BR0116781B1 - interlabial absorbent device. - Google Patents

Description

INTERLABIAL ABSORBENT DEVICE TECHNICAL FIELD The present invention relates to absorbent devices and, more specifically, to an interlabial absorbent device used in the interlabial region of the woman's body during the menstrual period, as a protector in cases of incontinence or both. for absorption of body fluids such as menstruation, urine and feces are well known. With reference to female protective devices, the state of the art offers two basic types, which are the external sanitary pads used over the genital region, and the internal tampons used within the vaginal cavity so that menstrual flow is blocked and absorbed in this region. some hybrid devices that attempt to fuse the structural characteristics of sanitary pads and tampons into a single device. Such hybrid devices are described in U.S. Patent No. 2,092,346, entitled "Catamenial Pad", issued to Arone on September 7, 1937 and in U.S. Patent. No. 3,905,372 issued to Denkinger on September 16, 1975. Other less intrusive hybrid devices are known as labial or interlabial hygienic tampons and are characterized by having a portion that resides at least partially within the user vagina and a portion that resides at least partially outside the vagina. Such devices are described in U.S. Patent No. 2,662,527, issued to Jacks on December 15, 1953 and U.S. Patent No. 4,631,062, issued to Lasen et al., December 23, 1986.

Interlabial plugs have the potential to provide even greater freedom because of their small size and reduced risk of leakage. Numerous attempts have been made in the past to produce an interlabial tampon that combines the best characteristics of tampons and sanitary tampons while avoiding at least some of the disadvantages associated with each of these individual device types. Some examples of such devices are described in US Patent No. 2,917,049 issued to Delaney on December 15, 1959, US Patent No. 3,420,235 issued to Harmon on January 7, 1969 and US Patent No. 4,595,392 to Johnson et al. June 17, 1986.

However, since they have disadvantages, such devices have not been very commercially successful. For example, the device described in the Johnson patent and others does not appear to be easy and comfortable to insert correctly into the body. This is because users are unable to see and do not want to touch the body region into which the device is introduced. When the device is not inserted correctly, it causes user discomfort.

Even when introduced correctly, such a device tends to allow the flow to deviate around its edges. Such flow can cause stains on the body or panties, which is considered unacceptable by many users.

Based on the above, an improved interlabial device is required which, when used, reduces the incidence of spots on the body or panties. Such a device should be easy to introduce and comfortable during use. Likewise, a method of making such an interlabial device is required.

SUMMARY OF THE INVENTION

One aspect of the present invention relates to an interlabial absorbent device. The interlabial absorbent device has a body contact surface, a garment facing surface and opposed to the body contact surface, an inner region and a peripheral region surrounding the inner region. The contact surface with the body is permeable aliquids. The interlabial absorbent device comprises an absorbent element disposed between the garment facing surface and the body contacting surface. The absorbent member has a body facing surface and a surface facing the garment and opposite the body facing surface. The interlabial absorbent device has a convex portion on the body contact surface in the inner region, and a concave portion on the surface facing the innermost garment. The convex and concave portions are formed in a face-to-face relationship. Another aspect of the present invention relates to a method of manufacturing such an interlabial absorbent device. The method comprises the step of providing two absorbent elements, each of which has a first and a second surface, which are opposite each other. The first surfaces of the two absorbent elements are in a face-to-face relationship. The method also comprises the step of joining a portion of the two absorbent elements along a predetermined junction line so that the two elements form the concave and convex portions of the interlabial absorbent device.

The above addresses the need for an improved interlabial device that reduces the incidence of blemishes on the body or panties during use. Damesma shape also meets the need for fabrication detail interlabial device.

These and other features, aspects and advantages of the present invention will become apparent to those skilled in the art from reading the detailed description below.

BRIEF DESCRIPTION OF DRAWINGS

Although the specification ends with claims that specifically mark and distinctly claim the invention, it is believed that the present invention will be better understood from the description of the following preferred embodiments, in combination with the accompanying drawings, and similar designations are used to indicate substantially identical elements. , in which:

a) Figure 1 is a perspective view of a preferred embodiment of the interlabial absorbent device of the present invention;

b) Figure 2 is a simplified top view of the interlabial absorbent device shown in Figure 1 shows the surface of the device that comes in contact with the body;

c) Figure 3 is a cross-sectional view of the interlabial absorbent device shown in Figure 2, taken along section line 3-3 of Figure 2;

d) Figure 4 is a cross-sectional view of an interlabial absorbent device, which is another preferred embodiment of the present invention;

e) Figure 5 is a perspective view of the interlabial absorbent device shown in Figure 1 in the introduction configuration for use;

f) Figure 6 is a sagittal cross-sectional view of a user showing the location of the interlabial absorbent device of Figure 1 in the user's interlabial space;

g) Figure 7 is a simplified top view of a manufacturing process of an interlabial absorbent device, which is another embodiment of the present invention, h) Figure 8 is a cross-sectional view of the absorbent element shown along Figure 7. section 8-8 of Figure 7;

i) Figure 9 is a simplified top view of the interlabial absorbent device shown in Figure 7;

and

j) Figure 10 is a simplified top view of an interlabial absorbent device which is also a preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

All references cited herein are incorporated by reference in their entirety. The citation of any reference is not an admission regarding any determination as to its availability as prior art for the claimed invention.

In the present document, the terms "understand", "include" and "contain" mean that another step (s) that does not affect the end result may be added. Such terms encompass the expressions "consist of" and "consist essentially of".

In the present document, the term "layer" does not necessarily limit the element to a simple layer of material, since a layer may actually comprise laminates or combinations of sheets or blankets of the material type required.

In the present document, the term "joined" or "joining" encompasses configurations whereby an element is directly attached to another element by the direct junction between them, as well as configurations through which the element is indirectly attached to the other element by the member (s) joint. intermediate (s) which, in turn, is / are attached to the other element.

