MXPA00004723A - Absorbent interlabial device - Google Patents

Abstract

An absorbent interlabial device that is worn interlabially by female wearers for catemenial purposes, incontinence protection, or both, is disclosed. The absorbent interlabial device of the present invention is characterized by improved wearing comfort and increased capacity as compared to known interlabial devices. The absorbent interlabial device of the present invention includes at least a central absorbent portion (or core) surrounded by a liquid pervious topsheet. The topsheet is folded laterally inward over the central absorbent portion and downward to form a central groove on the top surface of the interlabial device. The central groove faces toward the vestibule of the wearer upon insertion into the interlabial space. The central groove improves the comfort associated with the wearing of the interlabial device, and allows the device to more rapidly acquire fluids, particularly viscous fluids. Additional features of the device may include a pair of flexible extensions, a secondary topsheet for improved acquisition rate, and tapered sealed ends for improved wearing comfort.

Description

INTERLABIAL ABSORBENT DEVICE FIELD OF THE INVENTION The present invention relates to absorbent devices, and more particularly to an improved absorbent device which is carried on by the 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 Applicator". Buffer with Means for Sterile Insertion ", issued to Jacobs on November 8, 1983. Hybrid devices have also been proposed that aim to merge the structural characteristics of sanitary pads and tampons into a simple device. These hybrid devices are 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 "Protection Shield for Hygiene. Feminine "issued to Denkinger on September 16, 1975. Other less invasive hybrid devices are known such as sanitary labial or interlabial towels and are characterized 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 user'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, 969, 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 performance, comfort, or both, with respect to previous 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 provide sufficient capacity for catamenial protection during times of heavier flow. The device described in the Vulkos et al patent requires an external storage module to achieve the described capacity and may have comfort disadvantages compared to the absorbent device of the present invention. 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 and under a broad spectrum of flow conditions. There is also a need for an interlabial device with an improved acquisition rate especially with respect to more viscous discharges. Ideally, an interlabial device should be highly comfortable, have a high capacity, be easy to insert and remove, and be disposable in the toilet. There is also a need for an interlabial device that meets these needs and that can also be easily manufactured using current frame management technology. Therefore, it is an object of present invention to provide a comfortable, high-capacity, inter-lablab absorbent device that is small in size and easy to insert. It is another object of the present invention to provide an interlabial absorbent device that is capable of rapid fluid acquisition, especially more viscous fluids. It is another object of the present invention to provide an interlabial absorbent device that consistently blocks the urethra in such a way as to provide protection against incontinence, menstrual discharges, and discharges of body exudates throughout a broad spectrum of movements of the urethra. user. 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, so that the user does not have to touch the dirty product. It is another object of the present invention to provide an interlabial absorbent device that can be optionally removed with the fis 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 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. It is another object of the present invention to provide an interlabial absorbent device that satisfies the objects described above and that can be conveniently manufactured using current frame management technology.

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 web absorbent device of the present invention comprises a central absorbent portion and a liquid permeable upper sheet wrapped around the central absorbent portion. The length of the interlabial absorbent device is greater than the width of the interlabial absorbent device. The top sheet is folded laterally inwardly on the central absorbent portion and down substantially in the Z direction. This folding defines a central groove substantially oriented in the Z direction, which extends in the X direction along at least a part of the length of the interlabial absorbent device. The groove faces towards the surface of the wearer's vestibule upon the insertion of the interlabial absorbent device into the interlabial space of the wearer. In preferred embodiments, the longitudinal cross section (ie, the cross section seen in the y-z plane) of the absorbent device is generally of a cardioid or heart shape. The cross-sectional shape of the absorbent device can also be described as two U-shaped bends on the upper surface of the device, which defines a central groove. The lower surface of the device is characterized by a simple, larger U-shaped fold.

In a further preferred embodiment, of the present invention, the device also comprises a pair of flexible extensions attached to the upper sheet permeable to the liquid and extending outwards. Preferably, the flexible extensions are able to maintain contact with the internal surfaces of the wearer's lips when the absorbent device is worn. The flexible extensions are also preferably able to cover the tips of the wearer's finger as the absorbent device is inserted into the interlabial space of the wearer. In a preferred embodiment, the device may include a liquid-impermeable backsheet attached to at least a portion of the topsheet. In yet another preferred embodiment, the absorbent device may comprise a slit core for increased flexibility. Additionally, the absorbent device may comprise a secondary acquisition layer disposed between the absorbent central portion and the liquid permeable topsheet. In a preferred embodiment, the longitudinal edges of the topsheet are sealed to form an absorbent device with sealed ends. In the preferred embodiments of the present invention, these sealed ends are oriented in the Z direction. In the most preferred embodiments, the sealed ends are also oriented in a longitudinally outward to inward relationship as viewed from an outward to inward along the height of the device. The device in said preferred embodiments has a generally trapezoidal shape in the cross section. In still further preferred embodiments the absorbent device is downloadable in the toilet. Preferably, the absorbent device is constructed at least partially from biodegradable materials. Additionally, the interlabial absorbent device will preferably disperse in at least two, and more preferably in several fragments within two hours of exposure to the water at room temperature, slightly agitated. In the preferred modalitiesapproximately half of the absorbent device resides within the user's labial space upon insertion. The interlabial absorbent device, in the preferred embodiments, blocks the urethra and the opening of the vagina when inserted. A preferred method of making the absorbent device of the present invention includes the steps of providing a piece of top sheet material, layering a piece of absorbent core material on top sheet material, folding the edges of both the stock material upper sheet as the central absorbent material as an inward and downward unit to define a central groove, and securing the folded material to form an interlabial absorbent device having a central groove oriented upwards.

