MXPA99011291A - Emollient-treated absorbent interlabial device - Google Patents

Emollient-treated absorbent interlabial device

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Publication number
MXPA99011291A
MXPA99011291A MXPA/A/1999/011291A MX9911291A MXPA99011291A MX PA99011291 A MXPA99011291 A MX PA99011291A MX 9911291 A MX9911291 A MX 9911291A MX PA99011291 A MXPA99011291 A MX PA99011291A
Authority
MX
Mexico
Prior art keywords
emollient
interlabial
absorbent
wearer
absorbent device
Prior art date
Application number
MXPA/A/1999/011291A
Other languages
Spanish (es)
Inventor
James Klofta Thomas
Ward Osborn Thomas Iii
Original Assignee
The Procter & Gamble Company
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by The Procter & Gamble Company filed Critical The Procter & Gamble Company
Publication of MXPA99011291A publication Critical patent/MXPA99011291A/en

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Abstract

Absorbent devices, and more particularly absorbent devices that are worn interlabially by female wearers for catamenial purposes, incontinence protection, or both, that have an emollient composition on their body-contacting surface are disclosed. The interlabial device has a body-contacting surface that is pre-moistened or pre-heated with an emollient to prevent drying of the wearer's labial tissue and to reduce friction of the structure against the wearer's labial tissue. The absorbent device is preferably capable of maintaining contact with the inside surfaces of the wearer's labial majora when worn. The emollient composition comprises a plastic or fluid emollient such as mineral oil, petrolatum and/or polysiloxane, an immobilizing agent such as a fatty alcohol or wax to immobilize the emollient on the body-contacting surface of the device, and optionally a hydrophilic surfactant to improve wettability of the coated surface. Because the emollient is substantially immobilized on the surface of the absorbent device, less emollient is required to impart the desired therapeutic or protective emollient coating benefits.

Description

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. The devices described in these patents are believed to be potentially inconvenient to use due to discomfort due to friction associated with the rubbing of the product against the walls of the lips and the sticking of the surfaces of the device to the walls of the lips. In addition, the frictional drag and the gluing of the surface that is in contact with the body of these devices against the lips, can prevent these devices from being inserted properly, leading to discomfort. The problem of drying the labial vestibule area of the female user has been discussed in the patent literature. For example, U.S. Patent No. 4,846,824 issued to Lassen, et al., And July 11, 1989, is directed to a sanitary lip pad having a "physiologically hydrated" cover (i.e., a cover material). supposedly designed to "maintain a wet interface between the tissues of the vestibule and the pad"). The types of cover materials specified in the Lassen patent include a bonded non-woven polyester fiber nonwoven material and a rayon cover. The Lassen et al. Patent states that covers can be provided with various "coatings" to maintain physiologically hydrated characteristics, but none of the specific coatings to be disclosed. j. The European patent application EP 0 692 263 A2, "Method for reducing the coefficient of friction of absorbent products and wax-produced products eff ectively", is directed to lubricated absorbent products having a coating of an amount small of solid waxy substance of high molecular weight, which has a softening point above the body temperature.
However, there are disadvantages associated with the use of high molecular weight materials for this purpose. The high molecular weight materials will not be as comforting or similar to the user's skin lotion as the lower molecular weight materials. In addition, high molecular weight materials will not be able to transfer to the user's skin to provide the benefits of skin care. High molecular weight waxes can also become brittle and tend to flake or deburr an absorbent article because of its lack of flexibility if the absorbent article is of a type that is required to bend or flex. Further, if the softening point of these materials is higher than the ambient temperature, the application of these materials to an absorbent article will be more difficult, and will require the material to be heated in order to coat an absorbent article with this material. A vaginal tampon with balanced moisture and a process is disclosed in European Patent Application 0 685 215 A1. However, the interlabial device of the present invention is not intended to be used intervaginally as a tampon. 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 movements of the user. There is a need for an interlabial device that is absorbent, has a reduction in frictional discomfort associated with the rubbing of the product against the walls of the lips and the bonding of the surfaces of the device to the walls of the lips. There is also a need for an interlabial device that has a reduced tendency to dry the inner surface of the wearer's lips. ThusIt is an object of the present invention to provide an interlabial absorbent device which is small in size and easily inserted and which provides protection against incontinence, menstrual discharges, and discharges of body exudates throughout a broad spectrum of user movements. . It is another object of the present invention to provide an interlabial device that is absorbent but has a reduction in frictional discomfort associated with rubbing the product against the walls of the lips and gluing the surfaces of the device to the walls. lipstick. It is another object of the present invention to provide an interlabial device that has a reduced tendency to dry the inner surface of the wearer's lips. It is yet another object of the present invention to provide an interlabial device that can be inserted into the space between the user's lips with less friction in such a way that it can be more easily inserted fully into the desired position of use. 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 an absorbent device that is insertable within the interlabial space of a female user for catamenial purposes, protection for incontinence, or both. The interlabial device has a contact surface with the body (in particular, a surface that is in contact with the labial vestibule) which is pretreated with an emollient to prevent drying of the wearer's labial tissue and to reduce the friction of the structure against the labial tissue of the user.
The nterlabial absorbent device of the present invention, in a preferred embodiment, comprises a main absorbent portion and a pair of flexible extensions attached to the main absorbent portion. The main 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 placed farther inward toward the space between the wearer's lips in this way 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. The flexible extensions extend downwards and outwards from the upper portion of the main 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. At least a portion of the surface that is in contact with the body of the interlabial device comprises an effective amount of an emollient coating that is preferably semi-solid or solid at room temperature, 68 ° F (or 20 ° C). The coating preferably comprises a substantially water-free emollient having a plastic or fluid consistency at 20 ° C and comprising a member selected from the group consisting of petrolatum-based emollients, fatty acid ester emollients, alkyl ethoxylate emollient and / or polysiloxane emollients, and mixtures thereof. In a preferred embodiment, the emollient contains about 5% or less of water and comprises a petrolatum-based emollient selected from the group consisting of mineral oil, petrolatum, and mixtures thereof. In a preferred alternate embodiment, the emollient contains about 5% or less of water and comprises a polysiloxane emollient. The interlabial device treated with emollient provides a reduction in the frictional discomfort associated with the rubbing of the product against the labial walls and the gluing of the surfaces of the device to the labial walls. The interlabial device treated with emollient also has a reduced tendency to dry the interior surfaces of the user's lips. The interlabial device, due to the presence of the emollient, can be inserted into the space between the user's lips with less friction in such a way that it will be more easily inserted from the total maenra toward the desired position of use.
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 main absorbent portion.
Figure 5 is a bottom view of a preferred alternate embodiment of the present invention showing a main absorbent portion having a multiple layer 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 user's inter-labial space. 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 sectional view of the wearer's body showing how a hypothetical prior art device that is not treated with an emollient can be adjusted. Figure 12 is a sectional view of the wearer's body showing how the interlabial device treated with emollient of the present invention can be adjusted. Figure 13 is a schematic perspective view of the Three Point Bending Test apparatus. Figure 14 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 15 is a cross-sectional view of the discharge-capable apparatus of Figure 14, taken along line 15-15 thereof.
DETAILED DESCRIPTION OF THE INVENTION The present invention is directed to an interlabial absorbent device (or "interlabial absorbent structure" or interlabial absorbent device ") having a surface that is in contact with the body that is previously lubricated to prevent drying of the wearer's labial tissue. 1-3 show a preferred embodiment of the interlabial absorbent structure 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 FIGS. 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 interiabial space of a female user during use. , more than a third, more preferably more than the mit ad 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 interlabial absorbent device 20 resides within the interlabial space of a female user during 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 outer 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 interiabial absorbent device 20 shown in Figure 1, has a center line longitudinal 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 that is generally aligned with (for example, 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 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 "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 main absorbent portion (or "central absorbent"), 22, and a pair of flexible extensions 24 attached to the main absorbent portion 22. The main absorbent portion 22 must be less partially absorbent. The main absorbent portion 22 may comprise nonabsorbent portions, such as a liquid impermeable barrier to prevent the absorbed liquids from leaking or leaking from the main absorbent portion 22. The main 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 main absorbent portion. In use, the upper portion 26 is positioned farther inward toward the interlabial space of the wearer. The interlabial device has a surface facing body 20A (or "that is in contact with the body") and a backing surface 20B. The surface facing the body 20A may be composed of at least a portion of the absorbent portion 22, at least a portion of the flexible extensions 24, or at least a portion of both. The interlabial device 20 should be of a suitable size and shape that allows at least a portion of it to fit comfortably within the user's labial space, and to cover the vaginal orifice of the wearer, and preferably also the urethra of 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, of between about 35 mm and about 100 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 main 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 about 6 mm, most preferably, the gauge is about 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 main absorbent portion 22 thereof. The main absorbent portion 22 preferably has a capacity of at least about 1 gram of 0.9% by weight of saline, and can have a capacity of up to about 30 grams using gels or absorbent 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 main 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 (eg, menses and / or urine).
