MXPA00000057A - Toilet-device disposable absorbent interlabial - Google Patents

Abstract

Absorbent devices, and more particularly toilet-disposable absorbent devices that are worn interlabially by female wearers for catamenial purposes, incontinence protection, or both, are disclosed. The absorbent interlabial device of the present invention comprises a central absorbent portion and preferably a pair of flexible extensions joined to the central absorbent portion. The main absorbent portion comprises an upper portion, and a lower portion opposed to the upper portion. In use, the upper portion is positioned furthest inward into the space between the wearer's labia majora. The pair of flexible extensions extends downwardly and laterally outward from the upper portion of the main absorbent portion, and preferably is capable of maintaining contact with the inside surfaces of the wearer's labia majora when the wearer's body goes through a range of motions, including squatting. Additionally, the flexible extensions are preferably capable of covering the fingertips of the wearer as the absorbent device is inserted into the interlabial space. The components of the absorbent device are preferably biodegradable. The device disperses into a plurality of fragments when exposed to mildly agitated room temperature water. The small size of the device contributes to its flushability. The dispersibility, flushability, and biodegradability of the device all contribute to the ability of the device to be effectively and reliably disposed of in a toilet.

Description

INTERLABIAL ABSORBENT DEVICE DISPOSABLE IN THE TOILET FIELD OF THE INVENTION The present invention relates to absorbent devices, and more to a disposable absorbent device in a toilet having flexible extensions that are worn interlabially by female users for catamenial purposes, protection against incontinence, or both.

BACKGROUND OF THE INVENTION Of course, all forms and varieties of absorbent articles configured for the absorption of bodily fluids such as menses, urine and feces are, of course, well known. With respect to feminine protection devices, the technique has offered two basic types: sanitary napkins that have been developed for external use around the pudendal region while tampons have been developed for internal use within the vaginal cavity for interruption of menstrual flow through them. These tampon devices are disclosed in U.S. Patent No. 4,412,833, entitled "Buffer Applicator," issued to Weigner et al. On November 1, 1983, and U.S. Patent No. 4,413,986 entitled "Buffer Assembly". Buffer with Means for Sterile Insertion ", issued to Jacobs on November 8, 1983. Hybrid devices that aim to merge the structural characteristics of sanitary pads and tampons into a simple device have also been proposed. disclosed in U.S. Patent No. 2,092,346, entitled "Catamenial Pad" issued to Arone on September 7, 1937, and in U.S. Patent No. 3,905,372 entitled "Shield of Protection for Female Hygiene" issued to Denkinger on September 16, 1975. Other less invasive hybrid devices are known, such as lip or interlabial sanitary napkins. curled by having a part that resides at least partially within the wearer's vestibule and a part that resides at least partially external of the wearer's vestibule. These devices are disclosed in U.S. Patent No. 2,662,527 entitled "Sanitary Pad", issued to Jacks on December 15, 1953, and in U.S. Patent No. 4,631,062, entitled "Sanitary Lip Pad". , issued to Lassen and others on December 23, 1986. Interlabial pads have the potential to provide even greater freedom of inconvenience because of their small size and reduced risk of leakage. In the past, numerous attempts have been made to produce an interlabial pad which would combine the best characteristics of tampons and sanitary napkins, while avoiding at least some of the disadvantages associated with each of these types of devices. Examples of these devices are described in U.S. Patent No. 2,917,049 issued to Delaney on December 15, 1959, U.S. Patent No. 3,420,235 issued to Harmon on January 7, 1969, U.S. Patent No. 4,595,392, issued to Johnson et al. On July 17, 1986, and in U.S. Patent Nos. 5,074,855 and 5,336,208 issued to Rosenvluth et al. On December 24, 1991 and August 9, 1994, respectively, and in US Pat. U.S. Patent No. 5,484,429 issued to Vukos et al. on January 16, 1996. A commercially available interlabial device is the FRESH'N FIT® Padette in which it is marketed by Athena Medical Corp. of Portland, OR and is discloses in U.S. Patent Nos. 3,983,873 and 4,175,561, issued to Hirschman on October 5, 1976 and November 27, 1979 respectively. However, many of these devices have not found great commercial success. There are disadvantages associated with all of the above products. For example, the device described in the Delaney patent does not appear to be capable of easy and convenient insertion, due to the possibility that the layers of the absorbent material open upwards during insertion. Commercially available Padettes suffer from the disadvantage that they can not consistently cover the vaginal introitus and / or the urethra during all movements of the body (for example, when the user bends over). The Padette product also can not be reliably expelled as the user urinates. Interlabial devices should preferably be designed to be dispersed by a stream of urine, which dislodges the product so that it flows to a conventional toilet where it can be discharged. It is important that any product disintegrate quickly in the sewer system in a way that does not obstruct or otherwise damage sewer systems. However, it is also important that the product maintain sufficient integrity while being worn in such a way that it does not disintegrate or tear during use. In this way, there is a need for an interlabial device that is small in size and can be easily inserted and that provides protection against incontinence, menstrual discharges, and discharges of body exudates throughout a broad spectrum of conditions. movements of the user. There is also a need for an interlabial device that will be reliably ejected when the user urinates. A need also exists for an interlabial device that facilitates sanitary insertion and removal. That is, a need exists for a device that can be inserted into the interlabial space of a user while covering the tips of the fingers, thus preventing the tips of the fingers from becoming stained. A need also exists for an interlabial absorbent device that will maintain its integrity when worn in such a way that it does not disintegrate or tear during use. A further need exists for an interlabial device that is disposable in a conventional toilet facilitating a convenient elimination when the device is expelled by urination, or optionally, removed with the fingers. Therefore, it is an object of the present invention to provide an interlabial absorbent device that consistently blocks the urethra and orifice of the vagina, so as to provide protection against incontinence, menstrual discharges, and discharges of the vagina. body exudates in a wide range of user movements. It is another object of the present invention to provide an interlabial absorbent device that can be inserted interlabially without the user's hand touching the inner surfaces of the lips. It is another object of the present invention to provide an interlabial absorbent device that will be reliably ejected when the user urinates such that the user does not have to touch the stained product. It is another object of the present invention to provide an interlabial absorbent device that can be optionally removed with the fingers without the user's hand touching her body. It is another object of the present invention to provide an interlabial absorbent device that maintains sufficient integrity while being worn such that it does not disintegrate or tear during use. It is another object of the present invention to provide an interlabial absorbent device that can be easily disposed of in a conventional toilet.

These and other objects of the present invention will be more readily apparent when considered with reference to the following description, and when taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF THE INVENTION The present invention relates to absorbent devices, and more particularly to a disposable absorbent device in the toilet capable of being inserted into the interlabial space of a female user for catamenial purposes, protection for incontinence, or both. The interlabial absorbent device of the present invention comprises a central absorbent portion and a pair of flexible extensions attached to the central absorbent portion. The central absorbent portion preferably comprises an upper portion and a lower portion opposite the upper portion. The upper portion faces the inner surface of the wearer's vestibule during the insertion of the absorbent device into the interlabial space of the wearer and during use. That is, the upper portion is positioned farther inward toward the space between the wearer's lips in this manner leading the lower portion of the absorbent device during insertion. Upon insertion, the lower portion is inserted less completely into the interlabial space of the wearer than the upper portion, and the lower portion away from the inner surface of the wearer's vestibule. In a preferred embodiment, the central absorbent portion is generally of an ovoid shape in the cross section. The central absorbent portion of this preferred embodiment comprises an upper portion with a larger cross sectional dimension relative to that of the lower portion. The juncture of the upper portion and the lower portion of the central absorbent portion preferably comprises a substantially abrupt change in the transverse dimension, thus forming a shoulder-like configuration in such a joint. In a preferred additional embodiment of the present invention, the central absorbent portion comprises a continuous web of folded material in a folded structure. This structure improves the surface area available for fluid absorption by allowing the fluid to easily penetrate between the folds of the central absorbent portion. In still another preferred embodiment, the main absorbent comprises a plurality of individual layers joined in a face-to-face relationship. This structure also improves the surface area available for fluid absorption, allowing the fluid to easily penetrate between the layers of the central absorbent portion. The flexible extensions extend downwards and outwards from the upper portion of the central absorbent part and are attached thereto. Preferably, the flexible extensions are able to maintain contact with the inner surface of the wearer's lips and cover a substantial portion thereof. The flexible extensions are also capable, preferably, of covering the tips of the fingers as the absorbent device is inserted into the interlabial space of the wearer. Preferably, the flexible extensions are able to maintain contact with and cover the internal surfaces of the wearer's lips when the wearer's body goes through a range of movements, including stooping. The flexible extensions of the preferred design also block a direct "line of sight" from the outer perimeter of the labia majora to the vaginal introitus, so that exudates from the body can not "miss" the product and the flow of these exudates will be intercepted by the interlabial absorbent device.

