U.S. patent application number 13/343276 was filed with the patent office on 2012-05-03 for intravaginal device with fluid transport plates and methods of making.
Invention is credited to Curt Binner, Samuel C. Carasso, David J. Chase, Tara Glasgow, Julia K. Iris, David L. Kimball, Erin Marsee, Tony C. Ng.
Application Number | 20120103529 13/343276 |
Document ID | / |
Family ID | 46332234 |
Filed Date | 2012-05-03 |
United States Patent
Application |
20120103529 |
Kind Code |
A1 |
Binner; Curt ; et
al. |
May 3, 2012 |
INTRAVAGINAL DEVICE WITH FLUID TRANSPORT PLATES AND METHODS OF
MAKING
Abstract
Apparatus for producing an intravaginal device includes a
forming tool having an aperture, a male tool having a plurality of
forming blades arranged radially about an aperture, at least one
bonding element, and at least one moveable pushrod. The forming
tool includes a holding plate having a plurality of vacuum ports,
and the aperture of the forming tool is located in the forming
plate. The aperture of the forming tool has a plurality of slots
connected to and extending therefrom. The bonding element is
moveable toward the aperture in the forming tool. The apertures are
aligned along a machine axis to permit the pushrod to move a fluid
storage element through each aperture, the forming blades of the
male tool are aligned with the slots of the forming tool, and guide
edges of the forming blades accommodate a fluid storage element
aligned with the aperture of the male tool.
Inventors: |
Binner; Curt; (Furlong,
PA) ; Carasso; Samuel C.; (Milltown, NJ) ;
Chase; David J.; (Somerville, NJ) ; Marsee; Erin;
(Nicholasville, KY) ; Glasgow; Tara; (Glen Ellyn,
IL) ; Kimball; David L.; (Flemington, NJ) ;
Iris; Julia K.; (North Wales, NJ) ; Ng; Tony C.;
(East Brunswick, NJ) |
Family ID: |
46332234 |
Appl. No.: |
13/343276 |
Filed: |
January 4, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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11661535 |
Mar 26, 2009 |
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PCT/US2005/017113 |
May 13, 2005 |
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13343276 |
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10848257 |
May 14, 2004 |
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11661535 |
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10847951 |
May 14, 2004 |
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10848257 |
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60572055 |
May 14, 2004 |
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Current U.S.
Class: |
156/443 |
Current CPC
Class: |
A61F 13/2051 20130101;
A61F 13/2065 20130101; Y10T 156/1015 20150115; A61F 13/2082
20130101; A61F 13/55175 20130101 |
Class at
Publication: |
156/443 |
International
Class: |
B32B 37/02 20060101
B32B037/02; B32B 38/00 20060101 B32B038/00; B32B 37/06 20060101
B32B037/06 |
Claims
1. Apparatus for producing an intravaginal device comprising: a. a
forming tool comprising: i. a holding plate having a plurality of
vacuum ports formed in a face thereof; ii. a substantially circular
aperture disposed on the plate having a plurality of slots
connected to and extending therefrom; b. a male tool comprising a
plurality of forming blades, each blade having a guide edge,
arranged radially about an aperture; c. At least one bonding
element moveable toward the aperture in the forming tool; and d. at
least one pushrod moveable through the apertures of each of the
forming tool and the male tool; wherein the apertures of the
forming tool and male tool are aligned along a machine axis to
permit the pushrod to move fluid storage element through each
aperture, the forming blades of the male tool are aligned with the
slots of the forming tool, and the guide edges of the forming
blades are arranged and configured to accommodate a fluid storage
element aligned with the aperture of the male tool.
2. Apparatus of claim 1 wherein each forming blade has a pleating
edge engageable with a sheet held on the face of the holding
plate.
3. Apparatus of claim 2 wherein the pleating edge is adjacent the
guide edge.
4. Apparatus of claim 2 wherein the pleating edge is separated from
the guide edge by at least one intermediate portion of the forming
blade.
5. Apparatus of claim 1 wherein the at least one bonding element is
moveable in a plane parallel to the face of the holding plate.
6. Apparatus of claim 5, wherein the at least one bonding element
is moveable to extend into a space between adjacent forming blades
when the forming tool and male tools are in an engaged
position.
7. Apparatus of claim 1 wherein the at least one bonding element is
a thermobonding element.
8. Apparatus of claim 1 wherein the fluid storage element has a
length, and the guide edge of each forming blade has a length that
is not greater than the length of the fluid storage element.
9. Apparatus of claim 1 wherein the fluid storage element has a
length, and the guide edge of each forming blade has a length that
is greater than the length of the fluid storage element.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a divisional of U.S. application Ser.
