WO2000013622A1

WO2000013622A1 - An individual urinary device with a transformable package

Info

Publication number: WO2000013622A1
Application number: PCT/US1999/020749
Authority: WO
Inventors: Richard Joseph Sunberg; Charles John Berg, Jr.; Nicholas Albert Ahr; Thomas Ward Osborn, Iii
Original assignee: The Procter & Gamble Company
Priority date: 1998-09-09
Filing date: 1999-09-09
Publication date: 2000-03-16
Also published as: AU6032399A

Abstract

The invention comprises an individual urinary device (20) within a transformable package (60) for the absorption of urine. The individual urinary device (20) has a top surface and a bottom surface. The device further comprises a first side; a second side positioned opposite to the first side wherein the individual urinary device absorbs urine from within or without the urethra of a user. Furthermore, the individual urinary device (20) comprises a transformable package (60) encompassing and protecting the individual urinary device (20) before use of the device by a user. The package (60) is at least partially removable from the individual urinary device (20) to expose the first side of the individual urinary device. The second side of the individual urinary device (20) may also be exposed. The package (60) is also preferably transformable into a grasping portion by which the device is held by a user upon use thereof. In practice, after urination has occurred, a user holds the individual urinary device in one hand by the grasping portion with the first side of the device positioned and facing towards the user's urethral opening to draw excess urine into the device while the grasping portion protects the fingers of the user from the excess urine. This transforming or transformable package (60) is especially useful where a user experiences light to moderately heavy incontinence after urination and/or where a user is another person helping one who urinates remain dry after urination (e.g., a father helping to toilet train his youngster).

Description

AN INDIVIDUAL URINARY DEVICE WITH A TRANSFORMABLE PACKAGE

TECHNICAL FIELD

This is an individual urinary device encompassed by a transformable package prior to its use. At use, the transformable package is folded back to reveal at least a portion of the individual urinary device for use in removing or wiping excess urine from the urethral area of a user, male or female.

BACKGROUND OF THE INVENTION

In the anatomy of the male human, urine which collects in the bladder is excreted during the act of urination by passage through the urethra tube, past the prostate gland which interacts in a valve-like manner with the urethra tube, ultimately exiting from the glans penis. If the prostate gland is dysfunctional, e.g., enlarged, such dysfunction may restrict the flow of urine causing a significant amount of residual urine to remain within the urethral tube after urination. Greater amounts of such residual urine occur with disorders of the prostate gland or with increased age. Eventually the residual urine will flow by gravity and/or by capillary action and soil the underclothing or trousers. To prevent such delayed gravity flow, the man may forcefully shake the penis while over a urinal to discharge the residual urine. In the course of this shaking, however, the path of the exiting urine is uncertain and may contact the hands, trousers, floor and wall. This situation is not only generally unsanitary, but could lead to the spread of contagious diseases. Although various devices and napkin-like products have earlier been proposed to cope with this problem, such earlier expedients have been either too expensive, impractical, uncomfortable or difficult to use.

A significant problem to be overcome in the urination process, and what the following references in this section do not teach, is the necessity to avoid contact with urine upon wiping the urethral area, whether male or female. In particular, it is important for a user to avoid the presence of urine on or about a user's hands. This is especially true where a user is in a health profession, is a food service profession, a school teacher and/or in any occupation, professionally or personally, requiring fairly intimate contact with others. The use of devices for incontinent males is well known in the prior art. More specifically, such devices heretofore devised and utilized for the purpose of absorbing residual urine are known to consist of familiar, expected, and obvious structural configurations, notwithstanding the myriad of designs encompassed by the crowded prior art which has been developed for the fulfillment of countless objectives and requirements.

For example, U.S. Patent No. 5,074,853 issued to Bryant discloses a male incontinence diaper. U.S. Patent No. 5,009,649 issued to Goulter, et al. discloses an expandable banded male urinary incontinence condom and supporting undergarment. U.S. Patent No. 4,790,835 issued to Elias discloses a urinary male diaper. U.S. Patent No. 4,673,401 issued to Jensen and Ferguson discloses a male incontinence device. U.S. Patent No. 4,944,733 issued to Casaie discloses a diaper for use in toilet training male children or for use by incontinent male adults. Lastly, U.S. Patent No. 4,675,012 issued to Rooyakkers discloses a method of forming an absorbent genitalia pouch for incontinent males.

Heretofore, users have not had the ability to control the transfer of residual urine present in the urethra after urination onto their skin or clothing, nor to avoid urine spillage onto their skin or clothing when attempting to extract the urine.

Therefore, it is an important object to provide a transformable package which will act as a barrier between a web's skin and clothing and the residual urine.

It is another object of the present invention to provide a flushable individual urinary device that will readily absorb excess urine after urination.

It is a further object herein to provide a flushable individual urinary device that will draw excess urine from within a user's urethral tube. It is another object herein to provide a flushable individual urinary device that will readily flush in a urinal, disperse in a urinal and/or dissolve in a urinal.

SUMMARY OF THE INVENTION

Accordingly, the invention comprises an individual urinary device within a transformable package for the absorption of urine. The individual urinary device has a top surface and a bottom surface. The device further comprises a first side; a second side positioned opposite to the first side wherein the individual urinary device absorbs urine from within or without the urethra of a user.

Furthermore, the individual urinary device comprises a transformable package encompassing and protecting the individual urinary device before use of the device by a user. The package is at least partially removable from the individual urinary device to expose the first side of the individual urinary device. The second side of the individual urinary device may also be exposed. The package is also preferably transformable into a grasping portion by which the device is held by a user upon use thereof. In practice, after urination has occurred, a user holds the individual urinary device in one hand by the grasping portion with the first side of the device positioned and facing towards the user's urethral opening to draw excess urine into the device while the grasping portion protects the fingers of the user from the excess urine. This transforming or transformable package is especially useful where a user experiences light to moderately heavy incontinence after urination and/or where a user is another person helping one who urinates remain dry after urination (e.g., a father helping to toilet train his youngster).

In one embodiment, the individual urinary device may consist of one layer of absorbent material. In a preferred embodiment of the individual urinary device herein, it may comprise multiple layers of material having at least a top layer and a bottom layer. In such a multi-layered individual urinary device, there may be several in-between layers of absorbent, acquisition and/or absorbent gelling material. Such in-between layers would be primarily responsible for the effective fluid distribution and/or absorption of urine from a user.

In a highly preferred embodiment of the individual urinary device herein, a handle may be formed into the individual urinary device or separately joined or attached onto the individual urinary device. Note that this is a handle separate from that which the transformable package may form, but one with which the transformable package may cooperate. This handle may serve as another mechanism by which a user may hold the individual urinary device. Furthermore, the handle may be so attached to the individual urinary device or formed onto the individual urinary device to allow a user to wick urine into itself. By such use, especially in tandem with the transformable package, a user may avoid substantially all contact with urine to be wicked when using the individual urinary device.

The individual urinary device may absorb and/or draw, by the action of capillary forces, urine into itself. For example, the individual urinary device may comprise a density gradient that facilitates the drawing of urine away from a user's urethra to the device. In one preferred embodiment herein, the density gradient may comprise i) a first tissue sheet having capillaries, the first tissue sheet being positioned adjacent to the top

3 3 layer and having a density from about 0.01 g/cm^" to about 0.1 g/cm ; and ii) a second tissue sheet having capillaries, the second tissue sheet being positioned adjacent to and

3 below the first tissue sheet and having a density of from about 0.08 g/cm to about 0.3 g/cm , the difference in density between the first and the second tissue sheets being from

3 3 about 0.01 g/cm to about 0.2 g/cm . A density gradient is formed between the adjacent first tissue sheet and second tissue sheet such that fluid impacting the first tissue sheet will be drawn from the first tissue sheet by capillary suction exerted by the smaller capillaries of the lower and more dense second tissue sheet. In another preferred embodiment herein, the density gradient further substantially locks in urine to prevent the urine from wicking out of the individual urinary device. The individual urinary device may be in any of a number of shapes including, squares, triangles, ovals, polygonals, etc. Furthermore, the individual urinary device may comprise a topsheet and a backsheet joined to that topsheet with an absorbent member positioned therebetween. The individual urinary device, including the transformable package, may also be flushable and preferably, but not necessarily, disperse into many smaller parts. The top surface of the individual urinary device, whether covered with topsheet material or not, may employ a surfactant, a lotion, an emollient, anti-microbial agents, cranberry extract, medicine, alcohol, water, perfume, fragrance, pH indicators, vitamins, moistening agents, cleaning agents or any of a combination of these or like substances. Finally, the individual urinary device when used will at least partially cover the urethral opening of a male user's penis and may substantially cover the head of a male's penis.