The disposable interlabial absorbent device in the toilet is downloadable. Preferably, the interlabial absorbent device is constructed at least partially from biodegradable materials. Additionally, the downloadable interlabial absorbent device will disperse in at least two, and more preferably in several fragments within two hours of exposure to room temperature, slightly shaken water.

BRIEF DESCRIPTION OF THE DRAWINGS Although the description concludes with the claims pointing out in a particular way and claiming differently the exposed matter that is considered as formant of the present invention, it is believed that the invention will be better understood from the following description taken in combination with the drawings that they accompany it, which: Figure 1 is a perspective view of the preferred embodiment of the interlabial absorbent device of the present invention. Figure 2 is a bottom view of the absorbent device shown in Figure 1. Figure 3 is a bottom view of a variant of the preferred embodiment shown in Figure 2. Figure 4 is a background view of an alternate embodiment preferred of the present invention having a folded central absorbent portion. Figure 5 is a bottom view of a preferred alternate embodiment of the present invention showing a central absorbent portion having a multi-layered structure.

Figure 6 is a cross-sectional view of the wearer's body surrounding and including the major and minor lips of the wearer showing how an interlabial device of the prior art could fit within the space between the wearer's lips when she is the user. Figure 7 is a cross-sectional view of the same region of the wearer's body shown in Figure 6, showing how the prior art device could adjust when the user bends over. Figure 8 is a cross-sectional view of the same region of the wearer's body shown in Figure 7, showing the flexible extensions of the present invention covering the tips of the wearer's fingers as the absorbent device of the wearer is inserted. the present invention, in the interlabial space of the user. Figure 9 is a cross-sectional view of the same region of the wearer's body shown in Figure 6, showing how the interlabial absorbent article of the present invention adjusts when the wearer is standing. Figure 10 is a cross-sectional view of the same region of the wearer's body shown in Figure 7, showing how the interlabial absorbent article of the present invention adjusts when the user bends over. Figure 11 is a schematic perspective view of the Three Point Bending Test apparatus. Figure 12 is a plan view of an apparatus suitable for determining the discharge capacity according to the method described in the TEST METHODS section, below. Figure 13 is a cross-sectional view of the unloading apparatus of Figure 12, taken along line 13-13 thereof.

DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to a disposable interlabial absorbent device in the toilet. Figure 1 shows a preferred embodiment of the interlabial absorbent device of the present invention, interlabial device 20. The present invention, however, can be in many other forms, and is not limited to a structure having the particular configuration shown in the drawings . As used herein, the term "interlabial absorbent device" refers to a structure having at least some absorbent components, and is specifically configured to reside at least partially within the interlabial space of a female user during use. Preferably, more than half of the entire interlabial absorbent device 20 of the present invention resides within this interlabial space, more preferably substantially all of the interlabial absorbent device 20 resides within this interlabial space, and most preferably the entire absorbent device. Interlabial 20 resides within the interlabial space of a female user during use. As used here, the term "interlabial space", refers to that space within the pudendal region of the female anatomy, which is located between the interior surfaces of the labia majora that extend into the vestibule. Located within this interlabial space are the labia minora, the vestibule and the main genitourinary limbs that include the clitoris, the hole of the urethra, and the orifice of the vagina. The authorities of standard medicine teach that the vestibule refers to the space joined laterally by the internal surfaces of the labia minora and that extends internally towards the inner surface of the clitoris and the orifice of the vagina. Therefore, it will be recognized that the interlabial space as defined above can refer to the space between the inner surfaces of the labia majora, including the space between the inner surfaces of the labia minora also known as the vestibule. The interlabial space for the purposes of the present disclosure does not extend substantially beyond the vaginal orifice of the vagina. The term "lips" as used herein, generally refers to both of the labia majora and labia minora. The lips end anteriorly and posteriorly to the anterior commissure and posterior commissure, respectively. It will be recognized by those skilled in the art that there is a wide range of variations among women with respect to the relative size and shape of the labia majora and the labia minora. For purposes of the present description, however, these differences do not need to be specifically applied. It will be recognized that the arrangement of the interlabial absorbent device within the interlabial space of a wearer as defined above, will require placement between the inner surfaces of the labia majora without considering the precise location of the boundary between the labia minora and the labia majora for a user. in particular. For a more detailed description of this part of the female anatomy, attention is directed to Gray's Anatomy, Running Press, 1901 Ed. (1974) at 1025 to 1027. The term "disposable on the toilet" as used herein includes the features following an interlabial absorbent device: discharge capacity, dispersibility, and biodegradability. As used herein, the terms "downloadable or with discharge capacity" refers to the ability of the product to pass through typical, commercially available, home-made toilet and drainage pipe systems without causing occlusion or similar problems that they can be directly associated with the physical structure of the product. It is recognized, however, that there may be many differences between the various types of toilets available. Therefore, for the purposes of the appended claims, a test is established to determine the discharge capacity of a catamenial product, such as an interlabial absorbent device, in the TEST METHODS section of this disclosure. The term "dispersible" as applied herein to an interlabial absorbent device, refers to an article that will disperse in at least two fragments in slightly stirred water. Said device will break into pieces in a conventional toilet and / or domestic drainage system, and finally it will be processed effectively through a wastewater treatment system. The term "biodegradable" as used herein, refers to an absorbent device that is preferably constructed at least partially from biodegradable materials. The interlabial absorbent device 20 shown in Figure 1 has a longitudinal centerline L which runs along the "x" axis shown in Figure 1. The term "longitudinal", as used herein, refers to a line , axis or direction in the plane of the interlabial device 20 which is generally aligned with (e.g., approximately parallel to), a vertical plane that divides a user standing in left and right body halves when the interlabial device 20 is used. The terms "transverse", "lateral", or "direction and", as used they are interchangeable here, and refer to a line, axis or direction that is generally perpendicular to the longitudinal direction. The lateral direction is shown in Figure 1 as the "y" direction, the "z" direction, shown in Figure 1, is a direction parallel to the vertical plane described above. The term "upper" refers to an orientation in the z-direction towards the head of the user. "Bottom", or "down", is toward the user's feet. As shown in Figure 1, the interlabial device 20 comprises a central absorbent portion (or "main absorbent portion"), 22, and a pair of flexible extensions 24 attached to the central absorbent portion 22. The central absorbent portion 22 should be at least partially absorbent. The central absorbent portion 22 may comprise nonabsorbent portions, such as a liquid impermeable barrier to prevent the absorbed liquids from leaking or leaking from the central absorbent portion 22. The central absorbent portion 22 comprises an upper portion 26 and a lower portion 28 which it is opposite to the upper portion. The flexible extensions 24 are attached to the upper portion 26 of the central absorbent portion. In use, the upper portion 26 is positioned farther inward toward the interlabial space of the wearer. The interlabial device 20 should be of a suitable size and shape that allows at least a part of it to fit comfortably within the interlabial space of the wearer, and to cover the wearer's vaginal orifice, and preferably also the urethra of the wearer. the user. The interlabial device 20 at least partially blocks and at least preferably completely blocks and intercepts the flow of menses, urine, and other body exudates from the vaginal orifice and the urethra of the wearer. The size of the interlabial device 20 is also important for the comfort associated with the use of the device. In the preferred embodiment shown in Figure 1, the main absorbent portion 22 of the interlabial device 20 has a length as measured along the longitudinal center line L, between about 35 mm and about 120 mm. Preferably, the length of the interlabial device 20 is between about 45 mm and about 55 mm, and more preferably, about 49 mm. The gauge (or width) of the central absorbent portion 22 of the interlabial device as measured in the transverse direction (or "y" direction) is preferably less than or equal to about 8 mm, more preferably the gauge is between about 3 mm and approximately 8 mm, most preferably, the gauge is approximately 4.5 mm. The caliper measurements given here were measured using an AMES rule with a (calibrated) load of 0.25 psi and a diameter area of 0.96 inches. Those skilled in the art will recognize that if a diameter area of 0.96 inches is not appropriate for a particular sample size, the size of the area may be varied as the load on the calibrator is accordingly varied to maintain a confining pressure of 0.25. psi (calibrated). The height (or dimension in the "z" direction) of the main absorbent portion 22 is preferably between about 8 mm and about 35 mm, and more preferably is about 20 mm. The interlabial device 20 is preferably provided with sufficient absorbency to absorb and retain discharged exudates from the wearer's body. However, the capacity of the product is at least partially dependent on the physical volume of the interlabial absorbent device 20, particularly the central absorbent portion 22 thereof. The central absorbent portion 22 preferably has a capacity of at least about 1 gram of 0.9 wt.% Saline, and can have a capacity of up to approximately 30 grams using absorbent gels or foams that expand when wet. The capacities can typically vary from about 2 to about 10 grams, for saline solution. Those skilled in the art will recognize that the ability for absorption of body exudates, such as menses, will typically be less than the capacities given above for the absorption of saline. A method for measuring the absorbent capacity is described in the Test Methods section, below. Since the interlabial space can expand, larger volumes can be stored within the interlabial space, if the fluid is stored as a gel, which adjusts to body pressures. Additionally, if the interlabial absorbent device 20 does not reside completely within the interlabial space of the wearer, some of the absorbed exudates may be externally stored for the interlabial space of the wearer. The central absorbent portion 22 of the preferred embodiment shown in Figures 1 to 3, may comprise any type of suitable absorbent structure that is capable of absorbing and / or retaining liquids (e.g., menses and / or urine). The central absorbent portion 22 can be manufactured in a wide variety of ways. Non-limiting examples include ovoid, trapezoidal, rectangular, triangular, cylindrical, hemispherical, or any combination of the foregoing. The central absorbent portion 22 may also be manufactured from a wide variety of liquid absorbent materials commonly used in absorbent articles, such as crushed wood pulp, which is generally referred to as an air filter. Examples of other suitable absorbent materials include cotton fibers or cotton lintels; accreted cellulose wadding; blown polymers in the molten state, including coform; chemically hardened, modified or cross-linked cellulosic fibers; synthetic fibers, such as pleated polyester fibers; peat moss; tissue, including tissue wraps and tissue laminates, absorbent foams; absorbent sponges; superabsorbent polymers (in granular or fibrous form); gelling absorbent materials; or any equivalent material or combinations of materials, or mixtures thereof. Preferred absorbent materials comprise cotton blocks, folded tissues, woven materials, nonwoven webs, needle punched rayon, and foam layers or pieces. The central absorbent portion 22 may comprise a simple material or a combination of materials, such as a wrapping layer surrounding a central wadding composed of a different absorbent material. The central absorbent portion 22 preferably comprises at least partially biodegradable materials. As used herein, the term "biodegradable materials" refers to a material that has more than or equal to about 70% biodegradation (percentage of theoretical evolution of carbon dioxide) after 28 days when measured in accordance with the Strum Test, which has been designated Method 301 B by the Organization for Economic Cooperation and Development (OCD). Preferably, the materials comprising the present invention have a biodegradation greater than about 80% and, more preferably, the biodegradation is greater than or equal to about 90%. While biodegradable materials are preferred for the downloadable interlabial absorbent device 20, it is not necessary that each and every material used be biodegradable. For example, the device 20 may comprise super absorbent particles that do not degrade biologically, and this will not affect the ability of the total device to remain disposable in the toilet and be effectively processed in a sewage treatment system. The integrity of the product during use is achieved by recognizing that the shear force of the lips during walking does not exert large forces on a product inside the lips. Therefore, soft materials or those with a lower wet strength can provide sufficient integrity to prevent degradation during use, while still allowing disintegration in the toilet. Another feature of this invention is that the surface of the main absorbent portion 22 will be protected by the flexible extensions 24. Therefore, the softer or lower resistance materials can be used in the central absorbent portion 22 while the flexible extensions 24 they can be constructed of materials with superior strength to protect the central absorbent portion 22 from fragmenting within the interlabial space of the wearer. In the preferred embodiment shown in Figure 1, the central absorbent portion is formed of a soft absorbent material such as rayon fibers or other fibers or suitable natural or synthetic laminate. Super absorbent polymers can be added to said soft absorbent material. The central absorbent portion 22 shown in Figure 1 is generally oval in cross section as shown in Figure 2. The central absorbent portion 22 of the embodiment shown in Figure 1 and 2 comprises an upper portion 26 with a cross-sectional dimension greater than that of the lower portion 28. The upper portion 26 is preferably integral with the lower portion 28. In the less preferred embodiments, however, the upper portion 26 and the lower portion 28 may comprise separate elements joined together by any suitable means known in the art. In the preferred embodiment shown in Figures 1 and 2, the juncture of the upper portion 26 and the lower portion 28 of the central absorbent portion 22 comprises a substantially abrupt change in the transverse dimension, thus forming a configuration in the form of a shoulder in such a joint. In the embodiment shown in Figures 1 and 2, the juncture of the upper portion 26 and the lower portion 28 of the central absorbent portion 28 is formed by the seam 34. In a variation of the preferred embodiment described above and shown in FIG. Figures 1 and 2, the upper portion 26 may have a smaller cross-sectional dimension relative to the cross-sectional dimension of the lower portion 28, an absorbent device of the invention; 20 having such a configuration is shown in Figure 3. The central absorbent portion 22 can be made by any suitable process. U.S. Patent No. 4,995,150 issued to Gerstenberger et al. On February 26, 1991, and U.S. Patent No. 4,095,542 issued to Hrishman on June 20, 1978, describe methods for making absorbent devices that are suitable to be used as the central absorbent portion 22 of the interlabial absorbent device 20 shown in Figures 1 to 3. As shown in Figures 1 to 3, the interlabial absorbent device 20 also comprises a pair of flexible extensions 24, which are attached to the upper portion 26 of the central absorbent portion 22 of the interlabial absorbent device 20. Preferably, the flexible extensions 24 comprise a biodegradable material. Additionally, the flexible extensions 24 will preferably disengage from the central absorbent portion 22 when the interlabial absorbent device 20 is immersed in slightly stirred, room temperature water. More preferably, the flexible extensions 24 will fragment into a plurality of pieces in addition to disengage from the main absorbent portion 22, when the interlabial absorbent device 20 is immersed in slightly stirred water at room temperature. In a preferred embodiment shown in Figures 1 to 3, the flexible extensions 24 are generally rectangular in shape. Other shapes are also possible for flexible extensions 24 such as semicircular, trapezoidal or triangular. The flexible extensions 24 are preferably from about 40 mm to about 160 mm long, more preferably from about 45 mm to about 130 mm long, and most preferably to about 115 mm long. Although the flexible extensions 24 can have a length (measured in the x direction) that is shorter or longer than the central absorbent portion 22, they preferably have a length that is about 25 mm or greater. The width of each of the flexible extensions refers to the distance from the junction of the flexible extension 24 to the central absorbent portion 22 (or the proximal end 24A of the flexible extension 24), toward the distal end (or free end) 24B of the flexible extension 24. The width of the flexible extensions 24 is preferably equal to or less than the height of the central absorbent portion as described above. The caliper of the flexible extensions is preferably less than or equal to about 3 mm, more preferably less than or equal to about 2 mm, and most preferably less than or equal to about 1 mm. Ideally, the gauge of the flexible extensions 24 and the central absorbent portion 22 are selected such that the gauge of the overall interlabial absorbent device 20 is less than or equal to about 8 mm.