No. 11/661,535 filed Mar. 26, 2009, which is the national stage
filing under 371 of international application PCT/US2005/017113,
filed May 13, 2005, which claims the benefit of U.S. provisional
application 60/572,055, filed on May 14, 2004, and is a
continuation-in-part of U.S. application Ser. No. 10/848,257, filed
on May 14, 2004, and is a continuation-in-part of U.S. application
Ser. No. 10/847,951, filed on May 14, 2004, the complete
disclosures of which are hereby incorporated herein by reference
for all purposes.
[0002] This invention is related to the following copending
applications filed on even date herewith: "Intravaginal Device with
Fluid Acquisition Plates" (U.S. Ser. No. 60/574,054; Atty Docket
No. PPC-5073), "Intravaginal Device with Fluid Acquisition Plates"
(U.S. Ser. No. 10/847,952; Atty Docket No. PPC-5070), "Fluid
Management Device with Fluid Transport Element for use within a
Body" (U.S. Ser. No. 10/847,951; Atty Docket No. PPC-5071 G-2a),
"Method of Using Intravaginal Device with Fluid Transport Plates"
(U.S. Ser. No. 10/848,347; Atty Docket No. PPC-5076), "Tampon with
Flexible Panels" (U.S. Ser. No. 10/848,257; Atty Docket No.
PPC-5074), and "Method of Using an Intravaginal Device with Fluid
Transport Plates" (U.S. Ser. No. 10/848,208; Atty Docket No.
PPC-5075), the content of each of which is incorporated herein.
FIELD OF THE INVENTION
[0003] The present invention relates to devices for capturing and
storing body fluid intravaginally. More particularly, the present
invention relates to a method of capturing body fluid
intravaginally via a fluid transport element and transporting the
body fluid to a fluid storage element where the fluid is stored.
Additionally, this application relates to methods of making such
devices
BACKGROUND OF THE INVENTION
[0004] Devices for capturing and storing bodily fluid
intravaginally 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.
[0005] 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.
[0006] 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.
[0007] 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.
[0008] 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.
[0009] 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.
[0010] U.S. Pat. No. 6,177,608 (Weinstrauch) discloses a tampon
having nonwoven barrier strips that 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 bonding,
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.
[0011] 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.
[0012] 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.
[0013] 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, this 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.
[0014] 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.
SUMMARY OF THE INVENTION
[0015] We have found a novel way to address the problem of
premature product failure. This invention is not dependent on the
expansion of the compressed absorbent but rather incorporating an
element, which is adaptable to the vagina. In our invention, we
increase the contact area of the absorbent device and thereby
reduce by-pass leakage.
[0016] In one aspect of the invention, an intravaginal device has a
fluid storage element and at least one fluid transport element in
fluid communication with the fluid storage element. The fluid
storage element has a longitudinal axis, an insertion end, and a
withdrawal end. The at least one fluid transport element has a
first plate a second plate coupled to the first plate. The first
plate has an outwardly oriented surface and an inwardly oriented
surface. The second plate has a first surface disposed and
maintained in facing relationship with the inwardly oriented
surface of the first plate and an opposite surface. The second
plate is capable of separating from the first plate sufficiently to
provide inter-plate capillary action. The at least one fluid
transport element is bendable about an axis substantially parallel
to the longitudinal axis of the fluid storage element. The fluid
transport element may substantially envelop the fluid storage
element, and it may be attached to the withdrawal end of the fluid
storage element, on at least one longitudinal side of the fluid
storage element, to itself proximate the withdrawal end of the
fluid storage element, and/or to the withdrawal string.
[0017] In another aspect of the invention, a method of producing an
intravaginal device includes attaching an individual sheet to a
fluid storage element to form at least one fluid transport element
capable of extending radially away from the fluid storage element,
folding the at least one fluid transport element about an axis
parallel to the longitudinal axis of the fluid storage element, and
packaging the resultant intravaginal device. The material from
which the individual sheet is produced has properties useful to
move bodily fluids.
[0018] In still another aspect of the invention, an alternate
method of producing an intravaginal device includes separating an
individual sheet from a supply of material, engaging the individual
sheet with the insertion end of a fluid storage element and with
pleating edges of forming blades, urging the individual sheet
through a forming tool, bonding at least a portion of the
individual sheet to the fluid storage element, folding the at least
one fluid transport element about an axis parallel to the
longitudinal axis of the fluid storage element, and packaging the
resultant intravaginal device. The material from which the
individual sheet is produced has properties useful to move bodily
fluids. Relative movement of the forming tool in relation to the
fluid storage element and the pleating edges of forming blades
urges the individual sheet through the forming tool. Bonding the at
least one portion of the individual sheet forms at least a portion
of the individual sheet into at least one fluid transport element
that is capable of extending radially away from the fluid storage
element.
