U.S. patent application number 11/443917 was filed with the patent office on 2007-12-06 for method of using intravaginal device with fluid transport plates.
Invention is credited to Samuel Carasso, David J. Chase, Erin Danyi, Tara Glasgow, Mari Hou.
Application Number | 20070282289 11/443917 |
Document ID | / |
Family ID | 34979047 |
Filed Date | 2007-12-06 |
United States Patent
Application |
20070282289 |
Kind Code |
A1 |
Carasso; Samuel ; et
al. |
December 6, 2007 |
Method of using intravaginal device with fluid transport plates
Abstract
A method of capturing bodily fluid in a mammalian body includes
inserting the fluid management device into the mammalian body and
transporting bodily fluid. The bodily fluid is transferred via at
least one fluid transport element that is capable of interfacing
with a mammalian body element to provide a substantially
uninterrupted fluid conduit. The fluid conduit provides a fluid
path between at least one fluid transport element and the storage
element. A distal portion of the at least one fluid transport
element is capable of extending away from the fluid storage
element.
Inventors: |
Carasso; Samuel; (Milltown,
NJ) ; Chase; David J.; (Somerville, NJ) ;
Danyi; Erin; (Nicholasville, KY) ; Hou; Mari;
(Hoboken, NJ) ; Glasgow; Tara; (New Hope,
PA) |
Correspondence
Address: |
PHILIP S. JOHNSON;JOHNSON & JOHNSON
ONE JOHNSON & JOHNSON PLAZA
NEW BRUNSWICK
NJ
08933-7003
US
|
Family ID: |
34979047 |
Appl. No.: |
11/443917 |
Filed: |
May 31, 2006 |
Current U.S.
Class: |
604/385.18 ;
604/904 |
Current CPC
Class: |
G06F 8/72 20130101; A61F
13/2065 20130101; A61F 13/2051 20130101; A61F 13/2068 20130101;
A61F 13/206 20130101; A61F 13/202 20130101; A61F 13/472
20130101 |
Class at
Publication: |
604/385.18 ;
604/904 |
International
Class: |
A61F 13/20 20060101
A61F013/20 |
Claims
1. A method of capturing bodily fluid, the method comprising the
steps of: a) providing a fluid management device comprising: i) a
fluid storage element having a longitudinal axis; and ii) at least
one fluid transport element in fluid communication with the fluid
storage element and positioned within a mammalian body, the at
least one fluid transport element bendable about an axis
substantially parallel to the longitudinal axis of the fluid
storage element, the fluid transport element comprising: A) a first
plate having an outwardly oriented surface and an inwardly oriented
surface; and B) a second plate having a first surface disposed in
15 facing relationship with the inwardly oriented surface of the
first plate, and an opposite surface, and sufficiently spaced apart
from the first plate to provide inter-plate capillary action
between the first plate and the second plate; wherein the at least
one fluid transport element is positioned within the mammalian body
such that the outwardly oriented surface of the first plate and the
opposite surface of the second plate contact a surface of the body,
whereby bodily fluid is exposed to the at least one fluid transport
element and is transported between the first plate and the second
plate by inter-plate capillary action to the fluid storage element
where the fluid is stored.
2. The method of claim 1, wherein the at least one fluid transport
element comprises materials selected from the group consisting of
apertured polymeric film, coated fibrous webs, calendered
meltblown, and combinations thereof.
3. The method of claim 1, wherein at least one of the first and
second plates comprises an apertured polymeric film.
4. The method of claim 3, wherein the first and second plates are
formed of a folded sheet of apertured polymeric film.
5. A method of using a plurality of fluid management device in a
mammalian body to collect a plurality of volumes of bodily fluids,
the method comprising the steps of: a) providing a first fluid
management device comprising: i) at least one fluid transport
element comprising: A) a first plate having an outwardly oriented
surface and an inwardly oriented surface; B) a second plate coupled
to the first plate that is capable of separating from the first
plate sufficiently to provide inter-plate capillary action, the
second plate having a first surface disposed and maintained in
facing relationship with the inwardly oriented surface of the first
plate and an opposite surface; and ii) a fluid storage element
having a longitudinal axis, the fluid storage element being in
fluid communication with the at least one fluid transport element;
wherein the at least one fluid transport element is bendable about
an axis substantially parallel to the longitudinal axis of the
fluid storage element; b) positioning the first tampon within a
woman's vaginal canal while maintaining at least a portion of a
major surface of the fluid transport element in contact with at
least a portion of an outer surface of the fluid storage element;
c) collecting a first volume of vaginal discharge while holding the
first tampon in position; d) removing the first tampon from the
woman's vaginal canal and subsequently disposing of the first
tampon; e) providing a second tampon comprising: i) at least one
fluid transport element comprising: A) a first plate having an
outwardly oriented surface and an inwardly oriented surface; B) a
second plate coupled to the first plate that is capable of
separating from the first plate sufficiently to provide inter-plate
capillary action, the second plate having a first surface disposed
and maintained in facing relationship with the inwardly oriented
surface of the first plate and an opposite surface; and ii) a fluid
storage element having a longitudinal axis, the fluid storage
element being in fluid communication with the at least one fluid
transport element; wherein the at least one fluid transport element
is bendable about an axis substantially parallel to the
longitudinal axis of the fluid storage element; f) positioning the
second tampon within a woman's vaginal canal while maintaining at
least a portion of a major surface of the fluid transport element
in contact with at least a portion of an outer surface of the fluid
storage element; wherein the at least one fluid transport element
is bendable about an axis substantially parallel to the
longitudinal axis of the fluid storage element; wherein the steps
of positioning and disposing of the first tampon and the steps of
positioning and disposing of the second tampon occur during the
period of menstruation.
6. The method of claim 5, wherein at least one of the first and
second plates comprises an apertured polymeric film.
7. The method of claim 6, wherein the first and second plates are
formed of a folded sheet of apertured polymeric film.
8. The method of claim 5, wherein the step of positioning the first
tampon within a woman's vaginal canal further comprises
manipulating the first tampon to separate a distal portion of the
at least one fluid transport element from the outer surface of the
fluid storage element, whereby the outwardly oriented surface of
the first plate and the opposite surface of the second plate
contact the vaginal walls.
9. The method of claim 5, wherein the at least one fluid transport
element is wrapped convolutedly around the outer surface of the
fluid storage element, and the step of positioning the first tampon
within a woman's vaginal canal further comprises maintaining the at
least one fluid transport element wrapped convolutedly around the
outer surface of the fluid storage element.