The flexible extensions 24 can be constructed of a tissue layer. A suitable tissue is a tissue placed with air available from the Fort Howard Tisue Company of Greenbay, Wisconsin, and having a basis weight of 35 pounds / 3000 ft2. Another tissue placed with suitable air is available from Merfin Hygenic Products, Ltd., of Delta, British Columbia, Canada, which has a basis weight of 61 pounds / 3000 ft2, and which has the class designation number 176. Preferably, these Tissues are coated with a layer of nonwoven material that is heat sealed to the side that is in contact with the body of the tissue to help prevent the tissue layer from fragmenting on the lips. A suitable nonwoven material known as COROLIND and which is available from Corovin GmbH, Peine, Germany. The flexible extensions 24 can optionally be backed with a layer of material that is impermeable or semipermeable to body exudates, such as polyvinyl alcohol. The flexible extensions 24 can also be backed or coated with a polyethylene film, which is applied as a laminate or extruded onto the flexible extensions. In the preferred embodiments shown in Figures 1 to 3, the pair of flexible extensions 24 may comprise a single sheet of material extending on either side of the longitudinal center line L of the central absorbent portion 22 of the interlabial absorbent device 20. Alternately , the pair of flexible extensions 24 may comprise separate sheets of material, independently attached to the upper portion 26 of the central absorbent portion 22. Preferably, the flexible extensions 24 are arranged asymmetrically about the longitudinal centerline L of the absorbent portion. central 22. The flexible extensions 24 are attached to the upper portion 26 of the central absorbent portion 22 of the interlabial absorbent device 20. Most preferably, the flexible extensions are attached to the upper surface of the upper portion 26 of the central absorbent portion 22, or within about 3 mm of the surface its above the central absorbent portion 22.

The term "attached", as used herein, encompasses configurations in which the element is directly secured to the other element by attaching the element directly to the other element; configurations in which the element is indirectly secured to the other element by fixing the element to a member or intermediate members, which in turn are fixed to the other element; and configurations in which one element is integral with the other element, that is, one element is essentially part of the other element. The flexible extensions 24 can be attached to the upper portion 26 of the central absorbent portion 22 by any variety of means. For example, in the preferred embodiments shown in Figures 1 to 3, the flexible extensions 24 can be attached to the upper portion 26 using any suitable adhesive 36 centered around the longitudinal center line L of the central absorbent portion 22 (ie, about the opposite sides of the longitudinal center line L). The adhesive 36 may extend continuously along the length of the central absorbent portion 22, or it may be applied in a "dot" manner at discrete intervals. Alternatively, the flexible extensions 24 can be attached to the upper portion 26 of the central absorbent portion 22 by sewing (such as with cotton or rayon yarns), thermally bonded, melt bonded, or any other suitable means known in the art. , to join these materials. The flexible extensions 24 may be attached to the central absorbent portion 22 using a water soluble adhesive or being sewn using a water soluble yarn. These forms of fixation improve the capacity of the downloadable interlabial absorbent device 20 disperse in water at room temperature, slightly agitated, thus increasing the waste capacity in the toilet. As shown in Figures 1 to 3, the flexible extensions 24 are attached to the upper portion 26 of the central absorbent portion 28. The flexible extensions 24 extend downwardly and outward from the central absorbent portion 22 toward a free end 24B the which is disengaged from the central absorbent portion. The flexible extensions 24 may be slightly inclined outwardly from the central absorbent portion 22 to tend to keep the extensions 24 in contact with the inner surfaces of the lips when the interlabial absorbent device 20 is in place. Additionally, the naturally moist surfaces of the lips will have a tendency to adhere to the material comprising the flexible extensions 24, tending more to keep them in contact with the inner surfaces of the lips. Preferably, the flexible extensions 24 must be able to move from a position where the free ends of the flexible extensions 24 are located adjacent the central absorbent portion 22 (as shown in Figure 9), to a position where the flexible extensions 24 extend directly away from the central absorbent portion 22 in the transverse direction (as shown in Figure 4). The flexible extensions 24 should be of sufficient width and flexibility to allow the flexible extensions to cover the tips of the wearer's fingers as the interlabial absorbent device 20 is inserted into the wearer's interlabial space. Figure 8 shows how a wearer can hold the central absorbent portion 22 of the proximal absorbent device 20 while the flexible extensions 24 remain between the tips of the fingers and her body as the device 20 is inserted. Additionally, the flexible extensions 24 must be able to move with the internal surfaces of the user's lips to maintain contact with them. The flexible extensions 24 help hold the central absorbent portion 22 in place over the entire spectrum of movements of the wearer, such as when bending over. The flexible extensions 24 may be either absorbent or non-absorbent. Preferably, the extensions 24 have at least some absorbency. The flexible extensions 24 may have a greater absorbent capacity than the absorbent capacity of the central absorbent portion 22. The flexible extensions 24 may be as hydrophilic as the central absorbent portion 22 or less hydrophilic than the central absorbent portion 22. In one embodiment, the flexible extensions 24 can be treated to make them less hydrophilic than the central absorbent portion 22. That is, the flexible extensions 24 can have a lead contact angle greater than the lead contact angle of the central absorbent portion 22, such that that the fluid is preferably directed towards and absorbed by the central absorbent portion 22. Preferably, most of the fluid absorbed and retained by the interlabial absorbent device 20 will be finally retained within the central absorbent portion 22. For a more detailed description of the Hydrophilic capacity and contact angles see the publications following, which are incorporated by reference here: the American publication of the chemical society entitled "Angle of contact, wettability and adhesion", edited by Robert F. Gould and reserved by rights in 1964; and TRI / Princeton publications Publication No. 459, entitled "A microtechnique to determine surface tension" published in April 1992, and publication no. 468 entitled "Determination of contact angles within porous networks", published in January 1993, both edited by Dr. H. G. Heilweil. The stiffness of both of the absorbent portion, central 22 and flexible extensions 24 is important for product comfort. If the central absorbent portion 22 is too flexible, the device is not conveniently and easily placed between the folds of the lips, and if it is too rigid the device is uncomfortable and when the user is in a sitting position, the product can be forced against the clitoris causing discomfort. The central absorbent portion 22 preferably has a rigidity approximately equal to that of the products described in U.S. Patent Nos. 4,995,150 and 4,095,542.