[0019] In still another aspect of the invention, apparatus for
producing an intravaginal device includes a forming tool, a male
tool, at least one bonding tool, and at least one pushrod. The
forming tool includes a holding plate having a plurality of vacuum
ports formed in a face thereof. A substantially circular aperture
is disposed on the plate and a plurality of slots connects to and
extends from the aperture. The male tool has a plurality of forming
blades. Each forming blade having a guide edge, and the blades are
arranged radially about an aperture in the male tool. The at least
one bonding element is moveable toward the aperture in the forming
tool to engage and bond an individual sheet to a fluid storage
element held within the male tool. The pushrod is moveable through
apertures of the forming tool and male tool, and these apertures
are aligned along a machine axis to permit the pushrod to move
fluid storage element through the apparatus.
[0020] 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
[0021] FIG. 1a shows a side elevation of an intravaginal device
having a fluid transport element in fluid communication with a
fluid storage element.
[0022] FIG. 1b shows a cross-sectional view of the device in FIG.
1a taken along line b-b.
[0023] FIG. 1c shows the transverse cross-section shown in 1b,
after the introduction of a fluid between the plates of the fluid
acquisition element.
[0024] FIG. 2 shows an enlarged cross-section of an embodiment of a
fluid transport element of the present invention having nubbles to
separate a set of film plates.
[0025] FIGS. 3a-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.
[0026] FIGS. 4a-e show various aspects and orientations of an
intravaginal device of the present invention. [0027] FIG. 4a shows
a perspective view of a tampon having a plurality of fluid
transport elements extending therefrom that are formed from a
folded sheet material. [0028] FIG. 4b shows a side elevation of the
tampon with a plurality of fluid transport elements wrapped around
the fluid storage element. [0029] FIG. 4c shows a transverse
cross-section along line 4c-4c in FIG. 4b. [0030] FIG. 4d shows a
side elevation of the tampon of FIG. 4a. [0031] FIG. 4e shows a top
elevation of the tampon of FIG. 4a.
[0032] FIG. 5 shows a transverse cross-section of an alternate
embodiment having a pair of fluid transport elements partially
extending into the storage element.
[0033] FIG. 6a shows a side elevation of an alternate embodiment of
the present invention in which a cover material is bonded to itself
in the form of a bag to form a fluid transport element in fluid
communication with a fluid storage element.
[0034] FIG. 6b shows a cross-sectional view of the device in FIG.
6a taken along line 6b-6b.
[0035] FIG. 7 shows a side elevation of an embodiment of the
present invention in which the fluid transport element envelops the
fluid storage element and is bonded at the withdrawal end to the
withdrawal string.
[0036] FIG. 8 shows a side elevation of an embodiment of the
present invention in which the fluid transport element envelops the
fluid storage element and is bonded to the base of the fluid
storage element.
[0037] FIG. 9 shows a side elevation of an embodiment of the
present invention in which the fluid transport element is attached
to the insertion end of the fluid storage element.
[0038] FIG. 10 shows a side elevation of an embodiment of the
present invention in which the fluid transport element is bonded to
the base of the fluid storage element.
[0039] FIG. 11 shows a bottom plan view of the embodiment shown in
FIG. 10.
[0040] FIG. 12 shows a side elevation of an embodiment of the
present invention in which the fluid transport element is bonded to
the longitudinal side of the fluid storage element in a series of
aligned discrete bonds.
[0041] FIG. 13 shows a side elevation of an embodiment of the
present invention in which the fluid transport element is bonded in
at least one attachment zone having discrete spots of bonds on the
longitudinal side of the fluid storage element.
[0042] FIG. 14 shows an enlarged view of a section of the
embodiment shown in FIG. 13.
[0043] FIG. 15 shows a schematic perspective view of apparatus
according to the present invention useful to manufacture an
intravaginal device.
[0044] FIG. 16 shows the schematic perspective view of apparatus of
FIG. 15 including a fluid storage element and a sheet of material
prior to formation of the fluid transport element.
[0045] FIG. 17 shows a schematic perspective view of a male tool
useful in the apparatus of FIG. 15.
[0046] FIG. 18 shows a transverse cross-section of a human vagina
with an intravaginal device according to FIG. 4b disposed therein
with one fluid transport element extending away from the fluid
storage element.