The top layer of the individual urinary device will typically comprise a density ranging from about 0.01 g/cm³ to about 1.0 g/cm³. The bottom layer of the individual urinary device will typically comprise a density ranging from about 0.01 g/cm³ to about 1.0 g/cm³. The length of the device, regardless of its shape, will typically range from about 10 mm to about 310 mm. The width of the device, regardless of its shape, will typically range from about 5 mm to about 310 mm. Also, the thickness of the device will typically range from about 0.1 to about 50 mm, such thickness being substantially continuous or variable throughout the device. When the thickness varies throughout the device, the density throughout the device will also vary. Such variance of thickness and thereby density may be highly suitable for certain types of users to solve specific types of problems; e.g., a device of varying thickness for use by a physically challenged user who may have a certain type of hand disability.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims particularly pointing out and distinctly claiming the subject matter which is regarded as forming the present invention, it is believed that the invention will be better understood from the following descriptions which are taken in conjunction with the accompanying drawings in which like designations are used to designate substantially identical elements, and in which:

FIG. 1 is a perspective view showing how the present invention is used to protect the user's fingers;

FIG. 2 is a side view of an alternative preferred embodiment of the present invention showing a front tab for opening the package;

FIG. 3 is a perspective view of a partially opened package of the present invention.;

FIG. 4 is a side view of an alternative preferred embodiment of the present invention showing a side tab for opening the package.

FIG. 5 is a perspective view of a rectangular embodiment of the individual urinary device;

FIG. 6 is a plane view of a circular or oval embodiment of the individual urinary device;

FIG. 7 is a perspective view of an alternative embodiment of the individual urinary device;

FIG. 8 is a plane view of an embodiment of the individual urinary device comprising an animal shape;

FIG. 9 is a perspective view of a rectangular embodiment of the individual urinary device having a handle thereon;

FIG. 9A is an end plan view of the individual urinary device in FIG. 9;

FIG. 9B is a side plan view of the individual urinary device in FIG. 9;

FIG. 10 is an exploded side view of an absorbent embodiment of the invention; FIG. 11 is a top plan view of the apparatus suitable for the Flushability Test; and FIG. 12 is a cross sectional view of a portion of piping of the apparatus in FIG. 9.

DETAILED DESCRIPTION OF THE INVENTION

By the term "flushable" it is meant herein that the individual urinary device and the transformable package are designed to be flushed and have flushable (i.e., degrading) components therefor, and may be discarded into a urinal or toilet and subsequently flushed without damage being done to the attached plumbing. By the term "water dispersible" or "water dispersion" it is meant herein that the individual urinary device, once flushed, will substantially break apart into smaller components suitable for flushing. By the term "excess urine" or "residual urine" it is meant herein the urine, urethral discharge, blood, menses, or vaginal discharge present either on, around and/or within the urethral opening of a user, whether male or female with the understanding that certain types of discharges may be male and/or female specific. By the term "fully urinated" or "full urination" it is meant herein the completion of a user's exertion of substantially all urine that had been present in their bladder. By the term "individual urinary device" it is meant herein a device for wiping and/or cleaning urine from a user's urethral area or even a urinary device, such device being individually packaged in a transformable package. By the term "urethral area" it is meant herein the area in and/or around the urethral opening of a user, male or female. By the term "transformable package" or "transforming package" it is meant herein a package that individually encompasses or holds an individual urinary device and that once partially removed from the device, transforms or changes into a handle-like structure for grasping the individual urinary device which facilitates a sterile cleaning and/or wiping of a user's urethral area or that of a urinal or toilet.

All embodiments shown herein and any other variations of such a type of device may be packaged in the transformable package 60 as shown in FIG. 1. The transformable package 60 comprises a wrapper 50 that encloses the individual urinary device 20 to provide a sanitary environment. The wrapper 50 should at least partially enclose the individual urinary device 20, and preferably completely enclose the individual urinary device 20. The wrapper 50 preferably comprises a rectangular sheet of flexible material. The wrapper 50 can be folded about or wrapped around the individual urinary device 20 in any suitable manner necessary for achieving a singular wrapping about the individual urinary device 20. The wrapper 50 is preferably folded about or wrapped around the individual urinary device 20 with its longer sides oriented perpendicular to the longitudinal centerline L of the individual urinary device 20.

The transformable package 60 may be in any shape that is conducive for effective protection of a user's hand when using the individual urinary device 20. For example, as shown in Fig. 1, the package 60 comprises a rectangular wrapper 50 which suitably protects a user's fingers when wiping with the individual urinary device 20. However, the wrapper 50 may be in an oval, circular, square, polygonal or any other conceivable shape known in the art to protect a user from contact with urine. Additionally, the individual urinary device 20 may be in any shape conceivable, but preferably in a shape complimentary with the wrapper 50. By the term "complimentary" it is meant herein that the individual urinary device 20 will be in a shape that neither obstructs or prevents the proper use of the wrapper 50 either 1) when the wrapper encloses the device 20 or 2) when the wrapper 50 is peeled away from the device 20 prior to the use of the device 20.

In the preferred embodiment shown in FIG. 2, the wrapping of the wrapper 50 forms a longitudinal fold or bend 58 around the lower longitudinal edge 29 of the individual urinary device 20, upper longitudinal edge 52, side edges 54, and side panels 68. The upper longitudinal edge 52, that is, the longitudinal edge closest to the upper portion of the individual urinary device 20, and the side edges 54 are sealed to form the transformable package 60. The upper longitudinal edge 52 and side edges 54 are preferably frangibly sealed together forming crimped edges 56 to close off the sides and ends of the package. Suitable methods for frangibly sealing the edges of a package are described in U.S. Patent No. 4,556,146 issued to Swanson, et al., U.S. Patent No. 5,181,610 issued to Quick, and U.S. Patent 5,462,166 issued to Minton, et al. The transformable package 60 preferably has a line of weakness which can be in the form of perforations 66 that are positioned along the upper longitudinal edge 52 and extend substantially along each side edge 54 of the package. In other alternate embodiments, the line of weakness can be in the form of a score line, such as that made by laser scoring. The transformable package 60 preferably also has a tear strip or string 62 (see FIG. 4) that generally extends along and in the direction of the perforations 66. The transformable package 60 is opened by using the tear string 62 to break the perforations 66 along a significant portion of the periphery of the transformable package 60. This releases two distinct side panels 68 which will drape over both sides of the user's fingers, and exposes the individual urinary device 20. (See FIG. 3)

The wrapper 50 is partially removable from around the individual urinary device 20 and the portion of the wrapper 50 forming the longitudinal fold or bend 58 remains between the user's hand and the device 20 to assist in the positioning and placement of the device 20. This configuration assists the user in wiping and cleaning the urethral area while simultaneously shielding a user's fingers and hand from being soiled. FIG. 1 shows an opened transformable package 60, as described above, with one embodiment type of the individual urinary device 20 being used for wiping and cleaning the urethral area of a male or female.