The strength and rigidity of the flexible extensions 24 are important characteristics of their design. If the flexible extensions 24 have a wet breaking strength of approximately less than or equal to 15 grams, they will tend to fragment and may leave pieces that remain in the interlabial space of the wearer. Similarly, if the flexible extensions 24 are as rigid as a manila file folder, they do not provide sufficient flexibility to dynamically adjust the movement of the lips. The stiffness of flexible extensions is measured as a resistance to bending. Preferably, the flexible extensions 24 have a flexural strength of less than about 25 grams, measured using the Three Point Bending Test. More preferably, the flexible extensions 24 have a flexural strength of less than or equal to about 5 grams. A description of the Three Point Bending Test is contained in the Test Methods section, below. The flexible extensions 24 also have an inherent strength, such that during application and use they do not tear and serve to protect the main absorbent portion 24. The wet strength for the flexible extensions must exceed 15 grams, and preferably exceed 150. grams, and most preferably exceeds 300 grams. The wet strengths given above are measured using the Wet Rupture Test, which is described in more detail in the Test Methods section, below. Preferably, the interlabial absorbent device 20 disposable in the toilet of the present invention will disperse in at least two fragments within two hours of exposure to the water at room temperature, slightly agitated, as described in the Water Dispersion test in the section of METHODS OF TRIAL, below. More preferably, the downloadable interlabial absorbent device 20 will be dispersed in a plurality of fragments within about 60 minutes or, even more preferably within about 30 minutes and most preferably, within about 15 minutes as measured by the Water Dispersion Test . Preferably, the product will break into fragments that are less than about 15 cm2, more preferably less than about 5 cm2, most preferably less than about 3.7 cm2. In the particularly preferred embodiments of the present invention, each of the components of the downloadable interlabial absorbent device 20 will disperse in a plurality of fragments when immersed in slightly agitated water. Alternatively, the components of the interlabel absorbent device 20 can separate from each other without breaking themselves into a plurality of fragments (for example, the flexible extensions 24 can break apart from the central absorbent portion 22 while each other way it remains intact). In a preferred alternate embodiment shown in Figure 4, the central absorbent portion 22 of the interlabial absorbent device 20 comprises a folded structure. As shown in Figure 4, the central absorbent portion 22 comprises a weft of folded tissue. The folded tissue web preferably has a strength greater than that of the standard, non-wet resistance of the toilet paper. Preferably, the central absorbent portion 22 comprises a tissue having a temporary wet strength greater than or equal to about 100 grams. In a preferred design, this wet strength will decay to about 50% or less of the original strength for about 30 minutes. As shown in Figure 4, the tissue web comprising the central absorbent portion 22 is bent into a folded structure comprising a plurality of folds 30 that are arranged in a laterally side-by-side relationship. The tissue web can be folded in such a way that it has any suitable number of folds. Preferably, the tissue web is folded in such a way that the overall gauge (i.e., the width) of the central absorbent portion 22 of this embodiment is between about 2 mm and less than or equal to about 7 mm. The folds in the folded tissue web are preferably connected or attached (or retained), in some suitable manner such that the folded sections maintain their folded configuration, and are not able to fully open. The folds can be connected by a variety of means including the use of yarn, adhesives, or heat-sealed tissues such as the Merfin tissue discussed above. A preferred design uses the seam joining all the folds in the central absorbent portion 22 together. Preferably, the main absorbent structure 22 is provided with five sewing locations (four at the corners and an additional location approximately halfway between the two lower corners). The thread used for this seam can be water soluble to improve the ability of the device 20 to disperse in the toilet. In a variant of the folded structure shown in Figure 4, the central absorbent portion 22 may comprise a fold or simple fold. The space between the two sides of the central absorbent portion 22 folded once can be oriented in any direction up or down when inserted into the interlabial space of the wearer. The folded structure of the central absorbent portion 22 provides several advantages. An advantage provided by the folded structure is that the exudates can penetrate towards the folds of the structure, which present a greater absorbent surface and more effective for the acquisition than a flat surface. This is particularly important when dealing with potentially viscous fluids and particulate material such as cellular fibers and clots that can clog the surface of the structure presented to the body. A second advantage of this design is that the gauge (or width) of the product can be easily and conveniently controlled by varying the number of folds. The structure shown in Figure 4 also provides a convenient central area for holding the product and inserting it into the lips, while the body / fingers in the insertion hand are protected from contact with the wearer's body. As distinguished above for the preferred embodiment shown in Figures 1 to 3, the flexural stiffness of the central absorbent portion 22 is also important for the comfort of the product with the folded structure shown in Figure 4. An advantage of the structure folded is that the number, thickness, and compaction of the folds control the stiffness of the structure. The preferred embodiment shown in Figure 4 preferably has dimensions of the central absorbent portion 22 and of the flexible extension 24 similar to those described above for the embodiment shown in Figures 1 to 3. The width of the central absorbent portion 22 of the device interlabial 20 as measured in the transverse direction (y direction), is preferably between about 2 mm and less than or equal to about 7 mm. Preferably, in a preferred embodiment, the width of the central absorbent portion of the interlabial device 20 is approximately 4.5 mm. As shown in Figure 4, where the central absorbent portion 22 is of a uniform transverse dimension (i.e., there is no abrupt change in the transverse dimension defining the juncture between the upper portion and I to the lower portion). The division between the upper portion 26 and the lower portion 28 is considered to be an elevation equal to about half the total height of the central absorbent portion 22. The folded design shown in Figure 4 has the additional benefit of easily providing the flexible extensions 24. The extensions 24 may comprise the same material as the central absorbent portion 22, or these may comprise a different material. The extensions 24 are attached to the upper portion 26 of the central absorbent portion 22, and most preferably for this embodiment, they are attached to the upper surface of the central absorbent portion 22, or within 3 millimeters of the upper surface of the absorbent portion. central 22. Preferably in the embodiment shown in Figure 4, the extensions 24 are integral parts of the central absorbent portion 22 (ie, the extensions 24 comprise integral extensions of the tissue absorbent material that is folded to form the central absorbent portion 22. ). The central absorbent portion 22 and the flexible extensions 24 of the interlabial absorbent device 20 shown in Figure 4 can be constructed from any of the materials previously discussed for the embodiments shown in Figures 1 to 3. The embodiment shown in the Figure 4 can be provided with several optional features. For example, separators or raised or hollow floor areas may exist between the folds to improve the ability of the device 20 to move the exudates downwardly. Additionally, the folds on the parts of the product that are in contact with the pelvic internal surface do not need to be of uniform height. For example, the material folded in the center could be superior, and therefore, easily crushed under pressure. This arrangement can provide better fit and / or comfort. In another variation of the folded structure shown in Figure 4, the central absorbent portion 22 may comprise a plurality of individual layers 32 joined in a face-to-face relationship. This device is shown in Figure 5. The structure shown in Figure 5 can all have the same characteristics described above for the folded structure. In one embodiment, each of the individual layers 32 may be composed of a tissue with permanent resistance to moisture held together by the water-soluble thread or adhesive. Alternatively, the individual layers 32 can by themselves disperse in a toilet in addition to separating one from the other. An additional benefit of using a plurality of individual layers 32 is that the various layers may comprise different materials with different properties or characteristics. Each of the flexible extensions 24 can be integral with one of the individual layers 32 or can be separately joined to the upper portion 26 of the central absorbent portion 22. Preferably, the individual layers 32 are arranged in a side-by-side relationship , so that the spaces between the layers are oriented in the Z direction (as shown in Figure 5). The interiabial device 20 in any of the embodiments shown in the drawings, may comprise other optional components. For example, the interlabial device 20 may comprise an upper sheet 42 placed on and attached to all or a portion of the surface facing the body of the device 20, and / or a back sheet 38 placed on and attached to all or a portion of its back surface, including the flexible extensions 24. If an upper sheet 42 and / or a back sheet 38 is used, these components are preferably dispersible in slightly stirred water at room temperature. If the optional upper sheet 42 and / or the backsheet 38 do not fragment by themselves at room temperature, slightly stirred water, they should not inhibit the capacity of the remainder of the interlabial absorbent device 20 to disperse into at least two fragments when exposed. well to water at room temperature, slightly stirred. For example, the material of the upper sheet 38 or the back sheet 42 can disengage from the rest of the device 20 in slightly stirred water at room temperature. Alternatively, the topsheet 28 or the backsheet 42 may comprise a plurality of independent sections that are not directly joined together, but which are separately joined to the central absorbent portion 22 and / or the flexible extensions 24 of the interlabial absorbent device 20, such that components of the device 20 can freely detach from each other. Preferably, if an upper sheet 42 and / or the back sheet 38 is used, these components are attached to at least a portion of the central absorbent portion 22. In an alternate embodiment, the central absorbent portion may be at least partially enveloped by a top sheet 42. If the top sheet is used, the top sheet should be docile, soft feeling and non-irritating to the wearer's skin. In addition, the top sheet must be permeable to liquid allowing liquids (eg, menses and / or urine) to easily penetrate through its thickness. A suitable top sheet can be manufactured from a wide range of materials such as woven and nonwoven materials including natural fibers (eg, wood or cotton fiber), synthetic fibers, or from a combination of natural fibers and synthetic. Preferred materials for the topsheet 42 of the present invention include non-woven cotton webs and non-woven rayon webs, any of which can be mixed with polypropylene. In a preferred embodiment of the present invention, the body surface of the top sheet is hydrophilic to help transfer liquid through the top sheet faster than if the body surface were not hydrophilic, to decrease the likelihood that the menstrual fluid flows out of the topsheet 42 instead of flowing into and being absorbed by the central absorbent portion 22. The body surface of the topsheet 42 can be rendered hydrophilic by treating it with a surfactant such as described in the US Pat. United States No. 4,950,254 issued to Osborn. If a backsheet is used, the backsheet should be waterproof or semipermeable to liquids (eg, menses and / or urine), and is preferably flexible. As used herein, the term "flexible" refers to materials that are docile and that will easily conform to the contour and general shape of the human body. The backsheet prevents the exudates absorbed and contained within the central absorbent portion 22 from wetting the articles that are in contact with the interlabial device 20 such as the wearer's body or undergarments. Additionally, the use of the backsheet may provide an improved surface for the wearer to hold between the fingers as the interlabial absorbent device 20 is inserted, or as the device is optionally removed with the fingers. The backsheet 38 may comprise a woven or non-woven material, polymeric films such as polyvinyl alcohol, or composite materials such as a nonwoven film-coated material. Preferably, the backsheet 38 is a polyvinyl alcohol film having a thickness of about 0.012 mm to about 0.051 mm. As previously discussed, the interlabial absorbent device 20 of the present invention is preferably designed to be placed entirely within the interlabial space of a wearer. To use the interlabial absorbent device 20 of the present invention. The wearer holds the central absorbent portion 22 between her fingers. As shown in Figure 8, the flexible extensions 24 are spaced apart to cover the tips of the wearer's fingers during insertion. This feature provides a hygienic insertion of the interlabial absorbent device 20 of the present invention. The upper portion 26 is inserted first and further into the interlabial space. The user can assume a crouched position during insertion to help extend the labial surfaces. Once the interlabial absorbent device 20 is inserted, the flexible extensions 24 tend to adhere to the inner surfaces of the lips. When the user stands up, the labial walls close more closely around the interlabial absorbent device 20 as shown in Figure 9.

