# Patent

## Title
Method of using an intravaginal device with fluid transport plates

## Abstract

A method of capturing bodily fluid intravaginally providing an intravaginal device that has a fluid storage element having a longitudinal axis and is in fluid communication with at least one fluid transport element. The method involves providing at least one fluid transport element that is bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element and positioned within a human vagina.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a divisional application of U.S. Ser. No. 11/443,918 filed May 31, 2006 now U.S. Pat. No. 8,057,453, which is a continuation of PCT/US2005/017110 filed May 13, 2005, which is a continuation of U.S. Ser. No. 10/848,208 filed May 14, 2004 now abandoned, the complete disclosures of which are hereby incorporated herein by reference for all purposes.


FIELD OF THE INVENTION
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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
It has been discovered that intravaginal bodily fluid may be captured and stored intravaginally in such a manner that reduces premature leakage of and utilizes the absorbent capacity of an intravaginal absorbent device.
In one aspect of the invention, a method is described for capturing bodily fluid intravaginally. The method involves providing at least one fluid transport element in fluid communication with the fluid storage element and positioned within a human vagina, the fluid transport element being 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. The fluid transport element has:

    
    
        a. a first plate with an outwardly oriented surface and an inwardly oriented surface; and
        b. a second plate with a first surface disposed in facing relationship with the inwardly oriented surface of the first plate, and an opposite surface.
    
    


The second plate is sufficiently spaced apart from the first plate to provide inter-plate capillary action between the first and second plates. The transport element is positioned within the vagina such that the outwardly oriented surface of the first plate and the opposite surface of the second plate contact the vaginal walls. Intravaginal bodily fluid is exposed to the 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.
In another aspect of the invention, a method is described for storing bodily fluid intravaginally. The method involves providing a fluid storage element in fluid communication with a fluid transport element, with the fluid transport element being positioned within a human vagina and being bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element. The fluid transport element has:

    
    
        a. a first plate with an outwardly oriented surface and an inwardly oriented surface; and
        b. a second plate with a first surface disposed in facing relationship with the inwardly oriented surface of the first plate, and an opposite surface.
    
    


The second plate is sufficiently spaced apart from the first plate to provide inter-plate capillary action between the first and second plates. The transport element is positioned within the vagina such that the outwardly oriented surface of the first plate and the opposite surface of the second plate contact the vagina. Bodily fluid within the human vagina is exposed to the 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.
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
FIG. 1a shows a side elevation of an intravaginal device having a pair of fluid transport elements formed as extensions of a cover.
FIG. 1b shows a transverse cross-section of the device in 1a along line 1b-1b. 
FIG. 1c shows the transverse cross-section shown in 1b, after the introduction of a fluid between the plates of the fluid transport element.
FIGS. 2a-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.
FIG. 3 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.
FIGS. 4a-c show various aspects and orientations of an intravaginal device of the present invention.
FIG. 5 shows a transverse cross-section of a human vagina with a tampon according to FIG. 4b disposed therein with one fluid transport element extending away from the fluid storage element.
FIG. 6 shows a transverse cross-section of a human vagina with a tampon according to FIG. 4b disposed therein with the fluid transport elements remaining wrapped around the fluid storage element.
FIG. 7 shows a side view of a preconstruction of the tampon embodiment of FIG. 4a. 
FIG. 8 shows an embodiment of the present invention disposed within an applicator.



DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
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.
As used herein in the Specification and the Claims, the term “fluids” and variants thereof relate to liquids, and especially bodily fluids.
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.
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.
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
      ⁢
      σ
      *
      cos
      ⁢
      
        
      
      ⁢
      θ
    
    
      ρ
      *
      g
      *
      d
    
  