In an alternative embodiment shown in FIG. 2, the transformable package 60 is provided with a tab 64 instead of a tear strip or string. The transformable package 60 is opened by lifting the tab 64 and breaking the perforations 66 that are positioned along the upper portion of at least one side panel 68, that is closest to the upper portion of the individual urinary device 20, to create an opening for the individual urinary device 20. The crimped edges 56 are pulled apart to release the side panels 68. The tab 64 is formed when an extension of the upper longitudinal edge 52 is folded over or bent over onto a side panel 68. The side edges 54 are sealed as described above. In yet another alternative embodiment, the wrapper 50 of any of the embodiments described herein can be formed with two separate sheets that are frangibly sealed around the periphery of the sheets to form an transformable package. In the embodiment shown in FIG. 4, the transformable package 60 is provided with a side opening feature, which may be a side tab 65 rather than a tear string 62. The side tab 65 preferably aligns with perforations 66 along the upper longitudinal edge of the package. The transformable package 60 is opened by peeling back the side tab 65 and breaking the perforations 66 that are positioned along the upper longitudinal edge 52 to expose the upper portion of the individual urinary device 20. The crimped edges 56 are pulled apart to release the side panels 68 (see FIG. 1). The side tab 65 may be formed in a number of ways, one of which removes material to form the side tab 65 after the package has been sealed by cutting the desired pattern of the side tab 65. For example a notch 67 can be cut into the side edge 54 of the package to form the side tab 65. Another way to form the tab would be to precut the wrapper material prior to forming the transformable package.

The individual urinary device 20 shown in FIG. 1 preferably provides a convenient zone for grasping the product and wiping and cleaning the urethral are of a user, male or female. The lower portion 28 of the central absorbent portion 22 can be grasped by the user, and held as the wrapper 50 is opened as described above. As shown in FIG. 1, the wrapper 50 is still in contact with the individual urinary device 20, as the user positions the individual urinary device 20 for wiping and cleaning of a user's urethral area. Preferably, the wrapper 50 remains in contact with the individual urinary device 20 throughout the use of the device 20 during wiping and cleaning. The wrapper 50 may then preferably at least partially re-cover the device 20 in preparation for its disposal.

An advantage of the present invention, as shown in FIG. 1 , is that it protects the user's fingers from touching either the individual urinary device 20 or the urethral area when wiping and cleaning thereof. The side panels 68 drape completely over both sides of the user's fingers to maintain a hygienic environment for inserting and placing the product. Another advantage of the present invention is that it provides a protective covering for the individual urinary device 20 during transport or storage of the product. Maintaining a hygienic environment for the individual urinary device before and during use is vital to prevent transferring unsanitary particles to the urethral area.

Alternatively, the embodiment shown in FIG. 7 can have perforations that are longitudinally positioned midway between the upper and lower longitudinal edges 52 and 29, and are located on both sides of the transformable package 60. To open the package 60, the user would peel back and remove the upper portion of the wrapper and use the lower portion of the wrapper to grasp the lower portion of the individual urinary device 20. The wrapper would remain between the user's fingers and hands and the individual urinary device 20, assist the user in positioning and using the device 20, and keep the user's fingers from touching the device 20 to maintain a sterile environment.

Preferably, the wrapper 50 has a thickness of from about 0.0127 mm (0.5 mil) to about 0.127 mm (5.0 mils). The wrapper 50 may be made from plastic films which may be thermoplastic, nonwoven materials, collagen films, paper tissues, or laminates of tissue and a film, nonwoven material and a film, or any of the foregoing types of material with a coating thereon. One embodiment of the present invention may be made from a low basis weight tissue that disintegrates in water. The low basis weight tissue can be made of carboxymethyl cellulose with wood pulp fibers that will preferably disintegrate in water with a temperature of 75 °F (24 °C) in approximately 6 seconds; and disintegrate in water with a temperature of 50 °F in approximately 8 seconds. One such material is sold as DISSOLVO® WLD-35 water soluble purge dam material for gas-tungsten arc (TIG) welding by CMS Gilbreath Packaging Systems of Bensalem, PA.

In addition, such low basis weight tissues may be combined with coatings or films like polyvinyl acetate (PVA), polyvinyl alcohol (PVOH), or methyl hydroxy propyl cellulose (MHPC) that also dissolve in water. One such material is sold as Mono-Sol®

MC-8630 water soluble film by Chris Craft® Industrial Products, Inc., Gary, IN. One preferred laminate material is made using a Hot Roll Laminator obtained from

Chemlnstruments by combining a 0.089 mm (3.5 mil) thick sheet of DISSOLVO®

WLD-35 tissue with a 0.038 mm (1.5 mil) Mono-Sol® MC-8630 MHPC water soluble film. Laminating the tissue at a temperature between 344 °F (173 °C) to 366°F (185 °C) and at a feed rate between 35 ft/min to 50 ft/min with the MHPC film produces a material 0.1 mm (4 mil) thick that is preferred for making the wrapper of the present invention.

The laminated material preferably has a basis weight of about 93.6 g/mA The material will preferably disintegrate in water with a temperature of about 75 °F (24 °C) in approximately 6.1 seconds and about 7.9 seconds in water with a temperature of about 50 °F. The average time for the laminated material to dissolve is approximately 17.3 seconds in water with a temperature of about 75 °F (24 °C) and 34.4 seconds in water with a temperature of about 50 °F (10 °C).

The tear resistance (tear strength) of the film alone is approximately 1575 gf, while the tear resistance of the DISSOLVO® WLD-35 is approximately 25 gf in the direction of the process flow through a manufacturing line for making the paper, the machine direction (MD), and 25 gf in the direction perpendicular to the machine direction, the cross-machine direction (CD). The tear resistance of the laminated material is approximately 88 gf (MD), and 76.8 gf (CD). The tear strength of the laminate is significantly less than that of the film by itself. The increase in the tear strength when comparing the paper to the laminated material provides a stronger package that will not tear as easily as paper alone. The reduction in tear strength when comparing the film to the laminated paper and film enables the user to open the package with greater ease than if the package were made from the film alone. When the materials are laminated, the superior tear resistant properties of the film are compromised, yet the strength of the paper is significantly increased, providing an ideal package that is easily opened, yet strong enough to resist tearing from handling and transporting.

The laminated material, like a number of the other wrapper materials identified above, also aids in heat sealing the package, provides a sanitary and moisture-free environment, and reduces noise associated with tearing paper when opening and carrying the package. The laminated material also produces a wrapper that can be opened with or without a line of weakness.

The coated side of the paper can either face the product or serve as the outer portion of the wrapper that is touched by the user. The coated side can be placed adjacent to the individual urinary device 20 to protect against moisture. When the coating is applied or laminated to the wrapper material as a continuous film it forms a nonporous, impervious barrier that blocks moisture. However, placing the non-coated side of the wrapper 50 adjacent to the individual urinary device 20 provides an absorbent surface on the inside surface of the side panels 68, such that when the wrapper 50 is opened, the device 20 can be used to absorb and wipe away urine.

The wrapper 50 is preferably constructed of material that aids in providing comfort during insertion. The laminated material, like a number of the other wrapper materials identified above, provides a softer wrapper material. The wrapper 50 is preferably constructed of materials which are at least 70% biodegradable, more preferably at least 90% biodegradable, and/or which will fragment in water with agitation (as in a toilet). Preferably, the individual urinary device 20 and the wrapper 50 for the individual urinary device are both flushable separately or in combination, and when flushed the wrapper or the combination of the individual urinary device and the wrapper will clear the toilet 80% of the time and biodegrade at least 95% of the time in a 28 Day Sludge Test. As used herein the terms "flushable and flushability" refer to an article's ability to pass through typical commercially available U.S. household toilets and plumbing drainage systems without causing clogging or similar problems that can be directly associated with the physical structure of the article.