In the present document, the term "interlabial absorbent device" refers to a structure that includes at least one absorbent component or element and is specifically configured to be within the interlabial space of the wearer's body during use. When the interlabial absorbent device is correctly sized for a particular user, more than half of the interlabial absorbent device of the present invention is within such interlabial space. Preferably, substantially the entire interlabial absorbent device is within such an interlabial space and preferably the entire interlabial absorbent device within that interlabial space of a user during use.

In this document, the term "interlabial space" refers to the space in the genital region of the female anatomy that lies between the inner surfaces of the large lips and extends into the vestibule. Within this interlabial space are the small lips, the vestibule and the major urogenital elements, including the clitoris, the urethral orifice, and the vaginal orifice. Medical authorities define the vestibule as space limited laterally by the inner surfaces of the small lips and extending inwardly to the floor between the clitoris and the vaginal opening. Therefore, it should be understood that the interlabial space, as defined above, may refer to the space between the inner surfaces of the large lips, including the space between the inner surfaces of the small lips, also known as the vestibule. For the purposes of this description, the interlabial space does not extend substantially beyond the vaginal orifice in the direction of the vagina interior.

In this document, the term "lips" refers to both large and small lips. The lips terminate before and after the anterior and posterior commissures, respectively. Elements of skill in the art will recognize that there is a wide variation among women with regard to the relative size and shape of the large and small lips. However, for the purpose of the present description, such differences are not specifically focused. It should be recognized that placement of the interlabial absorbent device in a user's interlabial space, as defined above, must be between the inner surfaces of the large lips, regardless of the location of the boundary between the large lips and the small lips of each user. For a more detailed description of such part of female anatomy, see Gray1S Anatomy, Running Press 1901 Ed. (1974), p. 1025-1027. Figure 1 is a perspective view of an interlabial absorbent device 20 which is a preferred embodiment of the present invention. With

Referring to Figure 1, the interlabial device 20 has a body contact surface 22 and a garment surface 24 opposite the body contact surface 22. The body contact surface is liquid permeable. The interlabial device 20 includes the absorbent element 30 disposed between the body-contacting surface 22 and the face-facing surface 24 of the interlabial device 20. The absorbent element 30 has a body-facing surface 32 and a surface facing the workpiece. garment 34, which is opposed to the body facing surface 32. The interlabial device 20 has an inner IR region and a peripheral region PR surrounding the inner IR region. Interlabial device 20 has a convex portion 26 on the body contact surface 22 in the inner IR region, and a concave portion 28 on the surface facing the garment 24 in the inner IR region. Convex portion 26 and concave apposition 28 are formed in a face-to-face relationship, as shown in Figure 1 (and Figures 3 and 4). The general format of the interlabial device 20 is defined by the shape of the outermost circumference E of the device 20.

Figure 2 is a simplified top view of the interlabial device 20 shown in Figure 1, showing surface 22 that contacts the body. The interlabial device 20 has an internal IR region and a peripheral PR region surrounding the internal IR region. Convex apposition 26 is formed in the internal IR region. The interlabial device 20 shown in Figure 2 has a longitudinal central line L extending along the "x" axis. In the present document, the term "longitudinal" refers to a line, axis or direction in the plane of the interlabial device 20, which is generally aligned (e.g. approximately parallel) with a vertical plane that divides the standing wearer's body into two halves. , right and left when interlabial device 20 is used. In the present document, the terms "transverse", "lateral" or "y direction" are interchangeable and refer to the axis or direction that is generally perpendicular to the longitudinal direction. Lateral direction is shown in Figure 2 as "y" direction. Interlabial device 20 shown in Figure 2 also has a transverse centerline T.

The interlabial device 20 needs to be of appropriate overall size and shape so that at least most of the device 20 fits comfortably within the interlabial space, covers the vaginal orifice and preferably also covers the wearer's urethra. The size and overall shape of the interlabial device 20 should be conveniently selected so that the device 20 at least partially and preferably completely blocks and retains the flow of menstruation, urine, and other body exudates from the user's vaginal orifice and urethra. 20 can be manufactured in a wide variety of formats.

The non-limiting full-format examples shown in Figure 2 include oval, elliptical, trapezoidal, rectangular, triangular, rhombus, or any combination thereof.

The convex portion 26 (and thus the concave portion28) may also have a wide variety of global shapes. Non-limiting examples of total shapes shown in Figure 2 include oval, elliptical, trapezoidal, rectangular, triangular, rhombus or any combination thereof.

The size of the interlabial device 20 is important for comfort and effectiveness.

The longitudinal length L1 of the interlabial device 20 is measured along the longitudinal centerline L in the longitudinal direction (or in the "x" direction). Preferably, the interlabial device 20 has a longitudinal length L1 of approximately 50 mm to approximately 150 mm. Preferably, the length L1 is approximately 70 mm to approximately 100 mm. The transverse width W1 of the interlabial device 20 is measured along the transverse centerline T in the transverse direction (or "y" direction). Preferably, the interlabial device 20 has a transverse width W1 of from about 10 mm to about 80 mm. Preferably, the width W1 is from about 40 mm to about 60 mm. The caliber (or thickness) C of the interlabial device 20 is measured at edge E (as shown in Figure 1). Preferably, the interlabial device 20 has a caliber C of approximately 0.5 mm to approximately 10 mm.

Preferably, the C gauge is approximately 1 mm to approximately 3 mm. The gauge measurements presented here were made with an AMES gauge, with a 0.25 psi (1.7 kPa) load and a 2.46 cm (0.96 inch) diameter base. Those of skill in the art will recognize that if a 2.44 cm (0.96 inch) diameter base is not suitable for a given sample size, the base size may be modified with corresponding change in meter load. to maintain containment pressure of 1.7 kPa (0.25 psi).

