MXPA01010949A - Feminine sanitary disposable article having a blood detection means as sensor. - Google Patents

Abstract

The present invention relates to feminine sanitary disposable absorbent articles and, more particularly, to sanitary napkins or panty liners comprising a blood detection means for menstruation prediction by having sensors which have a recognition element to detect the presence of blood indicative of the approach of menstruation and which provide a visual signal indicating the approach of menstruation.

Description

FEMALE SANITARY DISPOSABLE ITEM THAT HAS A BLOOD DETECTION MEDIUM AS A SENSOR FIELD OF THE INVENTION The present invention relates to disposable feminine sanitary absorbent articles and, more particularly, to sanitary or panty-protective pads comprising a blood detecting means for predicting menstruation having sensors having a recognition element to sense the presence of blood indicative of the proximity of menstruation and which provides a visual signal that indicates the proximity of menstruation.

BACKGROUND OF THE INVENTION Today, disposable items, such as diapers, adult incontinence trusses, sanitary napkins, pantiliners, interlabial devices and tampons, are widely used in women's protection, baby and toddler care, and adult care. incontinent as a means of containing, isolating and eliminating bodily waste. 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 dispossession or dispossession of the user. However, none of these detect or predict in a specific way l «* tAAá ^ á. a ii when a discharge event related to menstruation is about to occur and signal that occurrence to the user or caregiver. The need of the consuming woman so far 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.

US Pat. No. 5,468,236 to Everhart et al., published November 21, 1995 discloses an absorbent disposable product incorporating a chemically reactive substance which provides the 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 topsheet or absorbent core. In a second example, the chemical compound that will be detected in a nitrate as an indicator of infections in the urinary tract by means of the GRAM negative 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-diagnosis system for vaginal yeast-related or unleavened infections in the form of a catamenial or pantilprotector 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 yeast infection or without yeast. International publication WO 97/43955 to 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 absorbent pad It is an interlabial or in a pad that is placed inside an opening with an opening which is placed in an interval to collect the fluid. The fluid can then be used for diagnostic purposes as desired. The European patent EP 704 195 of Echeveria, published on April 3, 1996 discloses a menstrual detector comprising a sanitary napkin or a pantlprotector including a chemical compound that provides a cooling reaction upon the occurrence of liquid absorption as an indicator of the onset of the 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 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, International Publication WO 90/06511 to Buck et al., Published June 14, 1990 discloses a stabilized indicator for determining 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 of Oksman et al., Published on November 7, 1984, related to wiper 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, especially in fecal occult blood. ttttut ?? * - * K¡A * í ?? t afcftt i. * -. ±? ,. > ,, -,, i, < * "" And? Í., 1 i t. ^ 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 relates to sanitary absorbent articles for women which provide a visual detection of blood of a quantity of blood in the vaginal discharges deposited on the article which are not distinguishable by the normal visual inspection by means of the human eye. The article is conventionally of a layered construction, each layer having a surface that gives the user and one to 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 article is preferably a sanitary napkin or a pantyhose, especially a thin pantyhose with less than 3mm thickness and a pantyhose which is suitable to be worn on an inner garment of cord and having a shape Mtu ^ generally triangular (also referred to as belt form or belt lining respectively). According to the present invention the article comprises a blood detection means comprising a chemical composition of at least one first component selected from peroxide or a per-acid or combinations thereof, and a second component selected from of guayacan gum or tetramethyl benzidine or combinations thereof. The composition preferably further comprises a surfactant material such as surfactant or preferably a polyethylene glycol. In a preferred embodiment according to the present invention, the first component is hepta-phthalimido-peroxy-hexanoic acid and the second component is guayacan gum. The first and second components are preferably separated in the absorbent article, more preferably one component is provided on the garment surface of one layer and the other component is provided on the garment surface of a second layer. or a component is provided on the surface that gives the garment a layer, preferably the core and the other component is provided on the surface that gives the learn of the same layer. When the composition is applied to the article, it is preferred to provide it in a liquid form, more preferably as a solution in an organic carrier which can evaporate after the composition has been applied. The application can be made by coating or preferably by sprinkling. It is within the scope of the present invention to provide the blood detector with additional detectors related to menstruation such as additional means of biochemical or electrochemical or chemical detection suitable for detecting physiological changes in the absorbed vaginal discharges which are indicative of the proximity of the menstruation and preferably create a separate visual signal, animated or modified to the user of said articles. Preferably said additional detection means comprises a pH indicator or an indicator of hormone progesterone or estrogen hormone or combinations thereof.

