MXPA01010952A - Panty liner with sensor for predicting the start of menstruation. - Google Patents

Abstract

The present invention relates to use of a pH sensor, blood sensor, progesterone and/or estrogen hormone sensor or combinations thereof in the manufacture of a sanitary napkin, panty liner for conventional use by a woman. The use of the sensor is for the purpose of providing a visual advance indication of at least 3 hours until the start of menstruation.

Description

PANTIPROTECTOR WITH SENSOR TO PREDICT THE BEGINNING OF MENSTRUATION FIELD OF THE INVENTION The present invention relates to the use of a pH sensor, a blood sensor, a progesterone hormone and / or estrogen sensor or combinations thereof in the manufacture of a sanitary napkin or pantyhose for conventional use by a woman. The use of the sensor is for the purpose of providing an early visual indication of at least 3 hours until the start of menstruation.

BACKGROUND OF THE INVENTION Today, disposable sanitary articles, such as sanitary napkins, pantiliners, interlabial devices and tampons, are widely used in female protection and in the care of incontinent adults as a means of containing, isolating and eliminating body wastes. These items have generally replaced washable, reusable fabric garments as the preferred medium for these applications because of their convenience and reliability. The disposable items respond to a discharge event by absorbing or containing the corporal dispossession deposited on the article. Some disposable articles comprise a chemically reactive medium for detecting and signaling various substances in the user's dispossession. However, none of these detect or predict in a specific way when the menstruation is about to occur and point out to the user or the person seeking care that occurrence. .. .. l-. ? ,. í_. '«.. - > - The need of the consumer woman until now without satisfying which is directed by the present invention is the desire to gain more information about the expected time of her menstruation. More generally, it is well established that women would like to know more about and monitor their body condition as it relates to the state of their menstruation cycle as well as to warn previously of any type of advancement of the related disease. Therefore, the present invention contains two aspects that can be considered in a set of different clauses according to the local patent law. One aspect is the purpose of diagnosing in a medical sense the development of the present invention while the other is the purely numerical benefit of providing early information about the approach of menstruation in order to allow the respective action by the consumer such as initiating the use of sanitary pads or tampons. A number of disclosures exist in general aspects of diagnoses related to the female menstruation cycle and information related to the genital / urinary tract. However, none of the references cited below provide the specific teaching of the present invention. U.S. Patent No. 5,217,444 to Schonfeld et al., Published June 8, 1993 discloses absorbent pads such as buffers comprising a pH indicator material to indicate the acidity or alkalinity of a liquid by a color change. The pH indicator is meant to be wetted by the vaginal secretions that are absorbed by the pad. Depending on the pH this will provide an indication of the health condition of the woman's vaginal tract. U.S. Patent No. 5,468,236 to Everhart et al., Published November 21, 1995, discloses a disposable absorbent product incorporating a chemically reactive substance which provides visual indication of a chemical component in the absorbed liquid such as vaginal discharges. . The patent is not specific as to its particular purpose but exemplifies a disposable diaper in which a glucose indicator gel can be applied to the top sheet or the absorbent core. In a second example, the chemical compound to be detected in a nitrate as an indicator of infections in the urinary tract by means of the negative GRAM bacteria. In particular, Everhart provides a reaction that is stable to the point of evaporation due to a catalytic sequence such that the absorption of additional liquid will not alter the indication. U.S. Patent No. 4,231, 370 to Morz et al., Published November 4, 1980, discloses disposable diapers with a pH sensitive moisture indicator in a solid adhesive matrix. U.S. Patent No. 5,823,953 to Richards et al., Published October 20, 1998, relates to a self-diagnostic system for 5 yeast-related or unleavened vaginal infections in the form of a catamenial or pantiprotector pad with a chromatic strip indicating the pH, detachable, mounted on the upper sheet. The pH indicator identifies whether the pH of the absorbed liquid is above or below a threshold value of 4.5 and is intended to allow health care decisions to be made without a physician regarding the treatment of a vaginal infection by yeast or without yeast. The international publication WO 97/43955 of Buck et al., Published on November 27, 1997, describes a home kit used for the collection of vaginal fluid and vaginal cells exfoliated in the menstrual fluid for diagnostic purposes. The fluid or cells are collected in an interlabial absorbent pad or in a pad that is placed inside a housing with an opening - * ~ «». < A »- ^? .. j & . . . . . . . I. . ,. , ^,.? . which is placed intervaginally to collect the fluid. The fluid can then be used for diagnostic purposes as desired. European patent EP 704 195 of Echeveria, published on April 3, 1996 discloses a menstrual detector comprising a sanitary napkin or a pantiprotector 5 including a chemical compound that provides a cooling reaction upon the occurrence of liquid absorption as an indicator of the onset of menstruation in order to allow the user ample time to replace the indicator absorbent article with a sanitary pad or tampon of total size and total capacity. Of course, many indicators as such are known and are 10 usually independent of the liquid source for which the analysis is desired. For example, European Patent EP 386 562 to Ismael et al., Published on September 12, 1990, discloses a dried enzyme test composition with a color indicator result. Similarly, the international publication WO 90/06511 of Buck et al., Published on June 14, 1990, discloses a stabilized indicator for determining 15 the presence of an analyte in a liquid sample. Similarly, the international publication WO 89/1 1643 of Bouse et al., Published on November 30, 1989, discloses an indicator composition designed to increase the concentration range of the analyte which can be analyzed. European patent EP 124 215 and European patent EP 124 214 both 20 of Oksman et al., Published on November 7, 1984, related to cleansing type indicators or hidden blood cloth particularly useful for analyzing the presence of blood in feces. Similarly, European patent EP 93595 of Wells, published on November 9, 1983, relates to a dry diagnostic aid for use in a one-step determination of hemoglobin, 25 especially in fecal occult blood.

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European Patent EP 113 896 of Rothe, published on July 25, 1984, relates to a chemical test strip in which a test reagent is provided on a strip of plastic film for quantitative evaluation. This patent exemplifies the blood and glucose test. European patent EP 101 980 and European patent EP 101 979, both of Roy, published on March 7, 1984, relate to the determination of dehydrogenase for the purpose of clinical analysis and rapid diagnosis. In the latter case, it is said that the carrier can be a buffer containing cellulose fibers. In addition, many publications in the medical field related to the pathological conditions of the female genital and urinary organs including methods to detect and cure them have been published.