10. A method of using a plurality of fluid management device in a
mammalian body to collect a plurality of volumes of bodily fluids,
the method comprising the steps of: a) providing a first fluid
management device comprising: i) a fluid storage element having a
longitudinal axis; and ii) at least one fluid transport element in
fluid communication with the fluid storage element and capable of
interfacing with a mammalian body element to provide a
substantially uninterrupted fluid conduit to the fluid storage
element, wherein a distal portion of the at least one fluid
transport element is capable of extending away from the fluid
storage element; b) positioning the first fluid management device
within a mammalian body while maintaining at least a portion of a
major surface of the fluid transport element in contact with at
least a portion of an outer surface of the fluid storage element;
c) collecting a first volume of bodily fluid that contacts the at
least one fluid transport element and transporting the first volume
to and storing the first volume in the fluid storage element while
holding the first tampon in position; d) removing the first fluid
management device from the mammalian body and subsequently
disposing of the first fluid management device; e) providing a
second fluid management device comprising: i) a fluid storage
element having a longitudinal axis; and ii) at least one fluid
transport element in fluid communication with the fluid storage
element and capable of interfacing with a mammalian body element to
provide a substantially uninterrupted fluid conduit to the fluid
storage element, wherein a distal portion of the at least one fluid
transport element is capable of extending away from the fluid
storage element; f) positioning the second fluid management device
within the mammalian body while maintaining at least a portion of a
major surface of the fluid transport element in contact with at
least a portion of an outer surface of the fluid storage element;
wherein the steps of positioning and disposing of the first fluid
management device and the steps of positioning and disposing of the
second fluid management device occur at least sequentially.
11. The method of claim 10, wherein the step of positioning the
first fluid management device within the mammalian body further
comprises manipulating the first fluid management device to
separate a distal portion of the at least one fluid transport
element from the outer surface of the fluid storage element.
12. The method of claim 10, wherein the at least one fluid
transport element is wrapped convolutedly around the outer surface
of the fluid storage element, and the step of positioning the first
fluid management device within the mammalian body further comprises
maintaining the at least one fluid transport element wrapped
convolutedly around the outer surface of the fluid storage
element.
13. The method of claim 10, wherein the at least one fluid
transport element comprises materials selected from the group
consisting of apertured polymeric film, coated fibrous webs,
calendered meltblown, and combinations thereof.
14. A method of capturing bodily fluid in a mammalian body, the
method comprising the steps of: a) providing a fluid management
device comprising: i) a fluid storage element having a longitudinal
axis; and ii) at least one fluid transport element in fluid
communication with the fluid storage element and capable of
interfacing with a mammalian body element to provide a
substantially uninterrupted fluid conduit to the fluid storage
element, wherein a distal portion of the at least one fluid
transport element is capable of extending away from the fluid
storage element; and b) inserting the fluid management device into
the mammalian body; and c) transporting bodily fluid that is
exposed to the at least one fluid transport element to the fluid
storage element where the fluid is stored.
15. The method of claim 14, wherein the at least one fluid
transport element comprises materials selected from the group
consisting of apertured polymeric film, coated fibrous webs,
calendered meltblown, and combinations thereof.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This invention is related to the following copending
applications filed on even date herewith: "Intravaginal Device with
Fluid Acquisition Plates" (U.S. Ser. No. 60/572,054; Atty Docket
No. PPC-5073), "Intravaginal Device with Fluid Acquisition Plates
and Method of Making" (U.S. Ser. No. 60/572,055; Atty Docket No.
PPC-5072), "Fluid Management Device with Fluid Transport Element
for use within a Body" (U.S. Ser. No. 10/847,951; Atty Docket No.
PPC-5071), "Tampon with Flexible Panels" (U.S. Ser. No. 10/848,257;
Atty Docket No. PPC-5074), "Method of Using an Intravaginal Device
with Fluid Transport Plates" (U.S. Ser. No. 10/838,208; Atty Docket
No. PPC-5075), and "Intravaginal Device with Fluid Acquisition
Plates" (U.S. Ser. No. 10/847,952; Atty Docket No. PPC-5070), the
content of each of which is incorporated herein.
FIELD OF THE INVENTION
[0002] The present invention relates to methods of capturing and
storing bodily fluid intravaginally and devices that may be used
for such purposes. More particularly, the present invention relates
to a method of capturing bodily fluid intravaginally via a fluid
transport element and transporting the bodily fluid to a fluid
storage element where the fluid is stored.
BACKGROUND OF THE INVENTION
[0003] Devices for intravaginally capturing and storing bodily
fluid are commercially available and known in the literature.
Intravaginal tampons are the most common example of such devices.
Commercially available tampons are generally compressed cylindrical
masses of absorbent fibers that may be over-wrapped with an
absorbent or nonabsorbent cover layer.
[0004] The tampon is inserted into the human vagina and retained
there for a time for the purpose of capturing and storing
intravaginal bodily fluids, most commonly menstrual fluid. As
intravaginal bodily fluid contacts the tampon, it should be
absorbed and retained by the absorbent material of the tampon.
After a time, the tampon and its retained fluid is removed and
disposed, and if necessary, another tampon is inserted.
[0005] A drawback often encountered with commercially available
tampons is the tendency toward premature failure, which may be
defined as bodily fluid leakage from the vagina while the tampon is
in place, and before the tampon is completely saturated with the
bodily fluid. The patent art typically describes a problem believed
to occur that an unexpanded, compressed tampon is unable to
immediately absorb fluid. Therefore, it presumes that premature
leakage may occur when bodily fluid contacts a portion of the
compressed tampon, and the fluid is not readily absorbed. The
bodily fluid may bypass the tampon.
[0006] To overcome this problem of premature leakage, extra
elements have been incorporated into a basic tampon to try to
direct and control the flow of fluid toward the absorbent core.
[0007] For example, U.S. Pat. No. 4,212,301 (Johnson) discloses a
unitary constructed digital tampon having a lower portion
compressed preferably in the radial direction to form a rigid,
rod-like element, which provides a central rigidified elongated
core and an upper portion left substantially uncompressed. After
insertion, the uncompressed portion may be manipulated to contact
the vaginal wall to provide an immediate seal against side leakage.
The uncompressed portion allows for high absorbent capacity
immediately upon insertion. While this tampon may allow for a
certain amount of protection from bypass leakage, the uncompressed
portion may become saturated before the compressed portion has a
chance to expand and become absorbent.
[0008] U.S. Pat. No. 6,358,235 (Osborn et al.) discloses a "hollow"
bag-like tampon that may have an interior projection made from
highly compressed absorbent material. The interior projection is
preferably attached to the inside surface of the head of the
tampon. The hollow tampon portion may include at least one pleat in
the absorbent outer surface and is soft and conformable. The tampon
is not pre-compressed to the point where the fibers temporarily
"set" and re-expand upon the absorption of fluid. The absorbent
portions of the tampon can saturate locally, which leads to bypass
leakage.
[0009] U.S. Pat. No. 6,177,608 (Weinstrauch) discloses a tampon
having nonwoven barrier strips which are outwardly spreadable from
the tampon surface to reliably close the free spaces believed to
exist within a vaginal cavity. The nonwoven barrier strips extend
about the tampon in a circumferential direction at the surface or
in a helical configuration about the tampon and purportedly conduct
menstrual fluid toward the tampon surface. The nonwoven barrier
strips are attached to the cover by means of gluing, heat sealing,
needle punching, embossing or the like and form pleats. The
nonwoven barrier strips are attached to the tampon blank and the
blank is embossed, forming grooves extending in a longitudinal
direction. While this tampon purports to direct fluid to the core,
it attempts to achieve this by forming pockets of absorbent
nonwoven fabric. In order to function, it appears that these
pockets would have to be opened during use to allow fluid to enter.