The main 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 main 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 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; gelling absorbent materials; or any equivalent material or combinations of materials, or mixtures thereof. Preferred absorbent materials comprise woven tissues, non-woven wefts, needle-punched rayon, and thin layers of foam. The main 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. In the preferred embodiment shown in Figure 1, the absorbent portion 22 is formed of a soft absorbent material such as rayon fibers or other suitable natural or synthetic fibers or laminates. The main absorbent portion 22 shown in Figure 1 is generally oval in cross section as shown in Figure 2. The main 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 main absorbent portion 22 comprises a substantially abrupt change in the transverse dimension, thus forming a shoulder-shaped configuration 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 main 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 interlabial absorbent device 20 having such a configuration is shown in Figure 3. The portion 22. Main absorbent 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 main absorbent portion 22 of the interlabial absorbent device 20 shown in Figures 1 to 3. As shown in Figures 1 to 3, the proximal absorbent device 20 also comprises a pair of flexible extensions 24, which are joined together. to the upper portion 26 of the main absorbent portion 22 of the interlabial absorbent device 20. 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 than the main absorbent portion 22, preferably they have a length that is the same as or greater than the main absorbent portion of the interlabial absorbent device 20. The width of each of the flexible extensions refers to the distance from the junction of the flexible extension 24 to the main absorbent portion 22 (or the proximal end 24A of the flexible extension 24), toward the distant end (or free end) 24B of the flexible extension 24. The width of the flexible extensions 24 is preferably equal to or greater than the height of the main 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 main 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. Still other material suitable is a block of cotton placed with air such as that sold as cosmetic frames by Reveo Stores, Inc., of Twinsberg, Ohio. The flexible extensions 24 may optionally be backed with a layer of material that is impermeable or semipermeable to body exudates, such as polyethylene, polypropylene, or a polyvinyl alcohol.
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 centerline L of the main 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 main absorbent portion 22. Preferably, the flexible extensions 24 are arranged asymmetrically about the longitudinal centerline L of the absorbent portion. main 22. The flexible extensions 24 are attached to the upper portion 26 of the main 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 main absorbent portion 22, or within about 3 mm of the sup upper surface of the main absorbent portion 22. The term "attached", as used herein, encompasses configurations in which the element is directly secured to the other element by fixing 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 main 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 main 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 main absorbent portion 22, or it may be applied in a "dot" manner at discrete intervals. Alternatively, the flexible extensions 24 may be attached to the upper portion 26 of the main 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. As shown in Figures 1 to 3, the flexible extensions 24 are affixed to the upper portion 26 of the main absorbent portion 28. The flexible extensions 24 extend downward and outward from the main absorbent portion 22 toward a free end 24B the which is disengaged from the main absorbent portion. The flexible extensions 24 may be slightly inclined outward from the main 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 outer surfaces of the lips. Preferably, the flexible extensions 24 should be able to move from a position where the free ends of the flexible extensions 24 are located adjacent the main absorbent portion 22 (as shown in Figure 9), to a position where the flexible extensions 24 extend directly away from the main 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 main absorbent portion 22 of the interlabial absorbent device 20 while the flexible extensions 24 remain between the tips of the fingers and her body as the device 20 is inserted., 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 to hold the main absorbent portion 22 in place throughout the spectrum of movements of the user such as when tilting. The flexible extensions 24 may be hydrophilic or hydrophobic. The flexible extensions 24 can be treated to make them less hydrophilic than the main absorbent portion. The hydrophilic capacity of a material is generally expressed in terms of its contact angle. In this way, the flexible extensions 24 can have a greater contact angle of advance than the advancing contact angle of the main absorbent portion 22, such that the fluid is preferentially directed toward and is absorbed by the main absorbent 22. Flexible extensions 24 can be either absorbent or non-absorbent. Preferably, the extensions 24 have at least some absorbency. However, the majority of the fluid absorbed and retained by the interlabial absorbent device 20 will eventually be retained within the main absorbent portion 22. For a more detailed description of the hydrophilic capacity and contact angles see the following publications, 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 for 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 rigidity of both the main absorbent portion 22 and the flexible extensions 24 is important for product comfort. If the main 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 main 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 resistance, such that during application and use they are not tear. The wet strength for flexible extensions should exceed 15 grams, and preferably exceed 150 grams, and most preferably exceed 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. In a preferred alternate embodiment shown in Figure 4, the main absorbent portion 22 of the interlabial absorbent device 20 comprises a folded structure. As shown in Figure 4, the main 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 main 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 main 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 bent such that the overall gauge (i.e., width) of the main 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 bonded (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, which contain a thermoplastic material, such as polyethylene. A preferred design uses the seam joining all the folds in the main 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 folded structure of the main 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 main 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 main 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 main 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 main absorbent portion of the interlabial device 20 is approximately 4.5 mm. As shown in Figure 4, where the main absorbent portion 22 is of a uniform transverse dimension (ie, 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 main 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 main absorbent portion 22, or these may comprise a different material. The extensions 24 are attached to the upper portion 26 of the main absorbent portion 22, and most preferably for this embodiment, they are attached to the upper surface of the main absorbent portion 22, or within one millimeter of the upper surface of the absorbent portion. main 22. Preferably in the embodiment shown in Figure 4, the extensions 24 are integral parts of the main absorbent portion 22 (ie, the extensions 24 comprise integral extensions of the tissue absorbent material that is folded to form the main absorbent portion 22. ). The main 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 main 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. A 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 may be integral with one of the individual layers 32 or may be separately joined to the upper portion 26 of the main absorbent portion 22. Preferably, the individual layers 32 are disposed 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 interlabial 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. Preferably, if an upper sheet 42 and / or a back sheet 38 is used, these components are attached to at least a portion of the main absorbent portion. In an alternate embodiment, the main absorbent portion may at least partially be wrapped by an upper sheet 42. If the top sheet is used, the top sheet must 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 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. The top sheet 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 "Disposable absorbent article having a sheet stain-resistant ", 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 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". In a preferred embodiment of the present invention, the body surface of the formed top sheet of film is hydrophilic to help transfer the liquid through the top sheet faster than if the body surface were not hydrophilic, to decrease the likelihood of the menstrual fluid flowing out of the upper sheet instead of flowing into and being absorbed by the main absorbent portion 22. In a preferred embodiment, surfactant is incorporated into the polymeric materials of the formed film topsheet. Alternatively, the body surface of the topsheet 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. 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 main absorbent portion 22 from wetting the articles that are in contact with the interlabial device 20 such as the wearer's undergarments. The backsheet also helps the main absorbent portion 22 prevent the wearer's body from being soiled by the exudates. Additionally, the use of the backsheet may provide an improved surface for the user to hold between the fingers as the proximal absorbent device 20 is inserted, or as the device is optionally removed with the fingers. The backsheet 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 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 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. As previously discussed, the interlabial absorbent device 20 of the present invention is preferably designed to be placed entirely within the inter-labial space of a user. To use the interlabial absorbent device 20 of the present invention. The user holds the main 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.
Figure 12 shows the interlabial device 20 in place in a body of the wearer. The body parts of the wearer, W, shown in Figure 12 are designated as follows: bladder, B, clitoris, C, urethra, U, labia minora, N, labia majora, J, vagina, V, vaginal introitus, VI , anus, A, hymenal ring, H, and large intestine, I. The interlabial device 20 is inserted in such a way that it is worn between the lips minus N and the labia major lips of the user and blocks the vaginal introitus of the user VI without entering the vagina passing the hymen ring H. That is, the interlabial device 20 is located at least partially inside the vestibule joined by the labia minora when the device is worn. The interlabial device 20 may also cover, but not necessarily occlude, the urethra of the user U. Preferably, the interlabial device 20 covers both the vaginal introitus VI of the wearer and the urethra U of the wearer. Ideally, the interlabial device 20 is held in contact with such a large portion of the inner surface area of the labia minora N and the labia majora J of the wearer as possible. This will ensure that the interlabial device 20 intercepts as much of the exudates from the wearer's body as possible. Preferably, the entire interlabial device 20 is intended to be brought under the ring of the user's hymen H. The interlabial device 20 may also contain a part that is carried away from the labia major lips J. This portion can, for example, be used to store body exudates that are transferred from the part of the interlabial device 20 that is worn between the labia minora and the labia majora. The part of the interlabial device 20 that is worn between the labia minora and the labia majora of the wearer will, as a result, have the exudates drained therefrom, and will be able to receive additional loads of exudates from the body. 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 may 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. 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 interlabial 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 interlabial absorbent device 20 can be removed by holding the lower portion 28 of the main absorbent portion 22 with the fingers. Again, the flexible extensions 24 continue to cover the tips of the fingers thus allowing a more hygienic removal of the interlabial absorbent device 20 than that achieved with the prior art device. The interlabial absorbent device 20 can be used as a "single" 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 back staining. The interlabial device 20 can be used in conventional panties, or it can be used with menstrual shorts. 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 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 which will fragment in water with agitation (as in a toilet). Preferably, the interlabial absorbent device 20 is downloadable. 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 may 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 device, in the TEST METHODS section of this disclosure. The interlabial absorbent device 20 can also be constructed with a plurality of slots in the main absorbent portion 22 to allow the product to be bent in multiple independent directions. This structure allows the product to respond more easily to the tensions associated with body movements. As shown in Figure 12, in preferred embodiments of any of the embodiments shown in the figures of the previous drawings, the portions of the upper corners 26A and the lower corner portions 28A of the interlabial device 20 may be rounded to reduce the force that the product transfers to the user's body when the user sits down. The upper surface 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 nonlinear surface of the pelvic interior surface 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, keeping the product in place. In addition, 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.