BRIEF DESCRIPTION OF THE INVENTION The present invention is about the accuracy with which the onset of menstruation can be predicted with at least 3 hours of advance notice. This serves the purpose of allowing the taking of a desired action, for example, preparing to use a "sufficient size" sanitary article such as a tampon or sanitary pad, preparing to use a collection device to allow collection of the menstrual fluid. for additional in vitro analysis, allow women who have complications with their menstruation to take the appropriate medication (ie use the prediction as part of a medication scheme). Of course, the use of menstruation prediction is not strictly limited to the prediction of menstruation of the female human but it can be equally used in animals. Technically, the present invention relates to the use of a pH sensor, a blood sensor, a progesterone hormone and / or estrogen sensor or combinations thereof in the manufacture of a sanitary napkin, pantiprotector or interlabial article / insert for conventional use by a woman, said use of the sensor being for the purpose of providing an anticipatory visual indication of at least 3 hours until the onset of menstruation. Of course, it is preferred to provide at least one early warning of a full day of the onset of menstruation. In an embodiment according to the present invention it is highly desirable to have as accurate as possible a prediction about the onset of menstruation for an individual for each menstruation cycle. It is therefore preferred if the sensor is selected such that it provides a visual indication of the approximate time until the onset of menstruation whose time is consistent within the range of +/- 4 hours for a specific individual over at least 3 consecutive periods of menstruation. According to another embodiment of the present invention, this accuracy can be achieved by selecting a sensor composition appropriately. If the sensor includes a blood sensor then in a preferred embodiment the blood sensor is selected from a guayacan gum with a peroxide and optionally cyclodextrin; or guayacan gum with hepta-phthalimido-peroxy-hexanoic acid; or tetra methyl benzidine with a peroxide and optionally cyclodextrin; tetra methyl benzidine with hepta-phthalimido-peroxy-hexanoic acid. It is of course clear that a blood sensor needs to be sensitive enough to ensure that blood is detected in a quantity that is not discernible by normal visual inspection by the human eye. Alternatively, if the sensor includes a pH sensor then in a preferred embodiment the pH sensor is selected to show a change in pH within the pH range of 4 to pH 7, preferably the pH sensor is provided by a composition comprising carminic acid.

In even further improved modalities according to the present invention the use of a sensor is achieved using a combination of at least 2 separate sensors selected from pH sensors, blood sensors, or progesterone hormone sensors and / or estrogen This can be even further improved by selecting the sensors so that they provide a simple output signal. In accordance with the present invention, articles in which sensors are used for the prediction of menstruation are sanitary absorbent articles, such as sanitary napkins, panty-protectors or interlabial articles / inserts for women. Said articles are conventionally of a layer construction, each layer having a surface that gives the user and a surface that gives the garment. In general, the article comprises a liquid-permeable upper sheet on the surface that gives the wearer, a back sheet of liquid barrier on the surface that gives the garment, an absorbent core sandwiched between the upper sheet and the back sheet. According to the present invention, the pantiprotector must be thin with less than 3 mm thickness and a panty protector that is suitable to be worn in an undergarment of net and has a generally triangular shape (also referred to as the shape of a pantyhose) is very preferred. string or cord lining respectively). It is within the scope of the present invention to supplement the sensor by means of additional detectors related to the menstruation cycle such as additional biochemical or electrochemical or chemical detection means suitable for detecting the physiological changes in the absorbed vaginal discharges which are indicative of the time until the onset of menstruation and preferably create a separate visual signal, animated or modified to the user of said articles. However, other sensors are also preferred, capable of indicating the potential for current or future health-related risks.

DETAILED DESCRIPTION OF THE INVENTION DEFINITIONS As used herein, the term "absorbent article" refers to devices that absorb and contain exudates from the body, more specifically, refers to devices that are placed against or close to the user's body to absorb and contain the several discharged exudates from the body. The term "disposable" is used herein to describe absorbent articles that are not generally intended to be washed or restored or reused in another way as an absorbent article (ie, they are intended to be disposed of after a simple use ). As used herein, the term "attached" encompasses configurations by which one element is directly secured to another element by fixing the element directly to the other element, and configurations by which an 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. A "unitary" absorbent article refers to absorbent articles that are formed of separate parts joined together to form a coordinated entity such that separate manipulated parts such as a fastener and separate liners are not required. A preferred embodiment for the present invention is a unitary disposable sanitary napkin, panty-protector or interlabial article / insert. Of course, other single-use disposable absorbent articles if used during the period before menstruation, such as diapers, trusses and other incontinence devices, tampons, and cleaning towels, incontinence undergarments, absorbent inserts and tampons, may benefit from the present invention is not the subject of the appended claims.

An absorbent article, such as a sanitary napkin, a pantiprotector or an interlabial article / insert, is conventionally constructed of three main elements: the top sheet, which gives the user of the article during use and which is permeable to the liquid in order to avoid that the liquids pass to the article; the backsheet, providing a liquid containment such that the absorbed liquid does not spill through the article, this backsheet conventionally provides the pledge surface of the article; and the absorbent core sandwiched between the topsheet and the backsheet and which provides the absorbent capacity of the article to acquire and retain the liquid which has entered the article through the topsheet. Many absorbent articles and constructions are known in the art and have been described in extensive detail over time. All of these materials are useful in the context of the present invention, as long as they do not interfere with the selected menstrual prediction sensors. Only those examples are mentioned below, which are particularly beneficial for use in the preferred absorbent articles according to the present invention. Those skilled in the art will then be able to identify alternative materials that can also be used and which may be particularly desirable in the context of the absorbent articles that predict menstruation according to the present invention.

Top sheet In general, the top sheet is docile, flexible, soft feeling and non-irritating to the user's skin. The top sheet may also preferably have elastic characteristics that allow it to stretch in one or two directions. As used herein, the term "flexible" refers to materials that are docile and that will easily conform to the general figure and contom of the human body.