However, based upon current understandings of vaginal pressures, it
is not understood how the described structure could form such an
opened volume.
[0010] U.S. Pat. No. 6,206,867 (Osborn) suggests that a desirable
tampon has at least a portion of which is dry expanding to cover a
significant portion of the vaginal interior immediately upon
deployment. To address this desire, it discloses a tampon having a
compressed central absorbent core having at least one flexible
panel attached along a portion of the side surface of the core. The
flexible panel appears to provide the "dry-expanding" function, and
it extends outwardly from the core away from the point of
attachment. The flexible panel contacts the inner surfaces of the
vagina when the tampon is in place and purportedly directs fluid
toward the absorbent core. The flexible panel is typically attached
to the pledget prior to compression of the pledget to form the
absorbent core and remains in an uncompressed state.
[0011] U.S. Pat. No. 5,817,077 (Foley et al.) discloses a method of
preserving natural moisture of vaginal epithelial tissue while a
using a tampon where the tampon has an initial capillary suction
pressure at the outer surface of less than about 40 mm Hg. This
allows the tampon to absorb vaginal secretions without
substantially drying the vaginal epithelial tissue. The multiple
cover layers can be used to increase the thickness of the cover
material. While this represents a significant advancement in the
art, this invention does not address by-pass leakage.
[0012] Additionally, U.S. Pat. No. 5,545,155 (Hseih et al.)
discloses an external absorbent article that has a set of plates
separated by spacer elements. The plates may be treated to affect
wettability so that fluid will flow easily across the surface.
Extending through the upper plate is a plurality of openings, which
allow fluid to flow with little restriction into the space between
the upper and lower plates. When the fluid flows downward in the
z-direction from the upper plate to the lower plate, it will then
flow laterally in the x- and y-directions. Therefore, an external
absorbent article can contain fluid gushes, but it does not appear
to address the problems relating in particular to intravaginal
devices, such as a tampon.
[0013] Still others have created density differences within the
absorbent structure of the tampon to try to encourage fluid
transport within the tampon's absorbent structure. These density
differences may allow the tampon to absorb somewhat more fluid, but
premature leakage still occurs.
[0014] A further attempt to solve the problem of premature tampon
leakage has been to create holes of different sizes within the
tampon cover. The areas with the larger holes may absorb more
fluid, but the areas with the smaller holes are limited in the
amount of fluid that they can absorb, and premature leakage may
still occur.
[0015] While the prior art is replete with examples of sanitary
protection articles that capture bodily fluids both externally and
intravaginally, these examples do not overcome the problem of
premature failure often identified as by-pass leakage that commonly
occurs while using internal sanitary protection devices. Many
solutions to this problem have involved increasing the rate of
expansion of a highly compressed absorbent article.
[0016] Therefore, a need exists for a method of capturing and
storing intravaginal bodily fluid in such a manner that reduces
premature leakage and utilizes the absorbent capacity of an
intravaginal absorbent device.
SUMMARY OF THE INVENTION
[0017] In one aspect of the invention, a method is described for
capturing bodily fluid intravaginally. The method involves
providing an intravaginal device having at least one fluid
transport element capable of interfacing with a body element to
provide a substantially uninterrupted fluid conduit to a fluid
storage element in fluid communication therewith. The distal
portion of the at least one fluid transport element is capable of
extending away from the fluid storage element. The fluid transport
element is bendable about an axis substantially parallel to the
longitudinal axis of the fluid storage element and the fluid
transport element being positioned within a human vagina.
[0018] Intravaginal bodily fluid is exposed to the at least one
transport element and is transported between the at least one
transport element and the body element by inter-plate capillary
action to the fluid storage element, where the fluid is stored.
[0019] Other aspects and features of the present invention will
become apparent to those ordinarily skilled in the art upon review
of the following description of specific embodiments of the
invention in conjunction with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWING
[0020] FIG. 1a shows a side elevation of an fluid management device
having rod-like fluid transport elements extending from the fluid
storage element.
[0021] FIG. 1b shows a transverse cross-section of the fluid
transport elements of FIG. 1a along line 1b-1b.
[0022] FIG. 2 shows a side elevation of an alternative embodiment
of an fluid management device having capillary tube fluid transport
elements extending from the fluid storage element.
[0023] FIG. 3a shows a side elevation of an alternative embodiment
of an fluid management device having a pair of fluid transport
elements formed as extensions of a cover.
[0024] FIG. 3b shows a transverse cross-section of 3a along line
3b-3b.
[0025] FIG. 4 shows a transverse cross-section of a human vagina
with a tampon according to FIG. 3a disposed therein with one fluid
transport element extending away from the fluid storage
element.
[0026] FIG. 5a shows a side elevation of an fluid management device
having a pair of fluid transport elements formed as extensions of a
cover.
[0027] FIG. 5b shows a transverse cross-section of the device in 5a
along line 5b-5b.
[0028] FIG. 5c shows the transverse cross-section shown in 5b, l
after the introduction of a fluid between the plates of the fluid
transport element.
[0029] FIGS. 6a-c show enlarged cross-sections of alternate
embodiments of fluid transport elements of the present invention
formed of polymeric apertured formed film having differing
orientations of the formed film plates.
[0030] FIG. 7 shows an enlarged cross-section of an alternate
embodiment of a fluid transport element of the present invention
having nubbles to separate a set of film plates.
[0031] FIGS. 8a-e show various aspects and orientations of an
intravaginal device of the present invention.
[0032] FIG. 8a: Side view of alternate embodiment with lateral
parallel plates.
[0033] FIG. 8b: Transverse cross-section 8a.
[0034] FIG. 8c: Transverse cross-section of alternate embodiment
with parallel plates formed by cover pleats.
[0035] FIG. 8d: Transverse cross-section of alternate embodiment
with parallel plates partially extending into storage element.
[0036] FIG. 8e: Side view of alternate embodiment with multiple
extending parallel plates.
[0037] FIG. 9 shows a transverse cross-section of an alternate
embodiment with layered fluid transport elements substantially
contained within the fluid storage element.
[0038] FIG. 10a shows a side view of an alternate embodiment with
fluid transport elements substantially contained within the fluid
storage element and extending to its outer surface.
[0039] FIG. 10b shows an axial cross-section along 10b-10b of FIG.
10a.
[0040] FIG. 11 shows a transverse cross-section of an alternate
embodiment having a pair of fluid transport elements partially
extending into the storage element.
[0041] FIG. 12 shows a side view of an alternate embodiment with
multiple fluid transport elements extending from the fluid storage
element in planes substantially perpendicular to its longitudinal
axis.
[0042] FIG. 13 shows a further alternate embodiment having a
continuous plate rolled up on itself to form a series of
convolutedly wound plates.
[0043] FIG. 14 shows a transverse cross-section of a human vagina
with a tampon according to FIG. 8b disposed therein with the fluid
transport elements remaining wrapped around the fluid storage
element.
[0044] FIG. 15a shows a side elevation of an alternate embodiment
of the present invention in which fluid transport elements connect
a plurality of fluid storage elements.
