cavity. This may be
repeated, as necessary, to meet the needs of the user.
Alternatively, the method may relate to managing
bodily fluids during a period of menstruation. Such a
method may include the steps of inserting a catamenial
device into a vaginal canal, having a wall, transferring
fluid from the external reservoir into the insertable
reservoir, the amount of fluid being sufficient to distend
the insertable reservoir to cause it to engage the wall of
the vaginal canal; maintaining the insertable reservoir in
the vaginal canal for preventing passage of the bodily
fluids from the vaginal canal for a duration of at least 2
hours; transferring fluid from the insertable reservoir to
the external reservoir; and removing the insertable
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reservoir from the vaginal canal. A device useful in this
method has an insertable reservoir that is capable of
being inserted into the vaginal canal and distending to
engage the wall of the vaginal canal, an external
reservoir, and a conduit providing fluid connection
between the reservoirs. The insertable reservoir has a
cervix-facing side and an opposing side, and a valve
capable of alternatively preventing and allowing fluid to
flow, via the conduit, from the external reservoir to the
insertable reservoir and from the insertable reservoir to
the external reservoir, as desired by a user, is
associated with the conduit.
Brief Description, of the DraWiIIGS
FIG. 1 is a perspective view of an insertable device
according to the present invention wherein the working
fluid is substantially contained in the external
reservoir.
FIG. 2 is a schematic illustration of an insertable
device according to the present invention.
FIG. 3 is a side elevation of an insertable device
according to the~present invention wherein the working
fluid is substantially contained in the insertable
reservoir.
FIG. 4 is a side elevation of an insertable device
according to the present invention wherein the working
fluid is substantially.contained in an alternative
insertable reservoir.
FIG. 5 is a schematic illustration of an alternative
embodiment of the insertable device according to the
present invention.
FIGS. 6A and 6B depict a sequence of steps
illustrating the use of an insertable device in
conjunction with an applicator.
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FIG. 7 is a side elevation of an insertable device
according to the present invention wherein an alternative
insertable reservoir contains an absorbent tampon.
FIGS. 8A and 8B are side elevations of an insertable
device according to the present invention wherein an
absorbent tampon substantially surrounds an alternative
insertable reservoir.
FIGS 9-11 are side elevations of several alternative
embodiments of insertable devices according to the present
invention wherein an absorbent tampon substantially
surrounds the respective alternative insertable reservoir.
Detailed Description of the Preferred Embodiments
FIG. 1 depicts a perspective view of an insertable
device 10 according to the present invention, and FIG. 2
is a schematic illustration of such a device 10. The
device 10 comprises an insertable reservoir 20, an
external reservoir 22, and a conduit 24 having a first end
26 in fluid communication with the insertable reservoir 20
and a second end 28 in fluid communication with the
external reservoir 22. A valve 30 is located between the
insertable reservoir 20 and the external reservoir 22 to
control movement of a working fluid between them.
Moving the working fluid from the insertable
reservoir 20 to the external reservoir 22 allows the
insertable reservoir 20 contract (as shown in FIG. 1) to
allow for easier insertion of the device 10 into a body
cavity or removal of the device 10 from a body cavity.
Moving the working fluid from the external reservoir 22 to
the insertable reservoir 20 causes the insertable
reservoir 20 to distend. When the insertable reservoir 20
contains substantially all of the working fluid, it
distends to a predetermined shape (as shown in FIGS. 3 or
4). The working fluid employed in the device 10 may be
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any suitable fluid, including liquids and gases. A
representative, non-limiting list of suitable working
fluids, includes aqueous liquids such as water, saline
solution, douche solutions, acetic acid solutions,
hydroxyethyl cellulose solutions or dispersions, and the
like; polymeric liquids such as polyethylene glycols,
liquid silicones as used in prostheses, and the like;
nonaqueous liquids; common gases such as air, carbon
dioxide, and the like; and inert gases such as nitrogen,
noble gases, and the like.
The valve 30 controls the passage of fluid between
the insertable reservoir 20 and the external reservoir 22.
The device 10 of the present invention preferably provides
for repeated distension (and contraction) of the
insertable reservoir 20 within a short time period. As
stated in the background section of the instant
specification, collection devices comprising inflatable
members currently known in the art require destructive or
time delayed techniques for deflation (i.e., via tear-away
portions or construction with microporous materials).
There are several benefits associated with the
capability of repeated distension within a short time
period. First, a user may wish to contract the insertable
reservoir 20 slightly to reposition it after insertion and
distension, due to a sense of discomfort in the placement.