B. The Emollient Composition The emollient compositions used in the interlabial devices of the present invention can be solid, liquid or semi-solid at 20 ° C, that is, at ambient temperatures. Preferably, the emollient compositions have a simysolid consistency that can be described with a consistency similar to jelly at 20oC. By "semi-solid" is meant that the emollient composition has a typical rheology of pseudoplastic or plastic fluids. The term "fluid", as used herein, means liquid (as opposed to gas). The physical states of the emollient composition and its components described herein refer to its states at any time after the product is manufactured and the emollient composition is applied to the product. Thus, for the purpose of the appended claims, the device will be considered to be in the claimed state if it is in the state specified in storage, on storage shelves, or in use. When no shear is applied, the emollient compositions described herein may have the appearance of a semi-solid but may be flowed as the shear rate increases. This is due to the fact that, while the emollient composition contains mainly solid components, it also includes less liquid components. If these emollient compositions are solid or semi-solid at ambient temperatures, they will have a reduced tendency to flow and migrate into the interlabial absorbent device to which they are applied. This also allows less emollient composition to be used to impart the benefits of softness and smoothness. When an effective amount of the emollient compositions is applied to the surface that is in contact with the body of the interlabial device 20, the emollient compositions described herein impart a smooth, smooth and lubricated feeling to the user of the device. This particular sensation has also been characterized as "silky", "smooth", "smooth", etc. The emollient compositions of the present invention preferably comprise: (1) an emollient or emollients; (2) an immobilizing agent or agents for the emollient; (3) optionally a hydrophilic agent or agents and (4) other optional components. 1. Emollient The key active ingredient in these emollient compositions is one or more emollients. As used herein, an emollient is a material that softens, softens, relaxes, coats, lubricates, moisturizes, or cleanses the skin and / or mucous membranes. An emollient typically achieves several of these objects such as soften, moisturize and lubricate the skin. For the purposes of the present invention, these emollients have either a plastic or fluid consistency at 20 ° C, that is, at ambient temperatures. By "plastic consistency" is meant that the emollient behaves like a non-Newtonian liquid that can be flowed when enough shear rate is applied. By "fluid consistency" it is understood that the emollient behaves like a Newtonian fluid that flows immediately when subjected to stress, with the fluid regime being proportional to the stress. This plastic or fluid consistency of the emollient allows the emollient composition to impart a sensation similar to the soft, lubricating and smooth lotion. The emollients will, therefore, preferably have a softening point at body temperature, 37 ° C. (The body temperature will be slightly lower in the area of a labial vestibule of the female user.) Preferably, the emollient composition has at least one component with a maximum heat absorption of less than 37 ° C. This will ensure that at least part of the components will melt below the body temperature to provide a more fluid feel and reduced friction against the body. further, in the preferred embodiments, the emollients will soften over a range of temperatures, instead of having an acute transition in which it changes from a solid to a liquid. For example, emollients can begin to soften at about 20 ° C, or less, and be approximately 80% melted ("melted", as used herein, means completely liquid) at 38 ° C. This will provide the emollient coated device with a lubricating feel at body temperatures, which will increase as it adjusts from ambient temperature to body temperature. The emollients used in the present invention preferably do not contain any high molecular weight hydrocarbon component. If the emollients used herein contain hydrocarbon components, the molecular weights of these components are preferably less than 1, 500, more preferably less than or equal to about 1400, and most preferably less than or equal to about 1200. These emollients will provide greater smoothness or benefits similar to lotions to the user's skin than materials with high molecular weight. These will also be able to transfer to the user's skin to provide the benefits of skin care unlike the high molecular weight materials. In addition, these will remain flexible when the interlabial device flexes or bends, and will not tend to peel or deburr the interlabial device. The emollients useful in the present invention are also substantially free of water. Preferably, the emollient composition in general is also substantially free of water. By "substantially free of water", it is implied that water is not intentionally added to the emollient (or emollient composition). The addition of water to the emollient (or emollient composition) is not necessary when preparing or using the emollient compositions of the present invention and may require an additional drying step. However, minor amounts or traces of water in the emollient (or emollient composition) are captured as a result of, for example, environmental humidity, which can be tolerated without adverse effects. Typically, the emollients (or emollient composition) used in the present invention contain about 10% or less of water, preferably about 5% less of water, more preferably about 1% or less of water, and most preferably about 0.5% of water or less. The emollients useful in the present invention can be petroleum based, fatty acid ester type, alkyl ethoxylate type, fatty acid ester ethoxylates, fatty alcohol type, polysiloxane type or mixtures of these emollients. Suitable oil-based emollients include those hydrocarbons, or mixtures of hydrocarbons, having chain lengths of 16 to 32 carbon atoms. Oil-based hydrocarbons that have these chain lengths include oil in mineral water also known as "liquid petrolatum" and petrolatum (also known as "mineral wax," "petroleum jelly," and "mineral jelly." Mineral oil usually refers to mixtures of lower viscosity of hydrocarbons having 16 to 20 carbon atoms Petrolatum usually refers to more viscous mixtures of hydrocarbons having 16 to 32 carbon atoms Petrolatum is a particularly preferred emollient for the compositions emollients for use in the interlabial device of the present invention Suitable emollients of the fatty acid ester type include those derived from C 2 -C 28 fatty acids, preferably saturated C 16 -C 22 fatty acids, and short chain monohydric alcohols ( Ci-Cs, preferably O1-C3.) Representative examples of these esters include methyl palmitate, methyl stearate, laurate d and isopropyl, isopropyl myristate, butyl myristate, butyl stearate, octyl palmitate, isopropyl isostearate, isopropyl palmitate, ethylhexyl palmitatium and mixtures thereof. Suitable fatty acid ester emollients can also be derived from monoesters and diesters of both fatty esters of short chain fatty alcohols (C1 to C10) and longer esters (C12-C28, preferably C? 2-C16) and from acids more short chain fatty acids, for example, lactic acid such as lauryl lactate and cetyl lactate. Additional examples include diisopropyl sebacate, dimethyl sebacate, dioctyl sebacate, dibutyl sebacate, diisopropyl adipate, and dicapryl adipate. In addition, mixtures of petrolatum-based emollients and fatty acid ester emollients, if mixed in the correct proportions, can sometimes provide emollient systems that have a superior feel compared to pure components individually. Suitable alkyl ethoxylates emollients include the C 12 -C 22 fatty alcohol ethoxylates having an average degree of ethoxylation of from about 2 to about 30. Preferably, the fatty alcohol ethoxylate emollient is selected from the group consisting of ethoxylate of lauryl, cetyl and stearyl, and mixtures thereof, having an average degree of ethoxylation ranging from about 2 to about 23. Representative examples of these alkyl ethoxylates include laureth-3 (a lauryl ethoxylate having a degree of of average ethoxylation of 3), laureth-23 (a lauryl ethoxylate having an average degree of ethoxylation of 23), ceteth-10 (a cetyl alcohol ethoxylate having an average degree of ethoxylation of 10), steareth 10 (a stearyl alcohol ethoxylate which has an average degree of ethoxylation of 10) and ceteareth-10 (a mixture of ethoxylates of cetyl and stearyl which has a degree of ethoxylate) average ion of 10). These alkyl ethoxylate emollients are typically used in combination with petroleum-based emollients, such as petrolatum, at a weight ratio