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 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 one element is indirectly secured to the other element by fixing the element to a member or intermediate members who, on the other hand, 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 of an absorbent article of the present invention is a unitary disposable sanitary napkin or pantyhose or interlabial absorbent article, however also disposable incontinence briefs, underwear for incontinence, t i *? * i > , L ~ - absorbent inserts and buffers, can benefit from the present invention are used during the period before menstruation. The absorbent article, according to the present invention is conventionally constructed of three main elements: the upper sheet, which gives the user of the article during use and which is permeable to the liquid in order to prevent liquids from passing into 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. How is it used ÍO.? to here, the term "flexible" refers to materials that are docile and that will easily conform to the figure and general outline 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 means that predict menstruation which are within the article to allow visual inspection if a color change has occurred. 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 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 thin plastic film 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 thermoplastic films of polyethylene or polypropylene, or composite materials such as a nonwoven material coated with film or a film coated with fiber. Conventionally, the absorbent articles comprise a backsheet of a polyethylene film having a thickness of about 0.012 mm to about 0.051 mm, which may 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 t ~ tk & < fc. £. However, without sacrificing its main purpose of providing protection to leaks for absorbed liquids. The backsheet may also comprise more than one breathable layer to replace a single breathable backsheet layer by at least two or three layers of a different or the same 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 nonwoven composite material 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 tinted color filler, preferably yellow or light blue.

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. to. 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 £ a a Á < * ». * - £. ii final distribution to the storage layer. This transfer of fluid through the primary distribution layer runs mainly in thickness, but may also provide distribution along the longitudinal and transverse directions of the belt lining. b. Optional secondary fluid distribution layer Also optional in accordance with the present invention is a secondary fluid distribution layer. 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. o Fluid storage layer Located in fluid communication with, and typically being below, the primary or secondary distribution layers, is a fluid storage layer. It preferably, but not necessarily, comprises superabsorbent gelling materials commonly referred to as "hydrogel" materials, "superabsorbent", "hydrocolloid". The gelling absorbent materials are those materials which, when in contact with 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 J, tf * * • * - - - gelation are typically in a granular form of non-fibrous, discrete particles. However, according to the present invention, these gelling superabsorbents 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 may 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 10 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 of cellulose acetate, polyvinyl fluoride, polyvinylidene chloride, acrylics (such as orlon), polyvinyl acetate, polyvinyl alcohol not Soluble, 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. 20 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 can also include 25 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 can 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 homogeneously 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. 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 . In addition, the storage layer may comprise from 5% to 95% of carrier fibers, preferably from 95% to 50%, most 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 include acrylic acid, methacrylic acid, and 2-acrylamido-2-methyl propan acid.

J ^^ at ^^^ jÍ ^ jíg¿ sulfonic. The acrylic acid itself is especially preferred for the preparation of the superabsorbent material, it also has a "natural" transparency which is not optimal but acceptable if it is desired that the transparency is not so high. Whatever the nature of the basic components of the polymer of hydrogel-forming polymeric absorbent polymer materials, such materials will generally be slightly crosslinked. Cross-linking serves to make the gelling materials hydrogel-forming polymers substantially insoluble in water, and the crosslinking in this manner in part determine the gel volume and the extractable characteristics of the polymer of the hydrogellets formed from these polymeric gelling materials. Suitable crosslinking agents are well 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. Crosslinking agents preferred are di or polyesters of mono- or polycarboxylic unsaturated acids with polyols, bis-acrylamides and di-trialll amines. Other preferred crosslinking agents are N, N'-methylenebisacrylamide, trimethylol propane triacrylate 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 polymer gel forming materials are generally employed in their partially neutralized form. For the purposes of the present invention, said partially neutralized materials are considered when at least 25 mole percent, and preferably at least 50 mole percent of the monomers used to form the polymer are monomers containing the acid group that have been neutralized with a eiÁ-i salt forming cation. Suitable salt-forming cations include alkali metal, ammonium, substituted ammonium and amines. This percentage of the total monomers used which are monomers containing the neutralized acid group is referred to herein as the "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 particulate gelling absorbent material 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 make the agent The crosslinking reacts with the particulate gelling absorbent material to form a porous, composite absorbent macrostructure. Such absorbent, porous macrostructures 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 according to the present invention 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. | ^ i ^ ^^ to ^^^^ ^ -1 ^^^^ - or ktA e. Other optional components The absorbent cores according to the present invention may 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. 1. J Í. i .. -L > ~ di »Jl ^ ^^ JH» .-, «-fe ,,.