[0047] FIG. 19 shows a transverse cross-section of a human vagina
with an intravaginal device according to FIG. 4b disposed therein
with the fluid transport elements remaining wrapped around the
fluid storage element.
[0048] FIG. 20 shows the device of FIG. 4 contained in an
applicator device packaging element.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0049] As used herein in the Specification and the Claims, the term
"bodily fluid" and variants thereof mean bodily exudates,
especially 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 relates 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 relates 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 were "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 in the Specification and the Claims, the term
"separable plates" and variants thereof mean 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.
[0065] As used herein in the Specification and the Claims, the term
"coupled" and variants thereof relate to the relationship between
two 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 pervious" and variants thereof relate to a material that
permits fluid or moisture to pass through without additional
processing, such as aperturing. Therefore, for example, an
untreated woven or nonwoven material is fluid pervious and a
continuous, plastic film or metal foil is not. A nonwoven permits
fluid flow via the interstices between fibers, such that fluid can
flow through, either by capillary action and/or via a pressure
differential from one side of the nonwoven to the other such as the
pressure experienced by a tampon in use.
[0067] Referring to FIG. 1a-1c, this invention provides an
intravaginal device 10 having at least one fluid transport element
12 in fluid communication with a fluid storage element 14 (FIGS.
1a-1c show two fluid transport elements 12 located on opposite
sides of the fluid storage element 14). The device may also include
a withdrawal mechanism, such as a string 16.
[0068] 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) bridging or connecting
the sections. The fluid storage element can be made of any
structure known in the art, such as compressed fibrous webs, rolled
goods, foam, and the like. The material may be formed as a unitary
mass or a plurality of discrete particles or agglomerations. The
material may be compressed to maintain a relatively stable form, or
it may be left relatively uncompressed. For example, the absorbent
material may include a central portion of absorbent wood pulp
material. The pulp may be covered by a thin absorbent woven or
nonwoven fabric and may be coterminous with the fluff pad or
completely envelop it on all sides. Absorbent materials which are
uncompressed or of low density have a much higher holding capacity
for fluids than high density materials. A consideration for using
uncompressed materials is the bulk or volume that may be required
in order to achieve sufficient absorbency.
[0069] In one preferred embodiment, the fluid storage element 14 is
an absorbent tampon. 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 fluid-permeable cover (which may include or be
replaced by another surface treatment) and a withdrawal string or
other removal mechanism.
[0070] 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.
[0071] 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).
[0072] 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
[0073] The fluid transport element has at least a first plate 18
and a second plate 20. The first and second plates combine to
provide a set of parallel plates, and the fluid transport elements
12 are shown as extending radially away from the fluid storage
element 14. Additional plates may also be incorporated into each
fluid transport element 12.
[0074] The plates are configured and arranged to allow the
introduction of bodily fluid 22 to separate a plate from adjacent
plate(s) (FIG. 1c). At least one opening 24 allows the introduction
of bodily fluids 22. Optionally, one or more spacer elements 26 can
be inserted to establish and to maintain space between adjacent
plates.
[0075] FIG. 1b shows a pair of parallel plates prior to the
introduction of a fluid. In this view, the facing surfaces of the
adjacent plates 18, 20 are in contact. On the other hand, FIG. 1c
shows the set of parallel plates separated by a bodily fluid 22,
providing an inter-plate capillary gap 28 between the inwardly
oriented surface 30 of the first plate 18 and the first surface 32
of the second plate 20. This inter-plate capillary gap 28 is
sufficient to provide inter-plate capillary action to allow the
fluid transport element 12 to acquire, to spread, and to move
bodily fluids 22 from the vagina to the fluid storage element 14.
The first plate 18 also has an outwardly oriented surface 34, and
the second plate 20 also has an opposite surface 36.
[0076] The plates 18, 20 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.
[0077] In particular, materials useful for forming the fluid
transport element may have properties such as thermobondability to
provide means to incorporate it into the intravaginal 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. 2a-2c illustrate three combinations of the apertured film of
Thompson.
[0078] 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 18 and
20 may be made from the same material or alternately, plate 18 may
be made from a different material than plate 20.
[0079] 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 30 of the first plate 18 and the
first surface 32 of the second plate 20 that is less than the
resistance to fluid flow vector in the direction perpendicular to
the plates. Preferably, the plates are made from any smooth
material with a non-fibrous surface. Suitable materials include,
without limitation, foil, waxed sheets, film, apertured film, etc.
Each plate does not need to be made of the same material as its
corresponding parallel plate. For instance, the first plate 18
could be an apertured film to allow fluid to enter and the second
plate 20 could be a solid film to move fluid to the storage element
(as shown in FIG. 2). Of course, the parallel plates should be able
to transport fluid between the two layers.