... The top sheet can be made from a nonwoven or woven material or a film that has been made permeable to the liquid by perforation. The topsheet may also be provided as a composite or be comprised of more than one simple layer, for example it may have a secondary topsheet or a flow control layer. Said films and non-woven materials and woven materials can be made from polymers such as polyethylene or polypropylene compositions. Conventionally said polymers have been filled with a coloring material such as titanium dioxide to provide a white opacity. Said top sheet can also be provided without the coloring material to provide a transparent film or a nonwoven material having a high degree of light transmission while the absence of the color filler, such as titanium dioxide, does not cause any substantial change of the material. Said upper sheet would be particularly beneficial in the context of the sensors that provide the visual indications, whose sensors are inside the article to allow visual inspection. Therefore the absence (or reduction below 15%, ie about half the conventional amount) of an opaque color filler in the polymeric material from which the top sheet can be made provides the additional benefit of better characteristics of inspection (in addition to less costs and a reduced environmental burden). It would also be possible to provide a nuanced, non-opaque color filler that allows partial transparency or transparency while providing a color. This shading can be beneficially used to hide the initial or final color of the chromatic indicators according to the present invention, and is preferably light yellow or blue. The top sheet may be transparent or may be only partially transparent. However, it is sufficient for most of the embodiments according to the present invention if the top sheet is translucent to allow visual inspection of a color change.

Back sheet 5 In general, the back sheet is docile, flexible, and soft feeling. The backsheet prevents the exudates absorbed and contained in the absorbent core from wetting the garments that are in contact with the absorbent article such as undergarments. Preferably, the backsheet is impervious to liquids (e.g., menstruation, sweat and / or urine). This can be manufactured from a plastic film 10 thin although other flexible liquid impervious materials can also be used. As used herein, the term "flexible" refers to materials that are docile and that will easily conform to the general figure and contom of the human body. The backsheet may preferably also have elastic features that allow it to stretch in one or two directions. 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 nonwoven material coated with film or a fiber-coated film. Conventionally, the absorbent articles comprise a backsheet layer of a polyethylene film having a thickness of about 20 0.012 mm to approximately 0.051 mm, which can be waterproof or made microporous by the use of an inert filler and subsequent mechanical stretching. The backsheet is preferably breathable, that is, it allows the transmission of water vapor, or even more preferably the air transmission, without However, without sacrificing its main purpose of providing protection to leaks for absorbed liquids. The back sheet can also comprise more than one layer ^ ri - .. ^ »- ^ - ^ &-Breathable maflfi to replace a single layer of breathable backsheet by at least two or three layers of a different or equal material. In particular two breathable layers, in which for example one is formed that provides the surface that gives the user, film with openings with a three-dimensional structure and for example the other, layer that gives the garment is a non-woven composite of fibers blown in the molten state and bound by spinning, are the preferred constructions of the breathable backsheet. As with the top sheet, the back sheet can be provided from a transparent or translucent material which allows easier inspection of the detectors within the article. Similarly, it can also be provided with a colored, colored, preferably yellow or light blue filler.

Absorbent core Conventionally the absorbent core can be a simple entity or comprise several layers. This may include the following components: (a) optionally a primary fluid distribution layer; (b) optionally a secondary fluid distribution layer; (c) a fluid storage layer; (d) optionally a fibrous layer that is below the storage layer; and (e) other optional components. 20 a. Primary layer of fluid distribution An optional component of the absorbent core according to the present invention is the primary fluid distribution layer. This primary distribution layer is typically below the top sheet (if present) and is in fluid communication with it. The primary distribution layer acquires the body fluid for 25 final distribution to the storage layer. This fluid transfer through the primary distribution layer runs mainly in thickness, but it can also ~~. * ¡? * A ?? * ~. Fe - .., provide the distribution along the longitudinal and transverse directions of the belt lining. b. Optional secondary fluid distribution layer 5 Also optional according to the present invention is a secondary distribution layer of fluid. This secondary distribution layer is typically below the primary distribution layer and is in fluid communication with it. The purpose of this secondary distribution layer is to easily acquire the body fluid from the primary distribution layer and distribute it along the longitudinal and transverse directions of the belt lining before transferring to the underlying storage layer. This helps to fully utilize the fluid capacity of the underlying storage layer. c. Fluid storage layer 15 Placed in fluid communication with, and typically being below, the primary or secondary distribution layers, is a fluid storage layer. This preferably comprises but not necessarily superabsorbent gelling materials commonly referred to as "hydrogel", "superabsorbent", "hydrocolloid" materials. The gelling absorbent materials are those 20 materials that, when in contact with the aqueous fluids, especially body fluids, imbibe said fluids and thus form hydrogels. These gelling absorbent materials are typically capable of absorbing large quantities of aqueous fluids from the body, and are also capable of retaining said absorbed fluids under moderate pressures. In the prior art, these absorbent materials of The gels are typically in a granular form of non-fibrous, discrete particles. However, according to the present invention these superabsorbent materials of - »?. ~~, Ja-Ait ^. «-fafc.