Second, the user may wish to contract the insertable
reservoir 20 sufficiently to drain any bodily fluids into
a disposal means, such as a toilet, and then to again
distend it for additional use. Third, the user may find
that the initial distension is too great and may desire to
slightly reduce the pressure exerted by the insertable
reservoir 20 without completely contracting.
Valves capable of two-way fluid communication include
both two-way valves and releasable one-way valves.
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Clamps, ball valves, stop cock valves, and gate valves are
examples of two-way valves, wherein the valve may be
manipulated to either an open or a closed position, but is
not biased to either one of the positions. Check valves,
reed valves, umbrella valves, and duckbill valves are
examples of one-way valves. One-way valves are normally
in a closed position, allowing pressurized fluid to flow
in one direction, while resisting flow in the opposite
direction.' When one-way valves are used in the present
invention, it is critical that they are accessible and
manipulable by the user, so that the valves may be
releasable, thereby providing two-way fluid communication.
For example, having the capability of manually compressing
the spring in a spring-loaded check valve, or compressing
peripheral portions of a duckbill valve sufficient to urge
normally closed sealing lips apart.
In the practice of the present invention, it may be
helpful to employ a pair of oppositely disposed one-way
valves (see FIG. 5). A first valve 30a would operate to
maintain fluid in the insertable reservoir 20, a second
valve 30b would operate to maintain fluid in the external
reservoir 22. Thus, when the device 10 is manipulated to
direct the fluid into the external reservoir 22, the
second valve 30b would keep the fluid there (again, as
shown in FIG. 1). The device 10 could then be
manipulated, e.g., by compressing the external reservoir
22 and opening the second valve 30b to direct fluid from
the external reservoir 22, through the conduit 24, and
into the insertable reservoir 20. The first valve 30a
would then keep the fluid in the insertable reservoir 20
(again, as shown in FIGS. 3 or 4).
In addition to the properties of the valve itself, a
manipulable valve may also require appropriate
environmental properties. As used in the Specification
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and Claims, the term "environmental properties" relates to
the condition or circumstances corresponding to the
materials or elements of the device surrounding the valve.
This includes, but is not limited to, physical properties
of the valve housing and valve placement within the
housing, such as depth. For example, if a duckbill valve
resides within a fluid conducting conduit, then the
conduit must be sufficiently flexible and resilient, in at
least portions proximal the duckbill valve, so as to
permit transfer of compressive forces applied to the outer
surface of the conduit, to open the normally closed
sealing lips. Upon release of the compressive forces, any
environmental changes, such as distortion of the conduit
in areas proximal the valve dissipates, due to its
resiliency. This dissipation allows for repeated
manipulation of valves used in the present invention.
In contrast, if a duckbill valve were residing within
a rigid conduit, then compressive forces applied to outer
surfaces of the rigid conduit would not be sufficiently
transferable to open the normally closed lips to release
fluid from the insertable reservoir 20. However,
additional features in communication with the valve could
render it useful. For example, such features could allow
remote manipulation of the valve, or the valve could be
manipulated by inserting a mechanical means, such as a
rod, through the conduit and into the valve to open the
normally closed lips.
The insertable reservoir 20 may be of any shape to
block and/or collect discharged bodily fluids. As shown
in FIG. 3, the insertable reservoir 20 has the form of a
collection cup having a rim 40, a receptacle 42, and a
conduit 44. The receptacle 42 has a closed end 46, and
fluid channels 48 provide fluid communication from the
conduit 44 through the receptacle 42 to the rim 40. In an
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alternative embodiment shown in FIG. 4, the insertable
reservoir 20' has the form of a substantially spherical
(or, alternatively oval) balloon. Additional forms of the
insertable reservoir 20 will be apparent to the ordinarily
skilled practitioner. For example, those forms
illustrated in Zadini et al., US Pat. No. 5,674,239 and
PCT Pub. No. WO 99/07433, and DEKA Products Limited
Partnership, PCT Pub. No. WO 99/13810 (the disclosures of
which are herein incorporated by reference) may be used.
Suitable materials for the insertable reservoir 20
include, but are not limited to elastomeric materials such
as latex, silicone, polyurethanes, polyvinyl chlorides,
and the like; inelastic materials such as polyester
terephthalate and the like; laminates of materials such as
adhesively laminated films, co-extruded films, and the
like.
The external reservoir 22 may be of any shape and
size appropriate to contain the working fluid prior to
introduction into the insertable reservoir 20. The
external reservoir 22 may be maintained under high
pressure so it has a lower volume than the insertable
reservoir 20, or it may have substantially the same volume
as the insertable reservoir 20. The external reservoir 22
may also contain a chemical source of the working fluid
that can be reacted to generate the predetermined quantity
of the fluid.