[0080] The fluid transport element 12 should be strong enough to
prevent rupturing during handling, insertion, and removal and to
withstand vaginal pressures during use.
[0081] It is preferable that the surfaces of the fluid transport
element 12 are sufficiently wettable by the bodily fluids that the
intravaginal device 10 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.
[0082] Surface treatments can be used to modify the surface energy
of the plates 18, 20. In a preferred embodiment a surfactant is
applied to increase the wettability of the outer or inner surfaces
of the parallel plates. This will increase the rate at which the
bodily fluids are drawn into and spread between a pair of plates.
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.
[0083] 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.
[0084] In order to accomplish this, the materials of plates can be
chosen from those materials that are known in the art to have low
energy surfaces. It is also possible and useful to coat materials
that have high-energy surfaces with a surface additive, such as a
non-ionic surfactant (e.g., ethoxylates), a diol, or mixtures
thereof, in order to increase their wettability by bodily fluids.
Such additives are well known in the art, and examples include
those described in Yang et al., US App. No. 2002-0123731-A1, and
U.S. Pat. No. 6,570,055. Other means of increasing wettability can
also be used, such as by corona discharge treatment of, for
example, polyethylene or polypropylene, or by caustic etching of,
for example, polyester.
[0085] 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.
[0086] The surfaces of the first and second plates facing each
other can have a variety of surface textures, ranging from smooth
to highly textured. The texturing element may be included as a
spacer 26.
[0087] The value of spacers 26 or texture may be based on the
material's ability to withstand wet collapse when simultaneously
subjected to compressive forces and fluid.
[0088] The spacer elements 26 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.
[0089] Integral spacer elements 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 38 of a "three-dimensional" polymeric apertured formed
film material shown in FIGS. 3a-3c. First and second plates 18, 20
made from apertured formed film with the sidewalls 38 facing each
other as the inward surface 30 of the first plate 18 and the first
surface 32 of the second plate 20 can be used to increase the
texture of the plates. While not wishing to be held to this theory,
it is believed that the texturing reduces the viscosity of the
fluid being transported. The texture can also be in a gradient. For
example, in one embodiment, the texture of the plates has a
gradient from smooth near the edge of the plates where the fluid
enters the fluid transport element to more textured where the fluid
is absorbed.
[0090] Referring again to FIG. 2, the spacer elements may be formed
as nubbles 40 extending from the inward surface 30 of the first
plate 18 and resting on the first surface 32 of the second plate
20.
[0091] 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 26 and the adjacent plate or
even between spacer elements 26 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.
[0092] The at least one opening 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 may be located at the edge of the plates
and a plurality of smaller openings or apertures 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.
[0093] A plurality of openings or apertures 42 may extend through
at least one of the first and second plates 18, 20. These apertures
42 may extend completely through the plate and may be present in
both of the plates. The apertures 42 allow fluid that contacts the
outward surface 34 of the first plate 18 or the opposite surface 36
of the second plate 20 to flow into the inter-plate capillary gap
28 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 28.
[0094] It is preferable that any individual opening (e.g., edge
opening 24 of fluid transport element 12 or aperture 42) is large
enough to easily pass any highly viscous material, including
menstrual fluid. While the geometry of the openings is not
critical, the openings 24, 42 should be sized sufficient to allow
easy passage of non-absorbable material. If the apertures 42 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.
[0095] In the example of unapertured film that has an opening 24 at
the ends of the plates 18, 20, the size of the opening 24 is a
result of the fluid's ability to separate the plates.
[0096] It is preferred that the apertures 42 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 42 is circular and is between 10 mils and 40
mils in diameter. Most preferably it is between 18 mils and 27
mils.
[0097] 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.
[0098] 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.
[0099] Referring for example, to FIGS. 4 and 5, the first and
second plates 18, 20 may be extensions of the same sheet-like
material, e.g., formed by a fold in a sheet of material (as shown
in FIGS. 4a-4c), or they may be separate elements (i.e., adjacent
to each other but not necessarily joined). In a folded embodiment,
the material is preferably folded to form a pleat with the first
and second plates facing each other.
[0100] A preferred embodiment with pleats is shown in FIGS. 4a-4e,
where the pleats 44 are folds in the cover material 46. The pleats
44 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 48 and withdrawal end 50.
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. 4a.
[0101] The fluid transport element 12 is in fluid communication
with the fluid storage element 14 and directs fluid from the vagina
to the storage element 14. Generally, fluid will be directed from
each fluid transport element 12 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 12, the fluid
will contact the fluid storage element in one interface 52.