Preferably, the convex portion 26 has a longitudinal length L 2 of approximately 10 mm to approximately 80 mm. Preferably, the length L2 is from about 30 mm to about 55 mm. Preferably, the convex portion 26 has a transverse width W2 from approximately 1 mm to approximately 25 mm. Preferably, the width W2 is approximately 5 mm to approximately 8 mm.

Preferably, the ratio between the longitudinal length L2 of the convex portion 26 and the longitudinal length L1 of the device 20 is from approximately 1: 1.1 to approximately 1:10, preferably from approximately 1: 1.3 to approximately 1: 3.3.

In a preferred embodiment, the longitudinal length L1 of the device 20 is approximately 80mm, the transverse width W1 is approximately 50mm, the longitudinal length L2 of the convex portion 26 is approximately 45mm and the transverse width W2 is approximately 6mm.

Figure 3 is a cross-sectional view of the interlabial device 20 shown in Figure 2, taken along section line 3-3 of Figure 2. Referring to Figure 3, the interlabial device 20 has, in the internal region IR, the convex portion 26 which has an upper portion 46 on the body contacting surface 22 and the concave portion 28 on the garment facing surface24. The height of the convex portion 26 is measured as the perpendicular distance from the body contact surface 22 of the peripheral region PR to the maximum amplitude point in the upper portion 46, when no pressure is applied externally to the device 20. Preferably, the convex portion 26 has a height H approximately 5 mm to approximately 50 mm. Preferably, the height H is from about 10 mm to about 25 mm.

In the embodiment shown in Figure 3, the absorbent element 30 in the peripheral region PR is substantially parallel to the horizontal plane, which is defined by the longitudinal center line L and the transverse center line T (not shown in Figure 3, but Figure 2). An example of the horizontal plane is shown by the HP line in Figure 3.

Preferably, the absorbent element 30 in the peripheral region PR is inclined to the horizontal plane HP. Specifically, as shown in Figure 4, the absorbent element 30 in the peripheral region PR preferably has an angle AG relative to the horizontal plane HP. about 45 degrees, preferably about 0 degrees to about +10 degrees.

The interlabial device 20 which preferably has the specific size parameters provided above is a comfortable and effective product in cooperation with the function of the convex portion 26 and the concave portion 28.

Figure 5 is a perspective view of the interlabial device 20 shown in Figure 1, in an insert configuration for use. The tip (s) of the user's finger (s) are inserted into the concave portion 28 of the interlabial device 20 of the present invention, whereas the convex portion 26 (or the body contact surface) 22) faces the lip surface. The user may crouch during introduction to help separate the labial surfaces. Therefore, the user may indirectly touch the area of her body into which the device 20 is introduced without dirtying the finger (s). This facilitates the correct introduction of device 20 into the interlabial space, ensuring even greater user comfort during use of the device. Correct insertion of the device 20 also effectively avoids the diversion of the body fluid flow that may occur between the body of the user and the device 20, and thereby can avoid stains on the body or panties. Preferably, at least a portion, preferably most, of the convex portion 26 of the device 20 is introduced into the inner part of the small lips with the orientation of the wearer's finger (s).

Figure 6 is a sagittal cross-sectional view of a user W showing the location of the interlabial device 20 of the present invention in the interlabial space. The urogenital elements shown in Figure 6 include the bladder B, the vagina V, the urethra U, the clitoris C, the large intestine I, the anus A, the vaginal introphyte VI, and the annular H. In this figure, the small and large lips are not shown to clarify the relationship between such anatomical features of user We and the interlabial device 20 when the device is correctly inserted for use. Once the interlabial device 20 is placed in the interlabial space, the body contact surface 22 of the convex portion 26 preferably adheres to the skin of the interlabial space, preferably to the inner surfaces of the small lips. When the user W is standing, the walls Lips tend to bend the concave portion 28 of the interlabial device 20. Preferably, the interlabial device 20 is placed at least partially in place by a slight lateral and external oriented pressure on the inner surfaces of the small or large lips, or both. . The released body fluids are absorbed by the absorbent element 30 of the convex portion 26. In addition, the interlabial device 20 can also be maintained by attracting the naturally moist labial surfaces and the body-contacting surface material 22. Optionally, the contacting surface with the body 22 of the device 20 it may have a compatible adhesive to assist the adherence of the device 20 to the inner surfaces of the wearer's lips. The strength of such a grip should be selected to help the interlabial device 20 stay in place and also allow the device to be reliably and comfortably removed from the user's interlabial space.

Preferably, the peripheral region PR of the device 20 covers at least the lips and preferably also covers the adjacent area to prevent leaks that may occur through the space between the device 20 and the wearer's skin. Therefore, the body fluids may be absorbed by the absorbent element 30 in the peripheral region PR, as well as in the convex portion 26.

Intravaginal device 20 is preferably sufficiently absorbent to absorb and retain body fluids (or body exudates). However, the capacity of the product depends at least partially on the physical volume of the interlabial device 20.

Preferably, the interlabial absorbent device has a capacity of at least about 1 gram of 0.9 wt% saline and may have a capacity of up to approximately 30 grams with the use of absorbent gels or foams that expand when wet. Typically, capacities may range from about 2 to about 20 grams for the saline solution. Preferably, the capacity of device 20 is greater than about 10 grams for the saline solution. Elements skilled in the art will recognize that the capacity for absorption of body exudates, such as menstruation, will typically be less than the above indicated capacity for absorption of saline solution. A method for measuring absorbent capacity is described below in the Test Methods section. Since the interlabial space may expand, larger volumes may be stored in the interlabial space if fluid is stored as a gel that adjusts to body pressures. Additionally, if the interlabial device 20 is not completely within the interlabial space, some of the absorbed exudates may be stored. in the external part interlabial space of the user.