[0045] FIG. 15b shows a transverse cross-section along line
15b-15b. in FIG. 15a.
[0046] FIG. 16 shows an axial cross-section of an alternative
embodiment of a device according to the present invention.
[0047] FIG. 17 shows a cross-section of a device having fluid
transport elements folded in an accordion-like manner.
[0048] FIG. 18 shows a wrapped tampon packaged within an
applicator.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0049] As used herein in the Specification and the Claims, the term
"bodily fluid" and variants thereof mean liquids that are produced
by, secreted by, emanate from, and/or discharged from a human
body.
[0050] As used herein in the Specification and the Claims, the term
"fluids" and variants thereof relate to liquids, and especially
bodily fluids.
[0051] As used herein in the Specification and the Claims, the term
"sheet" and variants thereof relate to a portion of something that
is thin in comparison to its length and breadth.
[0052] As used herein in the Specification and the Claims, the term
"parallel plate" and variants thereof relate to a system of at
least two relatively parallel sheets that are capable of moving
fluids through inter-plate capillary action. The individual
"plates" in the system may be flexible and/or resilient in order to
move within their environment. However, they may be maintained in a
substantially facing relationship with relatively constant
separation at least in a localized portion of their structure (as
compared with their relative length and width). Thus, two sheets
could be fluted, but if the flutes are "nested", the sheets would
generally remain generally parallel in any given localized
portion.
[0053] As used herein in the Specification and the Claims, the term
"inter-plate capillary action" and variants thereof mean the
movement of fluid due to a pressure difference across a liquid-air
meniscus created within a gap between two substantially parallel
plates. The two plates need not be held apart a specific distance,
although they should be separable to allow fluid to move between
them by inter-plate capillary action. A general equation providing
the rise of a fluid between parallel plates is reported as:
h = 2 .sigma. * cos .theta. .rho. * g * d ##EQU00001##
[0054] in which:
[0055] h is rise of fluid between plates
[0056] .sigma. is the surface tension of fluid in contact
w/plate
[0057] .theta. is contact angle
[0058] .rho. is density
[0059] d is distance between plates, and
[0060] g is the gravitational constant
[0061] Therefore, as long as the contact angle, .theta., is less
than 90.degree., there will be some capillary attraction.
[0062] As used herein in the Specification and the Claims, the term
"porous medium" and variants thereof relates to a connected
3-dimensional solid matrix with a highly ramified network of pores
and pore throats in which fluids may flow.
[0063] As used herein, the term "separable plates" means any
condition of separation of the first plate and the second plate,
which allows fluid to move between the plates. This includes
situations in which facing surfaces of adjacent first and second
plates are touching one another in portions of or across
substantially all of their facing surfaces. This also includes
situations in which the facing surfaces of the adjacent first and
second plates are separably joined together such that upon contact
with fluid, the surfaces separate enough to provide for fluid to
move between them. This further includes situations in which facing
surfaces of adjacent first and second plates are joined together,
as long as fluid may still move freely between the surfaces.
[0064] As used herein in the Specification and the Claims, the term
"in fluid communication" and variants thereof relate to elements
that are arranged and configured to allow fluid to move
therebetween. The fluid movement may be by interfiber capillary
movement, intrafiber capillary movement, osmotic pressure,
interplate capillary action, mechanical channeling, and the
like.
[0065] As used herein in the Specification and the Claims, the term
"coupled" and variants thereof relate to the relationship between
portions of an integral structure that are either portions of the
same material (e.g., two portions of a folded sheet) or are
materials that are joined together (e.g., two separate sheets that
are bonded together).
[0066] As used herein in the Specification and the Claims, the term
"fluid-permeable cover" and variants thereof relates to materials
that cover or enclose surfaces of the device and reduce the ability
of portions (e.g., fibers and the like) from becoming separated of
the device and left behind upon removal. The term and variants
thereof include, without limitation, sheet-like materials, such as
apertured films and woven and non-woven fibrous webs, surface
treatments, such as coatings or cover layers of integrating
materials, such as binders and thermobondable fibers, and the
like.
[0067] Referring to FIGS. 1a & 1b, one embodiment of this
invention provides an fluid management device 10 having a plurality
of fluid transport elements 12 (four are shown in FIG. 1a) in the
form of flexible rods, preferably with a shaped cross-section as
shown in FIG. 1b. These flexible provide a substantially continuous
fluid path to the fluid storage element 14. The device may also
include a withdrawal mechanism, such as a string 16. When inserted,
the fluid transport elements 12 can create a substantially
continuous fluid path in the notch 18 between the arms 20.
[0068] An alternate embodiment having a plurality of capillary
tubes 12' is illustrated in FIG. 2. These tubes 12' also provide a
substantially continuous fluid path to the fluid storage element
14'.
[0069] Yet another alternate embodiment, illustrated in FIGS. 3a
& 3b, provides an fluid management device 10 having at least
one fluid transport element 12'' in fluid communication with a
fluid storage element 14'' (FIGS. 3a & 3b show two fluid
transport elements 12'' located on opposite sides of the fluid
storage element 14''). The device may also include a fluid transfer
layer 22 to move collected fluid about the fluid storage element
14''. The fluid transport element 12'' has at least one plate 24
that has a distal portion 26 that is capable of extending away from
the fluid storage element 14''. When inserted, the at least one
plate 24 can provide two surfaces that can interact with vaginal
walls "W" to create two sets of parallel plates as shown in FIG.
4.
[0070] As mentioned above, the fluid management device 10 of the
present invention may include a transfer or distribution layer 22.
The transfer layer or distribution layer, if present, is generally
positioned as an outer layer of the fluid storage element 14'',
although it may in turn be enclosed by a fluid-pervious cover 28,
and the transfer layer usually directly contacts the fluid storage
element. If included, the transfer layer may be made of any known
material that will take up fluid and then distribute and release it
to an adjacent absorbent layer for storage. Transfer layers have a
relatively open structure that allows for movement of fluid within
the layer. Suitable materials for such transfer layers include
fibrous webs, resilient foams, and the like.
[0071] The transfer layer provides a means of receiving bodily
fluid from the fluid transport element and holding it until the
fluid storage element has an opportunity to receive the fluid. The
transfer layer is, preferably, more dense than the fluid-pervious
cover layer and has a larger proportion of smaller pores than does
the cover layer. These attributes allow the transfer layer to
contain bodily fluid and hold it away from the outer side of the
cover layer, thereby preventing the fluid from re-wetting the cover
layer and its outer surface. However, the transfer layer is
preferably not so dense as to prevent the passage of the fluid
through the transfer layer and into the underlying fluid storage
element.
[0072] The transfer layer may include various materials, including,
for example, fibrous webs, resilient foams, and the like. The
transfer layer may include cellulose fibers such as from wood pulp,
single component or bicomponent fibers that include thermoplastic
materials (such as, polyester, polypropylene, polyethylene, among
others) in fiber or other forms, rayon, organic binders (such as,
copolymers of vinyl, acrylic and/or other monomers that may be
coated onto thermoplastic fibers or otherwise incorporated into the
transfer layer) among other materials known to the art. The
transfer layer may, for example, have-a basis weight in a range
from about 40 gsm to about 120 gsm, a thickness in a range from
about 0.5 mm to about 4 mm, a density in a range from about 0.03
g/cc to about 0.15 g/cc.