[0102] Therefore, additional fluid transport elements 12 directing
fluid to additional locations of the fluid storage element 14 will
improve the efficient usage of the fluid storage element 14. For
example, two fluid transport elements 12 could be directed to
opposite sides of the fluid storage element 14, as shown in FIGS.
1a-1c. Each additional fluid storage element 12 can direct fluid to
additional interface locations 52 of the fluid storage element 14.
For example, four evenly spaced fluid transport elements 12 allow
fluid to be directed to each quarter of the fluid storage element
14 surface as shown in FIGS. 4a-e. Five or more elements would
provide even more direct access. This can allow the fluid to
contact the fluid storage element 14 uniformly and help to prevent
or reduce local saturation of the fluid storage element 14.
[0103] While the above description provides for direct fluid
communication between a fluid transport element 12 and the fluid
storage element 14, 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.
[0104] Enlarging the area of the interface 52 between the fluid
transport element 12 and fluid storage element 14 can also help to
maximize the fluid communication. For example, elongating the
interface by increasing the length of the fluid transport element
12 allows more fluid to flow into the fluid storage element 14.
[0105] The fluid transport element 12 may extend in any orientation
from the surface of the fluid storage element 14. It is not
necessary for the fluid transport element to be on the surface of
the fluid storage element.
[0106] The inter-plate capillary gap 28 formed by first plate 18
and second plate 20 can terminate at the interface 52 or can extend
into and/or through the fluid storage element 14. An example of the
fluid transport element 12 extending into the fluid storage element
14 is shown in FIG. 5. The first and second 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 can
end at the boundary of the transport element or can extend into the
fluid storage element 14.
[0107] The fluid transport element 12 may be formed to extend from
the surface of the fluid storage element 14 as in FIGS. 1a-1c. It
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.
[0108] 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
element 12 including but not limited to heat, adhesive, ultrasonic,
sewing, and mechanically engaging the fluid storage element 14. An
example of a heat-bonded attachment 54 is shown in FIG. 4a.
[0109] The fluid transport element(s) 12 can be attached at the
sides, insertion end 48, and/or withdrawal end 50 of the
intravaginal device. Additionally, the fluid transport element(s)
12 may be attached to themselves and not to the storage element as
in a relatively loose bag covering of the storage element. The
fluid transport element(s) 12 could also be attached to the
withdrawal string.
[0110] The fluid transport element may be attached directly to the
fluid storage element or may be attached to itself in one or more
locations. Such attachment or adherence to itself or to the fluid
storage element may be by any known means, including, for example,
adhesive, ultrasonic, co-embossing, thermobonding, mechanical
bonding (such as crimping), and the like. In one embodiment, the
fluid transport element is formed of a material that is capable of
being thermobonded. Alternately, the material may formed of two
different materials having different melting points, at least one
of which would also be capable of thermobonding.
[0111] In an embodiment shown in FIGS. 6a and 6b, the cover
material 46 substantially envelops the fluid storage element 14
(shown as a tampon), forming a bag or sack structure 56. This
structure provides a pair of fluid transport elements 12' formed by
portions of the cover material 46. In this embodiment, the cover
material 46 is draped over the insertion end 48 of the tampon with
the edges of the material brought together about the withdrawal end
50 and then bonded to itself 54'. The resulting fluid transport
element 12' can then be folded around the tampon in the manner
shown in FIG. 4b.
[0112] Other embodiments similar to that shown in FIG. 6 are
possible. For example, FIG. 7 shows the attachment 54'' of the
fluid transport element 12 to the withdrawal string 16, and FIG. 8
shows the attachment 54''' at the withdrawal end 50, especially to
the base 58 of the fluid storage element 14 (the base 58 being the
generally circular surface from which the withdrawal string 16 may
extend). In all of these embodiments, the cover material 46 and the
associated fluid transport element 12 substantially envelop the
fluid storage element 14 but do not significantly affect the
performance of the fluid storage element 14. For example, if the
fluid storage element 14 had been compressed and expands upon
exposure to fluid, the expansion of the fluid storage element 14
would not be affected or inhibited by the attachment or bonding of
the fluid transport element 12 to the fluid storage element 14.
[0113] In the embodiments described and shown in FIGS. 6-8, it is
not necessary for the fluid storage element 14 to be a unitary
element. For example, the fluid storage element 14 may have
multiple distinct portions or segments. The segments may be
attached together or may be discrete. Examples of discrete segments
may be relatively loose absorbent material or compressed cellulosic
tablets. However, these discrete segments could be at least
partially contained to permit the fluid transport element 12 to
form parallel plates, as described above.