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. The absorbent cores should preferably be thin. A thickness less than 5 mm, preferably less than 3 mm and even more preferably between 0.8 and 1.8 mm, is desirable so that the resulting articles 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. Non-limiting examples of pantiliners and sanitary napkins that can be provided with a detection means include those manufactured by The Procter & amp;; Gamble Company of Cincinnati, Ohio as: ALWAYS® Pantiprotectors ALLDAYS® with DriWeave® manufactured in accordance with U.S. Patent Nos. 4,324,246; 4,463,045 and 6,004,893; ALWAYS® Ultrathin Slender Wired Maxi manufactured with US 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 Maxl with wings; ALWAYS® Maxi with wings; ALWAYS® Long Super Maxi with wings; and ALWAYS® Overnight Maxi with wings. 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. l -., - t¿, .t. », ^^» * j 4 ^^ - J¡ ^ ¡& The non-limiting examples of buffers that can be provided with a detection means and applicators therefor are described in U.S. Patent Nos. 4,726,805; 4,846,802; 4,960,417; 5,087,239; 5,279,541; 5,346,468; 5,348,534; 5,531, 674 and 5,566,435. In addition, the detection means can also be placed on a digitally insertable buffer.

Blood Detector The article according to the present invention also includes at least one sensor for blood detection. 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.

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 term "reactive" is defined as having the ability to selectively interact with the target substances. There are two categories of sensors that have different sensitivity: the biosensors and the 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 vaginal discharge. Electrochemical and chemical sensors, on the other hand, which adhere to chemically reactive media, a? -A. ? t »f A: they generally do not have any high selectivity or amplification properties of the biosensors but they are highly reliable, cheap, ie useful for consumer products, and often very well established, ie they prove to be safe to be used on human skin Frequently the target analyte is a minor component of a complex mixture comprising a multiplicity of biological components and other components. Therefore, in many applications of the biosensor, the detection of target analytes to parts per million, parts per billion, or even lower levels is necessary. According to the present invention, an absorbent sanitary article comprises a blood detection means in the form of a specifically selected chemical composition. The chemical composition comprises a color indicator component selected from guayacan gum or tetra methyl benzidine or combinations thereof, which reacts when oxidized and an oxidation component selected from peroxide or a per acid or combinations of the same. The oxidation component needs to be stable and insensitive to common storage conditions for such items (e.g., in a hot and high humidity environment of a bathroom). 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 said 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 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 the surface that gives the user of one layer and the other component on the surface that gives the user of the other layer or the same on the surface that gives the garment respectively. 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 detector components 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. tampons or interlabial articles). 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. i / ¡. .. 3 i-í ,. . TO. t 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. A highly preferred composition comprises ephthaphthalimido-peroxy-hexanoic acid and guayacan gum. Guaiacum gum is a resin found from the wood of Guaiacum officinale or Guaiacum santum (mainly found in Mexico or western India). Guaiacum gum is historically used as a flavoring agent for food (and therefore has a remote record of safe use by humans) and is known for its ability to indicate the presence of blood or hemoglobin, especially in feces. According to the present invention, the guaiac tree gum resin is preferred, however one or all of the active components, if they are naturally or artificially derived, can be used in place of the wood resin. The best known active components are guaiacol (OHC6H4OCH3, CAS 90-05-1), guayaconic acid and (furo) -guayacin. The components can be applied by means of coating or spraying whenever they are applied in solution. The solvent in this case can be either water or an organic solvent. If it is desired to remove the solvent then said solvent, especially if it contains water, must evaporate at temperatures below 100 ° C.