[0073] The mass of materials making up the transfer layer may be
absorbent, although the materials themselves are not absorbent.
Thus, transfer layers that are made of hydrophobic, nonabsorbent
fibers may be able to accept large volumes of fluid into interfiber
void spaces while the fibers themselves do not absorb any
significant quantities of fluid. Likewise, open-celled foam
structures that are made from nonabsorbent materials may also
absorb fluid into the cells of the foam. The walls of the cells,
however, do not absorb any fluid. The cumulative spaces within the
transfer layer, i.e., the interfiber void spaces in the fibrous
transfer layer or the open cells in the foam transfer layer,
function much like a container to hold fluid.
[0074] Typically, transfer layer fibrous webs are made of
resilient, nonabsorbent materials to provide void volume and to
allow for free movement of fluid through the structure. Transfer
layers that are made from webs of mostly absorbent fibers absorb
the fluid as it enters the structure and do not distribute it
throughout the rest of the structure as efficiently as webs
containing non-absorbent materials. Transfer layer fibrous webs
that include nonabsorbent materials are expected to provide void
volume and to allow for more free movement of fluid through the
structure. Examples of such materials include polypropylene,
polyethylene, polyester, bicomponent materials, nylon and mixtures
or combinations thereof. Alternative materials for transfer layers
include apertured film; it can be any other nonwoven material, such
as, foam or netting, which transports fluid and in combination with
the cover, may provide masking of the fluid storage element.
[0075] A further alternate embodiment is shown in FIGS. 5a-5c in
which a intravaginal device 50 has at least one fluid transport
element 52 in fluid communication with a fluid storage element 54
(FIGS. 5a-5c show two fluid transport elements 52 located on
opposite sides of the fluid storage element 54). The device may
also include a withdrawal mechanism, such as a string 56. The fluid
transport element has at least a first plate 58 and a second plate
60. The first and second plates combine to provide a set of
parallel plates, and the fluid transport elements 52 are shown as
extending radially away from the fluid storage element 54.
Additional plates may also be incorporated into each fluid
transport element 52.
[0076] The plates are arranged and configured to allow the
introduction of bodily fluid 62 to separate a plate from adjacent
plate(s) (FIG. 5c). At least one opening 64 allows the introduction
of bodily fluids 62. Optionally, one or more spacer elements 66 can
be inserted to establish and to maintain space between adjacent
plates.
[0077] FIG. 5b shows a pair of parallel plates prior to the
introduction of a fluid. In this view, the facing surfaces of the
adjacent plates 58, 60 are in contact. On the other hand, FIG. 5c
shows the set of parallel plates separated by a bodily fluid 62,
providing an inter-plate capillary gap 68 between the inwardly
oriented surface 70 of the first plate 58 and the first surface 72
of the second plate 60. This inter-plate capillary gap 68 is
sufficient to provide inter-plate capillary action to allow the
fluid transport element 52 to acquire, to spread, and to move
bodily fluids 62 from the vagina to the fluid storage element 54.
The first plate 58 also has an outwardly oriented surface 74, and
the second plate 60 also has an opposite surface 76.
[0078] In each of these embodiments, a distal portion 78 of the
fluid transport element 52 is capable of extending away from the
fluid storage element 54 and thereby creating a substantially
uninterrupted fluid conduit from a fluid source to the fluid
storage element.
[0079] The plates 58, 60 can be made of almost any hydrophobic or
hydrophilic material, preferably sheet-like. The thickness of each
plate is not critical. However, it can preferably be selected from
the range of from about 0.005 to about 0.050 inch. The materials of
construction and the thickness of the plates should be designed so
that they are sufficiently stiff and/or resistant to wet collapse
when exposed to fluid.
[0080] In particular, materials useful for forming the fluid
transport element may have properties such as thermobondability to
provide means to incorporate it into the fluid management device. A
representative, non-limiting list of useful materials includes
polyolefins, such as polypropylene and polyethylene; polyolefin
copolymers, such as ethylenevinyl acetate ("EVA"),
ethylene-propylene, ethyleneacrylates, and ethylene-acrylic acid
and salts thereof; halogenated polymers; polyesters and polyester
copolymers; polyamides and polyamide copolymers; polyurethanes and
polyurethane copolymers; polystyrenes and polystyrene copolymers;
and the like. The fluid transport element may also be
micro-embossed or apertured. Examples of films having apertures
include for example, three-dimensional apertured films, as
disclosed in Thompson, U.S. Pat. No. 3,929,135, and Turi et al,
U.S. Pat. No. 5,567,376, as well as two-dimensional reticulated
film, such as that described in Kelly, U.S. Pat. No. 4,381,326.
FIGS. 6a-6c illustrate three combinations of the apertured film of
Thompson.
[0081] It may be helpful to keep the exposed surface of the fluid
transport element as smooth as possible. It may also be helpful to
provide it with a low coefficient of friction. These
characteristics may provide at least two benefits: (1) the force
required to insert the intravaginal device is reduced, and (2) it
reduces the damage otherwise caused by scraping of soft, tender
vaginal tissue during insertion, wearing and removal. Plates 58 and
60 may be made from the same material or alternately, plate 58 may
be made from a different material than plate 60.
[0082] The parallel plates can have any physical structure to
provide a resistance to fluid flow vector in the direction parallel
to the inwardly oriented surface 70 of the first plate 58 and the
first surface 72 of the second plate 60 that is less than the
resistance to fluid flow vector in the direction perpendicular to
the plates. Preferably, the plates are made from any relatively
smooth material. Suitable materials include, without limitation,
foil, waxed sheets, film, apertured film, and the like. For example
fibrous or porous sheets may be coated with a substantially
continuous coating to provide a film- or foil-like surface. Each
plate does not need to be made of the same material as its
corresponding parallel plate. For instance the first plate 58 could
be an apertured film to allow fluid to enter and the second plate
60 could be a solid film to move fluid to the storage element. Of
course, the parallel plates must be able to transport fluid between
the two layers.
[0083] The fluid transport element 52 should be strong enough to
prevent rupturing during handling, insertion, and removal and to
withstand vaginal pressures during use.
[0084] It is preferable that the surface of at least one of the
plates of the fluid transport element 52 be sufficiently wettable
by the bodily fluids that the intravaginal device 50 is intended to
collect (this results largely from a correlation of the surface
energy of the plate surface and the bodily fluid(s)). Thus, the
bodily fluid will easily wet the plate, and capillarity between the
plates will draw these bodily fluids from a source to a fluid
storage element that is in fluid communication with the fluid
transport element.
[0085] Surface treatments can be used to modify the surface energy
of the plates 58, 60. In a preferred embodiment a surfactant is
applied to increase the wettability of the outer or inner surfaces
of at least one plate. This will increase the rate at which the
bodily fluids are drawn to and spread by plates, either between two
plates or between a plate and the vaginal wall. The surfactant can
be applied uniformly to either the inner or outer surfaces or it
could be applied with varying coating weights in different
regions.