It is recognized, however, that there can be many differences between the various types of toilets available. Therefore, for the purposes of the appended claims, a test to determine the flushability of a catamenial product, such as an individual urinary device and its wrapper (i.e., the transformable package) set out in the TEST METHODS section of this specification. In addition, numerous embodiments of the transformable packages described herein are possible. For example, the package could be provided in other configurations while still performing the functions described herein. Further, the packaging materials described herein can be used with a variety of absorbent articles configured for the absorption of body fluids such as female or male incontinence products, tampons, or externally worn sanitary napkins where a hygienic environment is a paramount concern. For instance, the adhesive on sanitary napkins and/or the wing adhesive of winged sanitary napkins can be covered by cover strips made of such materials. Additionally, a wrapper that serves as an transformable package for a sanitary napkin such as that described in U.S. Patent 4,556,146 entitled "Individually Packaged Disposable Absorbent Article" which issued to Swanson et al. on December 3, 1985 could be provided that is made of such a material.

Figure 5 discloses a rectangular embodiment of the individually packaged urinary device 20 or individual urinary device 20 or device 20. The individual urinary device 20 is shown with its first side 22 facing upward. The second side 24 is positioned opposed to the first side 22 and therefore is not shown. If the device 20 comprises multiple layers, i.e., more than one layer, then the first side 22 will also correspond to the top surface 22 of the device 20 and the second side 24 will correspond to the bottom surface 24 of the device 20. The individual urinary device 20 is hand-held because a user holds the device 20 in his/her hand rather than attaching the device 20 in one's undergarments; e.g., a user's briefs, panties, etc. The objective of the device 20 therefore is to provide an independent, separate mechanism that allows a user to, for example, partially remove the device 20 from a transformable package. Such individual urinary device's positioned within their individual transformable packages may be stacked into a box, not unlike a Puffs® tissue box or some such other similar device in the art that would allow the individual urinary device to be readily dispensed.

More specifically, the individual urinary device 20 comprises a first side 22, a second side 24 positioned opposite to the first side 22 wherein the individual urinary device 20 draws urine from within and/or without the urethra of a user, such that a user, after urination has occurred, holds the device 20 in one hand and in proximate location to the user's urethral opening to draw excess urine into the device 20. The user may be either male or female, and a user's age serves as no restriction for use of the individual urinary device.

By drawing urine into the individual urinary device 20, it is meant herein that the device by capillary forces actually pulls urine away from the urethral area of a user. For a male, the device 20 will have the ability to draw excess urine from within or without a user's urethra. Any number of known configurations in the art to effect a capillary gradient may be used for the individual urinary device 20 and are considered part of its use herein. In addition, such drawing away and absorbing of excess urine may be effected by the use of particularly suitable types of materials; e.g., soluble starch, capillary channel fibers, or treated polypropylene or polyethylene fibers.

In one embodiment, the individual urinary device 20 may consist of one layer of absorbent material. In a preferred embodiment of the device 20 herein, it may comprise multiple layers of material having at least a top layer and a bottom layer. In such a multi- layered device 20, there may be several in-between layers of fibrous absorbent material, acquisition material and/or absorbent gelling material. Such in-between layers would be primarily responsible for the effective fluid distribution and/or absorption of urine from a user. One layer of absorbent material may be formed from a wide variety of liquid- absorbent materials commonly used in absorbent articles such as comminuted wood pulp that is generally referred to as airfelt. Examples of other suitable absorbent materials include cotton; creped cellulose wadding; meltblown polymers including coform; chemically stiffened, modified or cross-linked cellulosic fibers; synthetic fibers such as crimped polyester fibers; peat moss; tissue including tissue wraps and tissue laminates; absorbent foams; absorbent sponges; superabsorbent polymers; absorbent gelling materials; or any equivalent material or combinations of materials, or mixtures of these. Some preferred absorbent materials may comprise soluble starch, folded tissues, woven materials, nonwoven webs, needle punched rayon, and thin layers of foam. The individual urinary device 20 preferably disperses into fragments which are readily flushable in a normal toilet. The preferred liquid pervious material for an individually packaged, urinary device 20 comprises a wet laid apertured layer having a temporary wet strength resin incorporated therein. Portions of the body surface of the tissue are further provided with a resinous material. Preferably, the resinous material comprises a water resistant resinous material that is provided in the form of fibrils printed on the body surface of the first and/or second sides of the device 20. Alternatively, the resinous material can provide at least one of the sides of the device 20 with a surface energy gradient between the body surface thereof and the garment surface thereof. If a topsheet is present, the preferred topsheet of the present invention acquires bodily fluids rapidly and serves to prevent such acquired fluids from rewetting the first and/or second side of the device 20 when used.

In an alternative embodiment, the first and second sides of the individually packaged, urinary device 20 each comprise a wet laid fibrous assembly having a temporary wet strength resin incorporated therein. The sides are further coated with a water resistant resinous material that causes each side of the device 20 to become impervious to body fluids without impairing the spreading of adhesive materials thereon. Materials of the type described herein represent an improvement over those described in the art in that flushable articles of the prior art typically use materials having a very low critical surface tension to help ensure their imperviousness with resulting difficulty in adhesively joining such materials to the remaining components of an absorbent article. The materials used as or in the device's first and second sides present no such joining issues.

An individual urinary device 20 herein may be assembled by disposing the first and second sides topsheet (where present) and backsheet (where present) of the device 20 such that the surface thereof that is coated with the water resistant resinous material is oriented toward any sort of absorbent or acquisition material; e.g., absorbent core 36 (FIG. 10). Each core and topsheet are disposed thereon, and the components joined using means known to those skilled in the art. A water soluble adhesive is used to join the components of the device 20 so that the components will separate the device 20 when flushed. Flushable absorbent articles are described in greater detail in U.S. Patent Application Serial No. 08/561,989, entitled "Water Dispersible and Flushable Absorbent Article" filed on November 22, 1995 by Christon, et al., which is incorporated herein by reference.

In one preferred embodiment herein, the individual urinary device 20 may comprise soluble starch. More specifically, the soluble starch is an expanded amylose starch product having at least 45% by weight amylose content, the expanded product having a low density, closed cell structure with good resilience and compressibility properties. More particularly, the expanded packaging material of this invention has a uniform closed cell structure with a bulk density of less than about 2.0 lb/ft.³, a resiliency of at least about 50% and a compressibility of from about 100 to about 800 g/cm². U.S. Patent No. 4,863,655 entitled "Biodegradable Packaging Material And The Method Of Preparation Thereof issued to Lacourse, et al. on Sept. 9, 1989 which describes the aforementioned starch is hereby incorporated by reference herein. It is further noted herein that other types of starches either soluble in water or readily made soluble in water are contemplated for the purpose of use in the individually packaged, urinary device 20.

In a highly preferred embodiment shown in Figs. 2 and 5-5B of the individual urinary device 20 herein, a handle 30 which is separate from the transformable package but preferably operable therewith, may be formed into or onto the device 20. In addition, the handle 30 may be joined or attached onto the bottom surface 24 of the device 20. The term "formed into" means herein that a handle or grasping portion has been made from material that is an inherent part of the device without the need for a separate element; it is therefore an integrated part of the device 20. By the term "formed onto" it is meant herein that an element may be joined or attached onto another element or structure herein. The term "joined", as used herein, encompasses configurations in which an element is directly secured to another element by affixing the element directly to the other element; and configurations in which the element is indirectly secured to the other element by affixing the element to intermediate member(s) which in turn are affixed to the other element. The handle 30 serves as a mechanism by which a user may hold the individual urinary device 20. Furthermore, the handle 30 may be so attached to the device 20 or configured on the device 20 as to allow a user to wick urine into itself and avoid substantially all contact with urine to be wicked when using the device 20.