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 cross-sectional bottom view of the absorbent device shown in Figure 1.

Figure 3 is a plan view of the materials comprising the interlabial absorbent device of the present invention before bending to form the device. Figure 3a is a perspective view of the composite materials shown in Figure 3 after the side margins have been folded in a first folding operation. Figure 3b is a perspective view of the composite materials shown in Figure 3 after they have been folded in a second folding operation. Figure 4 is a top plan view of the materials shown in Figure 3 after they have been folded and secured to form an interlabial absorbent device in accordance with the present invention. Figure 5 is a cross-sectional bottom view of the device shown in Figure 4. Figure 6 is a bottom view of an embodiment of the interlabial absorbent device of the present invention, showing the flexible extensions covering the tips of the fingers. of the user. Figure 7 is an exploded plan view showing the assembly of the materials comprising a preferred embodiment of the interlabial absorbent device of the present invention in a layered configuration prior to bending and securing the layers to form the complete device. Figure 8 is a cross-sectional sagittal view of a female user showing the placement of the interlabial absorbent device in the wearer's interlabial space. Figure 9 is a schematic perspective view of the Three Point Bending Test apparatus.

Figure 10 is a plan view of an apparatus suitable for the determination of the discharge capacity according to the method described in the TEST METHODS section, below. Figure 11 is a cross-sectional view of the discharge-capable apparatus of Figure 10, taken along line 11-11 thereof.

DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to an interlabial absorbent device. 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 labial space of a female user during use. Preferably, about half of the entire web absorbent device 20 of the present invention resides within this interlabial space, more preferably more than half of the entire web absorbent device 20 resides within the interlabial space of a female user during the use. As used herein, the term "interlabial space" refers to that space within the pudendal region of the female anatomy, which is located between the inner 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 orifice 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. A preferred embodiment of the interlabial absorbent device 20 of the present invention is shown in FIG. Figures 1 and 2. Figure 2 is a cross-sectional view of the interlabial device 20 shown in Figure 1. When viewed in combination with one another, Figures 1 and 2 more clearly show how the components form the interlabial device. twenty.

The interlabial absorbent device 20 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 nterlabial device 20 which is generally aligned with (e.g., approximately parallel to) a vertical plane that divides a wearer standing in left and right body halves when the interlabial device 20 is used. The "length" of the interlabial device 20 is the linear measurement of interlabial device 20 taken in the x direction. The terms "transverse", "lateral", or "y direction", as used herein are interchangeable, 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 "width" of the interlabial device 20 is the linear measurement of the interlabial device 20 taken in 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. The "height" of the interlabial device 20 is the linear measurement of the interlabial device 20 taken in the z-direction. The interlabial absorbent device 20 of the present invention includes at least a main portion 26 having an upper surface 22 and a lower surface 24. In use, the upper surface 22 is inserted farther into the user's liplabial space. The main portion 26 preferably comprises at least a central absorbent portion 28 (also referred to as an "absorbent core" or "absorbent main portion") and a liquid-permeable upper sheet 30. The topsheet 30 is folded laterally inward over the portion central absorbent 28 and down substantially in the z direction This folding defines a central slot 32 generally disposed along the upper surface 22 of the interlabial device 20.

The central slot 32 extends in the direction x along at least a part of the length of the interlabial device 20. The central slot 32 is substantially oriented in the z-direction, ie the space between the edges of the upper sheet 30. which defines the central groove 32, is generally oriented in an up and down direction starting from the upper surface 22 of the interlabial device 20 and going down towards the main portion 26 of the interlabial device 20. The central groove 32 faces the surface of the user's vestibule when inserting the interlabial absorbent device in the interlabial space of the user. The central slot 32 of the present invention allows the interlabial device 20 to acquire the fluids more quickly than the devices of the prior art. Fluids, as defined herein, refer to liquids that may include viscous material and solids. Particularly when exposed to more viscous fluids, the central slot 32 will reduce the tendency of the interlabial device 20 to act as a "stop" or "plug" and be more responsive to body exudates as compared to prior art devices. . The central slot 32 also allows the upper surface 22 of the interlabial device 20 to fit more easily around the clitoris. This ability of the central slot 32 to fit around the clitoris improves the level of comfort associated with the use of the device 20 within 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. Interlabial device 20 intercepts at least partially and at least preferably completely intercepts and absorbs the flow of menses, urine, and other body exudates from the vaginal orifice and the urethra of the user. The size of the interlabial device 20 is also important for the comfort associated with the use of the device. The length of the interlabial absorbent device 20 is greater than the width of the interlabial absorbent device 20. In the preferred embodiment shown in Figures 1 and 2, the main portion 26 of the interlabial device 20 has a length as measured along the line longitudinal central L, of between about 60 mm and about 120 mm. Preferably, the length of the interlabial device 20 is between about 80 mm and about 110 mm, and more preferably, it is about 100 mm. The gauge (or width) of the main portion 26 of the interlabial device 20 as measured in the transverse direction (or "y" direction) is preferably between 4.5 and 15 mm, more preferably the gauge is approximately 8 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 portion 26 is preferably between about 10 mm and about 30 mm, and more preferably is about 19 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 main portion 26 thereof. The main portion 26 preferably has a capacity of at least about 3 grams of 0.9% by weight of saline, and can have a capacity of up to about 20 grams using gels or absorbent foams that expand when wet. The capacities can typically vary from about 5 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 user, some of the absorbed exudates may be externally stored in the interlabial space of the wearer. As noted above, the main portion 26 of the interlabial device 20 preferably comprises at least one liquid-permeable topsheet 30 which is wrapped around an absorbent central portion 22 (or core). The central absorbent portion 28 of the preferred embodiment shown in Figures 1-2 can be manufactured from a wide variety of liquid absorbent materials commonly used in absorbent articles. The central absorbent portion 28 is preferably constructed from a material that is flexible, and has high absorbency. In the preferred embodiments of the present invention, the central absorbent portion 28 will provide at least 70% of the absorbent capacity of the interlabial device 20. The remainder of the capacity will reside in other features of the device., such as a secondary topsheet 38 or the flexible extensions 42. Sufficient absorbency can be obtained through the use of superabsorbent polymers in any particulate or fibrous form.