of emollients of alkyl ethoxylate to oil-based emollient of from about 1: 1 to about 1: 5, preferably from about 1: 2 to about 1: 4. Suitable fatty alcohol emollients include the C12-C22 fatty alcohols, preferably C16-C-8 fatty alcohols. Representative examples include cetyl alcohol, and stearyl alcohol, and mixtures thereof. These fatty alcohol emollients are typically used in combination with petroleum-based emollients, such as petrolatum at a weight ratio of fatty alcohol emollient to oil-based emollient of from about 1: 1 to about 1: 5, preferably about 1: 1 to approximately 1: 2. Other types of emollients suitable for use in the present invention include polysiloxane compounds. In general, polysiloxane materials suitable for use in the present invention, include those having the monomeric siloxane units of the following structure: wherein Ri and R2 for each monomeric independent siloxane unit can each independently be hydrogen or any of alkyl, aryl, alkenyl, alkaryl, arachidyl, cycloalkyl, halogenated hydrocarbon, or other radical. Any of these radicals can be substituted or unsubstituted. The radicals R1 and R2 of any particular monomer unit may differ from the corresponding functionalities of the next contiguous monomer unit. Additionally, the polysiloxane can be either a straight chain, a branched chain or have a cyclic structure. The radicals R and R2 can additionally independently be other cilice functionalities such as but not limited to siloxanes polysiloxanes, silanes and polysilanes. The radicals RT and R2 can contain any of a variety of organic functionalities, including, for example, alcohol, carboxylic acid, phenyl and amine functionalities. Exemplary alkyl radicals are methyl, ethyl, propyl, butyl, pentyl, hexyl, octyl, decyl, octadecyl and the like. Exemplary alkenyl radicals are vinyl, allyl, and the like. Exemplary aryl radicals are phenyl, diphenyl, naphthyl and the like. Exemplary alkaryl radicals are toyl, guyl, ethylphenyl and the like. Exemplary aralkyl radicals are benzyl, alpha-phenylethyl, beta-phenylethyl, alpha-phenyl-butyl and the like. Exemplary cycloalkyl radicals are cyclobutyl, cyclopentyl, cycloexoyl, and the like. Exemplary alkylated hydrocarbon radicals are chloromethyl, bromoethyl, tetrafluoroethyl, fluoroethyl, trifluoroethyl, trifluoromethyl, exafluoroxynyl, and the like. 1 The viscosity of the useful polysiloxanes can vary as widely as the viscosity of the polysiloxanes in general varies while the polysiloxane is able to flow or can be made to be flowable for applications to the surface that is in contact with the body of the interlabial device. This includes, but is not limited to viscosity as low as 5 centistokes (at 37 ° C as measured by a glass viscometer) at approximately 20,000,000 centistokes. Preferably, the polysiloxanes have a viscosity at 37 ° C ranging from about "5 to about 5,000 centistokes, more preferably from about 5 to about 2,000 centistokes, most preferably from about 100 to about 1000 centistokes.The high viscosity polysiloxanes per se They are resistant to flow can be deposited effectively on the surface that is in contact with the body by methods such as, for example, emulsify the polysiloxane in the surfactant or provide the polysiloxane in solution with the help of a solvent such as hexane, listed for exemplary purposes only, the particular methods for applying the polysiloxane emollients to the surface that is in contact with the body are discussed in more detail hereinafter The preferred polysiloxane compounds for use in the present invention are disclosed in US Pat. United States patent No. 5,059,282 (Ampulski et al.), Issued October 22, 1991, which is incorporated herein by reference. Particularly preferred polysiloxane compounds for use as the emollients in the emollient compositions of the present invention include polymethylsiloxane compounds with functional phenyl (e.g. Dow Corning 556 cosmetic grade fluid: polyphenylmethylsiloxane), and dimethicones functionalized with cetyl or stearyl such as Dow 2502 and Dow 2503 polysiloxane fluids, respectively. In addition, substitution with functional phenyl or alkyl groups can be effectively substituted with amino, carboxyl, hydroxyl, ether, polyether, aldehyde, acetone, amide, ester and thiol groups. Of these effective substituent groups, the family of groups containing phenyl, amino, alkyl, carboxyl and hydroxyl groups are more preferred than the others; and most preferred are groups with functional phenyl. Preferably, emollient compositions containing a polysiloxane will further comprise a petrolatum-based emollient selected from the group consisting of mineral oil, petrolatum, and mixtures thereof. However, the polysiloxane emollients described above can also be used alone. In addition to the petroleum-based emollients, the fatty acid ester emollients, the fatty ester ethoxylates, the alkyl ethoxylate emollients, and the fatty alcohol emollients, the emollients useful in the present invention may include minor amounts (e.g. , up to about 10% of the total emollient), of other conventional emollients / solvents. These other conventional emollients / solvents include propylene glycol, polyethylene glycol, hexylene glycol, glycerin, triethylene glycol, spermaceti and other waxes, fatty acids, and fatty alcohol ethers having from 12 to 28 carbon atoms in their fat chain, such as stearic acid, propoxylated fatty alcohols; glycerides, acetoglycerides and ethoxylated glycerides of C 2 -C 28 fatty acids; other fatty esters of polyhydric alcohols; lanolin and its derivatives; polyether silicone copolymers, and polysiloxanes having a viscosity at 20oC from about 5 to about 2,000 centipoises as disclosed in U.S. Patent No. 5,059,282 (Ampulski et al.), issued October 22, 1991, which is incorporated here by reference. These other emollients should be included in a manner such that the solid or semi-solid characteristics of the emollient composition are maintained. The amount of the emollient that can be included in the emollient composition will depend on a variety of factors, including the particular emollient involved, the desired lotion benefits, other components in the emollient composition and the like. The emollient composition may comprise from about 5 to about 95% of the emollient. Preferably, the emollient composition comprises from about 10 to about 90%, more preferably from about 20 to about 80%, most preferably from about 40 to about 75% of the emollient. 2. Immobilization Agent A particularly key component of the emollient compositions useful in the interlabial devices of the present invention is an agent capable of immobilizing the emollient on the surface of the surface that is in contact with the body 20A of the device. Because the emollient in the composition has a plastic or fluid consistency at 20 ° C, it tends to flow or migrate even when subjected to modest shear stress. When applied to an interlabial absorbent device, especially in a molten or melted state, the emollient will not primarily remain on the surface that is in contact with the body of the device. Instead, the emollient will tend to migrate and flow into the device. The need for an immobilizing agent is generally greater than the surface that is in contact with the body of the interlabial device comprising an absorbent material, such as cellulose, which is if the surface that is in contact with the body comprises a plastic film with openings, since the film with openings will not tend to absorb the emollient. The immobilization agent counteracts this tendency of the emollient to migrate or flow by keeping the emollient mainly located on the surface that is in contact with the body of the interlabial absorbent device. It is believed that this is due, in part, to the fact that the immobilization agent forms hydrogen bonds with any cellulose in the interlabial device. Through this hydrogen bonding, the immobilization agent becomes localized on the surface of the interlabial device. Since the immobilization agent is also miscible with the emollient (or solubilized in the emollient with the aid of an appropriate emulsifier), it entraps the emollient on the surface of the absorbent device as well. It is also advantageous to fix the immobilization agent on the surface that is in contact with the body of the interlabial device. This can be achieved by using immobilization agents which solidify rapidly (i.e., crystallize) on the surface of the interlabial device. Alternatively, the external cooling of the interlabial device treated by the air fluid on the surface of the device when the device is moving rapidly between the stations on a manufacturing line can accelerate the crystallization of the immobilization agent. In addition, external cooling of the interlabial device treated through blowers, fans, etc., can accelerate the crystallization of the immobilization agent.