As a secondary use, the individual urinary device 20 may also, once it has been used to absorb urine from a user, also be used to clean urine incidentally placed along the rim of a toilet. Especially for those devices 20 having handles 30 (Figs. 2 and 5-5B), a user may, once he has cleaned urine from himself, use the device 20 to remove urine either from the rim or toilet seat of a toilet. Use of the individual urinary device 20 to spot clean a toilet would provide a quick and convenient manner in which to keep a toilet substantially un-spotted between more thorough and exhaustive cleanings of a toilet or urinal.

Figure 7 provides an alternative embodiment of an individually packaged, urinary device 20 that comprises a bundle of fibers 45 substantially bound by a sheath or cover 45. The fibers 45 may protrude from one end of the sheath 45 as is shown or they may protrude from both ends of the sheath 45. In using the device 20 of FIG. 7, a user, male or female, would grasp the sheath portion of the individual urinary device 20 and touch, in the case of a male user, the area of the penis around the urethral opening to absorb any excess urine within or outside of the urethral opening. While not being bound by any particular theory, it is believed that the make-up of the fibers, i.e., their type, configuration, length, and diameter, control the draw of urine into the device 20. Of particularly preferred usage for fibers in the device 20 are capillary channel fibers. Capillary channel fibers are fully disclosed and discussed in U.S. Patent No. 5,688,259 issued to Osborn, et al. on November 11, 1997 entitled "Absorbent Article Having Resilient Center" and is fully incorporated by reference herein. Also, the fibers 45 may be manufactured from a wide variety of liquid-absorbent materials commonly used in absorbent articles such as comminuted wood pulp that is generally referred to as airfelt. Examples of other suitable absorbent materials include cotton; creped cellulose wadding; meltblown polymers including coform; chemically stiffened, modified or cross-linked cellulosic fibers; synthetic fibers such as crimped polyester fibers; peat moss; tissue including tissue wraps and tissue laminates; absorbent foams; absorbent sponges; superabsorbent polymers; absorbent gelling materials; or any equivalent material or combinations of materials, or mixtures of these. Some preferred absorbent materials may comprise folded tissues, woven materials, nonwoven webs, needle punched rayon, and thin layers of foam.

Figure 8 provides a fish shaped individual urinary device 20. The individual urinary device 20 may be manufactured in any of a number of shapes and sizes including animal shapes. The fish shaped device 20 represents just one of a myriad of possible animal shapes. Other shapes may include giraffes, lions, monkeys, snakes, turtles, birds, mythical creatures, people and nearly any conceivable type of animal shape, cartoon character and/or famous personality imaginable. In this instance, a child user in the midst of learning how to use an indoor toilet would also be taught how to keep himself or herself and the toilet area clean by using a urinary wipe, i.e., the individual urinary device 20.

The individual urinary device 20 may absorb and/or distribute urine within its structure. For example, the individual urinary device 20 may comprise a density gradient 50 (FIG. 10) that facilitates the drawing of urine away from a user's urethra to the device 20. In one preferred embodiment herein, the density gradient may comprise i) a first tissue sheet 52 having capillaries, the first tissue sheet 52 being positioned adjacent to the

3 3 • top surface 22 and having a density from about 0.01 g/cm to about 0.1 g/cm ; and ii) a second tissue sheet 54 having capillaries, the second tissue sheet 54 being positioned adjacent to and below the first tissue sheet 52 and having a density of from about 0.08

3 3 g/cm to about 0.3 g/cm , the difference in density between the first and the second tissue

3 3 sheets being from about 0.01 g/cm to about 0.2 g/cm . The density gradient 50 formed between the first tissue sheet 52 and the second tissue sheet 54 are positioned adjacent to one-another such that fluid impacting the first tissue sheet 52 will be drawn from the first tissue sheet by capillary suction exerted by the smaller capillaries of the lower and more dense second tissue sheet 54. In another preferred embodiment herein, the density gradient 50 further substantially locks in urine to prevent the urine from wicking out of the device 20. Discussion of the preferred density gradient herein is provided in U.S. Patent Application No. 08/791,094 entitled "Sanitary Napkin Comprising An Absorbent Core Having A Density Gradient", all of which discussion is incorporated herein by reference.

The individual urinary device 20 may be in any of a number of shapes including, squares, triangles, ovals, polygonals, etc. Furthermore, the device 20 may comprise a topsheet and a backsheet joined to that topsheet (FIG. 10). As described above, the device 20 is preferably flushable and may disperse into many smaller parts upon flushing. The top surface of the device, whether covered with topsheet material or not, may employ a surfactant, a lotion, an emollient, anti-microbial agents, cranberry extract, medicine, alcohol, water, perfume, fragrance, pH markers, moistening agents, cleaning agents or any of a combination of these or like substances. Finally, the device 20 when used by a male will preferably at least partially cover the end of a male user's penis but will more preferably cover substantially all of the end of a male user's penis.

In one preferred embodiment herein, the individual urinary device 20 according to the invention is characterized in that the first tissue sheet 52 is located closest to the top surface 22 and where a topsheet is present, the first tissue sheet 52 is located closest to and/or adjacent to the topsheet 32. The density of the first tissue sheet 52 ranges from about 0.01 g/cm³ to about 0.1 g/cm³. The density of the second tissue sheet 54, which is positioned closest to and/or adjacent to the bottom surface 24 or backsheet 34 where present, ranges from about 0.08 g/cm³ to about 0.3 g/cm³.

Preferably, the density gradient between the first and second tissue sheets causes the first tissue sheet 52 to be drained rapidly, the liquid being drawn from the first tissue sheet 52 by the capillary suction which is exerted by the smaller capillaries of the second and more dense tissue sheet 54. The first tissue sheet 52 is thereby quickly emptied and can receive subsequent trickles or gushes of liquids, specifically urine, so that the strike through rate of urine passing through the top surface 22 into the absorbent core 36 (FIG. 10), is increased. Since the caliper of the tissue sheets is relatively small, the density gradient is established over a relatively short distance, so that the capillary suction on the liquid exerted by the second tissue sheet 54, effectively extends throughout the thickness of the whole of the first tissue sheet 52.

The rapid draining of the first tissue sheet 52 and consequent permanent availability of the first tissue sheet 52 to absorb incoming liquids, increases the effective capacity of the individual urinary device 20, wherein the effective capacity is understood as the amount of urine absorbed before soiling occurs by migration of urine past the periphery of the individual urinary device 20.

In the second tissue sheet 54, the liquids are distributed in a lateral direction, the distributing capacity of the second tissue sheet 54 being relatively high, due to its high density. After distribution in the second tissue sheet, the urine may be absorbed and retained into a lower absorbent core 36 if it is present. Otherwise, the urine may remain in the second tissue sheet 54 which can also operate to have some absorptive capacity. Such absorptive capacity in the second tissue sheet 54 may come from the presence of absorptive fibers like cellulose and/or absorbent gelling particles that could be placed in the second tissue sheet 54. If an absorbent core 36 is present in the device 20, it will be positioned below the second tissue sheet 54 and will comprise suitable absorptive materials like cellulose fibers and/or absorbent gelling material, thus at least partially freeing the second tissue sheet 54 from comprising such materials.

When present in the device 20, the absorbent core 36 therein may comprise any suitable type of absorbent structure that is capable of absorbing and/or retaining liquids (e.g. menses and/or urine). The absorbent core 36 may be manufactured in a wide variety of shapes. Non-limiting examples include ovoid, trapezoidal, rectangular, triangular, cylindrical, hemispherical or any combination of the above. The absorbent core 36 may, likewise, be manufactured from a wide variety of liquid-absorbent materials commonly used in absorbent articles such as comminuted wood pulp that is generally referred to as airfelt. Examples of other suitable absorbent materials include cotton; creped cellulose wadding, meltblown polymers including coform, chemically stiffened, modified or cross-linked cellulosic fibers, synthetic fibers such as crimped polyester fibers, peat moss; tissue including tissue wraps and tissue laminates, absorbent foams; absorbent sponges, superabsorbent polymers, absorbent gelling materials, or any equivalent material or combinations of materials, or mixtures of these. Preferred absorbent materials comprise folded tissues, woven materials, nonwoven webs, needle punched rayon, and thin layers of foam. The absorbent core 36 may comprise a single material or a combination of materials, such as a wrapping layer surrounding a central wadding comprised of a different absorbent material.