A suitable material for the central absorbent portion 28 is a thermally bonded air laid (TBAL) material available from Technical Absorbentes, Ltd. De Grismby, United Kingdom, which incorporates approximately 40% OASIS superabsorbent fibers (available from Lantor, Ltd. , from Bolton, England). This material has an overall basis weight of approximately 150 g / m2. Another suitable material is a TBAL material that incorporates approximately 17.5% FIBERDRI superabsorbent fibers. The material has a basis weight of approximately 120 g / m2 and is available from Camelot Technologies, Ltd., of South High River, Alberta, Canada, (all percentages are by weight unless otherwise noted). A third material suitable for the central absorbent portion 28 is a TBAL material that is available from Merfin Hygienic Products of Delta, British Columbia, Canada. This material has a basis weight of less than about 150 g / m2 and incorporates approximately 15% of gelling absorbent material (MAG) by weight. Also slightly higher amounts of MAG are acceptable. The absorbent core portion 28 can also be constructed from Galaxi rayon which is available from Courtaulds Fibers / Allied Colloids (to a joint-venture company) of London, England. Additionally, a mixture of Galaxi rayon and cotton can also be used. Examples of other suitable absorbent materials include ground wood pulp, which is generally referred to as an air filter, 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 28 may comprise a simple material or a combination of materials. In the preferred embodiment shown in Figures 1 and 2, the central absorbent portion 28 is formed of a soft, flexible absorbent material. The flexibility of the central absorbent portion 28 is preferably increased by providing the central absorbent portion with a series of slits 34 as shown in Figure 3. Figure 3 shows a central absorbent portion 28 with slits. Figure 3 also shows the central absorbent portion 28 covering the topsheet 30 before the topsheet 30 and the absorbent central portion 28 are bent to define the central slit 32. A more complete description of an absorbent material with slits which is Suitable for use in the present invention is found in U.S. Patent No. 5,611,790 issued to Osborn III et al. on March 18, 1987. The absorbent core portion 28 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%. Preferably, the total interlabial absorbent device 20 is disposable in the toilet. The term "disposable in the toilet" as used herein includes the following features of 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 household toilet and drainage pipe systems without causing occlusion or similar problems 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 20, in the TEST METHODS section of this disclosure. The term "dispersible" as applied herein to an interiabial absorbent device 20, refers to an article that will disperse in at least two fragments in slightly agitated water. Said device will break into pieces in a conventional toilet and / or domestic drainage system. The term "biodegradable" as used herein, refers to an absorbent device that is preferably constructed at least partially from biodegradable materials. Although the biodegradable materials for the interlabial device 20 are preferred, it is not necessary that each and every material used be biodegradable. For example, the device 20 may comprise superabsorbent particles that do not degrade biologically, and this will not affect the ability of the total device 20 to remain disposable in the toilet and to be effectively processed in a wastewater treatment system. The main portion 26 of the interlabial device 20 of the present invention also comprises a liquid permeable topsheet, such as the topsheet 30. The topsheet 30 should be docile, of soft feel and non-irritating to the wearer's skin. The topsheet 30 also exhibits good transfer and has a reduced tendency to rewet, allowing discharges from the body to easily penetrate and flow to the central absorbent portion 28, but not allowing these discharges to flow back through the topsheet 30. A suitable top sheet 30 can be manufactured from a wide range of materials such as woven and non-woven materials; polymeric materials, such as thermoplastic films formed with openings, plastic films with openings and hydroformed thermoplastic films; porous foams; cross-linked foams; crosslinked thermoplastic films; and thermoplastic canvases. Suitable woven and nonwoven materials may be composed of natural fibers (eg, wood or cotton fiber), synthetic fibers, (eg polymer fibers such as polyester, rayon, polypropylene or polyethylene fibers), or from a combination of natural and synthetic fibers. When the upper sheet 30 comprises a nonwoven web, the web can be spun bonded, carded, wet laid, blown in the molten state, hydroentangled, combinations of the above, or the like. A top sheet 30 particularly suitable for use in the present invention is formed from rayon with a basis weight of about 18 g / m2 and is available from Veratec, Inc., of Toronto, Ontario, Canada. This material is particularly suitable for use as a top sheet 30 because it is biodegradable. The topsheet 30 may comprise a film formed with openings. Films formed with openings are permeable to body exudates, and, if properly perforated, have a reduced tendency to allow liquids to pass back through and rewet the user's skin. In this way, the surface of the formed film that is in contact with the body remains dry, thus reducing the staining of the body and creating a more comfortable feeling for the wearer. Suitable formed films are described in U.S. Patent No. 3,929,135 entitled "Absorbent structures having tapered capillaries", which was issued to Thompson on December 30, 1975, U.S. Patent No. 4,324,246 entitled "Article disposable absorbent having a stain-resistant sheet ", which was issued to Mullane et al. on April 13, 1982; U.S. Patent No. 4,342,314 entitled "Resilient plastic screen exhibiting properties in the form of fiber", which was issued to Radel et al. on August 3, 1982; U.S. Patent No. 4,463,045 entitled "Macroscopically expanded three-dimensional plastic screen exhibiting a non-glossy visible surface and a fabric-like fingerprint", which was issued to Ahr et al. on July 31, 1984; and in U.S. Patent No. 5,006,394"Multilayer Polymer Film", which was issued to Baird on April 9, 1991. The preferred top sheet 30 for the present invention is the formed film described in one or more of the previous patents and that is marketed in sanitary napkins by The Procter & Gamble Company of Cincinnati, Ohio, as the top sheet "DRI-WEAVE". Another upper sheet 30 suitable for the present invention is made in accordance with U.S. Patent Nos. 4,609,518 and 4,629,643 both issued to Curro et al. On September 2, 1986 and December 16, 1986, respectively. This formed film is manufactured by Tredegar Corporation of Terre Haute, Indiana. In a preferred embodiment of the present invention, the outward (i.e., body-facing) surface of the top sheet 30 of formed film is hydrophilic to help transfer liquid through the top sheet faster than if the surface that it gives out. This hydrophilic capacity decreases the likelihood that the menstrual fluid will flow out of the topsheet 30 instead of flowing into and being absorbed by the central absorbent portion 28. In a preferred embodiment, surfactant is incorporated into the polymeric materials of the sheet 30 upper of formed film. Additionally, the outward facing surface of the topsheet 30 can be made hydrophilic by treating it with a surfactant such as is described in U.S. Patent No. 4,950,254 issued to Osborn. The topsheet 30 is wrapped around