The interlabial device 20 is preferably at least partially retained in place by exerting light pressure laterally directed outwardly on the inner surfaces of the labia minora, labia majora or both of the wearer. Additionally, the product is also maintained by attracting the naturally moist labial surfaces to the fabric comprising the flexible extensions 24. Optionally, the flexible extensions 24 can be provided with a biocompatible adhesive to aid adhesion of the flexible extensions 24 to the inner surface of the user's lips. The strength of this adhesive must be selected to assist the interlabial absorbent device 20 in remaining in place, while still allowing for reliable and comfortable removal of the device from the interlabial space of the wearer. Examples of suitable adhesives are described in U.S. Patent No. 5,336,208 issued to Rosenbluth et al. The interlabial absorbent device 20 is believed to differ from the prior art in a number of respects. Figure 6 shows a prior art interlabial device positioned within the interlabial space when the wearer is standing. When the wearer tips, however, the lips tend to separate as shown in Figures 7 and 10. The prior art device may tend to deflect to one side or the other in such a situation (as shown in Figure 7) . If the user urinates when the prior art device is in the position shown in Figure 7, the urine stream will completely err or pass the device. The flexible extensions 24 of the present invention, however, are adapted to maintain contact with the inner surfaces of the lips in order to keep the interlabial absorbent device 20 in the proper position (as shown in Figure 10). It is believed that this action of the flexible extensions 24 keep the interlabial device 20 of the present invention in a position that more consistently blocks the urethral orifice than the prior art device. As a result, it is believed that the endothelial absorbent device 20 of the present invention is excreted in the urine more reliably than the prior art device. As previously distinguished the flexible extensions 24 also cover the tips of the wearer's fingers during insertion (as shown in Figure 8), thereby providing a more hygienic insertion achieved with the prior art device. Optionally, the web-absorbing device 20 can be removed by holding the lower portion 28 of the central absorbent portion 22 with the fingers. Again, the flexible extensions 24 continue to cover the fingertips thus allowing a more hygienic removal of the proximal absorbent device 20 than that achieved with the prior art device. The interlabial absorbent device 20 can be used as a "single" product for the protection of menstrual, incontinence or vaginal discharges. Alternatively, it can be used as a backing for a tampon, or in combination with a sanitary napkin, pantiliner or incontinence pad for menstrual or incontinence use. If the interlabial absorbent device 20 is used with a sanitary napkin, the sanitary napkin can be of any thickness. Use with a sanitary napkin may be preferred at night to reduce back staining. The interlabial device 20 can be used in conventional panties, or it can be used with menstrual shorts. The proximal absorbent device 20 of the present invention may be provided with gelling absorbent material (MAG) in any particulate or fibrous form. Numerous alternate embodiments of the interlabial absorbent device of the present invention are possible. For example, these products are designed to be removed through urine, although an alternate cord or loop can be used. These products can also be used with medicinal treatments. These products are designed to fragment in water with agitation and are constructed of materials that are biodegradable. These characteristics, combined with their size, allow the elimination by discharge in a conventional toilet. The interlabial absorbent device 20 can also be constructed with a plurality of slits in the central absorbent portion 22 to allow folding of the product in multiple independent directions. This structure allows the product to respond more easily to the tensions associated with body movements. In a preferred embodiment of the embodiment shown in Figure 4, the ends of the surface of the central absorbent facing away from the body may be rounded to reduce the force on the product during sitting. The upper surface or lateral edges of the structure may have one or more slits or have other preferred bending regions such that the product can easily adjust to vertical pressure against the pelvic surface to help accommodate the nonlinear surface of the surface pelvic interior between the clitoris and the perineum. The flexible extensions 24 of the above absorbent devices, can also like a spring in both of the wet and dry conditions such that the sides of the product tend to expand outwardly pressing against the side walls of the labial vestibule, in this way, maintaining the product in the place. Furthermore, it is preferred that the flexible extensions 24 maintain the ability to act as a "spring" when wet, such as when the product is saturated with the liquid. Structures, such as polyurethane foams, can provide these properties.

TESTING METHOD Absorbent Capacity Absorbent capacity can be determined as follows: the test is performed on samples that have been conditioned by leaving them in a room at a relative humidity of 50% and at 73 ° F for a period of two hours before the test. The test must be carried out under similar conditions. The item is weighed to 0.1 grams closer. The article is then immersed in a beaker of sterile 0.9% saline (obtainable from Baxter Travenol Company of Deerfiled, IL), such that the article is fully submerged and is not flexed or otherwise bent or twisted. The article is submerged for 10 minutes. The article is removed to the saline solution and suspended for two minutes in an upright position to allow the saline solution to drain from the article. The article is placed on the surface facing downwards on absorbent blotting paper, such as filter paper # 631 available from Filtration Science Corp., Eaton-Dikeman Division of Mount Holly Springs, PA. A uniform load of 17.6 grams per square centimeter is placed on the article to release the excess fluid. The absorbent blotting paper is replaced every 30 seconds until the amount of fluid transferred to the blotting paper is less than 0.5 grams in a period of 30 seconds. Next, the article is weighed to the nearest 0.1 gram and the dry weight of the item is subtracted. The difference in grams is the absorbent capacity of the article.

Three Point Bending Test The Three Point Bending Test is performed on samples that have been conditioned by leaving them in an environment at 50% relative humidity and at 73 ° F for a period of 2 hours before the test. This test must be performed under similar conditions. The Three Point Bending Test uses an INSTRON Model 4502 tension and compression tester which is available from Instron Corporation of Canton, Massachusetts. The test also uses a special scroll "T" bar and a special bra for the test sample. As shown in Figure 13, the "T" bar 1101 comprises a pair of 6.40 mm diameter metal bars perpendicularly mounted together. The drive rod 1102 is approximately 125 mm long and the push rod 1103 is approximately 75 mm long. Preferably, the end of the drive rod 1102 is used to fit the circumference of the push rod 1103 and both are glued, welded, and / or screwed together. The opposite end of the driving rod 1102 is mounted to the sliding unit of the INSTRON machine. The test sample holder 1104 comprises a template base 1105 for positioning and supporting a pair of support rods 1108. The template base 1105 comprises a base 1105 and twelve rectangular supports 1107 mounted in parallel on the base 1106. The base 1106 and supports 1107 are each preferably made from the LEXAN plate (plexiglass) from about 10 mm to about 13 mm thick. A support rod 1108 of the same materials as the "T" bar and approximately 150 mm long is mounted on each support 1107 of the template base 1105. The support rods 1108 are mounted to leave 10 mm of open space between them (measured at the point on each rod that is closest to the other). As shown in Figure 13, the "T" rod 1101 is centered between the support rods 1108. The INSTRON machine is fixed at a crosshead speed of 2.0 inches per minute (50.8 mm / min). The INSTRON machine is set in such a way that the slide unit will travel 10 mm down and back for each sample tested. Before testing a sample, the T-bar 1101 is lowered until it rests directly on the upper part of one of the support rods 1108. The vertical position of the T-rod 1001 is "zeroed" when the load as it rests on the support rod 1108 is about 1 gram. The T-rod 1101 is then raised to 5 mm from this zero position and is centered between the support rods 1108. The sample 1000 to be tested is a piece of a material taken from one of the flexible extensions. The sample 1000 taken from one of the flexible extensions. The sample 1000 taken from the side wrapping elements should have a dimension of approximately 25 mm in the longitudinal direction LD and a dimension in the transverse direction of approximately 10 mm. If the flexible extensions on the product to be tested are too small, a larger sample must be used for the test. The sample is positioned in such a way that the push rod 1103 is running parallel to the side of the sample that was oriented in the transverse direction. The T 1001 rod is then allowed to travel through a full 10 mm cycle (ie, 10 mm down and 10 mm back). Consequently, the T-rod 1101 will contact the sample 1000 after approximately 5 mm and the sample will bend an additional 5 mm. The flexural strength is the peak force required to bend the sample as the T-bar travels through a full 10-mm cycle.