^ J | j ^ ^^ ^^ * í ^ fc ^^^ j &A £, additional detectors ^^ In a particularly preferred embodiment of the present invention the article further comprises another detector blood sensor operates separately activated and independently to detect the approximation of menstruation. It is clear that the detection of blood in particular to allow the prediction of menstruation 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 only detect blood, ie it must be insensitive to other materials 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 (hidden) blood is well known as an indication of the approach of menstruation. However, injuries or pathological situations can also cause the presence of low blood levels in vaginal discharges. Therefore it is desirable to provide the sanitary napkin with an additional indicator that provides a second signal of the approach of menstruation. Said signal can be provided, for example, by changing the pH of the vaginal discharge within the days before the menstruation. In addition to or alternatively, hormones such as progesterone or estrogen may be used as additional indicators for predicting menstruation. Very preferred in this context are the pH sensors which can also be provided as indicators of color change. The pH sensors are well known and are commercially available for example from The Merck Company, Darmstadt, Germany. A highly preferred pH sensor, which has a well-established safe profile in this context, is carminic acid, which is used as a food dye, but undergoes a color change in the range of between pH 4 and pH ^ - ^ ^ 7. Carminic acid is a tricyclic compound which has the formula of compound C22-H20-O13. Ignoring which additional sensors are used if these are provided as color change indicators these may preferably be provided separately, for example in a different region of the article (of course, such that they will be exposed to the discharges). vaginal). Alternatively, these may be provided in conjunction with a color indicator that provides blood detection. In this way the color indicator can be used to provide a multiple color indication. 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 high accuracy and close time of the approach of menstruation. A different color change (such as only blue or only red) would indicate that either menstruation is still a little away from the period or that the potential for a health problem exists (a single pH change may be indicative, but it does not have to , of infections, while only the indication of blood can, but does not have to, indicate a wound). For such changes the packaging of the sanitary articles may include instruction to the user to consider visiting a physician to medically evaluate if there is any serious health problem (pathological situation). Of course the absence of a color change would indicate that there is still time until the next menstruation. In addition to the electrochemical sensors, to complement or assist the blood detector, the cyclic nature of the hormones of the menstrual cycle (ie, the total cycle of 28 days) makes them particularly useful to understand, the position of an individual during its cycle . This has historically been used in determining the Wé & vi zí * &? «& 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. The lack of simple visualization makes its use not very attractive in mass-produced articles. Thus the use of hormone detection in order to predict menstruation is preferably provided in combination with blood detection and / or pH detection to improve the accuracy of such predictions in the form of a completely separate detection 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. Therefore, 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 approach of menopause. This can be of use in the ¿T. «Ixj, j. »J: ^. ,; t, »; B-tai, »»,,. . -. ... '• - • ^ S ^ u ^ planning to close to menopause health, such as hormone replacement therapy, nutritional changes and checkups for osteoporosis?. 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 main useful for sanitary articles that are used in a situation by the person seeking the care. 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 usually works 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, piece of plant or mammal tissue, or all of cells, the selective binding sites "carry" (ie, they 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.

Bioaffinity sensors are generally applicable to bacteria, viruses, and toxins and include biosensors based quimoreceptores 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. Quimoreceptores based biosensors comprise one or more natural or synthetic quimoreceptores associated with means for providing a (visual, electrical, etc.) signal the presence or concentration of a biological target analyte. The quimoreceptores may include full or partial bundles nerves (for example, from an antenna or other sensory organs) and / or cell membranes natural or synthetic total or partial. On the other hand, in the elements of biological recognition of the immunosensors are generally antibodies. The antibodies are highly specific and can be directed to bacteria, viruses, fragments of microorganisms (for example, bacterial cell walls, parasite eggs or portions thereof, etc.), and larger 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 Journal of Chromatoqraphy. 510 (1990) 347-354 and in Kirk-Othmer Encvclopedia of 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. t.J j. ». «**« £? , -jk-lé? fcaa. j ^^? gA ^ Albicans, antibodies of pathogens 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 may precede the clinical presentation of irritation or inflammation of the skin. In 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 subject's body waste can detect residual contamination on a surface, such as the skin, in contact with the biosensor, and provide the appropriate 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 analogue) or quantitative (that is, 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). . lú? .i .. ^ ... á-a ».-. ^ ^ ¿« ^^^ faith «. ^. 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 the pathogenic bacteria that the biosensor can detect includes any of the various pathogenic strains of Escherichia co / (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; strains of Campylobacter such as C. jejuni and C. colr ', Bacteroides fragilis; and Clostridia strains, including C. septicum, C. períringens, C. botulinum, and C. difficile. A non-limiting example of a commercially available biosensor adapted to detect E. coli is available from AndCare.Inc. of Durha, NC, as test case # 4001. ABTECH, Scientific, Inc., of Yardley, PA offers "bioanalytical blot transducers", available as BB Au-1050.5-FD-X, which can be made bloospecific (for microorganisms or other biological target analytes as described herein) by immobilizing in a manner covalent 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; 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 rhinoviruses and human viruses. immunodeficiency (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 embodiments, the target analytes that the biosensors of the present invention are adapted to detect may be fungi such as Candida albicans. In addition, to the pathogen bacteria, certain beneficial colon bacteria can be detected and / or measured as an indicator of health, such as the Bifidobacteria and Lactobacillus strains. 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, They are involved in skin irritation (eg, 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 to extracellular products of the target bacterium, 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 "Electrochemical sensor. remote "issued to Joseph Wang and others on October 14, 1997 and in the United States Patent No. 5,091, 299 entitled "An enzyme electrode for use in organic solvents", issued to Anthony P.F. 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 toxins in U.S. Patent Nos. 5,496,452; 5,521, 101; and 5,567,301. ta,:? i «-.!.» «» fc aigi ...