Gelation can also be provided in non-granular form, preferably in a fibrous form. If the gelling absorbent materials are not provided then the storage layer can be provided by the material conventionally used as the carrier material described below. In the fluid storage layer, these gelling absorbent materials can be homogeneously or inhomogeneously spread in a suitable fibrous matrix also referred to as a carrier. Suitable carriers include cellulose fibers, in the form of fluff or tissue, as conventionally used in absorbent cores. Modified cellulose fibers such as hardened cellulose fibers or viscose fibers can also be used. Synthetic fibers can also be used and include those made from cellulose acetate, polyvinyl fluoride, polyvinylidene chloride, acrylics (such as orlon), polyvinyl acetate, non-soluble polyvinyl alcohol, polyethylene, polypropylene, polyamides (such as nylon), polyesters, two-component fibers, three-component fibers, mixtures thereof and the like. Preferred synthetic and man-made fibers have a denier of about 3 denier per filament to about 25 denier per filament, more preferably from about 5 denier per filament to about 16 denier per filament. The fibers of the carrier can be provided as carded, spin-bonded, meltblown, wet-laid, air-laid substrates or combinations of said placement methods or combinations of the substrates. Also preferably, the surfaces of the fiber are hydrophilic or are treated to be hydrophilic. A storage layer may also include filling materials, such as perlite, diatomaceous earth, vermiculite, etc., which reduce the problems of rewetting. In addition, the storage layer may comprise a binder including but not limited to latex binders which may be sprayed as an aqueous solution onto the surface of the storage layer before curing. If the gelling absorbent materials are dispersed in a non-homogeneous manner in a fibrous matrix, the storage layer can be locally homogeneous, that is, have a distribution gradient in one or more directions within the dimensions of the storage layer. The inhomogeneous distribution thus includes for example laminates of fibrous carriers that enclose the gelling absorbent materials or regions in which the gelling absorbent material has a different concentration relative to other regions. 0 If the gelling absorbent material is present, the storage layer preferably comprises from 5% to 95% of the gelling absorbent materials, preferably from 5% to 50%, most preferably from 8% to 35%, of gelling absorbent materials. Furthermore, the storage layer may comprise from 5% to 95% of carrier fibers, preferably from 95% to 50%, very preferably from 92% to 65% of carrier fibers. The gelling absorbent materials suitable for use herein will frequently comprise a partially neutralized, slightly crosslinked polymeric gelling material substantially insoluble in water. This material forms a hydrogel when in contact with water. Said polymeric materials can be prepared from polymerizable, unsaturated, acid-containing monomers. The unsaturated acid monomers for use in the preparation of the polymeric absorbent gelling material used in this invention include those listed in U.S. Patent No. 4,654,039 (Brandt et al.), Issued March 31, 1987, and returned to issued as RE 32,649 on April 19, 1988. Preferred monomers 5 include acrylic acid, methacrylic acid, and 2-acrylamido-2-methyl propan sulfonic acid. The acrylic acid itself is especially preferred for the preparation of the ^ t Uk_________ superabsorbent material, also has a "natural" transparency which is not optimal but acceptable if it is desired that transparency is not so high. Whatever the nature of the basic components of the polymer of hydrogel-forming polymeric absorbent polymer materials, said materials will generally be slightly crosslinked. The crosslinking serves to make the gelling materials hydrogel-forming polymers substantially insoluble in water, and thereby crosslinking in part to determine the gel volume and extractable characteristics of the polymer of the hydrogels formed from these polymeric gelling materials. . The appropriate crosslinking agents are well 10 known in the art and include, for example, those described in greater detail in U.S. Patent No. 4,076,663 (Masuda et al.), Issued February 28, 1978. Preferred crosslinking agents are di or polyesters of mono- or polycarboxylic unsaturated acids with polyols, the bis-acrylamides and the di-triallyl amines. Other preferred crosslinking agents are N, N'-methylenebisacrylamide, triacrylate 15 trimethylol propane and triallyl amine. The crosslinking agent can generally constitute from about 0.001 mole percent to 5 mole percent of the resulting hydrogel-forming polymer material. More preferably, the crosslinking agent will constitute from about 0.01 mole percent to 3 mole percent of the hydrogel forming gelling polymer material. The slightly cross-linked hydrogel-forming polymeric gelling materials are generally used in their partially neutralized form. For the purposes of the present invention, said partially neutralized materials are considered to be at least 25 mole percent, and preferably at least 50 mole percent of the monomers used to form the Polymers are monomers containing the acid group that have been neutralized with a salt-forming cation. Suitable salt-forming cations include alkali metal, The percentage of the total monomers used which are monomers containing the neutralized acid group is referred to herein as the ammonium, substituted ammonium and amines. "degree of neutralization." Although these gelling absorbent materials have typically been disclosed in the prior art in the granular form, it is possible within the context of the present invention that the gelling absorbent material be in a non-granular form for example as macrostructures such as fibers, sheets or strips or in a form suitable for coating, for example before curing or as part of an adhesive substance A macrostructure can be prepared by forming the absorbent material 10 gelation into particles in an aggregate, treating the aggregate material with suitable crosslinking agent, compacting the treated aggregate to densify it and forming a coherent mass, and then curing the compacted aggregate to cause the crosslinking agent to react with the gelling absorbent material in particles to form a porous, composite absorbent macrostructure. Said macrostructures 15 absorbent, porous, are disclosed, for example, in U.S. Patent No. 5,102,597 (Roe et al.), Issued April 7, 1992. d. Optional fibrous layer An optional component for inclusion in the absorbent cores of In accordance with the present invention, it is a fibrous layer adjacent to, and typically being below, the storage layer. This underlying fibrous layer would typically provide the same function as the secondary fluid distribution layer. and. Other optional components The absorbent cores according to the present invention can include other optional components normally present in the absorbent webs.

For example, a reinforcing fabric may be placed within the respective layers, or between the respective layers, of the absorbent cores. Said reinforcing sheets should be of such configuration so as not to form interfacial barriers to fluid transfer, especially if they are placed between the respective layers of the absorbent core. Given the structural integrity that commonly occurs as a result of thermal bonding, reinforcing canvases are not usually required for absorbent structures according to the present invention. Another component that can be included in the absorbent core according to the invention and is preferably provided near or as part of the primary or secondary fluid distribution layer are the odor control agents.

Typically activated carbon coated with or in addition to other odor control agents, in particular zeolite, silica, or suitable clay materials, are optionally incorporated into the absorbent core.