The individual component (s) that may be appropriated for various embodiments of the interlabial device 20 shown in Figure 1 will be described in more detail below.

In one embodiment, the interlabial device 20 is formed of a simple or uniform material from which the absorbent element 30 is formed. Preferred materials include absorbent foams, absorbent sponges and non-braided materials containing wood pulp (and absorbent gel materials, if desired). In a preferred manufacturing process, after the single or uniform material is heated in a vacuum cylinder, a pressure is applied to the heated material by means of a pressure bar to form the concave portion 28. A pressure cutter is used to form the external limit of the interlabial device 20.

Alternatively, in preferred embodiments, the interlabial device 20 includes a plurality of component materials which are joined together to form the absorbent element 30. For example, again with reference to Figure 1, the absorbent element 30 includes an absorbent core 40 having a facing surface. 42, and a garment facing surface 44, which is opposite the body facing surface 42. Preferably, the interlabial device 20 also includes a liquid permeable upper layer 36 which is disposed on the body facing surface 42 of the body. absorbent core40. The upper layer 36 has the body-contacting surface 22 of the interlabial device 20. Preferably, the interlabial device 20 also includes a liquid impermeable bottom layer 38 disposed on the facing surface for the garment 44 of the absorbent core 40. The lower layer 38 has the surface facing the garment part 24 of the interlabial device 20.

The topsheet 36 comprises a liquid permeable component. The topsheet 36 should be soft, soft to the touch and not irritating to the skin of the user. Additionally, the upper layer 36 is permeable to aliquids, which allows body fluids (eg menstruation and / or urine) to easily penetrate through its thickness (or gauge). A suitable topsheet 36 may be manufactured from a wide range of materials such as braided and non-braided materials, polymeric materials such as apertured molded thermoplastic films, plastics films with hydroformed thermoplastic films, porous foams, reticulated foams. cross-linked thermoplastic films and thermoplastic etamines. Suitable braided and unbraided materials may be natural fibers (e.g., wood or cotton fibers), synthetic fibers (e.g., polymer fibers such as polyester, rayon, polypropylene or polyethylene fibers) or a combination of synthetic natural fibers. A topsheet 36 suitable for use in the present invention is a non-braided rayon fiber molded material, with a basis weight of approximately 15 g / m2 to approximately 30 g / m2.

Preferably, the material particularly suitable for use as the topsheet 36 is a biodegradable material. In this document, the term "biodegradable materials" refers to materials having about 70% or more biodegradation (percentage of theoretical carbon dioxide evolution) after 28 days, as measured by the Sturm test, which was named Method 301B by the OECD - Organization for Economic Cooperation and Development.

Preferred materials have a biodegradation greater than about 80%, and preferably greater than or equal to about 90%. The upper layer 36 may also comprise an apertured molded film. Open-molded films are permeable to body exudates and, when properly provided with openings, reduce the possibility for liquids to return and moisten the wearer's skin. Thus, the surface of the molded film that stays in contact with the body remains dry, which reduces the possibility of stains the body and creates a feeling of comfort to the wearer. Suitable molded films are described in US Patent No. 3,929,135 issued to Thompson on December 30, 1975, US Patent No. 4,324,246 issued to Mullane and others April 13, 1982 in US Patent No. 4,342,314 issued to Radel and others on August 3, 1982, US Patent No. 4,463,045 issued to Ahre Others on July 31, 1984 and US Patent No. 5,006,394 issued to Baird on April 9, 1991.

In a preferred embodiment, the body-contacting surface 22 of the upper layer 36 is hydrophilic to aid in the transfer of liquids through the upper layer 36, more rapidly if it were not hydrophilic, thus reducing the possibility of menstrual flow leaking from the upper layer 36. upper layer 36 instead of fluire being absorbed by the absorbent core 40. The body-contacting surface 22 of upper layer 36 may become hydrophilic through treatment with a surfactant as described in US Patent No. 4,950,254, to Osborn, III . In a preferred embodiment, the surfactant is added to the polymeric materials of the upper layer of the molded film.

The inner surface of the upper layer 36 may be held in contact with an underlying absorbent layer. Such a contact relationship causes the liquid to penetrate the upper layer more quickly 36. The upper layer 36 may be maintained in a contact relationship with an underlying layer by joining them. However, it is not absolutely necessary to join the upper layer face 36 to the face. of the underlying layer. The upper layer 36 may be maintained in contact with an underlying absorbent component by interweaving the fibers of the underlying layer with the upper layer, by fusing the upper layer 36 with an underlying absorbent layer, or by a plurality of discrete individual melt bonds. any other method known in the art.