In addition to being miscible with (or solubilized in) the emollient, the immobilization agenet preferably has a melting point of at least about 35 ° C. This is such that the immobilization agent itself will not have a tendency to migrate or flow. Preferred immobilizing agents will have melting points of about 40 ° C. Typically, the immobilization agent will have a melting point in the range from about 50 ° to about 150 ° C. The viscosity of the immobilization agents should also be as high as possible to prevent the emollient from flowing into the interlabial device. Unfortunately, high viscosities can also result in emollient compositions that are difficult to apply without processing problems. Therefore, an equilibrium must be achieved in such a way that the viscosities are high enough to keep the immobilization agent localized on the surface of the interiabial device, but not so high as to cause processing problems, the viscosities suitable for the agent of Immobilization will typically vary from about 5 to about 200 centipoise, preferably from about 15 to about 100 centipoise, measured at 60 ° C. Immobilization agents suitable for the present invention may comprise a member selected from the group consisting of C ?4-C22 fatty alcohols., C12-C22 fatty acids and C12-C22 fatty alcohol ethoxylates having an average degree of ethoxylation ranging from 2 to about 30, and mixtures thereof. Preferred immobilizing agents include C16-C18 fatty alcohols, more preferably selected from the group consisting of cetyl alcohol, stearyl alcohol and mixtures thereof. Particularly preferred are mixtures of cetyl alcohol and stearyl alcohol. Other preferred immobilizing agents include C 6 -C 18 fatty acids, more preferably selected from the group consisting of cetyl acid, stearyl acid, and mixtures thereof. Particularly preferred are mixtures of cetyl acid and stearyl acid. Still other immobilization agents include C16-C18 fatty alcohol ethoxylates having an average degree of ethoxylation ranging from about 5 to about 20. Preferably, the fatty alcohols, the fatty acids are linear. Importantly, these preferred immobilization agents such as the C-? 6-C18 fatty alcohols increase the rate of crystallization of the emollient causing the emollient to crystallize rapidly on the surface of the interlabial device. Lower emollient levels can therefore be used or a superior feeling can be supplied can be supplied. Optionally, other types of immobilization agents can be used in combination with the fatty alcohols, fatty acids and fatty alcohol ethoxylates described above. Typically, only minor amounts of these other types of immobilizing agents would be used (ie, up to about 10% of the total immobilization agent). Examples of these other types of immobilizing agents include polyhydroxy fatty acid esters, polyhydroxy fatty acid amides, waxes (preferably waxes having a molecular weight less than 1500, more preferably less than or equal to 1400, and most preferably less than or equal to equal to 1200) and mixtures thereof. To be useful as immobilizing agents, the polyhydroxy portion of the ester or the amide must have at least one free hydroxy group. It is believed that these free hydroxy groups are the groups that crosslink through the hydrogen bonds with any of the cellulose fibers of the interlabial device to which the emollient composition and homo-crosslink is applied, also through the hydrogen bonds, the hydroxy groups of the alcohol, acid, ester or amide, entrapping and immobilizing in this way the other components within the emolinete matrix. Suitable waxes include, but are not limited to, microcrystalline waxes, synthetic waxes, such as polyethylene type waxes, and silicone waxes. It is also believed that molecules such as long chain fatty alcohols can orient themselves to interact with one another to form a lamellar structure. It is this laminar structure, the hydroxyl groups and the alkyl chains of the neighboring alcohol molecules that orient and interact with one another to form an organized structure. In this "packing arrangement", the hydroxyl groups of the alcohols form hydrogen bonds with the polar functionalities of cellulose (eg, hydroxy or carboxy) to "immobilize" the alcohols on the surface that is in contact with the body of the cell. Interlabial device. Since the alcohols are miscible with the preferred emollients, fixation and / or immobilization of the emollient will occur. The esters of. Preferred amides will have 3 or more free hydroxy groups on the polyhydroxy moiety and are typically non-ionic in character. Because of the possible skin sensitivity of those who use interlabial devices to which the emollient composition is applied, these esters and amides must also be relatively benign and non-irritating to the skin. The polyhydroxy fatty acid esters suitable for use in the present invention will have the formula: wherein R is a C5-C3 hydrocarbyl group preferably straight chain C7-C19 alkyl or alkenyl, more preferably straight chain C9-C17 alkyl or alkenyl, more preferably straight chain Cn-C17 alkyl or alkenyl or mixtures of the same; and is a polyhydroxyhydrocarbyl moiety having a hydrocarbyl chain with at least two free hydroxyls directly connected to the chain, and n is at least 1. The Y groups can be derived from polyols such as glycerol, pentaerythritol; sugars such as refining, maltodextrose, galactose, sucrose, glucose, gylose, fructose, maltose, lactose, mannose and erythrose; sugar alcohols such as erythritol, gylitol, malitol, mannitol and sorbitol; and anhydrides of sugar alcohols such as sorbitan. A class of polyhydroxy fatty acid esters for use in the present invention comprises certain glyceryl monoesters, preferably the sorbitan esters of saturated C 16 -C 22 fatty acids. Because of the manner in which they are typically manufactured, these sorbitan esters usually comprise mixtures of mono-, di-, tri-, etc., esters. Representative examples of suitable sorbitan esters include sorbitan palmitates (eg, SPAN 40), sorbitan stearates (eg, SPAN 60), and sorbitan benehatos, which comprise one or more versions of mono-, di-, and triesters of these sorbitan esters, for example, sorbitan mono-, di- and tri-palmitate, sorbitan mono-, di- and tri-stearate, sorbitan mono-, di- and tri-behenate, as well as mono-, , mixed di- and tri-fatty acid esters of bait. Mixtures of different sorbitan esters, such as sorbitan palmitates with sorbitan stearates, can also be used. Particularly preferred sorbitan esters are sorbitan stearates, typically as a mixture of mono-, di- and tri-esters (plus some tetra-ester) such as SPAN 60, and sorbitan stearates sold under the trade name GLYCOMUL- S by Lonza, Inc. Although these sorbitan esters typically contain mixtures of mono-, di- and tri-esters, plus some tetra-ester, mono-, di- and tri-esters are generally the predominant species in these mixtures. Another class of polyhydroxy fatty acid esters for use in the present invention comprise certain glyceryl monoesters, preferably glyceryl monoesters of saturated C 16 -C 22 fatty acids such as glycerol monostearate, glyceryl monopalmitate and glyceryl monobearate. Again like the sorbitan esters, the glyceryl monoester mixtures will typically contain some di and tri-ester. However, these mixtures should predominantly contain glyceryl ester mono species to be useful in the present invention. Another class of polyhydroxy fatty acid esters suitable for use in the present invention may comprise certain fatty acid esters of sucrose, preferably the saturated fatty acid esters of C6- C22. The sucrose monster and diester are particularly preferred and include sucrose mono- and di-stearate and sucrose mono- and di-laurate. The polyhydroxy fatty acid amides suitable for use in the present invention will have the formula wherein R 1 is H, C 1 -C 4 hydrocarbyl, 2-hydroxyethyl, 2-hydroxypropyl, methoxyethyl, methoxypropyl or a mixture thereof, preferably C 1 -C 4 alkyl, methoxyethyl or methoxypropyl, more preferably C 1 or C 2 alkyl, or methoxypropyl, more preferably C1-alkyl (ie methyl) or methoxypropyl; and R2 is a C5-C31 hydrocarbyl group, preferably straight chain C7-C19 alkyl or alkenyl, more preferably, straight chain C9-C17 alkyl or alkenyl, most preferably straight chain C11-C17 alkyl or a mixture thereof; and Z is a polyhydroxyhydrocarbyl moiety having a linear hydrocarbyl chain with at least three hydroxyls directly connected to the chain. See U.S. Patent No. 5,174,927 (Honsa), issued December 29, 1992 (incorporated herein by reference), which discloses these polyhydroxy fatty acid amides, as well as their preparation.