[0114] In an alternate embodiment of the invention shown in FIG. 9,
the fluid transport element 12 and the fluid storage element 14
have an attachment 54 at the insertion end 48 of fluid storage
element 14. Pleats 44 formed in the fluid transport element 12 may
be folded around the tampon as previously shown in FIG. 4b.
Additionally, the lower portions 60 of the sheet material may also
be attached to withdrawal end 50 of the fluid storage element 14,
as described above and below, to prevent inversion of the fluid
transport element 12 upon withdrawal.
[0115] In embodiments where the fluid transport element 12 is
bonded or gathered at the withdrawal end 50 of the fluid storage
element 14, it is preferable to minimize bunching of the fluid
transport element 12 material to limit interference during
insertion and withdrawal of the device.
[0116] Although not required, the sheet material used to form the
fluid transport element 12 may initially be in a shape such that
the sheet has at least one corner. The sheet material is placed
over the fluid storage element 14 such that at least one portion of
the sheet extends away from the fluid storage element 14. In one
embodiment, the sheet has a plurality of corners, and each corner
may be attached to the withdrawal end 50 of the fluid storage
element 14. For example, if four sets of parallel plates are
desired, the sheet material may be a square.
[0117] If the fluid storage element 14 is a compressed tampon
having embossed grooves such as those disclosed in U.S. Pat. No.
5,165,152 the disclosure of which is hereby incorporated by
reference, the attachment may be on the outer most surface
(non-embossed) or in the grooves. Attachment may take place before,
during, and/or after fluid storage element 14 compression.
[0118] The embodiment of FIGS. 10 and 11 is similar to that of FIG.
9. In particular, the corners of the fluid transport element 12 are
attached to the base 58 of the fluid storage element 14. As seen in
FIG. 11, the corners preferably do not overlap the center of the
circular base 58.
[0119] When a compressed tampon having grooves 60 is used as the
fluid storage element 14, it is likely that the tampon performs
optimally if permitted to expand without restriction by the fluid
transport element. While some compressed tampons expand due to dry
expansion, others expand when exposed to fluid. One example of such
a compressed tampon having grooves is the o.b..RTM. tampon
available from McNEIL-PPC, Inc., Skillman, N.J.
[0120] In the embodiments shown in FIGS. 12-14, the fluid storage
element 14 is a compressed tampon having an exterior surface 62 and
grooves 60. Grooves 60 have an interior portion, which becomes part
of the exterior surface 62 of the tampon upon absorption of fluids
and the resultant tampon expansion. Because the fluid transport
element 12 is attached to the exterior surface 62 of the tampon at
its withdrawal end 50, it does not extend into the tampon grooves
60. Thus, the fluid storage element 14 may expand without any
interference from the fluid transport element 12. In other words,
the fluid transport element 12 does not significantly limit the
functionality of the fluid storage element 14. Pleats 44' form in
the fluid transport element 12 and may be similarly folded around
the tampon as previously shown in FIG. 4b.
[0121] As shown in FIG. 12, a tampon having straight grooves is
attached to the fluid transport element 12 using a series of heat
bonds 54 along one or more single line(s) along the tampon. This
provides easier alignment of the attachment 54 and the exterior
surface 62 of the tampon as the bond line may be registered
accurately to avoid coinciding with the grooves 60. Thus, the fluid
transport element 12 may be readily attached along the longitudinal
side without interfering with the expansion of the tampon.
[0122] In a similar embodiment shown in FIGS. 13 and 14, the fluid
transport element 12 may be attached along the longitudinal side of
a tampon having spirally oriented grooves. In this embodiment an
attachment zone 64 of fluid transport element 12 extends from one
lobe 66 and across groove 60 to adjacent lobe 66'. As previously
described, materials such as apertured films have a certain amount
of elasticity and may be designed to permit the tampon expansion,
especially the material located within the interior portion of the
grooves 60.
[0123] If desired, the attachment zone 64 may be oriented in any
direction relative to the longitudinal axis X-X of the fluid
storage element 14. As shown in FIGS. 13 and 14, the attachment
zone 64 comprises a matrix or other grouping of discrete bonds,
such as dots or spots. This allows the interface between the fluid
transport element 12 and the fluid storage element 14 to remain as
open to fluid flow as possible.
[0124] As previously mentioned and shown, the fluid transport
element 12 may be attached to the fluid storage element 14 be any
number of methods and embodiments. For example and with reference
to FIGS. 15-17, a tampon may be manufactured as shown in Friese,
U.S. Pat. No. 4,816,100, and either Friese et al., U.S. Pat. No.