In addition, the external reservoir 22 may include
features that allow excess quantity of working fluid to be
released from the otherwise closed system of working
fluid. This would allow a user to reduce the volume
occupied by the insertable device 10 during use. For
example, the inserted volume may be modified by
incompletely inflating the insertable reservoir 22, and
the user may then expel some working fluid from the
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external reservoir 22 to avoid having a partially
distended external reservoir 22 from being particularly
noticeable during use, prior to removal.
Finally, the external reservoir 22 may comprise
several individual reservoirs or chambers within a single
reservoir to allow an alternative form of customization of
size in use. For example, one external reservoir 22 may
be appropriate for small or young users, while moderate or
average users may expel working fluid from two external
reservoirs or chambers, and large and/or post-partum users
may require three such reservoirs or chambers. One or
more of these additional reservoirs may be removable to
enhance comfort during use.
Suitable materials for the external reservoir 22
include, but are not limited to elastomeric materials such
as latex, silicone, polyurethanes, polyvinyl chlorides,
and the like; inelastic materials such as polyester
terephthalate and the like; laminates of materials such as
adhesively laminated films, co-extruded films, and the
l i ke .
The conduit 24 may be of any shape and size
appropriate to provide fluid communication between the
insertable reservoir 20 and the external reservoir 22 and
to provide sufficient environmental features for the
appropriate operation of the valve 30. The internal size
and length will generally be dictated by the working fluid
used and the dimensions of the body for which it is
designed for use. Suitable material used for the fluid
conducting conduit 24 may be similar or identical to that
used for the insertable and external reservoirs, such as,
without limitation, elastomeric materials such as latex,
silicone, polyurethanes, polyvinyl chlorides, and the
like; inelastic materials such as polyester terephthalate
and the like; laminates of materials such as adhesively
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laminated films, co-extruded films, and the like.
Preferably, the conduit 24 is made from a flexible
material to allow for comfortable use.
The system can be charged with the predetermined
quantity of the working fluid through ways that will be
known to those of ordinary skill in the art.
Representative, non-limiting examples of these methods
include (1) to inject the working fluid from a syringe or
syringe-like device through a self-sealing injection port;
and (2) to hold at least a portion of the inflation device
under an external vacuum allowing the interior of the
reservoir to be exposed to atmospheric pressure, charging
the reservoir and keeping the reservoir walls extended
(when sealed to the remaining elements, such as the
chamber and other reservoir, the charged reservoir would
contain the predetermined quantity of working fluid).
Referring to Figs. 6A-6B, the insertable device 10
may be used in combination with an applicator 60. The
applicator may be custom designed for the insertable
device 10 or it may be a generally cylindrical, tubular
applicator having a domed insertion end 62 as used to
insert tampons. The use of an applicator 60 may also
provide sufficient pre-insertion restriction on the
insertable reservoir 20 to substantially eliminate the
need for more than one valve 30. Fig. 6A illustrates the
insertable reservoir 20 in a contracted state enclosed in
the applicator 60. Fig. 6B illustrates the deployment of
the insertable reservoir 20 in a distended state during
the withdrawal of the applicator 60. After removal of the
applicator, the distended insertable reservoir 20 appears
substantially the same as shown in Fig. 3.
Absorbent material may optionally be associated with
the insertable reservoir for improving the fluid
management capabilities of the device, such as in an
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overlying position on at least a portion of the insertable
reservoir's outer surface. FIG. 7 depicts an insertable
reservoir 70 providing a receptacle for a singular
absorbent body 72, such as a commercially available
tampon. Alternative forms of absorbent bodies and
materials may also be used, such as for example
superabsorbent particles or fibers adhered to at least a
portion of the outwardly disposed surface of the
insertable reservoir 70. The use of construction
adhesives well known in the industry, such as styrenic
block copolymers, is one suitable method for adhering
absorbent material to the distensible member. Another
suitable form of absorbent material is a nonwoven web
comprising a blend of cellulosic fibers such as rayon and
thermoplastic fibers in an amount sufficient to provide
heat sealability to the outwardly disposed surface of the
distensible member. A representative, non-limiting list
of useful absorbent material includes natural cellulosics,
regenerated cellulosics, polyacrylates, grafted starch,
grafted cellulose, and polyvinyl alcohol. Cotton, wood
pulp, and peat moss are examples of natural cellulosics,
while rayon is an example of a regenerated cellulosic
fiber. The fibers may be generally cylindrical in their
cross-section, multilimbed as disclosed in EP 301 874,
flocked as disclosed in Lasko, US Ser. Nos. 09/356947 and
09/356948, and the like. A representative, non-limiting
list of useful absorbent materials includes highly
absorbent polymers such as superabsorbent materials,
including particles and fibers, hydrogel materials, and
the like; cellulosic fibers such as rayon, natural fibers
such as wood pulp and cotton, and the like; synthetic, and
non-cellulosic fibers such as polyolefins, polyesters, and
the like.