The topsheet 36 is not required to comprise a layer or material which is separate or different from the absorbent core 40. The topsheet 36 and absorbent core 40 may consist of a unitary structure in which the contact surface with the absorbent core body 4 0 will serve as a liquid-permeable topsheet 36. In such an embodiment, the liquid-permeable, body-contacting surface 22 may be hydrophilic or hydrophilically treated so that fluids easily penetrate through the surface 22 to the interior of the body. Additionally, the topsheet 36 and the absorbent core 40 may have a capillary, pore size, or hydrophilic gradient that assists in the absorption and retention of fluids within the absorbent core 40. The absorbent core 40 is positioned between the upper bed 36 and the lower layer 38. The absorbent core 40 allows the absorption of exons such as menstruation and other body fluids. Preferably, the absorbent core 40 is generally compressible, conformable and non-irritating to the wearer's skin. The absorbent core 40 may comprise any suitable material capable of absorbing and / or holding liquids (such as menstruation and / or urine). Preferably, the absorbent core 40 has the same generic shape as the interlabial absorbent device 20. The absorbent core 40 (and the interlabial absorbent device 20) can be manufactured in a wide variety of shapes. Non-limiting examples of absorbent core shapes 40, as seen from above, as in Figure 1, include oval, elliptical, trapezoidal, rectangular, triangular, rhombus or any combination thereof. As shown in Figure 1, the preferred format for the absorbent core 22 and the interlabial absorbent device 20 is generally the ovoid or elliptical. The absorbent core 40 can be made from a wide variety of liquid absorbent materials generally used in absorbent articles such as for example, ground wood pulp, which is commonly referred to as airfelt. Examples of other suitable absorbent materials are cotton fibers, wrinkled cellulose wadding, melt blown polymers including coformat, chemically stiffened cross-linked or modified cellulosic fibers, synthetic fibers such as polyester and peat mound fibers, sanitary paper such as toilet paper and sanitary paper laminates, absorbent foams, absorbent sponges, superabsorbent polymers (in fibers or particles), absorbent gel materials, or any equivalent materials, combinations or mixtures thereof. Preferred absorbent materials are folded toilet papers, cotton blankets, braided materials, non-braided blankets, rayon, including needle punched rayon, and thin layers of foam. The absorbent core 40 may comprise a single material. Alternatively, the absorbent core 40 may comprise a combination of materials. A particularly preferred material for the absorbent core 40 is the rayon mat or a mixture of rayon and cotton.

The bottom layer 38 prevents the exudates absorbed and contained by the absorbent core 40 from moistening articles and / or body parts that may come into contact with the interlabial device 20 such as pants, pajamas, underwear, pubic hair, thighs, etc. The lower layer 38 should be flexible and impermeable to liquids (e.g. menstruation and / or urine). The lower layer 38 is impervious to liquids (e.g. menstruation and / or urine) and is preferably flexible. In the present document, the term "flexible" refers to materials that are compliant and conform immediately to the shape and contours of the human body. The lower layer 38 also provides protection to the fingers of the user when the interlabial device 20 is introduced or when it is optionally removed with the fingers.

The bottom layer 38 may comprise a braided or non-braided material, polymeric films, such as thermoplastic polyethylene or polypropylene films, or composite materials, such as non-braided film-coated materials, or an organic material, such as a collagen film. The bottom layer may be made of a polyethylene film about 0.012 mm (0.5 mil) thick to about 0.051 mm (2.0 mil). A purpose-made polyethylene film is manufactured by Clopay Corporation, Cincinnati, Ohio under the name P18-0401. The lower layer may allow the vapor to escape from the device 20 (i.e. it can be breathable) and at the same time prevent exudates from passing through it.

Preferably, the lower layer 38 is dispersible and / or water-soluble. Polyvinyl alcohol (including polyvinyl alcohol copolymers) has been found to be a suitable material for the dissolvable lower layer 38. Polyvinyl alcohol may be coated with toilet paper, wax or other hydrophobic coating to reduce its rate of dissolution in water. This makes the bottom layer 38 maintain its integrity during use while preserving the ability to dissolve in water when device 20 is discarded. Alternatively, a rayon-shaped nonwoven material may be used for dissolvable underlayer 38.

The components of the interlabial device 20 described above (i.e. the upper layer 36, the lower layer 38 and / or the absorbent core 40) may be assembled in any suitable manner. In the preferred embodiment shown in Figure 1, the main part components are joined in a "sandwich" configuration (i.e. upper bed 36, absorbent core 40 and lower bed 38 are layered to form the laminate structure), with all components dimensioned for the formation of the edge E of the interlabial device 20.

In an alternative preferred embodiment, the topsheet 36 and the bottomsheet 38 are sized so that the edges of the topsheet 36 and the bottomsheet 38 extend beyond the edges of the absorbent core 40 (not shown in the Figures). Preferably, the upper layer 36 and the lower layer 38 are at least partially peripherally joined by known techniques, i.e. preferably the upper layer 36 is secured to the lower layer38 by a gasket which is preferably impermeable to liquids. Such a joint may be made by any method generally employed in the art for this purpose, such as blending, curling or heat-curing.

The components of the interlabial device 20 may be joined together by means of adhesive, seam, snap and / or heat joining, dynamic mechanical bonding, ultrasound welding, tangling or interlacing of fibers or other structural elements comprising the components of interlabial device 20. as, for example, by melt blowing the fibers of one component over another component, extruding one over the other, or by any other means known in the art. The components of the interlabial device 20 may be joined with water-soluble adhesives to improve the ability of the device 20 to break up into a plurality of fragments when placed in gently stirred water (as in the toilet).

Preferably, the interlabial device component material (s) 20 is / are dispersible and / or water-soluble. The term "dispersible" herein refers to an interlabial absorbent device or component material (s) thereof which will / will be dispersed in at least two fragments when placed in gently stirred water. Such a device or component material (s) will decompose into new conventional sanitary pieces and / or the home hydraulic system, and ultimately will be effectively processed into the sewage treatment system. "Dissolvable" herein refers to an interlabial absorbent device or material (s) component (s) thereof that will / will dissolve at least partially and essentially will be in liquid or invisible form (s). ) with the naked eye in the liquid medium in which it is / are dissolved.

In a preferred embodiment, the interlabial absorbent device 20 is disposable in the toilet. In this document, the term "disposable toilet bowl" encompasses the following characteristics of an interlabial absorbent device: toilet disposability, dispersibility, sedimentability, and biodegradability. In this document, the terms "disposable in the toilet" and "new sanitary disposal capacity" refer to the ability of the product to pass through commercially available household toilets and piping systems without causing clogging or problems. which may be directly associated with the physical structure of the product.

However, it is known that there may be many differences between the various types of toilets available. Therefore, for the purposes of the appended claims, a test has been established to determine the ability to dispose of toilets in products such as interlabial absorbent devices; This test is described in the Test Method section of this descriptive report.