6,310,269, or Leutwyler et al., U.S. Pat. No. 5,911,712. However,
after the tampon is formed and prior to packaging, an additional
process employing a forming tool 102, a male tool 104 having a
plurality of blades 106, and thermobonding elements 108 applies a
fluid transport element 12 to the fluid storage element 14. The
tools are aligned in a manner that the blades 106 of the male tool
104 cooperate with corresponding slots 110 in the forming tool 102.
In addition, each of the tools has a central aperture 112, 112'
through which a fluid storage element 14 may pass during
processing.
[0125] In somewhat more detail, an individual sheet 114 of material
is separated from a supply (not shown) and placed on the forming
tool 102. A vacuum is drawn across the forming tool 102 via a
plurality of vacuum ports 116 on the face 118 of the forming tool
102 to hold the individual sheet 114 in place.
[0126] The blades 106 of the male tool 104 are shown arranged
radially about the central aperture 112 in the male tool 104 (as
shown in FIG. 17). The blades 106 cooperate to hold the fluid
storage element 14 in line with the central aperture 112. A pushrod
(not shown) is arranged to penetrate the central aperture 112 of
the male tool 104 and to bear on the base of the fluid storage
element 14. In the preferred embodiment shown in FIGS. 15-17, four
blades 106 are arranged at equal angles about the central aperture
112. Each blade 106 provides a guide edge 120 facing the fluid
storage element 14 (when present) and a pleating edge 122 disposed
radially outwards from the guide edge 120. The pleating edge 122
may be an edge that is adjacent the guide edge 120, or it may be
separated by one or ore intermediate portions of the blade 106.
[0127] In operation, the male tool 104 holding a fluid storage
element 14 is moved along the machine axis (M-M) aligned with the
central apertures 112, 112' toward the forming tool 102 carrying
the individual sheet 114. The insertion end 48 of the fluid storage
element 14 contacts the individual sheet 114 and urges it through
the central aperture 112' of the forming tool 102. The pleating
edges 112 of the blades 106 urge corresponding portions of the
individual sheet 114 through the slots 110 of the forming tool 102
creating four sets of parallel plates 18, 20.
[0128] Once the fluid storage element 14 is inserted into the
central aperture 112' of the forming tool 102 with only a portion
of the withdrawal end 50 remaining exposed, thermobonding elements
108 extend into the space between the blades 106 to bond the four
corners of the individual sheet 110 to the exterior surface 62 of
the fluid storage element 14, forming the fluid transport element
12. The pushrod may then continue to move the insertable device 10
into and through the central aperture 112' of the forming tool 102.
The fluid transport element 12 may then be folded about the fluid
storage element 14. The resulting insertable device may then be
packaged in a hygienic overwrap as is well known in the art.
[0129] While the process described above in reference to FIGS.
15-17 employs blades 106 that have a guide edge 120 that is shorter
than the fluid storage element 14, this relationship may be
altered. For example, the blades 106 could be modified to have a
guide edge 120 that is longer than the fluid storage element 14 or
the system could otherwise be modified to allow the leading
portions 124 to contact the individual sheet 114, first. This
permits the formation of a small gap between the insertion end 48
of the tampon and the individual sheet 114 that may allow more free
expansion of the tampon without restriction by the fluid transport
element 14 during use.
[0130] During use, fluid transport element(s) 12 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. 18. Alternatively, and the fluid
transport element(s) 12 may remain wound about the fluid storage
element 14, contacting the vaginal wall "W" only through the first
surface 30 (FIG. 19).
[0131] A withdrawal mechanism, such as withdrawal string 16, is
preferably joined to the intravaginal device 10 for removal after
use. The withdrawal mechanism is preferably joined to at least the
fluid storage element 14 and extends beyond at least its withdrawal
end 50. 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.
[0132] 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.
[0133] While the applicator tampon is protected by the rigid
applicator device and the applicator tampon need not as have as
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.
[0134] Further, the intravaginal device can be collapsed for
packaging and insertion. For example, at least a portion of a major
surface of the fluid transport element 12, such as the first
surface 30, may be in contact with at least a portion of an outer
surface of the fluid storage element 14. This can be achieved by
wrapping the fluid transport element(s) around the fluid storage
element 14 (as shown in FIG. 4b). Alternatively, the fluid
transport element(s) 12 may be folded or pleated (e.g., in an
accordion-like manner) against the fluid storage element 14. The
thus-compacted device can then be packaged, (e.g., within an
applicator or alone in a wrapper). FIG. 20 shows a wrapped tampon
within an applicator 68 (in phantom).
[0135] 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.
* * * * *