The Z portion will preferably be derived from a reduced sugar in a reductive amination reaction; more preferably glycityl. Suitable reduced sugars include glucose, fructose, maltose, lactose, galactose, mannose and gylose. High-shelled corn syrups, high fructose corn syrup, and high-maltose corn syrup can be used, as well as the individual sugars listed above. These corn syrups can produce mixtures of the sugar components for the Z portion. The Z portion will preferably be selected from the group consisting of CH2- (CH0H) n -CH20H, -CH (CH2OHH (CHOH) n-.] -CH2OH, -CH2OH-CH2- (CHOH) 2 (CHOR3) (CHOH) -CH2OH, wherein n is an integer from 3 to 5, and R3 is H or a cyclic or aliphatic monosaccharide, more preferably are glycityls where n In the above formula R1 can be, for example N-methyl, N-ethyl, N-propyl, N-isoprcpyl, N-butyl, N-2-hydroxyethyl, N -methoxypropyl or N-2-hydroxypropyl R 2 can be selected to provide, for example, cocamides, stearamides, oleamides, lauramides, myristamides, capricamides, palmitamides, ceboamides, etc. The Z-portion can be 1-deoxyglucityl, 2-deoxyductuctitium, 1-deoxylactyl, 1-doxygalactityl, 1-deoxymanityl, 1-deoxy-thiotriotityl, etc. The most preferred polyhydroxy fatty acid amides have the general formula: wherein R 1 is methyl or methoxypropyl; R2 is a straight chain alkyl or alkenyl group of Cn-C17. These include N-lauryl-N-methyl glucamide N-lauryl-N-methoxypropyl glucamide, N-cocoyl-N-methyl glucamide, N-cocoyl-N-methoxypropyl glucamide, n-palmityl-N-methoxypropyl glucamide, N-ceboyl- N-methyl glucamide, or N-ceboyl-N-methoxypropyl glucamide. As previously indicated, some of the immobilization agents require an emulsifier for solubilization in the emollient. This is particularly the case for certain of the glucamides such as N-alkyl-N-methoxypropyl glucamides having HLB values of at least 7. Suitable emulsifiers will typically include those having HLB values below about 7. In this respect , the sorbitan esters described above, such as sorbitan stearates, having HLB values of about 4.9 or less have been found to be useful in solubilizing these glucamide immobilization agents in the petrolatum. Other suitable emulsifying agents include steareth-2 (polyethylene glycol ethers of stearyl alcohol which conform to the formula CH3 (CH2) 17 (OCH2CH2) nOH, where n has an average value of 2), sorbitan triestarate, isosorbide laurate and monostearate of glyceryl. The emulsifier may be included in an amount sufficient to solubilize the immobilizing agent in the emollient such that a substantially homogeneous mixture is obtained. For example, a mixture of approximately 1: 1 of N-cocoyl-N-methyl glucamide and petrolatum that will not normally melt in a single-phase mixture will melt in a single-phase mixture upon addition of 20% of a mixture of 1: 1 of Steareth-2 and sorbitan triestarate as the emulsifier. The amount of the immobilizing agent that should be included in the emollient compositions will depend on a variety of factors, including the particular emollient involved, the particular immobilizing agent involved, if an emulsifier is required to solubilize the immobilizing agent in the emollient other components in the emollient composition and similar factors. The emollient composition may comprise from about 5 to about 80% of the immobilizing agent. Preferably, the emollient composition comprises from about 5 to about 50%, more preferably from about 10 to about 40% of the immobilizing agent. 3. Optional Hydrophilic Surfactant The interlabial device of the present invention is preferably removed by discharging it into a conventional toilet. In such cases, it may be desirable that the interlabial device be sufficiently wettable so that it will not float. Depending on the particular immobilization agent used in the emollient composition, an additional hydrophilic surfactant (or a mixture of hydrophilic surfactants) may or may not be required to improve the wettability. For example, some immobilization agents, such as N-cocoyl-N-methoxypropyl glucamide have HLB values of at least about 7 and are sufficiently wettable without the addition of hydrophilic surfactants. Other immobilization agents such as C16-C18 fatty alcohols having HLB values below about 7 may require the addition of a hydrophilic surfactant to improve wettability. Similarly, a hydrophobic emollient such as petrolatum may require the addition of a hydrophilic surfactant. Suitable surfactants will be miscible with the emollient and the immobilizing agent to form homogeneous mixtures. Because of the possible skin sensitivity of those who use the interlabial devices, these surfactants must also be relatively benign and non-irritating to the skin. Typically, these hydrophilic surfactants are non-ionic to not only be irritating to the skin.
The nonionic surfactants may be substantially non-migratory after the emollient composition is applied to the interlabial device and will typically have HLB values in the range from about 4 to about 20, preferably from about 7 to about 20. Because they are non-migratory , these nonionic surfactants will typically have melting temperatures higher than the temperatures commonly encountered during storage, shipping, trade and use of disposable, absorbent products, for example, at least about 30 ° C. in this regard, these nonionic surfactants will preferably have melting points similar to those of the previously described immobilization agents. Nonionic surfactants for use in the emollient compositions of the present invention include alkyl glycosides, alkyl glycoside ethers as described in U.S. Patent No. 4,011,389 (Langdon, et al.), Issued March 8. of 1977, alkyl polyethoxylated esters such as Pegosperse 1000MS (available from Lonza, Inc., Fair Lawn, New Jersey), mono-di and ethoxylated sorbitan tri-esters of C 12 -C 18 fatty acids having an average degree of ethoxylation of about 2 to about 20, preferably, about 2 to about 10 such as TWEEN 60 (sorbitan esters of stearic acid having an average degree of ethoxylation of about 20), and TWEEN 61 (sorbitan esters of stearic acid having an average degree of ethoxylation of about 4), and the condensation products of aliphatic alcohols with about 1 to about 54 moles of ethyl oxide eno The alkyl chain of the aliphatic alcohol is typically in a straight chain (linear) configuration, and contains from about 8 to about 22 carbon atoms. Particularly preferred are the condensation products of the alcohols having an alkyl group containing from about 11 to about 22 carbon atoms with about 2 to about 30 moles of ethylene oxide per mole of alcohol. Examples of these ethoxylated alcohols include the condensation products of myristyl alcohol with 7 moles of ethylene oxide per mole of alcohol, the condensation products of coconut alcohol (a mixture of fatty alcohols having alkyl chains varying in length of 10). to 14 carbon atoms) with about 6 moles of ethylene oxide. A number of suitable ethoxylated alcohols are commercially available including TERGITO 15-S-9 (the condensation product of Cn-C15 linear alcohols with 9 moles of ethylene oxide), marketed by Union Carbide Corporation; KYRO EOB (condensation product of linear alcohols of C13-C15 with 9 moles of ethylene oxide) marketed by The Procter & Gamble Company., The commercially available surfactants NEODOL sold by Shell Chemical, Co., in particular NEODOL 25-12 (condensation product of linear alcohols of C12-C15 with 12 moles of ethylene oxide) and NEODOL 23-6.5T (condensation product of linear alcohols of C12-C? 3 with 6.5 moles of ethylene oxide which has been desitiated (primary distillate) to remove certain impurities, and especially the surfactants of the trademark PULRAFAC marketed by BASF Corp, in particular PLURAFAC A-38 (a condensation product of a straight chain alcohol of C18 with 27 moles of ethylene oxide: (Certain of the hydrophilic surfactants, in particular the ethoxylated alcohols such as NEODOL-25-12, can also function as alkyl ethoxylate emollients.) Other examples of ethoxylated alcohol surfactants include the class ICI's of the Frij surfactants and mixtures thereof with Brij 72 (i.e. teareth-2) and Brij 76 (ie, Steareth-10) which is especially preferred. Also, mixtures of ethoxylated cetyl alcohol and stearyl alcohol can be used at an average degree of ethoxylation of about 10 to about 20 as the hydrophilic surfactant.
Another type of surfactant suitable for use in the present invention includes the Aerosol OT, or a dioctyl ester of sodium sulfosuccinic acid marketed by the American Cyanamid Company. Yet another type of surfactant suitable for use in the present invention includes silicone copolymers such as General Electric SF 1188 (a copolymer of a polydimethisiloxane and a polyoxyalkylene ether) and General Electric SF 1228 (a silicone polyether copolymer). These silicone surfactants can be used in combination with another type of hydrophilic surfactants discussed above, such as ethoxylated alcohols. These silicone surfactants have been found to be effective at concentrations as low as 0.1%, more preferably from about 0.25 to about 1.0% by weight of the emollient composition. The amount of the hydrophilic surfactant required to increase the wettability of the emollient composition will depend on the type of emollient and immobilizing agent used, the HLB value of the surfactant used and the like. The emollient composition of the present invention may comprise about 1 to about 50% of the hydrophilic surfactant, when it is necessary to increase the properties of the wettability of the composition. Preferably, the emollient composition comprises from about 1 to about 25%, most preferably from about 10 to about 20%, of the hydrophilic surfactant when increased wettability is needed. It is also possible that a surfactant can be used, which is applied separately to the interiabial device, and is not included in the emollient composition. If a surfactant is applied separately to the interlabial device, it is preferably applied to the back surface 20B thereof in such a way that it does not come into contact with the body of the user. In other embodiments, particularly where the interlabial device is not provided with a backsheet impervious to liquid, the surfactant can be completely removed. In these cases, the interlabial device will be sufficiently capable of getting wet that it is downloadable. The back surface of such an interlabial device will typically not have an emollient coating on it, and will easily wet and sink when placed in a toilet. 4. Other Optional Components The emollient compositions may comprise other optional components typically present in emollients, creams and emollients of this type. These optional components include water, viscosity modifiers, pH modifiers, regulators, perfumes, disinfectants, antibacterial actives, pharmaceutical actives, film formers, deodorants, opacity modifiers, astringents, solvents, organic acids, preservatives, anti-viral assets , drugs, vitamins, aloe vera, panthenol, and the like. In addition, stabilizers may be added to increase the shelf life of the emollient composition such as cellulose derivatives, proteins and lecithin. All of these materials are well known in the art as additives to these formulations and may be employed in appropriate amounts within the emollient compositions of the present invention.