Physical characteristics of the absorbent cores The absorbent cores are usually non-extensible and inelastic, however, these can be made extensible and depending on the selected materials can also be made to have elastic characteristics. The term "extensible" as used hereafter refers to a structure which under external forces such as those that occur during use extends in the direction of forces or in the direction of a component of forces in cases where only directional mono extension capacity is provided. The term "elastic" as used hereafter refers to the extensible structures that return at least partially to their initial state after the forces that cause the extension grip are extracted. The absorbent cores can be corrugated or folded in one or several directions to provide a certain extension capacity while the selection of the elastic fibers for the structure can provide elasticity. If it is tried to be used in panty-protectors, the absorbent cores should preferably be thin. A thickness of less than 5 mm, preferably less than 3 mm 5 and even more preferably between 0.8 and 1.8 mm, is desirable so that the resulting panty-protectors can also have a low thickness. As with the top sheet or the back sheet, the transparency of or the shading of the materials forming the core may be particularly desirable to allow easy inspection of the state of the detector. 10 Non-limiting examples of panty protection and sanitary napkins that can be provided with a detection means include those manufactured by The Procter & Gamble Company of Cincinnati, Ohio as: ALLDAYS® pantiliners with DriWeave® manufactured in accordance with U.S. Patent Nos. 4,324,246; 4,463,045 and 6,004,893; ALWAYS® Ultrathin Slender Maxi with wings manufactured 15 with U.S. Patent Nos. 4,342,314, 4,463,045, 4,556,146, B1 4,589,876, 4,687,478, 4,950,264, 5,009,653, 5,267,992, and Re. 32,649; ALWAYS® Regular Maxi; ALWAYS® Ultra Maxi with wings; ALWAYS® Maxi with wings; ALWAYS® Long Super Maxi with wings; and ALWAYS® Overnight Maxi with wings. However, most other commercially available sanitary pads and pantiliners can also serve 20 as an example for potential use within the context of the present invention. Non-limiting examples of interlabial devices that can be provided with a detection means are described in U.S. Patent Nos. 5,762,644; 5,885,265; 5,891, 126; 5,895,381; 5,916,205; 5,951, 537; 5,964,689; 5,968,026; Des. 404,814; and Des. 413,669. 25 i ^ á &? ts = ftSii Detectors / Sensors According to the present invention at least one sensor for the detection of menstruation selected from blood sensors, pH sensors and sensors of the hormone progesterone and / or estrogen, is used in the manufacture of 5 sanitary napkins, pantiliners or interlabial articles / inserts. As used herein, the term "sensor" is defined as a component comprising one or more reactive media that is adapted to detect one or more target substances (also referred to as analytes) such as microorganisms or (bio) related molecules (e.g. , an enzyme sensor, an organelle sensor, tissue sensor, microorganism sensor, immunosensor, and chemical or electrochemical sensor), further having the ability to provide a signal of said detection to the user, the caregiver or an actuator. The term "reactive" is defined as having the ability to interact selectively with the target substances. There are two categories of sensors that have different sensitivity: 15 biosensors and chemical / electrochemical sensors. In general, biosensors function to provide a means of specifically linking, and thus detecting, a biologically active target analyte. In this way, the biosensor is highly selective, even when present with a mixture of many chemical and biological entities, such as are present in the vaginal discharge. The sensors Electrochemicals and chemistries, on the other hand, which adhere to the chemically reactive media, generally do not have either high selectivity or amplification properties of the biosensors but are highly reliable, cheap, ie useful for consumer products, and often very well established, that is, they prove to be safe to use on human skin. Frequently the analyte The objective is a minor component of a complex mixture comprising a multiplicity of biological components and other components. Therefore, in many l¡? máumamm¡M - * "- * •• '« applications of the biosensor, the detection of target analytes to parts per million, parts per billion, or even lower levels is necessary.

Blood sensor 5 A blood sensor can be used according to the present invention. There are many commercially available blood sensors which can be used whenever their sensitivity is sufficient to detect blood at amounts that are not visually discernible to the human eye. However, according to the present invention, a specific chemical composition is preferred. 10 selected as the blood sensor. When referring to blood here a typical component of blood, such as hemoglobin or iron, can of course also be used as the analyte. The preferred chemical composition comprises an indication chromatic component selected from guayacan gum or tetra methyl benzidine or 15 combinations thereof, which reacts when oxidized and an oxidizing component selected from peroxide or a per-acid or combinations thereof. In particular, the following combinations have been found useful as blood sensors within the context of this invention: - Guaiacum gum with a peroxide and optionally cyclodextrin 20 - Guaiacum gum with, ephthaphthalimido-peroxy-hexanoic acid - Tetra methyl benzidine with a peroxide and optionally cyclodextrin - Tetra methyl benzidine with ephta-phthalimido-peroxy-hexanoic acid Guaiacum gum is a resin found in the wood of Guaiacum officinale or Guaiacum santum (mainly found in Mexico or the west 25 from India). Guaiacum gum is historically used as a savoring agent for food (and therefore has a previous record of safe use for humans) and «. «» ^ A¿ftja -. ^ I- ..

It is known for its ability to indicate the presence of blood or hemoglobin, especially in feces. According to the present invention, guaiac tree gum resin is preferred, however one or all of the active components, if derived naturally or artificially, can be used in place of the wood resin. The best known active components are guaiacol (OHC6H4OCH3, CAS 90-05-1), guaionic acid and (furo) guaiacin. The cyclodextrin used in this composition is useful for improving the stability of the peroxide and helps bring the peroxide into an aqueous solution upon wetting. Alternatively or in combination with the cyclodextrin also the metal chelators, such as EDTA (ethylene di-amino tetra acetic acid or its salts) can be used. In general, the oxidation component needs to be stable and insensitive to common storage conditions for such articles (for example, in a hot, high-humidity environment of a bath). If the oxidation component is a peroxide then physical-chemical stabilization for example by the use of cyclodextrin or metal chelators is desirable. For per acids such stabilization has been found to be less necessary, in particular for the preferred hepta-phthalimido-peroxy-hexanoic acid. It is also desirable that the oxidation component is not activated by the conventional components in the sanitary articles and the moisture introduced during use (e.g., sweat) or absorption of vaginal discharges without the blood component. The same applies of course also for the chromatic indicator. Not only the stabilization of each component but also the premature or accidental reaction of the two components should preferably be avoided. This can be achieved by physically separating them in that one is applied on a surface of one layer of the sanitary article according to the present invention and the other component is applied on the other side of that layer. Alternatively, a component can be applied on one surface of one layer and the other component on the surface that faces in the same direction as the other layer. Finally, a component can be applied in such a way that it is located within a layer, for example, inside the central layer of the absorbent core while the other component is located on at least part of the surface of that layer. The application of both components on the same layer can be done in an alternate pattern such as strips, dots or different shapes. The sensor may be provided in discrete portions of a surface of a layer or as a total surface covering of the layer (both components or only one). The components can be provided either or both as powder, liquid or as components in an adhesive mixture for the best coating. It is also possible to separate the two components providing at least one, for example the component oxidation completely separate article (and therefore the other part) for example in the form of a spray or liquid or powder, which is applied to article after using to provide the desired detection. Such detection systems may be especially desirable in the context of items that are worn in close proximity and may be discharged or disposed of in the toilet (e.g. interlabial articles / inserts). Such systems will direct the importance of stability for the separate component but also the regulatory issues with the materials that are in close contact with the regenerative organs of a woman. The chromatic indicator and the oxidation material are both reactive only in aqueous solution. Therefore, they will only begin to react once they have been dissolved in the vaginal discharges and activated by the presence of blood. In order to accelerate and promote dissolution it is preferred to include a surfactant material such as a surfactant, preferably a nonionic surfactant, or polyethylene glycol or a combination thereof. The surfactant must be located so that it is first wetted before the liquid reaches the two components.