in which:
h is rise of fluid between plates
σ is the surface tension of fluid in contact w/plate
θ is contact angle
ρ is density
d is distance between plates, and
g is the gravitational constant
Therefore, as long as the contact angle, θ, is less than 90°, there will be some capillary attraction.
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.
As used herein, 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.
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, inter-plate capillary action, mechanical channeling, and the like.
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).
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.
In one aspect, this invention relates to a method for the intravaginal capture and storage of bodily fluids by providing a fluid storage element and a fluid transport element. In one embodiment, the fluid storage element and the fluid transport element are provided in the form of a tampon.
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. 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.
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.
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.
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.
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.
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.
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. Of course, the parallel plates must be able to transport fluid between the two layers.
The fluid transport element 12 should be strong enough to prevent rupturing during handling, insertion, and removal and to withstand vaginal pressures during use.
It is preferable that the surface of at least one of the plates of the fluid transport element 12 be 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.
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.
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.
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 with 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.
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.
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.
The desire to include spacers 26 or texture may be based on the material's ability to withstand wet collapse when simultaneously subjected to compressive forces and fluid.
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.
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. 2a-2c. 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 in order to break up 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.
In another example, shown in FIG. 3, the spacer elements are 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.
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.
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 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.
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.
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 opening 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.
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.
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.
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× objective, and a 2.50× eyepiece. The image can be produced with a DAGE MTI CCD72 video camera.
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×. The open area is determined from field measurements of representative areas. The Quantimet program output reports mean value and standard deviation for each sample.
Referring to FIGS. 4a-4c, the first and second plates 18, 20 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. In such a folded embodiment, the material is folded to form a pleat with the first and second plates facing each other.
FIG. 4a-4c shows one embodiment of a tampon 10 that may be used in the method of this invention. The tampon has a fluid storage element 14 and a fluid transport element 12. The fluid transport element has a first plate 18 and a second plate 20. The first plate 18 has an outwardly oriented surface 34 and an inwardly oriented surface 30. The second plate 20 has a first surface 32 disposed in facing relationship with the inwardly oriented surface 30, and an opposite surface 36.
A preferred embodiment with pleats is shown in FIGS. 4a-4c, where the pleats 44 are folds in a fluid-permeable cover material 46. The pleats 44 create plates that are bendable about an infinite number of bending axes (b1-i-b1-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 (b1-b1) is shown in FIG. 4a. 
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.
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-c. 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.
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.
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.
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.
The inter-plate capillary gap 28 formed by the first and second plates can terminate at the interface 52 or can extend into and/or through the fluid storage element 14. The parallel plates can have additional layers on top of them as long as these additional layers allow fluid to enter the plates. The parallel plates can end at the boundary of the transport element or can extend into it the fluid storage element.
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. In an alternative embodiment, the withdrawal string 16 could be replaced by a pair or another combination of ribbon-like parallel plates (not shown).
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, ultrasonics, sewing, and mechanically engaging the fluid storage element 14. In one embodiment, the fluid transport element is heat sealed to the fluid storage element (not shown).
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 parallel plates bag type covering of the storage element. The parallel plates could also be attached to the withdrawal string. These and other means of attachment are disclosed in the commonly-assigned, copending patent applications entitled “Intravaginal Device with Fluid Acquisition Plates” (U.S. Ser. No. 60/572054), “Intravaginal Device with Fluid Acquisition Plates and Method of Making” (U.S. Ser. No. 60/572055), both filed on May 14, 2004, the contents of which are herein incorporated by reference.
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. 5. Alternatively, and the fluid transport element(s) 12 may remain wound about the fluid storage element 14, contacting the vaginal surfaces only through the outwardly oriented surface 34 (FIG. 6).
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 also be in separate sections with the fluid transport element(s) 12 bridging or connecting the sections (not shown).
The fluid storage element 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.
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; and 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.
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.
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).
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
With reference to FIG. 7, the pre-construction of the exemplary tampon, a square sheet 56 of apertured film is centered on the insertion end 48 of the fluid storage member 14. The corners A, B, C, and D of the sheet of apertured film are then folded down along the sides of the fluid storage element and fastened to the fluid storage element in an area proximal to the withdrawal end 50 of the fluid storage element.
The resulting tampon, as illustrated in FIG. 4a, has four fluid acquisition elements extending outwardly from the sides of the fluid storage member. Each of the fluid acquisition elements comprises a first plate and a second plate comprising the apertured film described hereinbefore.
Before the tampon is used, the fluid transport elements 12 may be wrapped around the fluid storage element, as illustrated in FIG. 4b, and packaged. This wrapping presents the tampon in a compact configuration suitable for insertion into a human vagina. The insertion may be manually, that is, without the use of an applicator. Alternately, the compact configuration shown in FIG. 4b may be placed and packaged within an applicator. An example of this configuration is shown in FIG. 8. Intravaginal device 10 has been formed and placed within the insertion portion of a cylindrically shaped applicator 56.
After a desired period of time, the tampon with its captured and stored bodily fluid is removed by the user and disposed. A second, similar tampon assembly may then be inserted to capture and store additional fluid in the same manner.
In some further detail, 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.
During the insertion of the tampon, the user may choose to manipulate the tampon to unwrap or allow a distal portion of the at least one fluid transport element from the outer surface of the fluid storage element. In this manner, the outwardly oriented surface of the first plate and the opposite surface of the second plate may both contact the vaginal walls “W”, as shown in FIG. 5. Alternately, the user may insert the tampon without significantly disturbing the at least one fluid transport element, 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. 6.
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 having a fluid transport element that is bendable about an axis substantially parallel to the longitudinal axis of the fluid storage element, the fluid transport element having—a first plate having an outwardly oriented surface and an inwardly oriented surface; a second plate having a first surface disposed in 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; the acquisition element being positioned within the vagina such that the outwardly oriented surface of the first plate and the opposite surface of the second plate contact the vaginal walls; whereby bodily fluid within the human vagina is exposed to the liquid acquisition element and is captured and transported between the first plate and the second plate by inter-plate capillary action to the liquid storage element where the fluid is stored.
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.

## Claims

1. A method of using a plurality of tampons during a period of menstruation, the method comprising the steps of:
a) providing a first 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;

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.

2. The method of claim 1, wherein at least one of the first and second plates comprises an apertured polymeric film.

3. The method of claim 2, wherein the first and second plates are formed of a folded sheet of apertured polymeric film.

4. The method of claim 1, 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.

5. The method of claim 1, 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.