C. Treatment of the Interlabial Structure with the Emollient Composition The surface that is in contact with the body of the interlabial device 20 is pretreated. The surface that is in contact with the body 20B is treated with a substance or an emollient (such as a liquid), which is suitable to be in contact with the user's skin and which can help or assist in maintaining the level of hydration of the tissue of the lips and reduce friction between them. In preparing the interlabial lotion products of the present invention, the emollient composition is preferably applied to the surface that is in contact with the body 20A of the interlabial product. Any of a variety of application methods that uniformly distribute lubricious materials that have a molten or liquid consistency can be used. Suitable methods include spraying, printing (eg, flexographic printing), coating (eg, gravure or slot coating), extrusion, or combinations of these application techniques, eg, spraying the emollient composition onto a rotating surface, such as a calendering roller, which then transfers the composition to the surface that is in contact with the body of the interlabial device 20. The way of applying the emollient composition to the interlabial device, must be such that the interlabial device does not become saturated with the emollient composition. If the interlabial device becomes saturated with the emollient composition, there is a greater potential for the emollient to block the pores or openings in the surface that is in contact with the body, reducing the ability to transmit the fluid through the surface that is in contact with the body towards the absorbent portions of the interlabial device. Also, saturation of the interlabial device is not required to obtain the benefits described here. The emollient composition is preferably applied to the surface that is in contact with the body of the interlabial device of the present invention in an amount ranging from about 0.1 mg / inch2 to about 30 mg / inch2, more preferably about 1 mg / inch2 to about 15 mg / inch2 (milligrams of emollient per square inch of surface that is in contact with the coated body). Because the emollient is substantially immobilized on the surface of the surface that is in contact with the body, less emollient composition is needed to impart the desired benefits. These relatively low levels of the emollient composition are adequate to impart the desired benefits for the interlabial device, yet do not saturate the absorbency and / or wettability properties of the interlabial device. The emollient composition can be uniformly and evenly applied to the surface that is in contact with the body of the interlabial device or parts thereof. For example, the emollient composition can be applied to the portion that is in contact with the body of the main absorbent portion, to the portion that is in contact with the body of the flexible extensions, or to the portion that is in contact with the body. of both the main absorbent portion and the flexible extensions. Preferably, the emollient composition is applied to the portion that is in contact with the body of both the main absorbent portion and any of the flexible portions. The emollient composition can also be applied unevenly to the surface that is in contact with the body of the interlabial device. By "non-uniform", it is implied that the pattern, or distribution, etc., of the emollient composition may vary over the surface that is in contact with the body. For example, some of the parts of the surface that are in contact with the body may have greater or lesser amounts of the emollient composition including the parts of the surface that do not have any of the emollient composition thereon. If the emollient is applied non-uniformly, the levels of the emollient specified above are preferably averages of the amount of coating applied to the total surface. The emollient composition can be applied to the interlabial device at any point during assembly. For example, the emollient composition can be applied to the surface that is in contact with the body of the finished interlabial product before it has been packed. The emollient composition can also be applied to the components of the interlabial device before they are combined with other raw materials to form the finished interlabial device. The emollient compositions are typically applied from a fusion thereof to the surface that is in contact with the body of the interlabial device. If the emollient composition melts at temperatures above the environmental, this can be applied as a hot coating to the surface that is in contact with the body. Typically, the emollient composition is heated to a temperature in the range of about 35 ° to about 100 ° C, preferably 40 ° to about 90 ° C before being applied to the surface that is in contact with the body of the interlabial device. . Once the molten emollient composition has been applied to the surface that is in contact with the body of the interlabial device, it is allowed to cool and solidify to form a solidified coating or film on the surface that is in contact with the body. Preferably, the application process is designed to assist cooling / fixation of the emollient. When applying the emollient compositions of the present invention to the interlabial devices, the methods of slot coating, extrusion coating, gravure coating and spraying are preferred. A preferred method, when the interlabial device is provided with an upper sheet, is to spray the emollient on the upper sheet before assembling said upper sheet with other raw materials in the finished product. In carrying out this method, a web of the top sheet is unwound from a main roll of the topsheet and advanced to a spray station where one side of the web is sprayed with a hot, molten emollient composition (e.g. 65 ° C). After leaving the spray station, the weft of the upper sheet material becomes a top sheet treated with emollient, which is subsequently used in the assembly of the finished product. A preferred alternate method involves the continuous or intermittent spraying of the emollient composition on the surface that is in contact with the body of the assembled or partially assembled device. When it is said that the emollient composition can be applied to a partially assembled interlabial device, there are a number of ways for this to be achieved. These include, but are not limited to the following. If the interlabial device is provided with flexible extensions, the web of material that is converted into the flexible extensions can be treated before the material is attached to the central absorbent portion to form the interlabial device. The main absorbent portion can similarly be treated separately before the flexible extensions are attached thereto. In this regard, it is contemplated that the main absorbent portion will initially be in the form of a continuous cord-like web that will be intermittently cut into discrete lengths to form a plurality of main absorbent portions. It will often be very convenient to treat the main absorbent portion before it is cut into discrete lengths. By treating the interlabial device by spraying it with the emollient on the assembled or partially assembled device, the interlabial device or the desired portion or component thereof, can be carried out in any suitable manner towards a spray station where the surface which is in contact with the body of the interlabial device is sprayed with a hot, molten emollient composition (eg, 65 ° C). After leaving the spray station, the interlabial device has a contact surface with the body coated with emollient. The amount of the emollient composition transferred to the body contact surface can be controlled by: (1) the rate at which the molten emollient composition is sprayed from the spray station; and / or (2) the speed at which the interlabial device travels under the spray station. By providing the interlabial device with an emollient coating, a number of advantages are provided. The absorbent device treated with emollient provides a reduction in frictional discomfort associated with the rubbing of the device against the walls of the lips and the gluing of the surfaces of the device to the walls of the lips. The interlabial device also has less dry feeling towards the inner surfaces of the wearer's lips due to the presence of the emollient. Furthermore, as shown by comparing Figures 11 and 12, the interlabial device can be inserted into the space between the user's lips with less friction in such a way that it will be more easily inserted towards the desired position of use. Figure 11 shows a hypothetical example of a prior art liplabial device that is not treated with emollient. Figure 11 shows a prior art interlabial pad in place in a body of the wearer. When the wearer attempts to insert this device, friction between the contact surface with the body of the device and the outer walls of the wearer's lips may prevent the device from being fully inserted as shown in Figure 11. This may impede that the device provides maximum protection against leakage. It may also result that parts of the lower portion of the device, such as the lower corner portions 28A, remain outside the lip vestibule. When the user sits, these lower corner portions 28A can be pressed upward causing discomfort to the user. Figure 12 shows how, on the other hand, the interlabial device treated with emollient of the present invention will tend to be able to be inserted more completely into the vestibule of the lips in such a way that the lower corner portions reside completely within the lobby of the user's lips.
Another advantage of the interlabial device of the present invention is that the emollients described herein are substantially free of water. Moisturizing emollients are less preferred because these materials can withstand the growth of bacteria during the storage of the product before shipping to the consumer. In other embodiments, the emollients described herein may be applied to other types of absorbent articles, particularly other types of items for feminine hygiene, such as sanitary napkins, panty liners, incontinence devices, and tampons. The relatively lower molecular weight and melting temperature of the emollients described herein make them particularly suitable for use with absorbent articles having a top sheet of film with openings such as those sheet materials described above. Without wishing to be bound to any particular theory, it is believed that this is so because these top sheets will not have fibers that help to keep the coating thereon by the emollient embedded in the spaces between them. The molecular weight and the higher melting point temperature will typically easily unclog from the apertured films, when these films are flexed. 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.
TEST METHOD / Absorbing Capacity Absorbing 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 completely 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 the two 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-rod 1101 is lowered until it rests directly on the top of one of the support rods 1 108. The vertical position of the T-rod 1001 is "zeroed" when the load as it rests on the support rod 1108 it 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. 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 should 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 1 101 rod 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 Strain 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 other 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.
Water Dispersion Test Apparatus Magnetic stirrer, 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, Ine 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 . 2 cm above the surface of the water. Gently drip the sample over the surface of the water, 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. 4. Record the time required until the sample separates into at least two pieces. If the movement of the stirring bar is interrupted by the sample in such a way that it no longer turns, turn off the magnetic stirrer. Re-center the magnet without removing and restarting the agitator immediately. The recorded time is the total time the sample remains in the water, including the time required to restart the agitator. 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. However, if at least one of the four samples separates into at least two fragments during the time specified in the appended claims, the sample will be considered as dispersible in water. The term "fragments" as used herein is not intended to include the separation of merely a few loose fibers (i.e., the fibers constituting less than 5% of the total product mass) of the sample. The interlabial devices described herein preferably disperse in at least two fragments within about 1 hour, more preferably within about 30 minutes.