The term "sedimentability" refers to the tendency of an interlabial absorbent device, such as the interlabial absorbent device 20, to eventually settle to the bottom of a sewer or other sewage treatment system rather than to float on the surface of such pits or sewers. where it is processed.

Preferably, the interlabial device 20 of the present invention is disposable in a toilet and will dissolve in at least two fragments within two hours of exposure to mildly stirred water at room temperature as described in the Water Dispersion Test in the Test Method section below. Preferably the

Interlabial absorbent device 20 will dissolve into a plurality of fragments within 60 minutes or more preferably up to 30 minutes, more preferably within 15 minutes as measured by the Water Dispersion Test. Preferably, the product will decompose into fragments smaller than approximately 39 cm2 (6 in2), preferably smaller than approximately 13 cm2 (2 in2), more preferably smaller than approximately 10 cm2 (1.5 in2).

In particularly preferred embodiments of the present invention, each of the components of the interlabial absorbent device 20 will break apart into a plurality of fragments when immersed in gently swirling water. Alternatively, the components of the interlabial device 20 may separate from one another without decomposing a plurality of fragments. fragments (e.g. upper layer 36, lower layer 38 and core 44 may separate from each other, each remaining intact). Preferably, interlabial device 20 comprises biodegradable materials. Although biodegradable materials are preferred for interlabial device 20, it is not necessary that all materials used be biodegradable. For example, device 20 may comprise superabsorbent particles that are not biodegradable without affecting the ability of the device 20 as a whole to be disposed of in the toilet and effectively processed in the sewage treatment system.

The interlabial device 20 of the present invention may be used as a "standalone" product. In addition, better performance can be achieved by reducing the possibility of staining clothing and body during long periods of use (such as at night) by using the interlabial device20 as part of a "system" of hygienefeminine products. One such system, which is effective for reduced staining possibilities, is an interlabial absorbent device, such as interlabial device 20, used concurrently with a hygienic absorbent.

Such a system consisting of an interlabial device in combination with a sanitary napkin (or with a daily protector if desired) is more effective than the use of only a hygienic tampon or an interlabial tampon alone. The interlabial absorbent device used in such a system may and preferably should have all of the preferred characteristics of the interlabial device 20 described above. The sanitary napkin used in such a system may be any suitable conventional sanitary napkin. When underwear is worn in the normal position of use, the tampon is adjacent to the wearer's genital region. A sanitary pad

Suitable for use in the system described above is the "ALWAYS" Ultra-Thin Flapped Maxi Hygienic Absorbent, which is manufactured and packaged by Procter & Gamble Company, Cincinnati, Ohio, described in one or more of the following US Patent No. 4,342,314, 4,463 .045, 4,556,146, B4,589,876, 4,687,478, 4,950,264, 5,009,653, 5,267,992.5,413,568, 5,460,623, 5,462,166, 5,489,283, 5,569,231 and Re.32,649 . Other sanitary pads are also

acceptable, such as those without flaps or not of the "ultra-thin" type.

To make use of an interlabial absorbent device and a sanitary napkin as a feminine hygiene product system, the user introduces the interlabial absorbent device into the interlabial space and places a sanitary napkin at the bottom of her panties. These two steps can be performed in any order. Some women may prefer to first place the hygienic pad on the bottom of the panties to retain and absorb the menstrual flow that may be released before the interlabial pad is introduced. Other women may prefer to introduce the interlabial absorbent device first. After the interlabial absorbent device is introduced and the sanitary napkin is placed on the bottom of the panty, it is lifted and placed in its normal use position. Consequently, the hygienic absorbent will be adjacent to the genital region of theusus and will be used concurrently with the interlabial absorbent device.

Preferably, the interlabial absorbent device used with the system described above should be changed every time the user urinates. The hygienic absorbent may be used for a longer period (ie, it has a longer change interval than the interlabial absorbent device) because most of the body fluid will be deposited and absorbed by the interlabial device rather than the hygienic absorbent.

The sanitary napkin and interlabial absorbent device of the system described above may be packaged in a standard packaging such as a female hygiene kit. Such a kit facilitates the use of the system of the present invention. Preferably, the package of such a kit should include instructions on how to use the interlabial absorbent device and the sanitary napkin as a feminine hygiene product system according to the method described above.

A suitable alternative feminine hygiene product system comprises the interlabial device 20 of the present invention used simultaneously with an absorbent buffer. The tampon tampon of the feminine hygiene product system can be any conventional tampon, including those sold under the registered trademark "TAMPAX" and distributed by The Procter & GambleCompany, Cincinnati, Ohio. The internal tampon used may be of the type to be introduced with or without applicator, any known and appropriate applicator being used. First, the inner absorber is

introduced into the vaginal cavity. The interlabial absorbent device is then introduced into the interlabial space of the user. The interlabial device and the inner absorbent are then used simultaneously for a period of time. After the user has urinated, the interlabial absorbent device may be removed and replaced or may be removed and inserted again.

Similarly, the interlabial absorbent and absorbent tampon 20 of such a system may also be packaged in a standard package, such as a female hygiene kit. Such a kit facilitates the use of the alternative system of the present invention.

The systems and their kits may also comprise the simultaneous use of an interlabial absorbent device, an internal absorbent and a hygienic absorbent. Such kits comprising the three types of feminine hygiene products may also be packaged in a common packaging, with appropriate instructions on the use of such systems.

In addition to the systems described above, the interlabial device 20 may be used simultaneously with a daily protector or an incontinence pad, during menstrual flow or due to urinary incontinence. The interlabial device 20 described above may be combined and packaged with a daily protector or incontinence pad or hygienic pad to make up a female urinary incontinence kit. Preferably, such an incontinence kit includes an appropriate packaging material which provides instructions on how to use it. use of feminine hygiene products for mild incontinence. The interlabial device 20 may be worn with conventional or hygienic panties.