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Other alternative arrangements of insertable
reservoirs and absorbent materials are illustrated in
Figs. 8-11 in which the insertable reservoir is primarily
contained within an absorbent body. Fig. 8A illustrates
such an alternative embodiment prior to use. This
embodiment includes an insertable reservoir 80 contained
in an absorbent body 82, such as a tampon. Again, the
insertable reservoir 80 is coupled via a conduit 84 to an
external reservoir 86. After insertion into an
appropriate body cavity, such as a vagina, the insertable
reservoir 80 is distended to also distend a base portion
88 of the tampon. After use, the insertable reservoir 80
can again be reduced in sire to allow for easier removal.
Fig. 9 illustrates another alternative embodiment in
use. In this embodiment, an insertable reservoir 90 is
again substantially contained within an absorbent body 92,
such as a tampon. The insertable reservoir 90 extends
along much of the length of the tampon 92, but the
reservoir 90 is shaped to provide less radial expansion at
a head portion 94 of the tampon 92 than at the base
portion 96 when the working fluid is transferred from the
external reservoir 98.
Fig. 10 illustrates another alternative embodiment in
use. In this embodiment, an insertable reservoir 100 is
again substantially contained within an absorbent body
102, such as a tampon. The insertable reservoir 100
extends along much of the length of the tampon 102, and it
is shaped to provide substantially uniform expansion along
the length of the tampon 102 such that the head portion
104 of the tampon 102 has substantially the same diameter
as the base portion 106 when the working fluid is
transferred from the external reservoir 208.
Fig. 11 illustrates yet another alternative
embodiment in use. In this embodiment, an insertable
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reservoir 110 is again substantially contained within an
absorbent body 112, such as a tampon. The insertable
reservoir 110 is primarily disposed in the head portion
114 of the tampon 112 to provide substantial expansion
there. In addition, the tampon 112 has one or more
projections 116 located in the head portion 114 to allow a
more intimate fit with the body cavity. These projections
116 may be individual, or they may extend about the head
portion 114 to form a receptacle of absorbent material
when the working fluid is transferred from the external
reservoir 118.
As indicated above, the device may also include
additives to achieve particularly desired goals. A
representative, non-limiting list of potential additives
includes medicaments, moisturizers, vitamins and minerals,
and odor controlling agents.
In more detail, the conduit includes at least one
valve in a valve system. A preferred valve system is a
pair of releasable, one-way valves. More preferably, it
is a pair of one-way duckbill valves. Such valves are
disclosed in Fitzpatrick et al, a commonly assigned, co-
pending US Serial No. 09/342,544, filed June 29, 1999, the
disclosure of which is herein incorporated by reference.
Using an insertable device of the present invention
as a menstrual device a user inserts at least the
inflatable reservoir into her vaginal canal. This
insertion may be aided by an appropriate applicator, if
necessary. She can then force fluid from the external
reservoir into the inflatable reservoir. When the user is
ready to remove the device, she may manipulates the valve
from a closed position to an open position to allow her
body to exert unresisted pressure to force at least some
of the working fluid back into the external reservoir.
She may choose to completely, or alternatively, partially
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deflate the insertable reservoir to facilitate its easy
and comfortable removal from the vaginal canal.
The valve is preferably positioned external to the
opening of the user's vaginal canal. External includes
positions adjacent the opening, such as within the user's
labia minora and/or majora. Valve may also be positioned
within the user's vaginal canal. If a pair of valves are
used, it is preferred that both are preferably positioned
external to the opening of the user's vaginal canal.
The insertable reservoir 20 and the external
reservoir 22 may each be made by dipping a mandrel into
uncured material, curing or drying the material on the
mandrel, and then removing the formed distensible member
from the mandrel. Alternatively, they may made by blow
molding, adhering films, injection molding (including
liquid injection molding), rotomolding, and the like.
The conduit 24 may be initially formed as a
substantially tubular element through extrusion or
injection molding techniques, or formed through secondary
operations from a sheet of material. The insertable
reservoir 20, external reservoir 22, the conduit 24, and
the valve 30 are preferably manufactured separately and
then assembled together into a final form as shown in the
figures. A representative, non-limiting list of assembly
techniques and materials, includes adhesives, heat seal,
ultrasonic welding, solvent welding, and mechanical
fastening.
While particular embodiments of the present invention
have been illustrated and described, other changes and
modifications can be made without departing from the
spirit and scope of the invention. It is therefore,
intended to cover in the appended claims all such changes
and modifications that are within the scope of this
invention.
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