[0086] A useful measure to determine the wettability of a plate
surface is its contact angle with 1.0% saline. Preferably, the
contact angle with 1.0% saline is less than about 90 degrees.
[0087] The fluid transport element 52 should be strong enough to
prevent rupturing during handling, insertion, and removal and to
withstand vaginal pressures during use.
[0088] It is preferable that the surface of at least one of the
plates of the fluid transport element 52 be sufficiently wettable
by the bodily fluids that the intravaginal device 50 is intended to
collect (this results largely from a correlation of the surface
energy of the plate surface and the bodily fluid(s)). Thus, the
bodily fluid will easily wet the plate, and capillarity between the
plates will draw these bodily fluids from a source to a fluid
storage element that is in fluid communication with the fluid
transport element.
[0089] Surface treatments can be used to modify the surface energy
of the plates 58, 60. In a preferred embodiment a surfactant is
applied to increase the wettability of the outer or inner surfaces
of at least one plate. This will increase the rate at which the
bodily fluids are drawn to and spread by plates, either between two
plates or between a plate and the vaginal wall. The surfactant can
be applied uniformly to either the inner or outer surfaces or it
could be applied with varying coating weights in different
regions.
[0090] A useful measure to determine the wettability of a plate
surface is its contact angle with 1.0% saline. Preferably, the
contact angle with 1.0% saline is less than about 90 degrees.
[0091] The spacer elements 66 can be separate elements applied to
one or more of the plates, or they can be integral portions of a
plate that extend away from one of the plate's major surfaces. A
representative list of such separate spacer elements includes,
without limitation, foamed materials such as polystyrene foam;
particles such as beads and crystals; discontinuous material such
as netting, thread, wax, adhesive, any discrete element that causes
a separation between the plates and the like.
[0092] Integral spacer elements 66 can be thickened portions of the
plate material or deformations of the plate material. A
representative list of such an integral spacer element includes,
without limitation, nubbles, embossments, corrugations,
deformations, and the like. Included in this definition are surface
treatments that permanently bond a secondary material to a surface
of a first. One example of a deformation is provided as the
sidewalls 80 of a "three-dimensional" polymeric apertured formed
film material shown in FIGS. 6a-6c. FIG. 6a shows the sidewalls 80
of inwardly facing surface 70 and the first surface 72 of the
second plate 60 in facing relationship. FIG. 6b shows a second
arrangement of the apertured film plates where the sidewalls 80 are
nested. FIG. 6c illustrates a third configuration of the apertured
film plates where the sidewalls 80 are on the inwardly facing
surface 70 of the first plate 58, and sidewalls 80 are on the
opposite surface 76 of the second plate 60.
[0093] In another example, shown in FIG. 7, the spacer elements are
nubbles 82 extending from the inward surface 70 of the first plate
58 and resting on the first surface 72 of the second plate 60.
[0094] In order to maintain stability against sliding of the plates
with respect to each other and changing of the space between them,
it is acceptable, and may be preferable, to secure some local areas
of contact between the spacer elements 66 and the adjacent plate or
even between spacer elements 66 of two adjacent plates. The plates
may be secured through means known to those of ordinary skill in
the art. A representative list of such securing means includes,
without limitation, thermobonding, adhering, crimping, embossing,
ultrasonic bonding or welding, and the like. The adhesive may be
applied between the spacer elements and the first and second
plates. Preferably, the adhesive is wettable.
[0095] The at least one opening 64 can be at the edge of the
plates, e.g., edges of adjacent plates are separated or plates
themselves may have at least one opening. The openings need not be
uniform. For example, one opening 64 may be located at the edge of
the plates and a plurality of smaller openings or apertures 84 can
be distributed throughout one or more plate. Preferably, each plate
has a plurality of openings distributed throughout. An example of
openings distributed throughout is an apertured film. The
distribution can be uniform or arranged to provide regions of
higher open area and regions of lower open area.
[0096] A plurality of openings or apertures 84 may extend through
at least one of the first and second plates 58, 60. These apertures
84 may extend completely through the plate and may be present in
both of the plates. The apertures 84 allow fluid that contacts the
outward surface 74 of the first plate 58 or the opposite surface 76
of the second plate 60 to flow into the inter-plate capillary gap
68 between the plates with as little restriction as possible. In
the example of apertured film, it is preferred that the total
surface area of the plate occupied by the openings is from about 5%
to preferably about 50%. More preferably, it will be from about 25%
to about 45%. Having this much open area formed in a plate will
allow fluid that is deposited on that plate to easily flow into the
inter-plate capillary gap 68.
[0097] It is preferable that any individual opening 64, 84 is large
enough to easily pass any highly viscous material, including
menstrual fluid. While the geometry of the openings is not
critical, the opening 64, 84 should be sized sufficient to allow
easy passage of non-absorbable material. If the apertures 84 are
not circular, then the measurement should be made across the
narrowest part of the opening, which would be most restrictive to
the flow of non-absorbable material.
[0098] In the example of unapertured film that has an opening 64 at
the ends of the plates 58, 60, the size of the opening 64 is a
result of the fluid's ability to separate the plates.
[0099] It is preferred that the apertures 84 are large enough to
let viscous fluid pass through but not too large to create too
rough of a surface as to compromise the wearer's comfort. A
preferred aperture 84 is circular and is between 10 mils and 40
mils in diameter. Most preferably it is between 18 mils and 27
mils.
[0100] Open area may be determined by using image analysis to
measure the relative percentages of apertured and unapertured, or
land, areas. Essentially image analysis converts an optical image
from a light microscope into an electronic signal suitable for
processing. An electronic beam scans the image, line-by-line. As
each line is scanned, an output signal changes according to
illumination. White areas produce a relatively high voltage and
black areas a relatively low voltage. An image of the apertured
formed film is produced and, in that image, the holes are white,
while the solid areas of thermoplastic material are at various
levels of gray. The more dense the solid area, the darker the gray
area produced. Each line of the image that is measured is divided
into sampling points or pixels. The following equipment can be used
to carry out the analysis described above: a Quantimet Q520 Image
Analyzer (with v. 5.02B software and Grey Store Option), sold by
LEICA/Cambridge Instruments Ltd., in conjunction with an Olympus
SZH Microscope with a transmitted light base, a plan 1.0.times.
objective, and a 2.50.times. eyepiece. The image can be produced
with a DAGE MTI CCD72 video camera.
[0101] A representative piece of each material to be analyzed is
placed on the microscope stage and sharply imaged on the video
screen at a microscope zoom setting of 10.times.. The open area is
determined from field measurements of representative areas. The
Quantimet program output reports mean value and standard deviation
for each sample.
[0102] Referring to FIGS. 8a-18, the first and second plates 58, 60
may be separate elements (i.e, adjacent to each other but not
necessarily joined) or they may be extensions of the same
sheet-like material, e.g., formed by a fold in a sheet of material
(as shown in FIGS. 8a-8e). In such a folded embodiment, the
material is folded to form a pleat with the first and second plates
facing each other.