PH sensors In addition to or alternatively to the blood sensor a menstruation approximation signal in the form of a pH change of the vaginal discharge can be detected and used to provide a desired signal. PH electrodes or chromatic pH indicators are well known and have been used for the detection of vaginal infections or at least as indications of the occurrence of changes in the vaginal flora that imply some health concern. According to the present invention, and under the assumption of a healthy vaginal flora, a change in vaginal pH is also indicative of a time close to the onset of menstruation. Therefore any commercially available pH indicator composition which is indicative of the increase related to menstruation in the pH at values between pH 4 and pH 7 can be used in the present invention. Said pH sensors are subjected to a color change due to a change in pH in the range of between pH 4 and pH 7 and are commercially available for example from The Merck Company, Darmstadt, Germany. A highly preferred pH sensor, which has a very established safe profile in this context, is carminic acid, which is used as a food dye, but undergoes a color change in the range between pH 4 and pH 7. The acid Carmine is a tricyclic compound which has the formula of compound C22-H20-O13.

Hormone sensors In addition to or alternatively, the presence of certain hormones, especially progesterone or estrogen can be used as tracers in vaginal discharges to provide the prediction of time until the onset of menstruation. The cyclical nature of the hormones of the menstrual cycle (ie the total cycle of 28 days) makes them particularly useful for understanding the position of an individual during his cycle. This has historically been used in the determination of fertility, but the use according to the present invention goes beyond the current uses of hormones to predict ovulation and pregnancy. For example, progesterone goes up and then falls just before menstruation. Estrogen also declines just before menstruation. Therefore, in combination with other predictive means, such as blood detection or pH indication, the determination or assay for either of these two hormones will allow reliable prediction of the onset of the presence of menstruation. The measurement of the peak time or maximum value of these hormones, together with their subsequent fall, allows a highly accurate warning of the time before menstruation. The only potential disadvantage of such hormone sensors is the associated cost and complexity due to the lack of simple and inexpensive display systems. This makes its use especially for highly attractive medical purposes. Therefore, the use of hormone detection in order to predict menstruation is preferably provided in conjunction with blood detection and / or pH detection to improve the accuracy of such predictions. Such systems are particularly useful in the context of a medical scheme to serve an individual who has health-related problems in relation to the onset of menstruation. Such combined systems are discussed in more detail below but may be provided as partially integral with the absorbent sanitary napkin, panty-protector or interlabial article / insert according to the present invention or even as a completely separate system. The use of hormones can also be developed for other points of interest in the cycle. The follicle stimulation hormone (FSH) exhibits a maximum value approximately one week before ovulation, giving greater advance of the control of time to plan pregnancy than the trials for luteinizing hormone, which exhibits a pronounced maximum value at the time of ovulation They may be missing two to three days of fertility when they stick to the luteinizing hormone test alone. Thus, in a diagnosis for ovulation here, it is highly preferable to measure both the follicle stimulating hormone and the luteinizing hormone along with the estrogen. An elevation in the follicle stimulating hormone to an almost constant amount signals the proximity of the menopause. This may be of use in health planning near menopause, such as hormone replacement therapy, nutritional changes, and osteoporosis screenings.