TEST METHODS

Flushability

Overview

As noted above, the terms "flushable or flushability" refer to an article's capacity to pass through typical commercially available household toilets and plumbing drainage systems without causing clogging or similar problems that can be directly associated with the physical characteristics of the article. For the purpose of the appended claims, individually packaged, urinary devices and their wrappers are evaluated for flushability via relative ease of toilet bowl, urinal and trap evacuation and subsequent transport through a simulated plumbing system. The flushability of such an article should be measured by the following test procedure.

The test procedure is designed to simulate two days of normal toilet usage for a family of 4 (2 men, 2 women). The test employs a flushing sequence to simulate the following conditions: male urination visits, female urination visits (including post urinary drying with tissue), disposal of the individually packaged, urinary device or wrapper with cleaning using tissue, and bowel movement visits. The amount of tissue to be used for each tissue flush is a normal loading of 2 strips of seven sheets. The normal loading is based on consumer research regarding typical habits and practices. The test is designed to simulate the conditions an article will encounter if it is flushed through a conventional toilet and into a municipal sewer or into a septic tank. Samples are evaluated for: 1) toilet bowl and trap clearance, 2) drain line blockage, and 3) disintegration during flushing.

Apparatus

An apparatus suitable for the flushability test is shown in plan view in Figure 11. The apparatus includes:

• a 3.5 gallon (13.2 liter) water saver siphon vortex toilet referred to as 210 (additional toilets can also be attached to the piping layout shown in FIG. 11 to evaluate the behavior of test samples using different flushing mechanisms such as commercial, pressure toilets);

• approximately 59 feet (18 meters) of 4 inch (10 cm) inside diameter acrylic pipe (As can be seen from FIG. 11, the piping is assembled in roughly a square configuration having linear runs 211, 213, 215, 217, 219, 221 approximately 10 feet (3 meters) long);

• a cast iron tee 223 slightly downstream of the toilet 210 that is open to the atmosphere for venting;

• five cast iron ninety degree elbows 212, 214, 216, 218, and 220;

• a spike or snag 222 positioned vertically (FIG. 12) approximately 15 feet from the pipe's terminal end and approximately 1 inch (2.5 cm) long; and

• a screen 224 (No. 4 Tyler sieve) to capture solid effluent for evaluation of disintegration.

The apparatus used for this method is set up to be equivalent to ANSI Standard Al 12.19.2M-1990 for Vitreous China fixtures. The piping is plumbed to provide a drop of 0.25 inch per foot (2 centimeters/meter) of pipe length.

Materials

Tissue Product used in Test: Standard CHARMIN® toilet tissue manufactured by The Procter & Gamble Company of Cincinnati, Ohio.

Synthetic Fecal Material: Prepared according to the method described below

Test Flushing Sequence

The test flushing sequence, consisting of two routines, simulates 2 days of normal toilet usage for a family of 4 (2 men, 2 women; based on consumer habits and practices research). The sequence of 40 total flushes consists of 14 flushes with an empty bowl; 8 flushes with tissue only; 6 flushes with tissue and wrapper; 6 flushes with tissue, individually packaged, urinary device and wrapper; and 6 flushes with tissue and simulated fecal matter (SFM). When testing the wrapper and individually packaged, urinary device as a combination, perform routines 1 and 2 using both the wrapper and the individually packaged, urinary device placed individually into the bowl by first removing the product from the wrapper. The SFM, when it is used, is placed in the bowl just prior to the addition of tissue. The SFM loading of 160 g ± 5 g consists of two 1 inch (2.5 centimeter) x 4 inch (10 centimeter) pieces and one 1 inch (2.5 centimeter) x 2 inch (5 centimeter) piece. Folded tissue strips are placed in the bowl at 10 second intervals. Ten seconds after the final strip of tissue, the individually packaged, urinary device or wrapper is placed into the bowl, the toilet is flushed. The flushing sequence is described below as a series of two routines combined in the following order:

Routine #1 (To be performed first 6 times for a total of 36 flushes)

1) Flush With Tissue Only - Take a drain line blockage reading 2 minutes after the water reaches the simulated obstruction, the snag point, wait 1 additional minute, and move to step 2.

2) Flush With Empty Bowl. Take a drain line blockage reading 2 minutes after the water reaches the snag point and move to step 3.

3) Flush With Tissue and Wrapper - Take a drain line blockage reading 2 minutes after the water reaches the snag point, wait 1 additional minute, and move to step 4.

4) Flush With Tissue and individually packaged, urinary device and wrapper - Take a drain line blockage reading 2 minutes after the water reaches the snag point, wait 1 additional minute, and move to step 5.

5) Flush With Empty Bowl. Take a drain line blockage reading 2 minutes after the water reaches the snag point and move to step 6. 6) Flush With Tissue and Simulated Fecal Matter (SFM). Take a drain line blockage reading 2 minutes after the water reaches the snag point, wait 1 additional minute.

Routine #2 (To be performed 1 time for a total of 4 flushes)

1) Flush With Tissue Only - Take a drain line blockage reading 2 minutes after the water reaches the snag point, wait 1 additional minute, and move to step 2.

3) Flush With Tissue Only - Take a drain line blockage reading 2 minutes after the water reaches the snag point, wait 1 additional minute, and move to step 4.

4) Flush With Empty Bowl. Take a drain line blockage reading 2 minutes after the water reaches the snag point.

Total number of flushes for the sequence (Routine 1 + Routine 2) is 40.

If, after the second flush in the flushing sequence, the product remains in the bowl or trap after flushing, the tissue and/or catamenial product and/or individual urinary device and/or wrapper is plunged into the drainage line manually and the flushing sequence will continue. After completion of each trial loading, the drainage pipe will be cleared prior to beginning subsequent testing.

The above described flushing sequence is repeated three times for each test product.

Data Reporting

The degree of drain line blockage is determined by measuring the length of water dammed up behind the obstruction. Graduations are marked every 12 inches (30 centimeters) on the drainpipe upstream of the obstruction. Each one foot length that the water is backed up corresponds to 0.25 inch (0.6 centimeter) or 6.25% of blockage at the obstruction point. Test product residues which exit the drainpipe are also collected.

The following data are recorded for each evaluation:

1) Incidence of failure (%) of the individual urinary device or wrapper to clear the bowl and trap in one flush

2) Incidence of failure (%) of the individual urinary device or wrapper to clear bowl and trap in two flushes

3) Incidence of individual urinary device or wrapper on simulated snag

4) Maximum level (%) of drain line blockage

5) Cumulative level (%) of drain line blockage over the 2 day simulated test period.

Preferably, the individual urinary device and/or wrapper described herein will completely clear the bowl at least about 70% of the time in two or fewer flushes, more preferably at least about 80% of the time in one flush, and most preferably at least about 95% of the time in one flush. The individual urinary device and wrapper described herein will preferably have a maximum level of drain line blockage of less than or equal to about 80%. The individual urinary device and wrapper described herein will preferably have a cumulative level of drain line blockage over the 2 day simulated test period of less than or equal to about 50%.

Preparation of Synthetic Fecal Material

I. Materials Needed:

• Feclone synthetic fecal matter (900 grams);

(Available from Siliclone Studio, Valley Forge, PA as product BFPS-7 dry concentrate) • Tap water at 100° C (6066 grams)

II. Equipment Needed:

Mixer (Available from Hobart Corp., Troy, OH as Model A200)

Extruder (Available from Hobart Corp., Troy, OH as Model 4812)

• Disposable Centrifuge tubes with screw caps (50 ml) (Available from

VWR Scientific, Chicago, IL as Catalog No. 21-008-176)

Water Bath to control temperature to 37 C.