Several alternative embodiments of the interlabial absorbent device of the present invention are possible. For example, such products may also be used commingling and / or for medical treatment. For example, an appropriate environment for use with the interlabial device 20 contains approximately 50% petrolatum, approximately 39% cetearyl alcohol and approximately 15% cetearet-10. An emollient coating of approximately 0.03 g / device is considered appropriate.

If desired, the interlabial device 20 may be packaged individually. Such individual packaging may comprise a quantity of suitable materials known in the prior art, including films and materials which may be disposed of in sanitary ware. For example, the packaging is made with a film that is loosely sealed at the edges. Methods suitable for loosely sealing such packages are described in US Patent No. 4,556,146 issued to Swanson and US Patent No. 5,462,166 issued to Minton and others. Figure 7 is a simplified top view of a manufacturing process. of an interlabial absorbent device which is a preferred embodiment of the present invention. Referring to Figure 7, a unitary absorbent element 50 is shown having a first and second surface 51 and 52 opposite each other along the machine direction - DM (Step 61). The unit absorbent element 50 has a predetermined bend line 54. Preferably, the bend line 54 is parallel to the machine direction (MD). Preferably, bend line 54 is the line that equally divides the area of the unit absorbent element 50, as shown in Figure 7.

In Step 62, unitary absorbent element 50 is folded along fold line 54 to form two absorbent elements 50a and 50b, each of which has a first and a second surface opposite each other. Figure 8 is a cross-sectional view of the folded absorbent element 50 shown in Figure 7 taken along the line 8-8 of Figure 7. As shown in Figure 8 the surfaces 52a and 52b of the two absorbent elements 50a and 50b face one another. facing each other (that is, they are in a face-to-face relationship).

In an alternative embodiment, in place of Steps 61 and 62, two separate absorbent elements 50a and 50b may be employed, each having a first and a second surface opposite each other.

In Step 63, parts of the two absorbent elements 50a and 50b are joined along a predetermined junction line 56 such that the two absorbent elements 50a and 50b form the convex portion and the concave portion of the resulting absorbent interlabial devices. Any splicing process known in the prior art which is appropriate for the specific material employed in the two absorbent elements 50a and 50b may be used to form the splicing line 56. Preferred splicing processes include sonic sealing, heat sealing, adhesive bonding and seaming.

In Step 64, the absorbent elements 50a and 50b are intermittently cut along the machine transverse direction (TD), with a predetermined interval or spacing. The predetermined range defines the longitudinal length L1 of the resulting absorbent interlabial devices.

In addition, the unnecessary parts 57 of the absorbent elements 50a and 50b are cut and removed in Step 63. As a result, the individual absorbent interlabial devices 58 whose surface facing the garment 24 is exposed are fabricated. The resulting absorbent interlabial devices 58 manufactured in this manner are preferably stored and then packaged in a transport packaging.

Alternatively (and if desired), the resulting absorbent interlabial devices 58 may be stored and then packaged after each is turned (or inverted) so that the body contact surface 22 on the interlabial devices 58 is exposed for formation. convex portion 26 and concave portion 28 (Step 65).

Figure 9 is a simplified top view of the interlabial absorbent device 58 produced in Step 64 of Figure 7. As shown in Figure 9, the junction line 56 of this embodiment has two flat portions 56a and a convex portion 56b, which is interposed between the two flat portions 56a. The two flat portions 56a are parallel to the machine direction (MD).

Figure 10 is a simplified top view of an interlabial absorbent device 58 ', which is a further preferred embodiment of the present invention. Such figure corresponds to the interlabial absorbent device 58 shown in Step 64 of Figure 7. Similar to the modality shown in Figure 9, the junction line 56 of this embodiment has two flat portions 56a 'and a convex portion 56b interposed between the two flat portions 56a'.

However, in this embodiment, the two flat portions 56a 'of junction line 56 are inclined (with an AG angle) relative to the machine direction (MD), as shown in Figure 10. By employing such angled junction line 56 in absorbent interlabial devices 58 in the manufacturing process of Figure 7, absorbent interlabial devices 58 can be obtained with the peripheral region PRinclined from the horizontal HP plane, as shown in Figure 4. TEST METHODS

1. Absorption Capacity Test

Absorption capacity can be determined as follows. The test is performed on samples that were conditioned in an environment with 50% relative humidity and 23 ° C for a period of two hours before the test. The test must be performed under similar conditions.

The weight of the article is measured at 0.1 g resolution. The article is then submerged in a 0.9% sterile saline beaker (available from Baxter Travenol Company, Deerfield, IL) so that the article is completely submerged and not be warped, twisted or bent. The article is submerged for 10 minutes. The article is removed from the saline solution and extended horizontally over a mesh screen with 0.64 cm by 0.64 cm (0.25 inch by 0.25 inch) square openings for five minutes for the saline solution to flow from the article. Both sides of the article are then covered with absorbent paper, such as filter paper # 631, available from Filtration Science Corp., Eaton-Dikeman Division of Mount Holly Springs, PA. A uniform load of 7 kPa (1 pound per square inch) is placed over the article to squeeze out excess fluid. The absorbent paper is replaced every 30 seconds until the amount of fluid transferred to the absorbent paper is less than 0.5 g over a 30 second period. After that, the article is weighed with a resolution of 0.1 g, and the weight of the dried article is subtracted. The difference in grams is the absorption capacity of the article. Water Dispersion Test Equipment

Orbit Shaker Junior Shaker, available from Lab LineInstruments, Melrose Park, Illinois.

-1 to 49 ° C thermometer with 1 degree divisions

Timer Digital Stopwatch

Lid jar 0.5 liter Glass jar with lid.