Test the resistance of the rupture Revision A test specimen, held between annular fasteners, is subjected to the increasing force applied by a 0.625 inch diameter polished stainless steel ball. The resistance to rupture is that force that causes the sample to fail. The resistance to rupture can be measured on wet or dry samples.

Apparatus Rupture Tester Tension test instrument Intelect-ll-STD, No. 1451-24PGB or the Thwing-Albert rupture tester are both suitable. Both instruments are available from Thwing-Albert Instrument Co., Philadelphia, PA. The instruments must be equipped with a 2000 gram load cell. If wet breakage measurements are to be made, the instruments must be equipped with a load cell protection and water protection for the front panel. Room Condition The temperature and humidity must be controlled to remain within the following limits: Temperature: 73 + 3 ° F (23 ° C + 2 ° C) Humidity: Relative Humidity of 50 + 2% Paper Cutter Scissors can be used or another equivalent Tray To soak the samples for the wet break suitable for the sample size Water solution to soak the samples for the wet break that must be balanced at the temperature of the conditioned room Stopwatch Suitable for soaking time measurement Sample preparation 1) Cut the sample to an appropriate size for the test (minimum sample size 4.5 inches x 4.5 inches). If the sample to be tested is too small (for example, a flexible extension with overall dimensions less than 4.5 inches x 4.5 inches), a larger sample of the same material should be used to determine the wet breaking strength. Prepare a minimum of five samples for each condition to be tested. 2) If you are going to make measurements of the break in wet, place an appropriate number of samples cut into a tray filled with water at a balanced temperature.

Equipment layout 1) Arrange the break tester according to the manufacturer's instructions. If a ll-STD tension test instrument is to be used, the following is appropriate: Speed: 12.7 centimeters per minute Breakage sensitivity: 20 grams Peak load: 2000 grams 2) Calibrate the load cell according to the breaking strength expected Measurements and report 1) Operate the rupture tester according to the manufacturer's instructions to obtain a measurement of the breaking strength for each sample. 2) Record the breaking strength for each sample and calculate an average and a standard deviation for the breaking strength for each condition. 3) Report the average and standard deviation for each condition in the next gram.

Report the average and standard deviation for each group of four samples. This concludes the test.

Dispersion test in Aqua Magnetic Stirring Device, type Thermolyne Model S7225 or 7200 (no substitutions). Permanently inscribe a 8.9 cm circle on the top surface of the agitator. The center of the circle must be coincident with the geometrical center of the agitator. Agitation bar coated with 6.2 cm TEFLON with spin ring. Permanently mark one end of the bar with black ink for a distance of 1.2 cm back from the tip. Thermometer 30 to 120 ° F with divisions of one degree. Stopwatch Digital Strobe Strobe, variable speed Stroboscope, model 964 available from Strobette, Power Instrument, Inc from Skokie, IL is suitable. Weighted glass of 2000 ml of the brand Kimax with peak (no substitution), inscribe a filling mark at a height of 14.3 cm from the flat bottom of the weeping vessel. Do not use any pointed glass that does not have a flat bottom.

Room Condition The temperature and humidity must be controlled to remain within the following limits: Temperature: 73 ± 3 ° F (23 ° C + 2 ° C) Humidity: Relative Humidity of 50 + 2% Equipment layout 1. Fill the weeping glass to the filling mark with common water at 73 + 3 ° F. 2. Place the beaker on the magnetic stirrer centering it on the inscribed circle. 3. Add the stirring rod to the beaker. 4. Turn on the stroboscope and set the speed to 1000 revolutions per minute according to the manufacturer's directions. 5. Turn on the magnetic stirrer with the on / off switch. Adjust the speed of the magnetic stirrer until the stir bar appears to be fixed and both ends appear to be black. This indicates that the magnetic stirrer is rotating at 500 revolutions per minute (that is, the half set in the strobe). Turn off the magnetic stirrer with the on / off switch.

Procedure 1. Maintain a sample (eg, an absorbent interlabial device) of 7.6 to 10.2 cm above the surface of the water. Gently drip the sample over the water surface, turning on the timer when the sample touches the surface of the water. 2. Wait 5 seconds. 3. Turn on the magnetic stirrer with the on / off switch. If the sample interrupts the rotation of the stirring bar, stop the agitator, reorient the bar, and immediately turn on the agitator again. 4. Record the time required until the sample separates into at least two pieces. The separation does not include the disassociation of a few individual fibers from an otherwise intact sample. Time is the total time of the sample that is submerged in the water, including the time the agitator has been stopped to reorient the sample. 5. Repeat steps 1 to 4 with three additional samples.

Calculation and report Calculate and report the mean and standard deviation of the dispersion capacity in water for the 4 samples tested.

DISCHARGE CAPACITY Summary As distinguished above, the terms "downloadable or discharge capacity" refers to the ability of the product to pass through typical, commercially available household toilets and sanitary system drainage system without causing obstruction or similar problems. may be directly associated with the physical characteristics of the product. For the purpose of the appended claims, the catamenial products are evaluated for their discharge capacity through the relative facility of the toilet rate and the evacuation of the siphon and subsequent transport through a simulated sanitary system. The discharge capacity of such a device must be measured by the following test procedure. The test procedure is designed to simulate two days of normal toilet use for a family of four (two men, two women). The test used a discharge sequence that simulates the following conditions: male urination visits, female urination visits (including post-urinal drying with paper), disposal of catamenial products (ie, the interlabial device or other device that will be tested) with toilet paper and bowel evacuation visits. The amount of paper to be used for each paper discharge is a normal discharge of 2 strips of 7 sheets. Normal loading is based on consumer research regarding typical habits and practices. The test was designed to simulate the conditions of a product that will be found if it is discharged through a conventional toilet and into a municipal sewer or septic tank. The samples were evaluated for: 1) clear of the toilet and stump rate, 2) blockage of the drainage line, and 3) disintegration during discharge.

Apparatus A suitable apparatus for the discharge capacity test is shown in the plan view in Figure 12. The apparatus includes: • A 13.2-liter, water-saving whirlpool siphon, referred to as 210 (additional toilets may also be attached to the pipe arrangement shown in Figure 12, to evaluate the behavior of the test samples using different control mechanisms) discharge such as pressure toilets, commercial). • approximately 18 meters of 10 cm acrylic pipe (as seen in Figure 12, the pipe is generally assembled in a square configuration, which has linear runs 211, 212, 213, 215, 217, 219, 221 approximately ( 3 meters) long • a cast iron T 223 slightly downstream of the toilet 210 which is open to the atmosphere for ventilation • 5 elbowed pipes of 90 degrees cast iron 212, 214, 216, 218 and 220; stump 222 placed vertically (Figure 13) approximately 4.57 meters from the terminal end of the pipeline and approximately 2.5 cm long, and • A grating (Tyler No. 4 sieve) to capture the solid effluent for the evaluation of the disintegration. The apparatus used for this method is set to be equivalent to A112.19.2M-1990 ANSI Standard for Chinese ceramic fittings.The pipe is installed to provide a drop of 2 cm per meter of the length of pipeline.