the absorbent central portion 28 and is optionally also attached thereto. The term "joined" as used herein encompasses configurations in which one 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 topsheet 30 can be attached to the absorbent central portion 28 by any variety of means. For example, as shown in Figures 1 and 2, the topsheet 30 can be attached to the absorbent central portion 28 through the use of stitches 36 (such as with cotton or rayon yarn). Alternatively, the topsheet 30 may be attached to the absorbent core portion 28 using any suitable adhesive, thermal bond, melt bond, or any other suitable means known in the art to bond these materials together. Regardless of whether or not the top sheet 30 is attached to the central absorbent portion 28, the top sheet 30 will be wrapped around the central absorbent portion 28 as described above. The topsheet 30 should also be secured in a manner that acts to contain the central absorbent portion 28 in a wrapped relationship with respect to the topsheet 30 and maintain the structure of the central slit 32, previously described. Fig. 2 and Fig. 5 both cross-sectional longitudinal sectional views of the modalities of the proximal absorbent device 20 of the present invention. Figure 5 shows the absorbent central portion 28 and upper sheet 30 wrapped around the central absorbent portion and folded according to the present invention as described above. Figure 2 also shows the central absorbent portion 28 and the upper sheet 30 folded and wrapped as in Figure 5, but also shows additional optional components of the interlabial absorbent device 20 not shown in Figure 5. These optional components will be fully described below. . As seen in Figures 2 and 5, the longitudinal cross section of the interlabial absorbent device 20 is substantially cardioid or heart-shaped. Other shapes in longitudinal cross section that provide the characteristic of the central groove 32, described above, can also be used. In addition to the upper sheet 30 and the central absorbent portion 28, the main portion 26 of the interlabial absorbent device 20 may also contain several optional components. For example, as shown in Figure 2, the interlabial absorbent device 20 may be provided with a secondary topsheet 38 disposed between the topsheet 30 and the absorbent central portion 28. The topsheet 38 acts to pull the fluids rapidly from the top sheet 30 and to direct them towards the central absorbent portion 28 for storage. Preferably, the secondary topsheet 38 has some of the initial absorbent capacity, but quickly releases the absorbed fluids to the central absorbent portion 28. Suitable materials for the secondary topsheet 38 include rayon, polyester, rayon mixed with polypropylene, polyester blends. or some combination of these. A mixture of rayon and polypropylene that has a basis weight of approximately 68 grams. per square meter is in the preferred embodiments as a material for the secondary upper sheet 38. The secondary upper sheet 38, if used, can be attached to one or both of the central absorbent portion 28 or the upper sheet 30. Any of the The joining methods described above for the topsheet 30 are applicable for the topsheet 38. In the preferred embodiment shown in Figures 1 and 2, the topsheet 38 is attached to the topsheet 20 and to the absorbent central portion 28 by the stitches 36. These stitches 36 also serve to maintain the shape of the main portion 26 of the interlabial device 20 thus maintaining the structure of the central slot 32 when the device 20 is worn. The interlabial absorbent device 20 may also comprise a backsheet liquid impermeable 40 which is attached to at least a portion of the upper sheet 30. In the preferred embodiment shown in Figures 1 and 2, the back sheet 40 is attached to the upper sheet 30 on the lower surface 24 of the interlabial absorbent device 20. If the interlabial device 20 does not comprise the flexible extensions 42 (described more fully below), the back sheet 40 can be directly attached to the upper sheet 30 on the lower surface 24 of the device 20. If the flexible extensions 42 are used, these may comprise a web of simple material, a part of which is disposed between the upper sheet 30 and the back sheet 40. Such an arrangement is shown in Figures 1 and 2 and described more fully below. The backsheet 40 may be attached to the web absorbent device by any suitable conventional means known in the art. If a backsheet is used, the backsheet 40 must be impermeable 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 40 prevents the exudates absorbed and contained within the main portion 26 from wetting the articles that are in contact with the interlabial device 20 such as the wearer's undergarments. The backsheet 40 also helps the main portion 26 prevent the wearer's body from being soiled by the exudates. Additionally, the use of the backsheet 40 can 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 40 may comprise a woven or non-woven material, polymeric films such as polyethylene or polypropylene thermoplastic films; or composite materials such as a film-coated nonwoven material. Preferably, the backsheet 40 is a polyethylene film having a thickness of about 0.012 mm to about 0.051 mm. An exemplary polyethylene film is manufactured by Clopay Corporation of Cincinnati, Ohio, under the designation P18-0401. The backsheet 40 can allow the vapors of the main absorbent portion 22 (i.e., respirables) to escape, while still preventing the exudates from passing through the backsheet 40. As shown in Figures 1 and 2, the The interlabial absorbent device 20 also comprises a pair of flexible extensions 42. The flexible extensions 42 are attached to the main portion 26 and extend downward and outward therefrom beginning at a point surrounded by the upper surface 22 of the main portion 26 of the device. interlabial 20. In a preferred embodiment shown in Figures 1 and 2, the flexible extensions 42 are generally rectangular in shape. Other shapes are also possible for flexible extensions 42 such as semicircular, trapezoidal or triangular. The flexible extensions 42 are preferably from about 30 mm to about 70 mm long, more preferably about 50 mm long. Although the flexible extensions 42 may have a length (measured in the x direction) that is equal to or longer than the main portion 26, they preferably have a length that is shorter than the main portion 26 of the lip-absorbent absorbent device 20. The width of each of the flexible extensions refers to the distance from the junction of the most upper point of the flexible extension 42 to the main portion 26 (or the proximal end 42A of the flexible extension 42), toward the far end (or free end) 42B of the flexible extension 42. The width of the flexible extensions 42 is preferably approximately equal to or less than the height of the main portion 26 as described above. In the preferred embodiment shown in Figures 1 and 2, the width of the flexible extensions 42 is from about 13 mm to 20 mm, more preferably 17 mm. 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. The flexible extensions 42 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 g / m2, and which has the class designation number 176. 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. Flexible extensions 42 may optionally be supported with a layer of material that is impermeable or semipermeable to body exudates, such as wax, polyethylene, polypropylene or polyvinyl alcohol. Additionally, the flexible extensions 42 may also be coated with an emollient to improve the ease of insertion of the interlabial device 20 and to improve the wearing comfort of the device 20.