Additional sensors The sanitary article according to the present invention can be provided with several additional sensors and detector systems which allow for example indications or predictions of problems related to the health of the individuals. Said additional sensor systems are principal useful for items that are used in a situation by the caregiver. In general, said additional systems or biosensors comprise a recognition element or a molecular recognition element, which provides detection for a particular analyte. The recognition element can be a biologically derived material such as an enzyme or enzyme sequence; an antibody; a membrane receptor protein; DNA; an organelle, a natural or synthetic cell membrane; a cell of bacteria, plant or animal intact or partially viable or non-viable; or a piece of plant or mammal tissue, and generally functions to interact specifically with the target analyte. The recognition element is responsible for the selective recognition of the analyte and creates a physical-chemical signal that provides the basis for the output signal. Biosensors may include biocatalytic biosensors, and bioaffinity biosensors. In the biocatalytic biosensor modalities, the biological recognition element is "biocatalytic" and may comprise an enzyme, organelle, 10 part of plant tissue or mammal, or all cell sites selective linkage "move" (i.e., can be used again during the detection process), resulting in a significant amplification of the input signal. Biocatalytic sensors such as these are useful for continuous real-time perception. 15 Bioaffinity sensors are generally applicable to bacteria, viruses, and toxins and include biosensors based on chemoreceptors and / or immunological sensors (ie immunosensors). Chemoreceptors are complex biomolecular macro-assemblies responsible, in part, for the body's viable ability to perceive chemicals in its environment with high selectivity. The 20 biosensors based on chemoreceptors comprise one or more natural or synthetic quimoreceptors associated with a means to provide a signal (visual, electrical, etc.) of the presence or concentration of a biological target analyte. Chemoreceptors may include bundles of total or partial nerves (eg, from an antenna or other sensory organs) and / or natural or synthetic total cell membranes 25 or partial. On the other hand, in the elements of biological recognition of the immunosensors are generally antibodies. Antibodies are highly - "-" M ^ a - * "-" - - specific and they can be directed to bacteria, viruses, microorganisms fragments (for example, bacterial cell walls, parasite eggs or portions thereof, etc.), and major biomolecules. Suitable antibodies can be monoclonal or polyclonal. In any case, bioaffinity biosensors are generally irreversible because the biosensor receptor sites become saturated when they are exposed to the target biological analyte. In certain modalities, the biocatalytic and bioaffinity biosensors can be combined. The biocatalytic and bioaffinity biosensor systems are described in more detail in the Journal of Chromatoaraphv, 510 (1990) 347-354 and in Kirk-Othmer Encvclopedia of 10 Chemical Technoloav. 4, ed. (1992), John Wiley & Sons, NY. The biosensors of the present invention preferably also detect biologically active analytes related to the states of the impending human systemic disease (i.e., probable future presentation of symptoms) or current, including pathogenic bacteria, parasites, viruses, fungi such as Candida. 15 Albicans, pathogen antibodies and / or microbiologically produced toxins. Additionally, the biosensor can target biologically active analytes related to imminent or current localized health problems, such as stress proteins (eg, cytokines) and IL-1 a (interleukin 1 -alpha) that can precede the clinical presentation of irritation or inflammation of the skin. In the 20 preferred embodiments, the biosensor functions as a proactive sensor, detecting and indicating the subject or person seeking care of an imminent condition prior to the presentation of clinical symptoms. This gives time to the administrator of the prophylactic or therapeutic treatments to the subject which can reduce significantly, but avoid the severity and duration of the symptoms. In addition, the biosensor by detecting the presence of a biological target analyte in the body waste of the subject, it can detect residual contamination on a surface, such as the skin, in contact with the biosensor, and provide the proper signal. The signal generated by the biological recognition element or elements is visually communicated to the user or to the person seeking care, for example through a change of color visible to the human eye. The signal may be qualitative (for example, indicating the presence of the biological target analyte) or quantitative (ie, a measurement of the quantity or concentration of the target biological analyte). In any case, the signal is preferably durable, that is, stable and readable for a duration of time (typically at least the same amount as the period of use of the article). In addition, the sensor can be adapted to detect and / or indicate only the biological target analyte concentrations above or below a predefined threshold level (for example, in cases where the target biological analyte is normally present in the body waste). . As described above, the target analyte that the biosensors of the present invention are adapted to detect is pathogenic microorganisms such as the pathogenic microorganisms involved in gastrointestinal diseases in humans especially those that result in diarrhea. It has been found that severe chronic diarrhea can result in weight loss and in the retardation of permanent physical and mental development. A non-limiting list of pathogenic bacteria that the biosensor can detect includes any of the various pathogenic strains of Escherichia coli (commonly known as E. Coli); Salmonella strains, including S. typhi, S. paratyphi, S. enteriditis, S. Typhimurium, and S. heidelberg; strains of Shigella such as Shigella sonnei, Shigella flexneri, Shigella boydii, and Shigella dysenteriae; Cholera vibrio; Mycobacteria tuberculosis; Yersinia enterocolitica; Aeromonas hydrophila; Plesiomonas shigelloides Campylobacter strains such as C. jejuni and C. coli; Bacteroides fragilis; and Clostridia strains, including C. septicum, C. perfringens, C. botulinum, and C. difficile. A non-limiting example of a commercially available biosensor adapted to detect E. coli is available from AndCareJnc. of Durha, NC, as test case # 4001. ABTECH, Scientific, Inc., of Yardley, PA offers "bioanalytical biotransducers", available as BB Au-1050.5-FD-X, which can be made biospecific (for microorganisms or other target biological analytes as described here) by immobilizing covalently polypeptides, enzymes, antibodies, or DNA fragments to their surfaces. Other suitable microbial biosensors are described in U.S. Patent Nos. 5,869,272 (negative gram organisms); 5,795,717 (Shigella); 5,830,341; 5,795,453; 5,354,661; 10 5,783,399; 5,840,488; 5,827,651; 5,723,330; and 5,496,700. Target analytes that the biosensors of the present invention are adapted to detect can also be viruses. These may include viruses that induce diarrhea such as rotavirus, and other viruses such as rhinovirus and human immunodeficiency virus (HIV). An illustrative biosensor adapted to detect HIV is described in U.S. Patent Nos. 5,830,341 and 5,795,453, referenced above. In alternative embodiments, the target analytes that the biosensors of the present invention are adapted to detect may also be parasites, especially those that inhabit the gastrointestinal tract during some point in their life cycle. These parasites can include protozoa, worms, and other gastrointestinal parasites. Other examples of parasites that can be detected include entamoeba histolytica (which causes amoebic dysentery), trypana cruzi (which causes Chagas disease), and plasmodium falciparum. In still other modalities, the target analytes that the biosensors ofThe present invention is adapted to detect fungi such as Candida albicans. In addition, pathogen bacteria can be detected and / or measured ^^ tUámáU-miáiti certain beneficial colon bacteria as an indicator of health, such as strains Bifidobacteria and Lactobacillus. The target analytes that the biosensors of the present invention are adapted to detect may also be proteins and antigens related to skin pain. Preferably, these analytes are detectable on or on the surface of the skin, preferably before the presentation of clinically observable skin irritation. These may include proteins in strains such as cytokines, histamine, and other immune response factors including interleukins (such as IL-1 a, II-2, IL-3, IL-4, and IL-8) and interferons (including interferons) ayg). Again, these are preferably detectable by the biosensor before the onset of reddening, irritation or clinically observable dermatitis. Additionally, the biosensors of the present invention may be adapted to detect enzymes, or other biological factors, involved in skin irritation (e.g., diaper rash), including trypsin, chymotrypsin, and lipase. The biosensors of the present invention may also comprise biological recognition systems, including enzymes or binding proteins such as antibodies immobilized on the surface of the physico-chemical transducers. For example, a specific strain of bacteria can be detected through biosensors that use antibodies raised against that bacterial strain. Alternatively, the target bacterium can be detected by a biological recognition element (including antibodies or synthetic or natural molecular receptors) specific for extracellular products of the target bacteria, such as toxins produced by that strain (e.g., E. coli) . Illustrative enzyme electrodes that can be used to detect phenols (e.g., in urine or feces) include tyrosinase-based electrodes or polyphenol oxidase enzyme electrodes described in - U.S. Patent No. 5,676,820 entitled "Remote Electrochemical Sensor" issued to Joseph Wang et al. on October 14, 1997 and U.S. Patent No. 5,091,299 entitled "An Enzyme Electrode for Use in organic solvents ", issued to Anthony PF Tumer et al. On February 25, 1992, respectively. In any of the above examples, the specific microorganism can be directly detected or can be detected by ligating a toxin, enzyme or other protein produced by the organism or an antibody, such as a monoclonal antibody, specific to the organism. Exemplary biosensors adapted to detect proteolytic enzymes are described in U.S. Patent No. 5,607,567, and the toxins in U.S. Patent Nos. 5,496,452; 5,521, 101; and 5,567,301. The biosensor of the present invention may comprise one or more "proactive sensors". This is especially useful in modalities where the detection of the biologically reactive target analyte precedes the onset of clinically observable health symptoms. As used in this application, the term "proactive sensor" refers to a sensor that is capable of detecting changes or signals in the individual's body (ie, the skin) or in waste, ie, inputs, which directly related or, to a minimum, correlate with the occurrence of an event related to health or imminent or potential skin. Proactive sensors can respond to one or more specific inputs as described above. A proactive sensor can detect an impending event or detect a parameter that is directly related, or at a minimum it correlates with the occurrence of an imminent event, particularly an event or systemic or skin health condition (ie, presentation of clinically observable indications or symptoms). An imminent event that can be detected or predicted by a proactive sensor of the present invention may include diarrhea disease, irritation or skin rash (including candidiasis), and / or other types of ills or medical conditions of the subject such as an infestation of parasites. The biological analyte detected may be one or more steps that are removed from the actual presentation of clinical symptoms. For example, the biosensor can detect potential precursors of the above conditions (eg, faecal contamination of the skin which may precede the production of proteins which may, however, precede clinically observable skin irritation). A parameter that correlates with an event is any signal, measurable input, such as one or more of the potential entries listed above, which are correlated 10 with the occurrence of the event within the frame of reference of the system (ie, a signal caused by waste or by the subject). Proactive sensors in an article can measure one or more different inputs in order to predict an event. For example, the proactive sensor can monitor Candida albicans in vaginal discharges and residual colon bacteria on the skin (ie, detect the 15 residual contamination) both of which are signs that can precede skin irritation. In biosensor embodiments wherein the biological recognition element does not produce an easily visible signal (eg, a color change), the biosensor may include a transducer in communication with the element of the biosensor. 20 biological recognition in order to convert the physical-chemical signal from the biological recognition element into a usable signal for the subject, the person seeking care, or the component of the article (for example, an actuator). Illustrative transducers may include electrochemical transducers (including potentiometric, amperometric, and conductometric transducers), transducers 25 optics (including fluorescence, bioluminescence, total internal reflection resonance, and surface plasmon resonance), thermal transducers, and acoustic transducers, ~ - *** aa¡? * ta > ~ ^ ** v - l l ._. . as are known in the art. A power source, such as a miniature 3-volt clock battery or a thin-film printed lithium battery, can be connected to the sensor 60 to provide any required power.