[0103] A preferred embodiment with pleats is shown in FIGS. 8a-8e,
where the pleats 86 are folds in the fluid-pervious cover material
88. The pleats 86 create plates that are bendable about an infinite
number of bending axes (b.sub.1-i-b.sub.1-i) that are substantially
parallel to the longitudinal axis (X-X) of the product, which
longitudinal axis extends through the insertion end 90 and
withdrawal end 92. These bending axes allow the plates to wrap
around the product, either partially or completely. One such
bending axis (b.sub.1-b.sub.1) is shown in FIG. 8b.
[0104] The fluid transport element 52 is in fluid communication
with the fluid storage element 54 and directs fluid from the vagina
to the storage element 54. Generally, fluid will be directed from
each fluid transport element 52 to a particular region of the fluid
storage element associated with that fluid transport element. Thus,
if the device has only one fluid transport element 52, the fluid
will contact the fluid storage element in one interface 94.
[0105] Therefore, additional fluid transport elements 52 directing
fluid to additional locations of the fluid storage element 54 will
improve the efficient usage of the fluid storage element 54. For
example, two fluid transport elements 52 could be directed to
opposite sides of the fluid storage element 54, as shown in FIGS.
5a-5c. Each additional fluid storage element 5 can direct fluid to
additional interface locations 94 of the fluid storage element 54.
For example, four evenly spaced fluid transport elements 52 allow
fluid to be directed to each quarter of the fluid storage element
54 surface as shown in FIGS. 8a-8e. Five or more elements would
provide even more direct access. This can allow the fluid to
contact the fluid storage element 54 uniformly and help to prevent
or reduce local saturation of the fluid storage element 54.
[0106] While the above description provides for direct fluid
communication between a fluid transport element 52 and the fluid
storage element 54, direct fluid contact is not necessary. There
can be fluid communication through an intermediate element, such as
a porous medium (e.g., a foam or fibrous structure), a hollow tube,
and the like.
[0107] Enlarging the area of the interface 94 between the fluid
transport element 52 and fluid storage element 54 can also help to
maximize the fluid communication. For example, elongating the
interface by increasing the length of the fluid transport element
52 allows more fluid to flow into the fluid storage element 54.
[0108] The fluid transport element 52 may extend in any orientation
from the surface of the fluid storage element 54. It is not
necessary for the fluid transport element to be on the surface of
the fluid storage element.
[0109] The inter-plate capillary gap 68 formed by first and second
plates 58, 60 can terminate at the interface 94 or can extend into
and/or through the fluid storage element 54. An example of the
fluid transport element 52 extending into the fluid storage element
54 is shown in FIG. 7. The parallel plates can have additional
layers on top of them as long as these additional layers allow
fluid to enter the plates. The first and second plates may be
arranged such that they can be extended in a plane that is parallel
to, or even extending through, the longitudinal axis of the device
(e.g., FIGS. 9, 10a, 10b, and 11). Alternately, they may also be
arranged such that they can be extended in a plane that is
perpendicular to the longitudinal axis of the device, or in any
orientation between these extremes (not shown).
[0110] The first and second plates 58, 60 can end at the boundary
of the fluid transport element 52 or can extend into the fluid
storage element 54. FIG. 11 shows two sets of parallel plates
extending into the storage element. The parallel plates can have
additional layers on top of them as long as these additional layers
allow fluid to enter the plates.
[0111] The fluid transport element 52 may be formed to extend from
the surface of the fluid storage element 54 as in FIG. 5a-5c. In an
alternative embodiment, the withdrawal string 56 could be replaced
by a pair or another combination of ribbon-like parallel plates
(not shown).
[0112] The fluid transport element 52 can be made in any convenient
shape, including semicircular, triangular, square, hourglass etc.
Additionally the two plates of the element do not have to be
completely coextensive, as long as they are at least partially in a
facing relationship.
[0113] The parallel plates forming the fluid transport element can
be of any flexibility as long as the material is able to transport
fluid to the fluid storage element while the device is in use. It
is also preferable that the fluid transport element be sufficiently
flexible to provide the user with comfort while inserting, wearing
and removing the device.
[0114] Parallel plates can be held in close proximity to the
storage element in a variety of ways including directly or
indirectly via an additional element to the storage element. A
variety of methods can be used to attach the fluid transport is
element 52 including but not limited to heat, adhesive,
ultrasonics, sewing, and mechanically engaging the fluid storage
element 54. An example of a heat-sealed attachment 96 is shown in
FIG. 8a.
[0115] The fluid transport element(s) 52 can be attached at the
sides, insertion end 90, and/or withdrawal end 92 of the
intravaginal device 50. Additionally, the fluid transport
element(s) 52 may be attached to themselves and not to the storage
element as in a parallel plates bag type covering of the storage
element. The parallel plates could also be attached to the
withdrawal string 56. Additional means of attachment are disclosed
in the commonly-assigned, copending patent applications entitled
"Intravaginal Device with Fluid Acquisition Plates" (U.S. Ser. No.
60/______; Atty Docket No. PPC-5073), "Intravaginal Device with
Fluid Acquisition Plates and Method of Making" (U.S. Ser. No.
60/______; Atty Docket No. PPC-5072), both filed on even date
herewith, the contents of which are herein incorporated by
reference.
[0116] Multiple fluid transport elements can be layered on top of
each other or placed next to each other. FIG. 12 shows a plurality
of fluid transport elements 52 extending from the sides of the
storage element 54 in a plane perpendicular to the axial direction
thereof. These fluid transport elements 52 can be a variety of
lengths and can be on part or the entire surface.
[0117] A further alternate embodiment, shown in FIG. 13, has one
continuous plate 58' rolled up on itself to form a series of
convolutedly wound plates, each having a first surface and a second
surface. The first surface of the plate in one winding of the
device is disposed and maintained in facing relationship with the
second surface of an adjacent winding. The first surface is also
capable of separating from the second surface sufficiently to
provide inter-plate capillary action. In this embodiment, the inner
layers of the winding would also act to store fluid, allowing them
to function as a fluid storage element.
[0118] During use, fluid transport element(s) 12, 52 can take on
many configurations within the vagina. For example, a fluid
transport element 12'' may extend into the vagina away from the
fluid storage element 14'', as shown in FIG. 4. Alternatively, the
fluid transport element(s) 52 may remain wound about the fluid
storage element 54, contacting the vaginal wall "W" only through
the outwardly oriented surface 74 (FIG. 14). In a further
alternative embodiment, the fluid transport element(s) 52 may be
substantially contained within the fluid storage element 54 and
thus may not be in contact with the vaginal walls at all. Thus, the
fluid transport element(s) 52 may be completely contained within
the fluid storage element, or it may extend to an outer surface of
the fluid storage element, as shown in FIG. 9. in which the fluid
transport element 52 is disposed only within the fluid storage
element 54). Additionally, as discussed above in reference to FIG.
11, the fluid transport element(s) may extend beyond an outer
surface of the fluid storage element 54.