In the preferred embodiment shown in Figures 1 and 2, the pair of flexible extensions 42 may comprise a single sheet of material extending on either side of the longitudinal center line L of the interlabial absorbent device 20. Alternatively, the pair of flexible extensions 42 may comprise separate sheets of material, independently attached to the main portion 26 of interlabial device 20. Preferably, the flexible extensions 42 are arranged asymmetrically about the longitudinal center line L of the interlabial device 20. The flexible extensions 42 can be attached to the main portion 26 of the interlabial device 20 by any variety of means. For example, in the preferred embodiment shown in Figures 1 and 2, the flexible extensions 42 can be attached to the main portion 26 of the interlabial device 20 near the top surface 22 with the stitches 36. Alternately the flexible extensions 42 can be joined together. to the main portion 26 of the interlabial device 20 using a suitable adhesive. The adhesive may extend continuously along the length of the main portion 26, or it may be applied in a "dot" manner at discrete intervals. Other suitable joining means include thermal bonding, fusion bonding, or any other suitable means known in the art, for bonding these materials. As shown in Figures 1 and 2, the flexible extensions 42 are attached to the main portion 26 near the upper surface 22 of the interlabial device 20. The flexible extensions 42 extend downward and outward from the main portion 26 toward an end 42B which is not attached to the main portion 26. The flexible extensions 42 may be offset slightly away from the main portion 26 to tend to keep the extensions 42 in contact with the inner surfaces of the lips when in place. interlabial absorbent device 20. Additionally, the naturally wet surfaces of the lips will have a tendency to adhere to the material comprising the flexible extensions 42 tending more to keep them in contact with the inner surfaces of the lips. Preferably, the flexible extensions 42 should be able to move from a position where the free ends of the flexible extensions 42 are located adjacent the main portion 26 to a position where the flexible extensions 42 extend directly outward from the main portion 26 in the transverse direction. The flexible extensions 42 should be sufficiently wide and flexible to allow the flexible extensions 42 to cover the tips of the user's fingers as the interlabial absorbent device 20 is inserted into the wearer's interlabial space. Additionally, the flexible extensions 42 must be able to move with the internal surfaces of the wearer's lips to maintain contact with them. The flexible extensions 42 help to keep the main portion 26 in place on an entire scale of user movements such as when bending over. The flexible extensions 42 can be hydrophilic or hydrophobic. The flexible extensions 42 can be treated to make them less hydrophilic than the main portion 26. The hydrophilic capacity of a material is generally expressed in terms of its contact angle. In this way, the flexible extensions 42 may have a lead contact angle greater than the lead contact angle of the main portion 26, such that the fluid is preferentially directed toward and absorbed by the main portion 26. The flexible extensions 42 can be either absorbent or non-absorbent. Preferably, the flexible extensions 42 have at least some absorbency. The majority of the fluid absorbed and retained by the interlabial absorbent device 20, however, will preferably be retained preferably in the main portion 26, particularly in the central absorbent portion 28. For a more detailed description of the hydrophilic capacity and the contact angles see the following publications which are incorporated by reference herein: publication of the American Chemical Society entitled "Angle of contact, wettability and adhesion" edited by Robert F. Gould, and copyrighted 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. HG Heilweil. The flexibility of both the main portion 26 and the flexible extensions 42 is important for the comfort of the product. The interlabial device 20 must be provided with both compressibility and folding capacity. Folding ability refers to the ability of the device 20 to bend about the longitudinal axis L and / or the transverse axis (ie, the "y-direction") of the end-of-web device 20 when subjected to a bending force. The compressibility refers to the ability of the interlabial device 20 to deform locally in response to a compression force, the device 20 tending to have a soft, compliant feel. By providing the central absorbent portion 28 with slots 34, as described above, both the collapsible capacity and the compressibility of the interlabial device 20 are improved. The materials chosen for the components of the interlabial device 20 must be selected to provide a total device 20 that It is highly flexible to improve the comfort of use, still rigid enough to be easily placed between the folds of the lips and maintain its shape during use. If the interlabial absorbent device 20 is too flexible, the device is not placed conveniently or easily between the folds of the lips, if it is too rigid, the device is uncomfortable and when the user is in a sitting position, the device 20 can being forced inward against the clitoris causing discomfort. Preferably, the interlabial device 20 is composed of higher material near the upper surface 22 and more dense material near the lower surface 24. This arrangement provides a capillary structure from larger to smaller as the fluid travels downward toward the central groove 32 and towards the central absorbent portion 28 of the interlabial device 20. Additionally, this arrangement of material raised on the upper part and the denser material on the lower part of the interlabial device 20, results in a product that is more comfortable in the areas of contact with the body, thus improving the comfort of use. The interlabial absorbent device 20 is also preferably provided with sealed ends 44 as shown in Figure 1. Any suitable means of sealing the ends of the interlabial device 20 such as heat sealing can be used. In the preferred embodiment shown in Figure 1, the sealed ends 44 of the interlabial device 20 are oriented in both directions "x" and "z". That is, the distance between the sealed ends 44 is shorter on the upper surface 22 of the interlabial device 20 than the distance between the sealed ends 44 on the lower surface 24 of the interlabial device 20. This arrangement results in an interlabial device having a trapezium-shaped cross section, as shown in Figure 1. Alternatively, the sealed ends 44 may be rounded as seen from the cross-sectional view of the interlabial device 20. Preferably, the ends 44 are divided apart (ie, unsealed) in the vicinity of the upper surface 22 of the interlabial device 20. In the preferred embodiment shown in Figure 1, the sealed ends 44 are sealed to a point at approximately 4 mm. of the upper surface 22 of the interlabial device 20. The sealing feature of the end of the interlabial absorbent device 20 shown in Figure 1 improves the comfort associated with the use of the device 20. When the ends are sealed and adapted, they are more easily compressible or crushing when they press. This allows the device 20 to be less bulky at the sealed ends 44 and provides improved comfort during use.