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

Temperature: 23 ° C ± 2 ° C

Humidity: 50 + 2% Relative Humidity Test Preparation

1. Fill the glass jar with 300 ml of water at 23 ° C ± 2 ° C.

2. Adjust the speed of the OrbitShaker Junior Shaker to 250 rpm according to the manufacturer's recommendations.

Procedure

1. Keep the sample (eg an interlabial absorbent device 20) 7 to 10 cm above the water surface of the jar. Gently release the sample over the water surface.

2. Put the lid on the jar.

3. Place the jar on the Orbit Junior Shaker, so that the jar faces its side.

4. Turn on the Orbit Junior Shaker and trigger the timer as soon as the shaker is triggered.

5. Record the time required for the sample to split into at least two parts. Separation does not include disassociation of some individual fibers from the intact sample. The time is the total time the sample is agitated.

6. Repeat steps 1 through 5 with 3 other samples.

Calculation and Reporting

Calculate and record the mean and standard deviation with water dispersibility time for the four samples tested.

It should be understood that the examples and modalities are described herein by reference only and that various other changes and modifications may be suggested by one of ordinary skill in the art without departing from the scope of the present invention.

Claims (14)

1. Interlabial absorbent device (20) having a body contact surface (22), a garment facing surface (24) which is opposite the body contact surface (22), an internal region and a Peripheral region, which surrounds the inner region, and the body contact surface (22) is permeable to liquids, characterized by the fact that it comprises: a) an absorbent element (30) disposed between the surface facing the garment (24) and the body contact surface (22), the absorbent element (30) having a surface facing the garment (24) opposite the body facing surface (22); (b) the interlabial absorbent device (20) has a convex portion (26) on the body contact surface (22) in the inner region, and a concave portion (28) on the surface facing the garment (24) in the inner region, and the convex portion (26) and the concave portion (28) are molds face-to-face relationship, wherein the interlabial absorbent device (20) has a longitudinal length of approximately 60 mm to approximately 150 mm and a transverse width of approximately 20 mm to approximately 80 mm and the convex portion (26) is of a length. approximately 10 mm but approximately 80 mm and the ratio of the convex deposition length (26) to the longitudinal length of the interlabial absorbent device (20) is from about -1: 1, 1 to about 1: 10 with the absorbent element (30) in the The peripheral region PR preferably has an angle AG to the horizontal plane HP of approximately 45 degrees and two flat portions 56a of the junction line 56 inclined relative to the direction of the MD machine. Interlabial absorbent device (20) according to claim 1, characterized in that the absorbent element (30) and an absorbent core (40) have a body facing surface (42) and a surface facing the workpiece. (44) opposite the body-facing surface (42), and the interlabial device (20) also comprises a liquid-permeable top layer (36) disposed on the surface facing the body (42) of the absorbent core (40) and is bedridden. top (36) has the body facing surface (42). Interlabial absorbent device (20) according to claim 2, characterized in that it also comprises an aliquid permeable lower layer (38) disposed on the surface facing the garment (44) of the absorbent core (40), wherein the lower bed (38) has the surface facing the garment 44). Interlabial absorbent device (20) according to claim 3, characterized in that the upper layer (36), the absorbent core (40) and the lower layer (38) are layered to form a laminated structure. Interlabial absorbent device (20) according to claim 1, characterized in that the convex portion (26) and the concave portion (28) are dome, cone or column shaped. Interlabial absorbent device (20) according to claim 1, characterized in that the body contact surface of the peripheral region in the horizontal plane. Interlabial absorbent device (20) according to claim 1, characterized in that the contact surface with the body of the peripheral region is inclined with respect to the horizontal plane. Interlabial absorbent device (20) according to claim 1, characterized in that the convex portion (26) has a height of approximately 5 mm and approximately 50 mm. Interlabial absorbent device (20) according to Claim 1, characterized in that the peripheral region of the interlabial absorbent device (20) has a circle, ellipse, triangle, rectangle or cuvette-shaped edge. . 10. Method for manufacturing an interlabial absorbent device (20) having a body contact surface (22), a garment facing surface (24) opposite the body contact surface (22), an internal region , a peripheral region surrounding the inner region, a convex portion (26) on the body contacting surface (22) on the inner region, a concave portion (28) on the surface facing the garment (24) on the inner region, characterized by The fact that the convex portion (26) and the concave portion (28) are formed in a face-to-face relationship, which comprises the steps of: a) producing two absorbent elements (50a and 50b), each of which it has a first and second surface (51 and 52) opposite each other, and the first surfaces of the two absorbent elements (50a and 50b) are in a face-to-face relationship; and joining a portion of the two absorbent elements (50a and 50b) along a predetermined junction line (56) such that the two elements form the concave and convex portions, wherein the interlabial absorbent device (20) has a longitudinal length of approximately 60 mm but approximately 150 mm and a transverse width of approximately 20 mm to approximately 80 mm and the convex portion have a length of approximately 10 mm to approximately 80 mm and the ratio of the convex deposition length to the longitudinal length of the interlabial absorbent device (20) is from approximately 1: 1, to approximately 1:10. Method according to Claim 10, characterized in that the first or second surface of the two absorbent elements (50a and 50b) is liquid permeable. Method according to Claim 11, characterized in that the first surfaces of the two absorbent elements (50a and 50b) are permeable to liquids, and the method also comprises the step of turning the two absorbent elements (50a and 50b) so that the first surfaces of the two absorbent elements (50a and 50b) are exposed. Method according to claim 10, characterized in that the two absorbent elements (50a and 50b) are formed from a unitary absorbent element (50) which has first and second opposite surfaces (51 and 52). each other, and a predetermined fold line (54), and the production of the two absorbent elements (50a and 50b) comprises the steps of producing the unit absorbent element (50) and folding the unit absorbent element (50) along the line. of predetermined bending (54). Method according to claim 10, characterized in that the absorbent element (30) includes a liquid permeable topsheet material (36) and an absorbent core material (40) arranged in layers.