[0119] The fluid storage element can be any convenient shape
including cylindrical, cup like, hourglass, spherical, etc. It can
be an absorbent or a fluid collection device. It can be in separate
sections with the fluid transport element(s) 52 bridging or
connecting the sections. FIGS. 15a and 15b shows a plurality of
storage elements connected by two fluid transport elements 52''.
FIG. 16 shows two sides of the same unified storage element 54''
bridged by a fluid transport element 52''.
[0120] The fluid storage element 54 can be made of any composition
known in the art, such as compressed fibrous webs, rolled goods,
foam etc. The storage element can be made of any material known in
the art such as cotton, rayon, polyester, superabsorbent material,
etc.
[0121] In one preferred embodiment, the fluid storage element 54 is
an absorbent tampon 50. Absorbent tampons are usually substantially
cylindrical masses of compressed absorbent material having a
central axis and a radius that defines the outer circumferential
surface of the tampon. Such tampons are disclosed in e.g., Haas,
U.S. Pat. No. 1,926,900; Dostal, U.S. Pat. No. 3,811,445; Wolff,
U.S. Pat. No. 3,422,496; Friese et al., U.S. Pat. No. 6,310,296;
Leutwyler et al., U.S. Pat. No. 5,911,712, Truman, U.S. Pat. No.
3,983,875; Agyapong et al., U.S. Pat. No. 6,554,814. Tampons also
usually include a cover (which may include or be replaced by
another surface treatment) and a withdrawal string or other removal
mechanism.
[0122] Absorbent materials useful in the formation of the absorbent
body include fiber, foam, superabsorbent, hydrogels, and the like.
Preferred absorbent material for the present invention includes
foam and fiber. Absorbent foams may include hydrophilic foams,
foams that are readily wetted by aqueous fluids as well as foams in
which the cell walls that form the foam themselves absorb
fluid.
[0123] Fibers may be selected from cellulosic fiber, including
natural fibers (such as cotton, wood pulp, jute, and the like) and
synthetic fibers (such as regenerated cellulose, cellulose nitrate,
cellulose acetate, rayon, polyester, polyvinyl alcohol, polyolefin,
polyamine, polyamide, polyacrylonitrile, and the like).
[0124] The fluid storage element may also be in the form of a
collection cup. Examples of such devices are disclosed in Zoller,
U.S. Pat. No. 3,845,766 and Contente et al., U.S. 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 devices may be folded, or otherwise
manipulated, to facilitate insertion into the vaginal canal.
[0125] A withdrawal mechanism, such as withdrawal string 16, 56, is
preferably joined to the fluid management device 10, 50 for removal
after use. The withdrawal mechanism is preferably joined to at
least the fluid storage element 14, 54 and 10 extends beyond at
least its withdrawal end 92. Any of the withdrawal strings
currently known in the art may be used as a suitable withdrawal
mechanism, including without limitation, braided (or twisted) cord,
yarn, etc. In addition, the withdrawal mechanism can take on other
forms such as a ribbon, loop, tab, or the like (including
combinations of currently used mechanisms and these other forms).
For example, several ribbons may be twisted or braided to provide
parallel plates structures.
[0126] Tampons are generally categorized in two classes: applicator
tampons and digital tampons, and a certain amount of dimensional
stability is useful for each type of tampon. Applicator tampons use
a relatively rigid device to contain and protect the tampon prior
to use. To insert the tampon into a body cavity, the applicator
containing the tampon is partially inserted into the body cavity,
and the tampon can be expelled from the applicator into the body
cavity. In contrast, digital tampons do not have an applicator to
help guide them into the body cavity and require sufficient column
strength to allow insertion without using an applicator.
[0127] While the applicator tampon is protected by the rigid
applicator device and the applicator tampon need not as have high a
degree of column strength as a digital tampon, applicator tampons
do require dimensional stability (especially radial) to be
acceptable for use. This dimensional stability provides assurance,
for example, that the tampon will not prematurely grow and split
its packaging material or become wedged in a tampon applicator.
[0128] Further, the fluid management device can be collapsed for
packaging and insertion. For example, at least a portion of a major
surface of the fluid transport element 52, such as the outwardly
oriented surface 74, may be in contact with at least a portion of
an outer surface of the fluid storage element 54. This can be
achieved by wrapping the fluid transport element(s) around the
fluid storage element 54 (as shown in FIG. 8b). Alternatively, the
fluid transport element(s) 52 may be folded or pleated (e.g., in an
accordion-like manner as shown in FIG. 17) against the fluid
storage element 54. The thus-compacted device can then be packaged,
(e.g., within an applicator or alone in a wrapper). FIG. 18 shows a
wrapped tampon within an applicator 98 (in phantom).
[0129] In this invention, the intravaginal device can be used to
capture or store bodily fluid. In particular, a method is provided
for a capturing bodily fluid management device, the device having
at least one fluid transport element capable of interfacing with a
body element to provide a substantially uninterrupted fluid conduit
to a fluid storage element in fluid communication therewith;
wherein a distal portion 78 of the at least one fluid transport
element 52 is capable of extending away from the fluid storage
element 54.
[0130] Further, the invention provides a method of using a
plurality of tampons during a period of menstruation. The user can
obtain an intravaginal device, such as a tampon, as described
hereinabove. She can position a first tampon within her vaginal
canal while maintaining at least a portion of a major surface of
the fluid transport element in contact with at least a portion of
an outer surface of the fluid storage element. The tampon can be
left to collect a first volume of vaginal discharge while holding
the first tampon in position. She can then remove the first tampon
and subsequently dispose of it. The user can then obtain a second,
similar tampon to replace the first. These steps are performed
during a woman's period of menstruation, and they can be repeated
as often as necessary.
[0131] During the insertion of the tampon, the user may choose to
manipulate the tampon 50 to unwrap or allow a distal portion 78 of
the at least one fluid transport element from the outer surface of
the fluid storage element 54. In this manner, the outwardly
oriented surface 74 of the first plate 58 and the opposite surface
76 of the second plate 60 may both contact the vaginal walls "W",
as shown in FIG. 4. Alternately, the user may insert the tampon 50
without significantly disturbing the at least one fluid transport
element 52, and the element will more likely remain as it was
packaged. For example, a tampon having a convolutedly wrapped fluid
transport element may leave it in that position, as shown in FIG.
14.
[0132] Alternately, this invention provides a method for storage of
bodily fluids. The method provides a fluid management device
capable of storing bodily fluid intravaginally, the method
providing a fluid storage element positioned within a human vagina
and having a longitudinal axis and at least one fluid transport
element in fluid communication with the body element, the at least
one fluid transport element bendable about an axis substantially
parallel to the longitudinal axis of the fluid storage element,
whereby bodily fluid within the human vagina is exposed to the
fluid transport element and is transported between the at least one
fluid transport element and the body element interplate capillary
action to the fluid storage element where the fluid is stored.
[0133] The specification and embodiments above are presented to aid
in the complete and non-limiting understanding of the invention
disclosed herein. Since many variations and embodiments of the
invention can be made without departing from its spirit and scope,
the invention resides in the claims hereinafter appended.
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