The strength and rigidity of the flexible extensions 42 are important characteristics of their design. If the flexible extensions 42 have a wet rupture strength of less than or equal to about 15 grams, they will tend to fragment and may leave remaining pieces within the wearer's interlabial space. Similarly, if the flexible extensions 42 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 the flexible extensions 42 has a flexural strength of less than about 25 grams measured using the 3-point bending test. More preferably, the flexible extensions 42 have a flexural strength of less than or equal to about 5 grams. A description of the 3-point bending test is contained in the Test Methods section, below. The flexible extensions 42 also have an inherent resistance, such that during application and use they do not tear. The wet strength for the flexible extensions 42 must exceed 15 grams, and preferably exceed 150 grams, and most preferably exceed 300 grams. The wet strengths given above are measured using the wet break test which is described in more detail in the Test Methods section, below. The structure of the proximal absorbent device 20 of the present invention allows for easier fabrication using current weft management technologies than those associated with the manufacture of a cylindrically shaped adapted device (i.e., a product without the central slot 32 of the present invention). invention). The interlabial device 20 of the present invention can be manufactured by first assembling the materials forming the components of the device 20 in a layered configuration as shown in Figure 7.

The following describes a non-limiting example of the assembly of an interlabial absorbent device 20 of the present invention. If a back sheet 40 is to be used, it can be provided in strips of approximately 120 mm x 16 mm. The material strip of the backsheet 40 is provided in such a way that the side facing the garment of the material is facing downwards. If the device 20 is to have flexible extensions 42, these can be provided immediately in the form of a segment of rectangular material approximately 120 mm x 51 mm in size. The material of the flexible extension 42 is placed on top of the material of the backsheet 40 in such a way that the longest dimension is perpendicular to the longest dimension of the material of the backsheet. The material of the upper sheet 30 can be cut into rectangular segments of approximately 127 mm x 86 mm. The wefts of the material of the upper sheet 30 are placed with the side facing downwards towards the body, on the upper part of the material of the flexible extension 42 and the material of the backsheet 40, if provided. If the device 20 is to have a secondary upper sheet 38, the material for the secondary upper sheet 38 can be cut into rectangular segments of approximately 95 mm x 79 mm. The layer of the secondary topsheet 38 is placed on top of the top sheet layer 30. The absorbent central portion 28 can be provided with slits 34 and cut into rectangular segments of approximately 92 mm x 64 mm. The layer of the absorbent central portion 28 is placed on top of the layer of the secondary topsheet 38, if provided. Otherwise, the layer of the absorbent central portion 28 will rest directly on the material of the upper sheet 30. Once the materials are layered in the configuration shown in Figure 7, the layers are bent and secured to form the interlabial absorbent device 20. Figures 3 to 5 show how the layers are bent to form the complete device 20. For simplicity, Figures 3 to 5 show a device 20 comprising only an upper sheet layer 30 and a central absorbent portion 28. Figure 3 shows the composite layers before any folding. As shown in Figure 3, the central absorbent portion 28 is covering the top sheet layer 30. Both layers are rectangular segments. The longitudinal edges 30A of the topsheet 30 will become the ends of the device 20 after bending and securing the layers as shown in Figure 4. Similarly, the transverse edges 30B of the topsheet 30 will be folded together and secured to forming the central groove 32 of the present invention as shown in Figure 5. The transverse edges 30B of the layered materials are bent as a unit as shown in Figure 3A along the bending axes F in a first doubling operation to form a bent structure of "C" The device 20 is then subjected to a second folding operation shown in Figure 3B, wherein the two transverse edges of the device 20 after the first folding operation are bent upwards towards a the other. This second bending operation takes place along the second fold line F shown in Figure 3B. After this second bending operation, the top sheet layer 30 is in a configuration wrapped around the absorbent central portion 28 as shown in Figure 4. These two bending stages, the final result of which is shown in FIG. Figure 4 defines the central groove 32 which is more clearly shown in Figure 5. The transverse edges 30B of the topsheet can be secured using any suitable means known in the art (such as stitches or adhesive, not shown) to retain the device 20 in this bent configuration. The longitudinal edges 30A of the top sheet can be adjusted and heat sealed to form the configured end seals 44 described above and shown in Figure 1. As discussed previously, the interlabial absorbent device 20 of the present invention is designed to be placed within the interlabial space of a user. To use the interlabial absorbent device 20 of the present invention. The user holds the main portion 26 between her fingers. As shown in Figure 6, the flexible extensions 42 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 interlabial device 20 is inserted with the upper surface 22 inserted first and further into the interlabial space. The user can assume a crouched position during insertion to help extend the labial surfaces. Figure 8 shows a preferred embodiment of the interlabial absorbent device 20 of the present invention inserted into the interlabial space of a user W. The urinary genital members shown in Figure 8 include the bladder B, the vagina V, the urethra U, the clitoris C, the large intestine I, the year, the vaginal introitus VI, the ring of the hymen H, the labia minora N, and the labia majora J. Figure 8 shows the relationship of these anatomical aspects of the user W with respect to the absorbent device Nterlabial 20 when the device is inserted properly during use. Once the interlabial absorbent device 20 is inserted, the flexible extensions 42 tend to adhere to the inner surfaces of the lips. 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 wet labial surfaces to the fabric comprising the flexible extensions 42 or the topsheet 30., or both. Optionally, the flexible extensions 42, the topsheet 30, or both, can be provided with a biocompatible adhesive to aid adhesion of the device 20 to the inner surface of the wearer'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. A suitable adhesive strength would allow the interlabial device 20 to remain in place against a pressure tending to remove it where the pressure was on the scale of about 10 cm to 150 cm of water. The interlabial absorbent device 20 is believed to differ from the prior art in a number of respects. The interlabial absorbent device 20 of the present invention is provided with a central slot 32. This slot serves to assist the device 20 in acquiring the fluid more rapidly, particularly more viscous fluids, than the devices of the prior art. Additionally, the size and shape of the device combined with the size and shape of the central slot 32 contributes to the comfort of the product by allowing the device 20 to fit more easily around the clitoris. The design of the interlabial device 20 of the present invention provides an interlabial product that is conformable and compressible, and therefore comfortable to use, still large enough to achieve high absorption capabilities than many of the prior art products. The interlabial absorbent device 20 of the present invention is preferably adapted to consistently block the urethra and orifice of the vagina upon insertion. As a result, the interlabial absorbent device 20 of the present invention is believed to be expelled by the action of urinating more reliably than the devices of the prior art. As previously noted, when the flexible extensions 42 are provided, they cover the tips of the wearer's fingers during insertion (as shown in Figure 6) thus providing a more hygienic insertion that is achieved with the devices of the art. previous. Optionally, the interlabial absorbent device can be removed by grasping the lower surface 24 of the main portion 26 with the fingers. Again, if provided, the flexible extensions 42 continue to cover the fingertips thus allowing a more hygienic removal of the interlabial absorbent device 20 which is achieved with prior art devices. The nterlabial absorbent device 20 can be used as a "unique" product. 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 spotting of the backside. The interlabial device 20 can be used in conventional panties, or it can be used with menstrual pants. Numerous alternate embodiments of the proximal absorbent device of the present invention are possible. For example, these products are designed to be removed through urine, although an alternate extraction cord or loop may be used. These products can also be used with medicinal treatments. These products can be constructed of materials that are biodegradable and / or which will fragment in water with agitation (as in the toilet). The proximal absorbent device 20 can also be constructed with a plurality of slots in the main portion 26 to allow Doubling the product in multiple independent directions. This structure allows the product to respond more easily to the tensions associated with body movements. The upper surface 22 of the structure may have one or more slits or have other preferred flexion regions such that the product can easily adjust to vertical pressure against the pelvic surface to help accommodate the non-linear surface of the pelvic surface between the clitoris and the perineum. The flexible extensions 42 of the interlabial device 20 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, keeping the product in place. Furthermore, it is preferred that the flexible extensions 42 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 The 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 an 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, with a cell load of 10 N, 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 9, 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 9, 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 top 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 approximately 1 gramf. 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 42 The sample 1000 taken from one of the flexible extensions. The sample 1000 taken must 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, maintained between annular fasteners, is subjected to the increasing force applied by a 0.625 inch (1.59 cm) 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 (11.4 cm) x 4.5 inches (11.4 cm)). If the sample to be tested is too small (for example, a flexible extension with overall dimensions less than 4.5 inches (11.4 cm) x 4.5 inches (11.4 cm)) a larger sample of the same material should be used to determine the strength to break in wet. 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: 12J 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.