III. Preparation:

1. Pour the 100° C water into the mixing bowl of the mixer and add the dry

Feclone concentrate.

2. Mix on low for 1 minute.

3. Mix on medium speed for 2 minutes.

4. After the material is well mixed, transfer to the extruder.

5. Using an ice pick, punch a small hole in the tip of each centrifuge tube.

6. Extrude the Feclone into the centrifuge tubes.

7. Cap the centrifuge tubes and store in the refrigerator.

8. Before using, put the tubes in the water bath at 38° C. Water Dispersion Test

Apparatus

Stirrer Magnetic, Thermolyne type Model S7225 or 7200. Permanently inscribe a circle 3.5 inches (8.9 centimeter) on the top surface of the stirrer. The center of the circle must be coincident with the geometric center of the stirrer.

Stirring Bar 2.5 inch (6.2 centimeter) TEFLON coated with spinning ring. Permanently mark one end of the bar with black ink for a distance of 0.5 inch (1.2 centimeter) back from the tip.

Thermometer 30 to 120°F with 1 degree divisions

Timer Digital stopwatch

Stroboscope Variable speed stroboscope, model 964 available from Strobette, Power Instrument, Inc. of Skokie, IL is suitable

Beaker Kimax brand 2000 milliliter with spout with a diameter at the base of 135 ± 2 mm and a height at the 2000ml mark of 162 ± 2 mm, Inscribe a fill mark at a height of 5.6 inches (14.3 centimeters) from the flat bottom of the beaker. Do not use any beaker not having a flat bottom.

Conditioned Room Temperature and humidity should be controlled to remain within the following limits:

Temperature: 73±3°F (23°C±2°C)

Humidity: 50±2% Relative Humidity

Test Setup 1. Fill the beaker to the fill mark with 73±3°F (23°C±2°C)

tap water.

2. Place the beaker on the magnetic stirrer centering it in the inscribed circle.

3. Add the stirring bar to the beaker.

4. Turn the stroboscope on and set the speed to 1000 rpm according to the manufacturer's directions.

5. Turn the magnetic stirrer on with the on/off switch. Adjust the speed of the magnetic stirrer until the stirring bar appears to be stationary and both ends appear to be black. This indicates that the magnetic stirrer is turning at 500 rpm (i.e. half the setting on the stroboscope). Turn the magnetic stirrer off with the on/off switch.

Procedure

1. Hold a sample (e.g. an absorbent individually packaged, urinary device or wrapper ) 3 to 4 inches (7.6 to 10.2 centimeters) above the surface of the water. Gently drop the sample onto the water surface, starting the timer when the sample touches the water surface.

2. Wait 5 seconds.

3. Start the magnetic stirrer with the on/off switch. If the sample disrupts the rotation of the stirring bar, stop the stirrer, re-orient the bar, and immediately start the stirrer again.

4. Record the time required until the sample separates into at least two pieces. Separation does not include the disassociation of a few individual fibers from an otherwise intact sample. The time is the total time the sample is immersed in the water including the time the stirrer may have been stopped to re-orient the sample.

If the individual urinary device or wrapper repeatedly cause substantial disruption to the rotation of the stirring bar, the individual urinary device and wrapper may be suspended by a string attached to the individual urinary device and wrapper via a clamp attached to the individual urinary device and wrapper 3/8" (.95 cm) from the edge of the individual urinary device and wrapper, and then suspending the lowest end of the individual urinary device and wrapper 1 " above the stir bar.

5. Repeat steps 1 through 4 with an additional 3 samples.

Calculation and Reporting

Calculate and report the mean and standard deviation of the water dispersibility time for the four samples tested. Preferably, the individual urinary device and wrapper will disperse into at least two fragments in less than or equal to about two hours.

Wet-Out Time

1. Hold the absorbent individually packaged, urinary device or wrapper 3 to 4 inches (7.62 to 10.16 cm) above the surface of distilled water.

2. Gently drop the sample onto the water surface, so that the broad surface of the package strikes the surface.

3. Start timing when the sample is completely wet.

4. Repeat steps 1-2 for five samples. Report a mean and standard deviation for the wet-out time. The wet-out time is preferably less than or equal to 30 seconds and more preferably less than or equal to 15 seconds.

28 Day Sludge Test

Purpose:

To determine the extent to which a individual urinary device and wrapper disintegrates upon exposure to biologically active anaerobic sludge. Anaerobic conditions are typically found in household septic tanks, as well as in municipal sewage treatment facilities in the form of anaerobic sludge digesters. Test products, such as the individual urinary device and wrapper are combined with anaerobic digester sludge to determine the extent and rate of disintegration of test products over a 28 day period. Disintegration (as measured by weight change) is typically measured on days 3, 7, 14, 21 and 28 of the particular study. This protocol is modeled after the National Sanitation Foundation, Ann Arbor, Michigan, International Protocol: Evaluation of the Anaerobic Disintegration of a Test Product, November, 1992.

Materials:

Control Product

Tampax brand tampons will be used as a positive control product in the anaerobic disintegration test.

Material Preparation

Prior to the addition of the test and control products to the reactors, the materials will be dried in a hot air oven at 103° + 2°C for 2 hours and then weighed to determine the initial weight. Approximately equal weights of the control and test products will be placed in respective reactors. Anaerobic Sludge:

The sludge used in this evaluation will be anaerobic sludge obtained from a municipal waste water treatment plant, or raw sewage obtained as influent from a waste water treatment plant that has been concentrated by settling and decanting the overlying water. Prior to use in the evaluation, the following parameters of the sludge will be measured in accordance with standard laboratory operating procedures:

Total solids

Total volatile solids

pH

The sludge should meet the following criteria for use in the evaluation:

pH between 6.5 and 8

Total solids > 15,000 mg/L

Total volatile solids > 10,000 mg/L

The criteria for the activity of the sludge requires that the control tampon material must lose at least 95% of its initial dry weight after 28 days exposure.

Procedure:

The test and control products are added to a 2L wide mouth glass flask (reactor) containing 1500 ml of anaerobic digester sludge or concentrated raw sewage. Three reactor flasks per test material per sampling day are prepared. Thus, if disintegration is measured on days 3, 7, 14, 21, and 28, there will be a total of 15 reactor flasks for the test product and 15 flasks for the control product. The reactors are sealed and placed in an incubator maintained at 35+2°C. On the specified sampling days, three reactors each for the test and control material are removed from the incubator. On the designated sample days, the contents of each reactor will be passed through a 1 mm mesh screen to recover any non-disintegrated material. Any collected material will be rinsed with tap water, removed from the screen and placed in a hot air oven at 103 + 2°C for at least 2 hours. The dried material will be weighed to determine final weight. Visual observations of the physical appearance of the materials when recovered from the reactors will also be made and recorded.

Results:

The rate and extent of anaerobic disintegration of each test material and the control material is determined from initial dry weights of the material and the dried weights of the material recovered on the sampling days. The percent anaerobic disintegration is determined using the following equation (percent weight loss):

Percent Disintegration = (initial dry weight - final dry weight) _x I QO

( initial dry weight)

The average percent disintegration for the test and control products for each sampling day will be presented. For the purposes of the appended claims, the percent disintegration values are for day 28 of the study.

The disclosure of all patents, patent applications (and any patents which issue thereon, as well as any corresponding published foreign patent applications), and publications mentioned throughout this description are hereby incorporated by reference herein. It is expressly not admitted, however, that any of the documents incorporated by reference herein teach or disclose the present invention.