Combination of sensors In a particularly preferred embodiment of the present invention, the article comprises, in addition to a sensor, another separately activated sensor that works independently to detect the proximity of menstruation. For example, it is clear that blood screening in particular allows the prediction of menstruation that can not be considered to be one hundred percent accurate.

First of all, the indicator itself needs to be provided with a high degree of accuracy to detect only blood, that is, it must be insensitive to other materials to which it is exposed. On the other hand, the sensitivity must be high to allow the detection of low amounts of blood, that is, before its visual recognition. These two competing interests need to be balanced. In addition, the presence of blood is well known as an indication of the proximity of menstruation. However, also pathological situations or injuries can cause the presence of low blood levels in vaginal discharges. It is therefore desirable to provide the sanitary napkin with an additional sensor selected from pH sensors or hormone progesterone and / or estrogen sensors that provide a second signal independent of the proximity of menstruation. Then, it is of course necessary to use the resulting signal in combination to identify the time delay until the start of menstruation. For example, if additional sensors are provided as color change indicators they can be provided separately, for example in a different region of the article (of course, so that they will be exposed to vaginal discharges). Alternatively these can be provided together with a color indicator that provides a multiple color indication as explained in an example below. For example, in the context of guayacan gum, which provides a color change to blue and a pH sensor that provides for example a color change to red, the mixed color sensor (blue and red) would need to change to purple in order to provide an indication with a high accuracy of the moment until the start of menstruation. A different color change (such as only blue or only red) would indicate that the menstruation is still somewhat farther from the period or that there is a potential for a health problem (a pH change can only be indicative, but it does not have to be, of infections, while the indication of blood can only, but does not have to, indicate a wound). Of course the absence of color change would indicate that there is still time until the next menstruation. Preferably said sensors are provided separately close to each other so that the two color indications are indicative of the proximity of the menstruation and a simple color change is indicative as explained above.

Examples A pantiprotector with a blood indicator is provided and provides a consistent indication of the proximity of menstruation more than 4 hours in advance in different women. The pantiprotector was a conventional pantiprotector with an upper sheet and a secondary upper sheet layer between the upper sheet and the core, a core layer and a polyethylene film as the backsheet. The blood indicator comprised two components, a first component being a composition of 0.2 g of polyethylene glycol as the carrier and the surfactant component with 0.04 g of hepta-phthalimido-peroxy-hexanoic acid. He - J ^. second component was a composition of 0.2 g of polyethylene glycol as a carrier and the surfactant component with 0.02 gr of guayacan gum. The first component was spread on a strip 20 mm wide and 130 mm long on the surface that gives the garment of the secondary top sheet layer. The second component was spread on a strip 20 mm wide and 130 mm long on the surface that gives the garment of the absorbent core. Alternatively, a commercially available blood screening strip was inserted into a pantyhose as illustrated above between the topsheet and the backsheet also having acceptable results. Said strips are available for example as Chroma 6 ™ from the company Menarini, Florence, Italy, Arkray Aution Sticks ™, by KDK Corporation of Kyoto, Japan. In another alternative, a pH indicator strip used in the same manner as the blood indicator strip was used, again with acceptable results. Said pH indicator strips are available as Spezial Indikator, code 109542, from the Merck Company mentioned above.

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Claims (8)

1. The use of a pH sensor, a blood sensor, a progesterone hormone sensor, an estrogen hormone sensor or combinations thereof, in the manufacture of a sanitary napkin or pantiliner or interlabial article / insert for conventional use for a woman, said use of the sensor being for the purpose of providing an anticipated visual indication of at least 3 hours until the start of menstruation.

2. The use according to claim 1, wherein the sensor provides an advance indication of at least 24 hours.

3. The use according to claim 1, wherein the sensor provides a visual indication of the approximate time until the onset of menstruation whose time is consistent within the range of +/- hours for a specific individual over at least 3 cycles consecutive menstruation.

4. The use according to any of the preceding claims, wherein the sensor comprises a blood sensor and wherein the blood sensor is selected from: - Guaiacum gum with a peroxide and optionally cyclodextrin - Goma de guayacán with , ephta-phthalimido-peroxy-hexanoic acid-Tetra methyl benzidine with a peroxide and optionally cyclodextrin-Tetra methyl benzidine with ephthaphthalimido-peroxy-hexanoic acid or combinations thereof.

5. The use according to any of the preceding claims, wherein the sensor comprises a pH sensor and wherein the pH sensor is selected to undergo a color change due to a change in pH in the range of between pH 4 and pH 7, preferably the pH sensor is provided by a composition comprising carminic acid.

6. The use according to any of the preceding claims, wherein the sensor is provided by means of a combination of at least 5 2 separate sensors selected from pH sensors, blood sensors, progesterone hormone sensors, or estrogen hormone sensors. The use according to claim 6, wherein both sensors provide a separately detectable signal. The use according to any of the preceding claims 10, wherein the sensor comprises a blood indicator and in addition a surfactant material, preferably a polyethylene glycol. jtw-J-MiflttMhJ ».-,« ^ a. ' i? IM T. . . .., «« »« - «..