Water Dispersion Test 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 geometric center of the agitator, Stirring bar covered 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 directions of the manufacturer. 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. Note. If the sample repeatedly becomes entangled with the agitator bar, the test can be performed by suspending the sample above the bottom of the beaker with a piece of cotton yarn (for example, by tying the yarn around the sample). Any clamp or base such as a ring clamp can be used for this purpose. The length of the thread and / or the height of the clamp should be adjusted in such a way that when the thread is taught that the sample is suspended in the water, but not resting on the bottom of the weeping vessel. The test procedure is otherwise unchanged. 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 10. The apparatus includes: A toilet with swirl trap, water saver of 13.2 liters, referred to as 210 (additional toilets can also be fixed to the pipe layout shown in Figure 10, to evaluate the behavior of test samples using different discharge mechanisms such as pressure, commercial toilets). approximately 18 meters of 10 cm acrylic pipe (as seen in Figure 10, 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 that is open to the atmosphere for ventilation; • 5 angled 90 degrees cast iron tubes 212, 214, 216, 218 and 220; • a vertically placed stump 222 (Figure 11) approximately 4.57 meters from the terminal end of the pipeline and approximately 2.5 cm long, and • A grating (Tyier 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 accessories. The pipe is installed to provide a drop of 2 cm per meter of pipe length.