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 that 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 nterlabial device or other device that goes to 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 14. The apparatus includes: A toilet with a swirl trap, water saver of 13.2 liters, referred to as 210 (additional toilets can also be attached to the pipe layout shown in Figure 14, to evaluate the behavior of test samples using different unloading mechanisms such as pressure, commercial toilets). about 18 meters of 10 cm acrylic pipe (as seen in Figure 14, 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; or stump 222 positioned vertically (Figure 15) of approximately 4.57 meters from the terminal end of the pipe 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 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 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) Download with paper only - Take reading of blockade reading Drain line 2 minutes after the water reaches the simulated obstruction, wait an additional minute, and move to step 2. 2) Discharge 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 reach the stump point, wait 1 additional minute and move to step 4. 4) Empty discharge rate. Take a drainage line block reading 2 minutes after the water reaches the stump point and move to step 5. 15 5) Discharge with paper and simulated faecal 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 done 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 the step 2. 2) Download with the empty rate. Take a reading of the blockade 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. If, at any point in the discharge sequence, the product remains in the cap or the 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 95% of the time in one 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. 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. 8. Before use, place the tubes in the water bath at 38 ° C.
SPECIFIC ILLUSTRATIONS OF THE PREPARATION OF INTERLABLED DEVICES TREATED WITH EMOLLIENTE The following are specific illustrations of the interlabial devices with the emollient compositions according to the present invention. Example 1 A. Preparation of Emollient Compositions A water-free emollient composition (Emollient A) is made by mixing together the following molten (i.e. liquid) components: Mineral Oil (Carnation White Mineral Oil, USP, made by Witco Corp); Cetearyl Alcohol (a mixed primary C16-C18 linear alcohol made by The Procter &Gamble Company, under the name TA-1618); and Steareth-2 (Brij 72, to a linear ethoxylated C18 alcohol that has an average degree of ethoxylation of two, made by ICI America). The percentages by weight of these components are shown in Table I below: Table I Component% in Weight Mineral Oil 50 Cetearyl Alcohol 35 Steareth-2 15 B. Preparation of the interlabial device treated with emollient by thermal fusion spraying. The emollient composition A is placed in a heating tank operating at a temperature of 125 ° F. The composition is subsequently sprayed (using a Dynatec E84B1758 spray head, operating at a temperature of 165 ° F and a spray pressure of 2.40 psig) on the contact surface with the body of the interlabial device. The added level = 2.3 mg / cm2.
Example 2 A. Preparation of Emollient Compositions A water-free emollient composition (Emollient B) is made by mixing together the following molten (i.e. liquid) components: Mineral Oil (Oil) Mineral Blanco Carnation, USP, made by Witco Corp); and Cetearyl Alcohol (a mixed primary C16-C18 linear alcohol made by The Procter &Gamble Company, under the name TA-1618). The percentages by weight of these components are shown in Table II below: Table II Component% in Weight Mineral Oil 65 Cetearyl Alcohol 35 B. Preparation of the interlabial device treated with emollient by spraying under thermal fusion The emollient composition B is placed in a heating tank operating at a temperature of 125 ° F. The composition is subsequently sprayed (using a Dynatec E84B1758 spray head, operating at a temperature of 165 ° F and a spray pressure of 2.40 psig) on the contact surface with the body of the interlabial device. The added level = 2.3 mg / cm2.
Example 3 A. Preparation of the Emollient Composition A water-free emollient composition (Emollient C) is made by mixing together the following molten (i.e. liquid) components: White Protopet®1S (white petrolatum made by Witco Corp); Cetearyl Alcohol (a C16-C18 primary linear alcohol made by The Procter &Gamble Company under the name TA-1618); Cetearth 10 (a mixture or mixture of C16 and C18 alcohols ethoxylated at an average of 10 ethoxylate units obtained from BASF Corp., of Mount Olive, NJ). The percentages by weight of these components are shown in table III below: Table COMPONENT% IN WEIGHT White Protopet® 50 Ceteraryl Alcohol 35 Cetearth-10 15 B. Preparation of the interlabial device treated with emollient by spraying under thermal fusion The emollient composition C is placed in a heating tank operating at a temperature of 125 ° F. The composition is subsequently sprayed (using a Dynatec E84B1758 spray head, operating at a temperature of 165 ° F and a spray pressure of 2.40 psig) on the contact surface with the body of the interlabial device. The added level = 1.5 mg / cm2.
Example 4 A. Preparation of the Emollient Composition A water-free emollient composition (Emollient D) is made by mixing together the following molten (i.e. liquid) components, White Protopet® 1S (white petrolatum made by Witco Corp); Fluid Dow Corning 556 Cosmetic Grade (a polyphenylmethylsiloxane made by the Dow Corning Corporation); an example of a particularly preferred paraffin wax is Parrafin S.P. 434 (a paraffin wax made by Strahl and Pitsch Inc.); Cetearyl Alcohol (a mixed primary C16-C18 linear alcohol made by The Procter &Gamble Company under the name TA-1618); Ceteareth 10 a C16-C18 linear alcohol ethoxylate having an average degree of ethoxylation of 10 made by ICI America; PEG 2000 (a polyethylene glycol having a MW of 2000 made by Sigma-Aldrich Corp.). The percentages by weight of these components are shown in table IV below: Table IV COMPONENT% IN WEIGHT White Protopet® 52 1S Polyphenylmethylsiloxane 10 Paraffin Wax 15 Cetearyl Alcohol 20 PEG 2000 3 B. Preparation of the nterlabial device treated with emollient by spraying under thermal fusion The emollient composition D is placed in a heating tank operating at a temperature of 125 ° F. The composition is subsequently sprayed (using a Dynatec spray head E84B1758, which operates at a temperature of 165 ° F and a spray pressure of 2.40 psig) on the contact surface with the body of the interlabial device. The added level = 2.3 mg / cm2. 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. An interlabial absorbent device to be worn in the interlabial space of a female user, said interlabial device characterized in that it has a contact surface with at least a portion of the body which is able to be in contact with the inner surfaces of the lips of the body. the wearer when the absorbent device is used, and an absorbent portion, wherein at least a portion of said body contacting surface comprises an emollient composition comprising an emollient substantially free of water, and at least a portion of said composition The emollient remains on said contact surface with the body without being absorbed towards the interlabial device.
The interlabial absorbent device according to claim 1, wherein said emollient composition is free of hydrocarbon components having a molecular weight greater than or equal to 1,500.
The interlabial absorbent device according to claim 1 or 2, wherein said emollient also has at least one of the following properties: said emollient begins to soften at or below the temperature of the human body; and / or said emollient has a plastic or liquid consistency at 20 ° C.
The interlabial absorbent device according to claim 1, wherein said emollient composition is liquid, selid, or solid at 20 ° C, and said emollient composition comprises an emollient having a liquid or plastic consistency at 20 ° C and comprises a member selected from the group consisting of petroleum-based emollients, fatty acid ester emollients, alkyl ethoxylate emollients, and mixtures thereof.
5. The interlabial absorbent device according to claim 4, wherein said emollient composition comprises: (i) from 10 to 95% of said emollient substantially free of water; and (ii) from 5 to 90%, preferably from 5 to 50% of an agent capable of immobilizing the emollient on said body contacting surface, said immobilizing agent having a melting point of at least 35 ° C, preferably at least 40 ° C.
The interlabial absorbent device according to claim 5, wherein said emollient contains about 5% or less of water and comprises a petroleum-based emollient selected from the group consisting of mineral oil, petrolatum and mixtures thereof.
The interiabial absorbent device according to claim 5 or 6, wherein said immobilizing agent is selected from the group consisting of polyhydroxy fatty acid esters, polyhydroxy fatty acid amides, C 1 -C 22 fatty alcohols, C12-C22 fatty acids, C 2 -C 22 fatty alcohol ethoxylates, waxes and mixtures thereof.
The interlabial absorbent device according to claim 7, wherein said immobilizing agent comprises a C 6 -C 18 fatty alcohol selected from the group consisting of cetyl alcohol, stearyl alcohol, and mixtures thereof, or a paraffin or microcrystalline wax.
An interlabial absorbent device according to any of the preceding claims, wherein said emollient composition further comprises a hydrophilic surfactant.
10. A nterlabial absorbent device according to any of the preceding claims, comprising: a main absorbent portion comprising an upper portion comprising part of the contact surface with the body and a lower portion, said upper portion facing the walls of the vestibule during insertion into the interlabial space and leading to said lower portion during insertion therein, said lower portion being opposite said upper portion and inserting the absorbent device into the interlabial space said lower portion away from the walls of the vestibule of said user; and a pair of flexible extensions attached to the upper portion of the main absorbent portion and extending downwardly and outwardly thereof, said flexible extensions comprising part of the contact surface with the body.
MXPA/A/1999/011291A 1997-06-05 1999-12-06 Emollient-treated absorbent interlabial device MXPA99011291A (en)

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Application Number Priority Date Filing Date Title
US08869897 1997-06-05

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MXPA99011291A true MXPA99011291A (en) 2000-09-04

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