While particular embodiments of the present invention have been illustrated and described, it would be obvious to those skilled in the art that various other changes and modifications can be made without departing from the spirit and scope of the invention. It is therefore intended to cover in the appended claims all such changes and modifications that are within the scope of this invention.

Claims

WHAT IS CLAIMED IS:

1. An individual urinary device for the absorption of urine having a top and a bottom, comprising:

a first side;

a second side positioned opposite to the first side wherein the individual urinary, absorbable device absorbs urine from within or without the urethra of a user; and

a package encompassing and protecting the device before use of the device by a user, the package being at least partially removable from the device to expose the first side of the device, the package also being transformable into a grasping portion from which to hold the device upon use such that a user, after urination has occurred, holds the device in one hand by the grasping portion with the first side of the device positioned and facing towards the user's urethral opening to draw excess urine into the device while the grasping portion protects the fingers of the user from the excess urine.

2. The individual urinary device of Claim 1 wherein the package and the device are water dispersible.

3. The individual urinary device of Claim 1 wherein the device consists of one layer of absorbent material.

4. The individual urinary device of Claim 3 wherein the device comprises soluble starch.

5. The individual urinary device of Claim 1 wherein the device comprises multiple layers of material, the multi-layered device having a top layer and a bottom layer.

6. The individual urinary device of Claim 5 wherein the first side of the device is the top layer and the second side of the device is the bottom layer multi-layered device.

7. The individual urinary device of Claim 5 wherein the device further comprises absorbent material positioned between the first side and the second side of the device.

8. The individual urinary device of Claim 7 wherein the device comprises at least one acquisition layer positioned between the first side and the second side of the device.

9. The individual urinary device of Claim 1 wherein the device comprises a handle attached onto the device.

10. The individual urinary device of Claim 1 wherein the device comprises a density gradient that facilitates the drawing of urine away from a user's urethra to the device.

11. The individual urinary device of Claim 10 wherein the density gradient further comprises

i) a first tissue sheet having capillaries, the first tissue sheet being positioned adjacent to and below the top layer and having a density from about 0.01

3 3 g/cm to about 0.1 g/cm ;

ii) a second tissue sheet having capillaries, the second tissue sheet being positioned adjacent to and below the first tissue sheet and having a density

3 3 of from about 0.08 g/cm to about 0.3 g/cm^' , the difference in density between the first and the second tissue sheets being from about 0.01 g/cm to about 0.2 g/cm ; and

iii) a density gradient formed between the first tissue sheet and the second tissue sheet positioned adjacent to one-another such that fluid impacting the first tissue sheet will be drawn from the first tissue sheet by suction exerted by the smaller capillaries of the lower and more dense second tissue sheet.

12. The individual urinary device of Claim 10 wherein the density gradient further substantially locks in urine to prevent the urine from wi eking out of the device.

13. The individual urinary device of Claim 6 wherein the top layer has a density of about 0.01 g/cm³ to about 1.0 g/cm³.

14. The individual urinary device of Claim 6 wherein the bottom layer has a density of about 0.01 g/cm³ to about 1.0 g/cm³.

15. The individual urinary device of Claim 6 wherein the bottom layer of the device is semi-permeable to liquid.

16. The individual urinary device of Claim 6 wherein the bottom layer of the device is substantially impermeable to liquid.

17. The individual urinary device of Claim 1 wherein the user is a male.

18. The individual urinary device of Claim 1 wherein the user is a female.

19. The individual urinary device of Claim 1 wherein the device may be in the shape of a rectangle.

20. The individual urinary device of Claim 19 wherein the length of the device ranges from about 10 mm to about 310 mm.

21. The individual urinary device of Claim 19 wherein the width of the device ranges from about 5 mm to about 310 mm.

22. The individual urinary device of Claim 19 wherein the thickness of the device ranges from about 0.1 mm to about 50 mm.

23. The individual urinary device of Claim 1 wherein the device may be in the shape of an oval.

24. The individual urinary device of Claim 23 wherein the length of the device ranges from about 10 mm to about 310 mm.

25. The individual urinary device of Claim 23 wherein the width of the device ranges from about 5 mm to about 310 mm.

26. The individual urinary device of Claim 23 wherein the thickness of the device ranges from about 0.1 mm to about 50 mm.

27. The individual urinary device of Claim 1 wherein the device may be in the shape of a cylinder.

28. The individual urinary device of Claim 27 wherein the device comprises a diameter ranging from about 2.5 mm to about 150 mm.

29. The individual urinary device of Claim 27 wherein the device comprises a length ranging from about 10 mm to about 310 mm.

30. The individual urinary device of Claim 1 wherein the device may be in the shape of a polygonal.

31. The individual urinary device of Claim 30 wherein the length of the polygonal ranges from about 10 mm to about 310 mm.

32. The individual urinary device of Claim 30 wherein the width of the polygonal ranges from about 5 mm to about 310 mm.

33. The individual urinary device of Claim 30 wherein the thickness of the polygonal ranges from about 0.1 mm to about 50 mm.

34. The individual urinary device of Claim 1 wherein the device may be in the shape of a triangle.

35. The individual urinary device of Claim 34 wherein the length of the triangle ranges from about 10 mm to about 310 mm.

36. The individual urinary device of Claim 34 wherein the width of the triangle ranges from about 5 mm to about 310 mm.

37. The individual urinary device of Claim 34 wherein the thickness of the triangle ranges from about 0.1 mm to about 50 mm.

38. The individual urinary device of Claim 1 wherein the device may be in the shape of any of a number of animals from the group consisting of fish, reptiles, mammals or combinations thereof.

39. The individual urinary device of Claim 1 wherein the device comprises at least one type of substance selected from the group consisting of surfactants, lotions, emollients, anti-microbial agents, healing agents, perfumes, fragrances, pH indicators, impact markers, moistening agents, cleaning agents, odor inhibitors, cyclodextrins, vitamins, herbs, herbal extracts, aloe and medicines.

40. The individual urinary device of Claim 17 wherein the device at least partially covers the end of the male's penis.

41. The individual urinary device of Claim 40 wherein the device substantially covers the end of the male's penis.

42. The individual urinary device of Claim 2 wherein said wrapper has longitudinal edges, transverse side edges, and a pair of side panels for holding the absorbent device and covering the user's fingers when said package is opened.

43. The individual urinary device of Claim 42 wherein said wrapper has an opening feature extending at least partially across said wrapper along at least one said transverse side edge and at least one said longitudinal end.

44. The individual urinary device of Claim 43 wherein said opening feature is provided by perforations extending substantially along said transverse edges and longitudinal edges.

45. The individual urinary device of Claim 43 wherein said perforations are broken by a tear strip.

46. The individually packaged, urinary device of Claim 43 wherein said perforations are broken by a tab.

47. The individual urinary device of Claim 43 wherein said opening feature is a tear strip extending at least partially across said wrapper along at least one said transverse side edge and at least one said longitudinal end.

48. The individual urinary device of Claim 2 that is sufficiently flushable that it completely clears the bowl under the Flushability Test at least about 70% of the time in two or fewer flushes.

49. The individual urinary device of Claim 2 that is sufficiently flushable that it completely clears the bowl under the Flushability Test at least about 95% of the time in one flush.

50. The individual urinary device of Claim 2 wherein the time required for said wrapper to disperse into at least two fragments as measured by the Water Dispersion Test is less than about two hours.

51. The individual urinary device of Claim 2 wherein said wrapper is at least about 90% biodegradable according to the 28 Day Sludge Test.

52. The individual urinary device of Claim 2 wherein said wrapper causes drain blockage of less than 80%.

53. The individual urinary device of Claim 2 wherein said wrapper protects said absorbent device during storage and transportation by shielding said absorbent device from external contamination.

54. The individual urinary device of Claim 2 wherein said wrapper is completely removed from said device after said device has been used to remove urine from a user's urethral area..