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 an additional 1 minute and move to step 4. If the catamenial product and / or the tissue do not dislodge the cup after a discharge, Wait two minutes and download again. If after the second load, the cup and siphon are not cleared after discharge, the paper and / or catamenial product thrown into the drain line manually and the discharge sequence will continue. After completing each test load, the drain pipe will be cleared before starting the subsequent test. 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) Unload 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 downloads per sequence is 34. 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. 5. 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.

Before using, 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 herein. 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 (13)

1. An absorbent device capable of being inserted into the interlabial space of a female user, said absorbent device having a length, a width, and a height, said length, width and height being oriented in a x direction, an y direction, and a z direction , respectively, the absorbent device comprising a central absorbent portion and a liquid-permeable upper sheet, characterized in that the absorbent device comprises: the upper sheet has two spaced apart transverse edges and two separate longitudinal edges apart, the upper sheet being permeable to the liquid wrapped around it of the central absorbent portion, said length of the absorbent device is greater than the height of the absorbent device, said transverse edges of the liquid permeable upper sheet are folded laterally inwardly over the absorbent central portion and down substantially in the z direction to define a centr slot When oriented substantially in the z direction, said central slot extends in the direction x along the length of at least a portion of the length of the absorbent device, and said central slot faces toward the wearer's vestibule surface upon insertion of the absorbent device into the tissue. interlabial space of the user. The absorbent device according to claim 1, wherein the longitudinal cross-section of the absorbent device is cardioid or heart-shaped. The absorbent device according to any of the preceding claims, further comprising a pair of flexible extensions attached to the upper sheet permeable to the liquid and extending outward thereof, the flexible extensions being able to maintain contact with the internal surfaces of the user's lips when the absorbent device is worn. The absorbent device according to any of the preceding claims, further comprising a backsheet impermeable to the liquid attached to at least a portion of the liquid-permeable upper sheet. The absorbent device according to any of the preceding claims, wherein the central absorbent portion comprises a core with slits. The absorbent device according to any of the preceding claims, further comprising a secondary acquisition layer disposed between the absorbent central portion and the liquid-permeable upper sheet. 7. The absorbent device according to any of the preceding claims, wherein the longitudinal edges of the liquid permeable upper sheet are sealed in a closed configuration around the absorbent central portion such that the absorbent device has sealed ends, preferably the sealed ends being preferably oriented in the z direction, more preferably the cross section of the absorbent device being trapezoidal in shape. The absorbent device according to any of the preceding claims, wherein the time required for the absorbent device to disperse in at least two fragments as measured by the dispersion test in water is less than two hours. The absorbent device according to any of the preceding claims, wherein the absorbent device is sufficiently dischargeable that it completely dislodges the cup during the discharge capacity test at least 70% of the time in two or fewer discharges. The absorbent device according to any of the preceding claims, wherein said device is at least 70% biodegradable, preferably 90% biodegradable. The device according to any of the preceding claims, wherein more than half of the absorbent device resides within the interlabial space of the wearer upon insertion. The interlabial absorbent device according to any of the preceding claims, wherein the absorbent device has a length between 60 mm and 120 mm, preferably within 80 mm and 110 mm. The interlabial absorbent device according to any of the preceding claims, wherein the gauge of said device is between 4.5 mm and 15 mm.