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 body of the individual (ie, the skin) or in waste, ie, entries, which are directly related or, to a minimum, they 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 imminent event or detect a parameter that is directly related, or at a minimum correlates with the occurrence of an imminent event, particularly a systemic event or conon or skin health (ie, the presentation of clinically observable indications or symptoms). An impending 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 diseases 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 (for example, faecal contamination of the skin that 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, that correlate with the occurrence of the event within the system's reference frame (ie, a signal caused by the waste or by the subject). Proactive sensors in an article can measure one or more different inputs in order to predict an event. By ^^ ta ^^^^ K ^ t ^ * ^ example, the proactive sensor can monitor Candida albicans in the downloads * vaginal and in residual bacteria of the colon on the skin (ie, detect residual contamination) both of which are signs that can precede skin irritation. In biosensor modalities where 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 biological recognition element in order to convert the physical signal chemistry from the biological recognition element in a signal usable for the subject, the person seeking the care, or the component of the article (for example, an actuator). Illustrative transducers may include electrochemical transducers (including potentiometric, amperometric, and conductometric transducers), optical transducers (including fluorescence, bioluminescence, total internal reflection resonance, and surface plasmon resonance), thermal transducers, and acoustic transducers, as are known in the technique. 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.

Examples As an example a pantiprotector with a blood indicator and the Indication provided with the approximation of menstruation in different women was provided. The pantiprotector was a conventional pantiliner with an upper sheet, 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 ephthaphthalimido-peroxy-hexanoic acid. The second component was a composition of 0.2 g of polyethylene glycol as a carrier and the surfactant component with 0.02 g 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.

Claims (8)

1 . Sanitary absorbent article for the visual detection of the blood of a quantity of blood in the vaginal discharges deposited on said article whose blood quantities are not visually discernible, said article is of a layered construction, each layer having a surface that gives the user and a surface that gives the learn and said article comprises: • a liquid-permeable upper sheet on the surface that gives the user of the article, • a back sheet of liquid barrier on the surface that gives the garment of the article; an absorbent core sandwiched between the liquid permeable topsheet and the liquid barrier backsheet, said article further comprises a blood detecting means, the blood detection means being a chemical composition, said composition comprising a first selected component to starting from a peroxide or a per acid or combinations thereof, and a second component selected from guayacan gum or tetra-methyl-benzidine or combinations thereof.

2. Item according to claim 1, characterized in that the composition further comprises a surfactant component as a solvent agent, preferably a polyethylene glycol.

3. Article according to any of the preceding claims, characterized in that the first component is ephta-phthalimido-peroxy-hexanoic acid and the second component is guayacan gum. & «tt < ^^^^^^^^^^^^

4. Article according to any of the preceding claims, characterized in that the first and second components are separated in the absorbent article, preferably one component is provided on the surface that gives the garment a layer and the other component is provided on the surface 5 which gives the garment of a second layer or a component is provided on the surface that gives the user of the core and the other component is provided on the surface that gives the garment of the other layer.

5. Article according to any of the preceding claims, characterized in that the composition is applied to the article in a form Liquid, preferably as a solution in an organic carrier or water, said organic carrier being capable of evaporating at temperatures below 100 ° C after the composition has been applied by means of spraying or coating.

6. Item according to any of the preceding claims, characterized in that the article is a pantiprotector that has a smaller thickness 15 of 3 mm. Item according to claim 6, characterized in that the panty-protector has a generally triangular shape so as to be suitable for being worn on a cord garment. 8. Article according to any of the preceding claims 20, characterized in that the article further comprises additional biochemical or electrochemical or chemical detection means suitable for detecting physiological changes in absorbed vaginal discharges which are indicative of the approach of menstruation , preferably said additional detection means comprise a pH indicator or an indicator of the hormone progesterone or an indicator of the estrogen hormone or combinations thereof.