Materials Paper Product used in the Test: CHARMIN® standard toilet paper manufactured by The Procter & Gamble Company of Cincinnati, Ohio. Synthetic Fecal Material: Prepared to the method according to the method described below Test download sequence The test download sequence simulates 2 days of normal toilet use for a family of 4 (2 men, 2 women, based on the habits and practice of the consumer investigated). The sequence of 34 total downloads consists of 14 downloads with an empty rate, 8 downloads with paper only 6 downloads with paper and one catamenial product and 6 downloads with paper and simulated faecal matter (SFM). When this is used, the SFM is placed at the rate just before the addition of the paper, the SFM load of 160 degrees + 5 grams consists of 2 pieces of 2.5 cm x 10 cm and a piece of 2.5 cm x 5 cm. The folded paper strips (or the catamenial product) are placed at the rate at 10-second intervals. 10 seconds later the strip or final pad is placed on the rate, the toilet is discharged. The download sequence is described below as a series of two routines combined in the following order: Routine No.1 (A was performed 6 times for a total of 30 downloads) 1) Paper discharge only - Capture reading of drainage line taken 2 minutes after the water reaches the simulated obstruction, wait a minute additional, and move to step 2. 2) Download with the empty rate. Take a blocking reading of the drain line 2 minutes after the water reaches the stump point and move to step 3. 3) Discharge with paper and catamenial product. Take a drain line lock reading 2 minutes after the water reaches the stump point, wait 1 additional minute and move to step 4. 4) Download with empty rate. Take a drain line blocking reading 2 minutes after the water reaches the stump point and move to step 5. 5) Discharge with paper and simulated fecal matter (SFM). Take a reading of the blockage of the drain line 2 minutes after the water reaches the stump point, wait an additional minute.

Routine No. 2 (To be performed once) 1) Paper discharge only: Take a reading of the blockage of the drain line 2 minutes after the water reaches the stump point, wait an additional minute, and move to step 2. 2) Download with the empty rate. Take a reading of the blockage of the drain line 2 minutes after the water reaches the stump point and move to step 3. 3) Download with paper only. Take a reading of the blockage of the drain line 2 minutes after the water reaches the stump point, wait an additional minute, and move to step 4. 4) Download with the empty rate. Take a reading of the blockage of the drain line 2 minutes after the water reaches the point of the stump. The total number of discharges per sequence is 34. If, at any point in the discharge sequence, the product remains in the cap or siphon after discharge, the paper and / or the catamenial product thrown into the drain line manually and the download sequence will continue. After completing each test load, the drain pipe will be cleared before beginning the subsequent test.

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

Data Report The degree of blockage of the drain line is determined by measuring the length of standing water completely behind the obstruction. Graduations are marked every 30 cm on the drain pipe upstream of the extrusion. Each standing length that the water recedes corresponds to 6.6 cm or 6.25 cm of the blockade at the point of extrusion. The residues of the test product that exist in the drain pipe are also collected. The following data is recorded for each evaluation: 1) Incidence of failure (%) of the catamenial product to clear the siphon and the rate in a discharge. 2) Incidence of failure (%) of the catamenial product to clear the siphon and the rate in two discharges. 3) Incidence of the product on the simulated stump. 4) Maximum level (%) of the blockage of the drain line 5) Accumulated level (%) of the blockage of the drain line during the simulated test period of two days.

Preferably, the products described herein will completely clear the bowl at least 70% of the time of two fewer discharges, more preferably at least 80% of the time of one discharge, and most preferably at least about 90% of the time in one discharge, and most preferably at least about 95% of the time in a discharge. The products described herein will preferably have a maximum block level of the drain line of less than or equal to about 80%. The products described herein will preferably have an accumulated level of blockage of the drain line during the similar test period of two days less than or equal to about 70%.

Preparation of Synthetic Fecal Material I. Materials Needed: • Synthetic faecal material Felcone (900 grams); (Available from Silicone Studio, Valle Forge, PA as a dry concentrate BFPS-7) • Running 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 centrifugal tubes with screw caps (50 ml) (Available WVR Scientific, Chicago, IR, Catalog No. 21-008-176) • Water bath to control the temperature at 37 ° C. III. Preparation: 1. Drain the water at 100 ° C in the mixing bowl of the mixer and add the dry concentrate of Feclone. 2. Mix at low speed for one minute. 3. Mix at medium speed for two minutes. 4. After the material has been mixed well, transfer it to the extruder.

Use an ice pick, puncturing a small hole in the tip of each spin tube. 6. Extrude the Feclone in the centrifuge tubes. 7. Cover the centrifuged tubes and store in the refrigerator. 8. Before use, place the tubes in the water bath at 38 ° C.

This concludes the test. The disclosure of all patents, patent applications (and any of the patents issued thereon, as well as any of the corresponding published foreign patent applications), and the publications mentioned throughout this description are hereby incorporated by reference here. However, it is not expressly admitted that any of the documents incorporated by reference herein, teach or disclose the present invention. Although the 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 may be made without departing from the spirit and scope of the invention.

Claims (10)

1. CLAIMS 1.
2. A disposable absorbent device in the toilet insertable into the interlabial space of a female user, characterized in that said absorbent device comprises: a central absorbent portion having a length oriented in a x direction and a height oriented in a z direction, said length being greater than said height, wherein the time required for said interlabial absorbent device to disperse into at least two fragments as measured by the Dispersion Test is less than two hours, and wherein the interlabial device is capable of sufficiently discharging it. completely dislodges the cup under the Discharge Capacity Test at least 70% of the time in two or fewer discharges.
3. A disposable absorbent device in the toilet insertable into the interlabial space of a female user, characterized in that said absorbent device comprises: a central absorbent portion comprising an upper portion and a lower portion thereof, said upper portion facing the vestibule surface of said user during insertion into said interlabial space and leading said lower portion during insertion therein, with the lower portion opposite the upper portion and upon insertion of the absorbent device within the interlabial space the lower portion away from the surface of the wearer's vestibule, and a pair of flexible extensions attached to the upper portion of the central absorbent portion and extending downward and outward thereof, the extensions being flexible able to maintain contact with the inner surfaces of the lips of the user when she was to the absorbent device, wherein the absorbent device is capable of sufficiently discharging that it completely dislodges the cup under the Discharge Capacity Test at least 70% of the time in two or fewer discharges.
4. The absorbent device according to claim 2, wherein the flexible extensions disperse in at least two fragments in less than two hours, preferably in less than 60 minutes, more preferably in less than 30 minutes, as measured by the Water Dispersion Test.
5. The absorbent device according to claim 2, wherein the main absorbent portion disperses in at least two fragments in less than two hours, preferably in less than 60 minutes, more preferably in less than 30 minutes, as measured by Water Dispersion Test An absorbent device insertable into the interlabial space of a female user, characterized in that said absorbent device comprises: a central absorbent portion comprising an upper portion and a lower portion thereof, said upper portion facing toward the surface of said user's vestibule during the insertion into said interlabial space and leading to said lower portion during insertion therein, the lower portion being opposite the upper portion and upon the insertion of the absorbent device into the interlabial space the lower portion faces away from the vestibule surface. said user, and a pair of flexible extensions attached to the upper portion of the central absorbent portion and extending downwardly and outwardly thereof, the extensions being flexible able to cover the tips of the user's fingers as they are inserted the absorbent device inside the int space erlabial of the user, wherein the time required for the interlabial, downloadable, absorbent device to disperse into at least two fragments as measured by the Water Dispersion Test is less than two hours.
6. 6. The absorbent device according to any of the preceding claims, wherein the time required for the interlabial absorbent device, downloadable, dispersed in at least two fragments as measured by the Water Dispersion Test is less than 60 minutes, more preferably less than 30 minutes. The absorbent device according to any of the preceding claims, wherein the absorbent device is capable of sufficiently discharging that it completely dislodges the cup under the Discharge Capacity Test at least 90% of the time in a discharge . The absorbent device according to any of the preceding claims, wherein the device is at least 70%, more preferably at least 90%, biodegradable. The absorbent device according to any of the preceding claims, wherein the absorbent device substantially resides fully within the interlabial space of the wearer upon insertion. The absorbent device according to any of the preceding claims, wherein the absorbent device substantially blocks the urethra and orifice of the user's vagina upon insertion.